Aptorum Group Ltd., of London, said it has entered into a material transfer and option agreement with Yale University to evaluate a group of preclinical stage novel immunomodulators that may potentially target autoimmune and oncology diseases including rheumatoid arthritis, lupus and sclerosis, as well as a variety of cancers. Aptorum has an exclusive option to in-license the immunomodulators and affiliated intellectual property rights, it said. Financial terms of the arrangement were not disclosed.
Bio-Path Holdings Inc., of Houston, highlighted the publication of an analysis highlighting the potential of prexigebersen (BP-1001) within the antisense oligonucleotide drug delivery landscape in the journal Biomedicines. The article, which describes the challenges facing the antisense oligonucleotide drug delivery landscape, also outlines why prexigebersen, a liposome-incorporated antisense oligodeoxynucleotide targeted against the Grb2 mRNA, has the potential to overcome these challenges, the company said.
Biosplice Therapeutics Inc., of San Diego, Calif., and Samil Pharmaceutical Co. Ltd., of Seoul, South Korea, inked a licensing agreement which grants Samil the right to develop and exclusively commercialize lorecivivint (SM-04690) to treat knee osteoarthritis in South Korea. Lorecivivint has the potential to be the first drug therapy to offer substantial improvement in pain and function as well as structural benefit, the company said. An investigational CLK/DYRK kinase inhibitor that modulates the Wnt pathway, lorecivivint is currently being evaluated in phase III pivotal trials for the treatment of knee osteoarthritis in the U.S. Samil will lead development, regulatory and commercialization activities for lorecivivint in South Korea. Deal terms include $70 million in aggregate value, consisting of a combination of up-front payment and clinical, regulatory, and commercial milestones. In addition, Biosplice is eligible for double-digit royalties on future sales. Korea Development Bank advised Biosplice on the transaction.
Codiak Biosciences Inc., of Cambridge, Mass. announced the publication of a manuscript about exoSTING, an extracellular vesicle loaded with STING agonists, that it said promotes tumor immune surveillance, in Communications Biology. The manuscript details preclinical findings on the potential of the phase I/II asset to "stimulate a broad immune response without the detrimental effects on intratumoral T cells observed with other STING agonists," the company said. Safety, biomarker and preliminary efficacy data from the dose-escalation phase of the ongoing phase I/II study are expected in mid-2021.
Kempharm Inc., of Celebration, Fla., said it received a $10 million for the recent FDA approval of Azystrays (serdexmethylphenidate + d-methylphenidate) as part of a recently amended collaboration and license agreement with Commave Therapeutics SA, an affiliate of Gurnet Point Capital. Kempharm is eligible to receive up to $590 million in future regulatory and sales milestone payments for Azystrays, as well as tiered royalty payments on a product-by-product basis for net sales. The next regulatory milestone payment tied to the program is $10 million following the upcoming scheduling determination of serdexmethylphenidate, the prodrug component of Azystrays, by the Drug Enforcement Administration. The DEA action is expected to be completed on or around June 2, the company said.
Medicinova Inc., of La Jolla, Calif., received two milestone payments under an assignment agreement with Sanofi SA-owned Genzyme Corp. The payments, which total $4 million, are a result of the successful achievement of two clinical development milestones for a gene therapy product based on adeno-associated virus vector technology, it said.
The Russian Direct Investment Fund (RDIF) and Cairo-based Minapharm have agreed to produce more than 40 million doses of the COVID-19 vaccine Sputnik V. Rollout is expected in the third quarter of 2021, according to RDIF. Production will take place in Minapharm's biotech facility in Cairo. Minapharm's subsidiary, Probiogen AG, of Berlin, will lead process optimization.
Skye Bioscience Inc., of San Diego, said it established its chemical, manufacture and controls procedures for producing THCVHS, a THC prodrug for treating glaucoma, suitable for good laboratory practice nonclinical research. Preclinical pharmacology studies compared THCVHS’ effect on intraocular pressure vs. netarsudil and latanoprost then evaluated the potential additive and synergistic effects of THCVHS with the agents. A genotoxicity study will determine the effect THCVHS on the genetic material of cells that may lead to mutations that could cause cancer, the company said.
Synthekine Inc., of Menlo Park, Calif., said it will collaborate with Stanford University to license cytokine partial agonist programs for IL-10, IL-12 and IL-22. Research done at Stanford showed IL-10, IL-12 and IL-22 can be tuned to achieve specific signaling, according to Synthekine. Modifying cytokines enables selective activity to be directed to specific cell types for therapeutic benefit, often by decoupling efficacy from toxic effects driven by nonspecific immune system activation, the company added. Synthekine said it plans to leverage discoveries in IL-12 to develop cancer treatments, and IL-10 and IL-22 to develop autoimmune disease treatments.
Nearly 19 million more American adults, about a third of those now refusing to get vaccinated, would get vaccinated if they could take a pill instead of getting a shot, according to a poll conducted by Quadrant Strategies and commissioned by Vaxart Inc., of South San Francisco. The survey found 23% of respondents said they do not plan to get vaccinated but nearly a third said they would if the vaccine were available as a pill instead of by a needle injection. The results suggest, according to Vaxart, that about half of the additional vaccinated group would be drawn from minority populations, communities that have disproportionately not been vaccinated. Vaxart is developing a range of oral recombinant vaccines.
Vaxess Technologies Inc., of Cambridge, Mass., said it was awarded a Commercialization Readiness Program grant from the National Institute of Allergy and Infectious Diseases, a part of the NIH. Vaxess will receive up to $2.85 million if the project milestones are met. The grant will be used to advance the MIMIX sustained released vaccine patch toward a phase I clinical trial testing a seasonal flu and a COVID-19 vaccine under an FDA IND the company said it expects to file within a year.
Zenith Epigenetics Corp., of Calgary, Alberta, said it entered an agreement with Astellas Pharma Inc. to evaluate ZEN-3694, a BET inhibitor, in combination with Astellas and Pfizer Inc.’s androgen receptor inhibitor, Xtandi (enzalutamide) in treating metastatic castration resistant prostate cancer (mCRPC). Zenith will sponsor and conduct a phase IIb randomized study to evaluate the efficacy of the combination of ZEN-3694 and enzalutamide relative to single agent enzalutamide in mCRPC patients who have progressed on a prior androgen receptor signaling inhibitor. Astellas will supply enzalutamide and Zenith will retain all rights to ZEN-3694. The clinical study is expected to start in the second quarter of 2021.