Aptevo Therapeutics Inc., of Seattle, said it received an unsolicited nonbinding indication of interest from Tang Capital Partners LP, in acquiring the outstanding shares of Aptevo not already owned by Tang for $50 apiece in cash. Aptevo's board of directors said it will evaluate Tang’s outreach in the context of its strategic plans and cautioned that no decisions had been made by the board. Aptevo, which is developing bispecific antibodies, said it does not plan additional comment until its board completes its review. Morgan, Lewis & Bockius LLP is serving as Aptevo's legal advisor. On Nov. 20, 2020, Aptevo’s shares (NASDAQ:APVO) lost 6 cents to close at $45.63.
Black Diamond Therapeutics Inc., of Cambridge, Mass., said it nominated BDTX-1535 as its development candidate to treat glioblastoma multiforme (GBM) and initiated IND-enabling studies. In a presentation at the 2020 Society for Neuro-Oncology annual meeting, the company discussed preclinical data for BDTX-1535 and the biological rationale for a so-called masterkey approach to treat GBM tumors harboring allosteric oncogenic mutations in epidermal growth factor receptor (EGFR). In cell-based assays, BDTX-1535 achieved masterkey inhibition of members of the family of oncogenic EGFR variants expressed in GBM with selectivity compared to wild-type-EGFR. BDTX-1535 showed a pharmacokinetic profile in mouse models that supported its ability to penetrate the blood-brain barrier, achieved complete and sustained inhibition of the phosphorylated state of EGFR in mouse models bearing Ba/F3 allosteric EGFR mutants and inhibited tumor growth in mouse models bearing intracranial PDX tumors expressing allosteric EGFR mutants.
Immunomic Therapeutics Inc. (ITI), of Rockville, Md., and Coimmune Inc., of Durham, N.C., said they inked a license agreement giving ITI access to Coimmune’s dendritic cell process to conduct manufacturing and cGMP work to advance ITI-1020, the company’s autologous dendritic cell vaccine loading with mRNA encoding LAMP:pp65 to treat newly diagnosed glioblastoma. Coimmune is eligible for milestone payments based on predetermined programmatic goals, including initiation of clinical studies and regulatory submissions, as well as royalty payments based on net sales of ITI-1020.
Mannkind Corp., of Westlake Village, Calif., said it achieved the final development milestone under its licensing and collaboration agreement with United Therapeutics Corp., of Silver Spring, Md., related to the dry powder formulation of treprostinil, earning a $12.5 million payment. The PGI2 agonist treprostinil Technosphere is in development to treat pulmonary arterial hypertension, with regulatory filings expected in 2021. Mannkind remains entitled to low double-digit royalties on net sales and is set to earn a manufacturing margin to supply product to United Therapeutics.
The Cystic Fibrosis Foundation said it provided a research award of up to $3.75 million to Matinas Biopharma Holdings Inc., of Bedminster, N.J., to develop an oral version of the antibiotic amikacin, which targets nontuberculous mycobacteria infections in people with cystic fibrosis. Matinas is investigating an encochleated oral formulation using its lipid nano-crystal delivery technology, which may reduce the risk of known side effects such as hearing loss and kidney problems. Matinas will use this funding for preclinical safety studies.
Neurotrope Inc., of New York, said its board of directors approved the conditional distribution and set the shareholder of record and distribution dates in connection with the spin-off of wholly owned subsidiary Neurotrope Bioscience Inc. (NBI). Subject to the closing of Neurotrope's proposed all-stock merger with Metuchen Pharmaceuticals LLC, of Manalapan, N.J., to form Petros Pharmaceuticals Inc., Neurotrope shareholders and certain warrant holders of record on Nov. 30, 2020, will receive on Dec. 7, 2020, a dividend at the rate of one share of NBI common stock for every five common shares held, one share for every five common shares issuable upon conversion of Neurotrope’s preferred stock held and one share for every five common shares issuable upon exercise of certain warrants. The Neurotrope shareholder meeting to approve the proposed merger is scheduled for Nov. 25, 2020. Neurotrope expects that NBI common shares will be quoted on the OTCQB market under a symbol that is yet to be determined.
Poxel SA, of Lyon, France, said Roivant Sciences Ltd., subsidiary Metavant Sciences Ltd., of Basel, Switzerland, declined to advance the type 2 diabetes candidate imeglimin into phase III development following a strategic review of its pipeline. Poxel said the decision was not based on efficacy, safety or other data generated through the partnership. The decision does not affect Poxel’s partnership for imeglimin with Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, where the phase III TIMES program was completed and the AMP activated protein kinase stimulator is under review to treat type 2 diabetes in Japan. Poxel said it will explore options to advance imeglimin into phase III development in regions covered under the agreement with Metavant, which will forego any payment from Poxel in the event that it relinquishes rights to the asset. Poxel said its projected cash runway and its cash and equivalents of €41.5 million (US$48.6 million) as of Sept. 30, 2020, were not affected by Metavant’s decision and remain sufficient to fund the company’s operations through 2022, based on current business plans. On Nov. 20, 2020, the company’s shares, trading on the Euronext Paris as POXEL, lost €0.89 to close at €6.32.
Sosei Group Corp., of Tokyo, said its R&D program targeting the SARS-CoV-2 coronavirus for treatment of COVID-19, initiated in April 2020, yielded three distinct series of compounds with antiviral drug-like properties. The compounds showed potency in inhibiting the activity of the SARS-CoV-2 Mpro protease, which plays a crucial role in viral replication, as well as promising oral bioavailability and blood plasma levels in animal studies. Several compounds are being optimized for preclinical studies.
Spring Bank Pharmaceuticals Inc., of Hopkinton, Mass., said its stockholders approved the company’s proposed combination with F-star Therapeutics Ltd., of Cambridge, U.K. Shareholders also approved a proposal for a reverse split of Spring Bank’s outstanding common shares, and Spring Bank and F-star agreed to an exchange ratio of one for every four shares of Spring Bank outstanding common stock, effective when trading opens on Nov. 23, 2020. The company will be renamed F-star Therapeutics Inc. at the transaction’s close, expected on Nov. 20, 2020. On that date, Spring Bank’s shares (NASDAQ:SBPH) closed unchanged at $1.21.
Contract development and manufacturing organization Vectura Group plc, of Chippenham, U.K., said the U.S. Court of Appeals for the Federal Circuit denied the motions for judgment, a new infringement trial and new trial damages sought by Glaxosmithkline plc (GSK), of London, in litigation concerning Vectura’s U.S. patent 8303991. Vectura said the decision upheld the District Court of Delaware’s 2019 ruling on post-trial motions by the parties, entitling Vectura to an award of $89.7 million in damages, ongoing royalties of 3% on U.S. sales of certain infringing GSK Ellipta products, supplemental damages of approximately $10.5 million based on GSK’s infringing sales and pre-judgment interest at the prime rate of approximately $6.7 million. Vectura said GSK has 30 days to file a petition for rehearing.