Adynxx Inc., of San Francisco, said it received notice of an award for $602,516 from the National Institute on Neurological Disease and Stroke, an NIH institute, to support development of AYX-2 to treat chronic pain. The non-opioid candidate is a transcription factor decoy targeting the activity of certain members of the Krüppel-like family of transcription factors.
Aytu Bioscience Inc., of Englewood, Colo., said it signed a three-year co-promotion agreement giving Validus Pharmaceuticals LLC, of Parsippany, N.J., exclusive promotional rights to Zolpimist (zolpidem) to psychiatrists in the U.S. in exchange for a fixed percentage commission payment based on total prescriptions written. The agreement added to Aytu's co-promotion efforts, which also include the testosterone agent Natesto and the extended-release cough and cold medication Tuzistra XR.
Biomica Ltd., a subsidiary of Evogene Ltd., both of Rehovot, Israel, said it initiated preclinical studies for BMC-321 and BMC-322, both rationally designed microbial consortia aimed to treat inflammatory bowel disease (IBD) by triggering multiple mechanisms to reduce intestinal inflammation. The IBD discovery program involved the implementation of a comparative analysis of hundreds of stool samples obtained from IBD patients, resulting in the detection of an array of microbial functions associated with states of inflammation and remission and the identification of specific bacterial strains carrying those functions. The findings were used to design the new live bacterial candidates, which are undergoing preclinical tolerability and efficacy studies using multiple IBD animal models.
Blueprint Genetics Oy, of Espoo, Finland, InformedDNA, of St. Petersburg, Fla., and the Foundation Fighting Blindness said they plan to launch an open access program to individuals in the U.S. with inherited retinal disease covering no-cost genetic testing and genetic counseling. The program, an expansion of the My Retina Tracker genetic testing program established in 2017, is intended to streamline clinical workflow by providing a high diagnostic yield to enable faster and more direct patient follow-up. Previously, participants were eligible for the genetic testing only if they were seen by an eligible specialist and if enrolled in the registry.
Dynacure SAS, Strasbourg, France, presented preclinical data at the International Congress of the World Muscle Society in Copenhagen, showing that palmitate-conjugated antisense can reduce expression of dynamin 2 (DNM2) in mice. The company's lead antisense candidate, DYN-101, is designed to modulate expression of DNM2 to treat centronuclear myopathies. A phase I/II study is set to start in the fourth quarter.
Entos Pharmaceuticals Inc., of Edmonton, Alberta, said it entered a research, development and collaboration agreement with an undisclosed clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds targeting autoimmune and inflammatory diseases. Under the terms, the partner has the option to exclusively license candidates developed under the agreement for further development and commercialization. In return, Entos receives research funding and is eligible for option exercise fees, research, development, regulatory and sales milestone payments of up to $109 million, plus royalties.
Health Sciences Acquisitions Corp. (HSAC), a special purpose acquisition company sponsored by RTW Investments, said it concluded a definitive share exchange agreement to acquire 100% of the issued and outstanding shares of Immunovant Sciences Ltd., of New York, a member of the Roivant Sciences Ltd. family based in Basel, Switzerland. Upon closing, the combined company will be called Immunovant Inc. and will be led by Immunovant's existing management team. HSAC said it received written commitments from certain of its shareholders to vote in favor of the transaction and not redeem their shares, satisfying the minimum cash closing condition set forth in the agreement. Immunovant also said it completed a $35 million private bridge financing with RTW Investments, BVF Partners and Roivant. The notes issued in the financing are set to convert into common shares of Immunovant immediately prior to the merger's completion, giving the combined company more than $100 million at the transaction's close. Immunovant is developing IMVT-1401, a fully human anti-FcRn monoclonal antibody targeting IgG-mediated autoimmune diseases. Proceeds from the transaction are expected to finance phase II development in Graves' ophthalmopathy, myasthenia gravis and warm autoimmune hemolytic anemia, with development in additional indications expected in the future. In May, Immunovant reported initial dosing in the phase IIa trial of IMVT-1401 in moderate to severe active Graves' ophthalmopathy. (See BioWorld, May 24, 2019.)
Immuron Ltd., of Melbourne, Australia, received $3.7 million from the Naval Medical Research Center in Silver Spring, Md., to develop a new product designed to protect against travelers' diarrhea caused by Campylobacter and enterotoxigenic E. coli pathogens. The product will undergo two human infection-model clinical trials, with one focusing on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis and the second focusing on ETEC infections.
Lonza Biologics, of Basel, Switzerland, will manufacture Paris-based Cellectis SA's allogeneic universal CAR T-cell candidates targeting hematological malignancies. The manufacturing will take place at Lonza's facility in Geleen, the Netherlands.
Mayne Pharma Ltd., of Adelaide, Australia, and Liege, Belgium's Mithra Pharmaceuticals SA signed an exclusive license and supply agreement to commercialize Estetrol (E4)/drospirenone (DRSP), a combined oral contraceptive, in the U.S. Subject to FDA approval, the companies expect the contraceptive to launch in first half of 2021. E4/DRSP is a combined oral contraceptive composed of 15 mg E4 and 3 mg DRSP. Estetrol is a native estrogen produced by the human fetal liver during pregnancy.
Ocular Therapeutix Inc., of Bedford, Mass., said the Centers for Medicare and Medicaid Services (CMS) has issued a permanent product-specific J-code for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use that is now effective and will replace the previously issued C-code for the drug. The company will retain transitional pass-through status granted for Dextenza, an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery, from CMS.
Puretech Health plc, of Boston, said it acquired the remaining 10% minority interests in Boston-based Ariya Therapeutics Inc., which has been renamed Puretech LYT Inc. In return, the company will issue 2.12 million new ordinary shares of 1 cent each and will grant options to the co-inventors of and advisors to the four platforms to purchase 2.14 million ordinary shares. The wholly owned subsidiary holds its four technology platforms in immuno-oncology, synthetic lymphatic targeting chemistry, milk exosomes and meningeal lymphatics.
Q Biomed Inc., of New York, said it entered a settlement agreement with Doral, Fla.-based Bionucleonics Inc. to complete the outright acquisition of the non-opioid cancer bone pain drug strontium-89 chloride USP. The ownership of the drug includes an abbreviated new drug application under a mutually favorable global royalty agreement.
Rentschler Biopharma SE, of Laupheim, Germany, terminated its active pharmaceutical ingredient manufacturing for Turku, Finland-based Faron Pharmaceuticals Oy's Traumakine, a recombinant human interferon-beta 1a. Faron officials said significant upgrading of the manufacturing process is required before Traumakine's MAA/BLA approval. The company hopes to get its flagship program in acute respiratory distress syndrome back on track following the Yoda pharmacokinetic/pharmacodynamic study of Traumakine in human volunteers, which demonstrated that concomitant administration of corticosteroids blocked the drug's action. (See BioWorld, June 17, 2019.)
Samumed LLC, of San Diego, said data demonstrating a novel mechanism of action for SM-08502 in preclinical gastrointestinal cancer models in which the small molecule generates strong antitumor effects via inhibition of CLK2 and CLK3, were published in Cancer Letters. Regulation of CLK2 and CLK3 is a strategy that leads to modulation of Wnt pathway signaling in cancer. SM-08502, a small-molecule CLK2/3 inhibitor, is being evaluated in a U.S. phase I study designed to assess the safety and pharmacokinetics in patients with multiple types of advanced solid tumors. The published data showed SM-08502 inhibited the Wnt signaling pathway in vitro and in vivo in colorectal cancer models and had significant antitumor effects in xenograft models of gastrointestinal cancer.
Scholar Rock Holding Corp., of Cambridge, Mass., said it is presenting preclinical data for SRK-015 at the World Muscle Society Congress in Copenhagen. SRK-015 is a highly selective inhibitor of the activation of myostatin, a negative regulator of muscle mass, and showed improved muscle strength following administration of muSRK-015P (mouse analogue of SRK-015) in mouse models of early and late survival motor neuron protein restoration. Treatment with muSRK-015P resulted in 20% to 51% increases in maximal torque (at ≥ 40 Hz) of the plantar flexor muscle group and a greater percentage of muscle fibers compared to treatment with placebo (vehicle). Relative dose-proportional accumulation of serum latent myostatin demonstrated target engagement in rats and cynomolgus monkeys following administration of SRK-015 compared to no meaningful change with placebo.
Trovagene Inc., of San Diego, reported preclinical data at the European Society for Medical Oncology meeting in Barcelona, Spain, showing significant tumor regression with the combination of onvansertib, its PLK1-targeting candidate, and paclitaxel vs. either agent alone in models of triple-negative breast cancer.
Ubiome Inc., of San Francisco, said it has requested that the Bankruptcy Court presiding over its pending Chapter 11 bankruptcy convert its case to a liquidation under Chapter 7 of the U.S. Bankruptcy Code. A hearing to consider the company's request has not yet been scheduled. The company was founded in 2012 and focused on microbial genomics.
Vericel Corp., of Cambridge, Mass., and Yavne, Israel-based Mediwound Ltd. said the Nexobrid expanded access treatment protocol (NEXT), an open-label, single-arm treatment protocol, which allows for the treatment of up to 150 burn patients with deep partial- and full-thickness thermal burns of up to 30% of total body surface area, has started in the U.S. A biologics license application is also being prepared.
Viscient Biosciences Inc., of San Diego, a company working at the intersection of 3D tissue technology and transcriptomics technology to discover and develop drugs across a range of therapeutic areas, said it submitted a merger proposal to San Diego-based Organovo Holdings Inc.'s board to combine the two companies. Organovo had begun exploring strategic alternatives in August after timeline challenges arose for its therapeutic liver tissue for clinical transplant lead program. The merger proposal involves the issuance of new Organovo shares to existing Viscient shareholders. It is expected that the combined entity could be up to 43% owned by Organovo's existing shareholders and the balance owned by Viscient's shareholders. The final ownership allocations will depend on the final mix of assets and cash in Organovo at closing. Viscient has been using 3D liver tissue to discover drug opportunities for nonalcoholic steatohepatitis.