SAN JOSE - Anixa Biosciences, Inc. (NASDAQ: NASDAQ:ANIX), a biotechnology firm engaged in cancer treatment and prevention, today disclosed plans for a Phase 2 study of its breast cancer vaccine. This follows the Phase 1 trial currently underway at Cleveland Clinic, which is supported by a grant from the U.S. Department of Defense.
The upcoming trial will assess the vaccine's effectiveness when given prior to surgery in conjunction with chemotherapy and Keytruda, a therapeutic antibody. The vaccine targets a breast-specific lactation protein, α-lactalbumin, which is not present in normal tissues post-lactation but is found in certain breast cancers. The Phase 2 study will include a broad spectrum of breast cancer patients and aims to reduce tumor size and recurrence, potentially leading to improved survival rates.
Anixa's strategic shift to treatment-focused research is influenced by the therapeutic market's quicker path to approval compared to primary prevention. The breast cancer treatment market, valued at approximately $38.35 billion in 2023, is projected to grow significantly, with expectations to reach $89.67 billion by 2030.
The trial's primary goals are to evaluate the immunological response to the vaccine and to compare the clinical efficacy of the vaccine plus standard therapy against the standard therapy alone. The trial is slated to begin in 2025 and is expected to last two to three years. Progress updates, including immunological responses, will be provided as the trial advances.
Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, expressed optimism about the Phase 2 study's potential to bring transformative therapy to breast cancer patients and to accelerate the regulatory approval process.
Initial Phase 1 results, presented at the San Antonio Breast Cancer Symposium in December 2023, indicated no safety concerns and observed immune responses in most patients. Further Phase 1 data will be shared at the Society for Immunotherapy of Cancer Annual Meeting in early November.
Anixa, which holds exclusive worldwide licensing for the vaccine technology developed at Cleveland Clinic, anticipates the Phase 2 study to facilitate potential approval and partnerships with pharmaceutical companies. The information in this article is based on a press release statement.
In other recent news, Anixa Biosciences has been making strides with its cancer-fighting therapies. The biotechnology company is progressing with its clinical trials, including one for a novel CAR-T therapy for ovarian cancer, which recently received approval from the FDA for a second dose administration. Anixa is also advancing in the creation of cancer vaccines, with one for triple-negative breast cancer and another for ovarian cancer.
EF Hutton recently commenced coverage on Anixa Biosciences, issuing a Buy rating with a price target of $10.00, reflecting confidence in the company's ongoing research. However, H.C. Wainwright adjusted its outlook on Anixa, reducing the 12-month price target to $7.00 from the previous $12.00, while maintaining a Buy rating.
Anixa Biosciences reported a net loss of $3.1 million for the second fiscal quarter of 2024, lower than the expected loss of $3.5 million. The company also announced a share repurchase program, signaling confidence in its financial health and future prospects.
In addition, Anixa Biosciences, in collaboration with Cleveland Clinic, has received a Japanese patent for its breast cancer vaccine technology. The company has also expanded its Cancer Business Advisory Board with the addition of Dr. Sanjay Juneja. These recent developments underscore Anixa's commitment to advancing cancer treatment and prevention through strategic partnerships and innovative technology.
InvestingPro Insights
Anixa Biosciences, Inc. (NASDAQ: ANIX) is navigating a critical phase with its breast cancer vaccine trials, and investors are closely monitoring the company's financial health and market prospects. According to InvestingPro data, Anixa boasts a market capitalization of $103.94 million, reflecting investor interest in its innovative research. Despite the challenges in profitability, with a negative P/E ratio of -8.41 indicating that the company has not been profitable over the past twelve months, analysts see a silver lining. An InvestingPro Tip highlights that Anixa holds more cash than debt on its balance sheet, providing some financial stability as it advances through costly clinical trials.
Moreover, another InvestingPro Tip points to anticipated sales growth in the current year, which could be a response to the company's strategic shift towards treatment-focused research—a move that could expedite the path to approval and revenue generation. With the breast cancer treatment market expected to grow substantially, Anixa's progress in its Phase 2 study could position it favorably within this expanding sector. However, it's important to note that analysts do not expect the company to be profitable this year, and net income is projected to drop, underscoring the high-risk nature of biotech investments.
For investors seeking more detailed analysis, there are additional InvestingPro Tips available on the platform. These insights could provide a deeper understanding of Anixa's financials and market potential, helping to make more informed investment decisions.
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