Allogene Therapeutics Inc., of South San Francisco, and The University of Texas MD Anderson Cancer Center disclosed a five-year collaboration agreement for the preclinical and clinical investigation of AlloCAR T candidates across Allogene’s portfolio of hematologic and solid tumors. MD Anderson and Allogene will team up on the design and conduct of preclinical and clinical studies with oversight from a joint steering committee. Allogene will provide funding, developmental candidates and other support. Responsibility for regulatory filings will be agreed upon by the joint steering committee.
Amag Pharmaceuticals Inc., of Waltham, Mass., formally requested a public hearing in response to the FDA proposal to withdraw its approval of Makena (progestin), the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth. Makena was approved in 2011 on the basis of the first trial with the product. A second, FDA-required trial called Prolong predominantly enrolled women outside of the U.S., in countries with markedly lower rates of preterm birth. The Prolong trial did not show a difference between treatment and vehicle arms with respect to preterm birth or neonatal outcome. However, maternal and fetal safety was re-affirmed. Separately, Covis Group S.à r.l., of Luxembourg, commenced a cash tender offer to purchase all of the outstanding shares of common stock of Amag, under a merger agreement disclosed Oct. 1.
Antlia Bioscience Inc., of San Diego, and XL-protein GmbH, of Freising, Germany, said they inked an alliance to use XL-protein's Pasylation technology for plasma half-life extension to develop a novel, long-acting, peptide therapeutic treatment for chronic heart failure. Financial terms of the agreement have not been disclosed.
Apellis Pharmaceuticals Inc., of Waltham, Mass., said observational study results found a correlation between COVID-19 severity and complement overactivation, which is a key immune response. Additionally, preliminary open-label safety data from six patients in a phase I/II study support advancement of APL-9, an investigational targeted C3 therapy designed for acute interventions, for severe COVID-19. The results also showed that key markers of inflammation were within or near normal range at the end of the APL-9 treatment period.
Astellas Pharma Inc., of Tokyo, through a subsidiary and Iota Biosciences Inc., of Berkeley, Calif., entered a merger agreement pursuant to which Astellas will acquire Iota, a 2017 bioelectronics startup. Iota’s technology uses ultrasound both to power the devices and to enable wireless communication, which has resulted in the ability to develop unprecedentedly ultra-small (millimeter-sized) battery-free, wireless implantable medical devices. Since the two firms signed an R&D agreement last year, they have advanced joint research and development by leveraging respective strengths of the parties. Clinical trials of multiple projects, including those under the R&D agreement, are expected to start in the early 2020s. Under the terms of the merger deal, Astellas will make an initial payment of about $127.5 million to acquire all of the outstanding equity in Iota not already held by Astellas. Iota’s shareholders (other than Astellas) will be eligible to receive additional payments of up to a total of about $176.5 million upon achievement of predetermined milestones by Iota within certain timeframes after completion of the transaction. Upon completion of the transaction, Iota will become a wholly owned subsidiary of Astellas. The deal is set to close next year. Astellas said it is also committing to spend a total of $125 million over the next five years to fuel Iota’s expansion.
Entos Pharmaceuticals Inc., of Edmonton, Alberta, launched its U.S.-based spinout company, Aegis Life Inc., focused on the development, manufacturing and global distribution of novel DNA vaccines using Entos’ Fusogenix technology. The most advanced program is a DNA vaccine designed to generate durable immunity against SARS-CoV-2, and Aegis is pursuing U.S. and international investment to support rapid development of its lead vaccine candidate.
Gemini Therapeutics Inc., of Cambridge, Mass., and FS Development Corp., of San Francisco, signed a merger agreement. Upon closing of the transaction, the company will be renamed Gemini Therapeutics Inc., and will be led by Jason Meyenburg, CEO of Gemini. The combined company’s common stock is expected to be listed on Nasdaq. In addition to the approximately $121 million held in FS’s trust account (assuming no redemptions are effected), a group of health care investors has committed to participate in the transaction through a common stock private investment in public equity (PIPE) of about $95 million at $10 per share. Investors in the PIPE include lead investor Foresite Capital, an affiliate of FS’s sponsor, and others.
Insilico Medicine HK, of Hong Kong, said Taisho Pharmaceutical Co. Ltd., of Tokyo, signed a research collaboration to identify novel therapeutics against aging. Insilico will utilize both the target discovery and generative chemistry parts of its Pharma.AI platform. It will also deploy its Pandomics Discovery Platform to identify novel targets for senolytic drugs and Chemistry42 platform for a molecular generation. Insilico will receive an up-front payment and milestone payments upon achievement of specified goals.
Mallinckrodt plc, of Dublin, received approvals from the U.S. Bankruptcy Court for the District of Delaware for its "first day" motions related to the company' s voluntary Chapter 11 petitions filed on Oct. 12. With the interim approvals, the company can access and use balance sheet cash to fund its operations, continue to pay employee wages and benefits without interruption, donor prepetition obligations owed to customers, such as chargebacks and rebates, and more, Mallinckrodt said.
Meabco Inc., of Chicago, said BP-C2, which is being developed as a radioprotective and radiomitigative agent with applications in oncology and public health preparedness, protected mice when administered 24 hours following lethal radiation exposure. The results expand the relevance and applicability of BP-C2 to severe, radiation-induced gastrointestinal acute radiation syndrome, the company said. BP-C2, a lignin-derived polyphenolic composition with ammonium molybdate, is also being developed to treat cutaneous radiation injury.
Mirum Pharmaceuticals Inc., of Foster City, Calif., said it will partner with Eversana Life Science Services LLC to lead the U.S. market access, distribution and patient services for maralixibat, a minimally absorbed, orally administered apical sodium dependent bile acid transporter inhibitor being evaluated to treat cholestatic pruritus in patients with Alagille syndrome. Mirum said it initiated a rolling NDA to the FDA in August, that it expects to complete the NDA in the first quarter of 2021 and is preparing for launch in the second half of 2021.
Oncopep Inc., of Boston, said it signed a licensing agreement to use Watertown, Mass.-based Mana Therapeutics Inc.’s platform for developing an autologous multitumor antigen adoptive T-cell therapy to treat multiple myeloma and solid tumors as an additional T-cell-focused immunotherapeutic for its product pipeline.
The National Comprehensive Cancer Network Oncology Research Program said it plans to evaluate neratinib, a type of tyrosine kinase inhibitor that works as a dual inhibitor of the epidermal growth factor receptor 1 and human epidermal growth factor receptor 2. The research funding is supported by a $2 million grant from Puma Biotechnology Inc., of Los Angeles. Projects may include preclinical, translational and clinical trials for treating pediatric tumors, and early stage and metastatic breast cancer.
Preclinical data of MRT-5500, an mRNA-based vaccine candidate against SARS-CoV-2 from Sanofi Pasteur, of Paris, and Translate Bio Inc., of Lexington, Mass., demonstrated a favorable immune response profile. The main findings of the preclinical studies demonstrated the potential of MRT-5500 to elicit neutralizing antibodies against SARS-CoV-2. A phase I/II trial is anticipated to begin in the fourth quarter of 2020, the companies said.
Science 37, of Los Angeles, and Signant Health said they will collaborate to strengthen capabilities for decentralized or virtual CNS clinical research. By bringing research to patients at home, the partnership said it will ease the participation burden typical of a traditional study and enable telepsychiatry services for a growing therapeutic market. Science 37's network of patients, telemedicine investigators, central raters, mobile nurses and technology platform will orchestrate decentralized clinical trials, while Signant brings electronic clinical outcomes assessment software.
Surrozen Inc., of South San Francisco, said it was awarded a U.S. NIH grant to support development of SZN-043, a liver-targeted regenerative antibody. The NIH grant is titled "A hepatocyte-specific R-spondin mimetic bispecific fusion protein to stimulate hepatocyte regeneration in patients with acute alcoholic hepatitis." The federal grant amount is $1 million for the first year. An additional potential $2 million in grants may be awarded over the subsequent four years subject to the availability of funds and progress of the project.
Tenax Therapeutics Inc., of Morrisville, N.C., (formerly Oxygen Biotherapeutics Inc.), said it entered an amendment to the existing licensing agreement with Orion Corp., of Espoo, Finland, to include the rights to develop and commercialize in the U.S. and Canada an oral formulation of levosimendan for use with type 2 pulmonary hypertension in heart failure patients with preserved ejection fraction (PH-HFpEF), or other pulmonary hypertension or heart failure-related indications. The amendment allows Tenax to access all of the manufacturing, preclinical and clinical data generated on oral levosimendan to support its use. The company recently completed a phase II study in PH-HFpEF using an intravenous formulation of levosimendan, which the company has exclusive development and commercialization rights to in the U.S. and Canada under the existing license agreement. Tenax now plans to utilize the oral formulation in its upcoming phase III trial in PH-HFpEF.
Titan Pharmaceuticals Inc., of South San Francisco, disclosed a restructuring it said will position it for future growth. Moves include a focus on Proneura-based product development, specifically a kappa opioid receptor agonist and nalmefene, while discontinuing U.S. sales of Probuphine (buprenorphine) and winding down Probuphine commercialization activities. While there will be costs in the near term associated with the wind down of commercial operations and Titan's transition back to a development-stage company, the firm said the change is expected to result in a lower operating cash burn moving forward. Also, in support of its efforts to continue as a research and development company, Titan is in negotiations to eliminate its outstanding debt, which is secured by a lien on all of its assets. The company also reported that its current executive chairman, Marc Rubin, will assume the position of chairman and CEO, taking over from Sunil Bhonsle, who expressed his desire to retire in August. The firm’s current executive vice president and chief scientific officer, Kate Beebe DeVarney, will be appointed president and chief operating officer.
Tonix Pharmaceuticals Holding Corp., of Chatham, N.J., said the first participant was enrolled in the observational Precision (TNX-C002) trial, to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T-cell and antibody responses to SARS-CoV-2. The research encompasses two projects. The study led by Ilya Trakht, associate research scientist at Columbia University Vagelos College of Physicians and Surgeons, has the potential to lead to the isolation and characterization of therapeutically relevant fully human monoclonal antibodies to SARS-CoV-2. The study led by Sergei Rudchenko, assistant professor of medical sciences at Columbia University Vagelos College of Physicians and Surgeons, is designed to generate DNA aptamer-based anti-idiotypes to selected monoclonal antibodies identified in Trakht’s study. Such aptamers have the potential to identify biomarkers for protective CoV-2 immunity and may lead to accelerated precision medicine-driven vaccines designed to protect against COVID-19, the company said.