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On February 5, 2021, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Lisocabtagene maraleucel is a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy. It consists of autologous T cells that are genetically modified to produce a CAR protein, allowing the T cells to identify and eliminate CD19-expressing normal and malignant cells. Efficacy was evaluated in TRANSCEND (NCT02631044), a single-arm, open label, multicenter trial that evaluated lisocabtagene maraleucel, preceded by lymphodepleting chemotherapy, in adults with R/R large B-cell lymphoma after at least two lines of therapy. Of the 192 patients evaluable for response, the overall response rate (ORR) per independent review committee assessment was 73% (95% CI: 67, 80) with a complete response (CR) rate of 54% (95% CI: 47, 61). The median time to first response was one month. Of the 104 patients who achieved CR, 65% had remission lasting at least 6 months and 62% had remission lasting at least 9 months. The estimated median duration of response (DOR) was not reached (95% CI: 16.7 months, NR) in patients who achieved a CR. The estimated median DOR among patients with partial response was 1.4 months (95% CI: 1.1, 2.2). Cytokine release syndrome (CRS) occurred in 46% of patients (Grade 3 or higher, 4%) and neurologic toxicity occurred in 35% (Grade 3 or higher, 12%). Three patients had fatal neurologic toxicity. Other Grade 3 or higher adverse reactions included infections (19%) and prolonged cytopenias (31%). FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy because of the risk of fatal or life-threatening CRS and neurologic toxicities. The recommended regimen is a single dose containing 50 to 110 x 106 CAR-positive viable T cells with a 1:1 ratio of CD4 and CD8 components, administered by IV infusion and preceded by fludarabine and cyclophosphamide for lymphodepletion. Lisocabtagene maraleucel is not indicated for the treatment of patients with primary central nervous system lymphoma. View the Approved Cellular and Gene Therapy Products webpage for further product information. This application was granted priority review, Regenerative Medicine Advanced Therapy designation, breakthrough designation and orphan drug designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. For information on the COVID-19 pandemic, see the following resources: FDA: Coronavirus Disease 2019 (COVID-19) NCI: Coronavirus: What People With Cancer Should Know CDC: Coronavirus (COVID-19) Follow the Oncology Center of Excellence on Twitter @FDAOncologyExternal Link Disclaimer

Foundational technology developed by UCLA for the Company’s Universal Cancer Vaccine can be adapted to function as an in-vivo CAR-T cell platform to dramatically lower the cost of CAR-T cell cancer therapiesLEHI, Utah, Sept. 12, 2023 (GLOBE NEWSWIRE) -- CancerVAX, Inc., a pre-clinical biotechnology company working with UCLA to develop breakthrough immunotherapy cancer treatments that use the body’s immune system to fight cancer, today announced an expansion of its development pipeline to include a Universal CAR-T Cell Platform that can dramatically lower the cost of CAR-T cell cancer therapies. CAR-T cell therapy is a type of immunotherapy treatment in which a patient’s T-cells are genetically modified in the laboratory, then reinjected back into the patient, so they will bind to specific proteins (antigens) found on cancer cells and kill them. These modified T-cells are called Chimeric Antigen Receptor (CAR) T Cells. Conventional CAR-T Cell therapy can cost more than $500,000 per dose due to complicated and expensive lab processes. We believe we can dramatically lower the cost to a few thousand dollars per dose by simply helping the body make its own CAR-T cells. During a remarkable meeting with Company executives recently, the UCLA research team reported significant project progress. Based on their recent findings, it is now clear that the foundational nanoparticle technology developed for the current Universal Cancer Vaccine project, can be easily adapted to target T-cells and carry genetic instructions to reprogram T-cells into CAR-T cells inside the body (in-vivo). Depending on the specific genetic instructions provided, different cancers can be targeted by the new CAR-T cells. Preliminary lab test suggests that this is easy to do. As a result, the Company has decided to expand its development pipeline to include a “Universal CAR-T Platform”. Conventional CAR-T Cell Therapy Steps: A patient’s T cells are removed from their blood.The gene for a special receptor called chimeric antigen receptor (CAR) is inserted into the T cells in the laboratory by gene editing. The gene forces the T cell to express a protein (receptor) on its surface that binds to the cancer cell’s surface protein (antigen).Millions of CAR-T cells are grown in the laboratory.They are then given to the patient by intravenous infusion.The CAR protein on the surface of the CAR-T cells bind to antigens on the cancer cells and kill them. CancerVAX Envisioned CAR-T Cell Steps: Genetic codes for targeting specific proteins on cancer cells are loaded into a smart nanoparticle using an innovative high-speed, low-cost manufacturing process.Millions of nanoparticles are injected into the patient as a shot. The nanoparticles attach to the patient’s natural T-cells inside the body, unload the genetic code, and reprogram the T-cells to target specific cancer cells and kill them. The Company’s pipeline of three projects with UCLA now includes: Children’s Cancer – Immunotherapy treatments for Ewing sarcoma, a children’s bone and tissue cancer with 100% death rate for recurrence.Universal Cancer Vaccine​ Platform – A novel and customizable Universal Cancer Vaccine (UCV), to be delivered as a shot, that can uniquely detect, mark and kill only cancer cells.Universal CAR-T Cell Platform – A novel and customizable low-cost treatment, to be delivered as a shot, that can reprogram natural immune T-cells inside the body to seek and destroy targeted cancer cells. Ryan Davies, CEO of CancerVAX commented, “CAR-T cell therapy is one of the more promising immunotherapies entering the mainstream of cancer treatment. There are currently six FDA approved CAR-T cell therapies, and they all cost around $500,000 per dose. While no amount of money is too much to save a single human life, we hope to dramatically lower the cost of CAR-T cell therapy by several orders of magnitude and help save many lives. The extreme low cost of the COVID vaccine, which uses similar technology and concepts, leads us to believe that this major cost reduction is possible with our Universal CAR-T Cell platform.” For more information about CancerVAX, please visit http://www.cancervax.com/. About Us CancerVAX, Inc., a pre-clinical biotechnology company working with UCLA to develop breakthrough immunotherapy cancer treatments that use the body’s immune system to fight cancer. Working with a team of experienced cancer researchers and physicians at UCLA, we are developing a pipeline that includes three innovative projects: (1) treating Ewing sarcoma, a deadly children’s cancer, (2) a Universal Cancer Vaccine that will detect, mark, and destroy only cancer cells while leaving healthy cells in-tact, and (3) a low cost Universal CAR-T Cell Platform that can reprogram natural immune T-cells inside the body to seek and destroy targeted cancer cells. All of our immunotherapy technologies are designed to be delivered as injections. We look forward to the day when treating cancer will be as simple as getting a flu shot – a better way to treat cancer. Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside our control. Our actual results and financial condition may differ materially from those in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this release is based only on information currently available to us and speaks only as of the date it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise. Press Contact:CancerVAX, Inc.Tel: (805) 356-1810communications@CancerVAX.com

Kite, a Gilead Company, has agreed to buy Tmunity Therapeutics (Tmunity), a private, clinical-stage biotech focused on cell therapy. The buy-out will further complement Kite’s established in-house cell therapy research capabilities by adding additional pipeline assets, platform capabilities, bolstered by a strategic research and licensing agreement with the University of Pennsylvania. Tmunity has focused on next-generation CAR T-therapies and technologies, and by joining Kite, will offer its pre-clinical and clinical programmes, including an ‘armoured’ CAR T technology platform. This has the potential to be applied to a variety of CAR Ts to enhance anti-tumour activity, in addition to rapid manufacturing processes. Not included in the transaction are Tmunity’s prostate-specific membrane antigen (PSMA) and prostate stem cell antigen (PSCA) assets, which will be spun-out by Tmunity as part of the agreement. According to the agreed terms, Kite will oversee continuing the R&D collaboration between Tmunity and University of Pennsylvania – also referred to as the Amended Research License Agreement (ARLA) – including research funding to the university along with options and licences to certain cell engineering and manufacturing technologies invented and developed in specific University of Pennsylvania laboratories. Once the agreement is finalised, the ARLA will be extended until 2026 with an option to extend further. Tmunity was founded in 2015 by Dr Carl June, who is also the Richard W Vague Professor of Immunotherapy in Penn’s Perelman School of Medicine and director of Penn’s Center for Cellular Immunotherapies. June founded the company with a group of early innovators in the cell therapy field, including the University of Pennsylvania’s Bruce Levine, James Riley and Anne Chew. The company was formed to rapidly advance early-stage cell therapy research and innovation done in academia into the clinic, to produce new treatments for patients with unmet needs. As part of Kite’s acquisition, the Tmunity founders will become senior scientific advisors for Kite. Christi Shaw, chief executive officer of Kite, said: “The Kite team is thrilled to be joining forces with the researchers at Tmunity who are rapidly advancing cell therapy research from the labs into the clinic through their unique partnership with the University of Pennsylvania. “Together, we bring a deep understanding of cell therapy as an effective platform, and combined with Kite’s industry-leading global scale, we collectively have a singular focus: to use cell therapy to develop potential cures, and to get them to patients as quickly as possible.” The deal is expected to close in the first quarter of 2023, and after closing, Tmunity’s employees will join Kite. The financial terms of the agreement were not disclosed.