On September 13, 2023 J INTS BIO reported that Phase 1/2 study of its novel, orally administered 4th generation EGFR-TKI ‘JIN-A02’ was presented at the 2023 IASLC World Conference on Lung Cancer held in Singapore from 9th to 12th September, during the official session entitled "Metastatic Non-small Cell Lung Cancer – Targeted Therapy – EGFR/HER2" (Press release, J INTS BIO, SEP 13, 2023, View Source;presentation-of-phase-12-study-of-jin-a02-a-novel-oral-4th-generation-egfr-tki-301925918.html [SID1234635149]).

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JIN-A02, a 4th generation EGFR TKI, selectively and reversibly binds to EGFR mutations, in particular C797S mutation that led to resistance to Osimertinib therapy. In preclinical studies, JIN-A02 has demonstrated potent activities as monotherapy in models with EGFR mutations that are resistant to Osimertinib.

This global phase 1/2 clinical study seeks to evaluate the safety, pharmacokinetics, and anti-tumor activity of "JIN-A02" in advanced NSCLC patients carrying EGFR mutations.

This study is divided into three parts with dose escalation (Part A), dose exploration (Part B), and dose expansion (Part C). Part A explores ascending doses of oral JIN-A02 monotherapy in 28-day cycles to evaluate the maximum tolerated dose in patients with advanced NSCLC harboring C797S or T790M mutation. Based on the results obtained in part A, a safety review committee will select 2 doses to be further evaluated in Part B by determining the safety, pharmacokinetics, and efficacy in the same way as Part A albeit in a larger cohort of patients. Once the recommended Phase 2 dose (RP2D) is determined, Part C, the dose expansion study, will begin with five cohorts of patients based on the EGFR mutations and brain metastasis status.

Dosing of the first patient with JIN-A02 was achieved in July 2023 and as of 11th of September 2023, a total of three subjects have completed MTD evaluation period for Dose Level One of Part A. There was no DLT, no treatment related AE, and no clinical disease progression was noted.

On September 13, 2023 ThirtyFiveBio Limited, a biotechnology company developing first-in-class small molecule inhibitors of G protein-coupled receptor 35 (GPR35) for the treatment of gastrointestinal (GI) disease, reported that the company has been awarded a highly competitive Biomedical Catalyst (BMC) grant from Innovate UK, the UK’s innovation agency (Press release, ThirtyFiveBio, SEP 13, 2023, View Source [SID1234635148]). The grant, for a total of £495,000 (~$625,000), will fund research designed to enable the company to conduct translational studies of first-in-class GPR35 inhibitors for the treatment of gastrointestinal inflammatory diseases and cancers, ultimately allowing for the advancement of those compounds into clinical development.

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The project is focused on optimising first-of-their-kind rodent-GPR35 antagonist small molecules to support preclinical evaluation of opportunities for GPR35 inhibitors in clinically translational murine models of disease. This effort will result in a critically needed research tool capable of addressing the fact that human GPR35 inhibitors do not cross-react with rodent-GPR35 receptors and therefore cannot be deployed to many animal models of disease. The resulting small molecules will be essential in defining clinical scope of human-GPR35 inhibitors and enabling advancement of clinical candidates to proof-of-concept studies in humans.

"We believe that GPR35 inhibition represents an extremely promising and novel therapeutic approach to addressing GI cancers and inflammatory diseases, many of which need new therapies that can deliver durable results with improved tolerability. As a company at the forefront of research in this emerging area, one of our focuses is creating innovative preclinical tools for evaluating, optimising and advancing the most promising GPR35 inhibitors. Our work in this area will be significantly advanced by the grant funding received from Innovate UK and we would like to express our deep gratitude to the agency for recognizing the value of this project and providing the BMC grant," said James Westcott, Ph.D., chief executive officer of ThirtyFiveBio.

The role of GPR35 in GI diseases is genetically validated with several drug developers advancing programs designed to address the target. To date, virtually all these efforts have been focused on increasing the activity of GPR35 with targeted agonists. However, important recent scientific findings, including key insights from the ThirtyFiveBio team, support the hypothesis that GPR35 antagonism may represent a more appropriate therapeutic approach by blocking unwanted GPR35 signaling. Based on this evolved scientific perspective, supported by the company’s work with several world-leading, academic GPR35 specialists, ThirtyFiveBio is uniquely pursuing antagonism of the target with first-in-class small molecule GPR35 inhibitors.

Supporting the company’s focus on GPR35 inhibition is a collection of pre-clinical data generated by its scientists that highlights the association between GPR35 mutations and GI diseases. This includes research showing that GPR35 variants are linked to inflammatory bowel disease, and that GPR35 expression is upregulated in GI cancers. The company has also shown that pathogenic mutations of GPR35 drive its increased expression and function. Furthermore, study results have demonstrated that commonly dysregulated GI-cancer genes can be reversed by knocking out GPR35 in cancer cells. Taken together, these findings provide compelling evidence that hyperactive genetic mutations within GPR35 contribute to a range of GI disease processes, and that inhibiting GPR35 activity may have therapeutic utility in these diseases.

On September 13, 2023 Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, reported that the clinical trial of oral APL-1202 in combination with PD-1 inhibitor Tislelizumab as neoadjuvant therapy for muscular invasive bladder cancer (MIBC) completed the phase II interim analysis with positive results. Detailed results will be released on academical meeting (Press release, Asieris Pharmaceuticals, SEP 13, 2023, View Source [SID1234635147]).

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The primary objective of Phase II clinical trial is to evaluate the safety and efficacy of APL-1202 in combination with Tislelizumab compared to Tislelizumab monotherapy as neoadjuvant therapy for MIBC patients. The trial population includes patients newly diagnosed MIBC for whom radical cystectomy (RC) is planned, and who are cisplatin ineligible or refuse to receive cisplatin based neoadjuvant chemotherapy. The primary efficacy endpoint is the pathological complete response (pCR) rate. pCR is defined as the absence of residual tumor lesions in the bladder and lymph node specimens confirmed by histopathological assessment after RC (pT0N0).

Both the combination group and the Tislelizumab monotherapy group use Simon’s two-stage optimal design. According to the trial design, if at least 5 out of the first 18 evaluable patients in the first stage in the combination therapy group achieve pCR, this group will proceed to the next stage. For the Tislelizumab monotherapy group, if at least 3 out of the first 14 evaluable patients in the first stage achieve pCR, the group will continue to the next stage of evaluation.

According to the trial plan, efficacy interim analyses will be conducted when both groups complete the first stage. Both groups have now met the criteria for the first-stage efficacy set by Simon’s two-stage optimal design, and progressed to the second stage. After reviewing the data of interim analysis, the Safety Monitoring Committee (SMC) determined that the results met the pre-defined criteria.

"This promising outcome demonstrating the potential of APL-1202 in combination with Tislelizumab as neoadjuvant therapy for MIBC." said Dr. Linda Wu, Chief Development Officer of Asieris, "We look forward to the potential of this combination therapy for MIBC patients."

The phase I/II clinical trial obtained permission from the U.S. Food and Drug Administration (FDA) in June 2021 and received approval from the China National Medical Products Administration Center for Drug Evaluation (CDE) for the Investigational New Drug (IND) application by the end of September 2021. The first patient was enrolled in phase I in December of the same year. The trial move to Phase II stage in November 2022 after completing Phase I dose escalation. No dose-limiting toxicities (DLT) was observed in Phase I stage, and a recommended Phase II dose (RP2D) of 1125 mg daily was established.

Furthermore, two pivotal Phase II/III clinical trials of APL-1202 are ongoing, including APL-1202 combination with intravesical chemotherapy for intermediate- and high-risk chemo-relapsed NMIBC patients and APL-1202 monotherapy for naïve intermediate-risk NMIBC patients."

On September 13, 2023 ImmPACT Bio USA, Inc. ("ImmPACT BIO"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, reported that it will participate at the Jefferies Cell & Genetic Medicine Summit, to be held from September 26 -27, 2023 in New York, NY (Press release, ImmPACT-Bio, SEP 13, 2023, View Source;genetic-medicine-summit-301925364.html [SID1234635146]).

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Sumant Ramachandra, M.D., Ph.D., ImmPACT Bio’s president and chief executive officer, will participate in a fireside chat on Wednesday, September 27, 2023 at 10:00 AM ET.

Management will also participate in one-on-one investor meetings. To schedule a one-on-one meeting please contact your Jefferies representative.

On September 13, 2023 Devyser and Thermo Fisher Scientific reported to have entered into a collaboration agreement to promote laboratory services (Press release, Thermo Fisher Scientific, SEP 13, 2023, View Source [SID1234635145]). The goal is to partner with pharmaceutical companies to support their development projects utilising Devyser’s unique assays in its CLIA-certified laboratory.

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The companies will work together to promote the Devyser laboratory services to support and advance research and development for pharmaceutical companies.

"We are very excited to enter into this agreement. Being able to support pharmaceutical companies’ development projects to enable new and improved therapies is a part of our vision for Devyser. We are convinced that Thermo Fisher, with its global network and outstanding reach, will provide a strong platform for partnering with global pharmaceutical companies in addition to Devyser’s own discussions," says Fredrik Alpsten, CEO at Devyser. "This collaboration is in line with our strategy to expand our presence in the US."

Devyser established the US CLIA-certified laboratory during the spring of 2023 and received CLIA certification from the Centers for Medicare and Medicaid Services (CMS) in May 2023. The laboratory is based in Atlanta, Georgia.