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.

Key Partnerships:

  • 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.
  • BeiGene

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.

Investors are advised to conduct their own independent research into individual stocks before making a purchase decision. In addition, investors are advised that past stock performance is not indicative of future price action.

You should be aware of the risks involved in stock investing, and you use the material contained herein at your own risk. Neither SIMONSCHASE.CO nor any of its contributors are responsible for any errors or omissions which may have occurred. The analysis, ratings, and/or recommendations made on this site do not provide, imply, or otherwise constitute a guarantee of performance.

SIMONSCHASE.CO posts may contain financial reports and economic analysis that embody a unique view of trends and opportunities. Accuracy and completeness cannot be guaranteed. Investors should be aware of the risks involved in stock investments and the possibility of financial loss. It should not be assumed that future results will be profitable or will equal past performance, real, indicated or implied.

The material on this website are provided for information purpose only. SIMONSCHASE.CO does not accept liability for your use of the website. The website is provided on an “as is” and “as available” basis, without any representations, warranties or conditions of any kind.  

Leave a Reply

Your email address will not be published. Required fields are marked *