7 Hills Pharma Inc., of Houston, said preclinical studies reveal 7HP-349, an oral integrin activator that promotes cell adhesion, significantly increases IgG binding antibodies with a vaccine targeting COVID-19. The data also suggest 7HP-349 can be used as an immunostimulant for any COVID-19 vaccine and has the potential not only to augment the vaccines’ effectiveness, but also accelerate immune system response, allow for dose sparing and reduce or eliminate the need for boosters. The drug is the company’s lead product candidate in a platform of small-molecule integrin activators that significantly enhance cell adhesion, which is essential for producing an immune response.
Aboundbio Inc., of Pittsburgh, said a team led by its founders discovered human monoclonal antibodies with neutralizing activity in the laboratory against SARS-CoV-2, the virus that causes COVID-19. Selected from antibody libraries, the ultra-specificity of the antibodies has been shown by the absence of binding to more than 5,300 proteins in the human cell surface proteome. The antibodies do not increase infection in cell culture models of "antibody-dependent enhancement," a general concern about antibody for infectious diseases. The lead antibodies are effective at low doses in mouse and hamster models of SARS-CoV-2 infection but have not been tested yet in human clinical trials, the company said. Antibody production and clinical development for regulatory approval and commercialization in the MENA and ASEAN regions of the world are proceeding under an agreement with Saudivax, a Saudi-U.S. joint venture.
Akers Biosciences Inc., of Thorofare, N.J., said with its partner, Premas Biotech Pvt. Ltd., of Haryana, India, that animal studies have begun with their COVID-19 vaccine candidate in India. Premas has successfully completed the manufacturing process for the virus-like particle prospect, including three antigens from SARS-CoV-2. The four-week test is expected to be placebo-controlled, blinded and randomized in mice.
The Alliance for Regenerative Medicine (ARM) in Brussels published its response to the EU Pharmaceutical Strategy Roadmap, which is designed to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. While ARM welcomes the Roadmap’s recognition of the wider industry’s contribution to the EU economy and its focus on ensuring patients’ access to safe, state-of-the-art therapies, the alliance wants to ensure a continued pathway for the EU to benefit from innovative and life-changing advanced therapy medicinal products. ARM recommends the pharmaceutical strategy include ensuring that regulatory procedures are robust, transparent, evidence-based and harmonized in Europe.
Arca Biopharma Inc., of Westminster, Colo., and the University of Colorado Anschutz Medical Campus said the paper, titled "Dynamic Regulation of SARS-CoV-2 Binding and Cell Entry Mechanisms in Remodeled Human Ventricular Myocardium," was published in JACC: Basic to Translational Science, a member of the Journal of the American College of Cardiology family of journals. The paper provides new information on mechanisms involved in host cell binding and entry of the COVID-19 virus in the human heart. Investigators determined how known and potential mechanisms responsible for COVID-19 infection in the intact heart are altered by prior heart muscle disease, and to what extent they are changed when damaged heart muscle improves through reverse remodeling.
Byondis BV, of Nijmegen, the Netherlands, selected the company’s investigational antibody-drug conjugate, SYD-985 ([vic-]trastuzumab duocarmazine), for a new investigational treatment arm in its ongoing I-Spy 2 Trial for neoadjuvant treatment of locally advanced breast cancer. This treatment arm will focus on treatment for HER2-low early stage breast cancer. The study is a standing phase II randomized, controlled, multicenter study aimed at rapidly screening and identifying promising treatments in specific subgroups of women with newly diagnosed, high-risk, locally advanced breast cancer (stage II/III). Quantum Leap, sponsor of the I-SPY 2 TRIAL, leads a pre-competitive consortium that includes the FDA, industry, patient advocates, philanthropic sponsors and clinicians from 16 major U.S. cancer research centers.
Cabaletta Bio Inc., of Philadelphia, and Artisan Bio Inc., of Denver, signed a research and collaboration agreement to accelerate development of next-generation chimeric autoantibody receptor T-cell therapies for patients with B cell-mediated autoimmune diseases. Under the terms of the agreement, Artisan will collaborate with Cabaletta to enhance certain Cabaletta pipeline products at specific targets using its platform technology and gene editing expertise. Cabaletta will be responsible for the development, manufacturing and commercialization of the resulting modified cell therapy products. The financial terms of the agreement were not disclosed.
Cage Bio Inc., of San Carlos, Calif., said it entered an R&D deal with Nitto Denko Corp., of Osaka, Japan, for a transdermal formulation of undisclosed molecules. The goal of the partnership is to explore the potential for developing therapeutic products at Nitto using Cage’s deep eutectic ionic liquid technology. The companies said they will evaluate novel formulations of drugs that have been notoriously difficult to formulate and deliver into the skin. Financial terms were not disclosed.
Johns Hopkins University Hospital investigators report that promising data for treatment of COVID-19-induced acute respiratory distress syndrome with allogeneic, cord blood-derived T-regulatory (Treg) cell therapy, manufactured by Cellenkos Inc., of Houston, were published in the Annals of Internal Medicine. Two critically ill patients were intubated, and both had failed Actemra (tocilizumab, Roche Holding AG) and had multiorgan failure. Patients received cell therapy under an FDA emergency use IND for up to three doses. Clinical improvement was evident within 48 hours of first infusion and correlated with concurrent dampening of the cytokine storm as demonstrated by a rapid decline in peripheral biomarkers, including lactate, C-reactive protein and ferritin, as well as decreased blood levels of inflammatory cytokines including IL-6, IFNϒ and TNFα. A multicenter trial is set to launch in the third quarter, with patients assigned to treatment with multiple doses of CK-0802 or placebo, with two co-primary outcomes of safety (no severe toxicity) and efficacy (alive and extubated at day 28). CK-0802 will be manufactured by Cellenkos and shipped to the clinical site to be infused at the patient's bedside.
Clarametyx Biosciences Inc., of Columbus, Ohio, disclosed the publication of a new study in Ebiomedicine. The study demonstrates the potential impact of addressing resistant or recalcitrant infections by targeting the universal stabilizing structure of bacterial biofilms, a protective layer over bacteria that is present in as much as 80% of bacterial infections and contributes to persistent infections, inflammation and resistance to therapeutic interventions. The approach departs from prior antibiofilm technologies that attack species-specific targets, instead targeting the critical DNA-binding proteins within the scaffold of biofilms, a feature common to all bacterial pathogens, the company said.
Cytoagents Inc., of Pittsburgh, received an investment to accelerate the development of its lead drug candidate, GP-1681, a drug to treat cytokine storm induced by COVID-19, from the Richard King Mellon Foundation. The program-related investment is part of the foundation’s $25 million pandemic solutions package to jumpstart COVID-19 response strategies. GP-1681 is a small-molecule inhibitor of cytokine release in activated human immune cells. The candidate differentiates itself from other immunotherapy solutions as it will be an affordable, oral therapeutic that targets the optimal range of cytokines as an important component of a multifaceted treatment plan, the company said.
Editas Medicine Inc., of Cambridge, Mass., entered a multiyear agreement for cGMP-compliant cleanroom space with Azzur Group, of Waltham, Mass. Editas will use the space and services for preclinical and early phase clinical manufacturing activities for its cell medicines, including EDIT-301, in development for treating sickle cell disease and beta-thalassemia, and EDIT-201, a healthy donor natural killer cell medicine, in development for treating solid tumor cancers.
Evolus Inc., of Newport Beach, Calif., said the administrative law judge overseeing the U.S. International Trade Commission case filed by Dublin-based Allergan plc and Medytox, of Seoul, South Korea, in January 2019 against Daewoong Pharmaceutical Co. Ltd., also of Seoul, South Korea, and Evolus released a nonbinding initial decision that it found a violation of Section 337 of the Tariff Act of 1930. “We strongly disagree with the initial determination and we look forward to the full commission’s final determination targeted for Nov. 6, 2020. In addition, we intend to petition the commission to review the initial determination,” said David Moatazedi, Evolus’ president and CEO. Evolus added that the investigation represents an improper attempt to use the commission as a means to litigate a dispute between two Korean competitors that is completely disconnected from the U.S.
Hemostemix Inc., of Calgary, Alberta, said the U.S. District Court for the District of Delaware granted an order for the expedited briefing schedule on Hemostemix’s injunction application seeking immediate return of all clinical trial data from Accudata Solutions Inc. The order directs Accudata to file an answering brief in response to Hemostemix’s motion for preliminary injunction on or before July 9. The court scheduled a hearing on the preliminary injunction motion for July 15. Hemostemix said it needs its data to properly assess the midpoint analysis of its clinical trials of ACP-01, an autologous stem cell therapy.
Preclinical data from Hepion Pharmaceuticals Inc., of Edison, N.J., show its antifibrotic candidate, CRV-431, was efficacious in two research models related to COVID-19. CRV-431, a peptidyl-prolyl cis-trans isomerase A inhibitor, demonstrated strong anti-inflammatory actions in a nonviral, acute lung injury model and on some measures outperformed dexamethasone, a recently recommended treatment for COVID-19, according to Hepion. Also, cell culture experiments demonstrated CRV-431 antiviral activity towards SARS-CoV-2, the virus responsible for COVID-19 disease, the company added.
Hibercell Inc., of New York, said it acquired Roseville, Minn.-based Biothera Pharmaceuticals Inc.'s Imprime PGG program, an innate immune activator that binds to the dectin-1 receptor and activates innate immunity, reprogramming the immunosuppressive tumor microenvironment to enhance antigen presentation, trigger T-cell activation and enhance the immune response against tumors. Phase II studies of Imprime PGG combined with checkpoint inhibition demonstrated mechanistic proof-of-concept data including the activation of innate and adaptive immunity resulting in improved overall survival, overall response and disease control rates in metastatic triple-negative breast cancer, Hibercell said. Hibercell is developing therapeutics for treating or preventing cancer relapse and metastasis.
In vitro testing of Wakefield, Mass.-based Innovation Pharmaceuticals Inc.’s brilacidin for treating COVID-19 shows consistent anti-SARS-CoV-2 efficacy, the company said. Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2 in a human lung epithelial cell line, reducing viral load by up to 97% compared to control, the company added. Brilacidin also appears to be showing greatest efficacy in testing when administered as a pretreatment (virus pre-incubated with brilacidin prior to infection), in addition to being present during and post-infection, the company added.
Insmed Inc., of Bridgewater, N.J., said Arikayce (amikacin liposome inhalation suspension) has been included in the new international treatment guidelines for nontuberculous mycobacterial (NTM) lung disease. The evidence-based guidelines, issued by the American Thoracic Society, European Respiratory Society, European Society of Clinical Microbiology and Infectious Diseases, and Infectious Diseases Society of America, recommend the use for the treatment of patients with refractory NTM lung disease caused by Mycobacterium avium complex as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options.
Intelgenx Corp., of Saint Laurent, Quebec, said it entered a feasibility agreement with Toronto-based Cybin Corp. for the development of an orally dissolving film for the delivery of pharmaceutical-grade psilocybin.
Maia Biotechnology Inc., of Chicago, said preclinical results supporting newly identified immunogenic effects of its lead product candidate, THIO (6-thio-dG), a telomere-by-telomerase targeting agent in development for the treatment of cancer, were published in Cancer Cell. The data demonstrated that THIO kills cancer cells by targeting and uncapping telomeres and inducing DNA damage. The latest preclinical data showed that is complemented by an immunogenic effect, which may allow for more durable outcomes when used sequentially with immunotherapy. Low doses of THIO, followed by anti-PD-L1 therapy, eliminated advanced tumors in preclinical models and produced cancer cell-specific immune memory where the immune system continued to be active against the cancer cells after extended periods with no additional treatment. The company said the findings provide further support for plans to advance THIO into phase I studies next year.
Mylan NV, of Hertfordshire, U.K., said its U.S. business is conducting a voluntary nationwide recall to the consumer level of one lot of daptomycin for injection, 500 mg/vial, due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Ltd.’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to the recall.
Nasus Pharma, of Tel Aviv, Israel, said data from a preclinical collaboration with the University of Virginia School of Medicine that demonstrated Taffix, its nasal powder inhaler that blocks viruses from reaching nasal mucosa, was able to block more than 99% of SARS-CoV-2 viruses. The study demonstrated that the gel layer produced by Taffix powder after administration of a clinical equivalent amount, effectively blocked SARS-CoV-2 virus, as demonstrated by four log reduction in amount of viral RNA, and reduced the amount of infectious live virus by more than 99%. The powder, currently approved for marketing as a protective mechanical barrier against allergens and viruses within the nasal cavity in Europe and to block inhaled viruses and bacteria within the nasal cavity in Israel, was developed to create an acidic microenvironment in the nose, which is proven to prevent viruses from entering and infecting nasal cells.
Numab Therapeutics AG, of Waedenswil, Switzerland, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, said they entered a research collaboration and worldwide licensing agreement that will start with two projects aiming at novel therapies for difficult-to-treat lung and gastrointestinal cancers and patients with geographic atrophy, a progressive, irreversible retinal disease that occurs in patients with age-related macular degeneration for which there is no current treatment. The companies will work together to discover one multispecific antibody-drug candidate in each area. Boehringer Ingelheim will receive an exclusive worldwide license from Numab to develop and commercialize the resulting candidates in exchange for up-front and milestone payments, as well as tiered royalties on net sales of all products resulting from the alliance.
Pacgen Life Science Corp., of Vancouver, British Columbia, said it reached a definitive agreement where General Biologicals Corp., a Taiwan-based diagnostic and pharmaceutical company, will acquire its issued and outstanding shares in an all-cash transaction.
Plakous Therapeutics Inc., of Winston-Salem, N.C., said it received a notice of award for a Phase I-II Fast-Track Small Business Innovation Research grant providing up to $1.725 million from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the NIH. It will assist development of therapies for preventing necrotizing enterocolitis, the devastating disease of premature babies caused by inflammation and lack of development of the intestine.
Predictive Oncology Inc., of Minneapolis, a company focused on applying artificial intelligence to personalized medicine and drug discovery, completed its acquisition of Quantitative Medicine LLC (QM), a biomedical analytics and computational biology company, in an all-stock transaction (NASDAQ:POAI) valued at about $1.8 million. Integrating QM's machine learning platform with Predictive Oncology's database of drug response and genomic profiles could "revolutionize the role of our AI-driven predictive models" in the discovery and development of new cancer medicines, said Predictive Oncology CEO Carl Schwartz.
Prolynx LLC, of San Francisco, said the NIH has awarded it an Small Business Innovation Research grant for the development of a long-acting parathyroid hormone (PTH) that can be administered once-weekly for treatment of hypoparathyroidism. Prolynx will employ its platform half-life extension technology using its hydrogel microsphere carriers to the drug Natpara, an injectable bioengineered recombinant form of PTH (1-84).
Rakuten Medical Inc., of San Mateo, Calif., inked a multiyear deal with Darmstadt, Germany-based Merck KGaA, which will provide cetuximab to Rakuten for its ASP-1929 program. ASP-1929 is an investigational antibody-dye conjugate being studied for the treatment of recurrent, locoregional head and neck cancers. Financial terms of the agreement were not disclosed.
Reven Holdings Inc., of Golden, Colo., highlighted publication of two articles about the potential of its RJX platform for the potential treatment of COVID-19. One provides an overview of the development status, mechanism of action, and clinical potential of the RJX platform in the context of the infection. The other outlines the design of a potential placebo-controlled, double-blind phase II study of Rejuveinix in COVID-19 patients with acute lung injury and hypoxemic respiratory failure.
Tessera Therapeutics Inc., of Cambridge, Mass., has launched with technology designed to alter the genome by inserting genes and exons, introducing small insertions and deletions, or changing single or multiple DNA base pairs. The technology could, the company said, enable cures for diseases arising from genome errors, including monogenic disorders. It could also allow precise gene regulation in other diseases such as neurodegenerative diseases, autoimmune disorders and metabolic diseases, the company added. Tessera was launched by Flagship Pioneering.
Therapeutic Solutions International Inc., of Oceanside, Calif., said preclinical data supporting its effort to reposition its cancer immunotherapy Stemvacs candidate for the treatment of COVID-19 has been submitted to the Journal of Translational Medicine for possible publication. "We are in the process of collecting data from patients treated with Stemvacs for cancer and once these data are properly presented, we hope to file an IND amendment to request the FDA to allow us to initiate clinical trials in coronavirus," said company President and CEO Timothy Dixon.
Theratechnologies Inc., of Montreal, said it successfully completed a bioequivalence study evaluating a new formulation of tesamorelin compared to the original formulation approved by the FDA. The new formulation, which it said is patent protected in the U.S. until 2033 and until 2034 in major European countries, will allow the company to move forward with the development of a new multidose pen injector. Tesamorelin is the active ingredient in a line of products the company markets for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Theratechnologies said it expects to file an sBLA for the new product in early 2022.
Tonix Pharmaceuticals Holding Corp., of New York, said it intends to purchase an approximately 40,000-square-foot facility in Massachusetts to use as laboratories to enable R&D functions associated with its expanding portfolio of immunology candidates, including vaccines for COVID-19 and biological products for other disorders.
Turning Point Therapeutics Inc., of San Diego, and Shanghai-based Zai Lab Ltd. announced an exclusive license agreement for the development and commercialization of Turning Point’s lead candidate, repotrectinib, in greater China. Under terms of the deal, Turning Point will receive a $25 million up-front payment, with potential to receive up to an additional $151 million in development, regulatory and sales-based milestone payments. It will also be eligible to receive mid-to-high teen royalties based on annual net sales of repotrectinib in greater China.
UCB SA, of Brussels, and Ferring Pharmaceuticals Inc., of Parsippany, N.J., said they entered a co-promotion agreement to commercialize the prefilled syringe formulation of Cimzia (certolizumab pegol) in the U.S., specifically for the treatment of Crohn's disease. Ferring will take over marketing, sales promotion and field medical affairs activities, while UCB will continue to be responsible for all product-related activities, including revenue recognition. UCB will continue to promote and to commercialize the lyophilized formulation of Cimzia for all indications as well as the prefilled syringe formulation for Cimzia’s rheumatology and dermatology indications.