ADC Therapeutics SA, of Lausanne, Switzerland, said it initiated an expanded access program for loncastuximab tesirine (Lonca, formerly ADCT-402), an antibody-drug conjugate composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine dimer cytotoxin, for patients in the U.S. with relapsed or refractory diffuse large B-cell lymphoma. The program is for patients who cannot be treated by currently available drugs, cell therapy or clinical trials. Lonca’s BLA is being reviewed by the FDA.
Almirall SA, of Barcelona, and Tyris Therapeutics SL, of Moncada, Spain, will collaborate to develop treatments for rare genetic dermatology diseases using nonviral gene therapies. Tyris will be responsible for generating clinical lead candidates and progressing them to clinical development. Tyris would receive up-front and research milestone payments along with research funding, and Almirall will have exclusive options to acquire gene therapy products and progress them through clinical development to commercialization. Financial terms were not disclosed.
Alteogen Inc., of Daejeon, South Korea, said it entered an exclusive license agreement with Intas Pharmaceuticals Ltd., of Ahmedabad, India, to use ALT-B4 to develop and commercialize two products. Alteogen granted Intas worldwide rights, except for a few Asian countries, to develop two products in combination with ALT-B4. Alteogen will receive an initial payment of $6 million and is also eligible to receive payments upon Intas’ achievement of specified development, regulatory and sales milestones up to $109 million. In addition, Alteogen will be entitled to receive a tiered royalty ranging from mid-single digit to low double digit on sales of commercialized products. Alteogen will be responsible for regulatory development and commercial supply of ALT-B4 to Intas. ALT-B4 is a human recombinant human hyaluronidase enzyme and can enable the large volume subcutaneous administration of drugs that are typically administered as an I.V. injection.
Argenx SE, of Breda, the Netherlands, and Zai Lab Ltd., of Shanghai, signed an exclusive license agreement for the development and commercialization of efgartigimod in greater China, including mainland China, Hong Kong, Taiwan and Macau. Argenx will receive $75 million in up-front Zai Lab equity and $100 million in near-term milestones and other payments. Efgartigimod is an investigational antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process.
Arsenalbio Inc., of South San Francisco, formed a multiyear discovery collaboration with Bristol Myers Squibb Co., of New York, to advance next-generation T-cell therapies for the treatment of solid tumors. Arsenalbio will be responsible for discovering and building preclinical candidates against multiple targets, and BMS will have the option to obtain an exclusive worldwide license to develop and commercialize preclinical candidates. Following exercise of the option, BMS would be solely responsible for developing and commercializing the licensed candidates. BMS is making an up-front cash payment to Arsenalbio of $70 million. Arsenalbio will be eligible to receive additional payments associated with collaboration expansion, regulatory and sales milestones, as well as potential royalties. BMS will also make an investment in Arsenalbio for an undisclosed amount.
Avacta Group plc, of Cambridge, U.K., and Point Biopharma Inc., of Indianapolis, signed an agreement to provide access for Point to Avacta’s pre|Cision technology for the development of tumor-activated radiopharmaceuticals. The agreement provides Point with an exclusive license to the pre|Cision technology for use in the first radiopharmaceutical prodrug the company intends to develop, and a nonexclusive license to the pre|Cision platform for the development of a broader pipeline. Avacta will receive an up-front fee and development milestone payments for the first radiopharmaceutical prodrug totaling $9.5 million. Avacta will also receive milestone payments for subsequent radiopharmaceutical prodrugs of up to $8 million each, a royalty on sales of fibroblast activation protein-activated radiopharmaceuticals by Point and a percentage of any sublicensing income received by the firm.
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn., disclosed the acquisition of the remaining 58% interest of Kleo Pharmaceuticals Inc., of New Haven, Conn., that it did not previously own and the execution of an exclusive license agreement with Yale University for a novel extracellular degrader technology licensed from the Spiegel Lab. In connection with those two transactions, Biohaven assumed Kleo's laboratory facilities located in Science Park in New Haven, Conn., and formed Biohaven Labs to serve as the integrated chemistry and discovery research arm of Biohaven. Biohaven Labs will continue several existing Kleo discovery partnerships, including with the Bill and Melinda Gates Foundation for the development of a hyperimmune globulin mimic for COVID-19 and Peptidream Inc., of Tokyo, for the development of immuno-oncology therapeutics.
Brickbio Inc., of Boston, backed by Tiger Gene LLC, has spun out Encapsid, a gene therapy company focused on developing enhanced adeno-associated virus (AAV) delivery vectors using a technology that enables precise modification of all natural and engineered AAV capsids to enhance existing AAV capsids, as well as to create new classes of AAVs. These AAVs will expand the number of treatable diseases, increase the cargo-capacity of AAV, and enable a significantly more efficient CRISPR/Cas9 delivery vehicle, the company said. Encapsid's chemistries and strategy for AAV engineering are said to provide a robust and flexible platform to conjugate any entity onto the capsid, such as small molecules, peptides, nucleotides and proteins, including antibodies.
Cytodel Inc., of New York, disclosed the publication of preclinical data on the company’s lead product, Cyto-111, in Science Translational Medicine. Cyto-111 was conceived, expressed and purified in the laboratory of Konstantin Ichtchenko at the NYU Grossman School of Medicine, who was a principal investigator in the study, which was supported by grants from the U.S. NIH. Based on Ichtchenko’s hypothesis that the C1ad delivery vehicle previously reported could be used to transport therapeutic proteins into the neuronal cytosol, researchers developed and tested a potential treatment for botulism based on intracellular inhibition of the BoNT subtype A1 light chain metalloprotease. The main objective of the study was to develop and test a post-symptomatic botulism antidote that could rescue symptomatic animals challenged with a lethal dose of BoNT.
Evommune Inc., of Los Altos, Calif., said it entered an exclusive licensing agreement with Dermira Inc., a subsidiary of Indianapolis-based Eli Lilly and Co., to develop and commercialize three programs for treating various inflammatory diseases. The compounds include IRAK4/TrkA, a small molecule that broadly inhibits innate inflammation; RORγt, a small molecule addressing Th17-mediated inflammation; and MRGPRX2, a small molecule to treat chronic pruritus. Financial terms include an undisclosed up-front payment, potential future milestone payments per licensed compound to Dermira upon achievement of certain development and regulatory milestones as well as sales milestones and royalty payments.
Exacis Biotherapeutics Inc., of Cambridge, Mass., announced its formation along with completion of in-licensing deals for certain technologies from Factor Bioscience Inc., of Cambridge, Mass. The exclusive license allows Exacis to create allogeneic engineered T and NK cells from induced pluripotent stem cells (iPSCs). Exacis' next-generation approach avoids use of DNA and viruses by using mRNA. The technologies will be used for generating iPSC and for performing genetic editing to create stealthed, allogeneic cell products, termed ExaCAR-T or ExaCAR-NK cells. The company also added Gregory Fiore as CEO and named James Pan chief business officer. Exacis has secured initial seed funding and is seeking to raise series A funding in early 2021.
Fujifilm Corp., of Tokyo, said it is investing more than ¥200 billion (US$2 billion) to establish a new large-scale cell culture production site in the U.S. to accelerate the growth of its biopharmaceutical contract development and manufacturing business.
Iacta Pharmaceuticals Inc., of Irvine, Calif., and Pharmaleads SA, of Paris, with Pharmaleads Greater China, said they entered licensing agreements, with Iacta acquiring global rights to Pharmaleads’ Denki (dual enkephalinase inhibitors) candidates, a class of non-opioid compounds for treating acute and chronic ocular pain. Under the terms, Iacta will gain an exclusive, worldwide, royalty-bearing license to lead the clinical and commercial development of IC-800 (acute) and IC-805 (chronic) and other Denki drugs from Pharmaleads' portfolio. Pharmaleads and Pharmaleads Greater China will together be eligible to receive up to $100 million in total deal value, including up-front, development, regulatory and commercial milestone payments. Based on the ocular preclinical package already available and human systemic safety data, Iacta expects to start human proof-of-concept trials in ocular pain in 2021.
Imaginab Inc., of Los Angeles, said it signed a new multiyear nonexclusive license with Pfizer Inc., of New York, to supply 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients. Under the terms, Imaginab will supply clinical doses of 89Zr CD8 Immuno-PET for use in select oncology clinical trials and will also provide technical, clinical and regulatory support to Pfizer. Imaginab will receive license fees and payments for manufacturing and other support. No other terms were disclosed.
Logicbio Therapeutics Inc., of Lexington, Mass., said it expanded its research partnership with Children's Medical Research Institute to develop next-generation adeno-associated virus vectors for a range of gene therapy and gene editing applications in the treatment of serious diseases of the liver and two other tissues.
Merck KGaA, of Darmstadt, Germany, said it acquired Amptec, a Hamburg, Germany-based mRNA contract development and manufacturing organization, to strengthen its capabilities to develop and manufacture mRNA for its customers for use in vaccines, treatments and diagnostics applicable in COVID-19 and other diseases. Financial terms were not disclosed.
Noveome Biotherapeutics Inc., of Pittsburgh, said preclinical data published in Plos One demonstrated that the complete ST-266 secretome is required to obtain the full neuroprotective and myelin-protective effects in the experimental autoimmune encephalomyelitis (EAE) mouse model of optic neuritis. Data demonstrated that the full complement of the ST-266 secretome significantly improved retinal ganglion cell (RGC) survival and reduced optic nerve demyelination in EAE mice. In contrast, the <50kDa molecular weight ST-266 fraction significantly improved optic nerve demyelination, but only showed a trend toward improved RGC survival.
Nurix Therapeutics Inc., of San Francisco, said it expanded its global collaboration with Sanofi SA, of Paris, to discover develop and commercialize a pipeline of innovative targeted protein degradation drugs for patients with challenging diseases in multiple therapeutic areas. Sanofi has exercised its option to expand the number of targets in the collaboration agreement from three to a total of five targets. With the expansion, Nurix receives a payment of $22 million, in addition to the previously received up-front payment of $55 million. Nurix is also eligible to receive up to approximately $2.5 billion in total payments based on the successful completion of certain research, preclinical, clinical, regulatory and sales milestones.
Precision Biosciences Inc., of Durham, N.C., said it closed its in vivo gene editing research collaboration and exclusive license agreement with Eli Lilly and Co., of Indianapolis, following clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The deal, inked in November, calls for the companies to use Precision’s Arcus genome editing platform for preclinical and IND-enabling activities for up to six gene targets, with an initial focus on Duchenne muscular dystrophy and two other undisclosed gene targets. Under the terms, Precision will receive an up-front cash payment of $100 million, and has received $35 million from Lilly’s purchase of newly issued shares of Precision’s common stock. Precision is also eligible to receive up to $420 million in potential development and commercialization milestones per product, as well as tiered royalties ranging from the mid-single digits to low-teens.
Sirion Biotech GmbH, of Munich, granted Cellectis SA, of Paris, nonexclusive rights for its lentiviral transduction enhancer, Lentiboost. The product complements Cellectis’ portfolio of technologies involved in manufacturing allogeneic CAR T cells. Sirion is entitled to undisclosed up-front and milestone payments and is eligible to receive royalties on future product net sales plus license fees tied to commercial success.
Standigm Inc., of Seoul, South Korea, and SK Chemicals Co. Ltd., also of South Korea, said they found a new rheumatoid arthritis indication for an undisclosed FDA-approved drug and have filed a patent. This marks the first successful result of their open innovation partnership formed in July 2019 aimed at identifying lead compounds and repurposing existing drugs for RA and nonalcoholic steatohepatitis using Standigm’s AI-powered drug discovery platform.
Trigr Therapeutics Inc., of Irvine, Calif., said preclinical data published in the International Journal of Molecular Sciences showed that TR-009, a dual angiogenic bispecific antibody targeting VEGF/DLL4, demonstrated more potent in vitro and in vivo biological activity compared to VEGF- or DLL4-targeting monoclonal antibodies alone. Further, TR-009, in combination with paclitaxel and irinotecan, in human gastric and colon cancer xenograft models synergistically inhibited tumor progression as compared to each monotherapy. Tumor vessel regression and apoptotic tumor cell induction were noted along with TR-009's mechanistic effect on tumor vessel normalization. Immunohistochemical analysis of tumor blood vessels showed marked reduction of expression levels of VEGFR-2 and DLL4, dual targets of TR-009, in tumor endothelial cells after TR-009 treatment.
Xencor Inc., of Monrovia, Calif., and the University of Texas MD Anderson Cancer Center said they inked a research collaboration and commercialization agreement to develop CD3 bispecific antibody therapeutics for the potential treatment of patients with cancer. The collaboration will use Xencor’s Xmab technology and protein engineering expertise to create bispecific antibodies with MD Anderson’s expertise in antibody R&D. MD Anderson will conduct and fund all preclinical activities to advance candidates toward clinical studies. Xencor has certain exclusive options to license worldwide rights to develop and commercialize potential new medicines arising from the research collaboration. For programs not licensed by Xencor, Xencor will receive a portion of future payments received by MD Anderson. Xencor and MD Anderson are entering the collaboration with two predetermined, undisclosed antibody candidates.