T-Cells(Key Biologics)

- With no dose-limiting toxicities observed, treatment of second dose cohort to begin SAN JOSE, Calif., Oct. 13, 2023 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that, in partnership with Moffitt Cancer Center, it has completed treatment of the first patient cohort in the ongoing clinical trial of Anixa's novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer. All three patients in the first cohort received the same dose of engineered T-cells, with no dose-limiting toxicities observed. Following the requisite wait time after the last patient was dosed, a comprehensive review of the safety data from this cohort, and confirmation that it is safe to escalate, the trial will begin enrolling patients in the second dose cohort immediately. Patients enrolled in this second cohort will receive three times the cell dose compared to the first cohort. Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "We are pleased with the positive safety data from the first cohort and look forward to advancing to the next higher dose cohort. We hope to continue observing good safety results as we continue to increase dosage, and eventually objective efficacy data." The study (NCT05316129), which is being conducted at Moffitt Cancer Center, is a dose-escalation Phase 1 trial to evaluate the therapy's safety; determine the maximum tolerated dose of T-cells targeting the follicle stimulating hormone receptor (FSHR); and preliminarily assess clinical activity. All patients being enrolled in the trial have disease that is progressing and have failed at least two, but often more, therapeutic interventions. Dr. Robert Wenham, the Principal Investigator of the trial, and the Head of Gynecological Oncology at Moffitt stated, "We are very pleased with the results to date. The first three patients were dosed through a peritoneal catheter and no patient has had a dose-limiting toxicity. Since most lesions in ovarian cancer are within the peritoneum, we hope the delivered CAR-T cells remain localized and active in the vicinity of the tumors. It's possible that we may see very limited side effects due to this local, as opposed to systemic, delivery. The very selective target also gives us reason to hope that on-target, off-tumor effects will not be prevalent as in other solid tumor studies. Perhaps this delivery approach may enhance efficacy as well. However, we will also test this therapy by intravenous administration, in patients for whom peritoneal administration is not possible." The CAR-T approach used for Anixa's therapy is known as chimeric endocrine receptor T-cell (CER-T) since the target of the engineered T-cells is an endocrine receptor. While CAR-T therapy has shown efficacy in some hematological tumors, reproducing the same results with solid tumors, such as ovarian cancer, has proven challenging. One of the reasons for this difficulty is that effective CAR-T therapy needs to attack a specific antigen present only on targeted cells to avoid negatively affecting healthy cells. The cell therapy being evaluated in Anixa's Phase 1 study differs from traditional CAR-T therapy in that it targets the FSHR, which research indicates is exclusively expressed on ovarian cells in healthy adult females. About Anixa Biosciences, Inc. Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology. The Company's vaccine portfolio includes a novel vaccine being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on clinical development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit or follow Anixa on Twitter, LinkedIn, Facebook and YouTube. Forward-Looking Statements Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release. Contacts: Stephen Kilmer Investor Relations [email protected] 646-274-3580 Mike Catelani President, COO & CFO [email protected] 408-708-9808 SOURCE Anixa Biosciences, Inc.

FRIDAY, June 9, 2023 -- For patients battling late-stage lung cancer, prospects for survival have improved significantly since the advent of medications known as immune checkpoint inhibitors. But exactly how long patients with advanced non-small cell lung cancer (NSCLC) need to be on immunotherapy has not been known. Until now. According to new research involving more than 1,000 patients, those with stable disease can stop the treatment after two years without jeopardizing their survival odds. ("Stable" means their lung cancer shows no sign of progression.) Investigators found that those who stopped at 24 months fared just as well as patients who continued to take the medication indefinitely. Moreover, discontinuing immunotherapy at two years might diminish the risk for downsides that can accompany open-ended inhibitor treatment, the researchers said. "Long-term treatment with immunotherapy carries significant risk for toxicity," explained study lead author Dr. Lova Sun , an assistant professor of hematology-oncology with the University of Pennsylvania School of Medicine, in Philadelphia. Sun pointed out that immunotherapy is also quite expensive, so the longer patients stay on the treatment, the higher their potential out-of-pocket cost, depending on insurance. According to the U.S. National Cancer Institute, immune checkpoint inhibitors also pose a risk for a wide array of side effects, including rashes, diarrhea and fatigue. In rare cases, the treatment may also trigger widespread inflammation, which can interfere with proper organ function. Targeted immunotherapy drugs include pembrolizumab (Keytruda), ipilimumab (Yervoy), nivolumab (Opdivo) and atezolizumab (Tecentriq). They work by preventing tumor cells from undermining a key weapon in the immune system: T-cells. T-cells can be effective at killing off cancer cells. The problem is that when lung cancer develops, proteins found on tumor cells end up finding and binding with specific proteins found on T-cells. The result: T-cells get turned off. But immune checkpoint inhibitors can stop that binding from happening in the first place. In so doing, the treatment preserves a T-cell's cancer-fighting power. For this work, investigators studied roughly 14,400 patients with advanced NSCLC, using information from a national U.S. electronic database. All were aged 18 years or older when diagnosed with NSCLC between 2016 and 2020. And all had received immunotherapy, sometimes in conjunction with chemotherapy. Two years after the start of immunotherapy, only about 1,100 patients were still alive, had not started any additional treatment, and had cancer that was stable. Among this group, one-fifth had stopped taking immune checkpoint inhibitors precisely at the two-year mark. All who continued the treatment beyond that point were characterized as “indefinite” treatment patients. After comparing survival rates among both groups, the study team found nearly identical results: 79% survival among those who stopped treatment versus 81% among the ongoing treatment group. The difference was deemed to be "statistically" insignificant. The findings are "quite appealing,” said Sun. Moreover, “for a small group of patients who stopped at two years and then progressed, many of them were able to restart the same medication with clinical benefit,” she added. But that suggests patients taken off immune checkpoint inhibitors should continue to be monitored, and "immunotherapy re-challenge should certainly be considered,” Sun noted. Dr. Thomas Marron is director of the early-phase trials unit at the Tisch Cancer Institute of Mount Sinai, in New York City. For lung cancer patients, he said immune checkpoint inhibitors have essentially doubled life expectancy and likely cured cancer altogether among somewhere between 10% and 30% of patients. In effect, “immunotherapy is curing what was previously incurable cancer,” said Marron, who was not part of the study team. Still, he noted that the “financial toxicity to patients” on the treatment for years is significant, even for wealthy patients, depending on where they live and their insurance. “Along with co-pays for therapy,” explained Marron, “you have to consider the co-pays for all the blood tests and imaging assessments, which can be high, as well as the transit to and from the cancer center every few weeks for years.” Side effects from long-term treatment are also a legitimate concern, he added. Also, some patients and their doctors “are nervous to stop therapy” when things appear to be going well, he acknowledged. But the preponderance of research suggests “that most patients who are in remission at two years stay in remission upon cessation,” Marron said. The findings were published online June 4 in JAMA Oncology and presented at the annual meeting of the American Society of Clinical Oncology, in Chicago. Sources Lova Sun, MD, assistant professor, hematology-oncology, University of Pennsylvania School of Medicine, Philadelphia Thomas Marron, MD, PhD, director, early-phase trials unit, Tisch Cancer Institute of Mount Sinai, New York City JAMA Oncology , June 4, 2023, online Posted June 2023