Alphamab Oncology Co. Ltd., of Suzhou, China, said subsidiary Jiangsu Alphamab Biopharmaceuticals Co. Ltd. established a partnership with Simcere Pharmaceuticals Group, of Nanjing, China, and 3D Medicines (Beijing) Co. Ltd., of Beijing, to advance the development and commercialization of KN-035 (also known as envafolimab), a checkpoint inhibitor for PD-L1, for oncology indications in mainland China. Under the terms, Alphamab Oncology is the exclusive manufacturer of KN-035 and responsible for production and supply. 3DMed will oversee KN-035's clinical development, registration and commercialization. Simcere will exclusively market KN-035 in mainland China upon the product's registration, and charge a marketing fee to 3DMed. Specific financial details were not disclosed.
Altimmune Inc., of Gaithersburg, Md., and the University of Alabama at Birmingham said they created AdCOVID, a single-dose, intranasal COVID-19 vaccine candidate and are preparing for immunogenicity studies and manufacture of phase I trial material. Initially, the firm will work with university investigators on preclinical animal studies and characterization of the vaccine immunogenicity with the goal of enabling a phase I trial in the third quarter.
Aptorum Group Ltd., of New York, said it is initiating an additional research and development project targeting the coronavirus group and has completed initial screening under the Smart-ACT platform, a repurposed and new drug discovery platform, to select, out of more than 2,600 approved small drug molecules, at least three potential candidates for further preclinical investigation against COVID-19. Aptorum is collaborating with Toronto based Covar Pharmaceuticals Inc. and has also entered an agreement with the University of Hong Kong’s Microbiology Department to conduct further preclinical investigation of the selected candidates prior to seeking approval from regulatory agencies to initiate clinical trials on suitable candidates. In particular, Aptorum will focus on investigation of at least three small-molecule drugs that have shown potential interference against two enzyme targets, namely 3CL-protease and RNA dependent RNA polymerase, with both playing pivotal roles in COVID-19’s replication cycle.
Aravive Inc., of Houston, said AVB-500 improves antitumor effects when combined with anti-angiogenic drug Avastin (bevacizumab, Roche Holding AG) or PARP inhibitor Lynparza (olaparib, Astrazeneca) in preclinical uterine cancer models. Additional research also showed that inhibition of GAS6/AXL signaling with AVB-500 induces “BRCA-ness,” increasing response to platinum and PARP inhibitor drugs in a preclinical model of ovarian cancer.
Bellerophon Therapeutics Inc., of Warren, N.J., said expanded access treatment with the Inopulse inhaled nitric oxide system was initiated for the first time in a patient with a diagnosis of COVID-19 at the University of Miami School of Medicine. The treatment follows the recent decision by the FDA to grant emergency expanded access that allows Inopulse to immediately be used for the treatment of COVID-19 under the care and supervision of their physician.
Benitec Biopharma Ltd., of Melbourne, Australia, said the Supreme Court of Queensland has approved the scheme of arrangement to redomicile the Benitec group from Australia to the U.S. Benitec shares have been suspended from trading on ASX from the close of trading on Monday, March 30.
Cobra Biologics Ltd., of Keele, U.K., and the Karolinska Institutet in Sweden said they were awarded €3 million (US$3.3 million) in emergency funding by Horizon 2020 for research and development, and phase I testing of a DNA vaccine against COVID-19, as part of the OPENCORONA consortium to support global efforts tackling the pandemic. Partners in the consortium also include Karolinska University Hospital, Public Health Authority, IGEA, Adlego AB and Giessen University.
Compass Therapeutics Inc., of Cambridge, Mass., said data published in JCI Insight demonstrate the preclinical efficacy and safety of the company’s lead investigational therapy, CTX-471, which is being evaluated in a phase I trial. The paper describes the discovery and preclinical characterization of CTX-471, a fully human antibody that binds and activates an epitope of the CD137 receptor and has demonstrated a favorable and differentiated efficacy and safety profile, including monotherapy activity against multiple syngeneic tumor models and tolerability in animals.
Diverse Biotech Inc., of Doylestown, Pa., said it signed an initial partnership agreement with The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center to study its potential new therapeutic candidates in glioblastoma. The research will be performed in animal models of the disease to evaluate the efficacy and tissue distribution of Diverse Biotech's new drug compounds.
Gigagen Inc., of South San Francisco, said it has been developing a recombinant polyclonal antibody therapy for the treatment of COVID-19. The therapy, rCIG (recombinant anti-coronavirus 19 hyperimmune gammaglobulin), is designed to reproduce whole antibody repertoires of recovered COVID-19 patients, including high concentrations of those antibodies that target and prevent further replication of the COVID-19 virus. rCIG will be administered to the patients intravenously to provide passive immunity to help them fight infection and facilitate recovery. Gigagen is currently recruiting patients who have recovered from COVID-19 to donate blood for the development of rCIG, and the company has signed a collaboration agreement with Access Biologicals to expedite patient identification and assist with sample collection. The company has already discussed the manufacturing method with the FDA and said it will have further discussions to find ways to expedite development.
Gilead Sciences Inc., of Foster City, Calif., said the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with respect to Gilead's cash tender offer for Forty Seven Inc., of Menlo Park, Calif., expired at 11:59 p.m. on March 27. The deal, which values Forty Seven at about $4.9 billion, is set to close in early April. In separate news, Gilead said it will make remdesivir, a drug that it has been testing against COVID-19, available to severely ill patients, who cannot enroll in a trial, under a compassionate use program.
Harmony Biosciences LLC, of Plymouth Meeting, Pa., said Sleep Medicine published an article that reviews the mechanism of action (MOA) of available treatments for patients with narcolepsy. Among those discussed is Wakix (pitolisant) and its differentiated MOA that increases histamine transmission in the brain and the release of other neurotransmitters that promote wakefulness. Wakix, a selective histamine 3 receptor antagonist/inverse agonist, was approved in August 2019 by the FDA for treating excessive daytime sleepiness in adult patients with narcolepsy.
Hoth Therapeutics Inc., of New York, said it entered a nonbinding letter of intent (LOI) with Isoprene Pharmaceuticals Inc., of Baltimore, to acquire the full licensing rights of VNLG-152 retinamides (retinoic acid metabolism blocking agents, or RAMBAs) for the treatment of dermatological diseases. Isoprene is a cancer therapeutic company that is a University of Maryland, Baltimore New Venture Initiative startup founded by Vincent Njar, the lead scientific inventor, and is developing small molecules for the treatment of cancer. Hoth previously announced that preclinical work is underway at Weill Cornell Medicine to examine the efficacy of RAMBAs in blocking acne pathogenic gene expression and carcinogenesis in mice, which is currently ongoing. The LOI contemplates that the firms would enter a definitive agreement, in which Hoth will make a $50,000 investment in Isoprene in the form of a convertible promissory note, which shall bear annual interest at a rate of 6%, and shall have a discount upon conversion of 10% from the equity purchase price of the qualified financing into which the promissory note converts. As part of its licensing rights, Hoth also will receive royalty payments from Isoprene for any use of its VNLG-152.
I-Mab Biopharma Co. Ltd., of Rockville, Md., and Shanghai, said it inked a partnership with Kalbe Genexine Biologics (KG Bio), a joint venture of Kalbe Farma Tbk, of North Jakarta, and Genexine Inc., of Seongnam, South Korea. Under the terms, KG Bio will receive a right of first negotiation for an exclusive license for the commercialization of two I-Mab-discovered product candidates: TJD-5, a differentiated anti-CD73 antibody in phase I development for advanced solid tumors, and an I-Mab product candidate to be agreed upon by both parties. KG Bio will have a right of first negotiation for exclusive rights to commercialize those two candidates in the ASEAN and MENA regions, as well as Sri Lanka.
Imaginab Inc., of Los Angeles, said it signed a multiyear nonexclusive license agreement with Astrazeneca plc, of Cambridge, U.K. Under the terms, Imaginab’s CD8 ImmunoPET technology will be used in Astrazeneca's clinical trials in North America and Europe to facilitate clinical development of Astrazeneca's immunotherapies and to advance the clinical utility of Imaginab's CD8 ImmunoPET. Imaginab will receive license fees and other contingent payments. Specific terms were not disclosed.
IMV Inc., of Dartmouth, Nova Scotia, provided updates on development of vaccine candidate DPX-COVID-19. It has used sequences of the virus and immunoinformatics to predict and identify several hundred epitopes, of which 23 were selected for their biological relevance to the virus and potential to generate neutralizing antibodies against SARS-CoV-2. Based on that analysis, IMV has begun manufacturing peptide candidates targeting those epitopes as well as planning with its suppliers and contract manufacturers to prepare for the cGMP batch required to support a clinical study in humans. It is working in collaboration with the Research Centre on Infectious Diseases at the University Laval in Quebec City on preclinical assays in animal models, planned in April through May, and the design of a phase I study in 48 healthy subjects has been completed. IMV has initiated discussions with Health Canada in preparation of a clinical trial application, and a meeting is being scheduled in the week of April 20, with the goal to initiate the clinical study in the summer of 2020.
Lifemax Laboratories Inc., of Redwood City, Calif., said it formed Ammax Bio Inc., with an exclusive license from Thousand Oaks, Calif.-based Amgen Inc. for the right to develop, manufacture and commercialize AMG-820, a monoclonal antibody against the colony-stimulating factor 1 receptor, which has completed phase I/II studies in solid tumors. Ammax intends to develop AMG-820 initially for tenosynovial giant cell tumors, with additional orphan indications to be explored. Terms of the deal were not disclosed.
Moderna Inc., of Cambridge, Mass., said based on the special concerns for the safety and health of pediatric patients and their caregivers, and the risks of disruption to the integrity of trials from COVID-19, the company decided to pause new enrollment of its phase I rare disease trials (mRNA-3704 for methylmalonic acidemia, mRNA-3927 for propionic acidemia) and its age de-escalation trial for its pediatric respiratory vaccine (mRNA-1653 for hMPV/PIV3). Those decisions will be re-evaluated on an ongoing basis as the COVID-19 situation evolves, the company said.
Noveome Biotherapeutics Inc., of Pittsburgh, said it launched a program to evaluate ST-266, its lead product candidate, as a potential treatment of the severe inflammatory cytokine storm response frequently observed in the lungs of patients with COVID-19. The program is based on a body of evidence demonstrating that ST-266 significantly reduces the body’s inflammatory response in a wide range of diseases and conditions and has been shown to be safe and effective in humans. Noveome is in discussions with the FDA to complete an IND and is currently identifying clinical sites for a phase I/II safety trial, expected to initiate in the fourth quarter of 2020.
Numab Therapeutics AG, of Waedenswil, Switzerland, said it expanded its deal with Ono Pharmaceutical Co. Ltd., of Osaka, Japan, by executing another research and option agreement to discover and develop a multispecific antibody drug candidate for the treatment of various cancers. Similar to their earlier collaboration, initiated in March 2017, under the new agreement, Ono has obtained an option to acquire from Numab exclusive rights to develop and commercialize an immuno-oncology drug candidate that will leverage Numab’s platform technology in order to actualize one of Ono’s therapeutic approaches. In exchange, Ono will pay Numab up to CHF260 million (US$271 million) in up-front and milestone payments, plus tiered single- to double-digit royalties on sales.
Olix Pharmaceuticals Inc., of Suwon, Republic of Korea, said it signed an exclusive worldwide licensing agreement with AM Chemicals (AMC) for the rights to patents and know-how encompassing the technology to conjugate N-acetylgalactosamine (GalNAc) to Olix's asymmetric small interfering RNA molecules for liver targeting. Under the agreement, AMC will supply a selection of GalNAc-modified phosphoramidites and solid supports to Olix and will also provide support for RNA synthesis, for which AMC is entitled to receive up-front, milestone and royalty payments.
Opgen Inc., of Gaithersburg, Md., said shareholders voted to approve the proposed business combination with Curetis NV, of Holzergerlingen, Germany. The business combination is expected to close in the coming days.
Plus Therapeutics Inc., of Austin, Texas, said it entered a definitive agreement to license multiple rare cancer drug product candidates from private Texas-based radiotherapeutic company Nanotx Therapeutics Inc. The licensed drug portfolio is anchored around nanoliposome-encapsulated radionuclides for several cancer targets. The lead drug asset is a chelated rhenium nanoliposome, initially being developed for recurrent glioblastoma. The transaction terms include an up-front payment of $400,000 in cash and $300,000 in Plus voting stock. The company also may pay up to $136.5 million in development and sales milestone payments and a tiered single-digit royalty on U.S. and European sales. The transaction is expected to close in the second quarter of fiscal 2020.
Surrozen Inc., South San Francisco, said data published in Cell Chemical Biology describes the company’s Wnt-mimetic platform comprising potent, multivalent antibodies directly activating the Wnt signaling pathway. Those multivalent antibodies achieve Fzd receptor specificity and have potential applications as targeted therapeutics for tissue regeneration. The company said its research identified key requirements for maximal signaling and represents a new approach to utilizing the Wnt signaling pathway to potentially repair a broad range of tissues.