Tag: Biotechnology

Cadrenal Therapeutics (CVKD) – Data Presentation From LVAD Study Points Out The Need For Tecarfarin

Posted on by cpereira@noblefcm.com


Wednesday, June 05, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Patients With LVADs Need A New Anticoagulant. A new analysis of anticoagulant regimens from a study in cardiovascular devices patients was presented at the International Society of Heart and Lung Transplantation Annual Meeting. The presentation included data from the ARIES-HM3 study testing anticoagulation with warfarin and aspirin against warfarin alone. We believe the data highlights the need for tecarfarin in left ventricular assist device (LVAD) patients.

Abbott Has An Interest In LVAD Patient Outcomes. The ARIES-HM3 study was sponsored by Abbott (ABT, Not Rated), maker of the HeartMate3 LVAD. Patients with these devices cannot take DOAC anticoagulant drugs, leaving them with only warfarin. The study tested warfarin (a vitamin K antagonist, VKA) with and without aspirin. The findings showed lower time in the therapeutic range (TTR) is a predictor of excessive bleeding events, and warfarin patients are typically below target values.


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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. 

Release – Eledon Presents Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

June 3, 2024

PDF Version

Data from 13 participants presented at the American Transplant Congress continue to support safety and tolerability profile of tegoprubart

Overall mean eGFR of all reported time points after day 30 post-transplant of 70.5 mL/min/1.73m²

Mean eGFR measured above 60 mL/min/1.73m² at all reported time points after day 30 post-transplant

IRVINE, Calif., June 03, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today presented updated data from the Company’s ongoing open-label Phase 1b trial and open-label extension study evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the poster, titled “Biomarkers of Inflammation and eGFR in an Ongoing Phase 1B Study of an Anti-CD40L Antibody Tegoprubart, for the Prevention of Rejection in Kidney Transplant,” were presented at the American Transplant Congress (ATC) taking place in Philadelphia, PA from June 1-5, 2024.

“Eledon continues to build a robust set of encouraging results demonstrating the safety and efficacy of tegoprubart in kidney transplant recipients in our Phase 1b trial,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Calcineurin inhibitors, the current standard of care, do not adequately serve the transplant community due to frequent and difficult–to-manage side effects. By contrast, tegoprubart’s observed clinical profile to date gives us confidence in its potential to supplant calcineurin inhibitors as a next-generation immunosuppression agent for patients who have received a new kidney. We look forward to accruing incremental data through the ongoing Phase 1b and open-label extension studies while continuing to enroll in our Phase 2 BESTOW trial, with enrollment completion anticipated by the end of the year.”

As of the April 2024 cutoff date, updated data from the 13 participants in the ongoing Phase 1b trial support tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation. Data from historical studies using standard of care, calcineurin inhibitor-based immunosuppression therapy typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 50 mL/min/1.73m2 during the first year after kidney transplant. In the ongoing Phase 1b trial, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant. Two participants completed 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one-year post-transplant.

Results demonstrated that tegoprubart is generally safe and well tolerated in patients undergoing de novo kidney transplantation. Three subjects have discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively. There have been no cases of hyperglycemia, new onset diabetes, or tremor, all of which are side effects often associated with standard of care immunosuppression therapy. There have been no cases of graft loss or death.

Eledon is currently conducting a Phase 1b trial (NCT05027906), a Phase 2 trial (BESTOW; NCT05983770), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

A copy of the ATC poster can be found on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

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Source: Eledon Pharmaceuticals, Inc.

Release – MAIA Biotechnology Reveals New Clinical Data Showing THIO’s Strong Efficacy In Non-Small Cell Lung Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

June 04, 2024 8:41am EDTDownload as PDF

THIO’s favorable disease control and overall response rates exceed reported standard-of-care data in third line treatment

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced new efficacy data from its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens. Updated results show a favorable overall response rate (ORR) of 38% and a disease control rate (DCR) of 85% from THIO + CPI in third-line treatment. The new data was presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on June 3, 2024.

The primary objectives of THIO-101 Phase 2 trial are to examine the safety and tolerability of THIO as an anticancer drug and as an immune system primer, and to examine the clinical efficacy of THIO in the form of ORR. At the time of the most recent data cut-off (April 30, 2024), all evaluable patients had completed ≥1 post-baseline assessment.

Results from third-line treatment:

  • Disease control rate (DCR) was 85% for THIO vs. standard of care DCR of 25–35% for chemotherapy1
  • 65% of patients crossed the 5.8-month overall survival (OS) threshold2
  • 85% of patients crossed the 2.5-month progression-free survival (PFS) threshold3-4
  • Median survival follow-up time is currently 9.1 months (n=20)

Results from third-line treatment with THIO 180mg (optimal dose selection)

  • Median PFS of 5.5 months (24.1 weeks)
  • 78% OS rate at 6 months
  • 38% ORR vs. standard of care 6–10% for chemotherapy2
  • 75% of patients crossed the 5.8-month OS threshold2
  • 88% of patients crossed the 2.5-month PFS threshold3-4
  • Median survival follow-up time is currently 9.1 months (n=8)

1 Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89.
2 Girard N, et al. J Thorac Onc 2009;12:1544-1549.
3 Shepherd F, et al. N Engl J Med 2005;353:123-132.
4 Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.

“All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard of care treatments,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “The data presented at ASCO advances THIO’s excellent clinical profile as a strong, safe, and highly effective alternative for patients who progressed following chemotherapy and other available treatments. We eagerly anticipate full efficacy data from THIO-101 in the second half of this year.”

To date, treatment with THIO + cemiplimab has been generally well tolerated in a heavily pre-treated patient population. Full enrollment in THIO-101 was completed on February 19, 2024, earlier than expected as per trial design. The Company expects that THIO-101 will be the first completed clinical study of a telomere targeting agent in the field of cancer drug discovery and treatment.

The poster and updated Company presentations can be accessed on the company’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 cemiplimab (Libtayo®) followed by THIO 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240604727806/en/

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

Source: MAIA Biotechnology, Inc.

Released June 4, 2024

Eledon Pharmaceuticals (ELDN) – Data Update From Phase 1b Trial Shows Continued Tegoprubart Benefits

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, June 04, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Data From Phase 1b Trial Updated. Eledon presented data from the Phase 1b trial testing tegoprubart, its drug for prevention of kidney transplant rejection, at the American Transplant Congress. We found the data to continue to show improved kidney function during the first year after transplantation, a strong indicator of organ survival, with continued safety and tolerability.

Kidney Function Measures Continue To Show Improvements Over Tacrolimus. The Phase 1b data included 13 patients who had reached 30-day post-transplant evaluation. Their mean eGFR was above 60 mL/min/1.73m² at each reported time point. The overall mean eGFR after day 30 reached 70.5 mL/min/1.73m².  This is an improvement over standard-of-care immunosuppressive regimens that have eGFR rates around the 50ml/min/1.73m² level during the first year after the transplant.


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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.

Release – Data And Safety Monitoring Board Approves Simultaneous Enrollment In Cohort 3 And Phase 2 Initiation In OCU410 ArMaDa Study For Geographic Atrophy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 31, 2024

  • Established Medium Dose as Safe and Tolerable Dose in Current OCU410 Clinical Trial
  • DSMB Recommends Continuing with High-Dose Cohort Dosing with Concurrent Phase 2 Dosing

MALVERN, Pa., May 31, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced a positive outcome of the Data and Safety Monitoring Board (DSMB) Review for its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV5-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 2-3 million people in the U.S. and Europe combined.

Six subjects with GA were dosed in the Phase 1/2 clinical trial to date—three subjects were dosed with the low dose and three subjects were dosed with the medium dose. An additional three patients will be dosed with the high dose of OCU410 in the dose-escalation phase.

“The DSMB has recommended to proceed with dosing subsequent GA subjects with the high dose of OCU410 in the dose-expansion phase of the study and concurrently initiate Phase 2 dosing,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial. “No serious adverse events (SAEs) related to OCU410 have been reported to date in both low- and medium-dose cohorts. I believe that this marks a critical next step towards determining the maximum tolerated dose for OCU410 and is an important milestone for its clinical development.”

“We are delighted to report a second positive DSMB recommendation for the treatment of GA, which significantly builds on the favorable safety and tolerability profile exhibited by OCU410,” said Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen. “We are very enthusiastic about the potential of OCU410 as a potential one-time treatment for GA with a single sub-retinal injection. The currently approved treatments for GA target only the complement pathway and require approximately 6-12 intravitreal injections annually. OCU410 addresses multiple pathways causing dAMD, including complement, lipid metabolism, inflammation, and oxidative stress, providing long-term benefit to patients.”

The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

About dAMD and GA
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.

About OCU410
OCU410 utilizes an AAV delivery 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 in-vitro and in-vivo (animal model) studies. These results demonstrate the ability for OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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; 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
Head of Communications
Tiffany.Hamilton@ocugen.com

Tonix Pharmaceuticals (TNXP) – Tonmya Presentations From Previous and Upcoming Trials

Posted on by cpereira@noblefcm.com


Friday, May 31, 2024

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Presentations On Long COVID Trial, Upcoming PTSD Trial. Tonix presented data from its Phase 2 PREVAIL trial testing Tonmya, previously TNX 102 SL, at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The data showed improvement in symptoms that we believe support findings from Phase 3 trials in fibromyalgia. A poster presentation detailed design of an upcoming study in Acute Stress disorders after automobile accidents, expected to begin in 2Q24.

PREVIAL Data Showing Improvement In Symptoms. The study was designed as a proof-of-concept in Long COVID. Although the primary endpoint of multi-site pain reduction after 14 weeks was not met, the treatment group showed measures of effect size that met prespecified criteria for further evaluation. The study showed improvements in fatigue, sleep quality, cognition function, disability, and Patient Global Impression of Change. We believe these measures are consistent with effects seen in the Phase 3 RELIEF and RESILIENT trials.


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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).

Unicycive Therapeutics (UNCY) – Data Presentations For OLC and UNI-494 Trials Presented

Posted on by cpereira@noblefcm.com


Wednesday, May 29, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Data From Both Products Shows Clinical Progress. Unicycive presented data at the European Renal Association (ERA) Congress for OLC and UNI-494, its two products currently in clinical development. Earlier this month, the company presented data from its OLC bioequivalence study and a market survey study on phosphate binder compliance at the National Kidney Foundation Spring Clinical Meeting.

OLC Clinical Data Presented At National Kidney Foundation Meeting. Unicycive presented data from its Phase 1 bioequivalence study comparing OLC with lanthanum carbonate, the active compound in the phosphate binder Fosrenol. The second poster presented data from a survey of renal dieticians who help manage patients’ diet and phosphate levels. The survey is consistent with prior data showing that daily pill burden is a factor in patient compliance, and that OLC’s reduced pill burden could lead to better compliance and patient outcomes. 


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 – Ocugen Set to Join Russell 3000® Index Effective June 28, 2024

Posted on by slightbourne@noblecapitalmarkets.com

Research News and Market Data on OCGN

MALVERN, Pa., May 28, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced its expected upcoming inclusion in the Russell 3000® Index, according to preliminary Russell reconstruction information posted on the FTSE Russell website. The newly reconstructed index will take effect after the market closes on June 28, 2024.

“Inclusion of Ocugen to the Russell 3000® Index is our latest milestone, adding to what has already been a transformational year for the Company with three of our game-changing modifier gene therapies targeting blindness diseases—both rare and those affecting millions—in clinical trials,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This ranking signifies the value of our pipeline, including the recently initiated Phase 3 liMeliGhT clinical trial of OCU400 for broad retinitis pigmentosa, and robust growth strategy, supporting our efforts to enable long-term shareholder value, garner significant visibility of Ocugen within the investment community, and broaden our shareholder base.”

The annual Russell 3000® Index reconstitution measures the performance of the largest 3,000 U.S. companies representing approximately 96% of the investable U.S. equity market as of Tuesday, April 30.

Membership in the U.S. Russell 3000® remains in place for one year and means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings, and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Russell’s U.S. indexes serve as the benchmark for about $10.5 trillion in assets as of the close of December 2023. Russell indexes are part of FTSE Russell, a leading global index provider.

About FTSE Russell:
FTSE Russell is a leading global provider of benchmarking, analytics, and data solutions for investors, giving them a precise view of the market relevant to their investment process. A comprehensive range of reliable and accurate indexes provides investors worldwide with the tools they require to measure and benchmark markets across asset classes, styles, or strategies.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products, and index-based derivatives.

FTSE Russell is focused on applying the highest industry standards in index design and governance, employing transparent rules-based methodology informed by independent committees of leading market participants. FTSE Russell fully embraces the IOSCO Principles, and its Statement of Compliance has received independent assurance. Index innovation is driven by client needs and customer partnerships, allowing FTSE Russell to continually enhance the breadth, depth and reach of its offering.

FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit: https://www.lseg.com/en/ftse-russell.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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 the Company’s expected inclusion in the Russell 3000 ® Index, 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 changes may be made to the preliminary Russell reconstruction lists prior to finalization, that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical 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
Head of Communications
Tiffany.Hamilton@ocugen.com

Behind the Scenes of Biotech’s Battle for the Billion-Dollar Diet Pill

Posted on by slightbourne@noblecapitalmarkets.com

For biotech investors scouring for the next big opportunity, the massive manufacturing expansions underway at pharma giant Eli Lilly (LLY) are worth a close look. The company just announced another staggering $5.3 billion investment into a key production facility in Indiana to crank up supply of its blockbuster obesity and diabetes drugs.

This commitment brings Lilly’s total investment at the Lebanon, Indiana site to an incredible $9 billion – representing the firm’s largest-ever manufacturing bet in its nearly 150-year history. It highlights the huge demand that Lilly’s game-changing medications like Mounjaro and Zepbound are facing from physicians and patients alike.

For small biotech firms developing the next generation of weight loss, diabetes and metabolism therapies, Lilly’s supply chain moves send an important signal – this market is headed for explosive growth in the coming years. Companies sitting on promising pipeline candidates could emerge as attractive buyout targets.

At the heart of Lilly’s expansion plans are its incretin drugs, which mimic gut hormones to suppress appetite and regulate blood sugar. Mounjaro, approved for diabetes, and Zepbound, greenlit for chronic weight management, both contain the active ingredient tirzepatide.

Since their launches, demand for these effective and convenient once-weekly injectable treatments has far outstripped supply. Shortages have been widespread in the U.S. as Lilly raced to build out its production infrastructure.

The new $9 billion Indiana campus will be instrumental in increasing Lilly’s capacity to manufacture tirzepatide at scale. When fully operational in 2028, it will employ around 900 skilled workers including scientists, engineers and technicians.

But this plant is just one piece of Lilly’s supply chain mobilization for incretin drugs. Since 2020, the company has plowed over $18 billion into building, acquiring and expanding manufacturing sites in the U.S. and Europe. New facilities are also coming online in North Carolina, Ireland and Germany through 2026.

These investments are already paying dividends. On its latest earnings call, Lilly hiked its 2023 revenue guidance by $2 billion, citing greater visibility into ramping up production of Mounjaro, Zepbound and its incretin pipeline over the remainder of the year.

For small biotechs, the supply chain frenzy at Lilly underscores the commercial opportunity in obesity, diabetes and metabolism. With over 40% of U.S. adults classified as obese, safe and effective chronic weight management regimens like Lilly’s incretin franchise could disrupt a massive global market worth billions annually.

Take a moment to look at more emerging growth biotechnology companies by taking a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage list.

The manufacturing expansions suggest appetite for these therapies will continue to surge, fueling demand for the next generation of medications offering better efficacy, tolerability and dosing schedules. Smaller drug developers operating in this space could become prime M&A candidates as deep-pocketed pharmas look to build out their obesity and diabetes portfolios.

Case in point: Lilly itself acquired Zepbound through its $8 billion buyout of Protunor Biopharma in 2022. Several major deals have already reshaped the incretin drug landscape in recent years, including Pfizer’s $6.7 billion purchase of Akero Therapeutics for its NASH/diabetes pipeline.

With its bold investments, Lilly is putting its money where its mouth is when it comes to obesity and metabolic disease. For lean biotechs advancing the next wave of therapies in this booming treatment category, that could spell opportunity knocking in the form of lucrative buyout offers or partnerships down the line.

Keep an eye on this space as Lilly’s supply chain moves underscore that the fight against fat is only just beginning for the pharmaceutical industry.

Biogen’s Bold $1.8B Kidney Disease Treatment Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Biogen Inc. is doubling down on novel therapies for rare diseases, announcing an acquisition of Human Immunology Biosciences that could be valued at up to $1.8 billion. The deal gives Biogen full rights to HI-Bio’s lead drug candidate felzartamab, which is being studied for several chronic kidney conditions with large unmet medical needs.

The transaction reflects Biogen’s strategic shift under CEO Christopher Viehbacher to diversify beyond its core neuroscience franchise. Just months after the $6.5 billion buyout of kidney disease specialist Reata Pharmaceuticals, Biogen is opening its checkbook again to beef up its pipeline of potential rare disease medicines.

HI-Bio’s felzartamab has completed mid-stage trials for two types of kidney disorders – primary membranous nephropathy and transplant glomerulopathy where the immune system attacks a transplanted organ. Importantly, it is also being evaluated for IgA nephropathy, a leading cause of kidney failure with no approved treatments available.

For Biogen, the deal provides another shot on goal as it navigates an uncertain period. While its newly-launched Alzheimer’s drug Leqembi has shown promise, the company was forced to abandon its previous Alzheimer’s treatment Aduhelm after years of controversy. Biogen’s older multiple sclerosis franchises are facing rising competitive threats as well.

The HI-Bio acquisition gives Biogen added pipeline diversification into nephrology and autoimmune diseases. Felzartamab has a unique approach, as it is an anti-FcRn antibody that targets pathogenic IgG antibodies which can damage kidneys and other organs.

If felzartamab can demonstrate positive efficacy and safety in broader Phase 3 testing, it could eventually have multi-billion dollar peak sales potential across its targeted kidney indications according to analyst forecasts. However, there is no guarantee of clinical or regulatory success.

From a financial perspective, Biogen is paying $1.15 billion upfront for private HI-Bio, along with contingent value rights worth up to $650 million if certain development and commercial milestones are achieved. This is relatively modest compared to Biogen’s $6.5 billion acquisition of Reata announced in February.

The HI-Bio deal continues Biogen’s aim to revamp its R&D pipeline through a series of bold acquisitions and partnerships under Viehbacher. The company is betting that assembling a portfolio of high-risk, high-reward clinical candidates for diseases like Alzheimer’s and kidney disorders will ultimately pay off.

For the healthcare sector and public markets, Biogen’s aggressive business development approach is emblematic of the ongoing consolidation wave. With rising costs of drug development and payer pricing pressures, large biopharma companies are increasingly looking to acquisitions of smaller, more focused biotechs to source external innovation.

While Biogen’s M&A strategy carries substantial financial risk, the HI-Bio deal gives it a promising asset that could reshape treatment for serious kidney diseases if it can overcome the high hurdle of clinical success. For healthcare investors, absorbing Biogen’s evolving pipeline story will be crucial in evaluating the company’s future growth prospects.

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Release – Tonix Pharmaceuticals Announces Key Findings from Initial Phase of EVERSANA Market Opportunity Analysis for Tonmya™ for the Management of Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

CHATHAM, N.J., May 21, 2024 (GLOBE NEWSWIRE) —  Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that EVERSANA® Life Science Services, LLC, a leading provider of commercialization services to the global life sciences industry, completed the initial phase of an assessment of the U.S market opportunity for TonmyaTM (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets), a potential new first line therapy for the management of fibromyalgia. Tonix previously announced that EVERSANA was selected to support the launch strategy and commercial planning of Tonmya. Specifically, EVERSANA is working with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market (GTM) strategy.

“The primary research and analysis conducted by EVERSANA provides valuable insights and informs the vision for the commercialization of Tonmya,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We are excited to refine our business strategy for the anticipated launch of Tonmya in 2025. It has been approximately fifteen years since patients suffering with fibromyalgia have been provided a new therapeutic option. The market research conducted by EVERSANA with physicians indicates a continued high unmet need, with the need ranked > 4.0 on a 5-point scale.”

Dr. Lederman continued, “We were surprised to learn that opioids dominate the fibromyalgia prescription market, despite the well-known risks of dependency. Opioids are prescribed to more patients following fibromyalgia diagnosis than all the FDA-approved fibromyalgia drugs combined. If approved, we believe that Tonmya can provide a non-opioid, centrally-acting solution for fibromyalgia patients. This is corroborated by EVERSANA’s primary market research in which physicians indicated median interest of 4.0 on a 5-point scale and intended use of Tomya in 40% of their fibromyalgia patients, upon approval.1 We look forward to submitting the NDA for Tonmya in the second half of this year and expect an FDA decision on approval in 2025.”

EVERSANA’s analysis of the market size was based on medical claims databases and epidemiological studies on prevalence and diagnosis2. Primary research with physicians was conducted to test the potential adoption of Tonmya based on its activity and tolerability.  

Key findings from claims data analyses2:

  • ~2.7 million adults in the U.S. currently diagnosed and treated for fibromyalgia.
    • ~90 percent of patients diagnosed with fibromyalgia are female.
  • Percentage of fibromyalgia patients who were prescribed certain drugs3:
    • FDA-approved fibromyalgia drug prescriptions:
      1. Duloxetine (generic Cymbalta®): 23%, pregabalin (generic Lyrica®): 13%, and Savella® (milnacipran): 1%
    • Off-label drug prescriptions:
      1. Gabapentin: 26%, hydroxycodone: 20%, cyclobenzaprine: 18%, oxycodone: 19%, tramadol: 13%, meloxicam: 12%, and amitriptyline: 6%
    • Off-label opioids prescriptions:
      1. Hydroxycodone: 20%, oxycodone: 19%, and tramadol: 13%
  • Targeted prescriber strategy for launch.
    • High prescribers are rheumatologists, pain medicine specialists, primary care physicians, neurologists, and psychiatrists.
  • ~50 percent of diagnosed fibromyalgia patients are covered by Medicare.
    • Medicare population stands to benefit from a decrease in out-of-pocket prescription drug liability to $2,000 per year when the changes from the Inflation Reduction Act are enacted in 2025.

Key findings from primary physician research4:

  • High level of dissatisfaction with currently prescribed drugs.
    • Physicians interviewed estimate that 85% of their patients fail first-line therapy due to efficacy and tolerability issues and 79% of their patients are on multiple therapies.
    • Prescribers indicate high unmet need in fibromyalgia, ranked >4.0 on a 5-point scale.
  • High level of interest in Tonmya from physicians interviewed as a potential new treatment option based on favorable activity and tolerability profile observed in Tonmya fibromyalgia clinical studies.
    • Median interest in Tonmya of 4 on a 5-point scale.
    • Physicians indicated intended use of Tonmya in 40% of their fibromyalgia patients.1

Tonmya is a centrally acting, non-opioid medication. As previously announced, Tonix’s second statistically significant Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.

Tonix plans to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia and has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024.

1 40% was the median preference share among physicians interviewed, assuming no market access barriers.
2 EVERSANA analysis of claims database, May 2024; commissioned by Tonix
3Note: the total number of patients is greater than 100% because of switching between medications and polypharmacy.
4 EVERSANA primary physician research, May 2024; commissioned by Tonix

About Tonmya* (also known as TNX-102 SL)

Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

About EVERSANA®

EVERSANA® is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of 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, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully commercialize any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Matt Braun
EVERSANA
Matt.braun@eversana.com

Source: Tonix Pharmaceuticals Holding Corp.

Released May 21, 2024

This $850M Biotech Deal Could Disrupt the Atopic Dermatitis Market

Posted on by slightbourne@noblecapitalmarkets.com

In a strategic move to strengthen its dermatology portfolio, pharmaceutical giant Johnson & Johnson has agreed to acquire Proteologix, a privately-held biotech developing bispecific antibody therapies for inflammatory skin diseases like atopic dermatitis. The $850 million all-cash deal gives J&J access to promising clinical and preclinical stage assets.

The crown jewel of the acquisition is Proteologix’s lead candidate PX128, a Phase 1-ready bispecific antibody targeting two key drivers of atopic dermatitis and asthma – interleukin-13 (IL-13) and thymic stromal lymphopoietin (TSLP). By simultaneously blocking these complementary inflammatory pathways, PX128 could provide a substantial efficacy boost over current monospecific antibody treatments.

Proteologix’s second asset, the preclinical bispecific PX130, goes after IL-13 and IL-22 for the treatment of moderate to severe atopic dermatitis. J&J cited the differentiated design of these dual-acting antibodies, highlighting their potential for infrequent, convenient dosing that could improve adherence.

The acquisition aligns with J&J’s strategic focus on building an immunology pipeline centered around bispecific antibodies for improved disease control across a range of inflammatory conditions.

Atopic dermatitis, a chronic inflammatory skin disease, impacts over 100 million adults worldwide, representing a massive market opportunity. However, up to 70% of patients fail to achieve remission on standard systemic treatments, underscoring a significant unmet need.

“We see an opportunity for best-in-disease efficacy for both PX128 and PX130,” said David Lee, global immunology therapeutic area head at J&J. The company believes the bispecifics could be game-changers for underserved patient subgroups by more comprehensively targeting the heterogenous drivers of atopic dermatitis.

The deal comes on the heels of positive Phase 3 data from Eli Lilly’s IL-13 antibody lebrikizumab in atopic dermatitis. After manufacturing setbacks, Lilly resubmitted its lebrikizumab filing in April and anticipates a decision later this year, setting up a potential commercial clash with J&J’s dual-acting antibodies down the road.

Proteologix, based in California, will be eligible for additional milestone payments on top of the $850 million upfront cash paid by J&J. The transaction, expected to close in mid-2024 pending regulatory approval, will fold in Proteologix’s other preclinical bispecific antibody programs focused on autoimmune diseases and cancer.

For J&J, the deal provides a promising path toward next-generation, differentiated therapies for the significant population of atopic dermatitis patients struggling with existing treatment options. Proteologix’s dual-acting bispecific antibodies represent potentially transformative medicines for a disease area that has proven stubbornly difficult to treat.

The acquisition reinforces J&J’s commitment to immunology and dermatology while bolstering its pipeline with innovative, clinically advanced assets that could drive future growth. As the atopic dermatitis market heats up, J&J has made a preemptive strike to secure a competitive edge through its newest biotech addition.

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Release – MAIA Biotechnology Abstract Accepted For Poster Presentation At American Society Of Clinical Oncology (ASCO) 2024 Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

May 16, 2024 8:37am EDT

  • Poster to present new efficacy data from Phase 2 THIO-101 trial in non-small cell lung cancer (NSCLC)

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 an abstract about its Phase 2 THIO-101 clinical trial named “A phase 2, multicenter, open-label, dose-optimization study evaluating telomere-targeting agent THIO sequenced with cemiplimab in patients with advanced NSCLC: Updated results” was accepted for poster presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, to take place May 31-June 4, 2024, in Chicago, Illinois. The poster is scheduled for presentation on June 3, 2024, from 1:30pm to 4:30pm CST.

“We are proud to accept ASCO’s invitation to present at its 2024 Annual Meeting, the most significant gathering of oncology professionals worldwide,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “We look forward to revealing the newest efficacy results from THIO-101 and discussing our pioneering telomere targeting science underlying THIO, the first and only cancer treatment of its kind in clinical development.”

MAIA’s abstract will be available online at the ASCO Annual Meeting 2024 website during the week prior to the conference start date, and the poster will be published on maiabiotech.com on the day of the presentation, June 3, 2024.

The 2024 ASCO Annual Meeting will feature more than 200 sessions and 5,000 posters complementing the theme, “The Art and Science of Cancer Care: From Comfort to Cure.”

About ASCO

Founded in 1964, the American Society of Clinical Oncology is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer. Its mission is to conquer cancer through research, education, and promotion of the highest quality, equitable patient care. ASCO’s vision is a world where cancer is prevented or cured, and every survivor is healthy. asco.org

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240516196926/en/

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

Source: MAIA Biotechnology, Inc.

Released May 16, 2024