Adjuvance Technologies Inc., of Lincoln, Neb., was awarded supplemental contract funding from the National Institute of Allergy and Infectious Diseases. The funds will be used to evaluate TQL-1055, manufactured by Adjuvance, with SARS-CoV2 antigen, manufactured by the NIH. TQL-1055 is a saponin vaccine adjuvant, the company said, and the total funding in the contract is $1.47 million.
Aetion Inc., of New York, signed a research collaboration agreement with the FDA to use real-world data to advance the understanding of and response to COVID-19. The research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns, by making possible the use of relevant new data sources and analyzing the data according to well-established principles. Aetion and the FDA will identify and analyze fit-for-purpose data sources to characterize COVID-19 patient populations and their medication use, identify risk factors for COVID-19-related complications, and contribute to the scientific evaluation of potential interventions. The collaboration will make use of the Aetion Evidence Platform, which includes structured workflows and transparent reporting to allow efficient sharing, examination and reproduction of findings.
Be The Match Biotherapies LLC, of Minneapolis, is providing donor material for El Segundo, Calif.-based Nantkwest Inc.’s phase Ib trial to address acute respiratory distress syndrome (ARDS), a cause of COVID-19 deaths. Nantkwest’s allogeneic cell therapy, derived from human bone marrow, is designed to treat ARDS resulting from severe COVID-19. The therapy, BM-Allo.MSC, uses mesenchymal stem cells, multipotent progenitor cells known to have immunomodulatory properties, for reducing ARDS-associated lung inflammation.
Cabaletta Bio Inc., of Philadelphia, presented in vivo data demonstrating specific engagement and elimination of anti-muscle-specific tyrosine kinase (MuSK) antibody-expressing target cells by chimeric auto-antibody receptor (CAAR) T cells at the American Academy of Neurology 2020 Science Highlights Virtual Platform. Cabaletta Bio exclusively licensed the MuSK CAAR T-cell technology and developed the therapy with the University of Pennsylvania.
Centivax Inc., of South San Francisco, said three independent laboratories confirmed multiple Centivax antibody therapeutic candidates are potent neutralizers of COVID-19. Viral neutralization directly demonstrated that the antibodies are able to completely block the coronavirus from infecting human cells, the company added. Scientists at the U.S. Army Medical Research Institute of Infectious Diseases are testing the antibodies for their ability to prevent the coronavirus from infecting human cells.
With $9 million from the COVID-19 Therapeutics Accelerator, an international group of physicians and scientists is establishing a research network to evaluate promising therapies for COVID-19. The group, called the COVID-19 Research Outcomes Worldwide Network (CROWN) Collaborative, is testing whether the antimalaria drug chloroquine can prevent COVID-19 infection or decrease its severity in front-line health care workers, according to the Washington University School of Medicine in St. Louis, which is coordinating the study. An estimated 30,000 participants from across the globe will participate in the five-month trial, which the collaborative is calling the CROWN CORONATION trial. They'll be divided randomly into four groups, three of which will receive chloroquine at various doses, with the fourth receiving a placebo. Data from the trial sites will be compiled at University College London. Rising Pharma Holdings Inc., a privately held generics and OTC drug company based in East Brunswick, N.J., is donating chloroquine to the U.S. arm of the study.
Cytodyn Inc., of Vancouver, Washington, is providing leronlimab to the Mexican National Institutes of Health for a trial in Mexico’s severe/critical COVID-19 patients. Cytodyn is enrolling 390 patients for the randomized, placebo-controlled phase IIb/III trial. Cytodyn is also enrolling a phase II randomized clinical trial with 75 patients in the mild to moderate COVID-19 population. The FDA granted leronlimab fast track designation as a combination therapy with HAART for HIV-infected patients and for those with metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases and other diseases, including nonalcoholic steatohepatitis.
Dyne Therapeutics Inc., of Waltham, Mass., said it accelerated its programs in facioscapulohumeral muscular dystrophy (FSHD) through exclusive licensing of technologies to target the gene DUX4, the genetic basis of FSHD. The technology was developed at the University of Mons Molecular Biology Laboratory in Belgium. Dyne is advancing an FSHD program using the DUX4-targeting technology in combination with its platform. FSHD is a rare, debilitating muscle disease with no approved treatments. Dyne's platform enables targeted delivery of a therapeutic inside the muscle cells of FSHD patients, where it is expected to reduce aberrant expression of the DUX4 protein and halt the loss of muscle function that characterizes FSHD.
Genocea Biosciences Inc., of Cambridge, Mass., entered a material transfer agreement (MTA) and exclusive license option with Shionogi & Co., Ltd., of Osaka, Japan, to develop an HSV-2 vaccine using Genocea’s HSV-2 antigens from the GEN-003 program, which the company discontinued in 2017. Shionogi will pay $2 million for the exclusive option to evaluate the HSV-2 antigens and to negotiate a license prior to expiration of the MTA. Upon exercising Shionogi’s option, terms are expected to include an up-front payment, regulatory and sales milestones, as well as tiered royalties. Final terms will be based on MTA evaluation results and overall diligence. If licensed, Shionogi will assume responsibility for global development and commercialization of the HSV-2 vaccine product. The Genocea platform profiles T-cell responses to targets on tumors.
Imcheck Therapeutics SAS, of Marseille, France, and Haliodx SAS, also of Marseille, entered a collaboration in which Haliodx will work with Imcheck to generate tumor immune contexture information, which is determined by the density, composition, functional state and organization of immune infiltration into the tumor, for patients enrolled in EVICTION, the first-in-human trial of ICT-01. ICT-01 is a humanized monoclonal antibody that activates γ9δ2 T cells, part of the innate immune system that is responsible for immunosurveillance for malignancy and infection, by targeting BTN3A, a target expressed in several solid and hematologic tumors. Terms of the agreement were not disclosed.
Infectious Disease Connect Inc., a company backed by the University of Pittsburgh Medical Center that offers telemedicine services to hospitals for treatment of infectious diseases, has combined with Kenilworth, N.J.-based Merck & Co. Inc.'s ILÚM Health Solutions, a provider of technology and services to support infectious disease management, clinical decision-support and precision antibiotic therapy. As part of the agreement, UPMC Enterprises, the innovation and commercialization arm of UPMC, and Merck Global Health Innovation Fund are each investing $5 million to support the newly combined entity. ILÚM uses machine learning to evaluate a patient’s demographic factors, medication history, past hospitalizations and other data to generate individualized treatment recommendations. UPMC will retain a majority stake in the combined company.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said its anti-SARS-CoV-2 candidate, brilacidin, in an in vitro experiment using Vero cells, reduced the viral titer of SARS-CoV-2 by 75% after only one hour of preincubation prior to infection at a concentration of 10 μM as compared to vehicle control. Separately, the company and lab researchers agreed that brilacidin as a vaccine would not be studied further at this time.
The University of Texas MD Anderson Cancer Center and Innovent Biologics Inc., of Suzhou, China, formed a strategic collaboration agreement to co-develop Tyvyt (sintilimab), Innovent’s anti-PD-1 monoclonal antibody, in rare cancers in the U.S. Under the agreement, Innovent and MD Anderson will co-fund the development activities for the drug, which may include multiple clinical research studies to be conducted by MD Anderson, the partners said. Tyvyt won regulatory approval from China's NMPA for the third-line treatment of classical Hodgkin lymphoma in December 2018.
Ipsen SA, of Paris, said the first published comparative data for key second-line advanced hepatocellular carcinoma (aHCC) treatments using a matching-adjusted indirect comparison show that Cabometyx (cabozantinib) increased median progression-free survival by 80.6% (5.6 months vs. 3.1 months) compared with Stivarga (regorafenib, Bayer AG) in the second-line treatment of aHCC.
Onxeo SA, of Paris, reported preclinical data, to be presented at the virtual American Association for Cancer Research meeting, supporting the differentiated ability of AsiDNA, its DNA damage response inhibitor, to reverse resistance to PARP inhibitors (PARPi) by preventing death-tolerant cell regrowth. Those new data show for the first time that PARPi resistance can be caused by drug-tolerant cells, and that the addition of AsiDNA to PARP inhibitors prevents the regrowth of those cells, thereby completely and irreversibly abolishing the emergence of resistance in ovarian tumor cells. Onxeo plans to start a phase Ib/II study in combination with Zejula (niraparib, Glaxosmithkline plc) in recurrent ovarian cancer in the second half of 2020.
Oragenics Inc., of Tampa, Fla., said that through its wholly owned subsidiary, Noachis Terra, it has entered an agreement with Aragen Bioscience, a contract research organization focused on accelerating preclinical biologics development, to advance TerraCov2 the company’s SARS CoV-2 vaccine candidate. Aragen will provide cell line development services to Oragenics.
Pharmajet Inc., of Golden, Colo., said its needle-free injection system technology will be used to deliver a mRNA vaccine against SARS-CoV-2, in development by Abnova Corp., of Taiwan. Terms were not disclosed.
Prellis Biologics Inc., of Hayward, Calif., said it generated 300 human IgG antibodies that bind to either the S1 or S2 spike protein of the SARS-CoV-2-Wuhan strain of the novel coronavirus. Using the Prellis Externalized Human Immune System technology, the team produced 960 synthetic human lymph nodes that were challenged with a SARS-CoV-2 vaccine-like cocktail, leading to virus-specific antibody generation. The company recently closed a $4.3 million investment round led by Future Ventures, Khosla Ventures and Indiebio to support the development of human anti-SARS-CoV-2 antibodies.
Promis Neurosciences Inc., of Toronto, said, in addition to its ongoing program to develop a high-throughput and accurate test for detection of antibodies to the causative agent of COVID-19, it has expanded its collaboration with BC Neuroimmunology to include development of highly sensitive and specific assays to support accurate screening and diagnosis of Alzheimer’s disease. Terms were not disclosed.
Qingdao Primedicine Pharmaceutical Co. Ltd., of Qingdao, China, and Primary Peptides Inc., of Vancouver, British Columbia, said they entered an exclusive license to develop and commercialize an innovative product for the treatment of heart attack. Under the terms of the agreement, Primedicine receives exclusive rights to develop and commercialize the product in China, including the mainland, Hong Kong, Macau and Taiwan, while Primary Peptides retains rights in all other markets. Additional product details and financial terms were not disclosed.
Revance Therapeutics Inc., of Newark, Calif., said it signed a definitive agreement to acquire Hint Inc., a privately held company doing business under the name HintMD, which has created an integrated financial technology platform for the aesthetics industry. The transaction is expected to close in the third quarter of 2020. Revance is developing a next-generation neuromodulator product, DaxibotulinumtoxinA for injection.
Ritter Pharmaceuticals Inc., of Los Angeles, said its stockholders approved all of the proposals related to its merger with Carlsbad, Calif.-based Qualigen Inc. In connection with the closing of the transaction, the company will change its name to Qualigen Therapeutics Inc. and its shares are expected to continue trading on Nasdaq under the symbol QLGN.
Sernova Corp., of London, Ontario, reported results at the American Society of Gene and Cell Therapy meeting, presented by the Horizon 2020 Hemacure Consortium, from the ex vivo gene therapy, cell-based approach using its Cell Pouch for hemophilia A. The combination therapy strives to permanently replace missing clotting human factor VIII (FVIII) in the patient's own blood outgrowth endothelial cells (BOECs) transplanted into the Cell Pouch. Those corrected cells are to function to release FVIII into the bloodstream restoring the ability for blood clotting to occur during periods of bleeding. Data showed BOECs were safely isolated and grown from a small sample of circulating peripheral blood of volunteer hemophilia A patients unable to express the required FVIII for clotting. To regain function of the BOECs’ ability to produce clotting FVIII, techniques were successful in safely inserting the gene responsible for the correction and production of human FVIII into the patient's BOECs, and those corrected cells were safely multiplied to increase their number. In the preclinical model of hemophilia A, animals originally unable to clot their blood were implanted with a small vascularized Cell Pouch and transplanted with two different doses of human BOECs corrected for the ability to produce human FVIII. Histological investigation of the transplanted Cell Pouch sections demonstrated long-term survival of human FVIII BOECs present within the vascularized Cell Pouch achieved through co-staining for blood vessels (von Willebrand Factor stain) and the presence of the patients’ corrected human cells (HLA-ABC stain).
Sophiris Bio Inc., of San Diego, said its board formally approved an immediate shutdown of the operations of the company. Sophiris has been unable to find a partner or raise capital to support the continued development of topsalysin in either benign prostatic hyperplasia or localized prostate cancer. The company currently has outstanding liabilities of $4.3 million and cash and cash equivalents of approximately $500,000. It will not have any funds to distribute to the shareholders. Sophiris had been developing topsalysin (PRX-302), a pore-forming protein, and had reached agreement last year with the FDA on design of a pivotal program in prostate cancer.
Therapix Biosciences Ltd., of Tel Aviv, Israel, said it closed a joint venture transaction for collaboration in the field of developing pharmaceuticals for a sleep-related indication. It entered a definitive securities purchase agreement with Capital Point Ltd., an Israeli holding company traded on the Tel Aviv Stock Exchange, and Evero Health Ltd., an Israeli company, and a wholly-owned subsidiary of Therapix, pursuant to which Capital Point will sell to Evero about 6 million ordinary shares of Coeruleus Ltd., an Israeli company, and a subsidiary (approximately 40%) of Capital Point, engaged in developing innovative medications based on the active generic substance flumazenil, including a sublingual spray to reduce the side effects of hypnotic sleep medication and a sublingual spray to improve function and quality of life in patients with hepatic encephalopathy. As part of the joint venture, Therapix transferred to Evero its THX-110 sleep technology, to be fully owned by Evero, under the terms and conditions of an asset purchase agreement. In addition, the company appointed Arie Webber to its board.
Timber Pharmaceuticals Inc., of Woodcliff Lake, N.J., formerly known as Biopharmx Corp., said its merger with Timber Pharmaceuticals LLC closed May 18. The company’s shares now trade on the NYSE American market under the ticker TMBR. Immediately prior to the merger, Timber LLC completed a private placement financing resulting in gross proceeds of $25 million under the terms of the securities purchase agreement previously announced in March 2020.
Xenetic Biosciences Inc., of Framingham, Mass., said it entered a research funding and option agreement with Scripps Research to advance the development of the XCART CAR T technology for B-cell malignancies. Under the terms, Xenetic will be granted an exclusive license to certain intellectual property arising from the research program in the field of B-cell malignancies, as well as an option to acquire rights and licenses to new intellectual property outside of that field. Xenetic said it is actively engaged in ongoing discussions to advance the development of XCART through additional collaborations with academic or development partners.