Weekly Quick Hits (Philly) – Week of August 21, 2023

Geneos reports positive early clinical trial results in liver cancer, FORE Biotherapeutics announces Matthew Ros will step down as CEO, and Verismo and Penn sign licensing deal for anti-CD19 binders. For these are more Philadelphia Region life science stories, continue reading.

By Mark Terry | August 25, 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 

LAVA Q2: Focus on its Lead Program, LAVA-1207 in Prostate Cancer

LAVA Therapeutics (Utrecht, The Netherlands, and Philadelphia) reported its second-quarter financials and business updates. The focus was on the company’s progress with its lead program LAVA-1207 in metastatic castration-resistant prostate cancer (mCRPC). It reached dose level 8 in the study and is on track for recruitment across 10 sites in Europe and the U.S. The company noted that in June, as part of a portfolio reprioritization, it reduced 36% of staff and discontinued its LAVA-051 program in r/r CLL and MM.

Cabaletta Bio Expands GMP Deal with WuXi

Cabaletta Bio (Philadelphia) entered into certain work orders relating to GMP manufacturing under its existing master services agreement with WuXi Advanced Therapies. As part of the deal, WuXi will act as a cell processing manufacturing partner for the planned global clinical development of CABA-201 in multiple indications, including possible late-stage trials and commercial readiness.

FORE Biotherapeutics Announces $75M Series D and CEO Transition

Philadelphia’s FORE Biotherapeutics announced it had closed on a $75 million Series D financing, led by the SR One and co-led by Medicxi and joined by existing investors. In conjunction with the financing, Matthew E. Ros will step down as CEO and board member effective September 1. Shawn M. Leland, current advisor to SR One and former Founder, President and CEO of Elevation Oncology, has been appointed to replace him as interim CEO.

Verismo and Penn Ink Licensing Deal for 2 New Anti-CD19 Binders

Verismo Therapeutics, a Penn spinout, inked a licensing deal with the University of Pennsylvania for worldwide exclusive rights for two newly discovered anti-C19 binders. One will be used as the basis for Verismo’s SynKIR-310 product, a KIR-CAR T immunotherapeutic for blood cancer; both will be reserved for potential future partners.

Techdow USA and CTTQ Pharma Partner on Fosaprepitant

Techdow USA (Langhorne, Pa.), a wholly owned subsidiary of Hepalink USA, signed a Licensing, Supply, and Distribution deal with Chia Tai Tianqing Pharmaceutical Group Co. for fosaprepitant for injection. This is the therapeutic generic equivalent of EMEND (fosaprepitant) for injection in the U.S. market.

Baudax Bio Declared a Dividend of 1/1000^th of a Share of Newly Designated Series C Stock

Baudax Bio (Malvern, Pa.) declared a dividend of one one-thousands of a share of newly designated Series C Preferred Stock, par value $0.01 per share, for each outstanding share of its common stock held of record as of 5:00 p.m. Eastern Time on September 5, 2023. They will be distributed at 5:00 p.m. Eastern Time on September 7, 2023.

BMS Reports Progress Towards its ESG and Health Equity Initiatives

Bristol Myers Squibb (Princeton, NJ) published its 2022 Environmental, Social, and Governance (ESG) Report, which described its goals, strategies, and performance across all four ESG focus areas: ethics, integrity, and quality; healthy equity and access to healthcare; global inclusion and diversity; and environmental sustainability. 

Imunon Enters R&D Agreement with the National Institute of Allergy and Infectious Diseases

Imunon (Lawrenceville, NJ) entered into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate two Imunon DNA-based Lassa virus vaccine candidates. It will run for three years and NIAID will evaluate the DNA constructs in guinea pig and non-human primate disease models.

Verrica Announces First Sale of Ycanth to FFF Enterprises

Verrica Pharmaceuticals (West Chester, Pa.) announced the first commercial sale of Ycanth to its exclusive distributor, FFF Enterprises. Ycanth is approved to treat molluscum contagiosum, a highly contagious viral skin disease.

In the Clinic

Soligenix Q2: Multiple Clinical Trials Heading into a 2^nd Phase III Trial of HyBryte

Soligenix (Princeton, NJ) reported its second-quarter financial results and business update. The company noted it advanced multiple clinical trials while also continuing discussions with the FDA over the design of a second, confirmatory Phase III pivotal study of HyBryte (synthetic hypericin sodium) to treat cutaneous T-cell lymphoma (CTCL). The company also launched a Hybryte expanded treatment CTCL trial at the University of Pennsylvania, supported by a $2.5 million Orphan Products Development grand award from the FDA.

Eilean Doses 1^st Patient with ZE46-0134 for AML

Dover, Del.-based Eilean Therapeutics dosed the first patient in the Phase I trial of ZE46-0134. The drug is a highly potent and selective pan-FLT3 inhibitor. It is being developed to treat FLT3 mutated acute myeloid leukemia (AML).

Geneos Reports 8 of 34 Patients Achieved Complete Response in Liver Cancer Study

Geneos Therapeutics (Plymouth Meeting, Pa.) announced updated data from GT-30, an ongoing single-arm open-label multi-center Phase Ib/IIa trial in second-line advanced hepatocellular carcinoma (HCCC). To date, eight of 34 patients achieved complete response, complete molecular response, or secondary resectability.

XyloCor Presented Positive Phase II Angina Data

XyloCor Therapeutics (Wayne, Pa.) presented results from the Phase II portion of its Phase I/II EXACT trial of XC001 (encoberminogene rezmadenovec) for refractory angina at the European Society of Cardiology Congress 2023. XC001 is a one-time gene therapy designed to decrease ischemic burden by creating new blood vessels in the heart.

New Products

Teleflex Announces Extension of Arrow ErgoPack Complete System

Wayne, Pa.-based Teleflex announced the release of the Arrow ErgoPack Complete Kits with Hemodialysis and Large Bore catheters in the U.S. The update is designed to streamline the insertion workflow for doctors and provide more options.

Boekel Scientific Introduces New Centrifuge Product Line

Boekel Scientific (Feasterville-Trevose, Pa.) introduced a new product line made up of four families of centrifuges: economy, general purpose, STAT, and Blood Bank. They have distinct capacities of 6-place, 12-place, and 24-place with removable rotors.

New Patents

Windtree Receives Patent for Dual Mechanism SERCA2a Activators

Windtree Therapeutics (Warrington, Pa.) received a U.S. patent for its dual mechanism SERCA2a Activators. The patent titled, “17BETA-HETEROCYCLYL-DIGITALIS LIKE COMPOUNDS FOR THE TREATMENT OF HEART FAILURE,” offers patent protection through late 2039.

Research Roundup

Halberd Completes Samples, Marking Major Milestone for Mississippi State University Project

Halberd Corporation (Jackson Center, Pa.) reported Mississippi State University finalized the collection of tissue samples from a quantity of the planned test subjects. This allows the university to begin its preclinical model for Halberd’s patent-pending nasal spray’s ability to mitigate the effects of traumatic brain injury.

Wistar Research: Potential EBV Link to Gastric Cancers

The Wistar Institute’s Italo Tempera, Ph.D., Associate Professor in the Gene Expression & Regulation Program in the Ellen and Ronald Caplan Cancer Center, demonstrates that decitabine disrupts the genome of an Epstein-Barr Virus (EPV) dubbed EBVaGC. It genetically modifies the cancer’s DNA.

On the Hill – Regulatory and Advocacy

Verrica Issues Supportive Statement of FDA’s Warning Letters Regarding Unapproved Products

West Chester, Pa.-based Verrica Pharmaceuticals issued a statement in support of the FDA’s recent action against retailers and manufacturers of unapproved products to treat molluscum contagiosum. Verrica’s YCANTH is the only product approved by the FDA to treat the highly contagious skin disease.

People on the Move

Amicus Therapeutics Appoints Simon Harford as CFO

Philadelphia-based Amicus Therapeutics appointed Simon Harford as Chief Financial Officer, effective immediately. Harford most recently acted as CFO of Albireo Pharma.

Crystal S. Denlinger Named New CEO of National Comprehensive Cancer Network

The National Comprehensive Cancer Network or NCCN (Plymouth Meeting, Pa.) appointed Crystal S. Denlinger, MD, FACP, as the incoming CEO. She will replace Robert W. Carlson, MD, who is retiring. Dr. Denlinger is currently NCCN’s Senior Vice President, Chief Scientific Officer.