Contract Pharma

Editor’s Take: A lead candidate may have additional potential against a broad spectrum of IgG-mediated diseases. Biohaven inked a strategic licensing and collaboration agreement with Ono Pharmaceutical to develop and commercialize Biohaven’s immunoglobulin G (IgG) portfolio. Exclusivity in the deal applies to Japan, South Korea, Taiwan, and countries of the Association of Southeast Asian Nations (ASEAN).

Editor’s Take: Combining with Bio-Techne’s capabilities in Minnesota, this comes amid a pending acquisition by Merck KGaA, Darmstadt, Germany. Bio-Techne opened a new manufacturing facility in Bristol, United Kingdom, for good manufacturing practice (GMP)-grade small molecules. The site further expands Bio-Techne’s global capabilities in terms of supporting the growing cell therapy market.

Editor’s Take: Expanding the use of Tukysa to front-line maintenance treatment may further delay disease progression. Pfizer’s Tukysa (tucatinib) gained FDA approval for unresectable locally advanced or metastatic human epidermal growth factor 2-positive (HER2+) breast cancer. This approval for maintenance treatment of adults follows induction treatment, and combined with trastuzumab and pertuzumab.

Editor’s take: With the increasing complexity of CGT programs, sponsors are focusing on strategic partnerships to expand their offerings. Andelyn Biosciences, a US-based cell and gene therapy CDMO, and PQP Group entered a strategic partnership to expand support for sponsors supplying cell and gene therapy products to clinical sites in the EU and UK.

The Ritedose Corporation has opened a new current Good Manufacturing Practice (cGMP) laboratory in South Carolina. The more than $17 million investment in the new lab significantly expands Ritedose’s analytical chemistry and microbiology capabilities, tripling the Company’s laboratory footprint.

Why This Matters: Check out Contract Pharma’s Pharmaceutical Industry Mergers & Acquisitions Roundup. AmyriAD Therapeutics, a clinical-stage biopharmaceutical company focusing on cognition in central nervous system (CNS) disorders, has acquired Recognify Life Sciences. The transaction includes RL-007 (inidascamine), Recognify’s lead clinical-stage program. At the same time, it preserves Ismidenon (AD-101) as AmyriAD’s lead program against Alzheimer’s disease.

Editor’s Take: Abionyx sees this as a key manufacturing milestone in its regulatory strategy regarding LCAT deficiency. Abionyx Pharma has a strategic manufacturing partnership with Olon, a global CDMO, supporting development and commercialization of the asset CER-001. CER-001 incorporates full-length recombinant apoA-I, a 243-amino-acid protein. Subsequently, apoA-I is assembled, with specific phospholipids, to form a biomimetic high-density lipoprotein (HDL) nanoparticle.

On September 24th and 25th, Contract Pharma hosted its 25th Annual Contracting & Outsourcing Conference & Tabletop Exhibition at the Hyatt Regency in New Brunswick, NJ. The Conference was a great success, with a sold-out exhibit hall featuring 155 contract service providers, and great line up of speakers and sessions that addressed key industry topics.

Vir Biotechnology Inc. has appointed David Liu, M.D., Ph.D., as Executive Vice President and Chief Medical Officer (CMO) where he will be responsible for leading the clinical development, medical affairs and regulatory affairs functions.

Editor’s Take: Ultimately, the two sides hope to establish a framework for future clinical reporting to shape cancer treatment planning. 10x Genomics announced a multi-project research collaboration with Fred Hutchinson Cancer Center (Fred Hutch) to advance single-cell and spatial technologies. Research will focus on both solid tumor and hematologic malignancies; Fred Hutch is a leading United States cancer research institution.