Ability Pharmaceuticals SL, of Barcelona, said it has been awarded €5 million (US$5.4 million) in blended financing from the Horizon Europe, European Innovation Council Accelerator Pilot program that will fund a phase IIb trial in advanced pancreatic cancer patients to investigate ABTL-0812 in combination with Folfirinox. The compound is currently in phase IIa open-label trials in Europe in patients with endometrial cancer or squamous cell lung cancer, as a first-line treatment in combination with chemotherapy and as a maintenance treatment after the chemotherapy cycles.
Acura Pharmaceuticals Inc., of Palatine, Ill., said that Abuse Deterrent Pharma LLC, its licensee of LTX-03 (hydrocodone bitartrate and acetaminophen with Acura’s Limitx technology), has engaged Catalent Pharma Solutions LLC to perform tablet manufacturing for clinical testing supplies of the product. Acura previously engaged Catalent to perform microparticle process development for LTX-03. The company’s Limitx technology is designed to retard the release of active drug ingredients when too many tablets are accidentally or purposefully ingested by neutralizing stomach acid with buffer ingredients, and also to deliver efficacious amounts of drug when taken as a single tablet with a nominal buffer dose.
Akers Biosciences Inc., of Thorofare, N.J., said it entered a licensing agreement with Premas Biotech Pvt. Ltd., of Gurgaon, India, under which it will in-license a coronavirus vaccine candidate under development by Premas using its genetically engineered S. cerevisiae platform, D-Crypt, to recombinantly express the major structural proteins of the coronavirus. Under the terms of the agreement, Akers is acquiring Cystron Biotech LLC for a $1 million up-front payment, 622,756 shares of common stock or common stock equivalents and a royalty on net sales. It will make additional payments of cash and stock to the sellers of Cystron when certain milestones are achieved, along with a change of control. Akers is also required to make certain cash payments to Premas upon the achievement of additional milestones.
Aldeyra Therapeutics Inc., of Lexington, Mass., said it will begin screening its library of reactive aldehyde species inhibitors, including ADX-629 and reproxalap, for potential anti-inflammatory and antiviral activity in the treatment of COVID-19 infection. ADX-629 and reproxalap are structurally related to chloroquine and hydroxychloroquine, drugs currently in clinical testing for the treatment of COVID-19 infection. Both Aldeyra drugs have been shown to diminish inflammation in animal models of cytokine storm. Reproxalap has also demonstrated preliminary activity in a preclinical model of acute respiratory distress syndrome. The company also disclosed that it has submitted a proposal to the U.S. Biomedical Advanced Research and Development Authority for the development of ADX-629 for the treatment of COVID-19 infection. Shares of Aldeyra (NASDAQ:ALDX) gained 23%, or 43 cents, to close March 24 at $2.31.
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia, said it is developing its repurposed drug compound, NP-120 (ifenprodil), as a possible treatment for idiopathic pulmonary fibrosis (IPF), acute lung injury (ALI), chronic cough and coronavirus (COVID-19). The company intends to submit for ethics approval for a phase II trial for ifenprodil for IPF and chronic cough in Australia shortly. In addition, as a result of the data from an independent study showing the drug’s performance in an animal study for H5N1, the company has decided to expand its ifenprodil clinical trial program to include ALI, a specific form of injury with diverse causes, including influenza related pneumonia, and COVID-19.
Ampio Pharmaceuticals Inc., of Englewood, Colo., said it is preparing an expanded access FDA protocol to study the potential benefit of nebulized treatment with Ampion in SARS-Cov-2-induced acute respiratory distress syndrome. Ampion is a human blood-derived composition, currently approved for clinical use by the FDA as an anti-inflammatory, immunomodulating drug.
Atyr Pharma Inc., of San Diego, said its Hong Kong subsidiary, Pangu Biopharma Ltd., together with the Hong Kong University of Science and Technology, has been awarded a grant of approximately $750,000 to build a high-throughput platform for the development of bispecific antibodies. Initially the research focus will be on diseases, including cancer, in which neuropilin-2 overexpression is strongly implicated. The two-year project is being funded by the Hong Kong government’s Innovation and Technology Commission (ITC) under the Partnership Research program.
The Aurum Institute, of Johannesburg, South Africa, and its partners have announced that five high-burden tuberculosis (TB) countries, Cambodia, Ethiopia, Kenya, Malawi, South Africa and Zimbabwe, will roll out a new, shorter drug regimen (known as 3HP) to prevent TB. The previous standard of care, isoniazid preventive therapy (IPT), was long and complex, with people required to take a pill daily for six to 36 months. The 3HP regimen, taken only once a week for 12 weeks, offers numerous benefits for infected individuals, clinicians and programs.
Avectas Ltd., of Dublin, and Tampa, Fla.-based Vycellix Inc. signed a collaboration agreement to develop new approaches to address current limitations for cell-based immunotherapies. The companies will collaborate on the delivery of Vycellix's RNA immunomodulator VY-M using Avectas' cell engineering platform, Solupore. Studies will be conducted at Avectas' Dublin-based facility and at Karolinska Institutet, Stockholm.
Axim Biotechnologies Inc., of San Diego, said its subsidiary, Sapphire Biotech Inc., has completed preclinical drug studies on a new compound, SPX-1009, demonstrating 10 times greater potency than its parent compound, SBI-183, in inhibiting metastasis. It has proved to inhibit the enzymatic activity of quiescin sulfhydryl oxidase 1, an enzyme that is overexpressed by tumor cells in numerous cancers. In a non-metastatic xenograft of kidney cancer, SBI-183 suppressed primary kidney tumor growth by 51% and in a metastatic xenograft breast cancer model (MDA-MB-231-luc TNBC), SBI-183 reduced lung metastasis by 76% compared to control.
Bioinvent International AB, of Lund, Sweden, signed an agreement with Skylinedx BV, of Rotterdam, the Netherlands, to characterize the gene expression and immunological signatures in tumors of patients pre- and post-treatment with BI-1206. Together, the companies will research and develop predictive immunological signatures to help identify patients with non-Hodgkin lymphoma and solid cancers who are likely to show clinical responses if treated with the compound, Bioinvent's lead product candidate.
Carisma Therapeutics Inc., of Philadelphia, said preclinical findings outlined in a new article published in Nature Biotechnology indicate that its human chimeric antigen receptor macrophages (CAR-M), "could overcome the key challenges that cell therapies have encountered with solid tumors – limited trafficking to the tumor site, an immunosuppressive tumor microenvironment, and the heterogeneous expression of tumor-associated antigens." Its team is working toward an IND filing and developing operational plans with partners to initiate a phase I trial evaluating CT-0508, a HER2-targeted CAR-M.
Derm-Biome Pharmaceuticals Inc., of Vancouver, British Columbia, said one of its topical drugs produced "significant and dose-dependent inhibitory effects" in a mouse model of atopic dermatitis (AD). The compound both inhibits pro-inflammatory cytokine production and up-regulates anti-inflammatory mediators while "enhancing expression of proteins key to maintaining an effective skin barrier, the lack of which in skin is strongly linked to the development of AD," it said. A Canadian clinical trial application will be submitted by the middle of this year, with an IND application to follow, the company said.
Dynavax Technologies Corp., of Emeryville, and Chengdu, China-based Clover Biopharmaceuticals Inc. said they've formed a research collaboration to develop a vaccine candidate to prevent COVID-19. Clover is evaluating its protein-based coronavirus vaccine candidate, COVID-19 S-Trimer, in preclinical studies, while Dynavax is providing technical expertise and the company’s Toll-like receptor 9 agonist adjuvant, CpG 1018, to support the initiative. CpG 1018 is the adjuvant used in Dynavax's FDA-approved adult hepatitis B vaccine, Heplisav-B. Clover is also working on a recombinant subunit-trimer vaccine with Glaxosmithkline plc, of London.
Ethismos Research Inc., of Cambridge, Mass., said preclinical research published in Psychopharmacology reports that rats treated with the company's triple reuptake inhibitor, amitifadine, significantly reduced self-administration of the opioid drug remifentanil, without diminishing remifentanil’s analgesic effects. The company is planning a phase II program to evaluate amitifadine for opioid-sparing and facilitation of taper as an adjunct to opioids in patients with chronic noncancer pain.
Maxcyte Inc., of Gaithersburg, Md., said South San Francisco-based Allogene Therapeutics Inc. has gained rights to use Maxcyte's Flow Electroporation technology and Expert platform to develop and advance its AlloCAR T candidates through to commercialization. In return, Maxcyte will receive undisclosed development, approval and commercial milestones in addition to other licensing fees. The first two Allogene investigational therapies intended to utilize the technology are directed at CD19 and BCMA targets.
The U.S. Depart of Defense (DOD) has awarded Ology Bioservices Inc., of Alachua, Fla., an $11.9 million contract to work with Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., on DNA technology to manufacture Inovio’s DNA vaccine, INO-4800, to prevent infection from COVID-19 and deliver it for upcoming clinical trials. Ology is a privately held contract development manufacturing company. Ology received another DOD contract, this one for $14 million, to help Vanderbilt University develop and manufacture a monoclonal antibody for treating and preventing COVID-19 infection. The goal is to deliver the antibody to the DOD.
Ovoca Bio plc, of Dublin, said it plans to acquire the remaining shareholding in Ivix LLC, of Moscow, for about $5 million in cash. In September 2018, Ovoca acquired 50.02% of Ivix for about $4.1 million cash. In March 2019, Ovoca acquired nearly another 10% of the company for about $2 million. Ivix developed BP-101 for treating premenopausal women with hypoactive sexual desire disorder. The company said that in September 2019 it submitted a marketing authorization application for BP-101 with the Russian Ministry of Health. If approved, BP-101 could be available for marketing in the Russian Federation toward the end of 2020, the company added.
As part of the company’s strategy to achieve break-even for Jetrea (ocriplasmin), Leuven, Belgium-based Oxurion NV has entered a global commercial license agreement for the drug's distribution with Luxembourg-based Inceptua Group. Jetrea is approved for the treatment of symptomatic vitreomacular adhesion and vitreomacular traction. Financial terms of the deal were not disclosed.
Pieris Pharmaceuticals Inc., of Boston, said that after reviewing its portfolio, Les Laboratoires Servier SAS, of Suresnes, France, decided to adjust the collaboration between the two companies and focus on developing the two most advanced programs and discontinue developing two earlier-stage programs. Pieris and Servier will continue developing PRS-344/S095012, a 4-1BB/PD-L1 bispecific and the lead program in the collaboration. Pieris holds exclusive commercialization rights for PRS-344/S095012 in the U.S. and will receive royalties on ex-U.S. sales. The companies will also prioritize the development of PRS-352, a preclinical-stage program addressing undisclosed targets, and for which Servier has worldwide rights. Pieris is working to complete the non-GLP preclinical work for that program and expects to hand it over to Servier this year for IND-enabling activities. Pieris will retain all rights to the discontinued programs and will consider development and strategic options with regard to those programs upon reviewing the data generated as part of the collaboration.
Point Biopharma Inc., of Toronto, said it anticipates completing its search for a U.S. manufacturing site in the next quarter and will commit what it called “significant” capital funding to build a GMP pharmaceutical facility. Point launched in February with plans to develop radiopharmaceutical drugs. It anticipates the first pipeline candidate entering clinical trials in 2020.
Probiogen AG, of Berlin, said MD Anderson Cancer Center spin-out Immunogenesis Inc., of Houston, has signed a service agreement for cell line development, process development and GMP manufacturing for its lead immuno-oncology candidate, a bispecific monoclonal antibody. Financial terms were not disclosed.
Protokinetix Inc., of Marietta, Ohio, said it completed the sterilization, quality assurance and labeling of its glycopeptides for a clinical trial of PKX-001 for establishing patient safety of islet cells prior to transplantation into human test subjects. Protokinetix said it relies upon third-party suppliers and manufacturers in China to produce its glycopeptides. It also said it has sufficient quantities to last for the next two years.
Resverlogix Corp., of Calgary, Alberta, said it has shown apabetalone to inhibit specialized proteins –bromodomain and extraterminal domain proteins – from interacting with a SARS-CoV-2 viral protein, with potential for limiting viral reproduction in human cells. Resverlogix said it identified BRD2/4 as a binding partner of viral protein E. Apabetalone was shown to disrupt the interaction, the company said. Apabetalone is the company’s phase III candidate. Harnessing epigenetic modulation may slow COVID-19 virus spread and disease severity, the company said, adding that it is looking for collaborators with those who are testing drugs for COVID-19 in preclinical and clinical studies.
Santhera Pharmaceuticals AG, of Pratteln, Switzerland, said in its 2019 annual report that material uncertainties remain about its ability to continue as “a going concern” until Dec. 31, 2020. Santhera said it is evaluating different options to secure additional financing, including equity-based funding, debt financing, royalty financing, standby equity distribution agreement and monetizing receivables. At the annual general meeting on April 22, the board will propose the increase of authorized capital from CHF3 million (US$3.05 million) to CHF5.5 million and an increase of conditional capital from CHF 2.5 million to CHF 4.8 million.
Sorrento Therapeutics Inc., of San Diego, signed an exclusive license agreement with antibody biopharmaceutical company Mabpharm Ltd., of Taizhu, China, for the clinical development and commercialization of the ACE-MAB fusion protein (STI-4920/CMAB-020) for the potential treatment of COVID-19. Mabpharm has generated a fusion protein (CMAB-020) that binds to the spike protein of the SARS-CoV-2 virus. Designed as a bispecific fusion protein, ACE-MAB has two functional arms. One arm is a fully human antibody that targets the spike protein of SARS-CoV-2 with high affinity. The other arm is a truncated ACE2 protein that binds to a different epitope of the spike protein.
Triumvira Immunologics Inc., of Austin, Texas, and Lonza Group AG, of Basel, Switzerland, signed a collaboration aimed at the development of Triumvira's TAC01-HER2 T-cell therapy for treating solid tumors, and will leverage Lonza's expertise in process development and the usage of its Cocoon Platform. Within the collaboration, TAC01-HER2 will initially be tested in a phase I/II trial examining different HER2-overexpressing solid tumors.
Vero Biotech LLC, of Atlanta, said the first patient with COVID-19 infection complicating pulmonary hypertension has been treated with its inhaled nitric oxide delivery system, Genosyl DS, at home. The patient was treated under an emergency IND filed and approved by the FDA, Vero said.
Windtree Therapeutics Inc., of Warrington, Pa., said it is planning to study its KL4 surfactant to potentially mitigate the pulmonary effects of severe COVID-19 infection. The company is actively pursuing several nondilutive opportunities to fund that project, including government agencies and private foundations. Numerous preclinical studies have shown positive effects of the KL4 surfactant in various models of severe lung injury, and clinical studies have demonstrated beneficial effects in respiratory distress syndrome in premature infants, leading Windtree to believe there may be potential to provide benefit in patients with severe COVID-19 lung injury, the company said.