(NASDAQ: HILS) Profile

OUR NEW PROFILE IS:   (NASDAQ: HILS)

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Recent collaboration allows Hillstream to enter the rapidly growing Immuno-oncology therapeutics market

Dawson James starts Hillstream at “Buy” with a $4 Target Today

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Hello Everyone,

We are bringing back a recent profile that went on to make a 140% move in just about a weeks time.

Back on Feb. 3 we showed you HILS and the average trade on the session was 1.10.  On the 10th we saw this one EXPLODE all the way to 2.65 on strong interest.  

Not bad right?

Since then HILS has pulled back with the market.  It closed down 5 sessions in a row and today was the first green session since.

Dawson James Securities initiated coverage of Hillstream BioPharma (NASDAQ:HILS) with a “buy” rating and price target of $4 yesterday.

We want you to research this one right away if you haven’t already.

Hillstream Biopharma is a biotechnology company developing novel therapeutic candidates targeting 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, 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.

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

Development expected to capitalize upon tumor targeting Quatramers

MUC1-C could be effective against a number of drug resistant cancers such as metastatic triple negative breast cancer (TNBC), small cell lung cancer (SCLC), merkel cell carcinoma (MCC) and neuroendocrine prostate cancer (NEPC)

BRIDGEWATER, N.J., Jan. 31, 2023 (GLOBE NEWSWIRE) — 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.”

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Quatramer Platform

Quatramer is tumor-targeted platform with capacity to deliver drug and biologic combinations

Quatramer is a tumor targeting platform which allows us to leverage and exploit key tumor targets and novel emerging pathways such as IMCD to facilitate the delivery of potent drugs directly to the TME, while sparing healthy tissue. By efficiently extending the circulation half-life, as well as targeting delivery to the tumor site, Quatramer traps drugs into the TME. This emerging orthogonal anti-cancer approach utilizes a fundamental recognized mechanism of iron mediated tumor growth and metabolism. We are building a portfolio of long-acting, potent anti-cancer drug candidates using our Quatramer platform.

Quatramer based compounds with therapeutic cargoes from our product pipeline 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 TNF-alpha and potentially others. The platform’s 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 treatment resistant tumors with minimal or no treatment options.

TridentAI Platform

Trident is a Deep Learning Engine that identifies synthetic lethal sensitivities associated with degree of cell plasticity

Trident, as the name suggests, takes a multi-pronged approach to address each of the leading causes of tumor plasticity as the disease progresses namely Epithelial-to-mesenchymal transition, Dedifferentiation/Transdifferentiation, and Transient drug-induced tolerance and sensitivity. The platform builds on a deep foundation of diverse multi-modal and multi-omic private and public datasets which include not only genomic and transcriptomic data from patient derived blood or biopsy samples and sublines, and pan-cancer epigenetic and transcriptional drug response data from The Cancer Genome Atlas (TCGA), Cancer Cell Line Encyclopedia (CCLE) and Genomics of Drug Sensitivity in Cancer (GDSC), but also human cancer proteome datasets from emerging global efforts that include Human Cancer Proteome Project (HUPO; Cancer-HPP), The Cancer Proteome Atlas (TCPA) and The National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC). Inclusion of proteomics data is very critical for identifying dynamical re-wiring of intra-tumoral signaling circuitry which is likely to be missed if one looks at the genomic and transcriptomic level alone.

Trident is a Deep Learning Engine that integrates in vitro and in vivo epigenetic, transcriptomic and proteomic data characterizing genomic alterations, methylation states, cellular differentiation, and drug tolerance to identify:

Biomarker fingerprints that deconvolve a heterogeneous tumor biopsy into a discrete phenotypic state along a gradient of progressive cellular plasticity, Network of dis-regulated functional pathways that underscore a patient’s pathology, and Indication-specific synthetic-lethal sensitivities to drugs

Trident utilizes state-of-the-art convolutional neural networks to classify and select patients based on their tumor-derived multi-comic profiles thus enabling a targeted synthetic-lethal approach to kill persistent tumor cell populations and treat patients in select indications.

Trident maps the phenotypic tumor transition from a high-dimensional landscape onto a quantitative, measurable one-dimensional scale

Trident traces the complex high-dimensional landscape of tumor progression to identify biomarkers that mark milestones in this continuum and enable quantification of degree of plasticity along the trajectory. Trident’s Deep Learning Engine trains a model that can reduce this high-dimensional information into a one-dimensional quantitative and measurable scale which informs what is the degree of plasticity in a biopsy sample or cell line dataset. Trident’s unbiased search in the vast repository of multi-modal datasets enables identification of synthetic lethal sensitivities that correlate linearly but contrast with degree of plasticity. This biomarker-guided, state-specific approach enables to successfully deconvolve signals from a heterogenous tumor biopsy into a discrete phenotypic state along a gradient of progressive and divergent cellular plasticity and complementary synthetic lethal sensitivity.

Trident is designed to de-risk clinical development and deliver on the promise of precision medicine

Trident is designed to deliver on Hillstream Bio’s ultimate goal, which is to identify and treat the right patients that are most likely to benefit from treatment. Using Trident, biomarkers measured in patient blood/biopsy samples will assist in determining the degree of plasticity for a specific patient, which will then directly inform about a patient’s sensitivity to activation/inhibition of the synthetically lethal target and probability of successful treatment. More than just de-risking clinical development, Trident aspires to deliver on the promise of precision medicine by building a platform based on the robust foundation of patient-based biomarker research and deep learning artificial intelligence technologies.

The Hillstream Biopharma Pipeline

HSB-1216: Novel Inducer of Iron-Mediated Cell Death

Iron is a central player in cancer progression and metastasis and dysregulated in tumors. Certain cancer cells rely on an increased labile iron pool (LIP) which fosters tumor growth, metastasis and relapse. HSB-1216 (Hillstream’s lead compound) normalizes the LIP in tumors and causes cell death by de-linking cancer’s addiction to iron. HSB-1216, is a novel and potent inducer of a powerful mechanism involving iron-mediated cell death. This process which sequesters iron in lysosomes allows HSB-1216 to cause lysosomal membrane permeabilization of hard-to-treat cancer cells – causing them to rupture and stop replicating. An area of interest for the development of HSB-1216 are rare cancers with high unmet need.

HSB-1216 is for multiple, therapy resistant or high unmet need solid tumors. HSB-1216 exploits a key feature of certain tumors that rely on an excessive LIP within the cell to modify the dysregulated iron microenvironment of cancer. In our Phase 1 study we intend to test HSB-1216 in a variety of solid tumors. Although we have received orphan drug designation (ODD) in small cell lung cancer for HSB-1216’s active drug, we may pursue ODD in multiple indications. HSB-1216 has the potential to be used in cancer patients who have failed standard-of-care therapies in solid tumors. HSB-1216 is being advanced to alleviate these devastating consequences due to a lack of therapies.

HSB-888: Novel Inducer of Iron-Mediated Cell Death + Ultra Low-Dose Anthracycline

The components of HSB-888 are two anticancer drugs with distinct and complementary mechanisms of actions which together constitute an active combination for treating sarcomas. Hillstream investigated whether the efficacy of this combination could be improved by controlling drug ratios following in vitro and vivo administration. The combinations were evaluated systematically for drug ratio-dependent synergy in vitro using multiple tumor cell lines. In vitro screening informatics on drug ratio-dependent cytotoxicity identified a consistently antagonistic region between payloads at various molar ratios, which also showed multiple synergistic ratios, dependent on the chemical characteristics of either DNA intercalating payload combined with an inducer of iron-mediated cell death.

Co-formulations of these two agents were developed that maintained a fixed drug ratio for stability and release profiling over broad timelines. Drug ratio-dependent antitumor activity was demonstrated in vitro and in vivo for these ratios and improved antitumor activity was observed for a specific molar ratio of DNA intercalator:inducer of iron-mediated cell death (designated HSB-888) compared to drug cocktails in models tested. HSB-888, is a fixed-ratio formulation of DNA intercalator:inducer of iron-mediated cell death, and a lead near-clinical candidate for development in multiple sarcomas.

HSB-510: Novel Bi-Functional Inhibitor for Solid Tumors & Leukemias

HSB-510 is a novel highly targeted bifunctional inhibitory compound in Quatramer with single digit nanomolar IC50 against PI3K-delta and HDAC6, which is also known to downregulate c-myc, a highly pursued and yet undruggable cancer drug target. The Quatramer platform achieves optimal tumor targeting and bioavailability of the highly potent targeted small molecule. HSB-510’s active drug, in co-development via a Cooperative Research and Development Agreement with the National Center for Advancing Translational Sciences, part of the National Institutes of Health, induced necrosis in several mutant and FLT3-resistant acute myeloid leukemia (AML) cell lines and primary blasts from AML patients, while showing no cytotoxicity against several normal cells. The FLT-3 gene is associated with high risk of relapse and poor clinical outcomes upon treatment with conventional chemotherapy in AML patients. Target specific engagement of PI3K-delta and HDAC6 was further demonstrated using the cellular thermal shift assay. HSB-510 also showed ideal pharmacokinetic properties in mice via intraperitoneal administration which provides a means to examine the biological effects of inhibiting these two enzymes with a single molecule, either in vitro or in vivo.

HSB-114: TNF-alpha DNA

HSB-114 is a novel immunotherapeutic agent which uses our proprietary Quatramer technology to deliver tumor necrosis factor-alpha (TNF-alpha or TNF-α) gene into cancer cells. Previous immunotherapeutic strategies used adenovector technology requiring replication deficient gene deletions and complex manufacturing controls in order to deliver the TNF-alpha gene, but posed a theoretical risk of systemic toxicity and adjacent tissue damage due to overflow of TNF-alpha in blood from the tumor, resulting in some dose-limiting toxicities. We believe our novel non-viral immunotherapeutic TNF-alpha gene therapy, HSB-114, builds on the previous clinical development program with improved scalability and tunability to treat metastatic soft tissue sarcomas.

Hillstream BioPharma Announces Development of Proprietary Targeted Biologics, Knob Quatrabodies™ (HSB-1940) against PD-1, by combining Quatramers™ with OmniAb’s Picobodies™, via a Collaboration Agreement, against Novel, Unreachable and Undruggable Epitopes in High Value Validated Targets

Collaboration allows Hillstream to enter the rapidly growing Immuno-oncology therapeutics market

By capitalizing on the long half-life of tumor targeting Quatramers™ combined with OmniTaur™-derived Picobodies™, the lead program, HSB-1940, is being developed to target PD-1

Picobodies are the smallest known antibody fragment, comprised of ultra-long CDR H3 sequences of 30-40 amino acids rich with cysteines that create tightly folded structures capable of binding recessed epitopes

BRIDGEWATER, N.J., Dec. 01, 2022 (GLOBE NEWSWIRE) — Hillstream BioPharma, Inc. (Nasdaq: HILS) (“Hillstream”, the “Company”) today announced the development of proprietary targeted biologics, Knob Quatrabodies™ (HSB-1940) against PD-1. Hillstream signed separate collaboration agreements with a subsidiary of OmniAb, Inc. (Nasdaq: OABI) (“OmniAb”) and with Minotaur Therapeutics, Inc. (“Minotaur”) to advance Picobodies against novel, unreachable and undruggable epitopes in high-value validated targets starting with PD-1.

The technologies of Hillstream and Minotaur will be combined under a previously disclosed license from OmniAb to discover, develop and advance biotherapeutics against high-value validated targets. Picobodies are antibody “knob” domains comprised of cysteine-rich ultralong complementary determining region (CDR) H3 sequences of 30-40 amino acids, which have the potential to access challenging epitopes better than full size antibodies can.

By combining Quatramers with their long half-life coated with a PD-1 Picobody™to create HSB-1940, Hillstream believes it could more efficiently target novel epitopes with greater binding affinity than approved biologics. Targeting PD-1 is a step toward enabling Hillstream to enter the rapidly growing Immuno-oncology (IO) therapeutics market with additional IO targets after PD-L1.

Dr. Vaughn Smider, Founder and Chief Executive Officer of Minotaur, stated, “We are excited to contribute our expertise to help in combining OmniAb’s OmniTaur-derived ultralong CDR H3 antibody fragments and Hillstream’s tumor-targeting Quatramers to discover and develop novel next-generation targeted cancer therapeutics.”

Antibodies derived from mouse or human sources use the surface formed by complementarity determining regions (CDRs) on the variable regions of the heavy chain/light chain heterodimer, which typically forms a relatively flat binding surface. Alternative species, particularly camelids and bovines, provide a paradigm for antigen recognition through novel domains which form the antigen binding site. However, for camelids, heavy chain antibodies bind antigen with only a single heavy chain variable region, in the absence of light chains. Meanwhile, in bovines, ultralong CDR-H3 regions form an independently folding mini-domain, which protrudes far out from the surface of the antibody and forms a “stalk and knob” structure which is diverse in both its sequence and disulfide patterns. The “knob” (Picobody) component can be expressed as an independent antigen binding domain. At ~4-6 kDa, these are three times smaller than a camelid “nanobody”, and are the smallest known antibody fragment. These atypical antigen binding sites of bovines potentially provide the ability to interact with different antigenic determinants, particularly recessed or concave surfaces, compared to traditional antibodies.

Randy Milby, Chief Executive Officer of Hillstream, stated, “The Picobodieswhich OmniAb brings to this collaboration combined with our Quatramers to create a novel and disruptive Knob Quatramer platform will be a great addition to our portfolio starting with HSB-1940. We are doubly excited that Dr. Vaughn Smider, a pioneer in the discovery, engineering and understanding of these unique proteins, will be leading Minotaur’s services. The Quatramer is a key Hillstream platform which is now poised to create novel therapeutics using “smart carriers” with multiple approaches for enhancing targeted cancer immunotherapy.”

NEWS

  • GlobeNewswire7 days ago

    Hillstream BioPharma Regains Compliance with Nasdaq Listing Minimum Bid Price Rule

    Company Hosted its R&D Day to Discuss Product and Pipeline Goals Across 4 Pipeline Candidates and its Quatramer™ Tumor-Targeting Platform; Multiple inflection points over the next 12-18 Months Company’s Novel Emerging Anti-Cancer Mechanism, Ferroptosis, Addresses Potential Key Target Oncology Markets Projected to reach $11 Billion in 2028 Signs Exclusive Option Agreement with Applied Biomedical Science Institute to License Technology for HER2 and HER3 to be Developed for Potential Treatments Aga

  • GlobeNewswire9 days ago

    Hillstream BioPharma Provides Webcast for its R&D Day on February 14th, 2023 at 10:00am ET

    Company’s Novel Emerging Anti-Cancer Mechanism, Ferroptosis, Addresses Potential Key Target Oncology Markets Projected to reach $11 Billion in 2028 Signs Exclusive Option Agreement with Applied Biomedical Science Institute 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 Highlight Recent Preclinical Study of its Lead Drug Candidate HSB-12

  • GlobeNewswire9 days ago
  • GlobeNewswire2 days ago

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

    Development expected to capitalize upon tumor targeting Quatramers™ MUC1-C could be effective against a number of drug resistant cancers such as metastatic triple negative breast cancer (TNBC), small cell lung cancer (SCLC), merkel cell carcinoma (MCC) and neuroendocrine prostate cancer (NEPC) BRIDGEWATER, N.J., Jan. 31, 2023 (GLOBE NEWSWIRE) — Hillstream BioPharma, Inc. (Nasdaq: HILS) (“Hillstream”, or the “Company”), a biotechnology company developing novel therapeutic candidates targeting fe

  • GlobeNewswire16 days ago

    Hillstream BioPharma to Present at the Virtual Sidoti Micro-Cap Conference on January 18-19, 2023

    BRIDGEWATER, N.J., Jan. 17, 2023 (GLOBE NEWSWIRE) — 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, will present at the Virtual Sidoti Micro-Cap Conference being held on January 18-19, 2023. Mr. Randy Milby, Founder and Chief Executive Officer of Hillstream BioPhar

  • GlobeNewswire2 months ago

    Hillstream BioPharma Announces Development of Proprietary Targeted Biologics, Knob Quatrabodies™ (HSB-1940) against PD-1, by combining Quatramers™ with OmniAb’s Picobodies™, via a Collaboration Agreement, against Novel, Unreachable and Undruggable Epitopes in High Value Validated Targets

    Collaboration allows Hillstream to enter the rapidly growing Immuno-oncology therapeutics market By capitalizing on the long half-life of tumor targeting Quatramers™ combined with OmniTaur™-derived Picobodies™, the lead program, HSB-1940, is being developed to target PD-1 Picobodies are the smallest known antibody fragment, comprised of ultra-long CDR H3 sequences of 30-40 amino acids rich with cysteines that create tightly folded structures capable of binding recessed epitopes BRIDGEWATER, N.J.

  • GlobeNewswire2 months ago

    Hillstream BioPharma to Present at the RHK Capital Disruptive Growth Conference on December 5-6, 2022

    BRIDGEWATER, N.J., Nov. 22, 2022 (GLOBE NEWSWIRE) — 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, will present at the 2022 RHK Capital Disruptive Growth Conference hosted at Reed Smith in New York City on December 5-6, 2022. Mr. Randy Milby, Founder and Chief Exe

  • GlobeNewswire4 months ago

    Hillstream’s New Anti-Cancer Mechanism Quatramer-based Ferroptosis Inducer, HSB-1216 Abstract Available for Viewing at EORTC-NCI-AACR Symposium

    Abstract highlights data from HSB-1216 in acute myeloid leukemia (AML) growthBRIDGEWATER, N.J., Oct. 18, 2022 (GLOBE NEWSWIRE) — Hillstream BioPharma, Inc. (“Hillstream”), 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 that an abstract highlighting the progress of the Quatramer-based Ferroptosis Inducer, HSB-1216, are ava

  • GlobeNewswire4 months ago

    Hillstream BioPharma, Inc. to Present at Upcoming Investor Conferences

    BRIDGEWATER, N.J., Oct. 06, 2022 (GLOBE NEWSWIRE) — Hillstream BioPharma, Inc. (Nasdaq: HILS) (“Hillstream” or the “Company”), a biotechnology company developing novel therapeutic candidates targeting ferroptosis, an emerging anti-cancer mechanism resulting in iron-mediated cell death for drug resistant and devastating cancers, today announced that Randy Milby, Founder and Chief Executive Officer will present in-person and host one-on-one meetings with investors at the following conferences: Ev

  • GlobeNewswire5 months ago

    Hillstream BioPharma to Participate in the Fierce Biotech Summit on September 19-20

    BRIDGEWATER, N.J., Sept. 14, 2022 (GLOBE NEWSWIRE) — 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, will participate in the Fierce Biotech Summit, being held at The Westin Copley Place in Boston, on September 19-20, 2022. Mr. Randy Milby, Founder and Chief Executi

  • GlobeNewswire7 months ago

    Hillstream BioPharma to Attend the 12th Annual World Orphan Drug Congress USA on July 11-13

    BRIDGEWATER, N.J., July 08, 2022 (GLOBE NEWSWIRE) — 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, will attend the 12th Annual World Orphan Drug Congress USA 2022, being held at the Hynes Convention Center in Boston, on July 11-13, 2022. Mr. Randy Milby, Founder a

  • GlobeNewswire7 months ago

    Hillstream BioPharma Announces Collaboration with Sapien Biosciences in Cancer Treatments

    Investigating the synergy between HSB-1216, a Ferroptosis inducer, and Immune Checkpoint InhibitorsBRIDGEWATER, N.J., June 27, 2022 (GLOBE NEWSWIRE) — 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 a collaboration with Sapien Biosciences to evaluat

  • GlobeNewswire8 months ago

MANAGEMENT  

Randy Milby – CEO & Chairman

Mr. Milby was the former Chief Executive Officer and Member of the Board of Directors at CorMedix, a publicly traded biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of inflammatory and infectious diseases. A seasoned executive who led the increase in market capitalization from $3M to a peak of $350M of Cormedix while improving the company’s financial position with capital raises from equity markets. He oversaw efforts to gain CE Market approval of Neutrolin® in the European Union and held increasing roles of responsibility at Goldman Sachs and Dupont Merck prior in his career.

Thomas Hess CPA – Chief Financial Officer

Thomas Hess is an experienced financial expert. From August 2014 until June 2021, Mr. Hess served as Chief Financial Officer and Senior Vice President of Finance of Genomind, Inc., a mental health company that developed and sold a pharmacogenomic test that analyzed how an individual’s genes may affect medication outcomes. From September 2011 until its sale in April 2014, Mr. Hess served as Chief Financial Officer and Executive Vice President of Finance of The Keane Organization, a comprehensive provider of unclaimed property services. Mr. Hess also previously served in various other capacities including, but not limited to, Chief Financial Officer and Senior Vice President of Yaupon Therapeutics, Inc.; Chief Financial Officer and Vice President, Finance of Adolor Corporation; Corporate Controller of Vicuron Pharmaceuticals, Inc.; and Senior Manager – Accounting and Audit of KPMG. Mr. Hess was formerly an adjunct faculty member/lecturer at Pennsylvania State University and DeSales University. Mr. Hess received his B.S. in accounting from The Pennsylvania State University and his MBA from Katz Graduate School of Business, University of Pittsburgh. Mr. Hess is a Certified Public Accountant in the state of Pennsylvania. He currently serves on the Alumni Council of Penn State and is the Chairman of the Nittany Lion Club Annual Fund.

Ron Weitzman, MD – Clinical Development

Ron is a US trained board certified medical oncologist having worked in the biopharmaceutical industry since 1999. Over his career, Ron has worked in all areas of clinical development including phase 1, 2 and 3 clinical trials. He has drug development experience in both solid and hematological malignancies and has interacted extensively with FDA, EMEA, Canadian and Japanese health authorities. In his most recent role at Exelixis, he oversaw cabozantinib’s (XL184) development in prostate cancer with two ongoing phase 3 registrational studies underway. Over the years, Ron has managed both large and small groups and very much enjoys mentoring colleagues.

Barry Rosenblatt, PhD – Manufacturing

Dr. Korczak is a translational science executive with established track record of developing drugs from discovery through IND and into clinical Proof of Concept (POC) studies. She has an excellent knowledge of drug discovery, pharmacology, pharmacokinetics (PK), toxicology, manufacturing of drug substance/product, early clinical development and regulatory requirements. Her leadership in start-up and early stage biotechnology companies resulted in accelerated drug development across multiple therapeutic areas including oncology, dermatology, inflammatory diseases, cardiology, and infectious diseases.

Gautam Goel, PhD. – Data Science

Gautam Goel is an expert computational biologist and a seasoned biotech professional with an impactful 15-year track record enabling clinical development of precision medicines. Gautam advises biotech and pharmaceutical companies on challenges in early-stage target discovery, lead candidate drug identification, and biomarker analysis for clinical development. Gautam has enabled his clients to raise tens of millions of dollars in collaborations with strategic pharmaceutical companies on the basis of machine-learning based target and drug discovery pipelines that he has helped design and build. Previously, he spearheaded cross-functional R&D operations as Director of Precision Medicine at a biotech startup to accelerate path to clinical development for an Antigen-specific Immunotherapy for Type 1 Diabetes (Discovery to FIH studies in 3 years). Simultaneously, he led the biomarker discovery program in Celiac Disease which resulted in the 1st blood-based diagnostic for patients on gluten-free diet. Additionally, he developed an immune response monitoring toolkit to support Phase 2 clinical trials for an antigen-specific peptide vaccine to treat Celiac disease. Prior to that, Gautam was a Research Fellow at Massachusetts General Hospital in Boston where he investigated mechanisms of IBD pathogenesis and discovered druggable targets and drug candidates. Gautam’s work has led to over 40 publications in disease areas including Crohn’s disease, Ulcerative Colitis, Celiac Disease, Chronic Inflammation and Infectious diseases. His technical expertise includes Antigen-specific Immunotherapy, Systems Immunology, Dynamical Systems Theory, Time-Series Data Analysis, Machine Learning, Deep Learning and Big Data Analytics & Systems Biology (Single cell analysis, RNA-seq, CyTOF, Nanostring, Proteogenomics, Metabolomics, Immunophenotyping).

Sincerely,

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THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT, AND MAY BE FORWARD-LOOKING STATEMENTS. FORWARD-LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD-LOOKING STATEMENTS MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEES, EXPECTS, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, MAY, COULD, OR MIGHT. THERE IS NO GUARANTEE THAT PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS.
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