Leap Therapeutics Inc
LPTX is a clinical-stage immuno-oncology biotech. Their clinical programs primarily focus on inhibiting the Wnt signaling pathway and targeting Claudin18.2, both of which play crucial roles in cancer development and progression.
I met with management on December 13, 2023. The company’s $70 million +/- in cash is sufficient to reach upcoming readouts from two randomized clinical trials. The team is commercially-focused on getting to Phase 3 end points with business development options in place.
Baker Bros Advisors LP own nearly 20% of LPTX stock and warrants. Baker Bros first invested in LPTX in 2020 via Series A mandatorily convertible preferred stock. Series A converted into 14 million pre-funded warrants.
Wnt, also known as Wingless/Int-1, refers to a family of secreted glycoproteins that play crucial roles in various cellular processes, including embryonic development, cell fate determination, cellular proliferation, tissue morphogenesis, and stem cell function. They are involved in a diverse range of pathways, most notably the Wnt signaling pathway, which regulates a multitude of cellular activities.
Wnt Signaling Pathway DKN-01 targets innate immunity by activating NK cells, reprogramming macrophages and inhibiting MDSCs, setting the stage for an enhanced adaptive immune response by anti-PD-1. This is a first-in-class DKK1 agonist currently being evaluated in multiple Phase 2 clinical trials across various cancer types, including:
- Esophagogastric cancer: DKN-01 is being investigated as a monotherapy and in combination with chemotherapy in Phase 2 trials.
- Gynecologic cancers: DKN-01 is being tested in combination with chemotherapy in Phase 2 trials for ovarian and endometrial cancers.
- Colorectal cancer: A Phase 2 trial (DeFianCe) is underway evaluating DKN-01 in combination with standard-of-care bevacizumab and chemotherapy for patients who have received prior systemic therapy. Part B uses mPFS as the primary endpoint and the benchmark varies from ~4.2m to 8.5m in this setting with Leap estimating ~6m as the target mPFS.
- FL-501: This is a humanized monoclonal antibody targeting Claudin18.2, currently in Phase 2 development for patients with gastric and pancreatic cancer.
Claudin18.2 FL-301: This is another humanized monoclonal antibody targeting Claudin18.2, currently in Phase 1/2 development for patients with advanced solid tumors. Preclinical Programs: LPTX also has preclinical programs targeting other novel targets, including:
- 2/CD137: This program combines the Claudin18.2 targeting of FL-301 with the immunostimulatory activity of CD137 to potentially enhance anti-tumor immune response.
- GDF15: This program focuses on developing therapeutic antibodies against GDF15, a protein associated with tumor growth and metastasis.
- MD Anderson Cancer Center: Collaboration involves research and clinical development of DKN-01 for pancreatic cancer.
- Memorial Sloan Kettering Cancer Center: Collaboration focuses on the development of FL-301 for gastric cancer.
- The Wistar Institute: Collaboration involves research on the role of Claudin18.2 in cancer and the development of FL-301.
LPTX plans to Advance DKN-01 through Phase 2 clinical trials and into pivotal Phase 3 trials, continue developing FL-301 and FL-501 in Phase 2 clinical trials and potentially expand into additional cancer indications. Also, the company will further explore the potential of its preclinical programs, such as Claudin18.2/CD137 and GDF15.
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