ALETA-001

The Phase 1/2 clinical trial will evaluate safety, dose, PK/PD, and early efficacy signals of Aleta’s first-in-class biologic CAR T-Cell Engager, ALETA-001 ALETA-001 entering the clinic is a critical milestone toward treatment availability to improve CAR T-cell patient response when a complete response is not achieved or maintained NATICK, Mass. & LONDON--(BUSINESS WIRE)-- Aleta Biotherapeutics (Aleta), a clinical stage, immuno-oncology company with a CAR T-Cell Engager (CTE) platform that enables cell cancer therapies to work more effectively, and Cancer Research UK’s Centre for Drug Development, today announce the first patient was dosed in a Phase 1/2 clinical trial. This trial is evaluating the Company’s first-in-class biologic CAR T-Cell Engager, ALETA-001, for the treatment of patients with B-cell malignancies who are relapsed/refractory to CD19-targeting CAR T-cell therapy. This press release features multimedia. View the full release here: Cancer Research UK’s Centre for Drug Development is sponsoring and conducting the Phase 1/2 clinical trial of ALETA-001, the lead agent in Aleta's portfolio. “It is very exciting and meaningful to have ALETA-001 now in the clinic. Clinical evaluation of ALETA-001 is a key milestone toward a much-needed treatment option for the many cancer patients whose CD19-targeted CAR T-cell therapies ultimately stop working. ALETA-001 restores and increases the effectiveness with which CAR T-cells can kill cancer cells, and we believe that it will enable more patients to successfully benefit from cell therapies,” stated Dr. Paul Rennert, President and Chief Scientific Officer, Aleta Biotherapeutics. The ALETA-001 Phase 1/2 clinical trial is an open-label, dose-expansion trial which will evaluate safety and tolerability, pharmacokinetic and pharmacodynamic effects, and early signals of clinical efficacy of ALETA-001 as a single agent. Chief Investigator Dr. Sridhar Chaganti is leading the trial from University Hospital Birmingham NHS Foundation Trust in Birmingham, UK, and will enroll patients who are relapsed/refractory following treatment with available CD19-targeting CAR T-cell therapies. For more information on this trial, please visit clinicaltrials.gov (NCT06045910) Dr. Lars Erwig, Cancer Research UK’s Director of Drug Development, said, "A significant number of patients with blood cancers unfortunately relapse following CD19-directed CAR T-cell therapy. ALETA-001 is being developed to provide patients with these cancers a better chance for a successful treatment outcome. At Cancer Research UK, we are very excited to study the clinical potential of ALETA-001 to transform a patient’s treatment journey - which can possibly be lifesaving in many cases." “Aleta-001 is a uniquely designed new molecule with a novel mechanism of action, coating tumor cells densely with the target antigen, thereby stimulating the tumor killing ability of activated CAR T-cells,” commented Dr. Sridhar Chaganti, Chief Investigator, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK. “This is an important new strategy being investigated to improve outcomes for patients with relapsed or refractory lymphomas who experience disease progression after CAR T-cell therapy and have a poor prognosis.” About CAR T-Cell Therapy Engager (CTE) ALETA-001 Aleta’s lead clinical stage program, ALETA-001, was designed specifically for the treatment of B-cell malignancies in patients who have received a CD19-directed CAR T-cell therapy and are at risk of treatment failure. Developed to improve the effectiveness of CD19-directed CAR T-cell therapies by increasing CD19 antigen density and restoring lost CD19 expression on the cancer cell, ALETA-001 contains the CD19 target protein which is further linked to an CD20 antibody domain. This allows CD19+/CD20+ cancer cells to be easily recognized and killed by CD19-directed CAR T-cells that were previously administered and are already circulating within a patient. Aleta previously secured landmark clinical support and funding from Cancer Research UK for the ALETA-001 Phase 1/2 clinical trials, and ALETA-001 has received a UK Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). ILAP designation is granted to medicines that address life-threatening or seriously debilitating conditions, and where there exists a significant patient or public health need. About Aleta Biotherapeutics Aleta Biotherapeutics is pioneering a transformation of cancer treatment by enabling CAR T-cell cancer therapies to work more effectively. The Company’s unique portfolio of multi-antigen CAR T Engagers (CTEs) are simple, potent biologic therapies designed to transform the expression of cancer tumor cells to match CAR T-cell therapies circulating in patient blood. These CTEs are being developed to produce deeper and more durable responses in patients receiving CAR T-cell therapies through increasing cancer target density, and preventing resistance and escape from therapy, thus increasing the speed and effectiveness with which CAR T-cells can kill cancer cells. Aleta’s lead clinical stage biologic, ALETA-001 was designed specifically for the treatment of B-cell malignancies in patients who have received a CD19-directed CAR T-cell therapy and are at risk of treatment failure. Aleta is further developing its CTE platform technology to address acute myeloid leukemia, multiple myeloma, and solid tumors including breast cancer, gastric cancer, and pediatric brain cancers. aletabio.com About Cancer Research UK’s Centre for Drug Development Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of over 20 new anti-cancer agents in preclinical development, Phase 1, or early Phase 2a clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. 13 other drugs are still undergoing active development. View source version on businesswire.com: Contacts Media: Linda Phelan Dyson, MPH Corporate Communications +1 973-986-5973 lpdyson@verizon.net Source: Aleta Biotherapeutics View this news release online at:

Aleta’s lead program, ALETA-001 has clinical support from collaborator Cancer Research UK, which will initiate the Phase 1/2 Clinical Trial during H2 2023 ALETA-001, previously granted a UK Innovation Passport, was developed to address the urgent unmet patient need of relapse after CD19 CAR T-Cell Cancer Treatment NATICK, Mass.--(BUSINESS WIRE)-- Aleta Biotherapeutics (Aleta), a privately-held immuno-oncology company with a platform of CAR T-Cell Engagers (CTE) which enable cell therapies to improve outcomes for patients with cancer, announces that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted clinical trial authorization (CTA) to evaluate investigational biologic ALETA-001 in a Phase 1/2 clinical trial in the treatment of patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T-cell therapy. Aleta’s lead program, ALETA-001 has clinical support and funding from its collaboration partner, Cancer Research UK’s Centre for Drug Development, which has sponsored and will conduct the Phase 1/2 clinical trial. “The authorization to clinically evaluate, in collaboration with Cancer Research UK, the potent activity of ALETA-001, our lead biologic CAR T-Cell Therapy Engager, marks important progress for the entire global oncology community - especially patients,” commented Paul Rennert, Ph.D., Chief Executive Officer and Chief Scientific Officer, Aleta Biotherapeutics. “Aleta’s CTEs act by transforming the expression of any cancer tumor cell to match the CAR T-cell therapies circulating in a patient’s blood, importantly restoring and increasing the effectiveness with which CAR T-Cells can kill cancer cells,” continued Dr. Rennert. Dr. Nigel Blackburn, Cancer Research UK’s Director of Drug Development, stated, "CAR-T cell therapy has been transformative for some cancer patients but there remains a critical need to ensure that this therapy is an option for all. ALETA-001 is working to address this treatment gap for people with blood cancers by advancing a potentially life-saving CAR-T cell therapy into the clinic. We are delighted to play a key role in this trial and look forward to seeing this treatment become available for more patients in the future." About CAR T-Cell Therapy Engager (CTE) ALETA-001 Aleta’s lead development program, ALETA-001, contains the CD19 target protein which is further linked to an CD20 antibody domain. ALETA-001 is designed to improve the effectiveness of CD19-directed CAR T therapies by increasing CD19 antigen density and restoring lost CD19 expression on the cancer cell. This allows CD19+/CD20+ cancer cells to be easily recognized and killed by CD19-directed CAR T-cells that were previously administered and are already circulating within a patient. Aleta previously secured landmark clinical support and funding from Cancer Research UK for the ALETA-001 Phase I/II clinical trials, and ALETA-001 has received a UK Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). ILAP designation is granted to medicines that address life-threatening or seriously debilitating conditions, and where there exists a significant patient or public health need. About Aleta Biotherapeutics Aleta Therapeutics is pioneering a transformation of cancer treatment by enabling CAR-T cell cancer therapies to work more effectively. The Company’s unique portfolio of multi-antigen CAR-T Engagers (CTEs) are simple, potent biologic therapies designed to transform the expression of cancer tumor cells to match CAR-T cell therapies circulating in patient blood. These CTEs are being developed to produce deeper and more durable responses in patients receiving CAR-T cell therapies through increasing cancer target density, and preventing resistance and escape from therapy, thus increasing the speed and effectiveness with which CAR-T cells can kill cancer cells. Aleta’s lead program, ALETA-001, is clinic-ready for the treatment of B-cell malignancies in patients who are relapsed/refractory to CD19-directed CAR T-cell therapy. Additional CTEs in the Aleta portfolio include: ALETA-004: a preclinical, multi-antigen binding CTE designed to extend the cancer killing activity of CAR-T cells to treat advanced acute myeloid leukemia, and ALETA-005: a discovery phase CTE that allows multiple myeloma tumors to present multiple antigen binding sites to B-cell maturation antigen (BCMA) CAR T-cells, stimulating optimal BCMA CAR-T cell killing of advanced multiple myeloma. Aleta is further developing its CTE platform technology to address solid tumors including breast cancer, gastric cancer, and pediatric brain cancers. About Cancer Research UK’s Centre for Drug Development Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 150 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.