Aeterna Zentaris Inc., of Charleston, S.C., signed an exclusive distribution and related quality agreement with Megapharm Ltd., of Ra’anana, Israel, for the commercialization in Israel and the Palestinian Authority of macimorelin, Aeterna’s orally available ghrelin agonist to be used in the diagnosis of patients with adult growth hormone deficiency (GHD) and child-onset GHD. Megapharm will be responsible for obtaining registration to market macimorelin in Israel and the Palestinian Authority, while Aeterna will be responsible for manufacturing, product supply, quality assurance and control, regulatory support, and maintenance of intellectual property. The regulatory process for macimorelin in Israel is expected to be completed in the second half of 2021.
Aldevron LLC, of Fargo, N.D., said it entered an agreement with Ziopharm Oncology Inc., of Boston, to produce plasmid DNA for T-cell therapy of solid tumors. Under the agreement Ziopharm, based on its analyses of patient tumors, will identify TCRs on a patient-by-patient basis as well as assemble TCRs in a library for use in clinical trials. The company will use Aldevron’s neoGMP service to manufacture multiple DNA plasmids. Financial terms were not disclosed.
Applied Biology Inc., of Irvine, Calif., said that a team of scientists, while studying the genetics of the androgen receptor in male pattern baldness, discovered a possible breakthrough treatment for COVID-19. The team, led by Andy Goren of the Alpert Medical School of Brown University and others, published their discovery in Dermatologic Therapy. The manuscript elucidates the possible role of androgens in controlling the infectivity of SARS-CoV-2 in human lung cells. A trial is planned to test the hypothesis.
Aptevo Therapeutics Inc., of Seattle, said it will receive a royalty from Pfizer Inc., of New York, related to sales of a rituximab biosimilar product, Ruxience (Rituximab-pvvr), which was approved by the FDA in July 2019 and launched by Pfizer in the U.S. and Japan in early 2020. The payment from Pfizer relates to an agreement acquired by Aptevo as part of its spin-off from Emergent BioSolutions Inc., of Gaithersburg, Md., in 2016, which applies a fixed royalty rate in the low single digits on net sales in the U.S., EU and Japan. Shares of Aptevo (NASDAQ:APVO) closed at $8.96, up $3.21, or 56%.
Atrogi AB, of Stockholm, was awarded a grant from Eurostars, an initiative of the European Commission that promotes research, and the intergovernmental innovation network called Eureka. The application was done in consortium with Stockholm University, Maastricht University, the Latvian Institute of Organic Synthesis and Excellerate Bioscience. The grant awarded is about €1 million (US$1.1 million) and will go toward developing the company’s obesity project.
Crispr Therapeutics AG, of Zug, Switzerland, is building a new cell therapy manufacturing facility in Framingham, Mass., for clinical and commercial production of the company’s investigational cell therapy product candidates. As the facility becomes fully operational, the company expects to hire up to 100 full-time employees. The new facility is being designed to provide GMP manufacturing according to the FDA and EMA regulations and guidelines to support clinical supply and commercial product,
Entos Pharmaceuticals Inc., of Edmonton, Alberta, said it selected two lead candidates for a pan-coronavirus Fusogenix DNA vaccine (Covigenix) from its prototyping program launched at the onset of the global COVID-19 pandemic. The selection of two lead candidates is based on preclinical results demonstrating high immunogenicity, high levels of SARS-CoV-2 neutralizing antibodies, and the potential for no antibody-dependent enhancement, the company said. A $4.2 million grant from the Canadian Institutes of Health Research, Research Nova Scotia and the Institute for Ageing will be used to further develop the Covigenix vaccine candidates through animal challenge studies and human clinical trials. Entos will partner with the Clinical Trials Research Center at the Canadian Center for Vaccinology in Nova Scotia to initiate phase I/II trials to evaluate the safety, tolerability, immunogenicity and efficacy of the Covigenix vaccine candidates in late July.
Hemostemix Inc., of Calgary, Alberta, filed a fast track appeal in relation to the Alberta Court of Queen's Bench erroneous service ex juris decision rendered on June 18, 2020, in relation to Hemostemix's replevin application seeking access to and a copy of Hemostemix's own property, which the company said is being wrongfully withheld from Hemostemix by Aspire Health Science LLC, of Orlando, Fla. Hemostemix said that on June 19, 2020, the court issued supplemental reasons, reversing a key portion of the court's previous decision issued a day earlier on the replevin application. Hemostemix said it believes its appeal raises meritorious issues of error of the court.
Immuneering Corp., of Cambridge, Mass., disclosed a collaboration between its neuroscience division, known as Alleo Labs, and Astex Pharmaceuticals, a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., of Tokyo, to identify novel therapeutic targets for an undisclosed neurodegenerative disease. The collaboration will leverage Immuneering’s experience in bioinformatics and computational biology to identify clinically actionable patient subsets with distinct biology. Once those are identified, Immuneering will apply its Disease Cancelling technology to systematically identify a series of targets that counteract distinct aspects of the disease biology. Astex will fund the research collaboration and has an option to exclusively license the results for further drug discovery research and development. Financial terms were not disclosed.
Intensity Therapeutics Inc., of Westport, Conn., disclosed the publication of results from the company’s nonclinical research in the International Journal of Molecular Sciences. The paper, titled “Intratumoral Administration of a Novel Cytotoxic Formulation with Strong Tissue Dispersive Properties Regresses Tumor Growth and Elicits Systemic Adaptive Immunity in In Vivo Models,” describes lead product candidate INT-230-6, a combination of cisplatin and vinblastine formulated with an amphiphilic diffusion enhancer molecule that noncovalently interacts with payloads to increase intratumoral (IT) drug dispersion when injected into solid tumors. Data demonstrated that INT-230-6 achieved greater inhibition of tumor growth and improved survival compared to the same drugs without enhancer given intravenously or IT. Animals demonstrating complete responses developed systemic immunity to the cancer. INT-230-6 when combined with anti-PD-1 antibodies resulted in improved survival and increased rate of complete responses.
Lineage Cell Therapeutics Inc., of Carlsbad, Calif., said manufacturing for its oligodendrocyte progenitor cell therapy, OPC-1, to treat acute spinal cord injury, has been transferred to its cGMP facility in Israel. Lineage also said it intends to meet with the FDA to discuss by the end of 2020 development of the OPC-1 program, which it acquired from Asterias Biopharmaceuticals Inc., of Menlo Park, Calif., in March 2019.
Moderna Inc., of Cambridge, Mass., and Catalent Inc., of Somerset, N.J., will collaborate on large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate, mRNA-1273, at Catalent’s biologics facility in Bloomington, Ind. Catalent will provide vial filling, packaging capacity and additional staffing required for round-the-clock manufacturing operations to produce an initial 100 million doses of the vaccine candidate intended to supply the U.S. market starting in the third quarter of 2020. The companies are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses. Catalent will also provide clinical supply services from its facilities in Philadelphia, including packaging and labeling, as well as storage and distribution to support Moderna’s phase III study of mRNA-1273.
Moleculin Biotech Inc., of Houston, said new preclinical data confirm the efficacy of annamycin, an anthracycline antibiotic that is not cross-resistant with doxorubicin and formulated in liposome, in treating lung metastases. The high cytotoxic potency of annamycin against multidrug-resistant cancer cells is related, in part, to its ability to overcome ABC transporter-mediated efflux and, in contrast to doxorubicin, achieve high intracellular uptake, the company said. A greatly increased concentration of annamycin in the lung, as compared to doxorubicin, leads to high drug efficacy in vivo in lung-localized tumor models, the company added.
Neurovation Labs Inc., of New York, said it was awarded a U.S. Air Force Small Business Innovation Research phase II contract. Also, Neurovation was selected to advance through the first stage of the Army Expeditionary Technology Search program v5 competition. The awards total more than $750,000. Neurovation is leveraging a brain biomarker to develop a molecular diagnostic and a companion targeted treatment. Both therapies are in preclinical development.
Nurix Therapeutics Inc., of San Francisco, said it formed a new adoptive cell therapy company, Decart Therapeutics, which has been initially formed as a wholly owned subsidiary of Nurix. Decart plans to combine the use of Nurix’s targeted protein modulation drugs with the latest T-cell genetic engineering technologies to create a drug-enhanced CAR T-cell process for cancer. Decart has been founded by Nurix in partnership with Carl June, the Richard W. Vague Professor in Immunotherapy and director of the Center for Cellular Immunotherapies in the Abramson Cancer Center of the University of Pennsylvania. June will lead the Decart founding team and also serve as the chairman of the scientific advisory board. Decart’s first program is expected to use Nurix’s small-molecule CBL-B inhibitor, NX-0255, for ex vivo enhancement of T-cell biology throughout the processing and engineering of CAR T cells. CBL-B is an E3 ligase target that functions as an intracellular immune checkpoint that regulates T-cell activation and immune response. Decart will explore development and commercialization of CAR T-cell therapies for both hematologic and solid tumors.
Onxeo SA, of Paris, said preclinical studies show OX-401, a PARP agonist, has strong antitumor activity and immunological properties. OX-401’s antitumor activity was demonstrated in an animal model of breast cancer, related to PARP hyperactivation and diversion of its DNA repair function in specific tumor cells, the company said. The activity on PARP induces a strong engagement of the cGAS-STING pathway2, as shown by the increase in key biomarkers of the tumor immune response, the company said.
Reneuron Group plc, of London, said it signed a new research evaluation agreement with a major U.S. biotechnology company to use Reneuron’s exosomes to deliver novel gene silencing therapeutics. The collaboration will focus on Reneuron's human neural stem cell-derived exosomes for the delivery of the undisclosed company's neuroscience therapeutic candidates. Reneuron will be responsible for manufacturing exosomes and then loading them with gene silencing sequences. The unnamed U.S. biotechnology company will evaluate the loaded exosomes.
Sanifit Therapeutics SA, of Palma, Spain, and San Diego, said the mechanism of action for its lead compound, SNF-472, allows it to selectively inhibit pathological calcification by binding to hydroxyapatite (HAP) crystals. Studies examined the binding features of SNF-472 for HAP crystals across a variety of in vitro and in vivo models. The binding was found to be fast (80% within five minutes) and insurmountable, the company said. SNF-472 inhibited HAP crystal formation with an EC50 of 3.8 µM, with complete inhibition at 30.4 µM. At the lowest concentration tested (1 µM) in vascular smooth muscle cells, SNF-472 inhibited calcification by 67%, with complete inhibition from 30 µM. SNF-472 is in a pivotal phase III trial for treating calcific uremic arteriolopathy.
Seelos Therapeutics Inc., of New York, said it started a preclinical study of SLS-007 in Parkinson's disease (PD) delivered through an adeno-associated viral (AAV) vector targeting the non-amyloid component core of alpha synuclein (α-synuclein). An in vivo study in rodents will assess the ability of two specific peptides, S62 and S71, delivered via AAV1/2 viral vector, to protect dopaminergic function in the preformed α-synuclein fibril model of PD. The study is designed to establish the in vivo pharmacokinetic and pharmacodynamic profiles and target engagement parameters of SLS-007. Top-line data are expected in late 2020 or early 2021.
Simcha Therapeutics Inc., of New Haven, Conn., said data presented this week at the American Association for Cancer Research virtual meeting detailed findings that the IL-18 variant, which was engineered to avoid the “decoy” receptors that abound in the tumor microenvironment, promotes a strong response by natural killer cells against “cold” tumors – those that are no longer expressing significant MHC class 1 antigens. The decoy-resistant IL-18 (DR-18) engineered in the lab of Simcha’s founder, Aaron Ring, showed an ability to rescue exhausted NK cells and thereby stimulate strong antitumor activity in multiple animal models. Simcha anticipates moving into the clinic with its DR-18 program in the first half of 2021.
Tetraphase Pharmaceuticals Inc., of Watertown, Mass., paid Melinta Therapeutics Inc., of Morristown, N.J., a $1.15 million termination fee under their merger agreement. Tetraphase instead agreed to be acquired by San Diego-based La Jolla Pharmaceuticals Inc.
Vaxart Inc., of South San Francisco, said it signed a memorandum of understanding with Attwill Medical Solutions Sterilflow LP (AMS) affirming the parties’ intent to establish AMS as a resource for lyophilization development and large-scale manufacturing including tableting and enteric coating for Vaxart’s oral COVID-19 vaccine. AMS will be assigning dedicated resources and equipment for the scale-up and commercial production of the vaccine upon entering a formal agreement.
Vistagen Therapeutics Inc., of South San Francisco, and Everinsight Therapeutics Inc., of Shanghai, said they entered a licensing and collaboration agreement for the clinical development and commercialization of PH-94B, Vistagen's rapid-onset neurosteroid drug candidate for multiple anxiety-related disorders, in greater China and other Asia markets. In December, Vistagen received fast track designation from the U.S. FDA for development of PH-94B for treatment of social anxiety disorder (SAD). Under the terms, Everinsight will be responsible for clinical development, regulatory submissions and commercialization of PH-94B neuroactive nasal spray for acute treatment of SAD, and potentially other anxiety-related indications, in markets in greater China (mainland China, Hong Kong, Macau and Taiwan), South Korea and Southeast Asia (Indonesia, Malaysia, Philippines, Thailand and Vietnam). Everinsight will make a nondilutive up-front payment of $5 million, and Vistagen is eligible to receive additional development and commercial milestone payments of up to $172 million. Vistagen also will receive tiered royalties on sales of PH-94B in the licensed territory, if phase III efforts are successful. Vistagen retains exclusive rights to develop and commercialize the drug in all other markets.