MUC1

The first 20 participants have been enrolled in an important national, multicenter trial to test whether ImmunityBio’s Nant Cancer Vaccine (NCV) comprising a tri-valent Adenovirus (Tri-Ad5) in combination with the company’s IL-15 superagonist N-803 could potentially prevent colon and other cancers in individuals with Lynch syndrome. With enrollment of the first two open-label phases of the trial completed, the study will now proceed to the randomized controlled phase. When fully enrolled, the completed randomized Phase 2 study will include up to 186 individuals. In the randomized controlled phase 138 participants will be randomized to ImmunityBio’s NCV or placebo. Lynch syndrome is associated with a genetic mutation present in an estimated one million Americans1 who are more likely to be diagnosed with cancer at a younger age and are at increased risk of developing multiple types of cancers during their lifetime. This NCV study is the first to evaluate vaccines, delivered by an adenovirus vaccine platform, combined with an immune-enhancer, N-803, to target cancer-specific proteins and activate natural killer (NK) and T cells to prevent cancer. CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that enrollment and initial follow-up has been completed for the safety portions of a clinical trial that is studying ImmunityBio’s investigational cancer vaccine of a tri-valent combination of antigens delivered by a second-generation Adenovirus vector (Tri-Ad5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803 for participants with Lynch syndrome. The study, sponsored by the National Cancer Institute, part of the National Institutes of Health, will include up to 186 participants when fully enrolled and is now open to the randomized controlled portion of the trial. Each of the three vaccines in Tri-Ad5 targets different proteins associated with precancer and cancer cells. The vaccine combination is studying whether activation of dendritic cells and training the immune system to recognize those proteins will destroy the precancer cells before the cancer occurs. The IL-15 superagonist N-803 is designed to enhance the effects of the vaccines by increasing proliferation and activation of natural killer (NK) and T cells, thereby increasing the potential for cancer prevention in study participants. “We are pleased to be selected to participate in this important and innovative cancer prevention study, one that could provide insights into how the immune system could be harnessed to prevent cancer in individuals with hereditary risk,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “With an estimated 5 to 10 percent of cancers inherited, understanding mechanisms that might prevent or delay their onset could potentially change the prospects for tens of thousands of people annually.” Lynch syndrome (also called hereditary non-polyposis colorectal cancer or HNPCC) is one of the most common hereditary cancer syndromes occurring in 1 in every 300 Americans.2 Not only can people with Lynch syndrome develop colorectal cancer 20 years before the average age of diagnosis for this cancer, they are also at an increased risk of developing multiple types of other cancers, including endometrial, stomach, ovarian, pancreas, ureter and renal pelvis, biliary tract, brain, and small intestinal cancers. Colorectal cancer is the second-deadliest cancer type in the U.S., and approximately 3% to 5% of the 153,000 cases of colorectal cancer annually are thought to be due to Lynch Syndrome, as are 2% to 3% of all cases of endometrial cancer.3 “We are encouraged by how rapidly this study has been able to enroll participants,” said Asad Umar, D.V.M., Ph.D., a senior advisor to the Director for Translational Research in NCI’s Division of Cancer Prevention (DCP) and a scientific lead for the trial. “It is a strong indication of an unmet need and of the willingness of participants to help science make new discoveries in the area of cancer prevention.” To learn more about this study, please visit . For patients interested in enrolling in this study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the website: and/or NCIMO_referrals@mail.nih.gov. ImmunityBio’s Tri-Ad5 Vaccines and N-803 are investigational. Safety and efficacy of these investigational agents have not been established by any Health Authority, including the FDA. About ImmunityBio’s Tri-Ad5 Vaccines ImmunityBio’s Tri-Ad5 vaccines target three tumor-associated antigens: brachyury, carcinoembryonic antigen (CEA), and mucin-1 (MUC1). Pre-clinical studies have demonstrated Tri-Ad5 vaccines elicit cytotoxic T cell-mediated tumor cell death and the establishment of memory T cells, and thus may provide protection against the growth and metastasis of cancer. Tri-Ad5 vaccines utilize a second-generation replication-defective human adenovirus serotype 5 (Ad5) vector with viral genes deleted to allow for production of the antigen and a vigorous immune response, without generating a host response to the vector and with the ability to overcome previous adenovirus immunity in cancer patients. Notably, in a phase 1 NCI trial, Tri-Ad5 generated antigen-specific T cells to MUC1, CEA, and/or brachyury in all 10 patients with no evidence of antigenic competition. The safety of multiple ImmunityBio product candidates utilizing the Ad5 technology has been demonstrated in phase 1 and 2 clinical trials for cancers across several tumor types. About ImmunityBio ImmunityBio is a vertically-integrated, clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. We are applying our science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, please visit: 1-3. American Society of Clinical Oncology (ASCO) Cancer.net Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding clinical trial protocols, phases and patient enrollment, information regarding potential patient population, potential benefit to patients, potential additional studies and trials, methods, regulatory pathways, and ImmunityBio’s investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) the risks and uncertainties associated with the regulatory review process including without limitation the Company’s BLA resubmission following receipt of the complete response letter (CRL) from the FDA and the ability of ImmunityBio and its third party contract manufacturing organizations to adequately address the issues raised in the CRL, (ii) whether or not the clinical trial referenced in this release will continue to progress as anticipated, including without limitation the ability to enroll additional patients, (iii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, (iv) ImmunityBio’s ability to retain and hire key personnel, (v) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (vi) ImmunityBio’s ability to successfully commercialize its product candidates and uncertainties around regulatory reviews and approvals, (vii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its product candidates and future approved products, and (viii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 1, 2023 and the Company’s Form 10-Q filed with the SEC on November 9, 2023, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at . ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

BriaCell’s Bria-IMT™ combination regimen with immune checkpoint inhibitors activated cancer-fighting CD8+ T cells turning “Cold” tumors “Hot” on ImmunoPET imagingAdvanced protein array technologies showed unique antibody responses in patients with disease control who were treated with the Bria-IMT™ regimen, and may be used to predict survival and clinical benefit in cancer patientsPotent activity of the BriaCell combination regimen supports the use of the regimen in the ongoing pivotal Phase 3 study in advanced metastatic breast cancerUpdated overall survival clinical data will be presented tomorrow 12:00 pm – 2:00 PM CT; Presentation ID: PO3-05-12 PHILADELPHIA and VANCOUVER, British Columbia, Dec. 06, 2023 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is presenting 3 posters including two today at the 2023 San Antonio Breast Cancer Symposium® at Henry B. Gonzalez Convention Center, San Antonio, TX. Today’s posters highlight the activation of cancer fighting immune cells by the Bria-IMT™ combination regimen that was identified using leading-edge technologies. These tools may be used to evaluate immune system responses to immunotherapy treatments, and perhaps to predict survival and clinical benefit in cancer patients treated with the Bria-IMT™ regimen. “I am very excited with our findings using advanced CD8 ImmunoPET imaging that may be able to transform the way we treat cancer patients,” stated Russ Kuker, M.D., Associate Professor of Clinical Radiology at the University of Miami Miller School of Medicine and the first author of the PO1-20-12 poster. “We were able to see that the Bria-IMT™ combination regimen treatment can activate cancer-fighting T cells to infiltrate some breast cancer tumors. This represents evidence of the effectiveness of the Bria-IMT™ combination regimen and demonstrates the potential of this approach.” “I am thrilled with the successful transformation of a cold immune suppressed tumor to a hot immune responsive one as well as the antibody responses seen with our immunotherapy,” stated Dr. William V. Williams, BriaCell’s President and CEO. “We strongly believe in the potential of our novel immunotherapy in cancer patients and will be working determinedly with experts to bring these safe and effective treatment options to cancer patients who have failed other therapies.” Poster #1 Abstract Title: CD8+ Tumor Infiltrating Lymphocytes Turn a Cold Tumor Hot in Metastatic Breast CancerSubmission ID: 1577766Presentation ID: PO1-20-12Spotlight Session: Poster Session 1Session Date and Time: Wednesday December 6, 2023 12:00 PM - 2:00 PM CT Bria-IMT™ combination regimen with immune checkpoint inhibitors activated cancer-fighting CD8+ T cells turning “Cold” tumors “Hot” on ImmunoPET imaging We present the first evidence that “cold” tumors can become “hot” with the Bria-IMT™ combination regimen treatment suggesting immune system activation in the patient.CD8 ImmunoPET imaging, an imaging analysis technology, is used to mark CD8+ T-cells (also known as cytotoxic T cells) that are important components of the immune system and key to cancer cell detection and destruction.The study demonstrated higher levels of cancer fighting CD8+ tumor infiltrating lymphocytes in some breast cancer metastatic sites and in lymphoid organs. This indicates activation of these cells and their invasion into the tumors potentially leading to destruction of cancer cells.We observed favorable changes in tumor markers (CEA and CA15-3), Circulating Tumor Cells, and Cancer Associated Macrophage Like cells suggesting activation of tumor fighting cells.Our findings support the use of Bria-IMT™ in combination with an immune check point inhibitor in our pivotal Phase 3 study. In summary, the use of leading technologies such as CD8 ImmunoPET imaging, peripheral blood tumor markers, and circulating cancer-associated cells demonstrate the therapeutic potential of the Bria-IMT™ combination therapy regimen. These findings support the use of this combination regimen in our pivotal Phase 3 study. Poster #2 Abstract Title: Analysis of Antibody Response to SV-BR-1-GM Therapeutic Vaccine in Breast Cancer Patients Using Human Protein Microarrays: Potential Correlations with Therapy ResponseSubmission ID: 1578637Presentation ID: PO2-13-06Spotlight Session: Poster Session 2Session Date and Time: Wednesday December 6, 2023 5:00 PM - 7:00 PM CT Using protein array technology, we were able to identify antibody responses that differed between clinical responders (defined as patients who achieved complete response, partial response or stable disease) and non-responders. Such responses may represent potential predictors of patients’ survival following treatment with the Bria-IMT™ treatment regimen.The Bria-IMT™ regimen (both monotherapy and combination with an immune check point inhibitor) produced non-overlapping patterns in antibody profiles suggesting the ability of the Bria-IMT™ combination therapy regimen to induce specific antibody responses. Overall, BriaCell’s data shows significant anti-tumor activity of its lead candidate, Bria-IMT™ (alone or in combination with immune check point inhibitors) in advanced metastatic breast cancer. Using innovative technologies, we believe that we have identified potential predictors of patients’ survival following treatment with the Bria-IMT™ combination therapy regimen. We plan to further investigate these findings in our ongoing Phase 3 study in advanced metastatic breast cancer. BriaCell’s third poster of this meeting titled “Randomized Phase 2 of Bria-IMT™, an allogenic human cell line with antigen presenting activity, in heavily pretreated metastatic breast cancer; will present updated overall survival clinical data tomorrow 12:00 pm – 2:00 PM CT; Presentation ID: PO3-05-12”. Copies of the posters will be posted at the following: https://briacell.com/scientific-publications/. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/. Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about: the potential to use advanced protein array technologies to find unique antibody responses in patients with disease control who were treated with the Bria-IMT™ regimen, and their potential use to predict clinical benefit in cancer patients; the potential for BriaCell to use advanced protein array technologies to predict survival and clinical benefit in cancer patients treated with the Bria-IMT™ regimen treatments; BriaCell's expectations to work determinedly with experts to bring safe and effective treatment options to cancer patients who have failed other therapies; BriaCell's belief that it has identified potential predictors of patients’ survival following treatment with the Bria-IMT™ combination regimen and BriaCell's expectation that it will further investigate those in its ongoing Phase 3 study in advanced metastatic breast cancer; and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company's most recent Management’s Discussion and Analysis, under the heading "Risk Factors" in the Company's most recent Annual Information Form, and under “Risks and Uncertainties” in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamDirector of Public RelationsCORE IR917-885-7378julesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com

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.