Medical, Industry Outlook
Globenewswire | August 16, 2023
Graf Acquisition Corp. IV and NKGen Biotech, Inc. on August 14, 2023 announced that Graf’s registration statement on Form S-4 relating to the previously announced business combination (the “Business Combination”) with NKGen, has been declared effective by the U.S. Securities and Exchange Commission (the “SEC”). Graf also commenced mailing the definitive proxy statement/prospectus on August 14, 2023, which was included in the Registration Statement, relating to the special meeting of its stockholders to be held in connection with the Business Combination (the “Special Meeting”) to stockholders of record as of the close of business on August 7, 2023 (the “Record Date”).
The Special Meeting will be held virtually at 10:00 a.m., New York City time, on August 30, 2023 at https://www.cstproxy.com/grafiv/sm2023. Graf’s stockholders of record as of the Record Date are entitled to vote at the Special Meeting. In connection with the Special Meeting, Graf’s stockholders who wish to exercise their redemption rights must do so no later than 5:00 p.m., New York City time, on August 28, 2023 by following the procedures specified in the definitive proxy statement/prospectus for the Special Meeting.
In addition, Graf announced on August 14, 2023 that it intends to voluntarily transfer the listing of its shares of common stock and public warrants to The Nasdaq Stock Market LLC (“Nasdaq”) from the New York Stock Exchange (the “NYSE”) following the completion of the Business Combination. In connection with the closing of the Business Combination, Graf will change its name to “NKGen Biotech, Inc.” and NKGen will change its name to “NKGen Operating Biotech, Inc.” The common stock and public warrants of the post-combination company are expected to commence trading on Nasdaq the day after the closing of the Business Combination under the symbols “NKGN” and “NKGNW,” respectively. Graf’s units, common stock and public warrants will continue to trade on the NYSE until the transfer is complete.
The decision to list on Nasdaq was made in consideration of the Business Combination and enables the post-combination company to be listed alongside the other innovative biotechnology companies that are also listed on Nasdaq. At the closing of the Business Combination, Graf will delist its units, shares of common stock and public warrants from the NYSE. The Nasdaq listing and NYSE delisting are subject to the closing of the Business Combination and fulfillment of all Nasdaq listing requirements and NYSE delisting procedures.
About Graf Acquisition Corp. IV
Graf is a blank-check company incorporated as a Delaware corporation and formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses.
About NKGen Biotech, Inc.
NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapies. NKGen is headquartered in Santa Ana, California, USA.
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.
Medical, Industry Outlook
Businesswire | August 02, 2023
Replimune Group, Inc. a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, and Incyte a global biopharmaceutical company, today announced a clinical trial collaboration and supply agreement to study RP1, Replimune’s lead product candidate, in combination with INCB99280, Incyte’s small molecule oral PD-L1 inhibitor.
“We are excited to enter into this collaboration with Incyte to explore the use of RP1 prior to surgery as we believe that our tumor-directed oncolytic immunotherapies could have a great impact in the neoadjuvant setting both in cutaneous squamous cell carcinoma (CSCC) and in other cancer types, given the high rates of complete responses we’ve seen to date, and data indicating RP1 is generally very well tolerated,” said Robert Coffin, Chief Research and Development Officer of Replimune. “The unique potential of the RPx platform to induce a patient-specific anti-tumor immune response with an off-the-shelf treatment speaks to the practicality and broad potential utility of the approach, and exploring its use with Incyte’s oral PD-L1 inhibitor has the potential to improve the patient experience further.”
“We look forward to collaborating with Replimune on this study evaluating INCB99280 and RP1 in patients with CSCC. Our oral PD-L1 program has shown promising safety and efficacy in early studies thus far, and we look forward to adding to the growing body of evidence for INCB99280 and learning more about its potential to improve clinical outcomes,” said Lance Leopold, M.D., Group Vice President, Clinical Development Hematology and Oncology, Incyte.
Under the terms of the agreement, Incyte will initiate and sponsor the clinical trial of INCB99280 and RP1 in patients with high risk, resectable cutaneous squamous cell carcinoma (CSCC), with the clinical trial expected to initiate in early 2024. Replimune will supply Incyte with RP1 for the study and share equally in the costs of the study.
RP1 is Replimune’s lead oncolytic immunotherapy product candidate and is based on a proprietary new strain of herpes simplex virus engineered for robust tumor selective replication and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
INCB99280 is a potent and selective small molecule oral PD-L1 inhibitor, which has demonstrated promising clinical activity and safety in patients with solid tumors. INCB99280 is being evaluated in multiple Phase 2 studies as monotherapy and in combination with other antitumor agents.
Replimune Group, Inc.headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel tumor-directed oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone with payloads added to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform has a unique dual local and systemic mechanism of action (MOA) consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment (TME) to ignite a strong and durable systemic response. This MOA is expected to be synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile the RPx platform has the versatility to be developed alone or combined with a variety of other treatment options.
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.