While September saw some major private financing deals for life sciences companies in the Philadelphia region — highlighted by stock sales of $165 million for Capstan Therapeutics, $75.2 million for SparingVision and $30 million for Carisma Therapeutics — four early stage biopharmaceutical firms reeled in more than $1.9 million in smaller private stock and debt deals.
Here's a look at those smaller financings, which were disclosed in Securities and Exchange Commission filings:
- Mebias Discovery, based in the University City section of Philadelphia, raised $630,682 in an equity financing. Founded in 2015, Mebias is focused on drug discovery targeting G-protein coupled receptors, which are cell surface receptors that detect molecules outside the cell and activate cellular responses. Its lead drug candidate is a non-addictive pain medicine called MEB-1170.
- Trevarx BioMedical, also based in University City, raised $500,000 in a debt sale. Founded in 2016, Trevarx is specializing in the development of radiopharmaceuticals. Radiopharmaceuticals are drugs that contain a radioactive substance and are used to diagnose or treat disease. The firm's lead drug candidate is in mid-stage testing for breast cancer.
- Epivario of West Philadelphia raised $135,000 in a debt financing. Founded in 2017, Epivario's goal is to treat memory-related disorders at the source by inhibiting the production of an enzyme, linked to such disorders, made by a non-essential gene known as ACSS2. The biotechnology company also this month received a $260,000 grant from the National Institute on Alcohol Abuse and Alcoholism to advance research on its proprietary small molecule inhibitors designed to reduce alcohol craving responses and help people with alcohol use disorder prevent a relapse.
- Rose Therapeutics of Norristown raised $650,000 in an equity financing. The biotechnology company was founded this year. Additional information about Rose Therapeutics was not immediately available. Company officials could not be reached for comment.
On the fast track
Ayala Pharmaceuticals (NASDAQ: AYLA) of Wilmington and Fore Biotherapeutics of Philadelphia both received Fast Track designations for their new drug candidates from the Food and Drug Administration.
The FDA grants Fast Track status to facilitate the development, and expedite the review of, new drug candidates for serious diseases with large unmet needs. The designation provides companies with frequent and early communication with the federal agency and the ability to make "rolling submissions" of the study data and other materials supporting a new drug application.
Ayala received the designation for AL 102, its experimental therapy targeting progressing desmoid tumors.
Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors typically found in the upper and lower extremities, abdominal wall, head and neck area, and chest wall. They can arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs.
People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors are diagnosed in about 1,700 people annually in the United States, most commonly in young adult females between 30 and 40 years of age. There are no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.
“We are very encouraged by the emerging body of clinical data supporting AL102 and, if approved, believe that this product could have a meaningful impact on patients’ lives," said Dr. Roni Mamluk, CEO of Ayala.
Ayala is conducting Phase 2/3 clinical trials for AL102. Positive interim results from the Phase 2 segment of the study were presented at a medical conference earlier this year. The company has initiated the Phase 3 portion of the study and is enrolling patients.
Fore Biotherapeutics received its designation for FORE8394, its experimental treatment for cancer patients with BRAF [a gene found on chromosome seven] altered or mutated tumors who have exhausted prior therapies.
The company expects to begin mid-stage testing of FORE8394 during the fourth quarter of this year.
“The FDA's Fast Track Designation for FORE8394 underscores the urgent need faced by patients with advanced BRAF-muted cancers who have no other options,” said Dr. Stacie Shepherd, chief medical officer of Fore Biotherapeutics.
Quick Hits
North Jersey-based Outlook Therapeutics Inc. (NASDAQ: OTLK) and AmerisourceBergen (NYSE: ABC) of Conshohocken have entered into a strategic relationship in preparation for Outlook's anticipated commercial launch in the United States of Lytenava. Lytenava, an ophthalmic formulation of bevacizumab for use in retinal indications, is under review by the FDA. Under the partnership, AmerisourceBergen will provide third-party logistics services and distribution, as well as medical information and pharmacovigilance services for Outlook in the United States. … Code Biotherapeutics, a Philadelphia biotechnology company focused on the targeted non-viral delivery of genetic medicines, appointed David Anderson as its chief scientific officer. Anderson was previously senior vice president for research as SwanBio Therapeutics and before that served as central nervous system research lead at Spark Therapeutics.
