• The year “gaslighting” of women with hard-to-diagnose maladies was finally given the kabosh?
• The year we found the hormone causing acute morning sickness?
• Impressive and large funding rounds despite a bleak funding environment?
• “Birth control for men” makes it to the clinical trial stage?

By Anna Zornosa - In the shadow of one very bad, no-good horrible development setting women’s health back decades (the overturning of Roe V. Wade), I spent the year taking note of some amazing advances happening in the pursuit of health solutions for women. Curious if others were also seeing bright spots, I asked some of the smartest women I know if they’d also seen events signaling notable progress.

My timing was bad: with the holidays upon us I knew some could not answer. But to my delight I got observations Barbara Levy, MD, FACOG, FACS : from CEO/Founders Somer Baburek, MBA (Hera Biotech), Melody Roberts (Liv Labs), and Melissa Bowley (Flourish Care); from author Susan Salenger; medtech designer and diversity driver Nada (Osman) Hanafi ; investors Jessica Karr and Susan Solinsky; and Ayse McCracken, Founder of the Ignite Accelerator for women leading life science companies.

What did we miss? A lot, certainly. Please add your own “brightspots of note” to comments. This will create something we can all turn to if (when) bad developments happen in 2024.

• CEPI to invest funding of up to $34.8 million to Barinthus Bio in addition to funds previously committed to the University of Oxford to develop and stockpile a ready reserve of emergency MERS vaccine candidate, VTP-500.
• VTP-500 project with Barinthus Bio and University of Oxford uses tested ChAdOx1 platform.
• If successful in Phase II trials, this will progress VTP-500 significantly towards regulatory approval and doses could be rapidly deployed in a clinical trial setting in response to a substantial outbreak.

OXFORD, United Kingdom, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced a project with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford, aiming to fast-track the development of a vaccine candidate known as VTP-500 for the prevention of Middle East Respiratory Syndrome (MERS), the often fatal disease caused by the MERS coronavirus. Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.

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GERMANTOWN, Md., Dec. 19, 2023 /PRNewswire/ -- Deka Biosciences ("Deka") today announced the appointments of Stanley Frankel, M.D., FACP, as senior clinical advisor, interim chief medical officer and scientific advisory board member, and Stuart Chaffee, Ph.D. as an independent director and chairman of the Board. Deka is a privately held biotech company developing next-generation cytokine therapies to treat cancer and inflammatory diseases based on a patient's individual immune response. Deka's lead asset, DK2¹⁰ (EGFR), is currently being evaluated for the treatment of multiple solid tumors in a Phase 1 clinical trial.

On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The following Q&A, in connection with our previously published Client Alert, illuminates the details of the Proposed Framework.

Q: If my company takes SBIR/STTR funding from a federal agency, does the Bayh-Dole Act apply?

A: Yes. A company that receives Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) funding is considered a “contractor” under the Bayh-Dole Act. As such, inventions conceived of or first actually reduced to practice using SBIR or STTR funds will be subject to the Bayh-Dole Act. This applies even if the funds are used only to develop confirmatory data for an invention conceived of without the use of SBIR or STTR funds.

Have you ever wondered about the true impact of Artificial Intelligence (AI) in the BioHealth industry? In this episode of BioTalk with Rich Bendis, we have the privilege of hosting Dr. Juergen Klenk, a Principal at Deloitte and a Board Member at BioHealth Innovation. Dr. Klenk brings a wealth of expertise and experience with a unique background combining formal scientific training and entrepreneurial ventures.

Join us as we embark on an insightful discussion about the current state of AI in the BioHealth industry, diving deep into the realities and challenges of this cutting-edge technology. Dr. Klenk shares his interest in AI and the reasons behind its increasing prominence in the field. We explore the historical origins of the AI hype cycle and how we've reached the stage we're in today.

Listen now via your favorite podcast platform:

• Apple Podcasts: 🍎🎙️ - https://apple.co/41u5PtL
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• Spotify: 💚🎶 - https://spoti.fi/470FMeZ
• Amazon Music: 📦🎵 - https://amzn.to/3tpILzZ
• TuneIn: 📻🔊 - https://bit.ly/3RvUF3l

Irazu Oncology, which is using a platform built by researchers at University of Maryland, Baltimore to develop cancer vaccines, has secured $2.6 million in debt from an undisclosed source, according to a recent listing on Crunchbase.

Founded by Marco A. Chacón, an industry veteran who founded and ran Paragon Bioservices for over two decades, Irazu Oncology is commercializing UMB’s novel immunotherapeutic vaccine technology. It operates out of the University of Maryland BioPark. The company is a winner of TEDCO’s Maryland Innovation Initiative Company Formation Awards.

Novel Approach

Irazu Oncology has a licensing deal with UMB to commercialize a membrane vesicle vaccine development platform built at the university by a research team led by James Galen, Ph. D. The platform uses the outer membrane of vesicles — a structure within or outside a cell — as cancer vaccines that can stimulate an immune response. Irazu Oncology’s proprietary, attenuated bacteria are engineered to produce OMVs bearing tumor antigens on their surface. These antigens are delivered to various sites in the body, stimulating a natural immune system that can destroy cancerous cells.

by Ellen D. Harpel | Dec 17, 2023

As Smart Incentives marks its 10th year, we have been revealing the top ten ways that incentives have changed since 2013. We are pleased to share the full list of incentive trends here in our last blog article of 2023. 

1. Big incentive deals are getting bigger. Top projects receive significantly higher offers than in the past. The most prominent incentive packages are for new electric vehicle and semiconductor facilities. However, looking past these high profile projects, the average incentive offer has been surprisingly stable over the past decade.

2. The rise of remote work. Remote and hybrid work continue to reshuffle our living and working patterns. Incentives to attract remote workers have become part of the landscape. Many traditional business incentive programs are adjusting how they count workers to account for remote or hybrid work.

3. Better project compliance and reporting. State and local governments have improved their ability to track incentivized projects, monitor performance, and share results with internal and external stakeholders. 

In a landmark study led by the University of Maryland School of Medicine, researchers discovered for the first time that a certain kind of protein similar to hemoglobin, called cytoglobin, plays an important role in the development of the heart. Specifically, it affects the correct left-right pattern of the heart and other asymmetric organs. The findings, published today in the journal Nature Communications, could eventually lead to the development of new therapeutic interventions to alter the processes that lead to these defects.

The team, led by senior author Paola Corti, PhD, along with along with University of Maryland School of Medicine Dean Mark T. Gladwin, MD, as senior co-author, used CRISPR gene editing technologies to knock out the cytoglobin gene in zebrafish. The lack of cytoglobin caused the development of embryos with a mirrored heart, meaning the heart had a reversed left-right pattern. In humans, cytoglobin is involved in processes involving nitric oxide, a compound that helps regulate healthy blood flow to organs.

By Dan Brendel – Staff Reporter, Washington Business Journal Dec 15, 2023 - 

United Therapeutics Corp. is teeing up major organ production facility at its Silver Spring biotech campus through a proposed land swap with Montgomery County.

The company (NASDAQ: UTHR), a longtime drugmaker of pulmonary hypertension therapies that in recent years has expanded into bioengineered organs, has agreed to trade several parcels it owns for a county-owned site on 3.8 acres adjacent to its headquarters at 1000 Spring St.

The site, now home to a parking garage and other county operations, could yield up to 831,000 square feet under existing zoning.

The U.S. National Science Foundation today announced the first-ever Accelerating Research Translation (ART) investment — more than $100 million to 18 teams at academic institutions across the nation. NSF's investment will enable academic institutions to accelerate the pace and scale of translational research that will grow the nation's economy.

"NSF endeavors to empower academic institutions to build the pathways and structures needed to speed and scale their research into products and services that benefit the nation," said NSF Director Sethuraman Panchanathan. "The Accelerating Research Translation program in NSF’s new Technology, Innovation and Partnerships (TIP) Directorate identifies, and champions institutions positioned to expand their research translation capacity by investing in activities essential to move results to practice."

• The collaboration will evaluate the ability of NeoImmuneTech's immune cell amplifier NT-I7 to increase the number of azer-cel allogeneic CAR T cells per batch during manufacturing.
• The combination potential of azer-cel and NT-I7 to increase the number and cancer-fighting properties of the patients own T cells during their treatment with azer-cel, will be evaluated in preclinical work.

ROCKVILLE, Md., Dec. 11, 2023 /PRNewswire/ -- Imugene Ltd ("Imugene") (ASX: IMU), a clinical stage immuno-oncology company, and NeoImmuneTech, Inc. ("NIT"), (KOSDAQ: 950220) a clinical-stage T-cell-focused biopharmaceutical company, today announced a strategic collaboration to evaluate Imugene's allogeneic CAR T, azer-cel, in combination with NIT's proprietary immune T cell amplifier "Fc-fused recombinant human interleukin-7", NT-I7, for the treatment of cancer.

Azer-cel is an allogeneic CD19 CAR T cell therapy program with extensive clinical data and a potentially fast-to-market development strategy. Azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile in blood cancers such as lymphoma and leukemia.  

By Anastassia Gliadkovskaya - Dec 11, 2023 4:00pm - 

Floreo, maker of virtual reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation. 

The company has also been accepted into the newer Total Product Life Cycle Advisory Program (TAP). While the breakthrough device designation helps streamline the process for medical device premarket approval, the TAP Program offers insights and resources to assist with the path to commercialization. 

“Floreo is seeking full market authorization and a label to further recognize its effectiveness in augmenting therapy and outcomes,” Vijay Ravindran, co-founder and CEO of Floreo, told Fierce Healthcare. The other goal with full market authorization is “opening up any and all reimbursement pathways so that Floreo can reach the million-plus families searching for better outcomes,” he added.

BALTIMORE, Maryland, December 11, 2023 – GlycoMantra, a University of Maryland, Baltimore (UMB) startup company developing therapeutics for unmet medical needs in metastatic castration-resistant prostate cancer (mCRPC), MASH liver fibrosis, and type 2 diabetes (T2D), was recently awarded a two-year, $3.7 million Small Business Innovation Research (SBIR) Phase II grant from the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health, to advance their therapeutic pipeline.

Currently, there are no United States Food and Drug Administration-approved drugs for mCRPC patients who develop a resistance to second-line hormonal therapies, or for the treatment of liver fibrosis or lung fibrosis. GlycoMantra is working to develop a therapeutic that will halt or reverse these diseases. The Phase II SBIR award will support the Company’s development of mammalian cell lines, a master cell bank (MCB), and the cGLP manufacturing for this drug.

Are you ready to dive into the world of groundbreaking biotechnology and the fight against chronic diseases? In this episode of BioTalk with Rich Bendis, we bring you an enlightening conversation with Dr. Nehal Mehta, Founder and CEO of Mobius Scientific, Inc. Dr. Mehta is not only a distinguished Professor of Medicine but also a visionary entrepreneur on a mission to revolutionize healthcare.

Join us as we explore the journey of Mobius Scientific, an early-stage biotechnology company with a transformative approach. Mobius is developing cutting-edge biologic therapies targeting the root cause of chronic diseases, starting with lipid accumulation. This innovative platform has the potential to change the lives of millions suffering from debilitating conditions.

Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy. 

Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S. It is most common in African Americans and, while less prevalent, also affects Hispanic Americans. The primary problem in sickle cell disease is a mutation in hemoglobin, a protein found in red blood cells that delivers oxygen to the body’s tissues. This mutation causes red blood cells to develop a crescent or “sickle” shape. These sickled red blood cells restrict the flow in blood vessels and limit oxygen delivery to the body’s tissues, leading to severe pain and organ damage called vaso-occlusive events (VOEs) or vaso-occlusive crises (VOCs). The recurrence of these events or crises can lead to life-threatening disabilities and/or early death. 

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BALTIMORE, Dec. 7, 2023 /PRNewswire/ -- BioGenCell, a pioneer in personalized cell therapy solutions, is excited to announce the launch of its fifth Phase II clinical trial site in the United States at the University of Maryland. The trial is focused on significantly reducing the need for amputation in patients with Chronic Limb-Threatening Ischemia (CLTI). The University of Maryland has joined this ambitious, global, placebo-controlled trial designed to offer transformative results for patients.

The prognosis for CLI patients is currently disheartening: within a year of diagnosis, nearly 20% of patients succumb to the disease while 30% will undergo amputation. Tragically, nearly 70% of these amputees do not survive beyond five years post-amputation.

WASHINGTON, Dec. 7, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has acquired U.S. and Canadian rights to PONVORY^® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company. PONVORY^® is approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. PONVORY^® has a proven safety profile with over 10 years of data.

"The acquisition of Ponvory is a significant milestone for Vanda, as it expands our commercial portfolio and gives us access to a versatile immune response modifier that can potentially have broad application in treating a number of autoimmune-based disorders," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board.

ARPA-H made its final hub location decision, selecting the historic Bowen Building in downtown Washington, D.C. as the site for its Stakeholder & Operations hub.

Why is this important? The new space will allow federal staff and contractors to work in one location, enhancing staff's ability to manage programs and coordinate with federal partners—such as Congress, Health and Human Services, Centers for Medicare and Medicaid Services, U.S. Food and Drug Administration, the National Institutes of Health, and the Administration. Since the agency was authorized in March 2022, much of ARPA-H's D.C. staff has been working remotely or from temporary offices.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics (Nasdaq: UTHR), a public benefit corporation, today announced that the company has been named on Newsweek’s list of America’s Most Responsible Companies 2024. This award is presented by Newsweek and Statista Inc., the world-leading statistics portal and industry ranking provider. The list of awards was announced on December 6, 2023, is available on Newsweek’s website, and recognizes the top 600 most responsible companies in the United States, spanning 14 industries.

ROCKVILLE, M.D. and SUZHOU, China, Dec. 6, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announces the licensing deal expansion with Synaffix B.V., a Lonza company (SIX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index.

The expanded deal builds on a previous agreement signed in June 2021, under which Innovent is granted to deploy Synaffix's ADC technologies on a target-specific, non-exclusive basis, including GlycoConnect®, HydraSpace® and one of its toxSYN® linker-payloads, for a therapeutic molecule (Innovent R&D code: IBI343, a CLDN18.2 ADC) which has advanced to Phase 1 clinical development.

WASHINGTON, Dec. 6, 2023 /PRNewswire/ -- Danaher Corporation (NYSE:DHR) ("Danaher") announced today it has completed its acquisition of Abcam plc (NASDAQ:ABCM) ("Abcam").

The acquisition of Abcam for $24.00 per share in cash was implemented by way of a Court-sanctioned scheme of arrangement under the UK Companies Act 2006 (the "Scheme") and the Scheme became effective in accordance with its terms on December 6, 2023. As a result, Abcam has become an indirect wholly owned subsidiary of Danaher. Trading of Abcam ADSs on Nasdaq has been suspended.

A powerful web app to help drug designers accurately predict the pKa value of titratable residues

December 5, 2023, Baltimore, MD – ComputChem, an Early Charm company that develops computational chemistry software for drug design, has just launched its first product, iTitrate.

iTitrate is a web app that accurately predicts the pKa values of titratable residues by simulating an acid-base titration experiment. It computationally allows a protein to adjust its protonation and conformational states to solution pH. This state-of-the-art approach has been rigorously validated through references available on the ComputChem website.

By Pratik Jain and Khushi Mandowara - Dec 5 (Reuters) - Weight-loss drug developer Altimmune (ALT.O) is open to deals and collaborations with large drugmakers as it actively looks for partners to launch and develop its experimental obesity drug, CEO Vipin Garg told Reuters on Tuesday.

Upbeat mid-stage trial data for its obesity drug and recent multi-billion dollar deals by companies such as Roche (ROG.S) and AstraZeneca (AZN.L) to grab a slice of the fast-growing market have fueled hopes of Big Pharma scooping up the company.

Gaithersburg, Maryland-based Altimmune last week reported mid-stage trial data for pemvidutide that showed the drug helped reduce weight by 15.6% on average and continued weight loss at the end of treatment.

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The National Heart Lung and Blood Institute (NHLBI) in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) will be providing training and resources for a new Innovator to Entrepreneur Program (ITEP). ITEP is designed to assist aspiring entrepreneurs by providing them with cohort-based training covering key elements of company launch, business strategy development, IP protection, market research, customer discovery, startup financing and SBIR/STTR grantsmanship.   

This new program encourages participation in the SBIR/STTR program by underrepresented groups, Women-Owned Small Businesses, socially/economically disadvantaged small businesses, and small businesses located in HUBZones programs.  

Attend the Informational Webinar on December 6th at 2PM ET to learn more about the new ITEP program. Information about ITEP is available on the ITEP website.  ITEP will begin accepting applications of interest on December 8th.  

MENLO PARK, Calif., Dec. 4, 2023 /PRNewswire/ -- Enavate Sciences, a portfolio company of Patient Square Capital, is pleased to announce that Sara M. Nayeem, M.D. has joined the firm as Executive Vice President, Investments. Dr. Nayeem reports to James Boylan, Chief Executive Officer of Enavate Sciences, and will serve an integral role in the origination, evaluation, and selection of Enavate investments, as well as support Enavate partner companies on governance, partnerships, fundraising, and other strategic initiatives.

Dr. Nayeem has 20 years of banking and institutional investing experience. She most recently served as Partner at Avoro Ventures, a biopharma venture fund she helped launch in 2021. Previously she was a Partner at New Enterprise Associates, Inc. (NEA), where she spent 12 years as part of the biopharma investing group. Prior to joining NEA, Dr. Nayeem was an Associate with Merrill Lynch's Global Healthcare Group, where she advised biotechnology and medical device companies. She began her career as an Investment Banking Analyst at Morgan Stanley.

AI Simulation on MIRA1a Showcases Significant Potential Advantages Over Plant-Based Medical Marijuana Related to Anxiety, Appetite and Cognition

BALTIMORE, Dec. 4, 2023 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on neurologic and neuropsychiatric disorders, has released new data from artificial intelligence (AI) simulations that show that, compared to plant-based medical marijuana, there may be significant potential advantages to the therapeutic potential of MIRA1a, such as its potential to offer a superior anti-anxiety treatment, increased cognition and without the increased appetite associated with THC.

The simulations on MIRA1a were conducted in conjunction with the Company's strategic collaboration with InSilicoTrials, a company specializing in leveraging AI and simulations to enhance drug and medical device development.

The Biological and Emerging Infections Research Resources Program (BEI-RRP) contract, which merges the two programs, represents the fourth recompete award with NIAID since 2003.

MANASSAS, Va.--(BUSINESS WIRE)--ATCC, the world’s premier biological materials management and standards organization, today announced a seven-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to continue the management of the BEI Resources Program. NIAID has made an initial award of over $21.5 million, with further funding expected if all project milestones are met. This contract will merge the NIH HIV Reagent Program with the BEI Resources Program under the Biological and Emerging Infections Research Resources Program (BEI-RRP) umbrella. ATCC has managed the BEI Resources Program since 2003 and the NIH HIV Reagent Program since 2020. This important merger will allow researchers to have streamlined access to all priority pathogens for human health under one program.

WAKEFIELD, Mass., Nov. 29, 2023 /PRNewswire/ -- 424 Capital announced today that it has completed a significant investment in VaLogic, a leading provider of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance software and services based in Frederick, MD. This strategic move by 424 Capital aims to expedite positive clinical outcomes by enabling pharmaceutical and biotechnology organizations to focus on the research, development, and production of cutting-edge therapeutics in a compliant and effective manner.

Founded in 2001 by CEO Bill Robertson, VaLogic provides a comprehensive range of software and compliance services to the life science and biotechnology market. These services help organizations and facilities maintain GMP compliance and enact high standards while focusing on advancing life-saving therapeutics.

VaLogic offers advisory and facility design, full commissioning and qualification, cleanroom environmental monitoring, HEPA/cleanroom certifications, calibration, preventative maintenance, and a proprietary SaaS software called LogiPoint™ for continuous monitoring of critical facilities and equipment.