In a KRAS G12C-mutated NSCLC cell line, Calu-1, Hillstream BioPharma Demonstrated Significantly Greater Tumor Inhibition Combining Pembrolizumab, an anti-PD-1 antibody, and HSB-1216, a Ferroptosis Inducer

Rhea-AI Summary

Hillstream BioPharma (Nasdaq: HILS) has announced promising initial results in a study evaluating the synergy between its therapeutic candidate HSB-1216 and Pembrolizumab, an anti-PD-1 antibody, in treating KRAS G12C-mutated non-small cell lung cancer (NSCLC). The study showcases a significant increase in tumor inhibition of Calu-1 cells, indicating a potential new avenue for enhancing treatment efficacy in NSCLC.

Despite advancements in anti-PD-1 therapies, survival rates in NSCLC remain low, suggesting a clear need for novel treatment combinations. HSB-1216 targets ferroptosis, a new anti-cancer mechanism, and is expected to enter clinical trials in 2023.

Positive

• Significant tumor inhibition observed with the combination of HSB-1216 and Pembrolizumab in Calu-1 cells.
• HSB-1216 targets a new anti-cancer mechanism, ferroptosis, which may improve treatment options for drug-resistant cancers.

Negative

• None.

Synergy and crosstalk between Ferroptosis and the Anti-PD-1 Pathways in KRAS G12C-mutated non-small cell lung cancer (NSCLC) cells

Lung cancer remains one of the leading causes of cancer-related deaths worldwide NSCLC accounts for approximately 80–85% of all cases of lung cancer

BRIDGEWATER, N.J., Feb. 10, 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 initial results evaluating the synergy of HSB-1216 with immune checkpoint inhibitors in KRAS G12C-mutated non-small cell lung cancer (NSCLC) cells, Calu-1, with Pembrolizumab, an anti-PD-1 antibody. The study demonstrated significantly greater tumor inhibition of Calu-1 cells, when grown with human PBMCs (SEB-activated) and treated with HSB-1216 and Pembrolizumab.

“We are greatly encouraged by the initial results showing crosstalk and synergy between an established and validated immuno-oncology pathway, anti-PD-1, and Ferroptosis, a new emerging iron-dependent cell death pathway and mechanism of action for HSB-1216,” said Randy Milby, Hillstream’s Chief Executive Officer.

Lung cancer remains one of the leading causes of cancer-related deaths worldwide with NSCLC accounting for approximately 80–85% of all cases. Despite significant progress and the development of anti-PD-1/PDL-1 therapeutics, the estimated 5-years overall survival (OS) remains low. anti-PD-1/PDL-1 therapeutics have substantially improved overall survival with an acceptable safety profile in NSCLC patients, however, not all patients respond. Several combination strategies are under evaluation, including evaluation of chemotherapy, targeted therapies and other modalities in combination with immunotherapy.

About Hillstream BioPharma Inc.
Hillstream BioPharma, Inc. is 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. The Company’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) of drug resistant cancers. The Company’s emerging immuno-oncology pipeline is led by the HSB-1940 Quatrabody™, an anti-PD-1 novel biologic coated onto Quatramers, expected to enter the clinic in 2024.

Hillstream’s Quatramer™ proprietary tumor targeting platform extends duration of action and minimizes off-target toxicity for biologics, mRNA, peptides, small molecules and other modalities in the tumor microenvironment. Quatrabody conjugates novel biologics developed against undruggable epitopes of validated immuno-oncology targets, including PD-1, HER2, PDL-1, TROP2 and now MUC1-C, with greater binding affinity than approved therapies. 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
www.hillstreambio.com

Source: Hillstream BioPharma Inc.

A graph accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/39734abf-bc37-43f3-91f8-ffb8063b817b

FAQ

What are the initial results of the HSB-1216 study with Pembrolizumab?

The study showed significantly greater tumor inhibition in KRAS G12C-mutated NSCLC Calu-1 cells when treated with HSB-1216 alongside Pembrolizumab.

When are HSB-1216 clinical trials expected to start?

HSB-1216 is expected to enter clinical trials in 2023.

What type of cancer does Hillstream BioPharma focus on?

Hillstream BioPharma focuses on drug-resistant cancers, particularly non-small cell lung cancer (NSCLC).

What is ferroptosis in cancer treatment?

Ferroptosis is an emerging anti-cancer mechanism that leads to iron-mediated cell death, being targeted by Hillstream's candidate HSB-1216.

How does HSB-1216 work with PD-1 inhibitors?

HSB-1216 has shown a synergistic effect with PD-1 inhibitors like Pembrolizumab, potentially improving treatment outcomes for NSCLC.