Category: Health

Release – Ocugen Announces Positive Opinion of EMA’s Committee for Advanced Therapies for ATMP Classification for Novel Modifier Gene Therapy Candidate OCU410 for Geographic Atrophy and OCU410ST for Stargardt Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

March 3, 2025

MALVERN, Pa., March 03, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU410 and OCU410ST Advanced Therapy Medicinal Product (ATMP) classification. OCU410 is a novel, multifunctional modifier gene therapy candidate being developed for the treatment of patients with vision loss due to geographic atrophy (GA)—an advanced stage of dry age-related macular degeneration (dAMD)—and OCU410ST is being developed for Stargardt disease due to ABCA4-related retinopathies.

GA affects 2-3 million people in the United States (U.S.) and Europe combined. There are two approved therapies in the U.S. that require frequent dosing (every month or every other month), however neither therapy has been approved in Europe. Stargardt disease affects 100,000 people in the U.S. and Europe combined, and there are no approved treatments available globally.

“Receiving ATMP classification for OCU410 and OCU410ST is a critical step to potentially address these severely unmet medical needs in the very near future,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Dosing of Phase 2 in the ongoing OCU410 ArMaDa clinical trial is complete, and we are on track to initiate the Phase 3 clinical trial next year to pursue potential Marketing Authorization Application (MAA) and Biologics License Application (BLA) filings in 2028. Last week, the U.S. Food and Drug Administration (FDA) endorsed Ocugen’s plan to move forward with a Phase 2/3 pivotal confirmatory clinical trial for OCU410ST, which can be the basis of BLA and potential MAA submissions in 2027.”

ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential one-time gene therapy for life. Additionally, this classification allows Ocugen to interact with EMA more frequently for scientific advice and protocol assistance.

Preliminary 9-month data of OCU410 in GA patients demonstrated considerably slower lesion growth (44%) from baseline and clinically meaningful 2-line (10-letter) improvement in visual function (LLVA) in treated eyes compared to untreated eyes in the Phase 1 portion of the trial. Furthermore, a single subretinal OCU410 treatment preserves more retinal tissue around GA lesions of treated eyes at 9 months compared to published data on currently available GA therapies.

6-month data from Phase 1 of the OCU410ST GARDian clinical trial demonstrated considerably slower lesion growth (52%) from baseline in treated eyes versus untreated fellow eyes and clinically meaningful 2-line (10-letter) improvement in visual function (BCVA), which is statistically significant (p=0.02) in treated eyes. The Company plans to initiate the Phase 2/3 pivotal confirmatory clinical trial for OCU410ST by mid-2025.

“The novel modifier gene in OCU410 and OCU410ST targets all four pathways linked with dAMD and Stargardt and is delivered through a single subretinal injection as a one-and-done treatment,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “We are very pleased with the structural and functional outcomes demonstrated by both of these candidates, along with a stellar safety profile.”

OCU410 and OCU410ST utilize an adeno-associated virus (AAV) platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in both in vitro and in vivo (animal model) studies.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410 and OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Perfect (PERF) – Positioning for New Revenue Opportunities

Posted on by slightbourne@noblecapitalmarkets.com


Friday, February 28, 2025

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Q4 results. The company reported Q4 revenue of $15.9 million, largely in line with our estimate of $16.2 million and up 12.4%, year-over-year. Adj. EBITDA of $0.25 million was below our estimate of $0.91 million, due primarily to lower-than-expected gross margins. This was likely due to the increased proportion of lower-margin B2C revenue as a share of total revenue.

Total Addressable Market (TAM) expansion. In our view, the company is poised to drive favorable revenue growth through expansion into untapped markets. For example, the emergence of its Skincare AI service allows it to reach new categories of clients. Through the recent Wannaby acquisition, the company also expanded its virtual try-on service offering to include additional fashion categories.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

GoHealth (GOCO) – Delivers a Robust Annual Enrollment Period

Posted on by slightbourne@noblecapitalmarkets.com


Friday, February 28, 2025

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Strong Q4. The company delivered impressive Q4 results driven by strong market dynamics during the Medicare Advantage Annual Enrollment Period (AEP). Quarterly revenue of $389.1 million was 16% stronger than our estimate of $336.0 million, and adj. EBITDA of $117.8 million exceeded our estimate of $80.4 million by 47%.

Improved efficiency. Average agent handle time was down roughly 9% from the prior year period and direct operating cost per policy submission was down 27% to $501. We believe these improvements are attributable to the company’s agent training and technology tool enhancements. Moreover, we believe the company’s focus on increasing productivity per agent could drive additional margin improvement over time.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – MAIA Biotechnology to Initiate Phase 3 Pivotal Trial of THIO Sequenced with Checkpoint Inhibitor Compared with Chemotherapy Treatment in Advanced Non-Small Cell Lung Cancer Patients

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 27, 2025 8:51am EST Download as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant to checkpoint inhibitors and chemotherapy. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients.

“THIO has consistently and substantially outperformed standard treatment options in our THIO-101 Phase 2 trial to date. THIO-104 will give us direct comparative data from a randomized study in patients in third line of treatment,” said Vlad Vitoc, M.D., CEO of MAIA. “We expect that the results from this study will further illuminate THIO’s unmatched benefits for advanced stage NSCLC patients.

“Our initiation of THIO-104 will mark an important milestone along our goal for THIO’s FDA commercial approval,” Dr. Vitoc added.

MAIA expects to begin enrolling patients in THIO-104 in the second half of 2025 in select countries in Asia, Europe and in the U.S.

The primary endpoint of the clinical trial is overall survival for THIO sequenced with a CPI compared to investigator’s choice of chemotherapy in a third line setting. The secondary endpoints include disease control rate, overall response rate, duration of response, progression-free survival and safety.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a third line of treatment for NSCLC for patients that are resistant to checkpoint inhibitors and chemotherapy.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released February 27, 2025

Release – Ocugen, Inc. Announces FDA Alignment on Phase 2/3 Pivotal Confirmatory Clinical Trial for Modifier Gene Therapy Candidate OCU410ST for Stargardt Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

February 27, 2025

PDF Version

MALVERN, Pa., Feb. 27, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that alignment has been reached with the U.S. Food and Drug Administration (FDA) to move forward with a Phase 2/3 pivotal confirmatory clinical trial for OCU410ST which, if positive, can be the basis of a biologics license application (BLA) submission.

The GARDian trial for OCU410ST demonstrated:

  • A favorable safety and tolerability profile with no serious adverse events related to OCU410ST, including no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization and no adverse events of special interest
  • Considerably slower lesion growth (52%) from baseline in treated eyes versus untreated fellow eyes at 6-month follow-up from the Phase 1 study
  • Clinically meaningful 2-line (10-letter) improvement in visual function (BCVA) at 6-month follow-up from the Phase 1 study, which is statistically significant (p=0.02) in treated eyes

“I am very pleased that the FDA has recognized the promise of Ocugen’s modifier gene therapy for Stargardt disease and accelerated the regulatory pathway for OCU410ST,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This new development allows us to initiate a pivotal confirmatory trial for this game-changing, one-time treatment for life in the next few months and prepare for a potential BLA filing by 2027. Now patients suffering from Stargardt disease have a new hope where previously none existed. This achievement furthers our mission to cure blindness diseases.”

Stargardt disease affects 100,000 people in the U.S. and Europe combined, and there is no treatment. OCU410ST received orphan drug designations from the FDA and the European Medicines Agency (EMA) in 2023 and 2024, respectively.

“Getting approval for a Phase 2/3 trial is a pivotal milestone, as this approach has never been explored in clinical trials for Stargardt disease. The FDA’s decision underscores the potential of OCU410ST to meet a critical unmet medical need for the approximately 44,000 Stargardt patients in the U.S.,” said Lejla Vajzovic, MD, FASRS, Director, Duke Surgical Vitreoretinal Fellowship Program, Professor of Ophthalmology, Pediatrics and Biomedical Engineering with Tenure, Adult and Pediatric Vitreoretinal Surgery and Disease, Duke University Eye Center, and Retina Scientific Advisory Board Chair of Ocugen.

The Phase 2/3 clinical trial will randomize 51 subjects, 34 of whom will receive a single, subretinal, 200-μL injection of OCU410ST at a concentration of 1.5 x 1011 vector genomes (vg)/mL in the eye with worse visual acuity, and 17 of whom will serve as untreated controls. The primary endpoint in the clinical trial is change in atrophic lesion size. Secondary endpoints include visual acuity as measured by best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) compared to untreated controls. One-year data will be utilized for the BLA filing.

“This approval pathway, established in collaboration with the FDA, has made it possible to expedite the clinical development of OCU410ST by two to three years and has aided in bringing an innovative gene therapy to patients desperate for a treatment option,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “Recent data from the OCU410ST clinical trial have shown significant improvements in both structural and functional outcomes. Additionally, OCU410ST has consistently demonstrated a very favorable safety and tolerability profile.”

Accelerating the clinical timeline of OCU410ST will save significant costs in addressing disease burden even sooner than anticipated.

About OCU410ST
OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.

About Stargardt Disease
Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Release – MAIA Biotechnology Announces Design for Expansion of THIO-101 Phase 2 Trial in Advanced Non-Small Cell Lung Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 26, 2025 8:47am EST Download as PDF

  • Expansion study to enroll patients in the U.S. and select countries in Europe and Asia
  • Multiple milestones attainable for 2025

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA,” the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the trial design for the expansion of its THIO-101 pivotal Phase 2 trial in non-small cell lung cancer (NSCLC). Following successful outcomes to date in THIO-101, the expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy.

The THIO-101 study in 3L will enroll up to 48 patients with two arms: Arm 1, continuing the evaluation of THIO sequenced with Libtayo® (cemiplimab); and Arm 2, evaluating THIO as a monotherapy, to further gain experience of THIO in the contribution of components. Treatment cycles for patients in both arms will administer THIO on 3 consecutive days, followed by immune activation on day 4. Arm 1 will administer Libtayo on day 5. The Company plans to enroll an additional 100 patients for the registration phase of the trial. MAIA expects to conduct the trials in the U.S. and select countries in Europe and Asia.

MAIA recently announced an amended clinical supply agreement with Regeneron to include the expansion portion of THIO-101. Under terms of the amended agreement, MAIA continues to sponsor THIO-101 and Regeneron will provide Libtayo for the treatment of all patients including the additional patients in the expansion and potentially, the registration studies.

“We are excited to start the expansion arm of our THIO-101 trial which is designed to determine overall response rates in third line NSCLC. We expect to have new patients enrolled in the coming weeks,” said Vlad Vitoc, M.D., CEO of MAIA. “Through THIO-101 to date, THIO has delivered unprecedented disease control, response, and survival results. Continued efficacy and safety data generated by our study could support an FDA NDA submission directly, particularly as we plan to seek an accelerated approval of THIO in the U.S.

“We have multiple milestones that we believe are attainable for 2025 and we look forward to keeping our shareholders and investors well informed of our progress on value creation,” Dr. Vitoc added.

As of January 15, 2025, data indicated that Median Overall Survival (OS) in third-line treatment was reached at 16.9 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months). The treatment has been generally well-tolerated to date in this heavily pre-treated population1.

________________________________
1Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA’s website.
 

About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by cemiplimab (Libtayo) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released February 26, 2025

Release – MAIA Biotechnology Announces Non-Brokered Private Placement of Approximately $1.43 Million

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 24, 2025 4:30pm ESTDownload as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 952,300 shares of common stock at a purchase price of $1.50 per share, in a non-brokered private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.85 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about February 26, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.43 million, prior to offering expenses payable by the Company. The Company closed a private placement of approximately $2.7 million on February 24, 2025 and the aggregate gross proceeds from both private placements are expected to be $4.1 million, prior to deducting offering expenses payable by the Company. The Company intends to use the combined net proceeds received from the two private placements to fund the starting cost for Part C of the Phase 2 THIO -101 clinical trial and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act or applicable state securities laws and do not have registration rights. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities issued in the Private Placement will be “restricted securities” under the U.S. Securities Act.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward-Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; (viii) the completion of the offering and (ix) the satisfaction of customary closing conditions related to the offering, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released February 24, 2025

Release – GeoVax Highlights the Role of MVA-Based Vaccines in Advancing Public Health Preparedness

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 24 February 2025
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Recent Studies Support Diversified Vaccine Strategies, Aligning with GeoVax’s MVA-Based GEO-CM04S1 for Enhanced Protection, Particularly for Immunocompromised Populations

ATLANTA, GA, February 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in immunotherapies and vaccines, today reaffirms the critical role that mRNA vaccines have played in combating the COVID-19 pandemic and highlights the growing recognition of the need for complementary vaccine platforms, particularly for immunocompromised patients and those requiring broader, more durable immunity.

The rapid development and deployment of mRNA vaccines were pivotal in mitigating the initial impact of the pandemic, offering a timely and effective response. However, the scientific literature continues to underscore the importance of a diversified vaccine strategy directed towards enhanced durability and expanded protection against variants for populations that may not mount a sufficiently strong immune response to a single vaccine platform. GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine candidates, such as GEO-CM04S1 (COVID-19), may complement other existing vaccine platforms by addressing specific challenges.

Building a More Resilient Vaccine Landscape

Recent scholarly analyses, including research from leading experts(1) and a strategic review by the Biomedical Advanced Research and Development Authority (BARDA)(2), stress the importance of broadening vaccine portfolios beyond mRNA. These publications highlight areas where alternative vaccine platforms, such as viral-vector and live-attenuated vaccines, may provide advantages in durability, cellular immunity, and accessibility.

GeoVax’s MVA-based vaccines may offer an alternative approach, by utilizing a well-established vaccine vector, particularly in high-risk populations. Unlike current mRNA COVID-19 vaccines, GEO-CM04S1 expresses both the Spike (S) and Nucleocapsid (N) antigens, to elicit a broader immune response. This enhanced immunogenicity may be especially valuable for immunocompromised individuals, including transplant recipients and cancer patients, who often exhibit suboptimal responses to mRNA vaccines.

GeoVax’s MVA-based COVID-19 vaccine can serve as an important addition to the global immunization strategy by offering:

  • Enhanced Immune Response: The inclusion of both Spike and Nucleocapsid antigens in GEO-CM04S1 is intended to elicit a more comprehensive immune response, potentially reducing the need for frequent boosters.
  • Durability and Broader Variant Protection: Studies suggest measures of T-cell responses induced by GEO-CM04S1 elicit protection against emerging variants, minimizing the need for frequent reformulation.
  • Better Suitability for Immunocompromised Populations: Clinical trials demonstrate that GEO-CM04S1 elicits robust T-cell responses in patients unable to generate adequate antibody responses to conventional (spike-only) COVID-19 vaccines. This is critical for individuals with immune systems compromised by disease (eg cancers, genetic defects) or immunosuppressive therapies.
  • Scalability and Global Accessibility: GeoVax is further addressing vaccine availability with plans to transition manufacturing to a Next-Generation MVA manufacturing platform, with the potential for improved production efficiency and reduced costs, facilitating global distribution.

A Proven Technology with a Strong Safety Record

MVA was originally developed as a safer smallpox vaccine. MVA-based vaccines have been safely administered for decades.  MVA’s extensive track record aligns with the U.S. Department of Health and Human Services’ (HHS) emphasis on vaccine safety, durability, and transparency. The well-documented safety and efficacy of MVA-based vaccines positions them as an important complement to existing mRNA-based approaches.

Government and Industry Support for Diversified Vaccine Strategies

Under BARDA’s $5 billion Project NextGen initiative, GeoVax was awarded a contract to conduct a 10,000-participant Phase 2b clinical trial evaluating an Omicron-updated version of GEO-CM04S1 in a comparison format against an approved mRNA COVID-19 vaccine. This study aims to validate the value of multi-antigen MVA-based COVID-19 vaccines in long-term pandemic preparedness and protection against future health threats.

Positioning for the Future of Vaccine Innovation

“The success of mRNA vaccines in responding to COVID-19 has been remarkable, but the evolving nature of infectious diseases calls for a diversified, complementary approach to immunization,” said David Dodd, Chairman & CEO of GeoVax. “Our MVA-based vaccines offer enhanced protection for those who need it most, including immunocompromised patients and populations requiring longer-lasting immunity. We are committed to advancing vaccine innovation in collaboration with public and private stakeholders.”

As the industry moves towards a more integrated and diversified vaccine ecosystem, GeoVax’s MVA-based vaccines should provide a scalable, durable, and globally accessible solution that enhances the existing landscape, ensuring broader protection for all populations.

References:

  1. Plotkin, S. A., Robinson, J. M., Fitchett, J. R. A., & Gershburg, E. (2024). Vaccine development should be polytheistic, not monotheistic. Clinical Infectious Diseases, 79(6), 1518–1520. https://doi.org/10.1093/cid/ciae460
  2. Parish, L. A., Rele, S., Hofmeyer, K. A., Luck, B. B., & Wolfe, D. N. (2025). Strategic and technical considerations in manufacturing viral vector vaccines for the Biomedical Advanced Research and Development Authority threats. Vaccines, 13(73). https://doi.org/10.3390/vaccines13010073

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:                                                                             

info@geovax.com                                                                               

678-384-7220                                                                                                    

Investor Relations Contact:

austin.murtagh@precisionaq.com

212-698-8696

Media Contact:

sr@roberts-communications.com

202-779-0929

Release – Nutriband Receives Certificate of Registration for Trademark covering Pharmaceutical and Product Research and Development

Posted on by aweinsoff@channelchek.com

Research News and Market Data on NTRB

February 21, 2025 07:00 ET 

ORLANDO, Fla., Feb. 21, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ: NTRB) (NASDAQ:NTRBW), a developer of transdermal pharmaceutical products, today announced that it received the Certificate of Registration from the United States Patent and Trademark Office (USPTO) on Feb 18, 2025, for trademark registration Number 7,692,920, covering the mark “Nutriband™.” The Trademark registration covers Goods/Services: Class: 042 Product research and development, scientific research and development; biochemical research and development; pharmaceutical research and development.

The Nutriband™ trademark is integral to the commercialization of the Company’s platform technology AVERSA which can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. Nutriband’s lead product under development is AVERSA™ Fentanyl, an abuse deterrent fentanyl transdermal system.

Nutriband, in partnership with Kindeva Drug Delivery, is progressing towards completing the scale-up of the commercial manufacturing process for AVERSA™ Fentanyl, the first product under the AVERSA Platform that the company intends to submit for FDA approval.

According to a market analysis report by Health Advances, AVERSA™ Fentanyl has the potential to reach peak annual U.S. sales of $80 million to $200 million. This reflects the significant impact that AVERSA™ technology could have on the market for abuse deterrent pharmaceutical products.

About AVERSA™ Technology

Nutriband’s AVERSA™ abuse deterrent transdermal technology is designed to incorporate aversive agents into transdermal patches, deterring abuse by making the experience unpleasant. This technology is especially significant for drugs like fentanyl, which have a high potential for abuse. AVERSA™ aims to ensure that these essential medications remain accessible to patients who need them while enhancing their safety profiles. The AVERSA™ technology is supported by a robust intellectual property portfolio, with patents granted in the United States and several other countries including Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.

About Nutriband Inc.

Nutriband Inc. is primarily engaged in developing a portfolio of transdermal pharmaceutical products. The Company’s lead product in development is an abuse deterrent fentanyl patch that incorporates AVERSA™ technology. This technology can be integrated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites, or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024 and Forms 10-Q, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

For more information, contact:

Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com

Release – Ocugen to Host Conference Call on Wednesday, March 5, 2025 at 8:30 A.M. ET to Discuss Business Updates and Fourth Quarter and Full Year 2024 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

February 21, 2025

PDF Version

MALVERN, Pa., Feb. 21, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s fourth quarter and full year 2024 financial results and provide a business update at 8:30 a.m. ET on Wednesday, March 5, 2025.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 5045393
Webcast: Available on the events section of the Ocugen investor site.

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com 

AstraZeneca Acquires FibroGen’s China Business for $160 Million, Expanding Presence in Anemia Market

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Acquiring FibroGen’s China operations for $160M secures rights to anemia drug roxadustat.
– The sale extends cash runway to 2027 and funds key drug development.
– Roxadustat leads in China, but faces generic competition and regulatory scrutiny.

AstraZeneca (AZN) has announced a $160 million acquisition of FibroGen’s (FGEN) China business, securing regional rights to the oral anemia drug roxadustat. This deal strengthens AstraZeneca’s footprint in the Chinese pharmaceutical market while providing FibroGen with a much-needed financial boost.

The relationship between AstraZeneca and FibroGen surrounding roxadustat dates back over a decade. Initially, AstraZeneca held broader rights to the HIF-PH inhibitor but returned control in the U.S. and select other markets last year. However, the company maintained an interest in China and South Korea, where the drug is marketed under the brand name Evrenzo.

With this acquisition, AstraZeneca will pay an enterprise value of $85 million, in addition to $75 million of net cash currently held by FibroGen’s Chinese operations. The transaction is expected to close in mid-2025, at which point FibroGen plans to use the proceeds to repay a term loan facility managed by Morgan Stanley Tactical Value, simplifying its capital structure.

For FibroGen, this sale represents a crucial financial lifeline. Entering 2024, the company held $121.1 million in cash and equivalents. The proceeds from this transaction, coupled with loan repayment, should extend FibroGen’s cash runway into 2027. The move allows the company to refocus on developing FG-3246, a CD46-targeting antibody-drug conjugate, and FG-3180, a companion PET imaging agent for metastatic castration-resistant prostate cancer (mCRPC).

“This deal bolsters our company on several fronts,” said FibroGen CEO Thane Wettig. “It strengthens our financial position, meaningfully extending our cash runway, and enables us to continue progressing key clinical development programs.”

Roxadustat is a leading treatment for anemia in chronic kidney disease in China, and regulatory bodies are considering its approval for chemotherapy-induced anemia. Despite its dominance, the drug faces increasing competition, as Chinese regulators approved a generic version from CSPC Pharmaceutical last summer. Several other companies are also seeking approval for their own generic versions.

China remains a crucial market for AstraZeneca, though the company has recently encountered challenges, including a slowdown in sales and an ongoing investigation into its former China head, Leon Wang, over potential tax violations. Nevertheless, AstraZeneca CEO Pascal Soriot remains optimistic, stating in a recent earnings call that “longer term, we see continuous opportunity for growth in China.”

While today’s deal secures AstraZeneca’s position in China, FibroGen retains the rights to roxadustat in other markets, including the U.S., where it has faced regulatory setbacks. The drug was rejected by the FDA in 2021 for chronic kidney disease and later failed a Phase 3 anemia trial in 2023. However, FibroGen is still evaluating development plans for anemia associated with lower-risk myelodysplastic syndrome, with hopes of meeting with the FDA in the second quarter to discuss potential next steps.

As the transaction moves forward, both AstraZeneca and FibroGen are positioning themselves for long-term growth, with AstraZeneca reinforcing its presence in China’s expanding pharmaceutical sector and FibroGen securing the resources to pursue future drug development.

Release – Unicycive Therapeutics Announces the Publication of Preclinical Data on Synergies Between Oxylanthanum Carbonate and Tenapanor in American Society of Nephrology Journal Kidney360

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

February 20, 2025 7:00am EST Download as PDF

Combination therapy with oxylanthanum carbonate plus tenapanor led to greater reductions in urinary phosphate excretion than either drug alone

LOS ALTOS, Calif., Feb. 20, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the publication of preclinical data describing the benefits of combination treatment of oxylanthanum carbonate (OLC) and tenapanor on phosphate management in the American Society of Nephrology (ASN) journal, Kidney360.

The publication, entitled “Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rats,” examines the potential synergistic benefits of a combination of OLC, a phosphate binder, with tenapanor, a sodium/hydrogen exchanger 3 (NHE3) inhibitor, on urinary phosphate excretion. Data demonstrated sizeable reductions in urinary phosphate excretion (a proxy for intestinal phosphate absorption) in response to both OLC monotherapy and the combination of OLC with tenapanor.

“With approximately 75% of patients receiving maintenance dialysis failing to meet serum phosphate targets set by international Kidney Disease Improving Global Outcomes (KDIGO) guidelines, we must explore new approaches to improve control of hyperphosphatemia” said Glenn M. Chertow, M.D., M.P.H., Professor of Medicine, Stanford University School of Medicine. “Based on the results of this pre-clinical study, we believe that OLC, an investigational phosphate binder, when used alone or in combination with tenapanor, could improve control of hyperphosphatemia in patients receiving maintenance dialysis who are either unresponsive to currently available phosphate binders or intolerant to their associated adverse effects, high pill burden, and poor palatability.”

“We’re excited by these preclinical data showing a synergistic treatment effect from the combination of OLC and tenapanor. OLC, with its low pill burden and more palatable formulation, could complement tenapanor, significantly enhancing patient adherence and clinical outcomes,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Further studies in patients with end-stage kidney disease and hyperphosphatemia will be required to understand the most effective and best tolerated OLC-containing regimens, as we aim to improve long-term control of hyperphosphatemia and prevent its myriad complications.”

Key Findings:

  • Treatment with tenapanor alone (0.15 mg/kg) led to 12.5% lower mean urinary phosphate excretion compared to the vehicle in rats fed a high phosphorus diet.
  • A pooled analysis of monotherapy with OLC (0.75%, 1.5%, and 3%) demonstrated a 17.7% reduction in urinary phosphate excretion compared to vehicle.
  • Treatment with tenapanor in combination with OLC demonstrated a more pronounced 41.3% reduction in urinary phosphate excretion compared to vehicle.
  • The combination of OLC and tenapanor was synergistic and statistically significant (p=0.009 for 0.75% OLC + tenapanor and p=0.010 for 1.5% OLC + tenapanor).

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

1Reason Research, LLC 2022 survey. Results here.
2 Fortune Business InsightsTM, Hyperphosphatemia Treatment Market, 2023-2030
3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM
4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com

Media Contact:

Rachel Visi
Real Chemistry
redery@realchemistry.com

SOURCE: Unicycive Therapeutics, Inc.

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Source: Unicycive Therapeutics, Inc.

Released February 20, 2025

Release – Mpox Clade 1 in the U.S. Highlights the Need for Vaccine Supply Diversification

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

    GeoVax Advances GEO-MVA to Strengthen U.S. and Global Readiness

    ATLANTA, GA, February 19, 2025 – The confirmation of a fourth case of Clade 1 Mpox in New York underscores the urgent need for a stronger and more diversified vaccine supply chain. GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in developing vaccines and immunotherapies for infectious diseases and cancer, is calling for immediate action to expand vaccine production and ensure timely distribution.

    The spread of Clade 1 Mpox, a highly virulent and transmissible strain with a fatality rate ranging from 3% – 10%, is raising alarms across the public health community. While the virus has been a persistent threat in Africa, its increasing presence in Europe and the United States signals a critical moment in the fight against the disease. Over the last 4 months, confirmed cases of Clade 1 Mpox have been reported in California, Georgia, New Hampshire, and New York. However, the nation remains heavily dependent on a single non-U.S. vaccine manufacturer of the preferred Mpox vaccine, based on Modified Vaccinia Ankara (MVA), leaving the U.S. and global markets vulnerable to supply chain disruptions, limited accessibility, and potential vaccine shortages at a time when demand is surging.

    Current Supply Chain Inadequate for Global Mpox Response

    The current reliance on a single supplier for the preferred Mpox vaccine presents numerous challenges, particularly as the outbreak grows:

    • Supply chain instability – Depending on a single foreign manufacturer introduces geopolitical and logistical risks that could delay vaccine availability during critical outbreaks.
    • Insufficient production capacity – African health agencies have requested 20 million doses in 2025 to curb the spread of the virus, yet only 2–5 million doses are expected to be available.
    • High costs and limited access – At as much as $270 per dose in the U.S., the preferred product for vaccination against Mpox can be prohibitively expensive for many, creating a barrier to widespread vaccination efforts.
    • Inability to respond swiftly to emerging strains – Current stockpiles, which were depleted during the 2022 outbreak, are likely inadequate to combat the increasing spread of Clade 1, leaving public health officials struggling to contain the outbreak.

    GeoVax’s GEO-MVA: A Critical Additional-Source Solution

    In response to these pressing concerns, GeoVax is advancing development of GEO-MVA, an alternative MVA based vaccine in the fight against Mpox. GeoVax is also further addressing vaccine availability with plans to transition manufacturing of GEO-MVA, once authorized, to an advanced MVA manufacturing platform with the potential to offer significant advantages over the currently utilized Chicken Embryo Fibroblast (CEF) manufacturing platform, a complicated manufacturing process highly dependent on the availability of Specific Pathogen Free (SPF) chicken eggs. GEO-MVA’s innovative MVA production process, once implemented, should enable:

    • Scalability for global demand – Rapid, high-volume manufacturing to meet urgent vaccination needs.
    • Flexibility to utilize existing vaccine manufacturing facilities vs need to construct new ones.
    • Lower cost and increased accessibility – The advanced technology behind GeoVax’s MVA manufacturing platform should help reduce production costs, making vaccination programs more affordable worldwide.
    • Eliminate the need for SPF eggs whose availability can be negatively impacted by supply disruptions such as those related to avian flu outbreaks.
    • Strengthening U.S. biosecurity – Unlike the current MVA vaccine, which is produced overseas, GEO-MVA can be manufactured within the U.S., reducing reliance on foreign supply chains.
    • Enhanced pandemic preparedness – A diversified vaccine supply ensures greater resilience in response to future outbreaks, preventing disruptions in availability.

    GeoVax has established strategic partnerships with OXB (France) and ProBioGen (Berlin) to support production scale up, while also actively engaging with U.S. and international health agencies to potentially expedite regulatory approvals and secure funding to bring GEO-MVA to market and eventually transition production to the next generation MVA manufacturing process. GeoVax recently completed cGMP (current Good Manufacturing Practice) manufacturing of the GEO-MVA drug substance and is currently in the process of fill-finish, with anticipated availability of clinical vialed material by mid-year.

    A Call to Action: Strengthening the Global Response

    With the growing threat of Clade 1 Mpox, it is imperative to diversify vaccine manufacturing capabilities and ensure the U.S. and global health agencies have access to multiple suppliers. GeoVax urges policymakers and regulators to take decisive action:

    • Increase federal funding and policy support to expedite the availability of GEO-MVA as an alternative Mpox vaccine.
    • Expedite regulatory approvals to bring GEO-MVA to market as quickly as possible.
    • Enhance collaboration with global health organizations to ensure equitable vaccine distribution, particularly in underserved regions.

    “We cannot afford to wait for another pandemic-level crisis before addressing vaccine shortages and supply chain vulnerabilities,” said David Dodd, Chairman & CEO of GeoVax. “The emergence of Clade 1 Mpox in the U.S. is a clear warning sign. Immediate action is needed to strengthen vaccine supply and access.  GEO-MVA, along with our efforts towards establishing our next generation MVA manufacturing platform, represents critical solutions to ensure we are better prepared for future outbreaks.”

    About GeoVax

    GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

    Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

    Company Contact:                                                                              

    info@geovax.com                     

    678-384-7220                            

    Investor Relations Contact:

    austin.murtagh@precisionaq.com

    212-698-8696

    Media Contact:

    sr@roberts-communications.com

    202-779-0929