AGC Biologics A/S, of Soborg, Denmark, said it was selected for commercial manufacturing of Clevegen (bexmarilimab) for partner Faron Pharmaceuticals Oy, of Turku, Finland. Clevegen targets CLEVER-1-positive tumor-associated macrophages and converts them to immune-stimulating M1 macrophages for use alone or in combination with other cancer treatments. Financial terms were not disclosed.
Ajinomoto Bio-Pharma Services, of San Diego, said it inked a manufacturing services agreement with Cytodyn Inc., of Vancouver, Wash., to supply the CCR5 chemokine antagonist leronlimab (PRO-140), currently the subject of trials in mild to moderate and severe COVID-19 infection.
Amgen Inc., of Thousand Oaks, Calif., said the U.S. District Court in Delaware issued a decision upholding the validity of claims from three U.S. patents (Nos. 7,417,042, 7,737,112 and 8,207,125) that protect Amgen's multiple myeloma therapy, Kyprolis (carfilzomib), preventing Cipla Ltd., of Mumbai, and subsidiary Cipla USA Inc. from making, using, selling, offering to sell or importing its generic version of the drug until the latest patent expiry in December 2027. Amgen’s wholly owned subsidiary, Onyx Therapeutics Inc., brought a patent infringement suit against Cipla in 2016. The decision followed a bench trial in the Delaware court in May 2019. Kyprolis accounted for $1.1 billion in revenues in 2019, according to Cortellis Competitive Intelligence. On May 5, Amgen’s shares (NASDAQ:AMGN) gained $5.45, or about 2.4%, to close at $236.36.
Antengene Corp., of Shanghai, said it broadened its partnership and territory expansion agreement with Karyopharm Therapeutics Inc., of Newton, Mass., covering development and commercialization of four oral drugs and candidates. The agreement broadens Antengene's rights in the Asia Pacific region for the approved selective inhibitor of nuclear export (SINE) Xpovio (selinexor, ATG-010); eltanexor (ATG-016), a second-generation SINE compound; verdinexor (ATG-527), a lead compound in development for antiviral and other non-oncology indications; and KPT-9274 (ATG-019), a dual inhibitor of PAK4 and NAMPT. As part of the agreement, which expanded a strategic collaboration inked in May 2018, Antengene gained extended rights to develop, manufacture and commercialize Xpovio and eltanexor in Australia, New Zealand, South Korea, Taiwan, Hong Kong and the ASEAN markets, while KPT-9274 and verdinexor rights were extended to Australia and New Zealand. Financial terms were not disclosed. In March 2020, Karyopharm disclosed new phase III multiple myeloma (MM) data that showed a statistically significant increase in progression-free survival. Antengene is expanding its commercial operations to support the launch of Xpovio in mainland China and other APAC markets and conducting trials with the drug in China in relapsed/refractory MM, diffuse large B-cell lymphoma and T-cell lymphomas.
Atyr Pharma Inc., of San Diego, said two abstracts originally accepted for presentation at the 2020 ATS International Conference will be published in the ATS journal, American Journal of Respiratory and Critical Care Medicine. One abstract characterized the molecular basis for the immunomodulatory properties of ATYR-1923, including its ability to bind specifically and selectively to NRP2, and reported that ATYR-1923 was found to bind to cells that endogenously express NRP2 on the surface, such as THP-1 polarized M1 macrophages, suggesting that modulation of the NRP2 signaling pathway could be a therapeutic approach to immune-mediated diseases. The second abstract showed that NRP2 is expressed on key immune cells in inflammatory conditions, including sarcoidosis granulomas, reinforcing its status as a key target in treating immune-mediated diseases.
Azurrx Biopharma Inc., of New York, said Azurrx SAS, its wholly owned subsidiary in France, received approximately €661,000 (US$721,000 US) for its 2019 French research tax credit, or Crédit d’Impôt Recherche (CIR), marking the third CIR payment for Azurrx SAS in 2020. Azurrx said the CIR will be re-invested in the company’s ongoing European phase II combination trial of lipase modulator MS-1819 and the phase IIb Option 2 monotherapy trial to treat exocrine pancreatic insufficiency in individuals with cystic fibrosis, expected to begin in several weeks. Azurrx said receipt of the CIR funds, which were not expected until year-end, allow the company to return in full the loan received in April 2020 through the CARES Act Paycheck Protection Program.
Preclinical results from Biocardia Inc., of San Carlos, Calif., show improvements in heart function for subjects treated with the company’s allogenic neurokinin 1 receptor-positive mesenchymal stem cell (NK1R+ MSC) program for heart failure. In 26 animals treated with both low-dose and high-dose NK1R+ MSC, echocardiographic measures of cardiac ejection fraction, fractional shortening and cardiac outflow were meaningfully improved, with all three measures being statistically significant for both dosage levels over control animals. The company said it plans to submit an IND to use NK1R+ MSC delivered via intravenous infusion to treat acute respiratory distress syndrome caused by COVID-19. MSC has reduced inflammation and injury in models of lung disease.
Bio Science Group Ltd., of Hong Kong, and Swiss company Ypsomed Holding AG, of Burgdorf, Switzerland, agreed to co-develop a prefilled injection pen for Roskilde, Denmark’s Uni-Bio’s pipeline products. According to the agreement, Ypsomed’s Ypsopen drug delivery platform will be developed for Beijing BKJ’s glucagon-like peptide-1 (GLP-1) agonist and parathyroid hormone analogue (PTH), two new biologic products to treat diabetes and osteoporosis. Beijing BKJ will be responsible for further clinical trial development and will share Ypsopen-related clinical trial information with Ypsomed. Ypsopen is an approved product with the Chinese NMPA. The group said it will be the first company in China to launch GLP-1 and PTH product with Ypsopen.
Cohbar Inc., of Menlo Park, Calif., said it initiated testing of its CB-5064 analogues in preclinical models of acute respiratory distress syndrome (ARDS) to assess their potential as therapeutics for COVID-19-associated ARDS. In preclinical studies, the peptides demonstrated the ability to activate the apelin receptor, a cell signaling pathway that could reduce the severity of acute lung injury by reducing lung fluid accumulation, hypoxemia and cytokine secretion, which occur in COVID-19-associated ARDS and lead to downstream injury to the kidney, heart and other organs. The apelin receptor is broadly expressed and abundant in lung tissue.
Crescendo Biologics Ltd., of Cambridge, U.K., and Cancer Research UK began a partnership to drive Crescendo’s bispecific immunotherapy, CD-213, into the clinic. Cancer Research UK’s Centre for Drug Development will sponsor and fund a phase I trial for CB-213 in patients with solid tumors. Crescendo retains the right to further develop the CB-213 immunotherapy program by licensing the results of the trial from Cancer Research UK for an undisclosed amount, success-based milestones and royalty payments. CB-213, a bispecific PD-1 x LAG-3 antagonist, is a checkpoint inhibitor designed to treat patients with cancers resistant or refractory to PD-1 blockade alone. In preclinical testing, CB-213 demonstrated dual checkpoint blockade and the ability to enhance the activity of dysfunctional patient-derived T cells, the company said.
Cycle Pharmaceuticals Ltd., of Cambridge, U.K., and Medherant Ltd., of Coventry, U.K., agreed to develop and commercialize products using Medherant’s transdermal delivery technology to develop formulations addressing unmet needs such as dysphagia and dyskinesia. Cycle will be responsible for clinical development and registration and will commercialize products arising from the collaboration.
Data from two studies of FX-201 by Flexion Therapeutics Inc., of Burlington, Mass, yielded positive data regarding osteoarthritis treatment in a rat model and in developing a productive and reproducible manufacturing process. FX-201 is a locally administered gene therapy that uses a helper-dependent adenovirus vector designed to stimulate production of the anti-inflammatory protein interleukin-1 receptor antagonist whenever inflammation is present within the joint.
Genprex Inc., of Austin, Texas, granted the University of Texas MD Anderson Cancer Center the exclusive worldwide license to a portfolio of 16 patent applications and related technology to treat cancer using Genprex’s lead drug candidate and TUSC2 gene therapy, GEN-00, in combination with immunotherapies. Genprex was recently awarded FDA fast track designation to use Oncoprex combined with Tagrisso (osimertinib, Astrazeneca plc) to treat non-small-cell lung cancer (NSCLC) patients with EGFR mutations whose tumors progressed after treatment with Tagrisso alone. Genprex said it is preparing to file an IND to initiate a clinical trial of Oncoprex in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in NSCLC. The license agreement also provides for payment to MD Anderson of an up-front license fee and annual maintenance fees, with the potential for milestone payments, sublicensing fees and product royalties.
Hoth Therapeutics Inc., of New York, said it completed a strategic investment in Zylö Therapeutics Inc., of Greenville, S.C. The companies entered a partnership last year to develop a topical nanoparticle formulation of the endocannabinoid anandamide using Zylö’s extended-release Z-pods for cutaneous lupus erythematous.
Inmed Pharmaceuticals Inc., of Vancouver, British Columbia, said it's working with Craigavon, U.K.-based Almac Group Ltd. on ways to optimize cannabinoid manufacturing processes to achieve cost-efficient, GMP-grade active pharmaceutical ingredients for prescription-based medicines.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said a leading U.S.-based public health research institute with access to a Biosafety Level-3 lab will help it evaluate the immunomodulatory and antiviral properties of brilacidin in relation to COVID-19. Coronavirus-focused studies of the candidate, a small-molecule defensin peptidomimetic also in development for the potential treatment of bacterial infections, are also underway at a U.S. regional biocontainment lab, Innovation said.
Lineage Cell Therapeutics Inc., of Carlsbad, Calif, said it has applied for grant funding from the California Institute for Regenerative Medicine (CIRM) to support the use of VAC, its allogeneic dendritic cell therapy, toward the development of a potential vaccine against SARS-CoV-2. CIRM approved $5 million in emergency funding for COVID-19 research in March, funding its first clinical study for COVID-19 with an award of $750,000 to City of Hope, where John Zaia, director of the Duarte, Calif.-based hospital's center for gene therapy is testing blood plasma from recovered COVID-19 patients as a potential treatment for other patients with the virus.
Netris Pharma SAS, of Lyon, France, said it will evaluate its first drug candidate, NP-137, with Keytruda (pembrolizumab, Merck & Co. Inc.), in patients with locally advanced/metastatic uterine tumors. NP-137 targets netrin-1, which is overexpressed in more than two-thirds of uterine tumors. The phase Ib/II trial will enroll up to 240 patients and be divided into a phase Ib part to evaluate the safety, tolerability and pharmacokinetics/pharmacodynamics of the combination and/or chemotherapeutic agents. The phase II part will assess via randomization the clinical activity of the combination in both tumor types.
Ose Immunotherapeutics SA, of Nantes, France, said its team of immunologists is working on the development of a prophylactic vaccine against the pandemic virus SARS-CoV-2. The company is leveraging its expertise in the selection and optimization of peptides of interest and its GMP formulation for a specific type of combination of multiple peptides. Ose said it will use the know-how from its Memopi epitope (neoepitope) optimization technology, recently validated in the first step of phase III testing for Tedopi, a combination of antitumor neoepitopes, to increase the memory immune response of T lymphocytes against specific antigens. Ose also is collaborating with deeptech company Mabsilico to accelerate optimization of those neoepitopes and increase their immunogenicity capacity to induce robust T-cell memory immunity.
Preveceutical Medical Inc., of Vancouver, British Columbia, said it is working on developing a water-based cannabidiol sol-gel formulation and nasal applicator to reduce the possibility of coronavirus infections. It expects a formulation could be ready for testing in as little as four months.
Rafael Pharmaceuticals Inc., of Cranbury, N.J., said it has established a research collaboration with Roswell Park Comprehensive Cancer Center to evaluate the effects of CPI-613 (devimistat) with or without chemotherapy agents, including oxaliplatin/cisplatin/5-FU/carboplatin/taxol, on esophageal cancer cells.
Valneva SE, of Saint-Herblain, France, and Instituto Butantan in Sao Paulo, Brazil, a producer of immunobiologic products, signed a binding term sheet for the development, manufacturing and marketing of Valneva’s single-shot chikungunya vaccine, VLA-1553, in low- and middle-income countries (LMICs). The collaboration falls within the framework of the $23.4 million in funding Valneva received from the Coalition for Epidemic Preparedness Innovations in July 2019. The definitive agreements are expected to be finalized in the next six months. After the signing, Valneva will transfer its chikungunya vaccine technology to Instituto Butantan, which will develop, manufacture and commercialize the vaccine in LMICs and also provide certain clinical and phase IV observational studies that Valneva will use to meet regulatory requirements. The agreement will include small up-front and technology transfer milestones. Specific terms were not disclosed.
Vaxil Bio Ltd., of Ness Ziona, Israel, signed a collaboration agreement with The Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Medical Center to advance the company's research program to develop a potential peptide vaccine against COVID-19. The work "provides a clear pathway to potential clinical trials during 2020," said David Goren, Vaxil's chairman and CEO.
Zyversa Therapeutics Inc., of Weston, Fla., said the Journal of Neuroinflammation published data showing that inflammasome inhibitor IC-100 attenuates the inflammatory response causing neuronal damage in multiple sclerosis (MS), and that it improves functional outcomes. Data were collected in the experimental autoimmune encephalomyelitis mouse model of MS, which exhibits the key pathological features found in humans. Results showed that IC-100 penetrates the brain and spinal cord, and it reduces infiltration of CD4-positive and CD8-positive T cells and CD11b+MHCII+ activated myeloid cells into the spinal cord and decreases the number of total and activated microglia. That was associated with improvements in functional outcomes, as reflected by a robust reduction in MS clinical disease scores throughout the study, and a 50% reduction in the cumulative MS disease index, the company said.