PSEN2

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.

Anti-tumor activity observed across all levels of folate receptor alpha (“FRα”) expression 89% of patients with cancers expressing FRα showed stable disease or a partial response following treatment with ELU001, and 21% had a treatment duration of at least nine months Generally well-tolerated, and exploratory dose/schedule selected for ongoing dose expansion cohorts in ovarian and endometrial cancers Clinical data from dose expansion cohorts expected in first half of 2024 MONMOUTH JUNCTION, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Elucida Oncology, a clinical-stage biotechnology company pioneering the next frontier in targeted cancer therapy, announced today that new data have been presented from its recently completed dose escalation/safety phase of its first-in-human Phase 1/2 clinical trial evaluating ELU001, its lead C’Dot drug conjugate (CDC) clinical candidate, at the ESMO Congress 2023 being held in Madrid, Spain. In total, 42 patients, with advanced malignancies and no meaningful life-prolonging therapy options available, were treated with ELU001 on a QW, Q2W or Q3W schedule, and 34 patients in the study completed at least one cycle of treatment. There were 19 patients with solid tumors expressing low to high FRα levels treated with ELU001 in the study, and among them 18 patients completed at least one cycle of treatment. FRα expression levels were assessed using the Ventana FOLR1 (FOLR1-2.1) assay and the PS2+ scoring system. Anti-tumor activity was observed in patients with low (≥25% - <50%), moderate (≥50% - <75%) and high (≥75%) FRα expression levels, across multiple tumor types including ovarian, colorectal, and endometrial cancers. For the 19 evaluable patients with ≥25% FRα expression (FRα positive), the study achieved a disease control rate (DCR) of 89%, with 1 partial response (PR) and 16 patients achieving stable disease (SD). Additionally, one patient with a FRα- tumor (FRα negative or <25% tumor cells) achieved a partial response, for a total of two PRs in the study. Four patients out of the 19 evaluable FRα positive patients (21%) achieved a duration of treatment of at least nine months suggesting tumor control and tolerability of ELU001. The longest duration of treatment was 16 months in a patient with endometrial cancer. Two patients were still on treatment as of October 6th, 2023. Importantly, there was no evidence of some of the severe adverse events that are associated with ADCs, including peripheral neuropathy, ocular keratopathy, cardiac, lung, liver, or kidney toxicities. Drug-related hematological and gastrointestinal adverse events, known to be associated with the exatecan payload, were observed, yet were generally spontaneously reversible, short in duration or otherwise easily manageable, and did not appear to be cumulative. Given the clinical benefit observed, we have advanced the 2.0 mg/m2 every two weeks (Q2W) as the exploratory dose of ELU001 in our on-going dose expansion study, which consists of 3 cohorts: ovarian cancer high FRα expression, ovarian cancer moderate and low FRα expression, and endometrial cancer positive (low, moderate, high) FRα expression. Notably, in the dose escalation phase of the study three patients with FRα positive endometrial and ovarian cancers were treated with ELU001 at the 2.0 mg/m2 Q2W dose/schedule that has been selected in the expansion study, one met the criteria of PR, and two had stable disease. Anemia and neutropenia were the most common adverse events observed at this dose, and were spontaneously reversible or manageable, and short in duration. Clinical data from the ongoing dose expansion study is expected in the first half of 2024. Geno Germano, CEO of Elucida Oncology, stated, “We are very pleased to see preliminary anti-tumor activity across all levels of FRα antigen expression, especially considering that the subject population was heavily pre-treated with a median of 5 prior lines of therapy. In addition, the long duration on treatment for some patients at this stage of development is particularly encouraging.” Geno added, “The manageable and favorable safety profile, that is devoid of off-target toxicities observed with antibody drug conjugates, combined with the observed anti-tumor activity have provided early, yet encouraging evidence that our CDC platform is differentiated from ADCs and add confidence in our path forward.” Dr. Eliel Bayever, Chief Medical Officer of Elucida Oncology, added, “These data are exciting and provide meaningful insights for the development of ELU001 and our platform as we continue to expand the application of our technology with the goal of making a difference to cancer patients. We expect to provide additional clinical data from the dose expansion part of the trial in the first half of 2024.” About ELU001 ELU001, Elucida Oncology’s lead clinical candidate, is a C’Dot drug conjugate (CDC) that contains ~20 molecules of the topoisomerase-1 inhibitor exatecan linked via a proteolytic cleavable linker, and ~13 folic acid molecules to target cancers that express folate receptor alpha (FRα). ELU001’s multi-valent targeting, greater payload delivery, deep tumor penetration, and ability to access difficult to target tumors in the brain, are important properties distinguishing it from antibody-drug conjugates (ADC). Pre-clinical studies across multiple cancer models demonstrate the significant ability of ELU001 to target both high and lower FRα expressing tumor cells, resulting in enhanced cell killing as compared to an ADC designed to target the same FRα antigen. FRα is overexpressed on a variety of tumors yet is minimally expressed on normal tissues making it an attractive tumor-associated antigen for targeted drug delivery. About the ELU001 Phase 1/2 Clinical Study The open-label, multi-center clinical study has two parts: Part 1 Dose Escalation Safety Study to identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D), and Part 2 Tumor Group Expansion Cohort(s) where specific cancer types will be evaluated for efficacy and safety at the RP2D. Part 1 was a basket study that enrolled patients with advanced cancers known to overexpress FRα, including ovarian cancer, endometrial cancer, colorectal cancer, gastric cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small cell lung cancer, and cholangiocarcinoma. The most promising tumor types studied in Part 1 were ovarian and endometrial, and both are being investigated in Part 2. More information about the trial is available at NCT05001282. About Elucida Oncology Elucida Oncology, Inc., is a clinical-stage biotechnology company pioneering the next frontier in targeted cancer therapy with its first-in-class, ultra-small nanoparticle C’Dot drug conjugate (CDC) platform. CDCs are designed to penetrate deeper into tumors and deliver a significantly higher payload compared to antibody drug conjugates (ADCs). This combined with greater avidity for the target antigen, longer retention in tumors with minimal systemic exposure due to rapid renal clearance confers CDCs unique Target or Clear® properties. In preclinical studies, this has resulted in enhanced efficacy irrespective of antigen expression levels with reduced off-target toxicity, thereby potentially addressing the limitations of ADCs and other novel drug carriers. For more information on Elucida Oncology, Inc., please visit . Investor and BD Contact: Media Contact: Ramzi Benamar, CFO media@elucidaoncology.com Elucida Oncology, Inc. rbenamar@elucidaoncology.com

The Phase 2b cancer vaccine trial will study a multiple vaccination approach called ‘Tri-Ad5’ that uses three ImmunityBio vaccines in combination with the company’s IL-15 superagonist N-803, to potentially reduce the risk of developing colorectal and other cancers in patients with hereditary Lynch syndrome. An estimated 1 in every 300 people may be carriers of a mutation in a gene associated with Lynch syndrome1. People with this syndrome 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 is the first study to assess the ability of vaccines, delivered by an adenovirus vaccine platform, combined with an immune-enhancer, N-803, to target cancer-specific proteins and activate NK and T cells to prevent cancer, with the goal of enrolling 186 participants at 14 centers throughout the U.S. CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc, (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced the opening of a clinical trial to study its investigational Tri-Ad5 vaccine combination (Adenovirus 5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803, an immune-enhancer, for people with a hereditary condition known as Lynch syndrome. This Phase 2b trial (NCT05419011) sponsored by the National Cancer Institute, part of the National Institutes of Health, will study whether Tri-Ad5 in combination with N-803 works to prevent colorectal and other cancers in study participants. 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 advances. 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 excited to partner with the NCI on this important cancer vaccine study to potentially prevent or delay the onset of cancer for people who carry the gene associated with Lynch syndrome,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “Lynch syndrome affects tens of thousands of people each year and the average age of cancer diagnosis for them is just 44. People known to have the gene for Lynch syndrome can be followed closely by their doctors with regular examinations and scans to watch for the development of cancer but, currently, there is no treatment that prevents the development of cancer in these patients. We hope to change that with this innovative study developed by the NCI.” Lynch syndrome is one of the most common hereditary cancer syndromes. Not only can people with Lynch syndrome develop colorectal cancer some 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.2 “The Tri-Ad5 vaccine trial will be the largest Lynch syndrome cancer prevention study done in the U.S.,” 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. 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. 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 multiple 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. 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. N-803 (Anktiva™), ImmunityBio’s lead cytokine fusion protein, is a novel IL-15 superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). N-803 is currently under review by the FDA for this indication with a Prescription Drug User Fee Act (PDUFA) target date of May 23, 2023. The company has established GMP manufacturing capacity at scale with cutting-edge cell therapy manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R&D, clinical trial, and regulatory operations, and development teams. For more information, please visit: 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 the information and data to be provided by the clinical trial described herein, the potential effects of the Tri-Ad5 vaccine combination together with N-803, the potential use and efficacy of ImmunityBio’s product candidates for the prevention and/or treatment of cancer, clinical trial protocol design, enrollment, advancement and potential results, potential regulatory pathway for certain of ImmunityBio’s product candidates and target indications, data from the clinical trials for certain of ImmunityBio’s product candidates, potential implications to be drawn from clinical trials, potential commercialization of product candidates, and ImmunityBio’s product candidates 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 ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, (ii) the risks and uncertainties associated with the regulatory submission, review and approval process, (iii) ImmunityBio’s ability to retain and hire key personnel, (iv) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (v) ImmunityBio’s ability to successfully commercialize its product candidates and uncertainties around regulatory reviews and approvals, (vi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its product candidates and future approved products, (vii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies, and (viii) the unknown future impact of the COVID-19 pandemic on certain clinical trials or their milestones and/or ImmunityBio’s business operations or operating expenses. 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 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. 1&2 American Society of Clinical Oncology (ASCO) Cancer.net