On May 28, 2021 HCW Biologics reported that it has filed to raise up to $50 million in an IPO (Press release, HCW Biologics, MAY 28, 2021, View Source [SID1234583286]). The money will set HCW up to take two immunotherapy treatments into the clinic in solid tumors and an autoimmune disorder.

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Florida-based HCW licensed rights to use its most advanced candidate, HCW9201, to Wugen, which is using the molecule in the generation of memorylike NK cell products in two phase 2 clinical trials in patients with relapsed or refractory acute myeloid leukemia. With Wugen initiating those studies with Washington University, HCW is working to get its next two drug candidates into the clinic.

The most advanced of the two wholly owned assets is HCW9218, a bifunctional fusion protein that HCW plans to take into a phase 1b/2 pancreatic cancer clinical trial by the end of the year. HCW9218 is designed to optimize the efficacy and minimize the side effects of chemotherapy by activating IL-15R signaling and trapping three TGF-β isoforms.

In its IPO paperwork, HCW said the "approach is unique from most other existing or investigational therapies," although it still expects to face competition from T-cell engagers, CAR-Ts and other drugs "that target specific tumor-associated antigens using immune cells or other cytotoxic modalities."

HCW is running IND-enabling studies of HCW9218 while carrying out earlier-stage work on its next candidate, HCW9302. The second asset is an IL2-based immunotherapeutic protein designed to treat autoimmune disorders such as alopecia areata by driving the expansion of regulatory T cells. HCW is aiming to take HCW9302 into clinical development in the first half of next year.

The biotech raised the money to reach this point across series A, B and C rounds from 2018 to 2020. HCW CEO Hing Wong and his spouse bought stock in the financing rounds, culminating in the pair holding a 51% stake in the company. Medmira Capital and DeepWork HCW Partners are the two other biggest stockholders.