Refractory Cancer

The final patient completes Phase I trial enrollment, evaluating safety and tolerability for Biomica's microbiome-based immuno-oncology drug, BMC128 REHOVOT, Israel, Jan. 17, 2024 /PRNewswire/ -- Biomica Ltd., a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), today announced that the final patient has been enrolled in its Phase I clinical trial. Initiated on July 11, 2022, the Phase I trial was specifically designed to evaluate the safety and tolerability of Biomica's microbiome-based immuno-oncology drug candidate, BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy, in patients with either non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC), who previously progressed on immunotherapy. Bristol Myers Squibb's Opdivo® is the immune checkpoint inhibitor in the trial. The study takes place at The Davidoff Center and the Rambam Health Care Campus in Israel. Biomica remains on track with preliminary results, and the first data point readout is expected in H1 2024. Dr. Elran Haber, CEO of Biomica, stated: "We are pleased to complete the Phase 1 Proof of Concept study enrollment, marking a critical step forward in developing our groundbreaking BMC128. We are excited about the progress made thus far and confident about the potential of BMC128 to address the unmet needs in the treatment of ICI-refractory cancer patients." About BMC128: BMC128 is a rationally designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by MicroBoost AI tech engine. Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes. Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host's microbial community with individually selected, cultured bacteria. About Biomica Ltd.: Biomica is a clinical stage biopharmaceutical company developing innovative microbiome-based therapeutics utilizing PRISM system, a proprietary computational platform powered by Evogene's MicroBoost AI tech-engine. licensed from Evogene. Biomica aims to identify and characterize disease-related microbiome entities and to develop novel therapeutics based on these understandings. The company is focused on the development of therapies for antibiotic resistant bacteria, immuno-oncology, and microbiome-related gastrointestinal (GI) disorders. Biomica is a subsidiary of Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN). For more information, please visit . About Evogene Ltd.: Evogene (Nasdaq: EVGN, TASE: EVGN) is a computational biology company aiming to revolutionize the development of life-science-based products by utilizing cutting-edge technologies to increase the probability of success while reducing development time and cost. Evogene established three unique tech-engines - MicroBoost AI, ChemPass AI, and GeneRator AI – leveraging Big Data and Artificial Intelligence and incorporating deep multidisciplinary understanding in life sciences. Each tech-engine is focused on the discovery and development of products based on one of the following core components: microbes (MicroBoost AI), small molecules (ChemPass AI), and genetic elements (GeneRator AI). Evogene uses its tech-engines to develop products through subsidiaries and strategic partnerships. Evogene's subsidiaries currently utilize the tech-engines to develop human microbiome-based therapeutics by Biomica, ag-biologicals by Lavie Bio, ag-chemicals by AgPlenus, medical cannabis products by Canonic and castor varieties, for the biofuel and other industries, by Casterra. For more information, please visit . Forward-Looking Statements: This press release contains "forward-looking statements" relating to future events. These statements may be identified by words such as "may", "could", "expects", "hopes" "intends", "anticipates", "plans", "believes", "scheduled", "estimates", "demonstrates" or words of similar meaning. For example, Evogene and its subsidiaries are using forward-looking statement in this press release when it discusses safety and tolerability of Biomica's microbiome-based immuno-oncology drug candidate, BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy and the success of BMC128 to address the unmet needs in the treatment of ICI-refractory cancer patients and the expected timing of the first data point readout in H1 2024. Such statements are based on current expectations, estimates, projections and assumptions, describe opinions about future events, involve certain risks and uncertainties which are difficult to predict and are not guarantees of future performance. Therefore, actual future results, performance or achievements of Evogene and its subsidiaries may differ materially from what is expressed or implied by such forward-looking statements due to a variety of factors, many of which are beyond the control of Evogene and its subsidiaries, including, without limitation, the current war between Israel and Hamas and any worsening of the situation in Israel such as further mobilizations or escalation in the northern border of Israel, and those risk factors contained in Evogene's reports filed with the applicable securities authority. In addition, Evogene and its subsidiaries rely, and expect to continue to rely, on third parties to conduct certain activities, such as their field-trials and pre-clinical studies, and if these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, Evogene and its subsidiaries may experience significant delays in the conduct of their activities. Evogene and its subsidiaries disclaim any obligation or commitment to update these forward-looking statements to reflect future events or developments or changes in expectations, estimates, projections, and assumptions. Contacts Rachel Pomerantz Gerber Head of Investor Relations at Evogene rachel.pomerantz@evogene.com Tel: +972-8-9311901 Logo - Logo - Company Codes: NASDAQ-NMS:EVGN, TelAviv:EVGN

Preclinical Update on HSB-510 and navitoclax, a Novel Quatramer™-based, First-in-Class Dual Inhibitor of PI3-Kδ/HDAC6 in combination with navitoclax (BCL-XL/BCL-2 inhibitor) BRIDGEWATER, N.J., Feb. 08, 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 that an abstract highlighting the progress of the Quatramer-based dual-targeted PI3-Kδ/HDAC6 inhibitor, HSB-510, and navitoclax (BCL-XL/BCL-2 inhibitor) has been scheduled for presentation in a Poster Session at the 2023 American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida and will be published in the online Proceedings of the AACR. The complete title: Co-loading of a novel PI3-Kδ/HDAC6 dual inhibitor and navitoclax into Quatramer biodegradable polymeric nanoparticles synergistically inhibit growth of ER+ breast cancer. Session Category: Experimental and Molecular Therapeutics Session Title: Drug Delivery Systems Session Date and Time: Monday April 17, 2023 1:30 PM - 5:00 PM Location: Section 15 Poster Board Number: 21 Abstract Presentation Number: 2718 The abstract will be published in the online Proceedings of AACR supplement prior to the meeting on Friday March 31, 2023. HSB-510 is a first-in-class isoform specific PI3-Kδ/HDAC6 dual inhibitor encapsulated in the Company’s Quatramer-based formulation. Preclinical studies have demonstrated that treating TNBC cells with HSB-510 is associated with substantial down regulation of the growth of TNBC cells both in vitro as well as in TNBC syngeneic mouse model. Furthermore, the results also indicated that treatment of TNBC cells with HSB-510 significantly inhibited MYC levels. These findings indicated that dual inhibitor HSB-510 is an effective agent targeting MYC and can be developed as effective therapy for multiple MYC-dependent tumor indications. About HSB-510 HSB-510 is a novel highly targeted bifunctional inhibitor encapsulated in Quatramer with single digit nanomolar IC50 against PI3-Kδ and HDAC6, which is also known to downregulate MYC, a highly pursued and yet undruggable cancer target. The Quatramer platform achieves optimal tumor targeting and bioavailability of the highly potent targeted small molecule. Through a Cooperative Research and Development Agreement with the National Center for Advancing Translational Sciences (NCATS), part of the NIH, novel dual PI3-Kδ/HDAC6 inhibitors and a lead compound showed good anti-proliferative activity against multiple cancer cell lines. HSB-510 obtained ideal pharmacokinetic properties in the Company’s proprietary Quatramer, while maintaining specific PI3Kδ/HDAC6 specificity. The Company intends to continue a collaborative effort with NCATS and expects to conduct IND-enabling studies for HSB-510 in 2023. 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: . 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 Source: Hillstream BioPharma Inc.

Six cohorts, totaling 50 late-stage cancer patients, received STP707 four times monthly by intravenous infusion at escalating dosages. All cohorts demonstrated a strong safety profile with no dose-limiting toxicity noted for any dosing cohort and the treated patients exhibited encouraging efficacy signal with 74 % of evaluable participants achieving a best response of stable disease with a time on study of approximate 77 days. HONG KONG, Germantown, Md. and SUZHOU, China, Aug. 30, 2023 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257.HK, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, today announced the Group has completed all dosing regimens for its Phase I study of STP707 for the treatment of multiple solid tumors in patients with various types of late-stage cancers who did not respond to multiple rounds of other oncology treatments. Approximately 74% of evaluable patients demonstrated a best response of stable disease (SD) and several patients exhibited reduction in tumor burden per Response Evaluation Criteria in Solid Tumors (RECIST). "This is the first time in the field of RNAi cancer therapeutics that a Phase I study has demonstrated very promising clinical potential for metastasized tumors. We observed patients achieving stable disease status with some realizing a reduction in tumor size treated with STP707," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics. "The results from this basket study encourages us to explore STP707 as a potential single drug or a combination treatment with immune check point inhibitor drugs." The basket study enrolled 50 patients with late-stage solid tumors including but not limited to pancreatic cancer, liver cancer, colon cancer, ovarian cancer and melanoma, who all exhibited progressive disease on prior rounds of treatment with marketed oncology drugs. Based on preliminary efficacy observations, 74% of evaluable patients demonstrated a best response of stable disease (SD) and several patients exhibited reduction in tumor burden per RECIST. The clinical study was conducted in the United States, with participation of multiple leading cancer centers, including Mayo Clinic Oncology, Yale Cancer Center, Next Oncology, Emory Cancer Center and University of Southern California/Hoag. The multi-center, open-label, dose escalation study evaluated the safety, tolerability and antitumor activity of STP707 with 50 participants receiving doses at 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and 48 mg via intravenous administration. All patients were dosed once weekly for a total of four doses over a 28-day treatment cycle. The treated patients will continue in the study until they exhibit progressive disease. Additional secondary endpoints are to determine the pharmacokinetics and biomarker of STP707 and to observe preliminary anti-tumor activity. After completing the required observation period for dose limiting toxicities for the six dose cohorts, each cohort exhibited no dose-limiting toxicity and dose escalation was recommended by the data safety committee. Additional clinical data will be announced after completion of all ongoing treatment and observations. "STP707 has exhibited a strong safety profile when compared to other novel oncology therapeutics, and we have seen encouraging efficacy signals where 74% of evaluable patients demonstrated a best response of stable disease and a number of patients exhibited reduction in tumor burden per RECIST ," said Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics, "It is important to emphasize that patients in this study received multiple forms of prior treatments including surgery, radiation, and tumor specific first-and second-line therapies. All patients had failed these prior treatment regimens, so this group of patients represent a subset of resistant tumor types. It is encouraging to see very strong safety combined with duration of response, and we look forward to continuing this study". Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT05037149. About STP707 STP707 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H) peptide as the carrier. The specific carrier peptide is distinct from the carrier used in Sirnaomics' STP705 product. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs and combining the two siRNA's produces a synergistic effect that diminishes pro-inflammatory factors. Over-expression of TGF-β1 and COX-2 have been well-characterized in playing key regulatory roles in tumorigenesis. In preclinical studies with STP707, intravenous administration (IV) administration resulted in knockdown of TGF-β1 and COX-2 gene expressions in various organs including liver, lung and xenograft tumor. In addition, in preclinical models STP707 had shown strong antitumor activity in various solid tumor types. Using a mouse liver orthotopic tumor model, a combination regimen of STP707 with an immune checkpoint antibody has demonstrated a potent antitumor activity. About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies: Polypeptide Nanoparticle Formulation and the 2nd generation of GalNAc conjugation, the Group has established an enriched drug candidate pipeline. Sirnaomics is currently holding a leadership position on advancing RNAi therapeutics for oncology application with multiple successes of its clinical programs for STP705 and STP707. STP122G represents the first drug candidate of GalAhead™ technology entering clinical development. With the establishment of the Group's manufacturing facility, Sirnaomics currently is undergoing a transition from a biotech company to a biopharma corporation. Learn more at: . SOURCE Sirnaomics