Funding, Awards and Collaborations
TELA Bio Announces Pricing of Public Offering of Common Stock
Malvern, Pa.-based TELA Bio announced it would offer 4,750,000 shares of its common stock at a public price of $9.50 per share, to raise $45.125 million. The company plans to use the funds raised for general corporate purposes, including sales and marketing, R&D, general and administrative matters, working capital and capital expenditures.
Lehigh Univ Research: NIH Grant for Antibiotic-Delivery System for Aggressive Gum Infections
Angela Brown and her research team at Lehigh University (Bethlehem, Pa.) were awarded an NIH grant to pursue a novel antibiotic-delivery system to target aggressive gum infections in adolescents. Brown is an associate professor of chemical and biomolecular engineering in Lehigh’s P.C. Rossin College of Engineering and Applied Science. The grant is to develop a liposome-based approach to kill periodontitis-causing leukotoxin while protecting immune cells. Total funding comes to $216,447.
In the Clinic
BriaCell Presented Positive Metastatic Breast Cancer Data at AACR
BriaCell Therapeutics (Philadelphia and Vancouver, BC) presented positive clinical data from Bria-IMT in four poster sessions during the 2023 American Association for Cancer Research (AACR) Annual Meeting. Bria-MT is the company’s experimental immunotherapy that induces an antitumor response by providing the tumor antigens for the immune system to recognize and by stimulating the immune system. The drug was being evaluated in metastatic breast cancer patients after receiving multiple previous therapies.
MorphoSys and Incyte Announce 5-Year Data from Lymphoma Study
MorphoSys (Boston) and Incyte (Wilmington, Del.) announced final five-year follow-up data from the Phase II L-MIND trial of Monjuvi (tafasitamab) plus lenalidomide followed by Monjuvi monotherapy in relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Presented at the AACR meeting, the results demonstrated prolonged, durable responses.
AstraZeneca’s Imfinzi Lung Cancer Study Shows Better Survival Benefits
AstraZeneca, with offices in Wilmington, Del., presented results at AACR 2023 from the AEGEAN Phase III trial. The data demonstrated that Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) versus neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC).
Ocugen Announces Positive Preliminary Data for Optical Diseases
Malvern, Pa.-based Ocugen announced positive preliminary data among retinitis pigmentosa participants in the first two cohorts of the Phase I/II trial of OCU400 for RP associated with NR2E3 and Rhodopsin (RHO) mutations and Leber Congenital Amaurosis (LCA) with mutations in the CEP290 gene. The drug is a gene-agnostic modifier gene therapy product based on NHR gene, NR2E3.
HuidaGene Receives Go-Ahead for Retinal Dystrophy Clinical Trial in China
HuidaGene, based in Shanghai and Clinton, NJ, announced its Investigational New Drug (IND) application had been approved by China’s regulatory authority. The approval is for a planned multi-regional, multinational trial of HG004 for patients with RPE65-associated inherited retinal dystrophies.
Annovis Bio Provides Update on Alzheimer’s Trial Recruitment
Berwyn, Pa.-based Annovis Bio announced patient recruitment is on track for its Phase II/III trial of buntanetap for treatment of moderate Alzheimer’s disease. So far, 27 sites have been activated and 38 patients have been screened, with 13 patients have been randomized to receive either one of three doses of the drug or placebo.
Oblato Initiates Enrollment of Phase I Glioma Trial
Princeton, NJ-based Oblato, a subsidiary of Korea-based HLB Therapeutics, initiated enrollment in a Phase I trial in the U.S. of its oral OKN-007 for recurrent high-grade glioma. The company is also running a Phase II trial in recurrent glioblastoma multiforme with a combination of OKN-007 injectable formulation and temozolomide.
New Products
PCI Pharma Services Offers Sterile Fill-Finish Capabilities in Melbourne and San Diego
PCI Pharma Services (PCI), a global contract development and manufacturing organization (CDMO) based in Philadelphia, announced three new state-of-the-art automated sterile fill-finish machines at its San Diego and Melbourne facilities. These pieces of equipment from Cytiva can be used to fill various sterile medications into vials and syringes for small-to-mid-scale client needs.
Research Roundup
Penn Med: New Target for Recurrent Ovarian Cancer
Researchers with the Perelman School of Medicine at the University of Pennsylvania presented preclinical research at AACR 2023 verifying a new target for drug-resistant ovarian cancer. The research focused on B7-HA, a protein that is a potentially high-impact target found in the majority of breast and ovarian cancers.
CHOP Research: Two Different Regulatory T-Cell Populations
Researchers with Children’s Hospital of Philadelphia identified a regulatory class of human T-cells that apparently descends from two different origins. One is associated with autoimmunity while the other relates to protective immunity. Published in Science Immunology, they believe the research could demonstrate possible new approaches to treating autoimmune diseases that target the immune system selectively.
Onconova Presented New Preclinical Data on Narazaciclib
Newtown, Pa.-based Onconova Therapeutics presented new preclinical data on narazaciclib at the AACR Annual Meeting. The drug is a proprietary multi-kinase inhibitor being evaluated in two separate and complementary Phase I dose escalation and expansion studies.
Imunon Presented Poster at AACR on Immune Response of IMNN-001
Imunon, headquartered in Lawrenceville, NJ, presented a poster at the AACR Annual Meeting highlighting its DNA-based immunotherapy IMNN-001. The therapy is an interleukin-12 immunotherapy in Phase II development for localized treatment of advanced ovarian cancer.
Penn Med Research: Habit Circuits Altered in People with Binge Eating Disorders
A study led by researchers with the Perelman School of Medicine at the University of Pennsylvania found that the neural circuits that form habits in the brain are altered in people with binge eating disorder (BED). The data was published in Science Translational Medicine.
Regulatory and Advocacy
Otsuka and Lundbeck Report Results of FDA Adcom on Alzheimer’s Trial
Otsuka Pharmaceutical Development & Commercialization, with offices in Princeton, NJ, and Lundbeck Pharmaceuticals, with offices in Deerfield, Ill., announced the FDA’s Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee met to discuss a supplemental NDA of Rexulti (brexpiprazole) for treatment of agitation associated with Alzheimer’s dementia. The joint committee voted 9-1 that the companies provided enough data to identify a population where the drug’s benefits outweigh its risks.
NYSE Suspends Trading in Lannett Company and Initiates Delisting
Trevose, Pa.-based Lannett Company, a generic pharmaceutical products manufacturing, packaging and distribution company, announced the New York Stock Exchange will initiate proceedings to delist its common stock from the NYSE. This is due to Section 802.01B of the NYSE’s Listed Company Manual because Lannett has fallen below the NYSE’s continued listing standard of maintaining an average global market cap of at least $15 million over a consecutive 30-trading day period.
People on the Move
Marinus Pharma Appoints Marvin Johnson, Jr. to Board
Radnor, Pa.-based Marinus Pharmaceuticals appointed Marvin H. Johnson, Jr. to its board of directors. Most recently, Johnson was the Chief Learning Officer for Merck’s Global Learning and Development department.
Penn Med’s Susan Taylor Elected President of the American Academy of Dermatology
Susan Taylor, MD, the Bennett L. Johnson, Jr. M.D. Professor and the vice chair of Diversity, Equity, and Inclusion in the Department of Dermatology at the Perelman School of Medicine at the University of Pennsylvania was elected the 84th president of the American Academy of Dermatology. A graduate of Harvard Medical School and a Penn undergrad alumna, Taylor was the VP of the AAD from 2020-2021.
CytoSorbents’ Chairman Al Kraus to Retire
CytoSorbents, based in Princeton, NJ, announced that Al W. Kraus, the company’s board chairman, will retire in early June 2023. Kraus has been with CytoSorbents for 20 years.
5 Penn Faculty Elected to the American Academy of Arts and Sciences
Five faculty affiliated with the University of Pennsylvania were elected to the American Academy of Arts and Sciences. They include E. John Wherry of the Perelman School of Medicine; Mirjam Cvetic of the School of Arts & Sciences; Nader Engheta of the School of Engineering and Applied Science and the School of Arts & Sciences; Vivial L. Gadsden of the Graduate School of Education and School of Arts 7 Sciences; and Petra Todd of the School of Arts & Sciences.
