Acquisition Positions Hillstream as a Diversified Biotechnology Company Developing Novel, IND-Ready
Immuno-Oncology Treatments for Orphan Tumors with Devastating and Unmet Need

Chester, NJ — September 10, 2019 – Hillstream BioPharma Inc. (“Hillstream”) today announced the acquisition of key immuno-oncology (IO) assets from privately held NanoProteagen, Inc., including its proprietary drug delivery platform QUATRAMER, a proprietary, non-viral tumor infiltrating enhanced injectable suspension.

The company believes this acquisition solidifies its position as a novel drug delivery platform company, as it includes several immuno-oncology drug candidates.  In addition to the QUATRAMER delivery platform, which forms the basis of the entire portfolio, Hillstream has acquired and is developing HSB-114, an immunotherapeutic agent delivering the human tumor necrosis factor-alpha (TNF-α) gene.  Hillstream is progressing towards a rapid IND filing process and plans to initiate a clinical trial in advanced, metastatic soft tissue sarcomas (STS).

“With the addition of QUATRAMER as our key platform, we are now poised to enter the IO space with a novel technology that we believe may provide a non-viral tumor specific delivery vehicle of cytokines with high efficacy in tumors with too narrow a therapeutic index for clinical feasibility, including TNF-alpha and others,” stated Randy Milby, chief executive officer of Hillstream. “With the preclinical success we’ve had to date with HSB-114, we anticipate a rapid progression toward an IND and initiation of Phase 1b/2a trials.  We look forward to sharing our progress of these and future milestones with current and potential shareholders.”

HSB-114 is a next generation therapy of a previously developed predecessor compound which demonstrated that replication-deficient adenovector delivery of TNF-a coding DNA in combination with single-daily fractionated radiation therapy was well tolerated in patients with STS of the extremity.  Of the 11/13 evaluable patients, 11 (85%) showed a pathological complete response/partial response.⁴   Building on these data, Hillstream believes its non-viral QUATRAMER technology would deliver the human TNF-a gene intratumorally into STS, which are unresectable or incurable with available drugs, would offer a distinct advantage of utilizing the cytotoxic killing effect while minimizing side effects to normal tissue.

“The acquisition by Hillstream marks the beginning of a new chapter in our scientific journey to advance our immuno-oncology assets,” said Surender Kharbanda, Ph.D. President & CEO, Co-Founder and Director, of NanoProteagen.  “This combines our shared vision to further advance the body of science in oncology and develop assets that will provide improved treatments for soft tissue sarcoma and multiple other cancers with significant unmet medical need.”

In addition, Hillstream continues progressing its pre-clinical pipeline assets of treatments against small cell lung cancer with HSB-1216.  HBS-1216 is a novel formulation of salinomycin, a potent cancer stem cell inhibitor, which also utilizes the company’s proprietary QUATRAMER delivery platform.  This combined portfolio enables Hillstream with additional capability to address unmet needs in multiple high unmet need orphan tumors.

About Hillstream Biopharma Inc.

Hillstream BioPharma Inc. (“Hillstream”) is a near-clinical stage biotechnology company advancing improved therapies for patients with cancer via its proprietary QUATRAMER technology.  QUATRAMER technology is a proprietary, enhanced sustained injectable system enabling novel therapeutics development in immuno-oncology. Developed by world-renowned cancer researchers and clinicians from Dana-Farber Cancer Institute, Harvard Medical School and Indian Institute of Technology (IIT), Hillstream is using the technology to develop a pipeline of unique drugs which leverages the platform via directed intranuclear and intracellular delivery of small molecules, peptides, genes, other macromolecules  and biologics to the tumor cell, while significantly minimizing exposure to normal tissues.  The pipeline is led by HSB114, an immunotherapeutic agent delivering the human tumor necrosis factor-alpha (TNF-a) gene using QUATRAMER technology, progressing towards a rapid IND filing process towards a clinical trial in advanced, metastatic soft tissue sarcomas (STS).  The QUATRAMER platform allows Hillstream to build a strong patent estate and seek both FDA Orphan Drug Designation and more rapid FDA review for specific indications.  For more information, please visit hillstreambio.com.

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

Investor Contact:
Jennifer K. Zimmons, Ph.D.
Investor Relations
Zimmons International Communications
Tel: +1 917.214.3514
Email: jzimmons@zimmonsic.com

Media Contact:
Jules Abraham
JQA Partners, Inc.
Tel: +1 917.885.7378
Email: jabraham@jqapartners.com
Source: Hillstream BioPharma Inc.

References:

1. Cancer Stat Facts: Soft Tissue including Heart Cancer Cancer Stat Facts: Soft Tissue including Heart Cancer. https://seer.cancer.gov/statfacts/html/soft.htmlaccessed August 8, 2019
2. Pennica D, Nedwin GE, Hayflick JS, Seeburg PH, Derynck R, Palladino MA, et al. Human tumour necrosis factor: precursor structure, expression and homology to lymphotoxin. Nature. (1984) 312:724–9. doi: 10.1038/312724a0
3. Eggermont AM, Schraffordt Koops H, Klausner JM, Kroon BB, Schlag PM, Liénard D, et al. (1996). Isolated limb perfusion with tumor necrosis factor and melphalan for limb salvage in 186 patients with locally advanced soft tissue extremity sarcomas. the cumulative multicenter European experience. Ann Surg. 224, 756–64; discussion 764–55. doi: 10.1097/00000658-199612000-00011
4. Mundt, JA. et. al. A Phase I Trial of TNFerade Biologic in Patients with Soft Tissue Sarcoma in the Extremities. Clinical Cancer Research Vol. 10, 5747-5753 (2014) doi: 10.1158/1078-0432.ccr-04-0296