Agex Therapeutics Inc., of Alameda, Calif., and Sernova Corp., of London, Ontario, will collaborate on engineering universal locally immune protected cell therapies for treating type I diabetes and hemophilia A. Sernova received a time-limited, nonexclusive research license by Agex. A commercial license for Sernova to use Agex’s gene technology to engineer cellular products for therapeutic and commercial purposes may be negotiated if study outcomes are successful. Agex technologies are designed to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases. Sernova technologies use a medical device and immune-protected therapeutic cells to treat diseases through protein or hormone replacement.
Arrevus Inc., of Raleigh, N.C., said it received two grants totaling $800,000 to support its protein inhibitor and lead candidate, ARV-1502. The NIH’s National Institute of Allergy and Infectious Diseases awarded a $300,000 grant to investigate ARV-1502 for treating sepsis, and the U.S. Army Medical Research and Development Command awarded $500,000 to investigate ARV-1502 in wound healing.
Chondrial Therapeutics Inc., of Bala Cynwyd, Pa., said it completed a reverse merger with Zafgen Inc., of Boston. The combined company is named Larimar Therapeutics Inc. Shares (NASDAQ:LRMR) began trading May 29, ending the day at $12.40. Larimar said it secured a private placement financing of common stock for $80 million of gross proceeds. The financing was led by Cowen Healthcare Investments.
Daiichi Sankyo Co. Ltd., of Tokyo, and Merck and Co. Inc., of Kenilworth, N.J., will evaluate the combination of DS-1062, a TROP2-directed DXd antibody-drug conjugate (ADC), and Keytruda (pembrolizumab) in patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. There are no TROP2-directed therapies and no ADCs approved for treating NSCLC, which often overexpresses the TROP2 protein, the companies said. Daiichi Sankyo will conduct a multicenter, two-part, open-label, non-randomized, phase Ib study of DS-1062 in combination with Keytruda in patients with advanced or metastatic NSCLC without actionable genomic alterations and previously treated with platinum-based chemotherapy with or without immunotherapy. The primary endpoints are safety and tolerability of the maximum tolerated dose/recommended expansion dose of DS-1062 in combination with Keytruda. The study is expected to enroll approximately 60 patients in the U.S. and Japan.
Immutep Ltd., of Sydney, said it received about €2.2 million (US$2.4 million) in a research and development tax incentive payment from the French government’s research tax credit program in which French companies conducting R&D in Europe can be reimbursed 30% of their eligible expenditure. The funds will be used to support the ongoing and planned global clinical development of eftilagimod alpha and preclinical development of IMP-761, a humanized IgG4 monoclonal antibody.
Icagen Inc., of Durham, N.C., expanded its license agreement with Roche Group, of Basel, Switzerland, to develop and commercialize small-molecule ion channel modulators for treating neurological disorders by adding a second program to the agreement. The new program is directed at an ion channel target relevant to neurodegenerative disease and is part of ongoing work on another novel CNS target. Roche made a cash up-front payment and will provide research funding. Icagen could receive development and commercial milestone payments of up to $274 million and royalty payments should a drug be commercialized. Icagen will be responsible for most preclinical activities up to lead optimization, with both Icagen and Roche applying resources to identify candidates for entry into IND-enabling studies. Roche will be responsible for the further development and commercialization.
Orpro Therapeutics Inc., of San Diego, said it expanded its technology platform for treating acute and chronic airway diseases, including cystic fibrosis, to address COVID-19. The company is developing ORP-100S to treat lung inflammation and obstruction associated with chronic airway disorders and progression to severe COVID-19 disease caused by SARS-CoV-2 infection. ORP-100S, a modified human thioredoxin-1 protein, is delivered by inhalation and is planned for home use with the objective of reducing COVID-19 severity and the need for hospitalization.
New data from San Francisco’s QED Therapeutics Inc. show clinical advancement of infigratinib, an oral FGFR-3 inhibitor, in urothelial carcinoma and cholangiocarcinoma. The company said infigratinib (BGJ-398) in advanced/unresectable or metastatic urothelial carcinoma demonstrated consistent treatment response in both first-line and later-line treatment settings. It also noted a retrospective analysis of the subset of a single-arm phase II study of infigratinib outcomes from patients with FGFR-fusion-positive bile duct cancer receiving infigratinib as third- and later-line therapy that were compared with the tumor response when those same patients received second-line therapy with chemotherapy. Treatment with infigratinib resulted in progression-free survival improvements, the company said.
Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, said it will merge its consolidated subsidiaries in the U.S., Boston Biomedical Inc., of Cambridge, Mass., and Tolero Pharmaceuticals Inc., of Lehi, Utah. On July 1, the merged company’s name becomes Sumitomo Dainippon Pharma Oncology Inc. Both companies conduct oncology R&D.
Takeda Pharmaceutical Co. Ltd., of Osaka, said the European Commission released the company from the obligation to divest the pipeline compound SHP-647 and certain associated rights, a commitment Takeda provided to secure regulatory clearance of its acquisition of Shire plc. Takeda will discontinue the current SHP-647 clinical trial program and provide all eligible trial participants continued access to SHP-647 in a post-trial access study. Takeda said in November 2018 that the commission approved its proposed acquisition of Shire if Takeda fulfilled commitments provided to the commission in connection with the regulatory clearance. Specifically, in relation to the future potential overlap in the area of inflammatory bowel diseases between Takeda’s marketed product, Entyvio (vedolizumab), and Shire’s pipeline compound, SHP-647, Takeda committed to divest SHP-647. The divestment of SHP-647 was not a condition to the completion of the acquisition, which became effective January 2019, Takeda said.
Tetraphase Pharmaceuticals Inc., of Watertown, Mass., said it revised its merger agreement with Acelrx Pharmaceuticals Inc., of Redwood City, Calif., with consideration of $30 million in stock and cash based on the Acelrx closing share price on May 22 plus an additional $14.5 million in contingent value rights (CVRs) payable in cash. Total consideration payable to Tetraphase stockholders and warrant holders includes Acelrx stock valued at $24.6 million, based upon the closing share price of Acelrx stock of $1.52 on May 22 plus $5.4 million in cash. In a second amendment, Tetraphase stockholders will receive, for each share of Tetraphase common stock, 0.5872 cents in cash and 0.7409 of a share of Acelrx common stock, representing approximately $1.7 in up-front per share value, based on the closing price of Acelrx’s common stock as of the close of trading on May 28. Acelrx said it proposed the second amendment in response to a proposal from Melinta Therapeutics Inc., of New York, on May 27 to acquire Tetraphase for $34 million in cash plus an additional $16 million in cash potentially payable under CVRs upon the achievement of certain future Xerava net sales milestones starting in 2021.
In new preclinical data from Turning Point Therapeutics Inc., of San Diego, comparing proxy molecules for approved and investigational RET inhibitors, TPX-0046 demonstrated potent in vitro and in vivo activity against a range of RET alterations, including greater potency against solvent-front mutations, G810S, G810R, G810C and G810N. A phase I/II trial of elective RET-inhibitor TPX-0046 in RET TKI-naïve and -pretreated patients is ongoing. In enzymatic and cellular assays, TPX-0046 was potent against wild-type RET and multiple RET mutations and fusions. TPX-0046 also demonstrated antitumor activity in RET-driven cell-derived and patient-derived xenograft tumor models, including those that harbor a RET G810R solvent-front mutation. The ongoing phase I/II open-label, single-arm, multicenter clinical study of TPX-0046 is enrolling TKI-naïve and -pretreated patients with RET-altered non-small-cell lung, thyroid and other advanced cancers in a phase I dose-escalation study of about 50 patients and phase II expansion study of approximately 300 patients with multiple cohorts to assess safety, tolerability, pharmacokinetics and clinical activity.
Vir Biotechnology Inc., of San Francisco, said it finalized a process development and manufacturing agreement with Biogen Inc., of Cambridge, Mass., for Biogen to perform process development and specified manufacturing and process transfer services to enable commercial supply of Vir’s SARS-CoV-2 monoclonal antibodies. Vir said its SARS-CoV-2 antibody development candidates, VIR-7831 and VIR-7832, demonstrated high affinity for the SARS-CoV-2 spike protein and the ability to neutralize SARS-CoV-2 in live-virus cellular assays.