4Bio Ventures Management Ltd., of London, said Kyowa Kirin Co. Ltd., of Tokyo, made an investment in 4Bio’s Ventures II LP Fund. The investment will provide Kyowa with access to advanced therapies across the U.K., Europe and the U.S. through 4Bio’s investment team, while Kyowa will provide 4Bio with access to its scientific and R&D teams to better inform its ongoing investment in the space. Terms were not disclosed.
A2A Pharmaceuticals Inc., of Boston, said it inked an agreement to co-develop SARS-CoV-2 main proteases inhibitors for the treatment of COVID-19 with Laxai Life Sciences Pvt. Ltd., of Hyderabad, India. Under the collaboration, A2A designed the molecules using its computational AI-enabled drug discovery platform Sculpt, which are currently being synthesized and will be evaluated by Laxai. Both parties will collaborate in preclinical optimization and selection of lead candidates to enter the clinic. Financial terms were not disclosed.
Achilles Therapeutics Ltd., of Hertfordshire, U.K., said it will be manufacturing advanced therapy products for clinical trials in one of the newly operational modules at the Cell and Gene Therapy Catapult center in London. The center has remained operational throughout the COVID-19 pandemic to prioritize the production of patient batches manufactured for clinical supply, and the facility is continuing to support companies as they accelerate their operations. Achilles is developing cancer immunotherapies targeting clonal neoantigens.
Aerami Therapeutics Inc., of Durham, N.C., signed a global license and development agreement with Vectura Group plc, of Chippenham, U.K., to develop and commercialize inhaled imatinib for the treatment of pulmonary arterial hypertension. Aerami will be responsible for the overall development and commercialization, with Vectura providing a combination of its development services expertise and a license to its Fox mesh nebulizer technology. The drug-device combination product is targeted to go into a phase I trial in the second half of 2020. Aerami plans to pursue orphan disease designation. In return for the license, the company will be obligated to pay Vectura certain regulatory and net sales-based milestones, a mid-single-digit royalty on global net sales and will purchase Fox devices from Vectura. Exact terms were not disclosed.
Aeterna Zentaris Inc., of Charleston, S.C., said it regained compliance with the minimum bid price for continued listing on Nasdaq as the closing bid price of its common stock has been at $1 or greater for 10 consecutive trading days.
Agex Therapeutics Inc., of Alameda, Calif., said it received a deficiency letter from the New York Stock Exchange on June 1, notifying the company it had stockholder equity of less than $2 million and has incurred losses from continuing operations and/or net losses during its two most recent fiscal years. Agex must provide the exchange with a plan by July 1 detailing how it can become compliant by Dec. 1. Agex generates defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases.
Applied DNA Sciences Inc., of Stony Brook, N.Y., said linear versions of its plasmid-based DNA COVID-19 vaccine candidates have begun dose-response trials. First injections of the candidate designed to neutralize antibodies in test animals began May 4. The company uses plasmid-based DNA templates to determine baseline results for the efficacy of the vaccine candidates in preclinical animal models.
BB Pureos Bioventures, of Zurich, and Baselaunch, Basel, Switzerland, formed a biotech venture capital fund, Baselaunch Phase II. Baselaunch Phase II plans to increase funding per venture with a maximum of $500,000, increase its pool of partners and accept applications year round instead of once annually. While Pureos is a new company that invests in private drug development companies, Baselaunch is an incubator for early stage ventures.
Cognition Therapeutics Inc., of New York, said it received a $75.8 million National Institute of Aging grant for its 540-patient phase II study of CT-1812, a brain-penetrant small-molecule drug targeting the sigma-2 receptor for treating Alzheimer’s disease. CT-1812 is designed to displace toxic amyloid beta oligomers from synapses and protect against further oligomer binding to stop synapse damage and destruction characteristic of neurodegenerative diseases such as Alzheimer’s.
Epivax Inc., of Providence, R.I., said it has licensed its advanced in silico toolkit for biologics immunogenicity screening, ISPRI, to Abcellera Biologics Inc., of Vancouver, British Columbia. The toolkit allows researchers to assess and mitigate the safety and efficacy of biologic candidates in real time. The platform enables identification of T-cell epitopes and the characterization of predicted T-cell response to biologics.
Newly published data from Evgen Pharma plc, of Cheshire, U.K., notes that SFX-01, a stable form of sulforaphane used in combination with endocrine therapies, prevents breast cancer stem-like cell (CSC) enrichment in patient samples and patient-derived xenograft tumors. The data prompted the company to conclude that SFX-01 reduces the formation of stem-like cells thought to be the clones that survive once tumors are treated with therapies, such as endocrine therapies, and cause metastases. SFX-01 also blocks STAT-3, which is implicated in resistance to endocrine therapies, the company said. In March 2019, Evgen announced positive results from the open-label phase II STEM trial of SFX-01 in 46 patients with estrogen-positive metastatic breast cancer.
Evotec SE, of Hamburg, Germany, said its Seattle-based subsidiary Just-Evotec Biologics Inc. inked an agreement with Advanced Bioscience Laboratories Inc. (ABL), of Rockville, Md., to develop a broadly neutralizing antibody against HIV. Just-Evotec Biologics plans to support ABL by designing a manufacturing process to produce cGMP clinical supply for the phase I program, to design a product formulation suitable for clinical infusion and to provide assay development and release and stability testing services. The project is fully funded under a $318.5 million contract from the National Institute of Allergy and Infectious Diseases of the NIH.
Find Therapeutics, of Montreal, was established by CTI Life Sciences, along with partners Admare Bioinnovations, Domain Therapeutics and Peptimimesis Pharma, to develop next-generation GPCR allosteric modulators to treat rare diseases. Launched with seed funding from CTI Life Sciences, Admare and Domain, and with an initial focus on inflammatory and fibrotic diseases of the airways, liver and gastrointestinal systems, Find Therapeutics is based on a set of technologies that capitalize on deciphering disease-modifying GPCR pharmacology: modulation by transmembrane peptides, precise ligand signaling, disease-contextual cellular systems and advanced molecular design.
Ideaya Biosciences Inc., of South San Francisco, said it nominated IDE-397 as a development candidate for its methionine adenosyltransferase 2a, or MAT2A, synthetic lethality program, which targets the treatment of tumors with methylthioadenosine phosphorylase (MTAP) deletions. As a monotherapy, IDE-397 inhibited tumor growth and showed pharmacodynamic modulation in multiple endogenous MTAP-/- in vivo models and prompted tumor regression in an MTAP-/- xenograft model. No changes in liver enzymes or increased unconjugated bilirubin levels were observed in preclinical studies. Ideaya initiated IND-enabling studies for the candidate, with the goal of filing an IND application in the fourth quarter of 2020.
Ilya Pharma AB, of Uppsala, Sweden, said it secured €5.3 million (US$6 million) in funding from the European Innovation Council Accelerator to accelerate a phase II trial of lead candidate ILP-100, a CXCL12 gene modulator with the potential to heal nonhealing wounds in diabetes up to 80% faster than existing therapies. Ilya is using its ILP-technology platform to genetically modify lactic acid bacteria as mini-bioreactors at the treatment site to direct the human chemokine to the afflicted site and to instruct local immune cells to dampen inflammation or to aid in and accelerate healing and regenerative processes. Ilya plans to open recruitment for the phase II program in 2021 and expects to close an additional related €5 million share issue in the near future.
Intravacc, of Bilthoven, the Netherlands, and Versatope Therapeutics Inc., of Lowell, Mass., said they signed a research service agreement to develop a universal vaccine against influenza based on Intravacc's outer membrane vesicles technology. The parties plan to advance the candidate through clinical development. Financial terms were not disclosed.
Microbiotica Ltd., of Cambridge, U.K., said it plans to collaborate with Cancer Research U.K. and Cambridge University Hospitals (CUH) NHS Foundation Trust to identify and develop microbiome co-therapeutics and biomarkers for cancer patients receiving immune checkpoint inhibitor therapy. The collaboration is based on clinical studies conducted by CUH that evaluate immune checkpoint inhibitor drug response in cancer patients. Microbiotica will conduct mass culturing of patient gut bacteria, microbiome sequencing and machine learning analysis with the goal of identifying gut bacterial signatures correlated with drug efficacy as well as side effects in individuals in treatment for melanoma, non-small-cell lung and renal cancer. Microbiotica then plans to advance into the clinic live bacterial products as co-therapies and microbiome biomarkers predictive of immunotherapy response and toxicity.
Nimbus Therapeutics LLC, of Cambridge, Mass., said it expanded its pipeline to include preclinical programs in AMP-activated protein kinase, beta-2 subunit, targeting cellular metabolic regulation to improve glucose and lipid homeostasis; CTP synthase 1 to control immune activation in autoimmune diseases and cancer; Cbl proto-oncogene B to enhance immune sensitivity in cancer; and Werner syndrome ATP-dependent helicase to target microsatellite-instability high tumors.
Oncoceutics Inc., of Philadelphia, said Wafik El-Deiry, director of the Cancer Center at Brown University, was awarded $3.4 million to support preclinical research, IND-enabling studies and a first-in-human trial of the company’s imipridone, ONC-212. The project builds upon previous work by El-Deiry’s team showing that ONC-212 inhibited tumor cell growth in vitro and in vivo, promoted cell death and showed activity against patient-derived models of pancreatic tumors. Oncoceutics received a related sub-award of $1 million to complete the IND-enabling studies for the candidate, a G protein-coupled receptor 132 agonist and mitochondrial protease ClpP stimulator. Additionally, the company assumed responsibility for GLP manufacturing, IND-enabling GLP toxicology studies and IND submission to the FDA for a phase I monotherapy trial conducted through the Brown University Oncology Group in individuals with metastatic pancreatic cancer who progressed on approved therapies.
Opiant Pharmaceuticals Inc., of Santa Monica, Calif., said the U.S. District Court for the District of New Jersey issued a decision in its patent litigation regarding Narcan (naloxone HCl) nasal spray, ruling in favor of defendant Teva Pharmaceuticals Industries Ltd., of Jerusalem, which became the first to market generic Narcan nasal spray to treat opioid overdose. Opiant said its commercial partner, Emergent Biosolutions Inc., of Gaithersburg, Md., plans to appeal the decision to the Court of Appeals for the Federal Circuit. On June 8, Opiant shares (NASDAQ:OPNT), fell $2.66, or 22.7%, to close at $9.04 while shares of Emergent (NYSE:EBS) lost $18.22 a drop of 21%, to close at $68.69.
Oxford Biomedica plc, of Oxford, U.K., said it was informed by Sanofi SA, of Paris, that following completion of a company-wide portfolio review, Sanofi intends to return rights to ophthalmology gene therapy programs SAR-422459 for Stargardt disease and SAR-421869 for Usher’s syndrome type Ib. That follows Oxford’s February 2019 announcement that Sanofi had informed the firm it intended to seek a new partner for those two programs, originally partnered with Sanofi in 2009. Timing of the return of those programs and operations details are yet to be determined, though Oxford said it will undertake its own internal evaluation to determine the future for those programs and decide whether to commit further resources to them. Oxford’s collaboration and license agreement with Bioverativ, a company that was acquired by Sanofi, for the development and manufacturing of lentiviral vectors to treat hemophilia, remains unaffected by the announcement.
Pharmacyte Biotech Inc., of Laguna Hills, Calif., said its manufacturing facility in Thailand passed a cGMP post-manufacturing audit.
Sernova Corp., of London, Ontario, said it acquired cellular immune protection technology through an asset purchase agreement with Converge Biotech Inc., of Miami. In the transaction, expected to close by June 11, Sernova is acquiring the intellectual property associated with Converge's conformal coating cell encapsulation technology. To fund the technology acquisition, Sernova plans to issue to a strategic investor a $1 million convertible unsecured debenture and 3 million non-transferable share purchase warrants that each may be exercised into one common share priced at 20 cents apiece.
Teneobio Inc., of Newark, Calif., said it inked a research collaboration and licensing agreement with Intellia Therapeutics Inc., of Cambridge, Mass., covering the use of Teneobio’s heavy chain antibodies, or Uniabs, for Intellia’s engineered cell therapies. Teneobio also will use its platforms to assess Uniabs against targets that can be used in engineered cell therapies to treat life-threatening diseases. Intellia retained an exclusive option to license the antibodies for global development and commercialization in exchange for an up-front payment to Teneobio, which is eligible for additional preclinical, clinical, regulatory and commercial milestone payments as well as sales royalties.
Xbrane Biopharma AB, of Solna, Sweden, said it inked an agreement with Akademiska Hus to lease premises on its Solna campus to relocate its headquarters and to establish an expanded biosimilars development lab that will enable production processes for mammalian cell- and E. coli-based biosimilars along with advanced analysis capacity. Following the changes, expected to occur in March 2021, Xbrane plans to expand its portfolio and initiate development of additional biosimilar candidates.
Xphyto Therapeutics Corp., of Vancouver, British Columbia, said its wholly owned German subsidiary, Vektor Pharma TF GmbH, finalized the formula for its transdermal delivery system for the non-ergoline dopamine agonist rotigotine and is proceeding with process implementation to manufacture rotigotine patches for human studies.