Metastatic osteosarcoma

Company’s therapeutic dendritic cell-based vaccine technology aims to offer new treatment options for children with recurring metastatic Ewing sarcoma and osteosarcoma LOS ANGELES--(BUSINESS WIRE)-- CellxLife today announced that Eric von Hofe, Ph.D., will serve as the company’s first Chief Executive Officer. The company was formed in late 2023 to advance a dendritic cell-based therapeutic vaccine candidate that aims to expand treatment options for children with recurring metastatic Ewing sarcoma and osteosarcoma. There are currently very few treatment options for children suffering from metastatic Ewing sarcoma or osteosarcoma. The most common treatment is surgical removal of the tumors in combination with radiation and chemotherapy. For children with recurring metastatic Ewing sarcoma or osteosarcoma, the 5-year survival rate is usually 20-30% and in the U.S., approximately $750,000 is spent on treatment over the course of a patient’s life. i,ii “Ewing sarcoma and osteosarcoma are devastating diseases that have far-reaching impact, particularly in pediatric patients and their caregivers,” said Dr. von Hofe. “I am honored to join the CellxLife team to help advance efforts in bringing this promising new biotherapeutic to the thousands of children and families fighting these cancers globally.” Through CellxLife’s proprietary platform, dendritic cells are taken from the body and presented with the patient’s own tumor cell antigens, then re-administered back into the body as an immunotherapeutic vaccine to educate the immune system. Study data generated to date has indicated that this both activates immune cells to attack remaining cancer cells in the body and shapes the immunological memory to greatly reduce the chances of cancer recurrence. In a prior Phase 1 study, 75% of pediatric participants diagnosed with metastatic Ewing’s or osteosarcoma, who responded well to surgery, overcame their cancer, and are still alive today. Out of all the participants in the trial, 62.5% of children with metastatic osteosarcoma who were treated with the dendritic cell-based therapy lived for more than 15 years. The CellxLife clinical team believes the therapy can cross over to other solid tumors, such as ovarian, breast, colorectal, pancreatic, glioblastoma, lung, and other solid tumors. The principle is the same; once a tumor is removed, the vaccine will shape the immunological memory of the cancer cells in the lymph nodes and greatly reduce the chances of cancer recurrence. “This could be a breakthrough for anyone who is faced with the horrible realization that cancer could reoccur after their tumor is removed,” said Ruvin Orbach, founder of CellxLife. “It’s an honor to have Eric on board as CEO at this important time of growth for CellxLife. We are committed to building the team and raising the capital required to further advance this de-risked therapeutic candidate. We are currently planning the Phase II trials with an orphan designation and significantly reducing the regulatory pathway for this promising immunotherapy.” Dr. von Hofe has over 30 years of experience in managing and overseeing biotechnology programs, with a focus on cancer immunotherapy and technology development. Most recently he led development efforts at AffyImmune Therapeutics where he oversaw the clinical development and orphan designation for a novel CAR-T cell therapeutic targeting refractory thyroid cancer. Previously, he was at Antigen Express where he led the development of an immunotherapeutic vaccine for breast and prostate cancer, resulting in a collaboration with Merck. Prior to that, he worked at Millennium Pharmaceuticals first as Program Director for Target Validation and later as Director of Programs & Operations, Discovery Research. Previously, Dr. von Hofe was Director, New Targets at Hybridon, Inc., where he coordinated in-house and collaborative research that validated gene targets for novel antisense medicines. Dr. von Hofe also held the position of Assistant Professor of Pharmacology at the University of Massachusetts Medical School, where he received a National Cancer Institute Career Development Award for defining mechanisms by which alkylating carcinogens create cancers. He received his Ph.D. in Experimental Pathology from the University of Southern California and was a postdoctoral fellow at both the University of Zurich and Harvard University School of Public Health. For more information, please visit . About CellxLife CellxLife is a Phase I/II-stage biotechnology company founded in 2023 to acquire promising biotherapies and accelerate their regulatory approval. The company’s initial program is focused on advancing a dendritic cell-derived vaccine therapy targeting metastatic Ewing sarcoma and osteosarcoma. The company is also currently planning a basket trial for five other solid tumor indications. Based in Los Angeles, California, CellxLife can be found online at . ____________________ i ii

1-year Event Free Survival (EFS) of 32.5% vs. 20% 1-year EFS for comparator Interim 1-year and 18-month Overall Survival (OS) of 90.4% 0 Grade 3, 4 or 5 Treatment-related Adverse Events (AEs) 41 patient trial fully enrolled Primary endpoint 12-month EFS data and interim co-primary endpoint 12-month OS data to be released in the fourth quarter of 2024 No novel therapeutic interventions for resected, recurrent osteosarcoma in 40+years ROCKVILLE, Md.--(BUSINESS WIRE)-- OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage oncology-focused immunotherapy company developing cancer vaccines and antibody drug conjugate (ADC) therapeutic candidates, today announced a positive clinical update for AOST-2121 (NCT04974008), its ongoing Phase 2b clinical trial of its immunotherapy OST-HER2 (OST31-154) in patients with resected, recurrent osteosarcoma. OST-HER2, a biologic therapeutic candidate, is a Lm (Listeria monocytogenes) vector-based off-the-shelf immunotherapeutic vaccine designed to prevent metastasis, delay recurrence, and increase overall survival in patients with Osteosarcoma. The AOST-2121 study is designed to demonstrate efficacy in patients who have already had recurrent disease and are highly likely to recur again. A total of 18 OST-HER2 doses are administered once every three weeks, for a total 51 weeks. Radiographic evaluation of recurrence is evaluated throughout treatment. The proposed OST-HER2 mechanism of action is based on innate and adaptive immune stimulating responses activated by the Lm vector. This treatment generates T cells that can eliminate or slow potential micrometastases that can grow into recurrent osteosarcoma. T cell responses home-in on HER2 expressed by the tumor and then kill the cell, releasing additional tumor targets. There are currently no approved adjuvant treatments for recurrent osteosarcoma in the United States. AOST-2121 has achieved full enrollment of 41 patients treated with OST-HER2 at 21 clinical trial sites across the United States. A few patients remain in the active treatment stage with the remainder in follow-up for overall survival. The primary endpoints for the AOST-2121 study are Event Free Survival (‘EFS’, defined as absence of recurrence of primary tumor or metastasis) at 12 months and Overall Survival at 36 months, with interim Overall Survival endpoints at 12 months and 24 months. Topline EFS data, interim 1-year OS data, as well as additional secondary data analyses are expected to be reported in the fourth quarter of 2024. No novel therapeutic interventions have improved the clinical outcomes for patients with resected, recurrent osteosarcoma in over 40 years. The clinical updates reported today include: 1-year EFS rate of 32.5% vs. 20% EFS rate for unsuccessful investigational therapeutic comparator1 1-year overall survival rate of 90.4% 18-month overall survival rate of 90.4% Treatment has been well tolerated and there have been no grade 3, 4 or 5 treatment-related adverse events reported for the 41 patients. “OST-HER2’s strong safety pro its potential to become a practical adjuvant therapy to delay or prevent subsequent recurrences and improve overall survival in the very difficult challenge of recurrent osteosarcoma. Promoting innate and adaptive immune surveillance against lurking micrometastases could become a potentially powerful tool for oncologists as they seek to improve the quality of life and prolong survival of patients who have suffered from Osteosarcoma,” said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. “OST-HER2 has the potential to significantly improve the standard of care in this difficult to treat patient population. In light of today’s encouraging clinical trial update, we are hopeful that final data coming in the fourth quarter of this year, combined with supplemental data that will follow in 2025, positions OST-HER2 to become available to help clinicians better protect people with difficult cancers like osteosarcoma.” “With historical 1-year EFS estimated in the low-to-mid teens with the current standard of care, and the most recent investigational therapeutic comparator yielding 1-year EFS of 20%, we believe that the 32.5% EFS data observed to date in this trial compares favorably and positions OS Therapies to deliver final Phase 2b co-primary endpoint data by the end of 2024,” said Paul Romness, President & CEO of OS Therapies. “With OST-HER2’s strong safety pro consistent overall survival at the 1-year and 18 month timepoints, and given the dearth of therapeutic options for the resected, recurrent osteosarcoma patient population, we are hopeful that OS Therapies will be gain approval for the first new osteosarcoma treatment, a novel immunotherapy, in over 40 years.” The FDA has granted Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for OST-HER2 in Osteosarcoma. References Lagmay JP, Krailo MD, Dang H, et al: Outcome of patients with recurrent osteosarcoma enrolled in seven Phase II trials through Children's Cancer Group, Pediatric Oncology Group, and Children's Oncology Group: learning from the past to move forward. J Clin Oncol. 2016;34:3031-8. About Osteosarcoma Osteosarcoma is a solid tumor of the bone that predominantly occurs in adolescents and young adults (AYA). Standard treatment includes surgery and chemotherapy. For patients with metastatic osteosarcoma or have recurrence after chemotherapy, the prognosis is poor. About OS Therapies OS Therapies, Inc. (NYSE-A: OSTX) is a clinical stage oncology company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2 is an immunotherapy leveraging the immune stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. The Company has fully-enrolled a 41-patient Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma, with results expected in the fourth quarter of 2024. OS Therapies is also developing the next generations Antibody Drug Conjugate (ADC) platform tunable ADC (tADC) centered around tunable, tailored antibody-linker-payload candidates built around the Company’s unique silicone linker technology that allows for multiple payloads to be delivered per linker. About OST-HER2 The OST-HER2 Lm vector platform technology has been administered to over 450 cancer patients in ongoing and completed clinical trials. AOST-2121 is a Phase IIB clinical trial intended to prevent or delay metastasis and improve Overall Survival (OS) in Osteosarcoma. OST-HER2 has already received Fast-Track, Orphan, and Rare Disease Designation (RDD). OST hopes to seek a Break-Through Designation (BTD) based on data from this Phase IIb clinical trial. OST31-164 has previously received USDA provisional approval for treatment of Osteosarcoma in canines. In a completed Phase III study in canines (n=180), early data demonstrated a clear separation of treated and untreated canine patients (p=.0007) in Overall Survival (OS) and Disease Progression. For more information, please see the Company's website at

ROCKVILLE, Md.--(BUSINESS WIRE)-- OS Therapies, a research and clinical stage biopharmaceutical company, is extremely excited to announce Full Enrollment for its lead OST-HER2 (OST31-164) program in its ongoing clinical trial AOST-2121 (NCT04974008). The trial is being conducted at 21 Children’s Oncology Group (COG) sites across the country for patients with Osteosarcoma that had metastasized to the lungs requiring surgical removal. Historically, 80-90% of these patients would develop additional metastasis within the period of the trial. The planned number of patients have now received treatment and the few remaining slots will be allocated to patients that have already been identified. Patients continue OST-HER2 treatment for 48 weeks and then are followed for survival 2 additional years. The primary endpoints of the trial are Event Free Survival and Overall Survival. “Several patients have completed the treatment phase of the trial and many more are undergoing treatment with OST-HER2. We hope that this treatment will reduce additional recurrences and extend the lives of all osteosarcoma patients and look forward to the outcome once all patients have completed treatment,” said Dr. Robert Petit, CMO/CSO of OS Therapies. Osteosarcoma is a rare but challenging disease for patients and their physicians, occurring primarily in teens and young adults. “Reaching thirty-nine patients enrolled is a major milestone in this trial, occurring more quickly than projected. A sincere thank you to the patients, families and healthcare providers - the Children’s Oncology Group, and the outstanding leadership of Principle Investigators Damon Reed, MD, and Kelly Bailey, MD,“ said Paul Romness, CEO of OS Therapies. About Osteosarcoma Osteosarcoma is a solid tumor of the bone that predominantly occurs in adolescents and young adults (AYA). Standard treatment includes surgery and chemotherapy. For patients with metastatic osteosarcoma or have recurrence after chemotherapy, the prognosis is poor. About OS Therapies OS Therapies Incorporated is a research and clinical-stage therapeutic company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other deadly cancers in kids and adults. OS Therapies has two platform technologies: OST-HER2 and OST-TDC being developed for therapies to treat Osteosarcoma (OS) and other solid tumors including ovarian. About OST-HER2 The OST-HER2 Lm vector platform technology has been administered to over 450 cancer patients in ongoing and completed clinical trials. AOST-2121 is a Phase IIB clinical trial intended to prevent or delay metastasis and improve Overall Survival (OS) in Osteosarcoma. OST-HER2 has already received Fast-Track, Orphan, and Rare Disease Designation (RDD). OST hopes to seek a Break-Through Designation (BTD) based on data from this Phase IIb clinical trial. OST31-164 has previously received USDA provisional approval for treatment of Osteosarcoma in canines. In a completed Phase III study in canines (n=180), early data demonstrated a clear separation of treated and untreated canine patients (p=.0007) in Overall Survival (OS) and Disease Progression. For more information, please see the Company's website at