Bristol-Myers is scouting new company startups; AbbVie and Idera team up to evaluate combination for HNSCC
→ Bristol-Myers Squibb has looped in a new partner to help scout new company creation opportunities. As a limited partner of BioMotiv, the pharma giant will work with the drug development accelerator to fund translational ventures “in disease areas where unmet medical needs remain” — and get first dibs to buy the resulting startups upon lead identification. The deal gives Bristol-Myers access to BioMotiv’s network of academic institutions and their cutting-edge, early-stage discoveries, said Bruce Car, interim head of discovery research.
One of BioMotiv’s portfolio companies, Dual Therapeutics, previously enticed Bristol-Myers Squibb to an oncology pact that came with $255 million in milestones. The tie-up appeared to have fizzled, but Bristol-Myers has continued to get on the ground floor of biotech whenever it could, for example by sponsoring BioLab‘s startup facilities.
→ It’s another deal for German pharma Boehringer Ingelheim. After inking a research pact with MD Anderson earlier last month to create a “Virtual Research and Development Center,” the company and Lupin Limited have entered into a partnership for Lupin’s MEK inhibitor compound (LNP3794) to be used in combination with Boehringer’s KRAS inhibitor for patients with gastrointestinal and lung cancers harboring a broad range of oncogenic KRAS mutations.
The company says that “Lupin will receive an upfront payment of $20 million and potential additional payments for successful achievement of defined clinical, regulatory and commercial milestones for a total deal value of more than $700 million. Additionally, Lupin will be entitled to receive double-digit royalties on the sales of the product.”
→ After AbbVie read the last rites to their final, failed Rova-T clinical trial last week, the company is now collaborating with Idera Pharma to test combinations of an OX40 agonist (ABBV-368) and a TLR-9 agonist (tilsotolimod) — hoping to stimulate the immune system resulting in anti-tumor responses — in a Phase Ib study in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
The study will test three separate treatment arms: ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and chemotherapy (nab-paclitaxel); and ABBV-368 plus tilsotolimod, nab-paclitaxel and PD-1 antagonist (ABBV-181).
→ Los Angeles-based Puma Therapeutics‘ drug Nerlynx has been granted orphan drug status by the FDA for the treatment of breast cancer patients with brain metastases.
Back in May, investor worries cratered the company’s stock $PBYI when Q1 sales of the drug fell short of Wall Street estimates — with patient discontinuations running high due to a poor tolerability profile, predominately relating to diarrhea. Nerlynx was in-licensed by Puma from Pfizer and was approved by the FDA in July 2017.
→ NICE has backed the NHS use of Novartis‘ gene therapy Luxturna for a rare, inherited form of blindness in England and Wales. The one-off treatment, which was approved in Europe last November, has been supported for use in children and adults who are living with vision loss due to genetic mutations in both copies of the RPE65 gene. Novartis bought the ex-US rights to the drug in 2018 for $170 million from Spark Therapeutics.
→ The FDA has granted regenerative medicine advance therapy (RMAT) designation for Cambridge, Massachusetts-based Magenta Therapeutics‘ MGTA-456, a one-time cell therapy for the treatment of multiple inherited metabolic disorders.
“The company is currently studying MGTA-456 in a Phase II clinical trial in patients older than 6 months of age with Hurler syndrome, cerebral adrenoleukodystrophy (cALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy (GLD) at four centers of excellence: Cincinnati Children’s Hospital, Duke University, Emory University and the University of Minnesota.”
→ Regenxbio has inked an option and license agreement for exclusive worldwide rights for Clearside Biomedical‘s SCS Microinjector “for the delivery of RGX-314 to the suprachoroidal space to treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other conditions for which anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care.”
The deal comes a little after Clearside Biomedical announced its prediction that the FDA would reject its uveitis drug after a request for more data.