Medical
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.
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Medical
Businesswire | July 26, 2023
SQZ Biotechnologies Company announced that Roche has determined that it will not exercise its option for HPV 16 positive solid tumors under the SQZ-APC-HPV program. SQZ Biotechnologies will regain full clinical development and future commercialization rights for its programs targeting HPV 16 positive tumors. The Company intends to explore potential strategic partnerships to support the advancement of its oncology programs and platforms.
The Company has completed a review of its portfolio and highlights the following achievements. SQZ® antigen presenting cells (APC) candidate was well tolerated in a Phase 1 trial and provided a significant survival benefit to a subpopulation of patients with enhanced tumor T cell infiltration. SQZ® enhanced antigen presenting cells (eAPC) candidate has completed enrollment of the highest dose monotherapy cohort in a Phase 1/2 trial, and initial data are anticipated in the second half of 2023. In addition, the low dose monotherapy cohort from the Phase 1 trial utilizing the Company’s Activating Antigen Carriers (AAC) candidate has demonstrated a confirmed complete response in one patient and an overall best response of stable disease in the other two patients. The high dose monotherapy cohort in this trial is currently enrolling, and initial data are anticipated in the fourth quarter of 2023. Finally, development and testing of the Point of Care Manufacturing system continue to advance and could significantly reduce the time and cost of cell therapy manufacturing and potentially make cell therapies more broadly accessible for patients.
“We have made meaningful progress across all our platforms this year and the management team and Board of Directors are enthusiastic about the power of Cell Squeeze® technology and the potential of the Company’s therapeutic programs,” said Howard Bernstein, Interim CEO and Member of the Board of Directors at SQZ. “As we move into the second half of this year, we are committed to assessing all of the Company’s potential strategic alternatives in an effort to advance our programs.”
About SQZ Biotechnologies
SQZ Biotechnologies is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies. The Company’s proprietary Cell Squeeze® technology offers the unique ability to deliver multiple biological materials into many patient cell types to engineer what the Company believes can be a broad range of potential therapeutics. The Company’s goal is to create well-tolerated cell therapies that can provide therapeutic benefit for patients and improve the patient experience over existing cell therapy approaches. With production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, the Company believes its approach could change the way people think about cell therapies.
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Industry Outlook
Businesswire | July 20, 2023
FOXO Technologies Inc.™ a leader in the field of commercializing epigenetic biomarker technology, announced the launch of its cutting-edge Bioinformatics Services to accelerate breakthroughs in biology, biotechnology, and healthcare, and redefine the growing field of epigenetic research.
FOXO’s Bioinformatics Services offers a comprehensive platform of advanced data solutions tailored to meet the specific needs of clients in academia, healthcare, and pharmaceutical research. Through its innovative suite of bioinformatic tools, FOXO will enable its clients to increase the speed and accuracy with which they process, analyze, and interpret data sets, accelerate discoveries, and advance their understanding of complex diseases.
“The launch of FOXO’s Bioinformatics Services marks a significant milestone for FOXO Technologies and the field of epigenetic research,” said Tyler Danielson, interim CEO and Chief Technology Officer of FOXO. “Epigenetics plays a key role in gene regulation and the interplay between lifestyle and environmental factors on biological systems. However, harnessing the full potential of epigenetic data has long been hindered by the challenges of data processing, analysis, and interpretation. With the introduction of our Bioinformatics Services, we aim to eliminate these barriers and empower researchers, clinicians, and other organizations to accelerate their research.”
Any researcher or research group that seeks to leverage DNA methylation microarrays can benefit from FOXO’s Bioinformatics Services. These services include ingesting and processing raw DNA methylation microarray data, performing sample- and probe-level quality control, and securely delivering publication-ready figures and results. FOXO’s expert team also offers the addition of advanced bioinformatic analyses including epigenome wide association studies (EWAS), and even AI-driven epigenetic biomarker development. These services can be applied to Illumina’s existing human and mouse DNA Methylation arrays, which cover over 935,000 and 285,000 CpG sites respectively. By leveraging state-of-the-art algorithms and world-class experts, the company’s bioinformatics platform can rapidly deliver accurate and high-quality data tailored to the needs of each client.
“Epigenetics is a nuanced science. Through years of experience, our team has developed niche expertise in bioinformatics with respect to epigenetics, specifically. Researchers who wish to incorporate epigenetic data into their studies can save valuable time and effort through our services offering,” says Brian Chen, Chief Science Officer.
As a leader in the field, FOXO remains committed to advancing epigenetic research and catalyzing breakthroughs in health and longevity. With Bioinformatic Services, FOXO is also opening the door to new research collaborations with industry and academic leaders.
About FOXO Technologies Inc.
FOXO is at the forefront of commercializing epigenetic biomarker technology. Their mission is to utilize the power of epigenetics and artificial intelligence to generate data-driven insights that promote optimal health and longevity outcomes for individuals and organizations alike.
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