Adagene Inc., of San Francisco, and Mitsubishi Tanabe Pharma Corp., of Suzhou, China, entered through a Mitsubishi subsidiary a collaboration under which Tanabe Research Laboratories U.S.A. Inc. will use Adagene's SAFEbody technology platform to generate a masked antibody in combination with the cytotoxic payload technologies used at Tanabe for the development of an antibody-drug conjugate against a solid tumor target. Adagene has developed SAFEbody for discovery of a masked antibody that is activated by factors present in tumor tissues but not in healthy tissues. Terms were not disclosed.
Alphamab Oncology Co. Ltd., of Suzhou, China, said Jiangsu Alphamab Biopharmaceuticals Co. Ltd., a wholly owned subsidiary, signed a partnership agreement with Institut Pasteur of Shanghai, Chinese Academy of Sciences for the co-development, manufacturing and commercialization of a therapeutic antibody for COVID-19 worldwide. The cooperation will fully leverage Institut Pasteur's prowess in R&D, and prior research findings in the area of infectious diseases, along with Alphamab’s R&D with its proprietary mixed antibodies platform. Terms were not disclosed.
Aptevo Therapeutics Inc., of Seattle, and Lund, Sweden-based Alligator Bioscience AB presented new preclinical data for ALG.APV-527, an immunotherapeutic bispecific candidate intended for the treatment of multiple solid tumors expressing 5T4, a tumor-restricted antigen, at the PEGS Virtual Interactive Global Summit. ALG.APV-527 is designed to activate antitumor responses by inducing signaling through the co-stimulatory receptor 4-1BB (CD137), which is an immune receptor that is up-regulated on activated T cells and natural killer (NK) cells. The data show that ALG.APV-527 may overcome many of the limitations of competitor 4-1BB antibodies as it selectively enhances the function of activated T cells and NK cells in the presence of the tumor antigen 5T4, as shown in vitro, and potently rejects tumors in an in vivo animal model.
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., established an expanded access program with oral, once-daily berotralstat, an investigational drug, for patients with hereditary angioedema in the U.S. Through the program, physicians may be able to request berotralstat for patients who do not have access to the product through a clinical trial. An NDA is under review by the FDA with an action date of Dec. 3. In separate news, Biocryst said data published in Science Translational Medicine show, in a primate model, that galidesivir was safe, provided post-exposure prevention of Zika viral replication across a range of doses, and rapidly reduced viral loads to undetectable levels when dosed up to 72 hours after infection with Zika virus. Galidesivir, a broad-spectrum antiviral, has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS. Biocryst said a phase I trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19 is currently enrolling patients across multiple sites in Brazil.
Bryn Pharma LLC, of Raleigh, N.C., said a series of preclinical studies supporting the benefits of its BRYN-NDS1C needle-free device in the delivery of emergency epinephrine were recently published in three peer-reviewed scientific journals. The studies were included in the April 2020 editions of Respiratory Research and Pharmacology Research and Perspectives, and in the May 2020 edition of Pharmaceutical Research. The company's candidate is designed to be easier to carry and use compared to auto-injectors which comprise the majority of the current emergency epinephrine market. The preclinical results described in the publications were used to support the advancement of BRYN-NDS1C into the human clinical trial program currently underway, Bryn said.
Curadigm SAS, of Paris, disclosed the publication, with Robert Langer’s lab at the Massachusetts Institute of Technology, of preclinical in vivo results showing that its Nanoprimer can improve the efficacy of RNA-based therapeutics. The collaboration utilized next-generation RNA technology developed at the Langer lab, in combination with Curadigm’s Nanoprimer technology, designed to precisely but transiently occupy the hepatic pathways responsible for therapeutic clearance. In preclinical studies, the combination resulted in significantly increased bioavailability and efficacy of siRNA and mRNA in vivo. Results were published in Nano Letters. Curadigm is a spinoff of Paris-based Nanobiotix SA.
Debiopharm SA, of Lausanne, Switzerland, signed an exclusive license agreement and research collaboration with Takeda Pharmaceutical Co. Ltd., of Tokyo, to develop microbiome therapeutics for the treatment of gastrointestinal (GI) disorders. The preclinical program is focused on novel, narrow-spectrum, microbiome remodeling agents targeting a combination of intestinal pathobiont bacterial species while sparing healthy commensal bacteria. Takeda will screen and optimize compounds derived from Debiopharm's discovery Debio 1454M program to identify candidates for further development for the treatment of inflammatory bowel disease and other GI disorders. Drug candidates will be evaluated for their effectiveness against specific disease-causing microorganisms while preserving the natural balance of the microbiota. Terms were not disclosed.
Delmar Pharmaceuticals Inc., of San Diego, said it will acquire Adgero Biopharmaceuticals Holdings Inc., of Princeton, N.J. The merger is an all-equity transaction, with Adgero stockholders receiving shares of Delmar common stock for shares of Adgero common stock. Once the merger is completed, Delmar and Adgero stockholders will own 50.5% and 49.5% of the combined company’s voting power, respectively. Privately held Adgero’s late-stage photodynamic therapy platform is for developing treatments for cutaneous oncology indications. Delmar’s pipeline is based around VAL-083, a small molecule that has demonstrated clinical activity against a range of cancers, the company said.
South San Francisco, Calif.-based Denali Therapeutics Inc. said it will pause its clinical studies of DNL-747 in Alzheimer’s disease and amyotrophic lateral sclerosis and concentrate on developing DNL-788, a small molecule the company said has a more rapid path toward proof-of-concept clinical studies in patients in multiple neurological indications. Chronic toxicity studies with DNL-747 in cynomolgus monkeys showed dose- and duration-dependent adverse preclinical findings at exposures higher than those tested in the clinic, the company said. Those findings, considered off-target and molecule-specific, impact the ability to increase the dose of DNL-747 and achieve higher levels of target inhibition without time consuming additional clinical safety studies in patients to evaluate the long-term safety and tolerability, the company concluded.
Dyadic International Inc., of Jupiter, Fla., said it was selected by the Frederick National Laboratory to engineer its C1 cell lines to produce COVID-19 vaccine candidates to be used by the Vaccine Research Center part of the National Institute of Allergy and Infectious Diseases, at the NIH. Dyadic’s platform is based on C1, the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila). The C1 microorganism enables development and large-scale manufacture of low-cost proteins, the company said, and could be developed into an expression system that may help speed up development, lower production costs and improve performance of biologic vaccines and drugs at flexible commercial scales.
E-therapeutics plc, of Oxford, U.K., and Galapagos NV, of Mechelen, Belgium, will collaborate to identify new therapeutic approaches to modulate a specific mechanism involved in idiopathic pulmonary fibrosis (IPF) and potentially in other fibrotic indications. E-therapeutics will select clinically relevant compounds for treating IPF and fibrosis and is responsible for all computational activities. Galapagos will perform all experimental testing. E-therapeutics will receive up-front and near-term payments and is eligible to receive preclinical and clinical development and commercial milestone payments.
Izana Bioscience, of Oxford, U.K., said namilumab (IZN-101) has been selected as the first potential treatment to be tested in a new major U.K. drug trial for hospitalized COVID-19 patients. The CATALYST trial, running in Birmingham, U.K., and in collaboration with Oxford and University College London, will test a series of investigational and already approved drugs. Those that prove successful in CATALYST will be recommended for further testing within large ongoing national trials. Namilumab, one of four potential treatments in the trial, is a fully human monoclonal antibody already in late-stage trials to treat rheumatoid arthritis. Researchers in Bergamo and Milan, Italy, began in April investigating it as a potential COVID-19 treatment in a compassionate use study, the company said.
Johnson & Johnson, of New Brunswick, N.J., said its Janssen Pharmaceutical Cos. division is accelerating initiation of a phase I/IIa first-in-human trial of SARS-CoV-2 vaccine Ad26.COV2-S, recombinant. The study is now expected to start in the second half of July rather than in September as previously disclosed. The company said it is also in discussions with the NIH’s National Institute of Allergy and Infectious Diseases with the objective of starting a phase III SARS-CoV-2 vaccine trial ahead of schedule, pending the outcome of phase I studies and approval of regulators.
New data from the preclinical study of LEAF-1401 from L.E.A.F. Pharmaceuticals LLC, of Valley Forge, Pa., show the treatment resulted in 20-fold higher intratumoral exposure levels of pentaglutamated pemetrexed, the main active form of pemetrexed, and 30-fold higher intratumor exposure levels of pemetrexed itself, when compared to treatment with currently approved Alimta (pemetrexed). LEAF-1401, an onco-immuno antimetabolite designed to disrupt dysregulated 1-carbon metabolism in cancer and the immune system, is a liposomal formulation of gamma L-pentaglutamated pemetrexed. Gamma L-polyglutamated pemetrexed has been shown to be 80 times more potent than pemetrexed in inhibiting thymidylate synthase, the company said.
Lyvgen Biopharma Holdings Ltd., of Shanghai, established a clinical trial collaboration agreement with a subsidiary of Kenilworth, N.J.-based Merck & Co. Inc., under which it is evaluating Lyvgen’s LVGN-6051, a second-generation 4-1BB (CD-137) agonist antibody, in combination with Keytruda (pembrolizumab) in a phase I study in adult patients with advanced malignancy including lung cancer, melanoma, gastrointestinal cancer with microsatellite instability-high or mismatch repair deficient, and lymphoma. The trial, started in October 2019, is NCT04130542.
Mateon Therapeutics Inc., of Agoura Hills, Calif., said its licensing of OT-101 (trabedersen) to Autotelic Inc., of Costa Mesa, Calif., became effective this week with the completion of the first milestone payment by Autotelic to Mateon as a planned phase I trial to test a combination of OT-101 and interleukin-2 nears. The amount of the milestone wasn't specified. Mateon is also entitled to profit sharing and royalties arising from the commercialization and/or licensing of OT-101/IL-2 by Autotelic.
Melinta Therapeutics Inc., of Morristown, N.J., said it plans to acquire Tetraphase Pharmaceuticals Inc., of Watertown, Mass., for $39 million in cash, plus an additional $16 million in cash, potentially payable under contingent value rights to be issued in the proposed acquisition. The transaction's close is subject to closing conditions and is expected to occur in the third quarter of 2020, at which time Tetraphase would become a privately held company of Melinta. The transaction would add to Melina's portfolio Xerava (eravacycline), a tetracycline approved by both the FDA and EMA.
Menarini Group, of Florence, Italy, completed its acquisition of Stemline Therapeutics Inc., of New York, for aggregate cash consideration up to $677 million on a fully diluted basis. It paid $11.50 per share of Stemline (NASDAQ:STML) in cash and one non-tradeable contingent value right that will entitle each holder to an additional $1 per share in cash upon completion of the first sale of Elzonris (tagraxofusp) in any EU5 country after European Commission approval. Stemline launched Elzonris for the treatment of blastic plasmacytoid dendritic cell neoplasm in adult and pediatric patients, 2 or older, following the approval by the FDA in December 2018.
Midatech Pharma plc, of Abingdon, U.K., said it received a letter purporting to terminate the agreement between Secura Bio Inc., of Henderson, Nev., and Midatech Ltd., a subsidiary of the company, related to the license of certain patents of panobinostat, the active pharmaceutical ingredient of Midatech's MTX-110. "The company regards the purported termination as entirely without merit and will take all available action to protect its rights and assets," Midatech said.
Nantkwest Inc., of El Segundo, Calif., highlighted the publication of two peer-reviewed manuscripts in the Journal of Immunotherapy of Cancer. It said the studies showed that the company's PD-L1-targeting high-affinity natural killer cells (PD-L1 t-haNK) demonstrated in vivo tumor trafficking, significant elimination of both monocytic and granulocytic myeloid-derived suppressor cells and demonstrated robust antitumor activity in cancer cell lines and in mouse models. The studies also demonstrated the ability of PD-L1 t-haNK to kill all 20 human cancer cell lines tested, including triple-negative breast cancer and lung, urogenital and gastric cancer cells.
Neurotrope Inc., of New York, and Bryologyx Inc., of Danville, Calif., said they formed a strategic partnership covering the supply of synthetic, GMP-certified bryostatin-1, manufactured by Albany Molecular Research Inc. (AMRI), for use in development initiatives to advance Neurotrope’s lead candidate to treat Alzheimer's and other neurodegenerative diseases and potentially to serve as a source of commercial drug supply. Bryologyx will supply specified amounts of bryostatin-1 manufactured by AMRI and pay a fee on gross revenues generated by commercial sale of the product for the treatment of acute lymphoblastic leukemia (ALL). In exchange, Neurotrope will transfer to Bryologyx program rights to develop bryostatin-1 with CAR T therapy to treat CD22-positive B-cell ALL in conjunction with the NCI. Neurotrope also will transfer the IND application in development and its cooperative research and development agreement (CRADA) with the NCI covering bryostatin-1 for the modulation of CD22 in relapsed/refractory CD22-positive disease, and Bryologyx will assume responsibility for the IND and CRADA going forward. In May, Neurotrope inked a definitive merger agreement with Metuchen Pharmaceuticals LLC, of Manalapan Township, N.J., to form Petros Pharmaceuticals Inc. When the all-stock transaction closes, bryostatin-1 and other Neurotrope assets, operations and liabilities will be spun out into a separately traded company under the name Neurotrope Bioscience Inc.
Orgenesis Inc., of Germantown, Md., said it launched its Bioshield Program, which is designed to accelerate the potential discovery and validation of neutralizing human antibodies as a possible rapid defense of the population and to potentially mitigate the spread of viruses such as COVID-19. The goal of Bioshield is to increase the level of preparedness to fight against emerging outbreaks and help avoid a global pandemic, the company said. Orgenesis plans to leverage its POCare antiviral technologies as part of the development efforts of the program, including exploration of alternative and breakthrough processes to induce neutralizing antibody discovery and validation against targeted pathogens.
Ose Immunotherapeutics SA, of Nantes, France, will present data at the upcoming American Association of Cancer Research meeting showing its bispecific anti-PD-1 checkpoint inhibitor antibody, or BiCKI, platform has improved manufacturability and drug exposure. By fusing co-stimulatory molecules, either cytokines or a dominant negative receptor to the anti-PD-1-blocking antibody, it is possible to generate and select a variety of efficient bispecific molecules that act synergistically to counteract primary and secondary resistance mechanisms of anti-PD(L)1 therapies, the company said. Additional preclinical data show BiCKI-IL-1, an anti-PD-1/IL-7 bifunctional therapy, favors the T-cell effector over T-regulatory immune cell balance by stimulating Teff cells and exhausted T cells, while in parallel disarming Tregs immunosuppressive functions as opposed to IL-2 (and IL-15).
Panacea Biotec Ltd., of New Delhi, India, said it is collaborating with Refana Inc. USA, of Middletown, Del., to form an Ireland-based joint venture seeking to make Panacea’s COVID-19 vaccine accessible globally. Panacea assumed responsibility for development and commercial manufacturing of the whole inactivated virus-based vaccine, with the joint venture undertaking clinical development and regulatory submissions across the world. The collaboration aims to manufacture more than 500 million doses of the COVID-19 vaccine candidate, including more than 40 million doses expected to be available for delivery in early 2021. The partners agreed to manage sales and distribution of the vaccine in their respective territories. Additional terms were not disclosed.
Pharmabcine Inc., of Daejeon, South Korea, said it entered a partnership with Thermo Fisher Scientific Inc., of Waltham, Mass., for the development and manufacturing of PMC-309, a next-generation immune checkpoint blockade to treat cancer. Under the agreement, Pharmabcine will take advantage of Thermo Fisher's Quick to Clinic integrated service offering, a program that accelerates drug development for IND submission for phase I. PMC-309 is a fully human monoclonal IgG targeting unique epitope of human VISTA (V-domain Ig suppressor of T-cell activation) primarily expressed on myeloid-derived suppressor cells.
Qualigen Therapeutics Inc., of Carlsbad, Calif., said it forged an exclusive license agreement with the University of Louisville (UofL) to facilitate development of AS-1411, a DNA aptamer, to treat COVID-19. AS-1411 targets and binds with nucleolin, and proof-of-concept in vitro studies suggested the mechanism may protect cells from the effects of SARS-CoV-2 infection. In conjunction with the agreement, Qualigen agreed to pay UofL royalties in the low- to mid-single-digit percentages on sales of AS-1411 anti-COVID-19 products that use the university’s technology or patents. The company also inked a sponsored research agreement with UofL for additional in vitro and preclinical animal studies with AS-1411 against COVID-19.
Supernus Pharmaceuticals Inc., of Rockville, Md., said it closed the acquisition of the CNS portfolio of US Worldmeds LLC, of Louisville, Ky., expanding its marketing and development efforts by adding three products marketed in the U.S. and a candidate in late-stage development.
Zealand Pharma A/S, of Copenhagen, said it formed a two-year research agreement with Intomics A/S, of Lyngby, Denmark, for the use of integrated bioinformatics and systems biology to complement Zealand’s early pipeline activities. The companies will work jointly to develop Zealand’s competencies in integrated bioinformatics, and Zealand will become a development partner of Inbio Discover, a component of Intomics’ platform solution for data analysis and interpretation that enables search, analysis, visualization and understanding of biological networks. Zealand researchers will use the tool, in combination with the company’s data, to explore various aspects of biology and seek to identify new targets.