Acelrx Pharmaceuticals Inc., of Redwood City, Calif., said the U.S. Army has awarded the company an initial contract of up to about $3.6 million for the purchase of Dsuvia (sufentanil sublingual tablet) to support a study to aid the development of clinical practice guidelines. Orders under the contract may be fulfilled over the next four years as specified in the agreement, with an initial purchase expected this year, the company said. Approved in 2018, the drug is a synthetic opioid analgesic formulation for the management of acute pain that is severe enough to require an opioid analgesic, and for which alternative treatments are inadequate.
Aequus Pharmaceuticals Inc., of Vancouver, British Columbia, expanded its partnership with Medicom Healthcare Inc., of Fareham, U.K., to include an additional formulation in the Evolve preservative-free dry eye product line. Aequus has submitted an application for this new product with Health Canada for processing of a new medical device license. The new product formulation combines hyaluronate and carbomer 980 for the treatment of patients with more intense dry eye symptoms.
Alx Oncology Inc., of Burlingame, Calif., signed a clinical trial collaboration with Merck & Co. Inc., of Kenilworth, N.J., to evaluate the combination of ALX-148, an investigational next-generation CD47 blocker, and Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with head and heck squamous cell carcinoma (HNSCC). Alx will conduct a phase II program comprising two studies. The first will evaluate the efficacy of ALX-148 in combination with Keytruda for the first-line treatment of patients with PD-L1-expressing metastatic or unresectable, recurrent HNSCC. The second study will test the combo and standard chemotherapy in the same setting.
Anokion SA, of Lausanne, Switzerland, expanded its exclusive global collaboration agreement with Bristol Myers Squibb Co. (BMS), of New York, to include Anokion’s lead antigen-specific drug candidate, KAN-101, for the treatment of celiac disease. Under the terms of the amended agreement, an undisclosed amendment fee was paid to Anokion to include KAN-101 for the treatment of celiac disease in the exclusive global collaboration. Anokion is responsible for preclinical activities and phase I development of partnered programs, and BMS will fund subsequent trials and commercial activities at clinical proof of concept.
Applied Biology Inc., of Irvine, Calif., and a team of scientists from Corpometria Institute in Brazil, along with other collaborators, published their discovery elucidating the possible role of androgens, the same hormones implicated in male pattern baldness and prostate cancer, in controlling the infectivity of SARS-CoV-2 in human lung cells. A study testing next-generation anti-androgen proxalutamide has cleared institutional review board approval and will be conducted in Brazil, recruiting non-hospitalized patients with mild to moderate COVID-19 disease.
Aqualung Therapeutics Inc., of Tucson, Ariz., said it has been awarded a one-year NIH Fast-Track award to support development of a humanized antibody therapy for pregnant women with intrauterine infection at risk for preterm birth. Company scientists have identified extracellular NAMPT (eNAMPT), a master regulator of tissue and systemic inflammation as a novel therapeutic target in chorioamnionitis. Robust NAMPT expression in placentas from women with chorioamnionitis has been demonstrated. In a preclinical pregnant mouse model of ChorP, an eNAMPT-neutralizing antibody was dramatically protective, improving preterm birth mortality and inflammation in newborn pups. The award will help drive the final selection of the lead eNAMPT-neutralizing humanized therapeutic antibody between two candidates, ALT-100 and ALT-200, with selection utilizing in vitro and preclinical in vivo models of chorioamnionitis. Upon confirmation of the optimal candidate in treating chorioamnionitis, the company said it will submit an R42 STTR grant to further support preclinical development and IND-enabling studies.
ARS Pharmaceuticals Inc., of San Diego, said it entered an exclusive licensing agreement with Recordati SpA, of Milan, Italy, for marketing rights in the EU, Iceland, Liechtenstein, Norway, Switzerland, the U.K., Russia/CIS, Turkey, the Middle East and French-speaking African countries, for ARS-1 (known as Neffy in the U.S.), an epinephrine nasal spray. Recordati will receive exclusive rights to develop, register and commercialize ARS-1 in 93 countries in return for an up-front and subsequent payments based on successful achievement of regulatory and commercial milestones. ARS Pharmaceuticals will manufacture and supply ARS-1 as part of the agreement, and receive tiered royalties based on net sales.
Basilea Pharmaceutica Ltd., of Basel, Switzerland, reported new preclinical data on its fibroblast growth factor receptor (FGFR) inhibitor, derazantinib, at the European Society for Medical Oncology virtual congress. The study showed that treatment-specific gene expression patterns in tumor models may help elucidate the biological processes driving differences in the clinical adverse event profiles of FGFR inhibitors. The results may also explain low rates of adverse events reported with derazantinib for retinal events, mucositis and nail toxicities. Results from a series of preclinical efficacy models of breast, colorectal, head and neck, lung, ovarian and gastric cancers with confirmed FGFR1-3 genetic aberrations showed they were particularly sensitive to treatment with derazantinib. In addition, gastric and lung cancer models showed the strongest correlation of FGFR1-3 expression vs. the anticancer activity of derazantinib. The results support the planned clinical investigation of derazantinib in gastric cancer as its next indication.
Bausch Health Cos. Inc., of Laval Quebec, and its gastroenterology business, Salix Pharmaceuticals, together with Salix's licensor, Alfasigma SpA, have agreed to resolve outstanding intellectual property disputes with Sun Pharmaceutical Industries Ltd., of Mumbai, India, regarding Xifaxan (rifaximin) 200-mg and 550-mg tablets. Sun will be granted a nonexclusive license, effective Jan. 1, 2028.
Bristol Myers Squibb Co., of New York, said it has completed its transaction to acquire Forbius, also known as Formation Biologics Inc., of Toronto, for its TGF-beta program, including its lead investigational asset, AVID-200, currently in phase I for oncology and fibrosis. Forbius’ non-TGF-beta assets were transferred to a newly formed private company, which is being retained by the company’s existing shareholders.
City of Hope said it licensed intellectual property relating to its chlorotoxin chimeric antigen receptor T-cell therapy to Chimeric Therapeutics Ltd., of London. The therapy is in a phase I trial at City of Hope to treat glioblastoma. Chimeric acquired exclusive worldwide rights to develop and commercialize certain patents relating to City of Hope’s CLTX-CAR T cells, as well as to further develop the therapy for other cancers.
Citius Pharmaceuticals Inc., of Cranford, N.J., said it achieved significant milestones for Mino-Lok, an antibiotic lock solution being developed as an adjunctive therapy for patients with central line-associated bloodstream infections or catheter-related bloodstream infections. Citius has manufactured three registration lots of Mino-Lok using commercial manufacturing, placed all registration lots on stability and developed a new synthesis process for disodium edetate, a chelating agent that supplants heparin as an anticlotting agent. Mino-Lok contains minocycline, ethanol and EDTA, which are combined into two vials, MLT01 (minocycline) and MLT02 (ethanol and EDTA).
Codagenix Inc., of Farmingdale, N.Y., said the Serum Institute of India Ltd. has begun manufacturing CDX-005, Codagenix’s intranasal, live-attenuated vaccine candidate for SARS-CoV-2. Codagenix, backed by investors Adjuvant Capital and Topspin Partners, is collaborating with the Serum Institute of India to develop CDX-005. Codagenix expects to initiate a phase I first-in-human trial in the U.K. by the end of 2020.
Covimro Ltd., of London, said it has electron microscope images showing its compound, Covimro, against coronavirus, disrupting the viral membrane and dislodging S spike proteins. Covimro has a virus agnostic, three-stage design architecture and structurally degrades the virus on contact, preventing it from attaching to the cell, and reduces its ability to multiply once inside the cell, the company said.
Sixty-four higher income economies have joined the Covax Facility, with another 38 economies expected to sign, These self-financing economies join 92 lower income economies eligible for financial support through the Gavi COVAX Advance Market Commitment. A total of 156 economies, representing nearly two-thirds of the global population, are now committed to or eligible to receive vaccines through the facility, a global initiative that brings together governments and manufacturers to ensure COVID-19 vaccines reach those in greatest need, Covax said.
Daewoong Pharmaceutical Co. Ltd., of Seoul, South Korea, said the U.S. International Trade Commission (ITC) plans to reconsider an administrative law judge’s initial determination involving a complaint that the company and partner Evolus Inc., of Irvine, Calif., violated the Tariff Act by importing and marketing certain botulinum toxin products in the U.S. The complaint was lodged by Medytox Inc., also of Seoul, and Dublin-based Allergan, now a unit of North Chicago-based Abbvie Inc. Daewoong and Evolus contend the judge’s initial determination, which recommended a 10-year import ban, contained legal and factual errors. The ITC said it will review several issues as requested by the companies, including subject matter jurisdiction, standing, trade secret existence and misappropriation, and domestic industry.
Dtx Pharma Inc., of San Diego, said it received grant funding from the National Institute of Neurological Disorders and Stroke at the U.S. NIH to advance its research program to treat Charcot-Marie Tooth. Dtx is conducting preclinical work with its platform technology, Falcon (Fatty acid long chain oligonucleotide), to suppress the overexpression of PMP22, the protein that causes CMT1A.
TPG Capital, the private equity platform of alternative asset firm TPG, said it formed Ellodi Pharmaceuticals to pursue development of APT-1011, a disintegrating tablet formulation of fluticasone propionate in phase III development to treat eosinophilic esophagitis. The program was spun out of Lawrenceville, N.J.-based Adare Pharmaceuticals Technologies, previously a subsidiary of Aptalis Pharma that was renamed after its divestiture from Aptalis' parent company, Actavis plc, to TPG. Ellodi was formed following TPG Capital’s sale of Adare’s specialty CDMO pharmaceutical technology and microbiome businesses to Thomas H. Lee Partners and Frazier Healthcare Partners. As part of that transaction, TPG Capital retained ownership of APT-1011 and its related science with the intention to establish an entity dedicated to the program’s continued development.
Evotec SE, of Hamburg, Germany, and Bayer AG, of Leverkusen, Germany, expanded their partnership in women’s health indications with a five-year, multitarget collaboration with participation from Celmatix Inc., of New York, to develop multiple clinical candidates for the treatment of polycystic ovary syndrome. Both companies will contribute drug targets and technology platforms. The alliance will also have access to targets from the recently formed partnership between Celmatix and Evotec.
Geneva Biotech, of Geneva, disclosed a SARS-CoV-2 therapeutics platform, based on a discovery that revealed mechanisms driving the high infectivity, broad tissue tropism and severe pathology of the virus that causes COVID-19. An international team of scientists, including Geneva Biotech co-founders Daniel Fitzgerald and Imre Berger, now published in Science Magazine findings demonstrating that the omega-6 fatty acid linoleic acid is a key component of the SARS-CoV-2 Spike, and that linoleic acid binding to Spike significantly decreases SARS-CoV-2 infectivity. The team further showed that linoleic acid synergizes with currently utilized COVID-19 therapeutics to suppress replication and shut down the virus.
Jupiter Orphan Therapeutics Inc., of Jupiter, Fla., said the National Institute on Aging at the U.S. NIH awarded a one-year, $1.76 million grant to support a phase I safety and pharmacokinetics study of Jotrol (resveratrol) to treat early stage Alzheimer's disease. Jotrol is an oral softgel formulation of resveratrol that crosses the blood-brain barrier and reduces gastrointestinal issues.
Kazia Therapeutics Ltd., of Sydney, said it agreed to collaborate with Dana-Farber Cancer Institute to assess its kinase inhibitor, paxalisib (formerly GDC-0084), in primary central nervous system lymphoma, a potential new indication for the candidate. Dana Farber researchers expect to launch an open-label, single-arm phase II trial in up to 25 people with relapsed or refractory disease who are resistant to existing treatments. The primary endpoint will be overall response rate, based on the agent’s ability to shrink tumors. The study also will examine tissue and cerebrospinal fluid samples to identify potential predictors of response. Recruitment is expected to begin in early 2021, with the trial lasting up to two years. Kazia will provide the study drug and grant funding.
Lantern Pharma Inc., of Dallas, said it inked a collaboration and research pact with Fox Chase Cancer Center to advance LP-184, a DNA damage binding protein inhibitor, in pancreatic cancer. The collaboration will focus on targeted use of the agent in molecularly defined subtypes of pancreatic cancer, assessing whether overexpression of the gene PTGR1, a biomarker linked to cancer cell proliferation, will indicate heightened sensitivity to LP-184, producing a more favorable response rate and better efficacy than standard-of-care drugs.
Marinus Pharmaceuticals Inc., of Radnor, Pa., said it planned to complete a 1-for-4 reverse stock split of its common shares (NASDAQ:MRNS) following the market’s close on Sept. 22. The reverse split, authorized at a special stockholder meeting on March 31, will reduce the number of common shares issued and outstanding from approximately 122.3 million to approximately 30.6 million and the number of authorized shares from 300 million to 150 million. On Sept. 22, MRNS closed at $3.14 for a loss of 7 cents.
Medigene AG, of Planegg/Martinsried, Germany, said it is taking measures to reduce cash burn and secure financing into the third quarter of 2022. The company has decided to concentrate all future preclinical research and development activities on developing functionally enhanced TCR-T cells as treatments for solid tumors, which it views as the most significant commercial opportunities. Contingent on results from the phase I part of its ongoing MDG-1011 phase I/II trial in acute myeloid leukemia and myelodysplastic syndrome patients, Medigene has decided to look for a partner for the phase II part. Furthermore, Medigene had so far expected the completion of dosing of the third dose cohort in the phase I dose-escalation part of the MDG-1011 trial by the end of 2020, a timeline now likely to be extended into the first quarter of 2021 due to feasibility challenges associated with treating hematological cancer patients with very advanced and highly aggressive disease. Other clinical trials and existing collaborations continue as planned. Medigene is reducing its workforce by about 25%, to be enacted beginning immediately. The company expects one-time expenses in the amount of about €1 million (US$1.2 million), which will be incurred in the fiscal years 2020 and 2021. The guidance for R&D expenses is reduced to the range of €22 million to €26 million (previously €24 million to €29 million).
Moderna Inc., of Cambridge, Mass., said the Canadian government increased its confirmed order commitment to 20 million doses of Moderna’s vaccine candidate against COVID-19, mRNA-1273. The updated agreement comes as Moderna’s phase III COVE study has enrolled more than 75% of its participants, 11,879 of whom have received their second vaccination as of Sept. 18. The company also made the complete, unredacted protocol for the phase III trial of mRNA-1273 available online on Sept. 17.
Neuren Pharmaceuticals Ltd., of Melbourne, Australia, said its contract manufacturer initiated production of its oral dipeptide, NNZ-2591, to supply planned phase II trials, expected to begin in 2021 in Phelan-McDermid, Angelman and Pitt Hopkins syndromes.
Oxgene Genetics Ltd., of Oxford, U.K., said it launched a scalable, plasmid-free manufacturing system for adeno-associated virus (AAV), using its Tessa technology to address challenges associated with robust and reproducible AAV manufacture at scale by exploiting AAV’s natural relationship with adenovirus. The company said it can manipulate the adenoviral life cycle to support AAV replication while ensuring the adenovirus is unable to manufacture itself. Using two Tessa vectors improves yields of AAV2 by 40-fold, accompanied by a 2,000-fold increase in particle infectivity compared to a standard three-plasmid manufacturing approach, according to the company, which said it developed and validated Tessa vectors for AAV2, 5, 6 and 9.
Promega Corp., of Madison, Wis., said it plans to develop the Promega Oncomate microsatellite instability assay as a companion diagnostic test for retifanlimab, an anti-PD-1 candidate from Incyte Corp., of Wilmington, Del., for the treatment of endometrial cancer. Microsatellite instability-high is a key feature of Lynch syndrome tumors that occurs frequently in endometrial cancer. Promega and Incyte said they intend to work together to develop the assay as a companion diagnostic in other markets. Financial terms of the global agreement were not disclosed.
Promis Neurosciences Inc., of Toronto, said it initiated a program to construct and test a multivalent peptide vaccine for Alzheimer’s disease (AD) capable of inducing an effective antibody response against amyloid beta toxic oligomers (ABOs). In a proof-of-concept study, Promis identified six peptide epitopes selectively exposed on toxic ABOs. Immunization of mice with each epitope produced protective antibodies against ABOs without binding to amyloid beta monomers or fibrils. Promis also conducted a proof-of-concept vaccination study with one peptide epitope in a mouse model of AD that suggested neuronal protection and improvement in cognitive deficits. The University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre will perform initial development steps, generating multivalent vaccine constructs based on Promis peptides linked to a carrier protein and formulated with an adjuvant to maximize induction of protective antibody response to ABOs.
Samsung Biologics Co., of Incheon, South Korea, and Astrazeneca plc, of Cambridge, U.K., said they formed a long-term global supply agreement, which they valued at approximately $330.8 million. Samsung will provide large-scale commercial manufacturing for drug substance as well as drug product to support Astrazeneca biologics, which could increase the deal value to $545.6 million.
Sanofi SA, of Paris, said the waiting period expired under the Hart-Scott-Rodino Antitrust Act with regard to its proposed acquisition of Principia Biopharma Inc., of South San Francisco. Sanofi’s tender offer to purchase Principia’s outstanding common shares for $100 apiece is set to expire at midnight ET on Sept. 25.
Sanofi SA, of Paris, and Glaxosmithkline plc, of London, said they signed agreements with the Canadian government for the supply of up to 72 million doses of an adjuvanted COVID-19 vaccine, beginning in 2021. Both companies have vaccine manufacturing sites in Canada that are contributing to overall global COVID-19 vaccine development. The companies started a phase I/II study Sept. 3 with a total of 440 subjects, with first results expected in early December, to support potential initiation of a pivotal phase III study before year-end.
Researchers from Critical Analytics for Manufacturing Personalized-Medicine, an interdisciplinary research group at Singapore-MIT Alliance for Research and Technology, said they were awarded grants from Singapore’s National Research Foundation as partner units of the Campus for Research Excellence And Technological Enterprise to support a two-year research program on retinal biometrics for glaucoma progression and a three-year program on neural cell implantation therapy for spinal cord injuries.