Acorda Therapeutics Inc., of Ardsley, N.Y., said it entered an agreement to sell its Inbrija (levodopa inhalation powder) manufacturing operations in Chelsea, Mass., to Catalent for $80 million in cash. In connection with the sale, Acorda and Catalent entered a long-term global supply agreement under which Catalent will manufacture and package Inbrija for Acorda. Catalent will absorb all Acorda employees who work at the Chelsea facility, and certain Acorda employees at the company’s Waltham, Mass., facility. Acorda also announced a corporate restructuring to reduce costs and focus its resources on Inbrija. In addition to the associates who will transition to Catalent, Acorda is reducing its combined Ardsley, Waltham and field headcount by approximately 16% through a reduction in force. After taking into account estimated transaction fees and other estimated expenses, Acorda’s net proceeds are expected to be about $70 million. In addition, Acorda expects to save about $10 million in annual operating expenses related to the operation of the manufacturing facility. Completion of the transaction is expected to occur in the first quarter of 2021.
Actinium Pharmaceuticals Inc., of New York, said it entered a research collaboration with Astellas Pharma Inc., of Tokyo, to develop targeted radiotherapies using its Antibody Warhead Enabling (AWE) technology platform. Under the agreement, Actinium will utilize its AWE technology to develop and characterize selected Astellas targeting agents labeled with the potent alpha-emitting radioisotope Actinium-225 (Ac-225). Financial terms were not disclosed.
Auravax Therapeutics Inc., of Houston, said it entered an exclusive license agreement with Massachusetts General Hospital (MGH) covering certain intellectual property and technology rights regarding compositions and discoveries of liposomal STING agonists by Mei X. Wu, of the Wellman Center for Photomedicine at MGH. Research related to that technology was published in Science in February 2020.
Cytokinetics Inc., of South San Francisco, will receive a $2.5 million milestone payment from Ji Xing Pharmaceuticals Ltd., of Shanghai, for treating the first patient in cohort 2 of the REDWOOD-HCM study testing its myosin inhibitor, CK-3773274, in patients with hypertrophic cardiomyopathy.
Cytovia Therapeutics Inc., of Cambridge, Mass., said it signed a licensing agreement with the National Cancer Institute (NCI), part of the U.S. NIH, to apply its gene-edited induced pluripotent stem cell-derived natural killer (NK) cell technology to develop GPC3 CAR NK cell therapeutics. Cytovia also signed a Cooperative Research and Development Agreement with the NCI. Cytovia expects to file an IND for its GPC3 CAR NK cells in the first half of 2022.
Diurnal Group plc, of London, said it inked a distribution agreement with Er-Kim, a partner for global biotech and pharma companies seeking to commercialize their products in Turkey. The agreement covers the distribution of Diurnal’s products Alkindi (hydrocortisone granules in capsules for opening) and Chronocort (modified-release hydrocortisone). The products will be available for the patients who qualify in Turkey through applicable early access programs for patients with diseases of cortisol deficiency who have no other treatment option.
Eloxx Pharmaceuticals Inc., of Waltham, Mass., said it expanded its agreement with the CF Foundation beyond the U.S. portion of the trial to include additional funding for the global clinical trial program which includes Europe and Israel. Top-line data from the phase II program testing ELX-02 in patients with nonsense-mediated cystic fibrosis are expected in the first half of this year.
Esperion Therapeutics Inc., of Ann Arbor, Mich., said it entered an agreement with Serometrix LLC, of Pittsford, N.Y., to in-license its oral, small-molecule PCSK9 inhibitor program. Under the terms, Esperion made an up-front cash payment of $12.5 million in December to Serometrix, with payments in future years tied to specific milestones. The company anticipates sharing more information later this year on the potential timing for an IND submission.
Essa Pharma Inc., of Houston, said it entered a clinical collaboration and supply agreement with Janssen Research & Development LLC, part of New Brunswick, N.J.-based Johnson & Johnson, to evaluate Essa’s N-terminal domain androgen receptor inhibitor, EPI-7386, in combination with apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer. Under the terms, Janssen may sponsor and conduct up to two phase I/II studies in patients who have failed a current second-generation antiandrogen therapy. Janssen will assume all costs associated with the studies, other than the manufacturing costs associated with the clinical drug supply of EPI-7386. The parties will form a joint oversight committee for the clinical studies, which are planned to start in 2021. Essa will retain all rights to EPI-7386.
Genmab A/S, of Copenhagen, Denmark, said it reached its first milestone in its collaboration with Abbvie Inc., of North Chicago. A $40 million milestone payment was triggered by the first patient dosed in the phase III study of subcutaneous epcoritamab vs. investigator’s choice of chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma.
Genprex Inc., of Austin, Texas, said it passed final release tests for its first scaled-up clinical-grade manufacturing run of Reqorsa immunogene therapy in advance of its upcoming Acclaim-1 and Acclaim-2 clinical trials for treating non-small-cell lung cancer. The studies, on track to be initiated in the first half of 2021, will combine Reqorsa with Tagrisso (osimertinib, Astrazeneca plc) and Keytruda (pembrolizumab, Merck & Co. Inc.), respectively. Reqorsa has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells, the company added.
Hemogenyx Pharmaceuticals plc, of London, said it completed the development of its CDX antibody with a global pharmaceutical company and has chosen a clone of the antibody that is ready for IND-enabling studies. In the original partnership agreement, Hemogenyx received, free of charge, technical support, access to advanced methods of discovering, developing and engineering antibodies, and certain intellectual property necessary for the successful preclinical development of the company's lead candidate bispecific CDX antibody for the treatment of acute myeloid leukemia.
Hibercell Inc., of New York, and Biodesix Inc., of Boulder, Colo., will develop an enzyme-linked immunosorbent assay as a companion diagnostic in future registrational trials in breast cancer for Imprime PGG programs. Terms were not disclosed. Hibercell is developing therapies to modulate stress-mediated adaptive biology and reprogram the immunosuppressive tumor microenvironment.
Jaguar Health Inc., of San Francisco, said it entered a binding agreement of terms for $6 million for the sale of partial rights to a possible tropical disease priority review voucher. Streeterville Capital LLC has a right to 18% of the sale of a voucher that Jaguar's wholly owned subsidiary, Napo Pharmaceuticals Inc., plans to pursue as incentive for developing its lechlemer drug candidate for symptomatic relief of diarrhea in cholera patients. Priority review vouchers are transferable and, in past transactions by other companies, have sold from $67 million to $350 million, according to Jaguar.
Jasper Therapeutics Inc., of Redwood City, Calif., and Graphite Bio Inc., of South San Francisco, will evaluate JSP-191, Jasper’s anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning regimen for Graphite’s investigational GPH-201 gene replacement therapy for severe combined immune deficiency in patients with IL2RG deficiency, known as x-linked SCID (XSCID). Each company will retain commercial rights to their respective technologies.
Kamada Ltd., of Rehovot, Israel, said it entered agreements with two undisclosed international pharmaceutical companies to commercialize three biosimilar product candidates in Israel. Subject to approval by the EMA and subsequently by the Israeli Ministry of Health, Kamada said it expects the three products to be launched in Israel between 2022 and 2024. The two pharmaceutical companies will maintain development, manufacturing and supply responsibilities for the three products.
Khondrion BV, of Nijmegen, the Netherlands, disclosed the publication of the mode of action and potential applications of selective inhibition of microsomal prostaglandin E synthase-1-mediated PGE2 by sonlicromanol’s in vivo active metabolite KH176m, in Scientific Reports. Sonlicromanol, Khondrion’s wholly owned investigational lead asset, which is in phase IIb development as a potentially disease-modifying treatment for mitochondrial disease, has already been shown to act as a potent redox modulator and ROS scavenger, which are two common cellular consequences of mitochondrial diseases. The paper reports the outcome of a novel metabolomics-based screening undertaken by the research team, targeted at inflammatory, oxidative and nitrosative stress markers to explore the role of oxidative stress and signaling lipids.
Ligand Pharmaceuticals Inc., of San Diego, said it will receive a $1.5 million milestone payment from Merck & Co. Inc., of Kenilworth, N.J., triggered by the FDA’s acceptance for review of a BLA for V-114, an investigational 15-valent pneumococcal conjugate vaccine candidate for the prevention of pneumococcal disease in adults. Ligand’s protein expression technology is described as a scalable platform for recombinant protein production, and is especially well-suited for complex, large-scale efforts.
Marker Therapeutics Inc., of Houston, completed the construction and qualification of its cGMP manufacturing facility in Houston, located near the George Bush Intercontinental Airport. The facility will allow production of MultiTAA-specific T-cell products according to FDA guidelines, and is designed to be scalable using modular processes. The company has initiated the technology transfer process and expects the facility to be fully operational in the first half of 2021.
Numab Therapeutics AG, of Waedenswil, Switzerland, formed a global co-development and regional licensing agreement with Kaken Pharmaceutical Co. Ltd., of Tokyo, for the company’s multispecific anti-inflammatory drug candidate, NM26-2198, which blocks three key pathways in the pathophysiology of atopic dermatitis. The alliance builds on a collaboration and option agreement established in 2017. Under the expanded agreement, Kaken receives commercial rights for NM26-2198 in Japan, China, South Korea, Taiwan, Singapore and Hong Kong, while Numab retains the commercial rights to the U.S., Europe and the rest of the world. The parties will jointly develop NM26-2198, with Kaken covering the majority of global development costs up to clinical proof of concept. Upon successful commercialization of products resulting from the alliance, Kaken will receive certain payments from Numab up to a cap that is calculated based on previous R&D payments made by Kaken to Numab.
Omega Therapeutics Inc., of Cambridge, Mass., selected its first Omega Epigenomic Controller development candidate, OTX-2002, to advance into IND-enabling studies. Omega scientists rationally designed OTX-2002 as an engineered therapeutic to specifically control c-myc (MYC) oncogene expression and demonstrated its effect in hepatocellular carcinoma. Preclinical animal studies show OTX-2002 potently down-regulates MYC. Successfully creating a way to control MYC expression in cancer has historically eluded the efforts of many groups, the company noted.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., will sell 1.25 million doses of its casirivimab and imdevimab anti-SARS-CoV-2 antibody cocktail to the U.S. Department of Health and Human Services and the Department of Defense. The government is obligated to purchase all finished doses supplied by June 30, 2021, up to 1.25 million doses, for up to $2.625 billion. Regeneron expects to be able to supply 750,000 finished doses by the end of June or the entire 1.25 million doses if the 1,200-mg dose is authorized. Roche Holding AG, of Basel, Switzerland, is responsible for development and distribution outside the U.S. where it's actively working with governments on potential supply agreements.
The Russian Direct Investment Fund (RDIF), of Moscow, and União Química Fernando De Castro Marques, part of União Química Farmaceutica Nacional SA, of Sao Paolo, Brazil, said they agreed to supply to Brazil 10 million doses of coronavirus vaccine Sputnik V in the first quarter of 2021, with deliveries beginning in January. Local production of Sputnik V in Brazil was launched in earlier this month, and RDIF and União Química said they will apply for emergency use authorization this week.
Salarius Pharmaceuticals Inc., of Houston, received the final installment of $900,000 of its $1.7 million grant from the Cancer Prevention and Research Institute of Texas after achieving specific goals and objectives for the development of LSD1 inhibitor seclidemstat.
Sarepta Therapeutics Inc., of Cambridge, Mass., obtained an option to license lipid nanoparticle (LNP) technology for up to four neuromuscular indications from Genevant Science Ltd., of Cambridge, Mass. Sarepta plans to use the muscle-targeted LNPs for delivery of gene editing therapeutics. Genevant is eligible for approximately $50 million in near-term payments as well as future development, regulatory and commercial milestone payments and tiered royalties ranging from the mid-single to low-double digits on future product sales.
Taysha Gene Therapies Inc., of Dallas, and UT Southwestern Medical Center said they launched an innovation fund to discover and develop novel gene therapy candidates and next-generation technologies for monogenic diseases of the CNS. Taysha will have an exclusive option on new programs and intellectual property associated with, and arising from, the research conducted under the agreement.
Urogen Pharma Ltd., of Princeton, N.J., established a three-year collaboration with The University of Texas MD Anderson Cancer Center to perform nonclinical and clinical studies for UGN-302, which is being developed as a treatment for high-grade non-muscle invasive bladder cancer. UGN-302 combines Urogen's Toll-like receptor 7/8 agonist, UGN-201, with a CTLA4 antagonist.