CK2

Compound has demonstrated in vivo results indicating potentially best-in-class profile in FLT3 mutated AML Pre-clinical development activities are underway, with IND enabling studies expected to commence in late 2024 NEW YORK, Jan. 30, 2024 /PRNewswire/ -- Harmonic Discovery (the "Company"), a precision pharmacology company focusing on developing next generation kinase inhibitors, today announced an exclusive licensing agreement of a novel small-molecule drug candidate for the treatment of FLT3 mutated acute myeloid leukemia (AML) from BioVentures (University of Arkansas for Medical Sciences) and UC San Francisco (UCSF). The compound, named HD-10019, is currently in pre-clinical development and is expected to commence IND-enabling studies in late 2024. HD-10019 was jointly developed in the laboratories of professors Hong-Yu Li, PhD, previously at the University of Arkansas for Medical Sciences, and Neil Shah, MD, PhD, of UCSF. HD-10019 is a type II kinase inhibitor that was rationally designed to overcome tyrosine kinase domain resistance mutations in the FLT3 kinase and improve myelosuppression versus standard of care agents for FLT3 mutated AML. Additionally, this molecule is anticipated to avoid cardiac liabilities seen in other kinase inhibitors. "Since we provided the first evidence that FLT3-ITD is a valid therapeutic target in AML in 2012, three FLT3 tyrosine kinase inhibitors have been approved in the USA and throughout much of the world. While these agents represent advances in the management of this poor-risk subset of AML patients, their impact on clinical outcomes has been modest as a consequence of their vulnerability to secondary drug-resistant kinase domain mutations in FLT3-ITD and their insufficient selectivity toward FLT3, which is hypothesized to be a prime reason for the myelosuppression observed with these agents," said Dr. Neil Shah, whose laboratory performed pre-clinical studies of the compound. "To this end, we have identified and characterized HD-10019. The clinical development of such an agent may facilitate the ability to achieve effective and durable FLT3 inhibition when used in conjunction with chemotherapy and as maintenance therapy thereafter." Harmonic Discovery's precision pharmacology platform has further corroborated the potential of HD-10019 as a best-in-class drug based on its selectivity profile. The Company intends to leverage its platform to further advance the development of this program. "We are excited to work with BioVentures and UCSF and take a step forward in delivering a novel treatment to FLT3 mutated AML patients," said Rayees Rahman, PhD, CEO of Harmonic Discovery. Wilson Sonsini Goodrich & Rosati served as legal advisor to Harmonic Discovery on matters relating to the Licensing Agreement and related corporate and patent strategy matters. About Harmonic Discovery Inc. Harmonic Discovery (the "Company") is a precision pharmacology company applying its generative AI platform to advance next-generation kinase inhibitors. The Company's platform is trained on multiple layers of proprietary data and is integrated with domain expertise to design safer and more efficacious kinase therapeutics. The Company's lead programs are focused on malignant hematology indications, with exploratory discovery efforts in additional therapeutic areas including immuno-oncology, immunology and inflammation. The Company has raised $8 million in Seed Financing to date from Innovation Endeavors, Fifty Years, Y Combinator and other select investment firms. The Company was founded in 2021 and is headquartered at Johnson & Johnson's JLABS ("JLABS@NYC") in New York City, New York. To learn more, visit CONTACT: pr@harmonicdiscovery.com SOURCE Harmonic Discovery Inc.

TAIPEI and SAN DIEGO, Dec. 26, 2023 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that Taiwan Food and Drug Administration has approved its Phase II IND application of Silmitasertib (CX-4945) to treat patients with community-acquired pneumonia (CAP) caused by viral infection. The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early intervention of Silmitasertib restrains the progression of CAP by inhibiting the elevated cytokine release associated with SARS-CoV-2 and Influenza viruses. This trial will be led by an inter-hospital team, which is specialized in infectious diseases and possesses extensive experiences in carrying out large-scale international clinical trials for various anti-viral new drugs, across five well-known hospitals including National Taiwan University Hospital, National Taiwan University Cancer Center, Far Eastern Memorial Hospital, Tri-Service General Hospital and Taoyuan General Hospital, Ministry of Health and Welfare. Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses. CK2 modulates inflammatory pathways, including NF-κB, PI3K–Akt–mTOR, and JAK–STAT. Inhibition of CK2 by Silmitasertib diminishes the secretion of IL-6 and MCP-1 (Rosenberger et al.). Silmitasertib treatment also reduces the expression of TNF-α and CCL4 in NiSO4-stimulated MoDCs (Bourayne et al.). "Senhwa regards this phase II as the proof-of-concept study to demonstrate Silmitasertib can be a therapeutic strategy that are not restricted to only a specific viral infection, but applicable to various viruses," said Jin-Ding Huang, CEO of Senhwa Biosciences, Inc. The global market for related therapeutic drugs has exceeded a value of over $120.6 billion USD in 2020 and it's projected to grow at a CAGR of 7.88% and reach more than $339 billion USD by 2030 according to market research. About Silmitasertib Silmitasertib is a first-in-class small molecule drug that targets the CK2 protein and acts as a CK2 inhibitor. Clinical studies thus far have shown Silmitasertib is safe and well-tolerated in humans and is easily administered with its oral formulation. Silmitasertib is currently under development through several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed while two other Phase I and II studies of Silmitasertib are still ongoing. The US FDA has granted Silmitasertib Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma in July 2020 and December 2021, respectively. Fast Track Designation was granted in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma. About Senhwa Biosciences Senhwa Biosciences, Inc. is a leading clinical-stage company focused on developing first-in-class, next-generation DNA Damage Response therapeutics and seeks to address unmet medical needs in oncology and infectious diseases. Headquartered in Taiwan, with an operational base in San Diego, California, Senhwa is well-positioned to oversee the development of its compounds. Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action as anti-cancer drugs for the treatment of multiple indications, are the core products in Senhwa Bioscience's pipeline. Clinical trials are currently ongoing in Australia, Canada, United States and Taiwan. Visit Senhwa Biosciences' website for more details: SOURCE Senhwa Biosciences, Inc.

TAIPEI, Nov. 21, 2023 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that U.S. Food and Drug Administration has approved its Phase II IND application of Silmitasertib(CX-4945) to treat patients with community-acquired pneumonia (CAP) caused by viral infection. The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early intervention of Silmitasertib restrains the progression of CAP by inhibiting the elevated cytokine release associated with SARS-CoV-2 and Influenza viruses. Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses. CK2 modulates inflammatory pathways, including NF-κB, PI3K–Akt–mTOR, and JAK–STAT. Inhibition of CK2 by Silmitasertib diminishes the secretion of IL-6 and MCP-1 (Rosenberger et al.). Silmitasertib treatment also reduces the expression of TNF-α and CCL4 in NiSO4-stimulated MoDCs (Bourayne et al.). "Senhwa regards this phase II as the proof-of-concept study to demonstrate Silmitasertib can be a therapeutic strategy that are not restricted to only a specific viral infection, but applicable to various viruses," said Jin-Ding Huang, CEO of Senhwa Biosciences, Inc. The global market for related therapeutic drugs has exceeded a value of over $120.6 billion USD in 2020 and it's projected to grow at a CAGR of 7.88% and reach more than $339 billion USD by 2030 according to market research. Prior to this phase II study, Silmitasertib was investigated in two investigator-initiated trials (IIT) in the United States and has showed clinical benefits by accelerating the recovery speed in patients with moderate symptoms of COVID-19. About Silmitasertib Silmitasertib is a first-in-class small molecule drug that targets the CK2 protein and acts as a CK2 inhibitor. Clinical studies thus far have shown Silmitasertib is safe and well-tolerated in humans and is easily administered with its oral formulation. Silmitasertib is currently under development through several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed while two other Phase I and II studies of Silmitasertib are still ongoing. The US FDA has granted Silmitasertib Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma in July 2020 and December 2021, respectively. Fast Track Designation was granted in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma. About Senhwa Biosciences Senhwa Biosciences, Inc. is a leading clinical-stage company focused on developing first-in-class, next-generation DNA Damage Response therapeutics and seeks to address unmet medical needs in oncology and infectious diseases. Headquartered in Taiwan, with an operational base in San Diego, California, Senhwa is well-positioned to oversee the development of its compounds. Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action as anti-cancer drugs for the treatment of multiple indications, are the core products in Senhwa Bioscience's pipeline. Clinical trials are currently ongoing in Australia, Canada, United States and Taiwan. Visit Senhwa Biosciences' website for more details: SOURCE Senhwa Biosciences, Inc.