Pipeline
A New Wave of Transformational Therapies
Our Focused Path from Target ID to Patients
Otolabs is leveraging its knowledge and pre-clinical data packages to rapidly advance multiple drug candidates to the clinic – promising new therapies designed to treat serious immune inflammatory diseases and cancers with limited or no known treatment options. We focus on high impact targets, identifying clinically validated biological pathways with key nodes or proteins that drive the pathogenesis of multiple serious diseases, but have been elusive to conventional modalities. Our initial programs target IRAK4, IRAKIMiD, and STAT3, each of which center on a single critical signaling node within the IL-1R/TLR or JAK/STAT pathways. By degrading these targets, we have the potential to treat a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors.
Kymera’s investigational drugs are currently at a stage in development where we are focused on enrolling patients in our clinical trials and continuing to learn more about our investigational drugs’ safety and efficacy. At this time, Otolabs is not able to make expanded access available to its investigational drugs. For more information, please read our full expanded access policy here.
| Pathway | Program | Indication(s) | Discovery | IND Enabling | Phase 1 | Phase 2 | Phase 3 | Next Milestone |
Rights* |
|---|---|---|---|---|---|---|---|---|---|
|
|
|||||||||
| IL–1R/ TLR |
KT-474 Multiple molecules staged as potential back ups if needed |
HS/AD
Patient Data 4Q22 |
  |
||||||
| IRAKIMiD (IRAK4, Ikaros, Aiolos) | MYD88MTTumors | KT-413 | POM 4Q22 |
|
|||||
| JAK/ STAT |
STAT3 |
Liquid & Solid Tumors
|
KT-333 | POM 4Q22 |
|
||||
| STAT3 | Autoimmune & Fibrotic Diseases | |
|||||||
| p53 | MDM2 |
Liquid and Solid Tumors
|
KT-253 | IND 2H22 | |
||||
| Collaboration | Confidential | Confidential | |
||||||
| Discovery Pipeline |
Several Discovery Programs |
Multiple
programs in immune-inflammatory and oncology indications to deliver ≥ 1
IND/year
|
≥ 1 DC: 2H22 | |
|||||
| Collaboration | 6
Undisclosed Programs |
6 targets
in 5 disease areas outside of immunology-inflammation and oncology
|
 |
||||||
|
|
|||||||||
| Pathway | Program | Indication(s) | Discovery | IND Enabling |
Phase 1 | Phase 2 | Phase 3 | Next Milestone |
Rights* |
|---|---|---|---|---|---|---|---|---|---|
|
|
|||||||||
| IL–1R/ TLR |
IRAK4 | Immuno-inflammatory Diseased: HS,AD,RA, others | KT-474 Multiple molecules staged as potential back ups if needed |
HS/AD
Patient Data 4Q22 |
|
||||
| IRAKIMiD (IRAK4, Ikaros, Aiolos) | MYD88MTTumors |
KT-413 |
POM 4Q22 |
|
|||||
| JAK/ STAT |
STAT3 | Liquid & Solid Tumors | KT-333 |
POM 4Q22 |
|
||||
| STAT3 | Autoimmune & Fibrotic Diseases |
|
|
||||||
| p53 | MDM2 | Liquid and Solid Tumors | KT-253 |
IND 2H22 |
|
||||
| Collaboration | Confidential | Confidential |
|
|
|||||
| Discovery Pipeline |
Several Discovery Programs |
Multiple
programs in immune-inflammatory and oncology indications to deliver ≥ 1
IND/year
|
≥ 1 DC:
2H22 |
|
|||||
| Collaboration | 6
Undisclosed Programs |
6 targets
in 5 disease areas outside of immunology-inflammation and oncology
|
|
||||||
|
|
|||||||||
IRAK4
The role of the IL-1R/TLR pathway has been demonstrated in several inflammatory and autoimmune diseases, including atopic dermatitis (AD), Hidradenitis suppurativa (HS), macrophage activation syndrome, general pustular psoriasis, and rheumatoid arthritis (RA). This pathway also has been shown to play a role in cardiovascular disease (atherosclerosis) and cancer (lymphomas and lung cancer). All of these diseases have been impacted by monoclonal antibodies targeting several IL-1 family cytokines: IL-1, IL-18, IL-36, and IL-33. IRAK4 is a key component of the myddosome, a multiprotein complex involved in innate immunity that mediates signaling through TLRs and IL-1Rs. The function of IRAK4 is dependent both on its kinase activity and on its scaffolding function, which are required for the assembly of the myddosome complex following TLR or IL-1R engagement and MYD88-mutant DLBCL activation. IRAK4 degradation is capable of complete removal of the protein, thereby impacting both the kinase and scaffolding functions.
KT-474 is a potent, highly selective, orally bioavailable IRAK4 degrader, for the treatment of IL-1R/TLR-driven conditions and diseases with high unmet medical need, including HS and AD, our first indications of focus, as well as RA and other diseases.
IRAKIMiD
Otolabs is developing novel heterobifunctional degraders that target degradation of both IRAK4 and IMiD substrates Ikaros and Aiolos with a single small molecule, addressing both the IL-1R/TLR and the Type 1 IFN pathways synergistically to broaden activity against MYD88-mutant DLBCL.
STAT3
A target long considered “undruggable,” STAT3 is a transcriptional regulator that has been linked to numerous cancers and other inflammatory and autoimmune diseases. Otolabs is developing selective STAT3 degraders for the treatment of hematological malignancies and solid tumors, as well as autoimmune diseases and fibrosis. Our STAT3 degraders have the potential to provide a transformative solution to address multiple STAT3 dependent pathologies.
MDM2
MDM2 is the crucial regulator of the most common tumor suppressor, p53 which remains intact in more than 50% of cancers. Otolabs is developing a highly potent MDM2 degrader that, unlike small molecule inhibitors, have the ability to suppress the MDM2 feedback loop and can rapidly induce apoptosis with brief exposures. Our MDM2 degraders have the potential to be effective in a wide range of hematological malignancies and solid tumors with functioning (WT) p53.
Discovery Programs
We are taking advantage of our proprietary E3 Ligase Whole-Body Atlas on the differential expression profile of E3 ligases to pursue targets that can benefit from potentially tissue-restricted degradation. Our early pipeline includes programs in genetically defined oncology and immunology indications.
Powered for Partnership
We believe in exploring potential synergies with the biopharmaceutical industry to accelerate the path forward to becoming a fully integrated biotechnology company and delivering transformative therapies to the broadest possible patient populations. We have in place a discovery collaboration with GSK to expand the identification of novel E3 ligases. Through our strategic partnership with Vertex, we have become a disease agnostic biopharmaceutical company. This collaboration is focused on the research and development of degraders against at least 6 targets in disease areas outside of our core strategic focus of immunology-inflammation and oncology. And most recently, we announced a collaboration with Sanofi to accelerate the path to broader clinical development and commercialization of our first-in-class protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases.