Altor BioScience Corporation Announces National Cancer Institute Phase II SBIR Grant Award And Publication Supporting Ongoing Clinical Trial Of IL-15 Super Agonist ALT-803 In Combination With Anti-CD20 Antibody Therapy For Relapsed / Refractory Non-Hodgki

MIRAMAR, Fla.--(BUSINESS WIRE)--Altor BioScience Corporation (Altor), a leading developer of cancer immunotherapies, announced today that it has been awarded a Small Business Innovation Research (SBIR) Direct-to-Phase II grant by the National Cancer Institute (NCI) to support an ongoing Phase 1/2 clinical trial of ALT-803, a proprietary interleukin-15 (IL-15) super agonist protein complex, in combination with the approved therapeutic antibody (Ab) rituximab in patients with relapsed or refractory indolent B cell non-Hodgkin lymphoma (iNHL). The antitumor activity of this combination therapy was demonstrated in preclinical efficacy studies recently published in the peer-reviewed journal Clinical Cancer Research. These preclinical studies were conducted by Altor in collaboration with Todd Fehniger, M.D., Ph.D., at Washington University, St. Louis. Dr. Fehniger is also the lead clinical investigator on this Phase 1/2 clinical trial.

ALT-803 is considered one of the most promising novel immunotherapeutic agents by NCI for cancer treatment. Preclinical studies have shown ALT-803 simultaneously mobilizes both the innate and adaptive arms of the immune system to elicit rapid, robust, and long-lasting responses against cancer and virally-infected cells. In the Sept. 30, 2015 Clinical Cancer Research OnlineFirst publication, ALT-803 was found to potently activate human effector natural killer (NK) cells and also enhance the antibody dependent cell-mediated cytotoxicity (ADCC) of rituximab against human B cell lymphoma cell lines and primary follicular lymphoma cells in various tumor models. The encouraging results of these combination studies led to a current clinical trial using ALT-803 plus rituximab in patients with iNHL, a common B cell malignancy (Clinicaltrials.gov ID: NCT02384954). The $2.0 million SBIR grant was awarded on Sept. 22, 2015, and will support this multi-center Phase 1/2 clinical trial. Patient enrollment for this trial was initiated in early 2015 and the ALT-803 dose escalation portion of the study is ongoing. The grant will fund further dose escalation and a two-armed Phase 2 study in iNHL patients who are either refractory or sensitive to rituximab-containing regimens. In addition, correlative studies of immune responses in treated patients will be conducted by Altor and Dr. Fehniger’s laboratory at Washington University’s Siteman Cancer Center through the SBIR grant support.

Todd Fehniger, M.D., Ph.D., commented, “This is an exciting time to bring cutting-edge immunotherapy, such as ALT-803, to cancer patients. We are very excited to lead this Phase 1/2 trial of ALT-803 plus rituximab for patients with relapsed/refractory indolent non-Hodgkin lymphoma. ALT-803 boosts the immune response directed by therapeutic antibodies such as rituximab, and may potentially lead to long-term immunity for our lymphoma patients.”

Hing C. Wong, Ph.D., Altor’s founder and CEO, commented, “Altor is thrilled to advance the development of ALT-803 as a cancer treatment into clinical trials. We are honored to receive support from NCI for this important iNHL trial. The funding for the trial is the third SBIR Phase II grant awarded to Altor in the past year for clinical studies using this promising immunotherapeutic. Our objective is to develop ALT-803 as a durable or potentially curative treatment for iNHL, a disease that remains incurable even with the advent of newly emerging therapies. This study will also guide the future clinical development of ALT-803 combination therapy approaches, such as with other therapeutic antibodies or checkpoint inhibitors to treat neoplastic malignancies.”

NHL is the most commonly diagnosed hematologic malignancy and the 6^th most common cancer in the United States. According to NCI, over 70,000 new cases of NHL and about 19,000 deaths due to NHL are expected in the U.S. in 2015. Over one third of all cases are slow-growing or indolent NHL and the most common iNHL, follicular lymphoma, comprises about 20% of all NHLs. The initial treatment of iNHL primarily consists of rituximab alone or in combination with chemotherapy. Although therapies for iNHL induce regression in most patients, about 25% of patients are not responsive to the initial rituximab-based therapy. Additionally, current therapies are not curative and iNHL patients typically exhibit disease recurrence a few years following front-line therapy. Thus, there is a need for effective, durable and well-tolerated treatments for iNHL.

About Altor’s IL-15 Technology

The cytokine IL-15 plays a major role in the development of cellular immune responses, driving T and NK cell proliferation and activation. Altor has developed ALT-803, a novel IL-15 super agonist complex, with improved pharmacokinetic properties and enhanced anti-tumor activity compared to recombinant human IL-15. Altor is collaborating with more than thirty leading research institutes and universities to explore potential clinical utilities of ALT-803 against cancer and viral infections. In various cancer models, ALT-803 exhibits potent activity when administered as a monotherapy and also as a combination therapy with other therapeutic agents. Six clinical trials with ALT-803 are currently being conducted in patients with hematologic and solid tumors and in HIV patients receiving antiretroviral therapy.

About Altor BioScience

Altor is a privately held biotechnology company developing immunotherapies for treating cancer, viral infections, and inflammatory diseases based on its proprietary IL-15 super agonist, T cell receptor and Tissue Factor antagonist platform technologies. Altor currently has five Phase 1 and two Phase 2 trials underway for its immunotherapeutics against cancer.

Visit www.altorbioscience.com for details.