Weekly Quick Hits (Philly) – Week of August 14, 2023

Annovis initiates Alzheimer’s Trial with 52 active sites, Legend Bio reports a cash runway of $1.5 billion, and more life sciences news. Read on for these stories and more…

By Mark Terry | August 18, 2023

Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn (BioHealth Capital Region, Greater Philadelphia, Research Triangle Park) or get it delivered to your inbox every week.

Funding, Awards and Collaborations 

Clario and AliveCor Collaborate on 6-Lead ECG Solutions for Decentralized Clinical Trials

Philadelphia-based Clario and Mountain View, Ca.-based AliveCor expanded their collaboration, which will allow clinical trial participants to collect medical-grade six-lead ECG readings from their own homes via KardiaRx, a clinical-trial-focused app. KardiaRx works with AliveCor’s FDA-cleared KardiaMobile 6L, a clinically validated personal ECG solution.

Annovis Bio Q2: 52 Sites Activated and 201 Patients Screened for Alzheimer’s Trial

Berwyn, Pa.-based Annovis Bio reported its second-quarter financials and corporate update. It has activated 52 sites and screened 201 patients, with 61 patients enrolled for its clinical trial of buntanetap for Alzheimer’s disease. The company reported $15.7 million in cash as of June 30, and reported a net loss of $9.5 million for the quarter.

Legend Bio Q2: Cash Runway of $1.5 Billion Should Carry Through 2025

Somerset, NJ-based Legend Biotech reported its second-quarter financials and business highlights, including submitting a supplemental Biologics License Application (sBLA) to the FDA and a Type II Variation Application to the European Medicines Agency (EMA) by Janssen for approval of Carvykti (ciltacabtagene autoleucel) for earlier treatment of relapsed or refractory multiple myeloma. The company also reported $1.5 billion in cash as of June 30, which will extend its cash runway through 2025.

Sonnet BioTherapeutics Q2: Initiated Combination Study of SON-101 with Tecentriq in Australia

Princeton, NJ-based Sonnet BioTherapeutics reported its second-quarter financials and business updates. The company initiated a combination trial of SON-101 with Roche’s Tecentriq (atezolizumab) for cancer. It also has ongoing collaborations with Janssen, a Johnson & Johnson company, of SON-1010, SON1210, and SON-1410 in combination with some of Janssen’s cell therapy assets.

Avertix Partners with Heart & Rhythm Institute on Heart Attack Monitoring

Avertix Medical (Eatontown, NJ) has partnered with Trinity, Fla.-based Heart & Rhythm Institute of Trinity to make the Guardian System available to Heart & Rhythm and its collaborative group of cardiologists. Avertix’s Guardian System detects acute coronary syndrome events, such as heart attacks in real time.

Frontage Acquires Nucro-Technics

Exton, Pa.-based Frontage Laboratories and its wholly-owned subsidiary, Frontage Canada, completed the acquisition of Nucro-Technics and its affiliate Nucro-Technics Holdings. Nucro-Technics is a pharma CRO as well as a consultant in quality control and assurance in Natural Health Product Regulations.

Helius Announces Reverse Stock Split

Helius Medical Technologies (Newtown, Pa.) announced a 1-for-50 reverse split of its Class A common stock. The split will result in a reduction in the number of shares of common stock outstanding and issuable upon the conversion of the company’s outstanding stock options and warrants in proportion to the ratio of the reverse split.

BriaCell Received NCI Grant for Bria-OTS Cancer Immunotherapy

BriaCell Therapeutics (Philadelphia and Vancouver, BC) announced the National Cancer Institute (NCI) awarded it a research grant to advance its Bria-OTS personalized off-the-shelf immunotherapies for cancer. The company plans to develop the platform for advanced metastatic breast cancer, prostate cancer, lung cancer, and melanoma.

Coeptis Completes Exclusive License for Allogeneic Immuno-Oncology Platform from Deverra

Coeptis Therapeutics (Wexford, Pa.) completed the exclusive license of key assets from Deverra Therapeutics related to its proprietary allogeneic stem cell expansion and directed differentiation platform. This is for the generation of multiple distinct immune effector cell types, including natural killer (NK) and monocyte/macrophages.

Baudax Bio Announces $1.9 Million Registered Direct Offering

Baudax Bio (Malvern, Pa.) entered into definitive agreements for the purchase and sale of 2,006,544 shares of its common stock and 1,395,243 Series E pre-funded warrants at a purchase price of $0.56 per share and $0.55, respectively. Per Nasdaq rules, this is a registered direct offering priced at-the-market rate.

In the Clinic

SFA Therapeutics Announced Phase Ib Cohort 1 Psoriasis Results

SFA Therapeutics (Jenkintown, Pa.) announced positive results from its SFA-002 Phase Ib cohort 1 trial for mild-to-moderate psoriasis. The drug simultaneously acts on multiple therapeutic pathways.

CytoSorbents Completed the Pivotal STAR-T Trial for Perioperative Bleeding

CytoSorbents (Princeton, NJ) reported it had completed the pivotal STAR-T trial. The study is evaluating the ability of DrugSorb-ATR to decrease perioperative bleeding to the widely-used blood thinner, ticagrelor (AstraZeneca’s Brilinta) in patients undergoing cardiothoracic surgery.

Minghui Enrolled 1^st Patient in Phase III Atopic Dermatitis Trial

Minghui Pharmaceutical (Shanghai, Hangzhou, China and Wilmington, Del.) enrolled the first patient in the Phase III clinical trial of MH004 Cream for mild to moderate atopic dermatitis. The company expects to report topline data in the second half of 2024.

PDS Biotech to Report Phase II Cervical Cancer Data

Princeton, NJ-based PDS Biotechnology Corporation will present data from the IMMUNOCERV Phase II trial of PDS0101 in combination with standard-of-care chemoradiotherapy for locally advanced cervical cancer. The data will be presented at the American Society for Radiation Oncology Annual Meeting October 1-4, 2023.

Research Roundup

CHOP Research: Versatile, Low-Cost Tech for Targeted Long-read RNA Sequencing

Researchers at Children’s Hospital of Philadelphia (CHOP) have developed a technology dubbed TEQUILA-seq, a versatile and low-cost technology for targeted sequencing of full-length RNA molecules. The research was published in Nature Communications.

Temple Research: Novel Gene-Editing Treatment Safely Removes HIV-Like Virus from Genomes

Researchers at the Lewis Katz School of Medicine at Temple University demonstrated that a single injection of a novel CRISPR gene-editing treatment safely and efficiently removed SIV from the genomes of non-human primates. SIV is a virus related to HIV. The research was published in Gene Therapy.

On the Hill – Regulatory and Advocacy

FDA Approves Janssen’s Akeega for BRCA-Positive Prostate Cancer

The FDA approved The Janssen Pharmaceutical Companies of Johnson & Johnson’s Akeega (niraparib and abiraterone acetate) for adults with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer. The drug is the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone.

Amicus’ Pompe Disease Therapy Approved and Launched in UK

Amicus Therapeutics (Philadelphia and Marlow, UK) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK granted marketing authorizations for Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for adults with late-onset Pompe disease. Also, the National Institute for Health and Care Excellence (NICE) issued final guidance recommending reimbursement for the drug combination for use within the National Health Service (NHS) in England and Wales.

FDA Accepts Venatorx’ NDA for Priority Review of Cefepime-Taniborbactam for cUTIs

Malvern, Pa.-based Venatorx Pharmaceuticals announced the FDA accepted its New Drug Application (NDA) for cefepime-taniborbactam for the potential treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis. The drug is a beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic. The FDA granted it Priority Review.

People on the Move

Penn Med Neurosurgeon Named Cancer Moonshot Scholar

The Biden Cancer Moonshot named Nduka M. Amankulor, MD, a Cancer Moonshot Scholar. Amankulor is an Associate Professor of Neurosurgery and Director of the Penn Brain Tumor Center at the Perelman School of Medicine at the University of Pennsylvania. He is among 11 scholars included in the program’s inaugural cohort, receiving a total of $5.4 million to support cancer research and innovation across the country.

Imunon Appoints Sachet A. Shukla to Scientific Advisory Board

Lawrenceville, NJ-based Imunon announced the addition of Sachet A. Shukla, PhD, to its Scientific Advisory Board. Shukla is an Assistant Professor in the Department of Hematopoietic Biology and Malignancy (HBM), Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.

AmerisourceBergen Elects Werner Baumann and Lauren Tyler to Board

Conshohocken, Pa.-based AmerisourceBergen elected Werner Baumann and Lauren Tyler to its Board of Directors. Baumann was formerly Chairman, CEO and Chief Sustainability Officer at Bayer AG. Tyler currently acts as Executive Vice President and Global Head of Human Resources for JP Morgan Asset and Wealth Management.

VintaBio Names Jennifer Kingsley Chief Commercial Officer

Philadelphia-based VintaBio named Jennifer Kingsley as its first Chief Commercial Officer. Kingsley was most recently Commercial Zone Leader at Cytiva.