Active Biotech AB, of Lund, Sweden, received a milestone payment of $750 000 from the partner Neotx Therapeutics Ltd., of Dublin, under the terms of license agreement for the immunotherapy naptumomab. Based on preclinical data and the previous clinical experience with the compound, a phase Ib/II study in patients with advanced solid tumors was begun by Neotx, in cooperation with Astrazeneca plc, of London, in 2019. The study is ongoing, and the results from the dose escalation part are expected early next year. Neotx plans to expand the clinical program in the combination of naptumomab and Imfinzi (durvalumab, Astrazeneca plc) with a focus on indications involving so-called “cold tumors” with poor response to checkpoint inhibition alone, as well as evaluate further combination strategies such as pairing the drug with docetaxel.
Bristol Myers Squibb Co., of New York, said its Celgene subsidiary, and Cipla Ltd., of Mumbai, have settled their litigation related to patents for Revlimid (lenalidomide). The parties will file consent judgments with the U.S. District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below. In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Cipla with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the U.S. beginning on a confidential date that is some time after March 2022.
Immunitybio Inc., of Culver City, Calif., said its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against SARS-CoV-2 in a challenge study. The study, sponsored by the Biomedical Advanced Research & Development Authority, provides further evidence supporting the company’s use of a second-generation adenoviral vector that induces the immune system to both activate T cells and generate antibodies against multiple viral targets, blocking virus replication and clearing existing infection. In the study, immunization with the hAd5-COVID-19 vaccine inhibited SARS-CoV-2 virus replication in 100% (10 of 10) of Rhesus macaques, with a drop in viral replication starting on the first day of vaccine administration, and undetectable viral levels as early as three to five days post-challenge in most of the animals.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, entered a research collaboration with the National Research Council (NRC) of Canada’s Human Health Therapeutics Research Center to develop its neutralizing PolyTope antibodies against COVID-19. The firm is also considering acquiring a license for the NRC Chinese hamster ovary (CHO) cell-based rapid expression platform to be used in preclinical and clinical manufacturing of their lead monoclonal antibodies. Researchers from the center will deploy the CHO-based expression platform to accelerate the identification and development of Immunoprecise’s lead antibody candidates.
Innate Pharma SA, of Marseille, France, said it will return U.S. and EU commercialization rights for Lumoxiti (moxetumomab pasudotox-tdfk) to Astrazeneca plc, of London. The FDA cleared the drug for certain patients with relapsed or refractory hairy cell leukemia in October 2018. The companies will develop a transition plan, including costs and transfer of the U.S. marketing authorization and distribution of Lumoxiti to Astrazeneca in 2021. Astrazeneca will remain the marketing authorization applicant for the EU filing.
Medivir AB, of Stockholm, said it renegotiated its agreement with Tetralogic Pharmaceuticals Corp., of Malvern, Pa., regarding financial obligations for birinapant, a SMAC mimetic for treating solid cancer tumors. The 2016 agreement included milestone payments with predetermined amounts as well as royalty obligations to Tetralogic if and when Medivir develops, markets or out-licenses birinapant further. Now the compensation Medivir is obliged to pay in a potential future transaction is based solely on distribution of actual future revenues to Medivir.
Privately held Fera Pharmaceuticals LLC, of Locust Valley, N.Y., will evaluate Sophia Antipolis, France-based Nicox SA‘s naproxcinod as a potential adjuvant treatment for patients with COVID-19 infection in preclinical proof of concept studies during early 2021. Naproxcinod is a non-steroidal anti-inflammatory product candidate engineered to release nitric oxide and naproxen. The two companies agreed in December 2015 to grant Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market. Nicox and Fera amended the agreement to include COVID-19 as an indication. Nicox also will grant to Fera warrants to acquire 10,000 Nicox shares.
Polyphor AG, of Allschwil, Switzerland, said it extended its 2019 grant agreement with CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global partnership led by Boston University supporting development of antibacterial products to diagnose, prevent and treat drug-resistant infections. The grant will support development of Polyphor’s OMPTA (Outer Membrane Protein Targeting Antibiotics) Bama program, which addresses resistant gram-negative bacterial pathogens, potentially active against all three critical priority 1 pathogens in the World Health Organization list. CARB-X is committing Polyphor an additional $2.3 million, bringing potential funding to $5.1 million. Polyphor may also receive up to $13 million in future option stages that could take the program through a first-in-human program if certain project milestones are met.
New preclinical data of QRA-244, Cambridge, Mass.-based Quralis Corp.’s lead candidate, showed the therapy is a Kv7.2/7.3 ion channel opener optimized for safety and efficacy as a potential treatment for motor neuron hyperexcitability-induced neurodegeneration in amyotrophic lateral sclerosis patients. The data showed QRA-244 has comparable effects to retigabine (ezogabine) at up to 20-fold lower concentration in motor neurons differentiated from patient-derived iPSCs as measured by an all-optical electrophysiology experiment. QRA-244 also showed dramatic in side effects associated with retigabine, including fatigue/somnolence, dizziness and bladder retention in head-to-head preclinical studies.