Weekly Quick Hits (BioHealth Capital Region) – Week of May 15, 2023

By Alex Keown and Sarah Ellinwood
May 19, 2023

Funding, Awards and Collaborations

PQE Group US Earns 2023 Great Place To Work Certification™

PQE Group US has been certified by Great Place To Work® for the second year in a row. This esteemed recognition is solely based on the feedback of present employees regarding their work experience at PQE Group. This year, a remarkable 91% of employees expressed their satisfaction with their workplace, which is 34 points higher than the average U.S. company.

Sirnaomics to receive subsidy from the HKSTP Clinical Translational Catalyst Plan

Sirnaomics, a biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, received approval of an HK$8 million ($1.02 million) subsidy from the Hong Kong Science and Technology Parks Corporation (KSTP), which will be used to accelerate research and development of its leading RNAi drug candidate, STP122G, a GalNAc-based innovative anticoagulant therapeutic. The subsidy comes under HKSTP’s Clinical Translational Catalyst (“CTC”) programme dedicated to catalysing clinical translation to bring innovative, life-changing therapies and technologies to patients advancing innovative therapies and technologies that can potentially improve patients’ lives. 

Fzata Selected for NIH Innovation Zone and Pitching Events in Boston

Fzata, Inc. will be showcased at upcoming conferences for the ongoing Series A raise supporting the first-in-class Bioengineered Probiotic Yeast Medicines modality.

Emergent BioSolutions Finalizes Sale of Travel Health Business to Bavarian Nordic

Emergent BioSolutions completed the sale of its travel health business to Bavarian Nordic. At the close of the deal, Emergent received $270 million and may receive up to an additional $110 million in potential future milestone payments. Bavarian Nordic has acquired the rights to Vivotif, a typhoid vaccine, and Vaxchora, a licensed cholera vaccine, as well as the development-stage chikungunya vaccine candidate CHIKV VLP. Bavarian Nordic also acquired manufacturing facilities in Bern, Switzerland, and development facilities in San Diego, California. The majority of Emergent employees supporting these products and facilities are joining Bavarian Nordic.

BiOneCure Therapeutics, Nanjing Leads Biolabs Join Forces to Develop ADCs

BiOneCure Therapeutics forged a strategic collaboration with Nanjing Leads Biolabs to develop a range of innovative anti-drug conjugates (ADCs) for treating solid tumors. BiOneCure is a clinical-stage biopharmaceutical company dedicated to developing next-generation ADCs, while Leads Biolabs is a clinical-stage biotech focused on the research, development, and commercialization of next-generation tumor immunotherapy antibody drugs. BiOneCure has developed several proprietary ADC payload-linker platforms, and its first product, BIO-106, an anti-Trop-2 ADC, is currently in a Phase I clinical study. Meanwhile, Leads Biolabs has established a rich portfolio of more than 20 novel mono- or bispecific antibody drug projects to fulfill unmet medical needs. 

RS BioTherapeutics Joins BioNTX Bioscience, a Texas Trade Organization

RS BioTherapeutics, whose mission is to harness the therapeutic power of cannabinoids in the research, development, and commercialization of life changing medicines, announced it is has joined BioNTX, the bioscience and healthcare innovation trade organization serving North Texas. As a member of BioNTX, RS BioTherapeutics will benefit from BioNTX’s various resources and benefits including legislative advocacy; networking, education and business collaboration opportunities; business services discounts through a purchasing consortium; and access to the organization’s talent network for recruiting.

PARI acquires Nortev, the Manufacturer of the Equine Inhaler Flexineb

Virginia-based PARI, manufacturer of medical devices and pharmaceuticals in the field of respiratory and inhalation, acquired the Irish company Nortev. Nortev manufactures and sells the equine nebuliser Flexineb, a device for respiratory therapy in horses by nebulising medication or saline. In addition, Nortev also offers nebulisation devices for companion animals.

In the Clinic

The Foundation for the National Institutes of Health Announces Selection of Eight Rare Diseases for the Bespoke Gene Therapy Consortium Clinical Trial Portfolio

The Accelerating Medicines Partnership® Bespoke Gene Therapy Consortium (AMP® BGTC) has selected eight rare diseases for its clinical trial portfolio. This portfolio pioneers a novel approach to gene therapy development for rare diseases by demonstrating that manufacturing and testing standards can provide a streamlined approval pathway for first-in-human clinical trials. The eight diseases that will make up the clinical trial portfolio are: Charcot-Marie-Tooth disease type 4J; Congenital Hereditary Endothelial Dystrophy; Morquio A Syndrome; Multiple Sulfatase Deficiency; NPHP5 Retinal Degeneration; Propionic Acidemia (PCCB); Retinitis pigmentosa 45; Spastic paraplegia 50

FDA Clears Flavocure Biotech IND Application for Caflanone

Flavocure Biotech received clearance of its Investigational New Drug (IND) application from the FDA to initiate a Phase I, first-in-human clinical study of Caflanone (FBL-03G) for the treatment of pancreatic cancer. Pancreatic Ductal Adenocarcinoma (PDAC) accounts for about 2% of all cancers and is associated with 5% of cancer‐related deaths. Caflanone treatment is combined with radiotherapy (RT) for enhanced efficacy against cancer cells. FBL-03G, a flavonoid is the unnatural isomer of cannflavin B, a metabolite of cannabis.

NImmune Biopharma Provides Update on Omilancor Clinical Development Programs

NImmune Biopharma announced Phase II data on an approvable population of ulcerative colitis (UC) patients that showed clinical remission was induced in 30.4% of omilancor treated patients relative to 3.7% of patients given placebo, meeting the primary endpoint. Endoscopic remission was induced in 41.7% of patients treated with omilancor relative to 18.6% of patients given placebo. In patients with elevated baseline FCP, normalization occurred in 43.8% of the omilancor 880 mg group and 40.6% of the omilancor 440 mg group relative to 21.4% of the placebo group after 2 weeks. The company plans to initiate a registration directed global Phase III program for omilancor for the treatment of UC. Omilancor is a wholly-owned, once-daily gut-restricted oral first-in-class LANCL2 therapeutic entering Phase 3 clinical testing in UC patients.

YS Biopharma’s PIKA Rabies Vaccine Receives Phase III Trial Approval in Pakistan

YS Biopharma announced its PIKA Rabies Vaccine received Phase III clinical trial approval from the Drug Regulatory Authority of Pakistan. The clinical trial will evaluate the safety and immunogenicity of the company’s PIKA Rabies Vaccine in preventing rabies infection.The PIKA Rabies Vaccine is a novel vaccine powered by YS Biopharma’s proprietary PIKA adjuvant technology to induce accelerated immunity and produce a higher immune response. YS Biopharma has also obtained approval to conduct Phase 3 clinical trials of the PIKA Rabies vaccine in Singapore.

HanAll Biopharma Phase III Tanfanercept Trial Misses Primary Endpoints

HanAll BioPharma announced its Phase III VELOS-3 evaluating the safety and efficacy of tanfanercept did not demonstrate statistical significance for either of the two primary efficacy endpoints, mprovement from baseline in central corneal staining score (CCSS) and in improvement from baseline in Eye Dryness Score via Visual Analogue Scale (VAS). VELOS-3 did demonstrate statistically significant improvement in the secondary endpoint of unanesthesized Schirmer testing to quantify change from baseline in tear volume in tanfanercept treatment arm relative to vehicle arm assessed at week 8. Tanfanercept is a novel, topical anti-inflammatory treatment being studied for the treatment of dry eye disease.

Histopathology and Tumor Biomarker Analysis Confirm CEL-SCI’s Multikine 

Virginia’s CEL-SCI Corporation announced that the latest results from its pivotal Phase III study of Multikine, a presurgical cancer immunotherapy, confirms Multikine [Leukocyte Interleukin Injection (LI)] treatment outcome in naïve locally advanced primary head & neck squamous cell carcinoma. The IT-MATTERS pivotal Phase II study revealed a statistically significant 14.1% absolute 5-year overall survival benefit in the intent to treat subjects who were categorized as lower risk to recurrence.

Aziyo Biologics Presents Positive Clinical Data on CanGaroo® Biologic Envelope

Aziyo Biologics (Nasdaq: AZYO) announced that positive data from the HEAL Study will be presented at Heart Rhythm Society (HRS 2023) on May 21, 2023, at 12:30 PM CT at the Morial Convention Center in New Orleans, LA. HEAL is a national multi-center study evaluating patients who previously underwent implantation of a cardiac implantable electronic device (CIED) with either an Aziyo CanGaroo® Envelope, Medtronic’s Tyrx™ non-biologic envelope, or no envelope, and are returning for a revision procedure at least four months after initial placement. The CanGaroo Envelope is made of an acellular biologic matrix that is designed to promote a natural healing response, resulting in a healthy, vascularized tissue capsule.

Innovent Announces Clinical Data of Multiple Trials Will be Presented at the 2023 ASCO and EHA Annual Meetings

Innovent Biologics (HKEX: 01801) shared that about 30 accepted abstracts of clinical data from multiple trials in relation to TYVYT® (sintilimab injection), olverembatinib (BCR-ABL TKI), IBI326 (equecabtagene autoleucel), IBI376 (parsaclisib), IBI110 (anti-LAG-3 monoclonal antibody), IBI939 (anti-TIGIT monoclonal antibody) and IBI351 (KRASG12C inhibitor) will be presented at upcoming international medical conferences.

New Products

BD Launches World’s First Spectral Cell Sorter with High-Speed Cell Imaging

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company with offices in Maryland, announced the worldwide commercial launch of a new-to-world cell sorting instrument featuring two breakthrough technologies that enable researchers to uncover more detailed information about cells that was previously invisible in traditional flow cytometry experiments. With BD CellView™ Image Technology, researchers can see detailed microscopic images of individual cells and sort at high speeds based on visual characteristics to confirm insights in real time.

Research Roundup

Study Highlights Dangers of Cumulative Exposure to Cardiovascular Risks 

Using sophisticated modeling techniques, University of Maryland School of Medicine (UMSOM) researchers have developed a new tool that can predict the risk of heart disease in individuls over 40 based on their total exposure, through the years, to heart disease risk factors, which includes high blood pressure, obesity, and elevated cholesterol. The new research findings, published in March in the Journal of the American College of Cardiology, used data from the Coronary Artery Risk Development in Young Adults (CARDIA), which recruited about 5,000 healthy young adults from four U.S. cities and followed them for 30 years. The researchers were able to calculate from this data the cumulative effect of individual risk factors, such as high blood pressure, diabetes, elevated cholesterol, and the additive effects of multiple risk factors that can cause cardiovascular disease. 

REGENXBIO’s NAV Technology Platform tol Support Bespoke Gene Therapy Consortium

REGENXBIO announced that preclinical research in Mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio syndrome, was selected for inclusion in the Foundation for the National Institutes of Health Accelerating Medicines Partnership Bespoke Gene Therapy Consortium clinical trial portfolio. The Consortium brings together partners such as NIH and FDA, as well as partners from private and non-profit sectors. Sponsored by Nemours Children’s Hospital, MPS IVA is one of eight programs selected as part of AMP BGTC’s first clinical portfolio to help accelerate the development of bespoke gene therapies, with the goal of streamlining the regulatory approval process. MPS IVA is  a metabolic condition that primarily affects the skeleton, and is estimated to impact 1 in 200,000 to 300,000 individuals.

Regulatory and Advocacy

Innovent Receives NMPA Breakthrough Designation for KRASG12C Inhibitor IBI351 

Innovent Biologics announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation (BTD) for IBI351 for the treatment of previously treated advanced colorectal carcinoma (CRC) patients with KRASG12C mutation. This designation was based on the pooled analysis of two ongoing clinical trials that include 54 CRC patients who received IBI351 monotherapy. Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed. The study results will be published at the upcoming American Society Of Clinical Oncology Annual Meeting 2023.

People on the Move

SAIC Announces CEO Transition 

Virginia-based Science Applications International Corp. announced the appointment of global technology veteran Toni Townes-Whitley as the company’s Chief Executive Officer, effective Oct. 2. She will succeed Nazzic S. Keene, who has decided to retire as CEO. To ensure a seamless transition, Townes-Whitley will join SAIC on June 12 as CEO-elect, while Keene continues as CEO through October 1. Keene will then become Special Executive Advisor to Townes-Whitley and the company through Feb. 2, 2024. In her most recent role Townes-Whitley was President, U.S. Regulated Industries at Microsoft. Prior to Microsoft, Townes-Whitley was President of CGI Federal and held several management roles at Unisys Corporation.

Rachel Hoover Named EVP at UM Faculty Physicians

Hoover is a healthcare leader with more than 20 years of experience in providing strategic oversight and planning for enterprise-wide initiatives in academic and private health care systems. Most recently she served as Chief Operating Officer for Johns Hopkins Regional Physicians and was previously Director of Global Services for Johns Hopkins Medicine.

Pinney Associates Announces Key Leadership PromotionsJoe Gitchell recently assumed the role of CEO, Lucy Owen is the new President, Judy Ashworth has been promoted to Senior Vice President, and Robyn Gougelet has been promoted to Vice President, Health Policy and Regulatory Strategy. In their new roles, they provide strategic advice and tactical support to help clients reduce regulatory risk and achieve regulatory approval across Pinney’s four practice areas.