On March 8, 2023 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2 (Press release, BioThera Solutions, MAR 8, 2023, View Source [SID1234628363]). The multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors aims to evaluate the safety and tolerability of BAT8008. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumors.

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BAT8008 is an antibody-drug conjugate (ADC) targeting Trop2 designed for the treatment of solid tumors. Trop2 (Trophoblast cell-surface antigens 2), also known as TACSTD2, M1S1, GA733-1, EGP-1, is a member of tumor associated calcium signal transduction protein (TACSTD) family, which is related to the regulation of intracellular calcium concentration.

Trop2 is not expressed or has low expression levels in normal human tissues while overexpressed in a variety of solid tumors, especially epithelial tumors including breast cancer, cervical cancer, colorectal cancer, esophageal cancer, gastric cancer, lung cancer, oral squamous cell cancer, ovarian cancer, prostate cancer, pancreatic cancer, thyroid cancer, urinary bladder cancer, uterine cancer, glioma, etc. High expression levels of Trop2 in tumors is correlated with poor prognosis for patients. Trop2 is a validated drug target with one approved drug for the treatment of solid tumors and is a target of high interest for new drug discovery.

BAT8008 was developed by using Bio-Thera’s proprietary ADC linker-payload that includes a cleavable but systemically stable linker, a small molecule topoisomerase I inhibitor and high DAR. The small molecule topoisomerase I inhibitor payload carried by BAT8008 has a strong cell membrane penetration ability. Consequently, when targeted cancer cells are killed, the payload has shown to be released and kill nearby cancer cells, producing a bystander effect, which has the potential to overcome the heterogeneity of the tumor. BAT8008 has demonstrated high anti-tumor activity, good stability, and safety in both in vitro and in vivo pharmacological studies. Preclinical data generated using BAT8008 was presented in a poster at the 2022 San Antonio Breast Cancer Conference (View Source).

Bio-Thera Solutions is also developing additional ADCs based on its proprietary linker-payload, including ADCs targeting FRα, B7H3, Her2, Nectin-4. All the ADCs in Bio-Thera’s pipeline are currently in early-stage clinical studies.

On March 8, 2023 JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, reported the initiation of clinical study of Carteyva (relmacabtagene autoleucel injection) for first-line treatment in patients with high-risk large B-cell lymphoma and the first patient infusion (Press release, JW Therapeutics, MAR 8, 2023, View Source [SID1234628362]).

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High-risk large B-cell lymphoma includes large B-cell lymphoma with International Prognostic Index (IPI) score ≥3, and high-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 translocations (double-/triple-hit lymphomas; DHL/THL). Patients with high-risk large B-cell lymphoma (IPI≥3) have a low response to standard first-line chemotherapy, with complete response rate (CRR) 47.3%, 3-year overall survival (OS) rate 58.9% and progression-free survival (PFS) rate 40.7%. HGBL patients with MYC and BCL2 and/or BCL6 translocations (DHL/THL) tend to have poor prognostic indicators (e.g. bone marrow involvement, central nervous system (CNS) involvement, and elevated lactate dehydrogenase) and no recommended standard first-line therapies, with poor efficacy (CRR 59.6%) to traditional standard first-line R-CHOP chemotherapy. CRR of these patients remains <60% when treated with DA-EPOCH-R therapy and there is no significant survival benefit with the more aggressive induction regimen compared with standard R-CHOP. Therefore, there are substantial unmet clinical needs in the first-line treatment of high-risk large B-cell lymphoma patients, and new treatment options are urgently needed.

In its pivotal clinical study (RELIANCE study), Carteyva has demonstrated manageable safety profiles and high efficacy in patients with relapsed/refractory large B-cell lymphoma who have received at least two lines of therapies. The encouraging results have inspired CAR-T therapy destined for earlier lines of therapies in high-risk large B-cell lymphoma.

The study is an open-label, single-arm, multicenter, and investigator-initiated trial (IIT) in China, aiming to evaluate the efficacy and safety of Carteyva as first-line therapy in adult subjects with high-risk large B-cell lymphoma.

References

McMillan, A. K., et al. Favorable outcomes for high-risk diffuse large B-cell lymphoma (IPI 3-5) treated with front-line R-CODOX-M/R-IVAC chemotherapy: results of a phase 2 UK NCRI trial. Ann Oncol, 31(9), 1251-1259 (2020).

Ying Zhao, et al. Prognostic analysis of DLBCL patients and the role of upfront ASCT in high-intermediate and high-risk patients. Oncotarget, 8(42), 73168-73176 (2017).

China Anti-cancer Association Lymphoma Committee, et al. Clinical practice guideline for lymphoma in China (2021 Edition). Chin J Oncol, 43(7), 707-735 (2021).

Bartlett, N. L. et al. Dose-adjusted EPOCH-R compared with R-CHOP as frontline therapy for diffuse large B-cell lymphoma: clinical outcomes of the phase III Intergroup Trial Alliance/CALGB 50303. J. Clin. Oncol. 37,1790–1799 (2019).

Ying Z, et al. Relmacabtagene autoleucel (relma-cel) CD19 CAR-T therapy for adults with heavily pretreated relapsed/refractory large B-cell lymphoma in China. Cancer Med. 10(3):999-1011 (2021).

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.

On March 8, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the Company will be presenting at the virtual Oppenheimer 33rd Annual Healthcare Conference on Wednesday, March 15, 2023, at 11:20 a.m. Eastern Time (Press release, ESSA, MAR 8, 2023, View Source [SID1234628361]).

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David R. Parkinson, President and Chief Executive Officer of ESSA Pharma; Peter Virsik, ESSA’s Chief Operating Officer; and David S. Wood, ESSA’s Chief Financial Officer, will host and participate in one-on-one meetings.

A live webcast of the Oppenheimer presentation can be accessed in the Investors/Events & Presentations section of ESSA’s website at www.essapharma.com. Following the event, the webcast will be archived on the ESSA website for 90 days.

On March 8, 2023 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported the activation of Washington University School of Medicine in St. Louis as the first clinical site in the CLEER-001 Phase 2a clinical trial of HT-001 for the treatment for rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy (Press release, Hoth Therapeutics, MAR 8, 2023, View Source [SID1234628360]). EGFR inhibitors are critical therapeutic agents for the treatment of non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer.

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"Today’s announcement is an important milestone as the Washington University School of Medicine in St. Louis becomes our first active site for this important clinical trial. The CLEER-001 clinical trial brings us one step closer to potentially improve the quality of life for cancer patients who need this novel therapeutic." said Robb Knie, CEO of Hoth Therapeutics, Inc.

Hoth is conducting the CLEER-001 clinical trial in the United States. Additional information and updates on the trial can be found by visiting Hoth’s website and ClinicalTrials.Gov.

On March 8, 2023 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, reported that the University of Chicago (UChicago) Medicine Comprehensive Cancer Center has joined the Caris Precision Oncology Alliance (POA) (Press release, Caris Life Sciences, MAR 8, 2023, View Source [SID1234628359]). The POA is a growing network of leading cancer centers across the globe that collaborate to advance precision oncology and biomarker-driven research. POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients.

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The UChicago Medicine Comprehensive Cancer Center includes more than 200 cancer specialists who offer innovative treatments, leading-edge research and clinical trials not available elsewhere in the Midwest. UChicago Medicine scientists study disease at the molecular level and clinical researchers apply the knowledge discovered in the institution’s laboratories to create and test promising new cancer treatments and procedures. The academic health system’s physician-scientists also specialize in cancer control, prevention and population research while implementing new approaches to screening and prevention. The institution is one of two NCI-designated comprehensive cancer centers in Illinois and a key part of its mission is community research to eliminate health disparities between ethnic and social groups.

"As home to a National Cancer Institute-designated Comprehensive Cancer Center, UChicago Medicine is excited to join colleagues across the country in this collaborative effort to advance precision medicine," said Walter M. Stadler, M.D., Senior Advisor to the Director of the UChicago Medicine Comprehensive Cancer Center and Dean for Clinical Research. "We look forward to working with colleagues throughout the country to translate genomic data into better care for cancer patients here in Chicago and around the world."

"We are excited to welcome the UChicago Medicine Comprehensive Cancer Center to the growing Precision Oncology Alliance network," said Chadi Nabhan, M.D., MBA, FACP, Chairman of the Caris Precision Oncology Alliance. "As a former UChicago Medicine faculty member, I know firsthand the dedication its physicians and researchers have to providing the most advanced and innovative therapies available to their patients. Our missions are the same – to improve the outcomes of all patients suffering from cancer through precision medicine."

The Caris Precision Oncology Alliance includes 79 cancer centers and academic institutions. These institutions have early access to the extensive database and artificial intelligence platform within Caris to establish evidence-based standards for cancer profiling and molecular testing in oncology. By leveraging the comprehensive genomic, transcriptomic and proteomic profiling available through Caris molecular profiling, Caris seeks to provide this network with the ability to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. POA members are also able to integrate with a growing portfolio of biomarker directed trials sponsored by biopharma. Additionally, as a member of the POA, institutions have access to Caris CODEai, the most comprehensive data solution in the industry with cancer treatment information and clinical outcomes data for over 350,000 patients covering over 1 million data points per patient.