Pipeline

HWK-007

HWK-007 represents a differentiated opportunity to be among the first next-wave ADCs in clinical development for high Protein Tyrosine Kinase 7 (PTK7) expressing cancers.

PTK7 is an oncofetal pseudo kinase that drives embryonic early development. It is down-regulated in adult tissues and broadly up-regulated and over-expressed in solid tumors, with moderate to high expression across a range of cancer types.

Pfizer’s first-generation ADC, cofetuzumab pelidotin provided proof of concept for PTK7-targeted ADCs.

HWK-007 is being evaluated in IND-enabling studies. The Phase 1 trial is planned in non-small cell lung cancer and platinum resistant ovarian cancer, with potential to expand into novel indications (e.g. gastrointestinal, gynecological).

PTK7 Expression Across Solid Tumors¹ (Annual US Incidence)

HWK-016

HWK-016 is the first ADC that targets the membrane-bound portion of Mucin 16 (MUC16), a glycoprotein often overexpressed in cancers of female origin, including ovarian, cervical and endometrial cancers. Shed MUC16, or CA125, is an important biomarker for cancer screening and disease monitoring in gynecologic cancers, specifically in ovarian cancer.

The effectiveness of therapeutics targeting MUC16 has been hindered by “antigen sink effect.” When MUC16 is cleaved from the tumor cells and released into circulation, ADCs can bind to this shed portion, which is then cleared from the patient rather than reaching the tumor.

MUC16 is clinically validated, including by Genentech’s ADC program that targets the shed portion of MUC16. HWK-016 is designed to overcome the limitations of first-generation MUC16 ADCs by directly targeting the membrane bound, non-shed portion of MUC16.

HWK-016 is currently being evaluated in IND-enabling studies. The Phase 1 trial is planned in ovarian cancer, with potential to expand into additional indications (e.g. endometrial, cervical).

HWK-206

HWK-206 is designed to address the clinically validated neuronal target seizure protein six (SEZ6), which is often overexpressed in cancers of neuroendocrine origin.

SEZ6 is a CNS-limited protein overexpressed in tumors of neuroendocrine origin, including small cell lung cancer (SCLC), other neuroendocrine neoplasms, and some CNS tumors.

HWK-206 utilizes a dual epitope binding, or biparatopic, approach which can potentially improve internalization and effectiveness of the ADC. HWK-206 is the only biparatopic ADC in development for small cell lung cancer. In preclinical models, HWK-206 has demonstrated the potential to outperform available treatment approaches and other single epitope ADCs in development.

HWK-206 is currently in candidate selection. The Phase 1 trial is planned in small-cell lung cancer and neuroendocrine neoplasms, where there are limited treatment options.