SAN JOSE – Anixa Biosciences, Inc. (NASDAQ: NASDAQ:ANIX), in collaboration with Moffitt Cancer Center, has submitted a protocol amendment to potentially allow a second dose of CAR-T therapy for patients in a clinical trial targeting ovarian cancer. The amendment, if approved, would enable suitable patients to receive an additional dose without the need for individual Investigational New Drug (IND) applications.
The clinical trial, which utilizes chimeric endocrine receptor-T cell (CER-T) technology, has previously granted a single patient a second dose of CAR-T after initial signs of biological activity in her cancer were observed. This amendment aims to extend the possibility of a second dose to all eligible patients, following a process called leukapheresis, which is a laboratory procedure in which white blood cells are separated from a sample of blood.
Dr. Robert Wenham of Moffitt Cancer Center, the principal investigator, explained that the patient who received the second dose had initially been given a low cell dose for safety verification. Despite her tumor meeting the criteria for progression, her cancer has remained stable without further treatment since the first infusion. A second, higher dose may improve her response and outcome, a potential benefit that the trial seeks to investigate more broadly among patients.
The optimism for the trial's progress was echoed by Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, who anticipates regulatory approval for the amendment. He highlighted the company's enthusiasm for the trial and its potential impact on treating additional patients.
Anixa Biosciences, a clinical-stage biotechnology company, is focused on cancer treatment and prevention, including vaccine development for various forms of cancer in collaboration with Cleveland Clinic. The company's approach involves partnering with research institutions to develop and commercialize emerging technologies.
The information in this article is based on a press release statement from Anixa Biosciences, Inc.
In other recent news, Anixa Biosciences has revealed plans for a Phase 2 study of its breast cancer vaccine, following a Phase 1 trial currently underway at Cleveland Clinic. The upcoming trial aims to reduce tumor size and recurrence, potentially improving survival rates. In analyst news, EF Hutton initiated coverage on Anixa Biosciences with a Buy rating, while H.C. Wainwright adjusted its outlook, reducing the 12-month price target to $7.00, but maintained a Buy rating.
Anixa Biosciences reported a net loss of $3.1 million for the second fiscal quarter of 2024, which was less than the expected loss of $3.5 million. Furthermore, the company announced a share repurchase program, signaling confidence in its financial health and future prospects. Anixa Biosciences, in collaboration with Cleveland Clinic, has received a Japanese patent for its breast cancer vaccine technology and expanded its Cancer Business Advisory Board with the addition of Dr. Sanjay Juneja.
Additionally, the FDA approved a second dose of Anixa's CAR-T therapy for a patient in a Phase I clinical trial for recurrent ovarian cancer. The company also advanced with its clinical trials, including one for a novel CAR-T therapy for ovarian cancer, which recently received FDA approval for a second dose administration. These are among the recent developments in Anixa Biosciences' pursuit of advancing cancer treatment and prevention.
InvestingPro Insights
As Anixa Biosciences (NASDAQ: ANIX) advances its clinical trial for ovarian cancer treatment, investors may find additional context from InvestingPro's financial metrics and tips valuable.
According to InvestingPro data, Anixa's market capitalization stands at $102.65 million, reflecting its position as a small-cap biotechnology company. This valuation aligns with the company's focus on developing innovative cancer treatments, such as the CAR-T therapy mentioned in the article.
An InvestingPro Tip highlights that Anixa holds more cash than debt on its balance sheet. This strong liquidity position is crucial for a clinical-stage biotech company, as it provides the financial runway needed to fund ongoing research and clinical trials, such as the ovarian cancer study discussed.
Another relevant InvestingPro Tip indicates that analysts anticipate sales growth in the current year. This projection could be tied to the potential success of Anixa's clinical trials and the possibility of advancing treatments towards commercialization.
It's worth noting that InvestingPro offers 6 additional tips for Anixa Biosciences, providing a more comprehensive financial picture for interested investors.
While the company's P/E ratio stands at -8.07, reflecting its pre-profit stage, the strong return over the last three months (44.34% according to InvestingPro data) suggests growing investor optimism, possibly linked to developments like the protocol amendment mentioned in the article.
These insights from InvestingPro complement the article by offering a financial perspective on Anixa's position as it pursues potentially groundbreaking cancer treatments.
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