4Teen4 Pharmaceuticals GmbH, of Hennigsdorf, Germany, said published data show the prognostic value of DPP3 in sepsis. In a recent study, DPP3 predicted the progression of organ function and survival in septic patients more accurately than standard parameters such as lactate and procalcitonin. The effects of sepsis have been shown to be reversed by procizumab, the company’s humanized monoclonal anti-DPP3 neutralizing antibody currently in preclinical development.
Abcellera Inc., of Vancouver, British Columbia, and Empirico Inc., of San Diego, said they entered a multitarget discovery collaboration in which Empirico will use its Precision Insights Platform, a human genetics-focused discovery platform, to select up to five therapeutic targets, while Abcellera will use its AI-powered antibody discovery technology to search and analyze natural immune responses to identify antibodies with the desired therapeutic properties against the selected targets. Under the terms, Empirico will have the rights to develop and commercialize antibodies resulting from the collaboration. Abcellera will receive research payments and is eligible to receive downstream clinical and commercial milestone payments and royalties on net sales of products from Empirico.
Alligator Bioscience AB, of Lund, Sweden, said it entered a joint research collaboration with Macrogenics Inc., of Rockville, Md., to develop and commercialize monoclonal antibody-based therapeutics for treating cancer. The work will lead to the expansion of Alligator’s patient-specific immunotherapy, Neo-X-Prime, by incorporating Macrogenics’ DART and TRIDENT multispecific platforms against two undisclosed targets. Under terms of the agreement, which covers activities from candidate drug generation up until IND-enabling studies, each company will be responsible for its own costs. The parties may continue further development of the resulting bispecific molecule under a separate co-development collaboration and licensing agreement.
Arch Biopartners Inc., of Toronto, said it entered an exclusive worldwide agreement with Telara Pharma SL, of Madrid, Spain, to clinically develop and market cilastatin, a small-molecule drug candidate for treating and preventing acute kidney injury (AKI). Under the terms, Arch secures commercial rights to the patents around the use of cilastatin that it does not already own. The patents held by Arch and Telara are now unified into one clinical development program to be led by Arch. Those patents include method of use claims for the use of cilastatin as a potential drug to prevent AKI from a variety of causes including ischemia-reperfusion injury, sepsis and toxins. Cilastatin is a known small-molecule inhibitor of the enzyme dipeptidase-1 (DPEP-1) previously developed in the 1980s to prevent the degradation of the antibiotic imipenem in the kidney. In the past, cilastatin was used only as an active ingredient in a dual formulation with imipenem and has yet to be approved or sold as a stand-alone product. The Arch team recently discovered that DPEP-1 is an adhesion receptor of neutrophil recruitment in the lungs, liver and kidneys, a pathway that is targeted by Arch’s lead drug candidate, Metablok (LSALT peptide). Currently, Arch is nearing completion of a phase II trial for Metablok targeting that new pathway in the prevention of acute lung injury and AKI in COVID-19 patients.
Arrowhead Pharmaceuticals Inc., of Pasadena, Calif., said the first muscle-targeted investigational RNAi therapeutic, developed using the company’s Targeted RNAi Molecule platform, is designed to target the gene that encodes human double homeobox 4 (DUX4) protein as a potential treatment for patients with facioscapulohumeral muscular dystrophy. Arrowhead is conducting IND/CTA-enabling toxicology studies, with plans to file for regulatory clearance in the third quarter of 2021.
Centogene NV, of Cambridge, Mass., said it extended its partnership with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, to diagnose patients with certain genetic disorders. As part of the agreement, which has been extended until March 2022, Centogene will continue providing access to genetic testing to patients around the world.
Claritas Pharmaceuticals Inc., of San Francisco, said it entered a binding letter of intent (LOI) with Salzman Group, Salzman Group Ltd. and Salzman Group Pty Ltd., under which Salzman Group will grant to Claritas an exclusive, worldwide license to develop and commercialize R-107, a nitric oxide-releasing compound, for the treatment of pulmonary arterial hypertension. The company expects the definitive agreements will be executed by May 15, 2021. Closing of the transaction is subject to receipt of all regulatory approvals, including approval of the TSX Venture Exchange. Under the LOI, Claritas agreed to issue 26 million shares of Claritas’ common stock to Salzman Group and will make cash license fee and milestone payments, plus royalties on net sales.
Compass Pathways plc, of London, said a study published in The New England Journal of Medicine indicated signals of positive activity in COMP-360 psilocybin compared with the standard antidepressant escitalopram for major depressive disorder.
Cytodyn Inc., of Vancouver, Wash., said it executed an exclusive supply and distribution agreement with local company Chiral Pharma Corp. to supply up to 200,000 vials of leronlimab to critically ill COVID-19 patients in the Philippines under CSP authorizations. The agreement will accelerate the delivery of leronlimab upon an expanded authorization under CSP. Terms were not disclosed.
Diamyd Medical AB, of Stockholm, said it contracted with CRO Icon plc for Diagnode-3, a placebo-controlled phase III precision medicine trial with diabetes vaccine candidate Diamyd. The study, expected to begin recruiting patients later this year, is designed to confirm efficacy and safety in individuals recently diagnosed with type 1 diabetes who carry the genetically defined haplotype HLA DR3-DQ2.
Galecto Inc., of Boston, said a paper published in Gastric Cancer demonstrates the key role galectin-3 plays in gastric cancer. It outlines how galactin-3 promotes cancer cell growth through the well-established STAT-WNT pathway. Preclinical data have shown that GB-1107, one of Galecto’s galectin-3 inhibitors optimized for mouse galectin-3, is potent in inhibiting the cancer-promoting effects of galectin-3.
Nanoview Biosciences Inc., of Boston, said it entered a collaboration with Beth Israel Deaconess Medical Center to study the involvement of biomarkers carried by exosomes in patients undergoing immune checkpoint inhibitor therapy for cancer. The ExoPD-L1 to Predict Immunotherapy Response in Cancer (EPIC) study will specifically investigate PD-L1 and status of disease as well as response to therapy.
Probiogen AG, of Berlin, said Nouscom AG, of Basel, Switzerland, activated a commercial product license to Probiogen’s cell-based vaccine platform, AGE1.CR.pIX. The cell line is designed for large-scale industrial production of various vaccines and viral vectors. Nouscom recently received regulatory approval to start a phase Ib trial of personalized cancer neoantigen vaccine.
Prestige Biopharma Ltd., of Singapore, and Pharmapark LLC, of Moscow, said they entered a binding agreement for the exclusive partnership and supply for the commercialization of Prestige Biopharma's bevacizumab biosimilar (HD-204) in the Russian Federation. HD-204 is in phase III development. Financial terms were not disclosed, but Prestige Biopharma will assume responsibility for product commercial supply out of its manufacturing facilities in Osong, Korea, while Pharmapark will be responsible for local registration, sales and marketing in the Russian Federation, with the option to manufacture the product in the Russian Federation in line with the Russian import substitution strategy.
Proteona Pte Ltd., of Singapore, said results from a long-term collaboration with researchers at the German Cancer Research Center and its National Center for Tumor Diseases to develop and characterize an innovative non-integrating CAR T vector system were published in Science Advances. Work characterized the novel CAR T cells using Proteona’s Escape CAR T assay, a single-cell multi-omics product designed for in-depth characterization of CAR T-cell therapy products and patient samples, and showed how single-cell multi-omics can pick up variations with important biological and clinical implications, adding precision and control to cell therapy development and manufacturing.
Recro Pharma Inc., of Gainesville, Ga., signed additional agreements with San Diego-based Ensysce Biosciences Inc. to provide early stage development and manufacturing services to support two of Ensysce's development programs. Ensysce, a prodrug specialist developing abuse-resistant and overdose-resistant medicines for severe and chronic pain announced in February plans to merge with the publicly traded special purpose acquisition company Leisure Acquisition Corp.
Revolo Biotherapeutics, a New Orleans-based company formerly known as Immune Regulation Ltd., has enlisted Cambridge, Mass.-based contract development and manufacturing organization Cordenpharma to manufacture the low-molecular weight peptide candidate '1104 (formerly IRL-201104) in support of two upcoming phase II trials in patients with eosinophilic esophagitis and allergic disease. Cordenpharma will manufacture the peptide at its Boulder, Colo.-based facility. Revolo said the trials would start before the end of the year.
Russian Direct Investment Fund, of Moscow, GL Rapha Co. Ltd., of South Korea, and Isu Abxis, a subsidiary of Isu Group, signed an agreement for technology transfer and production of the Russian Sputnik V vaccine against coronavirus in Korea. In February, GL Rapha completed organizing the consortium for production of Sputnik V in Korea, including eight pharmaceutical companies. The pilot production of the vaccine at the facility of Isu Abxis, located in Yong-In, is expected to begin at the end of April 2021.
Stemsynergy Therapeutics Inc., of Miami, highlighted the publication in Cancer Research of a study detailing NADI-351, which authors called "the first Notch1-selective inhibitor that suppresses tumor growth with limited toxicity by selectively ablating cancer stem cells." Scientists behind the study refined their previous proof-of-concept inhibitor using computer modeling and experimental validation to identify chemical compounds that are selective for the Notch1 transcriptional complex, the company said. "Our analysis confirms NADI-351 selectively disrupts Notch1-dependent transcription and that this mechanism has powerful downstream effects on cancer," said Annamil Alvarez-Trotta, a postdoctoral associate in cancer research at the University of Miami's Miller School of Medicine and the first author on the study.
Sutro Biopharma Inc., of South San Francisco, said it received a $15 million milestone payment from Merck & Co. Inc., of Kenilworth, N.J., for initiation of an IND-enabling toxicology study for the first program in its collaboration to develop novel cytokine derivative therapeutics for cancer and autoimmune disorders. The payment is tied to a July 2018 deal the partners struck.
Xoma Corp., of Emeryville, Calif., added three innate cell engager (ICE) programs from Heidelberg, Germany-based Affimed NV to its portfolio of potential future milestone and royalty assets. One asset is AF-M13, a CD30/CD16A ICE candidate that induces specific and selective killing of CD30-positive tumor cells by engaging and activating natural killer cells and macrophages. Another asset is AFM-24, a tetravalent, bispecific EGFR- and CD16A-binding ICE that uses the cytotoxic potential of the innate immune system by redirecting and activating NK cells and macrophages to kill EGFR-positive cancer cells through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis, respectively. The third asset was undisclosed.