4D Pharma plc, of Leeds, U.K., and Longevity Acquisition Corp., a special purpose acquisition company based in Shanghai, will merge. The deal is worth up to $37.6 million to 4D. 4D said it plans to launch a new Nasdaq-listed American depositary shares program under the ticker symbol LBPS and be admitted to trading upon completion. 4D will become dual-listed and ordinary shares will continue to be traded on the Alternative Investment Market under the ticker symbol DDDD. 4D also said it will benefit from $14.6 million cash held by Longevity. 4D’s clinical programs target cancer, including a clinical collaboration with Merck & Co. Inc., of Kenilworth, N.J., along with programs for respiratory diseases, including COVID-19 and asthma, gastrointestinal diseases, preclinical programs targeting neurological diseases such as Parkinson’s disease and autoimmune diseases.
Alligator Bioscience AB, of Lund, Sweden, said it will focus its resources on two proprietary candidate drugs, ATOR-1017 and mitazalimab, as positive safety and proof-of-mechanism data support moving both into phase Ib/II studies in 2021. Alligator said it will complete the ongoing dose-escalation study with the bispecific ATOR-1015 as planned during the fourth quarter of 2020, after which it will be partnered for further development. In April, Alligator said it would increase its focus on its clinical development portfolio and reduce investments in nonclinical activities so that it could extend its cash runway.
Amyris Inc., of Emeryville, Calif., and the Infectious Disease Research Institute signed collaboration and license agreements to advance a ribonucleic acid vaccine platform, including accelerating development of a COVID-19 vaccine. The collaboration combines the institute’s RNA vaccine platform, including its nanostructured lipid carrier platform, with Amyris's semisynthetic squalene. Amyris will co-own intellectual property developed to create the vaccine, any rights in any combination of institute materials and Amyris squalene, the preclinical and phase I trial data and the clinical study report.
Arixa Pharmaceuticals Inc., of Palo Alto, Calif., said it will be acquired by New York-based Pfizer Inc.’s Hospital Business. Financial terms were not disclosed. Arixa’s lead compound, ARX-1796, is an oral prodrug of avibactam, a beta lactamase inhibitor that was FDA-approved in 2015 as part of Avycaz. Sold by Pfizer as Zavicefta outside the U.S., it is an intravenous-only combination with ceftazidime for treating a number of indications caused by gram-negative pathogens.
Bioinvent International AB, of Lund, Sweden, said it received a €2 million (US$2.36 million) milestone payment in its collaboration with Daiichi Sankyo Co., of Tokyo, by initiating a phase I trial with an anti-glycoprotein A repetitions predominant (GARP)-directed antibody, DS-1055.
Catalent Inc., of Somerset, N.J., and Brainstorm Cell Therapeutics Inc., of New York, agreed to manufacture Nurown, Brainstorm’s autologous cellular therapy being investigated for treating amyotrophic lateral sclerosis. Nurown induces mesenchymal stem cells to secrete high levels of neurotrophic factors that Catalent said promotes survival of neurons and neuroprotection. The therapy has received fast track status from the FDA. Brainstorm is completing a 200-patient phase III study in the U.S.
New data from Eloxx Pharmaceuticals Inc., of Waltham, Mass., show that ELX-02, a small molecule designed to restore production of full-length functional proteins, produced significant read-through of premature stop codons leading to full-length proteins, as demonstrated using DMS-114 cells with the R213X nonsense mutation in the TP53 gene. Using three complementary techniques, no evidence of native stop codon read-through products could be detected, the company said. Those data suggest that ELX-02 does not promote native stop codon read-through at concentrations relevant to premature stop codon read-though, the company added.
Homology Medicines Inc., of Bedford, Mass., disclosed a new in vivo gene therapy development program for treating mucopolysaccharidosis type II, or Hunter syndrome. Candidate HMI-203 is a potential one-time AAVHSC treatment designed to deliver functional copies of the IDS gene to multiple target organs, including the peripheral and central nervous systems, following a single I.V. administration. Homology said it has initiated pivotal IND-enabling studies and scaled the new construct up to 500 L by leveraging its plug and play commercial manufacturing platform to support a potential regulatory submission for HMI-203.
Ideaya Biosciences Inc., of South San Francisco, said it entered a target and biomarker discovery partnership with the Sellers Laboratory at the Broad Institute of MIT and Harvard, which will use the CRISPR paralog screening platform developed at the Broad Institute to evaluate functionally redundant paralogous genes across ovarian cancer subtypes and to generate synthetic lethality (SL)-based target and biomarker discoveries. In addition, the collaboration will evaluate paralog CRISPR knockdown in selected cell lines in conjunction with pharmacological inhibition of PARG to inform patient selection and combination strategies in both ovarian and breast cancers. Ideaya has also become a member of the Depmap (Cancer Dependency Map) consortium led by the Broad Institute to further enhance the company's efforts in bioinformatics and cell-based screening for SL target and biomarker discovery and validation.
Insitro Inc., of South San Francisco, said it acquired Haystack Sciences Inc., also of South San Francisco, adding Haystack’s machine-learning drug discovery approach, which focuses on synthesizing, breeding and analyzing large, diverse combinatorial chemical libraries encoded by unique DNA sequences called DNA-encoded libraries, or DELs. Financial details of the acquisition are not disclosed.
Kamada Ltd., of Rehovot, Israel, will manufacture an investigational COVID-19 plasma-derived immunoglobulin therapy under a supply agreement with Israeli health authorities. Kamada, which is partnered on the development of the therapy with Lucca, Italy-based Kedrion Biopharma SpA, will manufacture the product, to be supplied to the Israeli Ministry of Health, from convalescent plasma collected by the Israeli National Blood Services, a division of Magen David Adom, and additional Israeli medical institutions. The initial order to be supplied in the next few months is sufficient to treat about 500 hospitalized patients. The companies' U.S. clinical development of a plasma-derived IgG product as a potential COVID-19 treatment is expected to begin in early 2021 pending IND acceptance by the FDA.
Medipharm Labs Corp., of Toronto, said its wholly owned subsidiary, Medipharm Labs Australia Pty Ltd., entered a new white-label supply agreement with Sunco Green Pharmaceutical Pty Ltd., marking its 12th supply agreement to bring GMP-certified finished cannabis-based products to the Australian and New Zealand markets.
Nonprofit scientific research organization IAVI and Serum Institute of India Pvt. Ltd., of Pune, India, said they entered an agreement with Merck & Co. Inc., of Kenilworth, N.J., to develop SARS-CoV-2 neutralizing monoclonal antibodies co-invented by IAVI and Scripps Research to address the COVID-19 pandemic. If the cross-reactive SARS-CoV-2 neutralizing antibody candidates being advanced through the partnership are shown to be efficacious in clinical trials, either as a single antibody or a potential combination of both candidates, Merck will lead commercialization in developed countries. Serum Institute will lead global manufacturing as well as commercialization in low- and middle-low-income countries, including India.
Oncurious NV, of Leuven, Belgium, said it reached preclinical proof of concept and has entered the lead optimization phase with its CCR8 Treg program. CCR8 has been validated to be a tumor-infiltrating Treg-specific marker in solid tumors in both patients and animal models. Oncurious is now accelerating its efforts toward initiation of preclinical development of the therapeutic antibody program in early 2021.
OSE Immunotherapeutics SA, of Nantes, France, said preclinical data published in the Journal of Clinical Investigation characterizes the efficacy and mechanism of action of BI-765063, formerly OSE-172, the first selective antibody antagonist of SIRPα-mediated “don’t eat me” signals. In in vivo models of resistance to anti-PD-1, PD-L1 or 4-1BB co-stimulation activators, studies demonstrated that T lymphocytes initially blocked at the tumor’s margin could penetrate efficiently into the tumor when blocking SIRPα in parallel. Crossing that barrier is associated with positive modulation of macrophage expression and secretion of chemokines allowing the penetration of T lymphocytes into the heart of the tumor. BI-765063, partnered with Boehringer Ingelheim GmbH, of Ingelheim, Germany, is in phase I testing.
Peptc Vaccines Ltd., of London, part of Treos Bio Ltd., said preclinical data published in bioRxiv showed peptide vaccine PolyPEPI-SCoV-2, administered with Montanide ISA 51VG adjuvant, was safe in two mouse models and elicited highly specific, TH1-biased CD8+ and CD4+ T-cell responses against all four structural proteins of the SARS-CoV-2 virus. PolyPEPI-SCoV-2 vaccination also induced humoral responses, as measured by total mouse IgG for BALB/c and human IgG for CD34+ humanized mouse models. Binding antibodies can act in cooperation with the vaccine-induced CD8+ killer T cells against viral reservoirs to help rapid viral clearance. The study also showed that PolyPEPI-SCoV-2 defines natural CD8+ and CD4+ T-cell responses observed in asymptomatic/mild COVID-19 patients one to five months after symptom onset. In tests of blood samples from 17 donors, the PolyPEPI-SCoV-2-specific CD8+ T-cell repertoire used for recovery from COVID-19 was extremely diverse: donors recognized on average seven different vaccine peptides out of nine; 87% of donors had multiple vaccine-specific T cells against three SARS-CoV-2 structural proteins and 53% against all four.
Probiogen AG, of Berlin, said Heidelberg Pharma AG, of Ladenburg, Germany, signed a master service agreement for the antibodies used in two of Heidelberg’s Antibody Targeted Amanitin Conjugate (ATAC) molecules. Under the agreement, Probiogen is conducting the full service package from cell line development using its CHO.RiGHT cell line expression platform. Financial terms were not disclosed. Heidelberg ATAC molecules are in development for cancer indications.
SOM Biotech SL, of Barcelona, Spain, said preclinical results presented at IDWeek 2020 demonstrate that eravacycline is a potent inhibitor of the SARS-CoV-2 3CL protease. Eravacycline, a tetracycline-related antibiotic approved for use against gram-negative pathogens, was identified using an AI-based screening technology (SOMAIPRO), that analyzed a database of clinically tested compounds in search of inhibitors of SARS-CoV-2 3CL protease, a viral protein essential for coronavirus infection and replication in host cells. Covalent docking calculations demonstrated that eravacycline establishes a covalent bond with Cys145 in the catalytic domain of the SARS-CoV-2 3CL protease. In vitro experiments confirmed inhibition of the protease with an IC50 in the low micromolar range. Eravacycline also inhibited the infection of SARS-CoV-2 in VeroE6 cells and showed no toxicity when applied alone. The studies also showed the drug can inhibit the 3CL proteases of other related coronaviruses, such as SARS-CoV and MERS-CoV, suggesting that it could be repositioned for the treatment of beta-coronavirus infections. A phase II study is planned for testing in hospitalized COVID-19 patients.
Storm Therapeutics Ltd., of Cambridge, U.K., said STC-15, its potentially first-in-class drug candidate targeting METTL3, has been selected for development toward clinical studies. The company intends to submit an IND application in 2021. STC-15 is an orally bioavailable, small-molecule METTL3 inhibitor to treat acute myeloid leukemia and other solid and hematological cancers.
Tetra Bio-Pharma Inc., of Ottawa, a cannabinoid-derived drug development company, said it signed a research collaboration agreement with Targeted Pharmaceutical LLC, of Worcester, Mass., and the George Mason University NCBID. Tetra previously acquired a 20% stake in Targeted Pharma. The research collaboration will allow the evaluation of ARDS-003, with and without antiviral drugs, to prevent and treat SARS-CoV-2 infection in animals.