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Pipeline

We are focused on the development of novel drug candidates with compelling mechanisms of action, regulatory pathways, and commercial opportunities

LX-101: a new approach to targeting IGF-1R

Our lead product candidate, LX-101, is a novel, clinical-stage, “next generation”, precision-engineered targeted therapy directed to the insulin-like growth factor-1 receptor (IGF-1R). IGF-1/IGF-1R pathway over-activity has been implicated in a host of malignancies and autoimmune diseases and we believe represents a scientifically rational target.

LX-101 has a differentiated mechanism of action, and consists of a proprietary, precision-engineered IGF-1 variant, with high affinity to IGF-1R, coupled to a cytotoxic payload, methotrexate. Methotrexate is a cytotoxic inhibitor of DNA synthesis, repair, and cellular replication and has been used to treat patients with certain cancers and autoimmune diseases, including thyroid eye disease (TED).

Active payload

Optimized

IGF-1R variant

LX-101

IGF-1

receptor

Precision targeting: Optimized IGF-1 variant targeting IGF-1R, enabling precise payload delivery to IGF-1R+ cells

Rational payload: Delivers methotrexate, used to treat cancer and autoimmune disease (including TED), directly to diseased cells.

Novel and differentiated: Offers a differentiated mechanism of action compared to past and present IGF-1R targeting agents

Positive clinical experience: Well-tolerated with single agent activity in Phase 1 trials of advanced, pretreated cancer patients

Large market opportunity: Development paths in a wide range of oncologic and autoimmune indications

LX-101, formerly 765IGF-MTX, has been clinically evaluated in Phase 1 trials conducted by the licensor of patients with advanced, pretreated cancer, where it was found to be well-tolerated and demonstrated single agent activity. We intend to further dose escalate and optimize the administration schedule given that the dose limiting toxicity or maximum tolerated dose were not reached.

As a next step, we intend to build upon LX-101’s positive Phase 1 clinical experience and, by leveraging its novel and differentiated features, along with the well-documented involvement of IGF-1R in a multitude of diseases. We plan to advance LX-101 to key clinical milestones that offer the potential for expedited regulatory pathways and attractive market opportunities in oncology and autoimmune disease. With this approach, we believe that we can create a positive impact on patients with certain debilitating diseases.

Pipeline

Oncology

LX-101

Pan-cancer

(IGF-1R              )

low-high

Adult

(IGF-1/IGF-1R enriched)

Pediatric

(IGF-1/IGF-1R enriched)

Autoimmune

LX-101

Thyroid eye disease

Other

IGF-1/IGF-1R enriched = tumor types with well-established IGF-1/IGF-1R pathway involvement, including those with known genetic alternations affecting the pathway and/or elevated IGF-1R expression

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