Hillstream BioPharma Completes Pre-IND Review with FDA on HSB-1216 for Small Cell Lung Cancer (SCLC)

October 1st, 2020

 Bridgewater, New Jersey, October 21, 2020 – Hillstream BioPharma Inc. (“Hillstream”, the “Company”), a clinical-stage pharmaceutical company, announced that it has successfully completed a pre-Investigational New Drug (IND) review citing a written response from the U.S. Food and Drug Administration (FDA).  The pre-IND review focused on the development plan for Hillstream’s HSB-1216, including the clinical study design and dosing strategy for the initial Phase 1 protocol for small cell lung cancer.  Hillstream proposed to conduct a multi-center, multi-national, first-in-human (FIH) dose escalation and dose expansion trial, Study HSB-1216-001, entitled, “A Phase 1 Study of HSB-1216 in Adult Subjects with Relapsed Tumors, or Who have Metastatic Small Cell Lung Cancer (SCLC) with Progression on or After Platinum-Based Chemotherapy (relapsed SCLC).”

“We are pleased to get such a timely response from the FDA, especially where Covid-19-related treatments are the main focus during these unparalleled times.  It should be noted that Covid-19 is relative to our plans as we file the IND and initiate a Phase 1 trial for HSB-1216 for small cell lung cancer,” stated Randy Milby, Chief Executive Officer of Hillstream.  “We appreciate the FDA’s guidance as we endeavor to find a cure for small cell lung cancer.”

About HSB-1216 (Salinomycin QUATRAMER™)

HSB-1216, a potent compound, which uses the Quatramer™ delivery platform and targets both chemotherapy resistant tumors due to its effects on epithelial-mesenchymal transition (EMT).  Recently, research suggests an even more powerful mechanism called ferroptosis is key to how the drug stops tumors – this process sequesters iron in lysosomes and allows HSB-1216 to cause lysosomal membrane permeabilization in hard to treat cancer cells – causing them to rupture and stop replicating.

About Hillstream BioPharma Inc.

Hillstream BioPharma Inc. (“Hillstream”, the “Company”) is a clinical stage platform company developing Quatramer™, a novel targeted and tunable therapeutics. Quatramer™ are designed with specific physico-chemical parameters to target specified cells or tissues and converge a therapeutic payload at the site of disease to boost efficacy while abating adverse effects on healthy tissue. The strategy is to leverage the platform to develop a pipeline of Quatramer™, initially in the oncology space.  The Company is advancing lead candidates, including novel small molecules and proprietary DNA expression vectors which encode inflammatory cytokines directly into the tumor’s genome.   The lead drug candidate, HSB-1216, is in IND-enabling studies and can be developed in the clinic in 2021 for small cell lung cancer, or SCLC, and triple-negative breast cancer. The Company has achieved orphan drug designation in SCLC for HSB-1216’s payload and plan to develop other Quatramer™ based compounds with therapeutic cargoes from the product pipeline, which include DNA-based contents which hijack the tumor’s genetic code and kill the tumor from within by generating an array of cancer killing cytokines, such as tumor necrosis factor alpha or TNF-a and interleukin-2 or IL-2.  The platforms’ tunability stems from the fact that the system can be modified and adjusted to deliver single or multiple ratios of payloads in order to optimize synergistic mechanisms of action in lower doses in order to eradicate rare cancers and devastating tumors with minimal or no treatment options. For more information, please visit tharimmune.com.

Forward Looking Statements
This press release includes forward-looking statements including, but not limited to, statements related to the development of drug candidates, our operations and business strategy, our expected financial results, and corporate updates. The forward-looking statements contained in this press release are based on management’s current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Actual results may differ materially from those expressed by these expectations due to risks and uncertainties, including, among others, those related to our ability to obtain additional capital on favorable terms to us, or at all, including, without limitation, to fund our current and future preclinical studies and clinical trials and the success, timing and cost of our drug development program and our ongoing or future preclinical studies and clinical trials, including, without limitation, the possibility of unfavorable new clinical and preclinical data and additional analyses of existing data, that the risks that prior clinical and preclinical results may not be replicated, and risks associated with the current coronavirus pandemic.  Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to review or update any forward-looking statement except as may be required by applicable law.

Hillstream BioPharma Inc.

Randy Milby
President & CEO
Hillstream Biopharma Inc.
Tel: +1 302.743.2995
Email: rmilby@tharimmune.com

Investor Contact
Jennifer K. Zimmons, Ph.D.

Investor Relations
Zimmons International Communications, Inc.
Tel: +1 917.214.3514
Email: jzimmons@zimmonsic.com

Source: Hillstream BioPharma Inc.