The University of Texas MD Anderson Cancer opted to license Caspacide from Houston-based Bellicum Pharmaceuticals Inc. The Caspacide safety switch, also known as inducible Caspase-9, or iC9, is a binding domain coupled to the signaling domain of Caspase-9, an enzyme in the apoptotic, cell death pathway. If a patient experiences a serious side effect, an activator agent, rimiducid or temsirolimus, triggers dimerization and safety switch activation, leading to selective apoptosis of Caspacide-expressing cells. Under terms of the original license agreement, Bellicum will receive $5 million up front and undisclosed future milestone payments and royalties on sales. The license agreement with Bellicum covers using the Caspacide safety switch in MD Anderson’s CD19-directed chimeric antigen receptor natural killer cell construct.
Biovie Inc., of Santa Monica, Calif., plans to submit an amendment to its CMC package for FDA review and plans to test BIV-201 (continuous infusion terlipressin) prefilled syringes in a phase IIb/III trial. It received orphan drug designation to treat ascites, abnormal abdominal fluid build-up, in outpatient settings. Terlipressin, unavailable in the U.S. or Japan, is used as a lyophilized powder for reconstitution in hospital pharmacies in Europe and Asia.
CNS Pharmaceuticals Inc., of Houston, granted WPD Pharmaceuticals Sp. z o.o., of Warsaw, the rights to research, develop and manufacture or sell berubicin in an area composed mainly of Eastern Europe and Central Asia. CNS receives a 1% royalty on all commercial sales in the territory. WPD has a $2 million minimum expenditure on the development, testing, regulatory approval and commercialization of Berubicin during the agreement’s three-year term.
Correvio Pharma Corp., of Vancouver, British Columbia, said it is seeking strategic alternatives that include an acquisition, merger, business combination or other transaction regarding the company or its assets. In a Dec. 10 advisory committee meeting, the FDA’s Cardiovascular and Renal Drugs Advisory Committee, having reviewed the company’s NDA, decided the benefit-risk profile of Brinavess (vernakalant I.V.) for atrial fibrillation conversion, was inadequate to support approval. Correvio intends to reduce operating costs in North America while concentrating on other commercial and business development activities. The company retained Piper Jaffray to review strategic alternatives.
Forendo Pharma Ltd., of Turku, Finland, said it signed a license and collaboration agreement with Basel, Switzerland-based Novartis AG focused on the discovery and development of drugs for chronic liver diseases. In exchange for an up-front payment and equity investment from Novartis, Forendo will grant the company an exclusive global license to candidates generated under the collaboration. Further financial details were not disclosed.
Genedit Inc., of Berkeley, Calif., granted Editas Medicine Inc., of Cambridge, Mass., an exclusive worldwide license, with rights to sublicense, to Genedit’s Cpf1-based technologies. Genedit receives undisclosed up-front and development milestone payments, including royalties on net sales of products incorporating the licensed intellectual property. Editas will provide research funding with an option to continue development after the initial collaboration period.
Foster City, Calif.-based Gilead Sciences Inc.-owned Kite Pharma Inc. and Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda, have agreed to collaborate on conducting a phase II study of mavrilimumab, an investigational fully human monoclonal antibody that targets granulocyte macrophage colony-stimulating factor receptor alpha, in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma. The objective of the study is to determine the effect of mavrilimumab on the safety of Yescarta. Santa Monica, Calif.-based Kite will sponsor and run the study.
Intec Pharma Inc., of Jerusalem, terminated its feasibility and option agreement with Novartis AG, of Basel, Switzerland, to develop an Accordion Pill for a Novartis compound. Intec’s Accordion Pill is an oral drug designed to improve the efficacy and safety of existing drugs and drugs in development using a gastric retention and specific release mechanism. Novartis, following an internal and revised commercial strategic assessment, told Intec the program no longer meets Novartis' needs. Novartis agreed to pay Intec $1.5 million when the program concluded. The drug and therapeutic area were not disclosed.
Indivior plc, of Slough, U.K., disclosed a research collaboration with Virginia Tech extending the RECOVER (Remission from Chronic Opioid Use Studying Environmental and Socio-Economic Factors on Recovery) Study. RECOVER is a multisite, noninterventional cohort study examining long-term recovery in individuals with moderate to severe opioid use disorder who received at least one dose of study treatment during the Sublocade (buprenorphine extended-release, Indivior plc) phase III trials. The study will be led by a team of researchers at the Fralin Biomedical Research Institute at Virginia Tech Carilion.
LNC Therapeutics SA, of Bordeaux, France, established a research partnership with the Paris-based National Institute for Agricultural Research to study relationships between the gut microbiome and inflammatory diseases. The company said it intends to harness the potential of beneficial bacteria such as Christensenella by developing single strain live biotherapeutic products to treat patients suffering from inflammatory diseases.
Neoimmunetech Inc., of Rockville, Md., said it will work with a subsidiary of Kenilworth, N.J.-based Merck & Co. Inc. to evaluate the combination of the company's long-acting human IL-7 candidate, Hyleukin-7, and Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in a basket study in patients with relapsed/refractory advanced solid tumors. The goal of the phase Ib/IIa study is to establish a recommended dosing regimen and explore the preliminary antitumor activity of the combination in patients with both checkpoint inhibitor (CPI)-treated and CPI-naïve relapsed/refractory tumors.
Novelion Therapeutics Inc., of Vancouver, British Columbia, said a hearing date has not yet been scheduled for consideration of its application materials, filed with the Supreme Court of British Columbia, relating to court orders sought by the company in connection with its voluntary liquidation and dissolution.
Proteostasis Therapeutics Inc., of Boston, said that early results of its ex vivo test of cystic fibrosis transmembrane conductance regulator (CFTR) modulators, PTI-801, PTI-808 and PTI-428, in people with CF ineligible for current standard-of-care CFTR modulator therapies, support plans to enroll responders into a new trial, slated to start in mid-2020. The new trial is designed to evaluate translation of organoid ex vivo response to potential clinical benefit, such as changes in FEV1 and sweat chloride.
Quantum Genomics, of Paris, and São Paulo, Brazil-based Biolab Sanus Pharmaceutical have struck an exclusive licensing and collaboration agreement to develop and commercialize firibastat. This is the first regional partnership for Quantum Genomics. Under the terms of the agreement, Biolab Sanus will receive exclusive commercialization rights to firibastat for the treatment of arterial hypertension in Latin America. Quantum Genomics will receive up-front and milestone payments amounting up to $21.2 million, plus royalties on sales. Biolab Sanus will fund part of a phase III study for the drug in difficult-to-treat/resistant hypertension in Latin America as part of the overall pivotal phase III trial led by Quantum Genomics.
Retrogenix Ltd., of High Peak, U.K., and Resonant Therapeutics Inc., of Cambridge, Mass., entered a nonexclusive strategic partnership to identify the targets of Resonant antibodies directed against the tumor microenvironment. Resonant exploits its Impact tumor microenvironment models and data platform to discover unappreciated targets and functionally active antitumor antibodies for difficult-to-treat tumors, the company said. By recapitulating the tumor microenvironment and using a live-cell, function-first approach, the platform generates therapeutic candidates that would not be discovered by other methods with more speed.
Transgene SA, of Strasbourg, France, and Bioinvent International AB, of Lund, Sweden, disclosed results from extensive in vitro and in vivo preclinical studies with BT-001, an oncolytic virus expressing an anti-CTLA4 antibody and the cytokine GM-CSF. BT-001 is being co-developed by the firms. It was generated using Transgene’s Invir.IO platform and its patented large capacity VVcopTK-RR-oncolytic virus, which has been designed to encode for a Treg-depleting anti-CTLA4 antibody derived from Bioinvent’s n-CoDeR/F.I.R.S.T. platforms as well as the cytokine GM-CSF. The therapeutic activity was assessed in several immunocompetent preclinical models, showing outstanding antitumoral activity for BT-001 murine surrogate antibody-encoding viruses, conferring cures in a majority of mice transplanted with different solid cancer tumors (>70% in all tested models), the companies said.
Twist Bioscience Corp., of South San Francisco, disclosed an expanded antibody optimization collaboration with Pandion Therapeutics Inc., of Cambridge, Mass. Based on the successful completion of its first project for Pandion, Twist Biopharma, a division of Twist Bioscience, will apply its antibody optimization platform to additional Pandion antibodies. Pandion is developing modular biologics and antibodies for autoimmune regulation that are designed to achieve lasting therapeutic outcomes for patients with autoimmune and inflammatory diseases.
WPD Pharmaceuticals Sp. z o.o., of Warsaw, was awarded a $5.8 million nondilutive grant from the EU/Polish National Center National Center for Research and Development to study the anthracycline berubicin, which is designed to damage the DNA of targeted cancer cells by interfering with topoisomerase II, an enzyme enabling cell proliferation. WPD plans to enter a phase I study determining the maximum tolerated dose of berubicin and also phase Ib and phase II trial in adults.