PRNewswire | August 08, 2023
Astellas Pharma Inc. and Poseida Therapeutics, Inc. announced a strategic investment to support the advancement of Poseida's commitment to redefining cancer cell therapy.
Under the terms of the transaction agreements, Astellas will invest a total of $50 million, including $25 million to acquire 8,333,333 shares of common stock of Poseida (approximately 8.8% of the outstanding common stock of Poseida) at $3.00 per share in a private placement and a one-time $25 million payment for a right of exclusive negotiation and first refusal to license one of Poseida's clinical stage programs: P-MUC1C-ALLO1, an allogeneic CAR-T cell therapy in development for multiple solid tumor indications. In addition, Poseida has granted Astellas a board observer seat, which includes the ability to attend Poseida's scientific advisory board meetings, and certain notice rights related to any potential change of control of Poseida.
Astellas has established the Focus Area Approach for its research and development strategy. One of Astellas' Primary Focuses within the strategy is immuno-oncology. Astellas is committed to developing next-generation immuno-oncology drugs using multi-functional platforms. Its portfolio includes oncolytic viruses, bispecific immune cell engagers, small molecules, and cell therapy platforms.
Poseida is engaged in the research and development of cell and gene therapies for cancer and rare genetic diseases by leveraging its proprietary genetic editing platforms. In oncology, Poseida has a broad pipeline of allogeneic CAR-T cell therapy product candidates for both solid and liquid tumors, including P-MUC1C-ALLO1, which is in Phase 1 development for the treatment of multiple solid tumor indications.
"By leveraging our extensive expertise, experience in cancer biology and unique technologies, we are focused on reinvigorating the immune system's ability to discover, disarm and destroy cancers in more patients. We are pursuing this ambitious goal through innovative and multifunctional modality platforms, using the capabilities at our global R&D sites as well as through partnership with external expert partners," said Adam Pearson, Chief Strategy Officer, Astellas. "We believe that this investment fits strategically with our long-term vision of expanding our capability in immuno-oncology and will ultimately lead to the development of new therapeutics for patients in need of cancer immunotherapy."
"We are excited to enter this strategic relationship with Astellas, a premier biopharmaceutical company that shares our long-term vision that cell and gene therapies represent an exciting growth area for the development of innovative medicines for improving patient care," said Mark Gergen, Poseida's Chief Executive Officer. "This investment further validates the potential of our proprietary genetic engineering technology platform and cell therapy approach, and we look forward to working with Astellas to advance our shared vision and explore future opportunities for collaboration to further unlock that potential."
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in Phase 1 development for multiple solid tumor indications. Poseida believes P-MUC1C-ALLO1 has the potential to treat a wide range of solid tumors derived from epithelial cells, such as breast, ovarian, colorectal, lung, pancreatic and renal carcinomas, as well as other cancers expressing a cancer-specific form of the Mucin 1 protein, or MUC1-C. P-MUC1C-ALLO1 is designed to be fully allogeneic, with genetic edits to eliminate or reduce both host-vs-graft and graft-vs-host alloreactivity. Poseida has demonstrated the elimination of tumor cells to undetectable levels in preclinical models of both breast and ovarian cancer. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT05239143.
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. Astellas is promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, Astellas is also looking beyond its foundational Rx focus to create Rx+® healthcare solutions that combine its expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients.
About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases. Poseida's pipeline includes allogeneic CAR-T cell therapy product candidates for both solid and liquid tumors as well as in vivo gene therapy product candidates that address patient populations with high unmet medical need. Poseida's approach to cell and gene therapies is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER Site-Specific Gene Editing System and nanoparticle and hybrid gene delivery technologies. Poseida has formed a global strategic collaboration with Roche to unlock the promise of cell therapies for patients.
Businesswire | July 11, 2023
Melinta Therapeutics, LLC a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics currently FDA-approved for adults, BAXDELA® (delafloxacin) and VABOMERE® (meropenem and vaborbactam), for use in pediatrics. In addition, Melinta and BARDA will partner on the development of BAXDELA® against biothreat pathogens. Under this contract, BARDA has awarded $20.5M for the base period, with the potential of additional funding of $121.4M, amounting to total funding up to $141.9M if all options are exercised. With this BARDA funding, Melinta aims to submit four supplemental New Drug Applications (sNDAs) for these new indications.
BARDA is part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response. This partnership may enable BAXDELA® and VABOMERE® to be integrated into national preparedness efforts as well as pediatric care for multi−drug-resistant bacterial infections, enhancing sustained availability of the products, increasing end-user familiarity, and striving for availability for the US pediatric population.
"I am thrilled and honored that BARDA and Melinta have agreed to partner for this important research marking a significant milestone in our journey toward becoming legendary for providing innovative therapies to people impacted by acute and life-threatening illnesses,” said Christine Miller, Melinta President and CEO. “This contract fuels our excitement to explore expanded applications of BAXDELA® and VABOMERE® through innovative research. We are poised to make a lasting impact in healthcare, unlocking new avenues for patient care and addressing unmet needs. We will drive progress and redefine what is possible, paving the way for a healthier future.”
BAXDELA® (delafloxacin) is a novel fluoroquinolone (FQ), approved for adults in IV and oral tablet formulations to treat acute bacterial skin and skin structure infection (ABSSSI) and community-acquired bacterial pneumonia (CABP). CABP remains a leading cause of pediatric hospitalization and mortality in the US, with the highest incidence and morbidity in children under 2 years of age. The partnership with BARDA will support the BAXDELA® pediatric development plan to extend the adult CABP indication to children aged 2 months to less than 18 years.
In addition, Melinta aims to advance BAXDELA® as a potential treatment option against biothreat pathogens for both adults and children. Given its broad spectrum of activity and availability in both IV and oral formulations, BAXDELA® can provide flexibility for use following a biothreat public health emergency, in varied care settings and across spectrums of disease severity.
VABOMERE® is an approved combination of the carbapenem, meropenem, and the novel ß-lactamase inhibitor (BLI), vaborbactam. VABOMERE® was specifically designed to address gram-negative bacteria that produce beta-lactamase enzymes, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme, the predominant form of carbapenem-resistant Enterobacterales (CRE) in the US. The CDC (Centers for Disease Control) classifies CRE as an “urgent” threat because there are few alternative antibiotics to treat CRE-infections. The VABOMERE® pediatric development plan will support the filing of sNDAs to extend the adult cUTI indication to children aged 3 months to less than 18 years and target the indication of late onset neonatal sepsis in children aged less than 90 days.
“The ability to partner with BARDA on these important programs is exactly the type of work that brought me to Melinta and what excites me about the work we do,” said Douglas Girgenti, MD, VP, Head of Development and Clinical Operations, Melinta. “Pediatric clinical development of BAXDELA® and VABOMERE® will help inform drug safety and tolerability as well as determine optimal antibiotic dosing, with the ultimate goal of enabling use in pediatric cases and expanding the arsenal of healthcare providers in their fight to save lives. The potential addition of BAXDELA® to the biodefense armamentarium will likewise provide a much-needed option for public health emergencies in both children and adults.”
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00022.
About Melinta Therapeutics
Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam).
About BAXDELA® (delafloxacin)
BAXDELA® is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
PRNewswire | July 27, 2023
Invivoscribe is excited to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA® (quizartinib).
The LeukoStrat CDx FLT3 Mutation Assay identifies FLT3-ITD positive AML patients who may be treated with this newly approved targeted therapy.
US Intended Use
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with FLT3-ITD+ AML for whom VANFLYTA® (quizartinib) treatment is being considered.
The test is for use on the 3500xL Dx Genetic Analyzer.
"FDA approval of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to VANFLYTA is a significant milestone for patients with newly diagnosed FLT3-ITD positive AML," said Invivoscribe CSO, CEO, and founder Jeffrey Miller. "Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identify those who may be eligible for treatment with VANFLYTA, and we are happy to collaborate with Daiichi Sankyo to help bring this important new therapy to patients."
AML is a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells.1 AML has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia.2 About 25% of AML patients have a FLT3-ITD mutation which contributes to the growth and survival of cancer cells and is associated with a poor prognosis.
Previously, the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to select FLT3-ITD positive AML patients eligible for VANFLYTA in Japan.
Invivoscribe is a global, vertically-integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.