Agex Therapeutics Inc., of Alameda, Calif., and Imstem Biotechnology Inc., of Farmington, Conn., said Imstem has obtained from Agex a nonexclusive, royalty-bearing sublicense to use Agex’s clinical-grade embryonic stem cell line, ESI-053, to derive Imstem’s investigational mesenchymal stem cell product candidate, IMS-001, for development in COVID-19 as well as acute respiratory distress syndrome (ARDS) from other causes. Imstem will endeavor to file one or more IND applications for IMS-001 in COVID-19 and/or ARDS with the FDA or EU authorities within 18 months. Agex will be entitled to receive revenues in the form of royalties on the sale of IMS-001 if successfully developed by Imstem. Earlier this year, the FDA cleared an IND application for the product in multiple sclerosis.
Alkido Pharma Inc., of New York, said it confirmed this week the successful synthesis of a critical intermediate compound for DHA-dFdC, its next-generation chemotherapeutic. Purification and isolation of that key intermediate were also completed and verified, and the company is in the process of optimizing the solid lipid nanoparticle delivery vehicle with respect to particle size and stability. In addition, the company recently expanded upon its manufacturing agreement with Parimer Scientific. DHA-dFdC is in development for treating pancreatic cancer.
Basilea Pharmaceutica Ltd., of Basel, Switzerland, signed a clinical trial collaboration and supply agreement with Eli Lilly and Co., of Indianapolis, for the use of the anti-VEGFR2 antibody Cyramza (ramucirumab) in the ongoing multicohort phase I/II study Fides-03 with FGFR inhibitor derazantinib in advanced gastric cancer patients with FGFR genetic aberrations. Basilea is the sponsor of the study and Lilly will collaborate on clinical aspects while providing clinical supply of ramucirumab. Cyramza is an anti-angiogenic therapy approved for the treatment of various cancers, including the second-line treatment of advanced gastric cancer as a single agent or in combination with paclitaxel.
Cerevel Therapeutics Inc., of Boston, completed its business combination with Arya Sciences Acquisition Corp. II, a special purpose acquisition company sponsored by Perceptive Advisors. Cerevel Therapeutics Holdings Inc., the resulting combined company, will trade under the symbol CERE and its warrants under the symbol CEREW Oct. 28 on Nasdaq. Net proceeds from the transaction totaled about $440 million.
Citrine Medicine Inc., of Shanghai, signed a development and licensing agreement with Bioprojet SCR, of Paris. The partnership provides Citrine with exclusive rights to develop, register, market and manufacture Wakix (pitolisant) in China for the treatment of narcolepsy and obstructive sleep apnea. Citrine is a therapeutics platform company that is developing the first rare disease ecosystem in China, the company said.
Entos Pharmaceuticals Inc., of Edmonton, Alberta, said it is working with Applied Pharmaceutical Innovation in enhancing its Alberta-based vaccine production capacity. Applied Pharmaceutical is a Canadian not-for-profit institute focused on providing translational capacity for life sciences companies. The organization’s engagement with Entos started in May, providing the rapidly growing team at Entos with enhanced space as they expanded their presence in Edmonton with the rapid development of their Fusogenix DNA vaccine candidates for COVID-19.
Indapta Therapeutics Inc., of San Francisco, and the Multiple Myeloma Research Foundation (MMRF) disclosed a partnership to support the advancement of the company’s universal G-NK cell therapy into clinical trials for the treatment of patients with multiple myeloma. The collaboration is supported with an investment in Indapta by the MMRF’s venture philanthropy arm, the Myeloma Investment Fund, Indapta said.
Insitro Inc., of San Francisco, signed a five-year, discovery collaboration with Bristol Myers Squibb Co. (BMS), of New York, focused on the discovery and development of therapies for the treatment of amyotrophic lateral sclerosis and frontotemporal dementia. Insitro will apply its Insitro Human (ISH) platform to create induced pluripotent stem cell-derived disease models. The ISH platform applies machine learning, human genetics and functional genomics to generate and optimize predictive in vitro models and drive therapeutic discovery and development. BMS will have the option to select a number of targets identified by Insitro to advance through clinical development and commercialization. Insitro will receive $50 million in an up-front payment and will be eligible to receive $20 million in near-term operational milestones and up to an aggregate of more than $2 billion in discovery, development, regulatory and commercial milestones in addition to royalty payments on net product sales. BMS will be responsible for clinical development as well as regulatory submissions and commercialization activities.
Pandion Therapeutics Inc., of Watertown, Mass., presented preclinical data at the Federation of Clinical Immunology Societies 2020 virtual annual meeting, including in vivo results showing its MAdCAM-tethered PD-1 agonist, PT-001, inhibits T-cell activation and ameliorates intestinal inflammation. It demonstrated tethered agonism of PD-1 without blocking the normal receptor and ligand interaction of either MAdCAM or PD-1 and, in an animal model of graft-vs.-host disease, treatment resulted in prolonged survival beyond the dosing period and reduced conventional T-cell infiltration of the colon, demonstrating localized effect of the tethered molecule. The company also presented data showing activity of localized immunomodulation of T cells. In an animal model of vitiligo, the skin-tethered PD-1 agonist reduced skin depigmentation and reduced skin-specific conventional T cells with no systemic effects on T cells, while, in an animal model of contact hypersensitivity, the skin-tethered CD39 agent significantly inhibited ear inflammation. A further presentation showed Pandion’s kidney-tethered IL-2 mutein selectively binds to kidney tubular epithelium in vivo.
Phagomed Biopharma GmbH, of Vienna, published data on the novel endolysin targeting Gardnerella, the main pathogen in bacterial vaginosis, in Medrxiv. Findings show that the company’s drug candidate not only lyses any Gardnerella strain in vitro, but also fully dissolves the Gardnerella-dominated biofilm in vaginal samples of patients who had previously endured years of unsuccessful antibiotic treatment. Due to the high specificity of the endolysin, the beneficial microbiome of the vagina remains unharmed by the treatment. The condition affects 100 million women every year.
Puretech Health plc, of Boston, said it filed a public registration statement Form 20-F with the U.S. SEC in conjunction with a potential listing of American depositary shares (ADSs) on Nasdaq. In light of the company’s strong cash position, the U.S. listing will not include the issuance or offering of any shares, it said. Following the U.S. listing, the company’s ADSs will trade on Nasdaq, and the company intends to continue trading its shares on the London Stock Exchange.
Releviate Therapeutics LLC, of San Diego, said it signed an exclusive license for two human monoclonal antibodies developed by researchers at the University of California Riverside and Duke University. Preclinical studies suggest RLVT-9-01, an anti-MMP-9 antibody, and RLVT-14-02, an anti-MMP-14 antibody, could directly target the specific matrix metalloproteinases (MMPs) activating neuropathic pain pathways, the company said. Recent studies implicate MMP-9, MMP-14 and MMP-2 as causes of chronic pain, the company added.
Preclinical data from Rubius Therapeutics Inc., of Cambridge, Mass., demonstrated that RTX-321, for treating human papillomavirus (HPV) 16-positive cancers, promotes antigen-specific T-cell expansion and antitumor activity. RTX-321 is an allogeneic, off-the-shelf aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex (MHC) class I proteins, the co-stimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions. Rubius said it demonstrated the dual mechanism of action of RTX-321 and its mouse surrogates to function as an aAPC to boost HPV 16 E7-specific CD8+ T-cell responses and promote HPV 16-independent stimulation of innate (NK cells) and adaptive immune (non-HPV antigen-specific CD8+ T cells) responses.
Sanofi SA, of Paris, and Glaxosmithkline plc (GSK), of London, said they signed a statement of intent with Gavi, the legal administrator of the Covax Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines. Sanofi and GSK said they intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved and subject to contract, to the Covax Facility. Sanofi and GSK initiated a phase I/II study Sept. 3 with 440 subjects enrolled and anticipate first results in early December, to support initiation of a pivotal phase III study before the end of the year.
Santen Pharmaceutical Co. Ltd., of Osaka, Japan, and Aerie Pharmaceuticals Inc., of Durham, N.C., said they formed an exclusive development and commercialization agreement for the ocular therapies Rhopressa (netarsudil mesylate) and Rocklatan (latanoprost + netarsudil mesylate) in Japan, along with rights for other Asian countries. Santen assumed responsibility for development and commercialization costs and activities in the covered territories along with sales, marketing and pricing decisions relating to the products. Aerie agreed to collaborate on the first phase III study of Rhopressa in Japan, expected to begin by year-end 2020. In exchange, Aerie is set to receive an up-front payment of $50 million and development and sales milestones of up to $99 million, along with additional consideration in excess of 25% of net product sales, including the cost of products it supplies to Santen and a royalty for its intellectual property. In addition to customary termination rights for both parties, in the event that patents are issued that impede commercialization of the products, Santen retained the right to terminate the agreement and require Aerie’s repayment of a portion of the up-front payment, all development milestone payments and a portion of development expenses incurred by Santen.
Seagen Inc., of Bothell, Wash., said it closed a $1 billion equity investment by Merck & Co. Inc., of Kenilworth, N.J., in 5 million newly issued shares of Seagen common stock at $200 per share. The investment was made in connection with a global collaboration with Merck to co-develop and commercialize ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1, which is in clinical trials for breast cancer and other solid tumors. Seagen and Merck will collaborate and equally share costs on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs. The companies said they agreed to jointly develop and share future costs and profits for ladiratuzumab vedotin equally worldwide.
Spartina Biotechnologies Inc., of Santa Fe, N.M., said it is developing a two-pronged approach to control COVID-19 without a vaccine. The company’s technology stops replication of the virus and prevents it from the suppressing immune system components, Spartina said. The process works, according to the company, using RNAi to silence genes in the virus that allow it to replicate.
SWK Holdings Corp., of Dallas, said a subsidiary, Enteris Biopharma, received a $2.5 million milestone payment from Cara Therapeutics Inc., of Stamford, Conn., related to the license agreement for Peptelligence oral formulation technology utilized in Oral Korsuva, a formulation of Cara's first-in-class KOR agonist, CR845/difelikefalin. SWK said it is entitled to $1.5 million of the payment per contractual splits agreed to in the Enteris acquisition agreement. SWK also is eligible to receive additional potential milestone payments over the next several quarters, subject to the achievement of certain development milestones for Oral Korsuva, the company added.
Titan Pharmaceuticals Inc., of South San Francisco, said it entered a definitive asset purchase agreement with JT Pharmaceuticals Inc., a Mount Pleasant, S.C.-based peptide drug development company, to acquire JT's kappa opioid agonist peptide, JT-09, for use in combination with Titan's Proneura drug delivery technology, for treating chronic pruritus. JT is entitled to receive future milestone payments based on the achievement of regulatory milestones, including potential regulatory approval for commercialization, plus single-digit percentage earn-out payments on net sales.
Xoma Corp., of Emeryville, Calif., said that NIS-793, an anti-TGFβ monoclonal antibody, has advanced to phase II, triggering a $25 million milestone payment from Novartis AG, of Basel, Switzerland. The phase II trial is designed to assess the efficacy and safety of NIS-793 in first-line metastatic pancreatic ductal adenocarcinoma. Approximately 30% of the milestone will be applied as a partial payment toward Xoma’s debt obligation to Novartis and the remaining balance will be paid in cash to Xoma. Under the terms of the 2015 anti-TGFβ development and commercialization agreement with Novartis, Xoma has the potential to earn up to $445 million in additional milestone payments. Upon receipt of regulatory approval to commercialize NIS-793, Xoma will receive tiered royalties on any net product sales that range from the mid-single digits to the low double digits.