1stOncology™: Cancer Intelligence Service – Page 1500 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

IND Application for a Phase I/II Clinical Study of Anti-HER2 Bispecific ADC Subcutaneous Co-formulation JSKN033 was Approved

On December 26, 2024 Alphamab Oncology (stock code: 9966.HK) announced that a phase I/II clinical trial (Study ID: JSKN033-102) of JSKN033, a high-concentration subcutaneous co-formulation consisting of anti-HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 immune checkpoint inhibitor, has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This study has previously been included in the "Pilot Program for Optimizing the Review and Approval of Clinical Trials for Innovative Drugs".

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

JSKN033-102 is an open-label, multicenter, Phase Ⅰ/Ⅱ clinical study designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and anti-tumor activity of JSKN033 in patients with advanced metastatic malignant tumors, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D).

JSKN033 is the global first high-concentration subcutaneous co-formulation consisting of ADC and PD-L1 immune checkpoint inhibitor in first-in-human clinical trials. Developed on top of the superior solubility and stability of the world’s first subcutaneously injectable PD-L1 inhibitor Envaforlimab, JSKN033 combines immunotherapy (KN035) and ADC (JSKN003), makes ADC subcutaneous injectable and leads to improved safety and convenience. The first-in-human phase I/II clinical study of JSKN033 conducted in Australia (JSKN033-101, NCT06226766) demonstrated favorable safety profile and encouraging anti-cancer activity in heavily treated patients. Detailed clinical data were presented at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in 2024 (SITC 2024).

With the incidence and mortality rates rising year by year, malignant tumors have become the leading cause of death globally and in China. According to relevant research statistics, there were 19.3 million new cancer cases worldwide in 2020, and nearly 10 million people died from malignant tumors. The incidence rates of breast cancer, lung cancer, colorectal cancer, prostate cancer, and gastric cancer rank the top five among all tumor types. Despite significant advancements in immunotherapy and molecular targeted therapies in recent years, the demand for innovative drugs and new treatment options continues to grow among clinicians and patients. Alphamab Oncology has long focused on unmet clinical needs, dedicated to developing differentiated, clinically valuable, and globally competitive new drugs to help cancer patients extend survival and improve the quality of life.

About JSKN033

JSKN033 is the global first high-concentration subcutaneous co-formulation consisting of ADC (JSKN003) and immune checkpoint inhibitor (Envafolimab), which is independently developed by the Company. JSKN003 is a an anti-HER2 bispecific ADC, comprising of three components: a bispecific antibody targeting two non-overlapping epitopes of HER2 extracellular domains, a cleavable linker, and a topoisomerase I inhibitor. Envafolimab is a Fc fusion protein consisting of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment, which has been approved by Chinese authorities as the global-first subcutaneous injection PD-(L)1 inhibitor in November 2021. By combining immunotherapy and ADC, JSKN033 is anticipated to significantly enhance efficacy. Leveraging the superior solubility and stability of Envafolimab, this formulation makes ADC subcutaneous injectable and leads to improved safety and convenience. The phase I/II clinical study of JSKN033 for the treatment of HER2-expression advanced or metastatic solid tumors is currently being conducted in Australia.

(Press release, Alphamab, DEC 26, 2024, View Source [SID1234657009])

Ascentage Pharma to Present at 43rd Annual J.P. Morgan Healthcare Conference

On December 26, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs primarily for malignancies, reported that its Chairman and CEO, Dr. Dajun Yang, has accepted an invitation to present on the company’s progress and prospects under its patient-centric global innovation strategy, at 1:15 PM, January 16, 2025, Pacific Time (5:15 AM, January 17, 2025, Beijing Time) at the 43rd Annual J.P. Morgan Healthcare Conference (Press release, Ascentage Pharma, DEC 26, 2024, View Source [SID1234649319]).

The annual J.P. Morgan Healthcare Conference is the largest and most informative event for the global pharmaceutical industry and the investment community. This year, the conference will take place in San Francisco, CA, the United States, on January 13-16, 2025.

Time:

January 16, 2025; 1:15-1:40 PM, Pacific Time
(January 17, 2025; 5:15-5:40 AM, Beijing Time)

Speaker:

Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma

You may sign up for the conference and listen to a live webcast of the speech at:
View Source;kiosk=true

Exicure, Inc. Partners with GPCR Therapeutics to Fuel New Growth in Biotech

On December 26, 2024 Exicure, Inc. (Nasdaq: XCUR, "Exicure", "the Company"), reported the signing of a Memorandum of Understanding (MOU) with GPCR Therapeutics, Inc. ("GPCR Therapeutics") on December 24, 2024, aimed at the acquisition of GPCR USA, a subsidiary of GPCR Therapeutics, and the technology transfer and collaborative research on GPCR Therapeutics’ ongoing drug development pipelines (Press release, Exicure, DEC 26, 2024, View Source [SID1234649317]). Through this acquisition, Exicure plans to secure key technical personnel by purchasing all shares of GPCR USA held by GPCR Therapeutics. Following this, Exicure intends to receive technology transfer for GPCR Therapeutics’ CXCR4 inhibitor, which is currently in Phase 2 clinical trials with the FDA, along with its related patents and intellectual property (IP). By acquiring excellent research personnel and clinical pipelines, Exicure aims to advance as a clinical-stage biotech company. GPCR Therapeutics plans to successfully finalize ongoing clinical trials involving stem cell mobilizers (SCM) targeting multiple myeloma patients and prepare for clinical studies related to acute myeloid leukemia (AML). The market size for the ongoing Phase 2 trials is estimated to be around $1 billion to $2 billion annually.

Moreover, Exicure plans to engage in collaborative research and development in various forms for GPCR Therapeutics’ ongoing research in immuno-oncology, fibrosis treatments, and obesity therapies. GPCR Therapeutics, the partner with Exicure in this MOU, is a South Korean drug development company specializing in GPCR (G Protein-Coupled Receptor, "GPCR"), which represents over one-third of all drug targets. GPCR Therapeutics has secured target patents around prominent GPCRs such as CXCR4 and possesses multiple pipelines addressing blood cancers and solid tumors, genetic disorders, idiopathic pulmonary fibrosis, and obesity, including ongoing Phase 2 trials in the U.S. for multiple myeloma. Dr. Pina Cardarelli, who previously served as Vice President at Bristol-Myers Squibb, where she led the development of the first-ever immuno-oncology drugs, Yervoy (ipilimumab) and Opdivo (nivolumab), has served as the Chief Scientific Officer (CSO) of GPCR Therapeutics since 2019.

In 2021, GPCR Therapeutics established a subsidiary in the U.S. to align its R&D with global pharmaceutical standards and demands. During the American Society of Hematology (ASH) (Free ASH Whitepaper) conference held from December 7-10, 2024, GPCR Therapeutics presented three exhibits detailing: (1) interim results from ongoing Phase 2 trials, (2) data on enhancing treatment efficacy for acute myeloid leukemia (AML), and (3) preclinical data on boosting T cell responses to offer various therapies, including in vivo CAR-T. Additionally, on December 24, 2024, Exicure completed the $8.7 million capital investment. Combined with the $2 million capital investment executed on December 9, 2024, the $1.3 million raised in November, and an expected additional $4 million, the Company plans to secure a total of $14 million in capital investments. The funds will primarily be used for the acquisition of GPCR USA, clinical trial costs, and its ongoing operations.

Viracta Therapeutics Announces Closure of NAVAL-1 Clinical Trial and Exploration of Strategic Alternatives

On December 26, 2024 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported that its Board of Directors has initiated a process to explore a broad range of strategic alternatives (Press release, Sunesis, DEC 26, 2024, View Source [SID1234649318]).

To maximize its cash runway while the Board conducts its review of strategic alternatives, Viracta has elected to close its ongoing pivotal Phase 2 clinical trial of Nana-val in relapsed/refractory EBV+ lymphomas (the NAVAL-1 trial). The company emphasized that its decision to voluntarily close the trial is not the result of any new safety finding.

"As we continue to look for ways to conserve resources and maximize value for the company, we made the very difficult decision to close the NAVAL-1 study while the Board undertakes its strategic review," stated Mark Rothera, President and Chief Executive Officer of Viracta. "I would like to thank the physicians and patients who participated in this important study, as well as the Viracta team members who worked so tirelessly on this program. I continue to believe that Nana-val has the potential to improve the treatment of relapsed/refractory EBV+ lymphomas, and I remain hopeful that it will one day be approved."

Viracta is making this announcement to inform shareholders and the public that the Company is engaging in discussions for strategic alternatives with the goal of maximizing value. Potential alternatives include, but are not limited to, a merger, licensing agreement, sale or other strategic transaction.

There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. Viracta does not intend to discuss or disclose further developments regarding the exploration of strategic alternatives unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate or required by law.

Northwest Biotherapeutics Announces $5 Million Convertible Note Financing and Standby Facility for Up to $50 Million Additional Financing

On December 26, 2024 Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that on December 19, 2024 it entered into a $5 million convertible Promissory Note financing with YA II PN, Ltd., an investment fund managed by Yorkville Advisors Global, LP ("Yorkville") (Press release, Northwest Biotherapeutics, DEC 26, 2024, View Source [SID1234649316]). The term of the Note is 13 months. The Note carries an Original Issue Discount of seven percent but no interest. Repayment of all outstanding amounts is due at maturity; no payments by the Company are due until maturity. The Note includes customary default provisions. During the term of the Note, it is convertible at the option of the holder, at a small discount to the then prevailing market price. The amounts of such conversions are limited to one sixth (1/6) of the overall Note amount in any given calendar month unless the conversion price is above $0.315. The Company plans to use the proceeds for general corporate purposes, including both its lead product and its in-licensed portfolios.

The Company and Yorkville also entered into a standby equity subscription agreement (the "Subscription Agreement") which the Company may use after the Note is repaid or converted. Under this Subscription Agreement, NW Bio has the option, in its discretion, to require Yorkville to subscribe for up to $50 million of common shares in the Company at any time during the 24-month term of the Subscription Agreement at a small discount to the then prevailing market price, after the Note is repaid or converted. The Company has no obligation to make any such use of this arrangement, and the Company can cancel the arrangement at any time after the Note is repaid or converted. The Company has no current plans to draw upon this standby facility; however, the Company believes it will be useful to have this facility available for special funding needs in connection with certain key potential upcoming milestones.

Joseph Gunnar & Co., LLC acted as the exclusive placement agent for the offering.