Category: Health

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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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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Release – Tonix Pharmaceuticals to Present at The National Academies Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures Public Meeting

Posted on by cpatches
Research News and Market Data on TNXP

CHATHAM, N.J., Dec. 11, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Seth Lederman M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the National Academies of Sciences, Engineering, and Medicine Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures public meeting on Thursday, December 14, 2023 via Zoom. Dr. Lederman will participate in a panel discussion on Vaccine Research & Development taking place from 2:00 – 2:45 p.m. ET.

Discussions will explore lessons learned from the recent COVID-19 pandemic and mpox multi-country outbreak to inform an evaluation of the current state of research, development, and stockpiling of smallpox readiness and response measures.

A webcast of the meeting can be found here and will be available under the IR Events tab of the Tonix website at www.tonixpharma.com following the presentation.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed the clinical phase of a potentially confirmatory Phase 3 study in the fourth quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin) is in development as a preventive treatment in chronic migraine, with analysis of topline data from a Phase 2 proof-of-concept study expected to be completed late December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology development portfolio includes 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. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

*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. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. 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 market 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Cigna and Humana Merger Unravels Amid Price Disputes, Cigna to Pursue Share Buyback

Posted on by cpatches

Cigna has reportedly withdrawn from a significant merger with Humana, citing failed negotiations on pricing as the primary reason, according to insider sources. The deal, if successful, would have propelled the combined entity’s value beyond $140 billion, positioning it as a major player in the insurance sector. The potential mega-deal would have undoubtedly faced scrutiny from regulators, especially in light of regulatory blocks on similar consolidations in the health insurance sector six years ago. Cigna, undeterred by the merger setback, has announced plans to repurchase $10 billion worth of shares, a move deemed by management as a value-enhancing use of capital given their belief that Cigna shares are currently undervalued.

Connecticut-based Cigna, whose shares rose 12.1% to $290.07 in premarket trading on Monday, is down approximately 22% this year, experiencing a 10% decline since late November when reports of the deal talks with Humana surfaced. The company remains open to the prospect of a future merger with Humana, asserting confidence in the deal’s regulatory feasibility despite the Biden administration’s stringent stance on mergers.

Both Cigna and Humana are significant players in the health insurance sector, each with distinct operations. Cigna, a global health service company, has a diversified portfolio covering insurance, pharmacy benefits, behavioral health, and related services. The company’s strategic decision to explore the sale of its Medicare Advantage business, which caters to government health insurance for individuals aged 65 and older, indicates ongoing efforts to refine its business focus.

On the other hand, Humana, a prominent health and well-being company, specializes in health insurance and wellness solutions. The potential merger with Cigna would have endowed the combined entity with increased scale, positioning it as a formidable competitor against larger U.S. health insurance players such as UnitedHealth Group and CVS Health.

As Cigna navigates the aftermath of the abandoned merger, the company’s shift towards share buybacks and potential bolt-on acquisitions aligning with its strategies reflects a strategic realignment. The health insurance landscape remains dynamic, and Cigna’s future moves, including a possible revisiting of a Humana combination, will undoubtedly shape the trajectory of both companies in this ever-evolving sector.

Get to know a selection of emerging growth biotechs by exploring Noble Capital Markets’ Senior Analyst Robert LeBoyer’s coverage list.

Pushing the Frontiers: Innovation and Investment in Organ Transplantation

Posted on by slightbourne@noblecapitalmarkets.com

The NobleCon19 panel discussion moderated by Nathan Cali, investment banker at Noble Capital Markets, on organ transplantation featured prominent figures in the field, including Dr. Karin Hehenberger, an organ transplant patient and founder of Lyfebulb, Dr. David Alexandre Gros, CEO of Eledon Pharmaceuticals, Dr. Muhammed Mohiuddin, director of the cardiac xenotransplantation program at the University of Maryland, and Dr. Pietr Witoski, surgery director of pancreatic and islet tranplant program at the University of Chicago. The discussion delved into their experiences, challenges in the organ transplant landscape, and revolutionary advancements, especially focusing on the concept of xenotransplantation.

Organ transplantation has come a remarkably long way since the first successful procedures in the 1950s and 60s. Yet there remain significant unmet needs and opportunities to further improve patient outcomes, quality of life, and access to these lifesaving procedures. At a presentation during NobleCon19, a panel of experts explored some of the latest breakthroughs and remaining challenges in areas ranging from immunosuppression to cross-species transplantation.

A Complex Treatment Paradigm

As patient-turned-advocate Dr. Karin Hehenberger related from personal experience, undergoing an organ transplant and living with a graft is filled with difficulties. The trauma of the surgery itself and needing immune-suppressing drugs just to avoid rejection deliver blows to physical health and mental wellbeing. This begins with a harrowing wait for a matching donor organ, continues through post-operative complications like infections, and extends for the rest of one’s life.

The panelists agreed the pressure on patients could be significantly reduced through innovation. More targeted immunosuppressants without harmful side effects would greatly improve quality of life after transplant surgery. Some emerging drug candidates like Eledon Pharmaceuticals Tegoprubart show early signs of progress on this front. There is also a global shortage of donor organs trailing far behind demand; new sources through xenotransplantation or regenerative medicine techniques could help resolve this shortage.

“We need a community where transplanted patients can come together, generate data, and advocate for change,” urged Dr. Hehenberger.

The valuable role of patient communities mirrors the interdisciplinary cooperation needed among the surgeons, specialists, social workers, and other caregivers that make organ transplantation successful. As Dr. Hehhenberger explained, the assessment process for transplant eligibility spans physical health, mental fitness, medication compliance, accessible transportation, and financial support. It is complex care with little margin for error.

An Evolving Market Landscape

Currently, the organ transplant market racks up over $5 billion in value each year and continues expanding at a steady pace. Much of this activity centers specifically around kidney transplants, where surgical innovations and public policy initiatives keep pushing the boundaries. As Dr. DA Gros noted, there are now a quarter million Americans living with a functioning kidney graft – proof of concept for an underappreciated treatment paradigm.

And yet, the surface has barely been scratched in terms of serving potential patients. Over half a million more remain tethered to dialysis as a stand-in for natural kidney function, with 125,000 added to this group annually in the U.S. alone. Dialysis generates its own burdens: decreased workplace productivity, infection risks, lower quality of life. From both humanitarian and financial viewpoints, empowering wider transition from dialysis to transplantation promises tremendous upside.

Experts on the panel targeted improved education around organ transplant options as a key opportunity. Many patients lack full information about the benefits transplant procedures can offer, or they confront social stigmas against this route. Policy revisions to widen access and increase support for lower-income patient communities could have an outsized impact as well.

Meanwhile, the business of organ transplantation continuously evolves. Major pharma companies like Bristol Meyers Squib remain heavily invested, yet a series of smaller players also drive momentum through novel immuno-therapy products. Audience members were encouraged to track firms like Aelix and Tacus for the next wave of clinical updates that will shape standard of care.

Pioneering the Future

Homing in on the future, speakers keyed in on barriers still to be conquered in transplantation medicine. While kidney procedures serve as a beachhead, there is a pressing need to expand reliable methods across more organ types while lengthening graft duration at the same time. This is no small task.

It will require rethinking conventional assumptions for a field that has relied predominantly on broad immune suppression since its inception. Some emerging biotech pipelines target specific T and B cell pathways implicated in chronic organ rejection, attempting to avoid toxicity associated with generalized immunosuppression. Early data hints at improved longevity for liver and heart grafts, but longer studies are still needed.

An even more radical solution highlighted by multiple panelists is the concept of xenotransplantation: introducing organs from other species like pigs into human patients. Recent demonstrations of human-pig heart and skin grafts saw patients survive months post-procedure compared to an anticipated span of days or weeks. The results electrified the transplant community given implications for essentially eliminating organ supply constraints.

That said, experts admit there are hurdles left to address before clinical adoption. Ethical quandaries exist around genetically modifying donor animals and infectious disease transmission risks from one species to another. Questions also persist about which immune pathways necessitate targeting for prolonged graft survival and how to refine the anti-rejection pharmaceutical regimens employed.

Signs point to countries with more flexible regulatory regimes as the likely springboards for refining xenotransplant methods and technology in the shorter-term. Yet the longer-term promise seems resoundingly clear. “If allowed, we will solve the organ shortage problem,” declared surgeon Dr. Peter Witoski when asked about outlook for the field.

A Call to Action

In closing the panel presentation, speakers underscored a sense of guarded optimism balanced with persistent unmet needs in transplantation medicine today. Limitations around donor organ supply and chronic graft failure continue exacting a real human toll, even if raw statistics showcase a steady rise in life-saving procedures overall.

It will take coordinated effort from policy makers, researchers, clinicians, investors and patient advocates to push new discoveries over the finish line – where they can impact the maximum number of lives. Key questions around optimal business models for novel therapeutics, data transparency, and equitable access are unlikely to solve themselves.

Yet the convergence of breakthrough technologies and innovative platforms for generating evidence, educating stakeholders and disseminating insights points toward a sea change for what the future may hold in this vital area of healthcare. The experts and audience members left the discussion around organ transplantation feeling energized to play their respective parts in driving that change.

Watch the webcast from The Organ Transplant presentation at NobleCon19 here

Release – ZyVersa Therapeutics Announces Publication Demonstrating That Plasma Levels of NLRP3 Inflammasomes Correlate with Progression of Diabetic Kidney Disease in Patients with Type 2 Diabetes

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Dec 7, 2023

  • Diabetic kidney disease (DKD), which affects around 240 million people with Type 2 diabetes worldwide, is the leading cause of end-stage renal disease, which requires dialysis or kidney transplant for survival.
  • The article published in Alternative Therapies demonstrates that plasma NLRP3 inflammasomes and their resulting proinflammatory cytokines are significantly elevated in early-stage DKD and that levels progressively increase as kidney function worsens, with highly significant elevations (p<0.01) at each stage of disease.
  • Data suggest that early DKD intervention with inflammasome inhibitors has potential to attenuate disease progression.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits multiple inflammasome pathways (including the inflammasome NLRP3 pathway) to attenuate initiation and perpetuation of damaging inflammation that is pathogenic in DKD and other inflammatory diseases.

WESTON, Fla., Dec. 07, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of renal and inflammatory diseases, announces publication of an article in the peer-reviewed journal, Alternative Therapies, demonstrating that plasma NLRP3 inflammasomes and their resulting proinflammatory cytokines are significantly elevated in early-stage DKD and that levels progressively increase as kidney function worsens.

In the paper titled, “Correlation Between Plasma NLRP3, IL-1β, and IL-18 and Diabetic Nephropathy in Patients With Type 2 Diabetes,” the authors evaluated the plasma of 152 patients with type 2 diabetes and DKD stratified by stage of disease (stages 1-5) and 30 patients with type 2 diabetes without kidney disease who serve as controls. Following are key findings reported in the paper:

  • Plasma levels of NLRP3 and proinflammatory cytokines, IL-1β, and IL-18, were significantly higher than controls in patients in each of the 5 stages of DKD, with progressively higher levels as kidney disease progressed (p<0.01).
  • NLRP3, IL-1β, and IL-18 levels positively correlated with DKD stage (p= 0.01), based on the Spearman correlation analysis.
  • These data are consistent with other studies demonstrating that inflammation has an important role in the development and progression of DKD.

To read the article, Click Here.

“The research published in Alternative Therapies reinforces the role of inflammasome-driven inflammation in development and progression of DKD, the leading cause of end-stage kidney disease, which requires dialysis or kidney transplant for survival,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Although substantial progress has been made in slowing progression of DKD with introduction of ACE inhibitors, ARBs, and most recently SGLT2 inhibitors, patients are still progressing to end-stage renal disease. The data published in Alternative Therapies suggest that early DKD intervention with inflammasome inhibitors has potential to help attenuate disease progression.”

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous 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.

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
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

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

AbbVie’s $8.7 Billion Acquisition of Cerevel Therapeutics: A Game-Changer for Neuroscience Innovations

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant AbbVie made a huge splash in the neuroscience space this week with the announcement of its definitive agreement to acquire clinical-stage biotech Cerevel Therapeutics for $8.7 billion. This transforms AbbVie’s position in neuroscience and adds multiple late-stage assets to its pipeline that could drive significant growth over the next decade.

At $45 per share in cash, AbbVie is paying a hefty premium for Cerevel, reflecting its belief in the blockbuster potential of the company’s pipeline. Cerevel has built an impressive roster of new compounds for psychiatric and neurological conditions—areas where AbbVie already has an established presence with treatments for Parkinson’s disease and migraine but now gains even more scale.

The crown jewel of the deal is emraclidine, an investigational antipsychotic for schizophrenia and other psychiatric disorders that could set a new standard of care. Currently in late-stage development, emraclidine has shown early signs of superior efficacy and safety compared to existing schizophrenia meds. With schizophrenia impacting over 5 million people across developed markets, emraclidine represents a multibillion-dollar opportunity for AbbVie commercially.

Beyond emraclidine, Cerevel has a range of other clinical-stage neuro assets that strengthen and complement AbbVie’s pipeline. These include tavapadon for Parkinson’s, CVL-354 for depression, and darigabat for epilepsy—all of which have potential for best-in-class status in their respective categories.

Take a moment to take a look at Noble Capital Capital Market’s Senior Research Analyst Robert LeBoyer’s coverage universe.

According to AbbVie’s chairman and CEO Richard Gonzalez, “Our existing neuroscience portfolio and our combined pipeline with Cerevel represents a significant growth opportunity well into the next decade.” He notes AbbVie’s global commercial infrastructure can help accelerate these drugs to market globally.

Gonzalez has orchestrated a highly successful strategy for AbbVie centered around building global therapeutic franchises in immunology, oncology, and aesthetics. Adding neuroscience as a fourth core franchise has been an ambition for awhile. Between Humira facing biosimilar competition and the need to fuel AbbVie’s next chapter of growth, this acquisition is a strategic step to position neuroscience as a more prominent piece of the puzzle.

For Cerevel, the buyout represents a major win and validation of the platform they have built. As CEO Dr. Ron Renaud comments, “Cerevel has always been committed to transforming what is possible in neuroscience…with AbbVie’s long-standing expertise in developing and commercializing medicines on a global scale, Cerevel’s novel therapies will be well positioned to reach more people.”

Wall Street is reacting positively to the deal announcement, with shares of both companies rising 3-4% the day it was announced. Investors recognize the growth implications and are cheering AbbVie’s move to recharge its pipeline.

While the deal is expected to close in 2024 pending approvals, it marks the continuation of a surge in biotech M&A driven by the appetite of large pharmas to augment their portfolios externally. With over 200 neuroscience programs in mid- to late-stage industrywide across CNS disorders, neurological treatments are having a moment right now. For AbbVie, the Cerevel transaction cements its intent to be at the forefront in capturing this opportunity.