Abveris Inc., of Canton, Mass., said it agreed to partner with startup Saccharo Inc., of San Francisco, to discover monoclonal antibodies that will advance Saccharo’s therapeutic pipeline. Abveris will perform services using its Diversimab mouse model in combination with its B-cell screening platform. A portion of Abveris’ compensation will come in the form of equity in Saccharo.
Adamas Pharmaceuticals Inc., of Emeryville, Calif., said it agreed to settle ongoing patent litigation with Osmotica Pharmaceutical US LLC, a subsidiary of Osmotica Pharmaceuticals plc, of Dublin, with both parties dropping their respective claims and Adamas set to acquire global rights to Osmotica’s Parkinson’s disease agent, Osmolex ER (amantadine extended release), for $7.5 million. The agreement is expected to close early in 2021. In conjunction with the settlement, Adamas said it agreed to amend certain terms of its royalty-backed loan agreement with Healthcare Royalty Partners, with repayment from a royalty on Osmolex ER provided on the same terms as, and in addition to, the royalty for its internal Parkinson’s disease asset, Gocovri (amantadine extended release). A potential royalty rate step-up to 17.5% that would have occurred in 2022 if cumulative payments did not reach minimum specified levels by Dec. 31, 2021, was eliminated, but the 22.5% royalty rate step-up linked to cumulative payments at Dec. 31, 2022, remains. Certain prepayment provisions were revised, and the maturity date was extended to March 31, 2027. The amendment also added a covenant requiring Adamas to maintain minimum cash and investments of $25 million through the term of the royalty-backed loan. The amendment will take effect when the Osmolex ER acquisition closes.
Aicuris Anti-infective Cures GmbH, of Wuppertal, Germany, said it received approval from Germany’s Federal Institute for Drugs and Medical Devices to initiate a compassionate use program for pritelivir to treat immunocompromised patients who have acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections plus foscarnet resistance or intolerance. Aicuris is preparing a pivotal phase III trial with the DNA primase inhibitor in immunocompromised patients whose HSV infections are resistant to acyclovir.
Aptevo Therapeutics Inc., of Seattle, said it expanded its Adaptir bispecific platform technology to include a multispecific platform called Adaptir-Flex. Its first bispecific candidate, APV-O442, to use the Adaptir-Flex technology is a T-cell engager targeting prostate-specific membrane antigen and CD3 targeting prostate cancer.
Atbtherapeutics NV, of Marche-en-Famenne, Belgium, said it formed a long-term manufacturing agreement with Ibio CDMO, a unit of Ibio Inc., of Newark, Del., to industrialize the GMP manufacturing process of its atbodies, whose technology leverages plant expression systems. Each atbody is composed of an antibody that delivers a peptide payload that is unloaded into a target cancer cell following a peptide linker cleavage. The antibody-based therapy is in development to treat hematological malignancies and solid tumors. The partnership covers manufacturing of programs for preclinical and clinical trials.
Biocardia Inc., of San Carlos, Calif., noted a study published in Cardiovascular Revascularization Medicine that analyzed the safety of delivery systems in a meta-analysis of 1,789 patients who underwent transendocardial injections. Biocardia's Helix system had a serious event rate of 1.1%, compared to 3.3% for an electro-anatomically tracked straight needle, 7.1% for a straight needle without tracking elements and 8.3% for a curved needle. Biocardia is using the Helix system in its pivotal phase III testing the infusion of Biocardia’s Cardiamp cell therapy to the myocardium.
Endo International plc, of Dublin, said it completed its acquisition of Biospecifics Technologies Corp., of Lynbrook, N.Y., for $88.50 per share in an all-cash transaction. The estimated enterprise value was approximately $540 million, net of approximately $120 million in cash acquired.
Exelixis Inc., of Alameda, Calif., said it exercised its exclusive option for South San Francisco-based Iconic Therapeutics Inc.’s lead oncology antibody-drug conjugate (ADC) program under the companies’ May 2019 agreement, which also included Zymeworks Inc., of Vancouver, British Columbia. Exelixis now has clinical development, commercialization and manufacturing duties of the tissue factor (TF)-targeting ADC XB-002 (formerly ICON-2). XB-002 comprises a TF-targeting antibody with Zymeworks’ linker-payload, creating potential for an improved therapeutic index and favorable safety profile as compared to earlier-generation, TF-targeting ADCs. Exelixis also said it plans to initiate a phase I trial of XB-002 in early 2021.
Global Blood Therapeutics Inc., of South San Francisco, said it initiated an early access program for voxelotor in Europe and other regions outside the U.S. to treat hemolytic anemia in sickle cell disease (SCD) in patients 12 and older. Oral, once-daily voxelotor inhibits hemoglobin polymerization, the root cause of sickling and destruction of red blood cells in SCD. Voxelotor is approved in the U.S. as Oxbryta for treating SCD in patients 12 and older. Global Blood said it plans to seek regulatory approval to treat hemolytic anemia in SCD in patients 12 and older in Europe.
New data from Hepion Pharmaceuticals Inc., of Edison, N.J., showed that its lead candidate, CRV-431, a cyclophilins inhibitor, decreased formation of a novel class of human blood platelets called procoagulant platelets. High levels of procoagulant platelets have been associated with transient ischemic attack and stroke, the company said. Human blood platelets were collected from eight human donors and activated with collagen and thrombin to simulate propagation phase of blood clotting. CRV-431 decreased membrane exposure of phosphatidylserine, a marker of procoagulant platelets, by up to 49% (mean 29% reduction; p<0.001), the company added.
Ionis Pharmaceuticals Inc., of Carlsbad, Calif., earned a $20 million milestone payment from Astrazeneca plc, of Cambridge, U.K., for the start of a phase IIb study in patients with dyslipidemia testing ION-449 (AZD-8233), an antisense drug targeting proprotein convertase subtilisin/kexin type 9.
Janssen Pharmaceuticals Inc., of Raritan, N.J., said it acquired rights to privately held Waltham, Mass-based Hemera Biosciences LLC's investigational gene therapy, HMR-59, administered as a one-time, outpatient, intravitreal injection to help preserve vision in patients with geographic atrophy, a late-stage and severe form of age-related macular degeneration. Financial terms were not disclosed. HMR-59 is designed to increase the ability of retina cells to make a soluble form of the protein CD59, helping prevent further damage to the retina.
Kancera AB, of Solna, Sweden, said Grünenthal GmbH, of Stolberg, Germany, will terminate the parties' research and option agreement. Since the end of 2018, Grünenthal has been responsible for developing Kancera's series of HDAC6 inhibitors. Kancera said it will take over rights to all results generated under the agreements, including new and further developed HDAC6 inhibitors that are protected by Kancera's two patent applications. HDAC6 is an enzyme involved in the control of how the internal fibers of immune cells work and how these cells transport proteins and migrate through the body to induce inflammation.
Nabriva Therapeutics plc., of Dublin, said it will effect a 1-for-10 reverse stock split of its outstanding ordinary shares on Nasdaq for trading Dec. 3. The company stock trades under the symbol NBRV. Nabriva is developing anti-infective agents to treat serious infections.
Neurotrope Inc., of New York, and privately held Metuchen Pharmaceuticals LLC, of Manalapan Township, N.J., said they completed their merger. Neurotrope shareholders also approved the spin-off of substantially all of Neurotrope's existing assets, operations and liabilities, except for certain cash retained in accordance with the terms of the merger agreement, into a separately traded public company. Neurotrope and Metuchen have merged in an all-stock transaction forming a newly traded holding company named Petros Pharmaceuticals Inc. Its shares are traded on Nasdaq under the ticker symbol PTPI.
Pharmacyte Biotech Inc., of Laguna Hills, Calif., completed nine-month product stability tests for its pancreatic cancer treatment, Cypcaps. The IND for a clinical trial of Cypcaps is currently under FDA review.
Puma Biotechnology, Inc., of Los Angeles, prevailed in the final appeal brought against its European patent covering the use of irreversible EGFR inhibitors in treating gefitinib- and/or erlotinib-resistant cancer and cancer with a T790M EGFR mutation. The European Board of Appeals rejected the opposition patent initiated by a Boehringer Ingelheim GmbH, of Ingelheim, Germany.
Qualigen Therapeutics Inc., of Carlsbad, Calif., completed the recertification of its supply of AS-1411. The company has started the final formulation and filling of the drug for a phase IIa trial of AS-1411 as a treatment for COVID-19, which is scheduled to start in the first half of 2021.
Regent Pacific Group Ltd., of Hong Kong, will receive a $800,000 payment from Wanbang Pharmaceutical Marketing and Distribution Co. Ltd., a unit of Shanghai Fosun Pharma Group Co. Ltd., of Shanghai, for the submission of an IND for Senstend to China's National Medical Products Administration.
Regulus Therapeutics Inc., of La Jolla, Calif., will use Proteinsimple and Exosome Diagnostics from Bio-Techne Corporation, of Minneapolis, to test levels of polycystin 1 and polycystin 2 in patients enrolled in its clinical trials testing RGLS-4326 as a treatment for autosomal dominant polycystic kidney disease.
Sterotherapeutics LLC, of Spring House, Pa., signed a cooperative research and development agreement with Eunice Kennedy Shriver National Institute of Child Health and Human Development to complete a phase II study testing dehydroepiandrosterone in patients with Cushing syndrome.
Tetra Bio-Pharma Inc., of Ottawa, Ontario, completed IND-enabling toxicology studies for ARDS-003, a synthetic cannabinoid-derived therapeutic, designed to treat the inflammatory response that is associated with COVID-19, sepsis, septic shock and other diseases.
Therapix Biosciences Ltd., of Tel Aviv, Israel, is collaborating with the University of Calgary to test the analgesic effect of Therapix's THX-160, a CB2R agonist.
Tubulis GmbH, of Munich, has contracted STA Pharmaceutical Co. Ltd., a subsidiary of Wuxi Apptec Co. Ltd., of Shanghai, and Wuxi Biologics, of Shanghai, to scale up manufacturing of Tubulis' antibody-drug conjugate drugs. STA will focus on the linker and payload and Wuxi Biologics will work on the monoclonal antibody and the enzyme used in Tubulis' Tub-tag technology. The companies will start with TUB-010, which is being developed for lymphoma.
Zymeworks Inc., of Vancouver, British Columbia, will receive a $10 million payment from Beigene Ltd., of Beijing, for the start of a phase IIb study in South Korea of its bispecific antibody targeting HER2, zanidatamab, in patients with advanced or metastatic HER2-amplified biliary tract cancer.