InnoCare Announces Dosing of First Patient in Clinical Study of the Combination of SHP2 Inhibitor ICP-189 and EGFR Inhibitor Furmonertinib
InnoCare Pharma announced the dosing of the first patient in China in a Phase 1b clinical study of the combination of ICP-189 and furmonertinib for NSCLC. The collaboration with ArriVent aims to accelerate the clinical trial, targeting EGFR mutations in lung cancer patients.
The initiation of the Phase 1b clinical study combining InnoCare's ICP-189 with ArriVent's furmonertinib marks a significant step in the exploration of new treatments for non-small cell lung cancer (NSCLC). The study's progression into patient dosing indicates a transition from theoretical research to practical application, which could potentially lead to a new standard of care if the results prove positive. The combination therapy targets two different molecular pathways, with SHP2 inhibitors like ICP-189 working to enhance anti-tumor activity and furmonertinib selectively inhibiting EGFR mutations known to drive cancer progression.
The strategic collaboration between InnoCare and ArriVent reflects an emerging trend in the pharmaceutical industry where companies combine resources and expertise to expedite the development of promising therapies. Given the prevalence of NSCLC and the limited treatment options for advanced stages, this study could have a substantial impact on the market if the therapy demonstrates a significant clinical benefit. The safety profile and preliminary efficacy of ICP-189 as a monotherapy, coupled with furmonertinib's Breakthrough Therapy designation by the FDA, suggest a strong foundation for the combination's potential success.
The pharmaceutical market, particularly within oncology, is highly competitive and subject to rapid changes based on clinical trial outcomes. The dosing of the first patient in this Phase 1b study is an important milestone for investors to monitor, as it signals the progression of InnoCare's pipeline and potential for future revenue streams. The Breakthrough Therapy designation already granted to furmonertinib by the FDA is indicative of the drug's potential and could facilitate a faster route to market if clinical trials are successful.
Investors should be aware of the implications of this study on InnoCare's market valuation and partnership dynamics. Positive trial results could lead to increased investor confidence and potential licensing deals, while any setbacks might negatively impact the company's stock performance. The focus on a significant unmet medical need within a large patient population provides a sizable market opportunity, which is a key factor for investment consideration.
The regulatory landscape for new drug approvals is complex, particularly for combination therapies targeting diseases like NSCLC. The fact that furmonertinib has already been approved in China and received Breakthrough Therapy designation in the U.S. for certain EGFR mutations bodes well for the regulatory pathway of the combination therapy. It is essential to consider the potential for expedited review processes that could arise from positive clinical data, especially in addressing high unmet medical needs.
Furthermore, the regulatory success of furmonertinib in China, developed by Allist Pharmaceuticals, provides a precedent for the approval of novel therapies in the region. The collaboration between InnoCare and ArriVent may streamline the clinical and regulatory process, leveraging each company's expertise and regulatory experience. Stakeholders should monitor the communication with regulatory bodies as the trial progresses, as any positive endorsements or guidance can significantly affect the development timeline and market potential of the combination therapy.
03/28/2024 - 08:30 PM
BEIJING, China --(BUSINESS WIRE)--
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company announced that the first patient in China has been dosed in the Phase 1b clinical study of the combination of InnoCare’s novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, ICP-189, with ArriVent’s furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor in patients with advanced or metastatic non-small cell lung cancer (NSCLC).
NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. In July 2023, InnoCare and ArriVent BioPharma, Inc. (Nasdaq: AVBP) announced a clinical development collaboration, accelerating the clinical trial of ICP-189 in combination with furmonertinib in patients with advanced or metastatic NSCLC in China .
Furmonertinib is being advanced by ArriVent in global studies in patients with advanced or metastatic NSCLC with EGFR mutations, including exon 20 insertion 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 Allist Pharmaceuticals (SSE: 688578) who discovered furmonertinib. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for furmonertinib for the treatment of patients with previously untreated, locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. Furmonertinib is also being evaluated for the treatment of NSCLC patients with EGFR P-loop alpha-c helix compressing (PACC) mutations.
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. Preliminary efficacy was observed in ICP-189 monotherapy. 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 have been demonstrated.
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said: “We are excited to see the latest progress of our clinical collaboration with ArriVent. SHP2 inhibitors are ideal for the treatment of solid tumors by combination with various targeted drugs and immunotherapies and are expected to address the huge unmet medical needs. We will accelerate the clinical study and expect this innovative therapy to benefit more NSCLC patients early.”
About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing , Nanjing , Shanghai , Guangzhou , Hong Kong , and United States . For more information, please visit: http://www.innocarepharma.com .
Forward-looking Statements
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Source: InnoCare Pharma
What is the significance of the Phase 1b clinical study announced by InnoCare Pharma?
The Phase 1b clinical study involves the combination of ICP-189 and furmonertinib for NSCLC, aiming to address the unmet medical needs of lung cancer patients.
Who is collaborating with InnoCare Pharma in this clinical trial?
ArriVent BioPharma, Inc. (Nasdaq: AVBP) is collaborating with InnoCare Pharma in this clinical trial.
What is the current status of furmonertinib in terms of FDA designation?
Furmonertinib has been granted Breakthrough Therapy designation by the FDA for the treatment of specific NSCLC mutations.
What is the potential benefit of the combination therapy with ICP-189 and furmonertinib?
The combination therapy aims to provide innovative treatment options for NSCLC patients by targeting EGFR mutations in lung cancer.
