Albany Molecular Research Inc. (AMRI), of Albany, N.Y., said it signed a supply agreement with Astrazeneca plc, of Cambridge, U.K., to support the manufacture of Astrazeneca’s COVID-19 vaccine candidate, AZD-1222. AMRI will be responsible for the sterile fill/finish at its drug product manufacturing facility in Albuquerque, N.M. The facility’s cGMP manufacturing capacity could potentially produce millions of doses of AZD-1222 annually, AMRI said.
Allergy Therapeutics plc, of Worthing, U.K., said it invested in virus-like particle (VLP) technology for applications beyond allergy immunotherapy by entering an exclusive license agreement with Saiba AG and Deepvax GmbH to use their VLP technology platform for developing and commercializing vaccines targeting solid cancer tumors, atopic dermatitis, asthma and psoriasis. The agreement includes up-front payments plus milestone payments at key points in clinical development, as well as royalty payments if candidates are commercialized.
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., said the U.S. Department of Health and Human Services exercised its option to purchase an additional 10,000 doses of Biocryst’s antiviral influenza therapy, Rapivab (peramivir injection), for approximately $7 million. The purchase helps supply the Strategic National Stockpile. The order is part of a $34.7 million contract the CDC awarded in 2018 to procure up to 50,000 doses of Rapivab over five years.
CNS Pharmaceuticals Inc., of Houston, said it completed synthesizing lead candidate berubicin’s active pharmaceutical ingredient and shipped it to manufacturers to prepare an injectable form. In preparation for production, CNS and Pharmaceutics International Inc. agreed on the manufacturing procedure and packaging components for and selected a sterile filter manufacturer. CNS said it expects to begin manufacturing berubicin in the third quarter of 2020.
Diurnal Group plc, of London, disclosed two further European market and distribution agreements for Alkindi (hydrocortisone granules in capsules for opening) and Chronocort (modified release hydrocortisone). An agreement with Consilient Health covers the Benelux Union, with Consilient receiving exclusive rights to market and sell the products in conjunction with its strategic partner, Goodlife Pharma. An agreement covering Switzerland involves an undisclosed commercial-stage pharma firm, which gained exclusive rights to market and sell Alkindi in Switzerland and will submit Alkindi for marketing authorization in Switzerland during 2020. As part of the agreement, the unnamed partner has a right of first negotiation for the marketing and distribution of Chronocort. Specific financial terms were not disclosed.
Enesi Pharma Ltd., of Oxford, U.K., said it is partnering with the University of Adelaide to develop a new thermostable, solid dose DNA vaccine for Zika virus to prevent infection of pregnant women and the resultant congenital effects in the unborn child. The project will employ Enesi's Implavax formulation expertise and platform to create a protective Zika virus DNA vaccine in a solid dose implant format for transcutaneous delivery via a needle-free device. The AU$1.35 million (US$981,396) collaboration aims to advance the vaccine to phase I trials.
Geovax Labs Inc., of Atlanta, said data published in Nature Partner Journals Vaccines demonstrated that guinea pigs vaccinated with MVA-MARV-VLP vaccine were 100% protected against death and disease caused by the Angola strain of Marburg virus. The vaccine-induced immune responses were characterized by Marburg virus-specific binding and neutralizing antibodies. The Angola strain is the most virulent strain of Marburg Virus characterized by up to a 90% fatality rate in humans.
Gilead Sciences Inc., of Foster City, Calif., through its Kite unit, signed a two-year research collaboration and license deal in acute myeloid leukemia (AML) with Hifibio Therapeutics Inc., of Cambridge, Mass., through which Hifibio will use its technology platforms to identify novel AML targets and anti-AML-specific antibodies for Kite’s use in cell therapies. Hifibio will receive an up-front payment and will be eligible for additional payments based on the achievement of certain research milestones. Kite gets an exclusive option to opt in on any targets discovered through the collaboration, for which Hifibio will receive an additional payment and will be eligible for development, regulatory and commercial milestone payments, as well as royalties.
Ionis Pharmaceuticals Inc., of Carlsbad, Calif., said results of a compassionate use study published in The New England Journal of Medicine found that antisense drugs IONIS-PKKRx and IONIS-PKK-LRx reduced plasma prekallikrein activity levels and showed evidence of clinical efficacy in reducing the number of breakthrough attacks per month over the course of the treatment in patients with severe bradykinin-mediated angioedema, including complete resolution in a patient with type 1 hereditary angioedema (HAE). During treatment with the ligand-conjugated IONIS-PKK-LRx and the unconjugated parent drug IONIS-PKKRx, there was a clinically meaningful reduction in HAE attack rates in both patients. Plasma prekallikrein activity levels also decreased substantially following treatment.
Pharnext SA, of Paris, formed a research collaboration with the Charcot Marie Tooth Association (CMTA), to investigate novel biomarkers associated with the CMT type 1A (CMT1A), the most common subtype of the disease. The primary objective is to identify and validate potential treatment responsive CMT1A biomarkers that could be further explored in future clinical studies, in particular the upcoming phase III study of PXT-3003, Pharnext's lead drug candidate. Pharnext intends to investigate blood samples collected from mild to moderate CMT1A patients enrolled in the first such experiment. PXT-3003 combines baclofen, naltrexone and sorbitol.
Redhill Biopharma Ltd., of Tel Aviv, Israel disclosed the selection of opaganib, a proprietary, first-in-class, orally administered, sphingosine kinase-2 selective inhibitor being evaluated for the treatment of severe COVID-19 pneumonia, to receive a $300,000 grant from Pennsylvania’s COVID-19 Vaccines, Treatments and Therapies program. The grant was awarded to Redhill’s partner, Apogee Biotechnology Corp., of Hummelstown, Pa., from whom Redhill licensed opaganib, which will conduct the research being supported by the grant.
Vistagen Therapeutics Inc., of South San Francisco, reported preclinical data demonstrating the combination with probenecid could substantially increase the brain concentration of AV-101's active metabolite, 7-Cl-KYN, a selective full antagonist of the NMDA receptor glycine co-agonist site, thereby reducing, rather than blocking, NMDA receptor signaling. The pharmacokinetic study involved four groups, with an without probenecid, collecting plasma and cerebral spinal fluid as an indicator of brain concentration of 7-Cl-KYNA in dogs. A single oral gavage administration of AV-101 at both 10-mg/kg and 50-mg/kg levels alone or in combination with intravenous probenecid was well-tolerated. CSF levels of both AV-101 and 7-Cl-KYNA increased roughly dose proportionally. AV-101 administered with probenecid increased the CSF 7-Cl-KYNA AUC (total drug exposure across time) by about 4.6 times, compared to AV-101 alone.
Xencor Inc., of Monrovia, Calif., and MD Anderson Cancer Center formed a collaboration to study investigational treatments for patients with a variety of cancer types. The parties will collaborate to design and execute additional clinical studies with Xencor’s portfolio of XmAb drug candidates, including bispecific antibodies and engineered cytokines. Xencor said it’s committing to funding and supporting those studies over an initial five-year term.