Category: Health

MAIA Biotechnology (MAIA) – MAIA Selects THIO Dose For Continued Studies In Non-Small Lung Cancer

Posted on by cpereira@noblefcm.com


Wednesday, December 20, 2023

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.

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.

MAIA Selects THIO Middle Dose Level For Future Studies. MAIA announced that it has selected the 180mg dose of THIO  to continue the Phase 2 THIO-101 trial in non-small lung cancer (NSCLC). The THIO-101 trial tested three THIO dose levels (60mg, 180mg, or 360mg) followed by cemiplimab (Libtayo), an anti-PD-1 checkpoint inhibitor from Regeneron. The 180mg dose level showed a better safety profile with better measures of efficacy. All future patients in the trial will be treated with the 180mg dose.

Trial Shows The Best THIO Disease Control Data To Date. MAIA also stated that the trial shows all dose levels exceed the disease control rate thresholds in stage 1 of the trial. Disease control rates in the first 8 out of 9 patients exceeded the goal of disease control in 8 out of 19 patients per arm. The 180mg dose had the best preliminary response rate compared with the 60mg and 360mg arms. We see strong results as consistent with prior data presentations showing large survival improvements for THIO treated patients.


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Release – Ocugen Announces OCU400 Receives Regenerative Medicine Advanced Therapy (RMAT) Designation for Treatment Of Retinitis Pigmentosa Associated With Rho Mutations

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

December 19, 2023

  • RMAT designation intended to help expedite development of new regenerative medicines

MALVERN, Pa., Dec. 19, 2023 (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 that the FDA has granted RMAT designation to Ocugen’s investigational product OCU400 for the treatment of retinitis pigmentosa (RP) associated with RHO mutations.

“RMAT designation is a significant accomplishment for the OCU400 clinical development program, as it validates the potential for our game-changing gene therapy approach to fulfill an unmet medical need for people who are facing blindness due to RP,” said Arun Upadhyay, PhD, Chief Scientific Officer and Head of R&D at Ocugen. “FDA’s decision also reinforces the sense of urgency to bring a therapeutic option to these patients.”

RMAT designation for OCU400 was based on preliminary clinical data supporting the maintenance and improvement of visual acuity and function in RP patients in the OCU400 -101 Phase 1/2 clinical trial as measured by Best Corrected Visual Acuity (BCVA), Low Luminance Visual Acuity (LLVA), and Multi-Luminance Mobility Test (MLMT).

RMAT designation is part of the 21st Century Cures Act. The program was created to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure a serious condition. Receiving RMAT designation offers sponsor companies all the benefits of the fast track and breakthrough therapy designation programs, including early interactions with the FDA. Ocugen is working with the FDA to finalize the Phase 3 protocol necessary to advance the clinical development for OCU400 to support an application for marketing authorization.

Current data support the gene-agnostic mechanism of action for OCU400, which suggests that it may be able to provide treatment benefit to a broader group of RP and Leber congenital amaurosis (LCA) patients. Ocugen intends to submit additional efficacy and safety data for OCU400 in RP and LCA patients to the FDA in the future to potentially expand this RMAT designation to broader RP and LCA patient populations.

RHO mutations affect more than 10,000 of the 110,000 people in the United States diagnosed with RP. In the latest clinical study update from the Phase 1/2 trial of OCU400, 86% (6/7) of RHO mutation subjects experienced either stabilization or improvement in MLMT scores from baseline, among which 29% (2/7) demonstrated 3 Lux luminance level improvement. There are currently no treatment options available for RP patients with RHO gene mutations.

OCU400 represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptors (NHRs) that regulate diverse physiological functions, such as homeostasis, reproduction, development, and metabolism to potentially improve retinal health and function.

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, the expected benefits of RMAT designation, and anticipated regulatory interactions, 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
IR@ocugen.com 

Release – MAIA Biotechnology Announces Dose Selection In Thio-101 Phase 2 Clinical Trial For Non-Small Cell Lung Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 19, 2023 7:00am EST

  • Selected dose shows unprecedented disease control and overall response rates in a NSCLC clinical trial

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, today announced dose selection for THIO-101, a Phase 2 clinical trial evaluating its lead asset, THIO, in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC).

During the dose-finding stage of THIO-101, patients were administered either 60mg, 180mg, or 360mg of THIO per cycle, followed by 350mg of cemiplimab (Libtayo®). The selected dose, 180mg/cycle, presented better safety profile and outperformed the other doses in the key measures of efficacy for NSCLC trials. Subsequently, all future trial participants will be treated with THIO 180mg/cycle.

“All THIO dose levels tested exceeded the disease control rate (DCR) thresholds in Stage 1 of the THIO-101 Phase 2 trial. We observed disease control in the first 8 to 9 patients with a post baseline scan in each arm, beating our goal of disease control in 8 out of 19 patients per arm. Among the three studied doses, the 180mg dose showed stronger DCR and preliminary response rates compared to other doses,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer.

“These results are particularly impressive in this pool of patients who were heavily pre-treated and resistant to prior treatments with immune checkpoint inhibitors, a group that does not yet have standard of care treatment. We are highly encouraged by the unprecedented clinical data generated thus far in our Phase 2 trial, and as we move forward, we plan to pursue accelerated approval for THIO in the U.S. for the treatment of patients with advanced NSCLC. We believe THIO’s DCRs and ORRs in second line treatment suggest the drug’s potential to define the standard of care for this NSCLC patient population.”

THIO is the only direct telomere targeting agent currently undergoing clinical development in the field of cancer drug discovery and treatment.

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/20231219972050/en/

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

Source: MAIA Biotechnology, Inc.

Released December 19, 2023

Bluebird Bio Announces $150 Million Public Offering to Fund Approved Gene Therapies

Posted on by slightbourne@noblecapitalmarkets.com

Cambridge-based gene therapy developer Bluebird Bio announced a public offering of $150 million in common stock to raise capital supporting its three approved treatments and provide working capital.

The pioneer in gene therapies will offer shares on the NASDAQ under the ticker symbol BLUE, with underwriters granted a 30-day option to purchase an additional $22.5 million in stock. Bluebird stated the final size and terms remain subject to market conditions.

Goldman Sachs and J.P. Morgan are serving as joint book runners on the deal, with Raymond James as co-manager on the offering. All shares sold will come directly from Bluebird Bio.

Proceeds from the public stock sale will specifically further commercialization, manufacturing, and launch efforts behind the company’s newly approved gene therapies – Zynteglo for beta thalassemia, Skysona for cerebral adrenoleukodystrophy, and Lyfgenia for sickle cell disease.

The capital raise also provides balance sheet support as Bluebird continues its transition into a fully-integrated commercial biotech selling proprietary therapies targeting rare diseases.

Analysts see the offering as a move to seize current investor enthusiasm and strengthen Bluebird’s financial position after a turbulent few years adjusting to regulatory setbacks.

With three potent gene therapies now approved since August 2022, Bluebird looks to ride accelerating momentum as its treatments reach more patients globally. But the specialized nature of gene therapy production and administration constrains rapid scaling despite massive market opportunities.

Hefty expenses can also accrue during the early stages of drug launches pending insurance coverage and reimbursement decisions country by country.

Tuesday’s proposed $150 million offering suggests management sees room to accelerate growth in 2024 while demand runs hot for novel gene therapies.

Gene Therapies Target Root Causes of Diseases by Manipulating Genes

The permanent gene corrections from one-time gene therapy represent potential cures promising to revolutionize treatment for blood disorders, cancers, inherited disorders and degenerative diseases.

After gene therapy showed immense promise in the 2010s, developmental and safety hurdles caused temporary setbacks for the emerging category.

But breakthrough approvals over the past 18 months from Bluebird and others have reinvigorated investor appetite to fund the next generation of radical genetic medicines now reaching patients in need.

While small in patient size, the market chances to generate multi-billion sales treating high unmet needs in rare diseases with no other solutions for the underlying condition.

Goldman Sachs and JPMorgan’s involvement arranging Bluebird’s latest stock sale reflects rising investor intrigue and renewed confidence in realizing gene therapy’s paradigm-changing potential after past stumbles.

Still Long Road Ahead as Gene Therapies Slowly Build Adoption

However, analysts caution the road remains long translating hype into real revenues as gene therapy faces entrenched barriers preventing mass adoption anytime soon.

Priced at over $2 million per treatment, gene therapies today dispense more hope than profit for developers. Reimbursement pushback from insurers and intense medical limitations temper growth projections.

Bluebird’s approved drugs currently treat tiny populations measured in the single digit thousands globally. But success establishing coverage helps pave the way for expanding into wider therapeutic indications in time.

With fresh financing now on tap, Bluebird Bio stock offers a investment into a maturing gene therapy leader well-positioned to ride coming decades of medical advancements illuminating genetics’ role beating back disease.

Yet expectations likely stay muted near-term for all gene therapy plays absent key inflection events bringing more treatments past global regulatory gates.

Cadrenal Therapeutics (CVKD) – Addressing Unmet Anticoagulation Needs In Orphan Populations

Posted on by cpereira@noblefcm.com


Monday, December 18, 2023

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.

Initiating Coverage Of CVKD.  Cadrenal Therapeutics is developing tecarfarin, an oral anticoagulant for prevention of systemic thromboembolism (blood clots) in rare medical conditions where patients cannot take the commonly prescribed oral anticoagulants. The only available therapy is warfarin, a drug with wide variations in bloodstream levels that requires frequent monitoring to prevent side effects including excessive bleeding risk.

Phase 3 Trial Is Expected In 2024. The lead orphan indication for tecarfarin is in patients with end-stage kidney disease (ESKD) with atrial fibrillation (AFib, irregular heartbeat). The ACTOR-AF Phase 3 trial has been designed as a randomized, double-blind, placebo-controlled study testing tecarfarin against placebo. The amended protocol is expected to be submitted in 1H24 to allow patient treatment to begin in 2H24.


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*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. 

Biotech Dealmaking Heats Up as Private Capital Charges Back In

Posted on by slightbourne@noblecapitalmarkets.com

A wave of multibillion dollar buyouts has swept the beaten-down biotech sector in recent months, marking a potential turning point for an industry hammered throughout 2022 – 2023.

With valuations of public companies still depressed, flush private investors have stepped up acquisitions of promising drug developers to bolster pipelines for the long-term. And in a bullish sign for the strategic direction of the space, therapeutics targeting high unmet needs and novel modalities remain key areas of focus amid dealmaking.

As macro gloom recedes, the renewed embrace of biotech M&A highlights a pivot back toward the innovation-driven spending required to sustain growth post-pandemic.

BMS Kicks Off Buying Spree With $13.2B Turning Point Deal

Bristol Myers Squibb fired the starting gun on big-ticket biopharma deals in October, announcing a $5.8 billion purchase of Mirati Therapeutics (MRTX). The buyout delivered a 122% premium in order to land Mirati’s promising portfolio of precision cancer medicines.

Market observers viewed the unsolicited, $58 per share bid as a credible benchmark of intrinsic value vigilantly researched by a strategic acquirer. Immediately in the deal aftermath, similar development-stage oncology names rallied sharply as traders priced in new takeout probabilities.

In fact, suitors moved swiftly to capitalize on improved biotech sentiment, with Horizon Therapeutics agreeing to a $26.4 billion around the same time. The transaction marked 2023’s largest healthcare buyout, further reinforcing peak valuations remain attainable for commercial-stage rare disease names.

Scaling Up to Compete in Gene Therapy

Gene therapy remains one especially alluring area for dealmaking despite lofty price tags. These ultra-rare disease medicines come with cure potential that commands premium sales and reimbursement pricing power.

Recognizing the imperative to bulk up gene therapy capabilities, Pfizer ponied up $5.4 billion to reinforce its genetic medicines pipeline through the acquisition of French outfit Vivet Therapeutics. The move added Vivet’s promising gene therapy for Wilson disease, along with manufacturing strengths across multiple delivery mechanisms.

And gene editing pioneer Sangamo Therapeutics is selling off its cell therapy assets to Sanofi for $700 million as it refocuses efforts around in vivo gene insertion. The deal hands Sanofi disruptive cell therapy technology utilizing precisely engineered zinc fingers to correct disease-causing mutations.

Analysts say more buyouts centered on next-gen platforms are likely on the horizon as drug developers vie for leadership in areas forecast to reshape therapeutic spaces.

Take a look at more biotechnology companies by looking at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.

Private Capital Eagerly Steps in to Back Innovation

Beyond M&A from strategic acquirers, private equity firms have swooped in to capitalize on depressed biotech valuations. The robust dry powder levels built up during the boom years leave private investors eager to allocate while achieving advantageous cost bases.

Among notable deals, Angel Pond Capital teamed up with life science investor OrbiMed to take gene therapy biotech Generate Biomedicines private for $478 million. The transaction represented a 130% premium to ensure locking up Generate’s base editing technologies believed to be capable of correcting over 75% of known point mutations.

In cybersecurity and enterprise software, sponsor-led take privates had utterly dominated deal flow in 2022. But order books are now once again filling up with biotech buyouts from special purpose acquisition vehicles, highlighting a normalization in deal dynamics after last year’s freeze-out from rate-sensitive private market valuations.

Market Recovery Taking Shape

The fresh upswing in biotech M&A follows a wave of dip buying from some the world’s largest asset managers in shares of industry leaders like Vertex Pharmaceuticals and Regeneron Pharmaceuticals. Warren Buffett’s Berkshire Hathaway has been particularly aggressive stepping in to purchase stakes in key biopharma bluechips.

Meanwhile, the fund-raising backdrop continues improving for earlier stage biotechs as well after deal activity all but shuttered for much of 2023. Multiple debt offerings and venture rounds have successfully priced in recent months, ensuring the all-important continuity of innovation cycling.

With fundamentals stabilizing and access to capital normalizing, the environment for biopharma dealmaking has markedly improved. Expect the momentum to carry through 2024 as drug developers position through M&A for the next, post-pandemic leg higher while private capital readily supports compelling technologies at discounted prices. The long-term health of the biotech ecosystem depends on transactions advancing today’s high-potential assets, and the industry appears to have emerged from its lull ready to strike the necessary deals.

Integra Bets on Ear, Nose, and Throat Growth With $280 Million Acclarent Purchase

Posted on by slightbourne@noblecapitalmarkets.com

Medical device maker Integra LifeSciences announced today it will purchase Acclarent, a leader in ear, nose and throat (ENT) technologies, from Johnson & Johnson’s Ethicon division for $275 million upfront plus future regulatory milestones. The deal values Acclarent at approximately 2.5 times sales, with the company generating $110 million in revenues during 2022.

For Integra, the acquisition provides an opportunity to significantly expand its footprint beyond neurosurgery and establish the company as a major player in the attractive ENT specialty devices segment. The global ENT market is projected to grow at a 5-6% clip annually, adding an estimated $1 billion in addressable market opportunity for Integra.

Acclarent brings to Integra pioneered balloon dilation platforms for treating chronic sinusitis as well as novel treatments for Eustachian tube dilations. Its flagship products are the only FDA-approved stents for maintaining sinus openings after surgery. Acclarent also provides image guidance systems to assist surgeons with minimally invasive procedures.

The company maintains strong brand awareness and deep clinical relationships after rebuilding its commercial presence following a period of declining sales between 2017-2020.

Integra management sees substantial room for additional share gains in ENT given Acclarent’s leadership in balloon dilation and the generally fragmented supplier landscape in ENT today. The global sinus dilation devices market alone is projected to reach $3.5 billion by 2030, providing a sizable growth pipeline for Acclarent’s portfolio.

Strategic and Financial Benefits

The acquisition furthers Integra’s strategy to complement its legacy strength in neurosurgery with scaled positions across faster-growth clinical applications adjacent to its core.

Integra aims to replicate its #1 share in dural repair for neuro procedures by becoming one of few dominant players in ENT. The company believes the combination of its commercial infrastructure and Acclarent’s innovative portfolio can support above-market growth for the foreseeable future.

Financially, Acclarent is being acquired at an attractive upfront valuation of 2.5 times sales. Integra management expects the deal will be immediately accretive to earnings per share after closing.

Acclarent generated gross margins in line with Integra’s overall company average in 2022, providing opportunities for further margin expansion from operating leverage as the business scales.

The transaction also comes at a time when medtech valuations have declined from their pandemic peaks, enabling Integra to obtain Acclarent at what it believes to be an opportunistic price.

Cultural and Portfolio Fit

Integra CEO Jan De Witte highlighted the cultural alignment between both organizations and focus on restoring patient lives as key rationales behind the deal.

De Witte said, “Acclarent’s culture of pioneering technologies aligns with Integra’s legacy of innovation to transform care and restore patients’ lives. We are looking forward to welcoming the Acclarent employees to the Integra team. Together, we can make a profound impact on the future of ENT and neurosurgery.”

Acclarent will operate as part of Integra’s $1.3 billion Codman Specialty Surgical division focused on neurosurgery. Integra sees substantial opportunities for its neurosurgery and ENT sales teams to collaborate on treating certain brain tumors by leveraging skull base surgical approaches.

Integra also gains access to a robust ENT product development pipeline, including next-generation surgical staplers, powered sinus surgery technologies, and potential new indications for Acclarent’s balloon dilation platforms.

Acclarent’s R&D and regulatory expertise will help accelerate Integra’s internal efforts to bring new generations of minimally invasive surgery products to market.

Smooth Post-Close Integration

Integra expects to retain Acclarent’s entire workforce as part of ensuring a smooth organizational transition after the deal closes. The company aims to operate Acclarent as an independent business unit during the near-term while integrating back-office functions.

Manufacturing operations will continue to be outsourced to third parties and Integra anticipates no supply chain disruptions to Acclarent’s product availability.

The transaction is projected to close by the second quarter of 2024, subject to customary antitrust and regulatory clearances globally. Transition services agreements will provide additional support for up to four years following deal closure.

By maintaining continuity of strategy, personnel and manufacturing, Integra hopes to achieve targeted revenue and cost synergies from the integration of Acclarent, while continuing its above-market growth trajectory in the ENT segment. The addition of Acclarent’s portfolio and innovative roadmap makes this transaction an important step forward in Integra’s strategy to complement leadership in neurosurgery with scaled positions in some of medtech’s most attractive and fastest-growing markets.

Release – ZyVersa Therapeutics Engages CRO, George Clinical, for Phase 2a Clinical Trial for Cholesterol Efflux Mediator VAR 200

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Dec 14, 2023

PDF Version

  • Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.

WESTON, Fla., Dec. 14, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces selection of contract research organization (“CRO”) George Clinical to manage its Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD). The clinical trial is expected to begin in the first quarter of 2024.

George Clinical is a leading global CRO, headquartered in Sydney, Australia, with more than 500 experienced people in 39 locations providing the full range of clinical trial services to pharmaceutical, medical device, and diagnostic customers for all trial phases, registration, and post-marketing trials. George Clinical, who combines scientific and clinical leadership with expert trial delivery to create distinctive world-class solutions, was the recipient of Citeline’s 2023 Clinical Research Team of the Year. They were recognized for their success in achieving their goals, effective work practices, creative solutions, and meeting major milestones within expected timelines.

“Initiation of the Phase 2a trial in patients with DKD marks a major milestone in the development of Cholesterol Efflux MediatorTM VAR 200 and for ZyVersa. It is the first clinical trial for VAR 200 and will help establish its effectiveness and safety in renal patients, and it will provide valuable insights to guide development for other planned renal indications (focal segmental glomerulosclerosis and Alport syndrome),” said Stephen C. Glover, ZyVersa’s Co-founder, Chief Executive Officer, and Chairman. “We are pleased to partner with George Clinical to manage this important study. With their unparalleled renal research experience in more than 50 chronic renal disease trials and their reputation as a high performing renal CRO, we are confident that our trial will be conducted in an efficient and timely manner to achieve our milestones and advance VAR 200’s development program to the next level.”

“Collaborating with ZyVersa Therapeutics on this trial shows not only our passion for kidney research but also the commitment to provide the necessary clinical research around innovative treatments that could help patients with unmet medical needs,” said George Clinical Chief Medical Officer Maria Ali.

About VAR 200

Cholesterol Efflux MediatorTM VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is a phase 2a-ready drug in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to kidney disease and its progression. VAR 200 passively and actively removes excess lipids from the kidney.

Preclinical studies in animal models of diabetic kidney disease, FSGS, and Alport syndrome, demonstrate that removal of excess cholesterol and lipids from the kidney’s filtration system with VAR 200 protects against structural damage and reduces excretion of protein in the urine (proteinuria). VAR 200 has potential to treat multiple kidney diseases, including diabetic kidney disease, and rare kidney diseases, FSGS (focal segmental glomerulosclerosis) and Alport syndrome. For more information about VAR 200, Click Here.

About ZyVersa Therapeutics, Inc.

ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs. Our focus is on patients with renal or inflammatory diseases who have significant unmet medical needs. Our development pipeline includes phase clinical stage Cholesterol Efflux MediatorTM VAR 200 in development to alleviate damaging accumulation of cholesterol and lipids in the filtering system of the kidneys. The lead indication is treatment of rare kidney disease, focal segmental glomerulosclerosis. VAR 200 has potential to treat other kidney diseases, including Alport syndrome and diabetic kidney disease. ZyVersa’s pipeline also includes proprietary inflammasome ASC inhibitor IC 100 that blocks initiation and perpetuation of damaging inflammation associated with a multitude of inflammatory diseases. IC 100 has potential to treat many different CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing. A discussion of these and other factors, including risks and uncertainties with respect to ZyVersa, is set forth in ZyVersa’s filings with the Securities and Exchange Commission, including ZyVersa’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

Corporate and IR Contact
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641                

Media Contacts
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
Dschemelia@tiberend.com
609-468-9325

Release – Ocugen, Inc. Announces First Patient Dosed In Phase 1/2 Clinical Trial Evaluating The Safety And Efficacy Of OCU410—Modifier Gene Therapy—For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

December 13, 2023

MALVERN, Pa., Dec. 13, 2023 (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 the first patient has been dosed in the ArMaDa Phase 1/2 clinical trial of OCU410 (AAV-RORA), a modifier gene therapy product candidate being developed for dry AMD (dAMD).

“OCU410, our first-in-class modifier gene therapy for dAMD, addresses gaps among other therapies available and in development for dAMD as a potential one-time treatment for life,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “We are very pleased to continue advancing our ophthalmic gene therapy pipeline, which remains the Company’s primary focus.”

This Phase 1/2 trial will assess the safety and efficacy of OCU410 for geographic atrophy (GA) secondary to dAMD and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study. Phase 2 is a randomized expansion phase in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 dose groups or to an untreated control group.

OCU410 is a potential curative therapy with a single sub-retinal injection that targets multiple pathways causing dAMD, including lipid metabolism, inflammation, oxidative stress, and complement activation. Currently, the other therapeutic options available target only complement activation and require approximately 6-12 intravitreal injections annually.

“Breaking new ground in the pursuit of vision restoration, our pioneering modifier gene therapy candidate, OCU410, achieves another major milestone by dosing a GA patient in a Phase 1/2 clinical trial,” said Arun Upadhyay, PhD, Chief Scientific Officer, Head of R&D at Ocugen. “OCU410 offers hope for those battling GA that are faced with limited treatment options and the real prospect of ultimately losing their vision.”

“There remains a great unmet need for novel durable and effective treatments for GA, which remains one of the most common causes of vision loss globally,” said Benjamin Bakall, MD, PhD, director of clinical research at Associated Retina Consultants (ARC) and clinical assistant professor at University of Arizona, College of Medicine – Phoenix. “I am excited that we performed the first surgery with this novel therapeutic approach—designed to restore homeostasis and slow disease progression following a single treatment—at ARC in Phoenix, AZ, with the surgical team led by Dr. Mark Kwong, medical director of ARC.”

The first surgery was successful in delivering the new gene underneath the retina; the light sensitive nerve tissue lining the inside of the eye.

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.

GA, an advanced form of dry age-related macular degeneration, affects approximately 1 million people in the United States alone.
About OCU410
OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR 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 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. Currently, the other therapeutic options available target only complement activation and require approximately 6-12 intravitreal injections annually.

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.

About Associated Retina Consultants
Associated Retina Consultants is the largest independent retina practice in the state of Arizona, taking part in groundbreaking clinical trials to bring new treatments for the benefit of patients with diseases affecting the retina. In addition to collaborating with Ocugen on the OCU410 clinical trial, in October 2023, Associated Retina Consultants—with a surgical team led by Dr. Mark Kwong—performed gene therapy with OCU400 on a pediatric CEP290 patient. This was the first retinal gene therapy of its kind performed on a child in Arizona.

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
Head of Communications
IR@ocugen.com

Onconova Therapeutics (ONTX) – Poster Presentations Show Activity Of Narazaciclib In Breast Cancer and Lymphoma

Posted on by cpereira@noblefcm.com


Wednesday, December 13, 2023

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

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.

Additional Presentations At Medical Meetings Show Broad Activity and Targeting. In the past week, Onconova has presented additional narazaciclib data at the American Society of Hematology (ASH) conference and the San Antonio Breast Cancer Symposium (SABCS). These presentations show broad multi-kinase activity, improved inhibition of tumor growth, and synergy with other drugs used in mantle cell lymphoma.

The Data Are Consistent With Earlier Presentations. The additional data details broad multi-kinase effects of narazaciclib. Comparisons with the three approved CDK4/6 inhibitors have shown narazaciclib stops cancer cell proliferation by inhibiting more targets and leads to potent, irreversible G1cell cycle blockade. Its side effect profile allows for daily dosing, rather than the 3-week dosing followed by a week of rest to allow recovery.


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*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. 

AstraZeneca’s $1.1B Investment in Next-Gen Vaccine Innovation via Icosavax

Posted on by slightbourne@noblecapitalmarkets.com

Pharma giant AstraZeneca (AZN) announced Monday that it will purchase clinical-stage biotech Icosavax (ICVX) for up to $1.1 billion to augment its pipeline of vaccines targeting respiratory illnesses. Specifically, AstraZeneca aims to leverage Icosavax’s innovative virus-like particle (VLP) platform to develop a first-in-class combination vaccine against respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

Icosavax’s novel VLP technology promises stronger efficacy, fewer side effects, and more durable protection than traditional vaccines – a potential game changer. And the biotech’s lead asset IVX-A12 delivered stellar phase 2 results earlier this year, prompting AstraZeneca to make this big bet on the future of infectious disease prevention.

Transformational Vaccine Approach

At the heart of this deal lies Icosavax’s VLP platform that engineers tiny proteins to mimic the structure of viruses and trigger a robust immune response. Think of VLPs as a sneaky way to train the body to fight off viruses without exposing it to any actual viral particles.

And the data so far indicates VLPs induce broader, more durable protection against infection than conventional vaccines. For example, the VLP approach is behind the extremely efficacious human papillomavirus and hepatitis B virus vaccines on the market today.

Icosavax builds on this proven concept with computationally designed VLPs targeting the unique antigens of RSV and hMPV. So AstraZeneca clearly coveted access to this next-generation technology that could change the way we immunize populations against common illness.

Expedited Path for Lead Asset

Central to the deal is Icosavax’s IVX-A12, a combo VLP vaccine to prevent RSV and hMPV, which both cause severe respiratory infection in the elderly and immunocompromised. IVX-A12 demonstrated outstanding immunogenicity – triggering enduring antibody responses – along with a clean safety profile in trials so far.

In fact, the vaccine’s phase 2 results were strong enough for the FDA to award IVX-A12 Fast Track designation. This promises an expedited path to approval given the high unmet need: there are no approved vaccines for older adults against these widespread, often dangerous pathogens.

So AstraZeneca leapfrogs development by 3-4 years via this acquisition rather than advancing an early-stage candidate itself. As part of a big pharma, IVX-A12 now has the resources for rapid phase 3 trials and submission for emergency use authorization potentially next year.

Aligns with Growth Strategy

Importantly, this deal fits squarely with AstraZeneca’s strategy of strengthening its portfolio in areas of high unmet need. As Executive VP Iskra Reic highlighted, adding IVX-A12 distinguishes AstraZeneca’s late-stage pipeline in preventative infectious disease treatments.

While the company already markets FluMist for influenza, a next-gen offering like IVX-A12 that could supplant outdated RSV vaccines or ineffective hMPV options would be a true differentiator. It also complements AstraZeneca’s leading COVID-19 antibody cocktail for immunocompromised patients unable to mount their own response.

Beyond the tech and pipeline boost, Icosavax also brings its experienced team and manufacturing capabilities to scale up production in anticipation of launch.

Investor Implications

Turning to the transaction itself, AstraZeneca’s upfront $15 per share offer in cash reflects a 43% premium to Icosavax’s December 9 close before rumors leaked. Including the $5 per share milestone payment, the total value exceeds $1 billion for a 91% premium.

Of course the back half requires IVX-A12 to gain approval and hit $750 million in sales, so some risk is baked in. But given peak revenue estimates exceeding $2 billion, this seems doable over 5-10 years post-launch.

Investors should watch for completion of the tender offer expected in Q1 2024. Passing majority shareholder approval should be straightforward with such a compelling premium. Then it becomes about execution – advancing IVX-A12 rapidly through late-stage trials.

Ultimately though, AstraZeneca makes a well-timed bet on revolutionary vaccine science that could elevate its infectious disease segment to new heights. And Icosavax investors get to participate in this next chapter via an up to 91% buyout windfall. Once again, merger mania in biopharma looks set to pay off handsomely.

Release – Onconova Therapeutics’ Narazaciclib Ash Poster Highlights Activity In Treatment Resistant Mantle Cell Lymphoma

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX


Dec 12, 2023

Preclinical data show that narazaciclib treatment led to significant tumor growth inhibition, demonstrating synergy with standard-of-care ibrutinib, in ibrutinib-sensitive and -resistant settings

Early Phase 1/2 studies suggest potential for an improved profile and daily dosing

Dose escalation is underway in lead indication of Low Grade Endometrioid Endometrial Carcinoma (LGEEC), with plans to define the Recommended Phase 2 Dose (RP2D) and prepare for registrational studies, with a planned update in H1 2024

NEWTOWN, Pa., Dec. 12, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced preclinical data, highlighting narazaciclib’s preclinical activity in Bruton’s kinase inhibitor (BTKi)-resistant mantle cell lymphoma (MCL), in a poster presented on December 11, 2023 at the 65th Annual Meeting of the American Society for Hematology (ASH 2023) in San Diego.

“We are pleased to have shared data at ASH 2023 from preclinical studies with narazaciclib in MCL models. These results, which are consistent with data presented this year at the international MCL conferences, demonstrate that treatment with narazaciclib led to significant tumor growth inhibition when used as a single agent and that combination with ibrutinib demonstrated synergy, in both ibrutinib-sensitive and -resistant in vitro and in vivo settings,” said Steve Fruchtman, M.D., President and Chief Executive Officer. “These data are important because they provide further evidence for the potential use of narazaciclib in cancers with cyclin over-expression and elaborate our understanding of narazaciclib’s mechanism of action, including its ability to promote G1 cell cycle blockade.”

Dr. Fruchtman continued, “We believe that these data, along with the preclinical data presented on Friday, December 8th at the San Antonio Breast Cancer Symposium (SABCS), further underscore the impressive and differentiated profile of narazaciclib. The data presented at SABCS highlight narazaciclib’s multi-kinase activity, its ability to target resistance pathways missed by other CDK4/6 inhibitors, and its differentiated anti-tumor and immunomodulatory activity. The data presented at ASH 2023 show that narazaciclib, in combination with BTKi’s such as ibrutinib, also trigger metabolic reprogramming alongside DNA damage.”

“The totality of these data is helping us to shape the clinical program for narazaciclib, including the lead indication of LGEEC, with further potential to expand into additional investigator-sponsored studies in breast, ovarian, and other cancers. We are pleased with the early Phase 1/2 data for narazaciclib monotherapy and in combination with letrozole, showing lower levels of neutropenia and diarrhea, and the potential for once daily dosing. Both of these attributes could position narazaciclib as a differentiated and improved CDK4/6i. Looking ahead, we are enthusiastic to advance the clinical program for narazaciclib in 2024 and to update our stakeholders regarding our progress, including the planned completion of dose escalation studies, definition of an RP2D, and development of our registrational trial plans for LGEEC. The data presented at ASH suggest narazaciclib is a drug with the potential to target a variety of cancer indications with an unmet medical need, including MCL,” concluded Dr. Fruchtman.

Poster Highlights

Title: Narazaciclib, a differentiated CDK4/6 antagonist, prolongs cell cycle arrest and metabolomic reprogramming, enabling restoration of ibrutinib sensitivity in BTKi-resistant mantle cell lymphoma

Objectives: To evaluate the activity and mechanism of action of narazaciclib as a single agent and in combination with ibrutinib, in comparison to the standard-of-care ibrutinib, in preclinical models of MCL that are sensitive and resistant to ibrutinib treatment.

Snapshot of the Results and Conclusions:

  • Tumor Growth Inhibition: Narazaciclib showed safety and efficacy as a single agent in preclinical MCL models, including ibrutinib-resistant settings, with significant reductions in cell viability.
  • Combination Synergy: The narazaciclib plus ibrutinib combination showed synergy in vitro and in vivo, especially in ibrutinib-resistant models, with overall greater synergy, measured by lower “Combination Index” values, versus ibrutinib-sensitive cells.
  • Cell Cycle Blockade: The combination of narazaciclib plus ibrutinib induces a superior G1 cell cycle blockade in both ibrutinib-sensitive and ibrutinib-resistant MCL cells.
  • Metabolic programming: In ibrutinib-resistant cases, the synergy between narazaciclib and ibrutinib triggers metabolic reprogramming alongside DNA damage, mediated by the USP24 and P53 axis, as evidenced by several assays to assess mitochondrial metabolism.

Together, these preclinical data suggest that narazaciclib has important single agent activity and the potential to restore ibrutinib sensitivity in BTKi-resistant models, successfully meeting the primary objective of the study.

A copy of the poster is available on the “Scientific Presentations” section of the Onconova website.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer, ovarian cancer, multiple myeloma, and mantle cell lymphoma.

Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).

For more information, please visit www.onconova.com.

Forward Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

MustGrow Biologics Corp. (MGROF) – New Commercial Agreement with Bayer

Posted on by cpatches


Tuesday, December 12, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

New Agreement. MustGrow announced yesterday that the Company signed a collaboration agreement with Bayer AG covering soil applications of MustGrow’s mustard-based biocontrol technologies in Europe, Middle East, and Africa, excluding home and garden, turf, and ornamental applications. Bayer also has been granted a right-of-first-negotiation for a license to use MustGrow’s technologies for use in bananas in particular applications.

Details on the Agreement. Under the terms, MustGrow will be receiving an initial upfront payment as well as additional payments linked to the achievement of certain business milestones. Once the commencement of commercial sales has begun, MustGrow also will be entitled to fees from royalties and manufacturing sales. Bayer will be responsible for regulatory and market development work to commercialize MustGrow’s mustard-based biocontrol technologies.


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