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InnoCare Announces Approval of Clinical Trial of SHP2 Inhibitor ICP-189 in Combination with EGFR Inhibitor Furmonertinib

On September 13, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported the approval of the Investigational New Drug (IND) to conduct the clinical trial of ICP-189, a novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, in combination with furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor, in China (Press release, InnoCare Pharma, SEP 13, 2023, View Source [SID1234635152]).

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In mid-July, InnoCare and ArriVent announced the clinical development collaboration to evaluate the anti-tumor activity and safety of ICP-189 combined with furmonertinib in patients with advanced non-small cell lung cancer (NSCLC).

Furmonertinib is being advanced by ArriVent in global studies in patients with advanced or metastatic NSCLC with EGFR or HER2 mutations, including exon 20 insertion mutations and other uncommon EGFR mutations. It is approved in China as a first-line treatment for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations, where it is being further developed for additional indications with Shanghai Allist Pharmaceuticals Co., Ltd, (SSE: 688578) who discovered furmonertinib.

ICP-189 is a potent and selective oral allosteric inhibitor of SHP2, developed by InnoCare for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. In the dose escalation study, the dosage has been escalated up to 120 mg with no DLT observed and a favorable PK and safety profile has been demonstrated. Preliminary efficacy was observed in ICP-189 monotherapy. One patient with cervical cancer in the 20 mg dose cohort achieved confirmed partial response.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said: "SHP2 inhibitor is an ideal partner for combination with multiple targeted and immune-oncology therapies in the field of solid tumor. ICP-189 has demonstrated significant anti-tumor effect in tumor models driven by KRASG12C mutation and EGFR over-expression. We will work with ArriVent to accelerate clinical development of the combination of ICP-189 and furmonertinib, so that this innovative therapy can benefit patients with advanced NSCLC earlier."

NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases.

Curiox Biosystems to Advance Next-Generation Cancer Cell Therapies Through Collaboration with Leading Cancer Researcher

On September 13, 2023 Curiox Biosystems, a global leader in providing innovative and automated sample preparation solutions for accurate and reproducible cell analysis, reported its collaboration with Dr. Marco Ruella, an Assistant Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania (Penn), to support efforts in the development of next-generation cancer cell therapies (Press release, Curiox BioSystems, SEP 13, 2023, View Source [SID1234635151]).

The collaboration will focus on leveraging Curiox Biosystems’ next-generation sample preparation platform alongside Dr. Ruella’s pioneering expertise in cell and gene therapies to establish improved metrics of cellular analysis.

"We are excited to embark on this collaboration with Dr. Ruella and Penn," stated the Leadership Team of Curiox Biosystems. "We are collaborating to advance therapeutic development in the field of cell therapy through automation that provides accurate and reproducible cell analytics."

Dr. Marco Ruella, an internationally recognized expert in cellular immunotherapies, brings his extensive experience in the development of innovative treatments, such as chimeric antigen receptor T-cell (CART) to this collaboration. His deep experience, including with industry collaborations, will be instrumental in this partnership to advance automated cell sample preparation in cell and gene therapy workflows.

"We are thrilled to partner with Dr. Marco Ruella and Penn to establish a collaboration around Curiox’s automated cell sample preparation platform," said Dr. Namyong Kim, CEO of Curiox Biosystems. "With this partnership we aspire to improve cell therapies by automating critical steps in the workflow which we hope will ultimately benefit patients worldwide."

Zuberitamab (Anruixi®), the first domestically developed anti-CD20 antibody as a Class I innovative drug from BioRay Pharmaceutical, has been approved for marketing in China

On September 13, 2023 BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "Bioray") reported that its independently developed Class I innovative therapeutic biological product, Zuberitamab Injection (trade name: Anruixi), indicated for the treatment of CD20-positive diffuse large B-cell lymphoma (DLBCL), was officially approved for marketing by the National Medical Products Administration (NMPA) (Press release, BioRay Pharmaceutical, SEP 13, 2023, View Source [SID1234635150]).

In preclinical studies, Anruixi showed stronger antibody-dependent cell-mediated cytotoxicity (ADCC), a larger volume of distribution at steady state, and more sustained clearance of B cells, demonstrating better efficacy compared to other products. Positive results were observed in a randomized, double-blind, active-controlled phase III clinical trial of Anruixi, conducted in 43 study sites nationwide with 487 subjects enrolled. In the head-to-head study with Rituximab, the overall response rate of Anruixi + CHOP was not inferior to that of R-CHOP in patients with early-stage DLBCL, and it had a significantly higher complete response rate vs. R-CHOP. In terms of long-term survival benefits, the Anruixi group achieved better 1-year, 2-year, and 3-year PFS and OS rates compared with the Rituximab group.

As the first domestically developed Class I anti-CD20 drug in China, Anruixi will become BioRay’s next major product following Anruize. Additionally, clinical research is being conducted to explore the use of Anruixi in the field of autoimmune diseases, such as primary immune thrombocytopenia (ITP).

"As the company’s sixth product on the market and its first new drug in the field of tumor immunology，we are particularly grateful for the tremendous efforts made by the clinical researchers who participated in the product’s clinical study, our partners, and our colleagues at Bioray." said Dr. Haibin Wang, CEO of Bioray. "In the future, Bioray will continue to focus on the field of immunology and the unmet medical needs, providing more clinical treatment options, and bringing more medical solutions to patients."

J INTS BIO, WCLC 2023 – Presentation of Phase 1/2 study of ‘JIN-A02’, a Novel Oral 4th Generation EGFR TKI

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]).

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.

ThirtyFiveBio Awarded Innovate UK Biomedical Catalyst Grant to Advance GPR35 Inhibitor Program for Treatment of Gastrointestinal Disease and Cancers

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.

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.