Hillstream BioPharma Signs Exclusive Option Agreement with Applied Biomedical Science Institute (ABSI) to License Technology for HER2 and HER3 to be Developed for Potential Treatments Against Drug Resistant Cancers Including HER2-Positive Metastatic Breast Cancer, Gastric Cancer, Lung Cancer and Ovarian Cancer

HER2 and HER3 Conformational Domain Bridging Epitopes in Antibodies via an Exclusive Option Allows Hillstream BioPharma to Develop Proprietary Multi-format Biologics (bispecific, ADC, CAR-T) against Drug Resistant Breast and Gastric Cancers

Anti-HER2 and Anti-HER3 monoclonal antibodies could be effective against a number of epithelial tumors including HER2-positive metastatic breast cancer, gastric cancer, lung cancer and ovarian cancer

Antibody CDRs against HER2 and HER3 Conformational Domain Bridging Epitopes can be used in multiple formats including bi- and tri-specific antibodies, ADCs (antibody drug conjugates), CAR-T and CAR-NKs, as well as in Quatramers™ and Quatrabodies™

BRIDGEWATER, N.J., Feb. 13, 2023 (GLOBE NEWSWIRE) — Hillstream BioPharma, Inc. (Nasdaq: HILS) (“Hillstream” or the “Company”), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancers using ferroptosis, an emerging new anti-cancer mechanism resulting in iron mediated cell death, and immuno-oncology targeted novel biologics, today announced signing an exclusive option agreement with Applied Biomedical Science Institute (ABSI) to license technology for HER2 and HER3 Conformational Domain Bridging Epitopes in human monoclonal antibodies to develop proprietary multi-format biologics (bi- and tri-specific antibodies, ADCs (antibody drug conjugates), CAR-T and CAR-NKs, in Quatramers and Quatrabodies) against drug resistant cancers including HER2-positive metastatic breast cancer, gastric cancer, lung cancer and ovarian cancer .

The ErbB family of cell surface proteins are some of the most well-known and validated oncology drug targets including ErbB2 or HER2 (human epidermal growth factor receptor) and Erb3 or HER3. The family of antibodies and biologics against HER2 starting with HERCEPTIN® (trastuzumab) approved in 1998 for breast cancer, one of the first few anti-cancer antibodies, as well as PERJETA®, KADCYLA® and PHESGO® totaled $8.4 billion in 2022 sales for Roche/Genentech. Antibodies against HER2 and HER3 bind to different domains of the extracellular portion of the proteins or epitopes with trastuzumab binding domain IV of HER2 primarily. HER2 is also one of the most utilized targeting antigens for antibody drug conjugates to treat HER2 positive cancers with two approved antibodies, Roche/Genentech’s PERJETA® and Daiichi Sankyo/AstraZeneca’s ENHERTU®.

The Applied Biomedical Science Institute has developed technology to target unique functional epitopes of the cancer targets HER2 and HER3.   Monoclonal antibodies being developed at ABSI are unique from the currently approved anti-HER2 antibodies.   ABSI has granted under an exclusive option agreement to Hillstream, certain of its proprietary technology which if converted to an exclusive license agreement, will allow Hillstream to develop HER2 and HER3 antibodies, including multi-specific and Quatramer- based therapeutics incorporating portions of the antibodies.

“We look forward to this unique opportunity to work with Dr. Smider and the Applied Biomedical Science Institute,” said Randy Milby, CEO of Hillstream. “This agreement allows Hillstream to build our antibody platform to advance our immune-oncology biologic pipeline with HER2 and HER3 agents targeting highly aggressive drug resistant metastatic tumors, representing a major unmet need for patients.”

About Applied Biomedical Science Institute
The Applied Biomedical Science Institute (ABSI) is a 501(c)(3) non-profit organization taking a leading role in basic research and its rapid clinical translation by performing cutting-edge basic and translational research.  With deep expertise in antibody genetics, biology, engineering, and discovery technologies, ABS Institute promotes therapeutic and diagnostic translation through their own internal research, collaborations, or licensing activities.  The Institute also trains early-stage researchers in biomedical research through post-doctoral fellow and internship programs.    

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 and TROP-2.  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.

Investor Relations Contact:
Email: investorrelations@hillstreambio.com


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