FBM-5712

Across the pharmaceutical industry, forging collaborations are a key tool to bringing new medications through the clinic and to market. This week, multiple companies have partnered in attempts to bring forth new therapies. BioSpace takes a look at some of these announcements. MannKind Deal Aims at Pulmonary Fibrosis MannKind Corporation and Thirona Bio paired up to advance the development of a novel small molecule inhibitor that has the potential for multiple indications. The two companies will collaborate on the development of FBM5712, an inhibitor of the ALK-5 kinase currently under development by San Diego-based Thirona. ALK-5 kinase is the transforming growth factor-β (TGF-β) receptor kinase. Thirona has been developing the asset as a topical product intended to prevent and/or reduce skin fibrosis. That company will continue to evaluate FBM5712 for dermatological applications, including scleroderma, keloid scars and certain cancers. However, TGF-β is implicated in lung fibrotic diseases, and that’s where MannKind will focus its efforts. MannKind Chief Scientific Officer Thomas Hofmann said TGF-β has been validated as a potential target for idiopathic pulmonary fibrosis. Under terms of the deal, MannKind and Thirona will assess FBM5712 for pulmonary fibrosis. MannKind intends to develop FBM5712 as a dry powder formulation. If initial studies are promising, MannKind can exercise certain rights to seek a full license to the compound for clinical development and commercialization for the treatment of fibrotic pulmonary diseases. Michael Castagna, chief executive officer of MannKind said evaluating FBM5712 in pulmonary fibrosis supports the company’s pipeline goals of launching a new product each year between 2025 and 2030. Oyster Point Eyes Ophthalmic Diseases Oyster Point Pharma tied up with Adaptive Phage Therapeutics to leverage that company’s PhageBank technology for the development of potential treatments for multiple ophthalmic diseases. Oyster Point Pharma CEO Jeffrey Nau said effective treatments are needed for ophthalmic bacterial infections today and antibiotic-resistant eye disease that may develop in the future. APT’s approach provides expanded bacterial coverage where prior, traditional, antibiotic approaches have diminished coverage or have become obsolete due to emerging antimicrobial resistance, the companies said. “Antibiotic resistance of bacterial pathogens and the formation of antibiotic resistant biofilm in the eye are a serious and growing problem, made more acute by the possibility of blindness where patient infections cannot be effectively treated using conventional approaches,” Nau said in a statement. Under the terms of the agreement, Oyster Point has an option to harness the PhageBank technology for an undisclosed sum that includes development and regulatory milestones, as well as royalties from any sales. Oyster Point will provide additional details regarding this collaboration at its upcoming Analyst Day set for July 15. Takeda Expands Agreement with Codexis for Fourth Target Takeda Pharmaceutical expanded its collaborative and licensing agreement with Codexis, Inc. to include research and development of additional gene therapy for a lysosomal storage disorder. The expanded agreement first struck in March 2020 brings the number of programs the two companies are working on to four. Codexis leveraged its CodeEvolver protein engineering platform to generate novel gene sequences encoding enzyme variants tailored to enhance efficacy by increasing activity, stability, and cellular uptake. Takeda is combining these improved transgenes with its gene therapy capabilities to develop novel candidates for the treatment of rare genetic disorders. Codexis CEO John Nichols said over the past year, his company’s CodeEvolver technology has generated novel genetic sequences that encode more efficacious enzymes for the potential treatment of Fabry and Pompe Diseases, as well as an undisclosed blood factor deficiency. ALX Strikes Agreement with Eli Lilly California-based ALX Oncology forged a clinical trial and supply collaboration with Eli Lilly to assess the combination of ALX148, a next generation CD47 blocker, and Cyramza (ramucirumab), Lilly’s anti-VEGFR2 antibody, for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction cancer. ALX intends to conduct a randomized Phase II/III study to assess the combination along with chemotherapy for the treatment of patients whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. The trial will build upon data from the ongoing ASPEN-01 Phase 1b trial in patients with HER2-positive gastric or gastroesophageal junction cancer who had progressed on one or more lines of trastuzumab therapy. In that study, ALX148 demonstrated a promising initial objective response rate of 64% with the combination with ramucirumab, trastuzumab and paclitaxel in patients who historically have low response rates and poor outcomes. Financial details were not disclosed. BeiGene and Shoreline Partner in Oncology BeiGene and Shoreline Biosciences forged a strategic collaboration to develop and commercialize a portfolio of NK-based cell therapeutics for different cancer indications. The partnership will pair Shoreline’s iPSC NK cells with BeiGene’s discovery and clinical development expertise. The companies will jointly develop cell therapies for four designated therapeutic targets, with an option to expand the collaboration at a later date. Under terms of the deal, BeiGene will pay Shoreline $45 million in upfront cash. Additional R&D funding and milestone payments were not disclosed. Additionally, BeiGene has an option to acquire an equity stake in Shoreline in its next round of equity financing.