Overview

G&L Healthcare Advisors partnered with an innovative biotechnology company developing a first-in-class anti-FGFR2b antibody for the treatment of gastric cancer (GC) and gastroesophageal junction cancer (GEJ).

This Phase III-ready asset required a comprehensive regulatory, clinical, and biomarker strategy to secure U.S. Food and Drug Administration (FDA) approval, including the preparation for a Type B End-of-Phase II (EOP2) meeting.

G&L assembled a multidisciplinary team to lead the client through critical regulatory submissions and trial design discussions with the FDA.

Challenges

The biotech company faced the following challenges in its development of a novel immune-oncology treatment:
Regulatory strategy and FDA engagement: The client needed expert regulatory guidance to prepare for a Type B FDA EOP2 meeting, which was critical for advancing their Phase III trial.
Clinical and biomarker strategy: The company required assistance in refining its clinical trial design, including patient stratification for populations overexpressing FGFR2b and the development of a pre-screening biomarker strategy.
Multidisciplinary support for Phase III planning: Effective integration of regulatory, clinical, and Companion Diagnostics (CDx) expertise was essential to ensure a robust strategy for FDA approval.

G&L’s Approach and Solution

To meet the client’s needs, G&L provided strategic support across multiple areas:
Assembled a multidisciplinary team: G&L brought together a team of experts in Regulatory Affairs, Companion Diagnostics (CDx), and Clinical Development to support the client through the regulatory and clinical process.
Authored and submitted the Type B EOP2 meeting request and Briefing Book: G&L worked closely with the client to prepare and submit the DA Type B EOP2 Meeting Request and Briefing Book. This included detailed discussions on the regulatory strategy, clinical design, and biomarker strategy.
Provided guidance on critical study design elements: G&L provided strategic input into key elements of the Phase III study design, such as:
Patient stratification: Defining subgroups based on overexpression of FGFR2b versus a broader FGFR2b-positive population.
Biomarker strategy: Developing a pre-screening strategy for selecting the appropriate patient population.
Safety monitoring plans: Ensuring rigorous safety protocols to mitigate risks during the Phase III trial.
Risk mitigation: Developing a plan to address potential challenges during trial execution.
Prepared the client for the FDA Type B meeting: G&L ensured the client was fully prepared for the FDA Type B EOP2 meeting, supporting the development of presentation materials and rehearsing potential regulatory questions.

Impact and Outcomes

With G&L’s regulatory and clinical guidance, the client achieved critical milestones:
Development of a robust and viable Phase III strategy: The client was able to finalize a commercially viable and scientifically sound Phase III development strategy, addressing both clinical and regulatory considerations.
Successful FDA Type B meeting preparation: G&L’s support ensured that the client was well-prepared for their interaction with the FDA, leading to constructive feedback and strategic regulatory advice.
Breakthrough Therapy Designation granted: As a result of G&L’s comprehensive support, the client secured ‘Breakthrough Therapy Designation’ from the FDA, expediting the development and review of the drug.
Asset acquired by a global biopharmaceutical leader: Following the success of the regulatory strategy and FDA engagement, the client’s asset was acquired by a major biopharmaceutical company, demonstrating the commercial viability of the therapy.