Hillstream BioPharma Signs an Exclusive Option Agreement to Advance Next-Generation Anti-MUC1-C Agents for Drug Resistant Cancers

Hillstream BioPharma, Inc. (Nasdaq: HILS) (“Hillstream”, or the “Company”), a biotechnology company developing novel therapeutic candidates targeting ferroptosis, an emerging new anti-cancer mechanism resulting in iron mediated cell death for drug resistant and devastating cancers, today announced signing an exclusive option agreement with Dana-Farber Cancer Institute to license technology targeting the MUC1-C oncoprotein.

The MUC1 gene was identified by Dr. Donald Kufe, Distinguished Physician and Researcher at Dana-Farber and based on its overexpression in human cancers. Dr. Kufe’s long-standing work has supported the premise that prolonged activation of MUC1-C in settings of chronic inflammation promotes cancer.

Dr. Kufe has demonstrated that MUC1-C is necessary for multiple hallmarks of the cancer cell, including (i) the persister cell (PC) state, (ii) drug resistance, (iii) immunosuppression, and (iv) poor clinical outcomes. Importantly, he has found a marked MUC1-C dependency for cancer stem cells (CSCs) derived from highly aggressive TNBCs, SCLCs, MCCs and NEPCs. Based on these findings, MUC1-C has emerged as an exceptional target for cancer treatment with agents developed in the Kufe laboratory.

Dana-Farber has granted under an exclusive option agreement to Hillstream Biopharma Inc., certain of its proprietary technology which if converted to an exclusive license agreement, will allow Hillstream to develop anti-MUC1-C antibodies to selectively deliver Hillstream’s Quatramer-based lead candidate HSB-1216 targeting CSC by the induction of ferroptosis. This approach combining HSB-1216 with conjugation to MUC1-C antibodies is highly synergistic for the elimination of CSCs, which is needed for long term responses and cures.

“We look forward to this unique opportunity to work with Dr. Kufe and Dana-Farber,” said Randy Milby, CEO of Hillstream. “This agreement allows Hillstream to leverage our Quatramer platform to advance anti-MUC1-C agents targeting CSCs for the treatment of highly aggressive tumors, which represents a major unmet need for patients.”

About Hillstream BioPharma, Inc.Hillstream BioPharma, Inc. is a biotechnology company developing novel therapeutic candidates against drug-resistant and devastating cancers. Hillstream’s most advanced candidate, HSB-1216, expected to enter clinical trials in 2023, targets ferroptosis, an emerging new anti-cancer mechanism resulting in iron mediated cell death (IMCD) for drug resistant and devastating cancers. Hillstream’s most advanced candidate is HSB-1216, an IMCD modulator, whose active drug was found to be efficacious in a clinical pilot study in Germany in drug resistant tumors, including triple negative breast cancer and epithelial carcinomas. Hillstream intends to initiate IND discussions with the FDA in first half of 2023. Hillstream uses Quatramer™, a proprietary tumor targeting platform which extends duration of action and minimizes off-target toxicity, with HSB-1216 as well as biologics, mRNA, peptides and other modalities in the tumor microenvironment. Quatrabody™ conjugates immuno-oncology targets with greater binding affinity than approved therapies. Hillstream Quatramers with novel biologics developed against proprietary undruggable epitopes of PD-1 and other validated will enter the rapidly growing immuno-oncology therapeutics market leading with HSB-1940, targeting PD-1, followed by additional targets including PD-L1, HER-2, TROP-2 and now MUC1-C.  For more information, please visit: www.hillstreambio.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Hillstream’s expectations, strategy, plans or intentions. These forward-looking statements are based on Hillstream’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Investors should read the risk factors set forth in our Form 10-K for the year ended December 31, 2021 and our periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Hillstream does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

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