19 Mar Infinity Pharmaceuticals: Can Eganelisib prove to be a gamechanger in Immuno-Oncology?
Infinity Pharmaceuticals (NASDAQ: INFI) novel approach is based on Targeting Immune Suppressive Macrophages by selectively inhibiting PI3K-Gamma. The Company’s lead candidate eganelisib, is a first-in-class, oral, once-daily selective inhibitor of phosphoinositide-3-kinase gamma (PI3K-gamma), that has the potential to transform the immuno-oncology space. IPI-549 has demonstrated the ability to reprogram M2 macrophages or myeloid derived suppressor cells (MDSCs) to perform an anti-tumor function, thereby reducing immune suppression and encouraging immune activation, resulting in the proliferation and activation of T cells that can combat cancer cells.
The results from a clinical study, which was designed from the insights of Bristol Myer Squibb’s (NYSE: BMY) CheckMate-275, shows that the combination of eganelisib with nivolumab achieved improved overall response rate, disease control rate and progression-free survival versus second line standard of care in nivolumab monotherapy, especially in the case of PD-L1 low patients.
PI3K-gamma plays a pivotal role in maintaining the immunosuppressive nature of tumor-associated macrophages within the tumor microenvironment (TME) and myeloid-derived suppressor cells (MDSCs) and presents a novel approach in cancer immunotherapy.
In 2016, Infinity entered into a collaboration with Bristol Myers Squibb to evaluate IPI-549 in combination with Bristol-Myers Squibb’s Opdivo for treatment of Urothelial Cancer, a form of bladder cancer. The candidate has been granted a fast-track designation by the U.S. Food and Drug Administration. The Company is planning a registration -enabling study and has presented data at the ASCO GU in February 2021. In addition, the Company is also evaluating eganelisib in combination with Opdivo for the treatment of Squamous Cell Cancer of the Head and the Neck.
The candidate is being evaluated in multiple clinical trials such as MARIO-275 (MAcrophage Reprogramming in Immuno-Oncology) a global, randomized, controlled combination study of eganelisib combined with Opdivo® in I/O naïve urothelial cancer; MARIO-3, a combination study evaluating eganelisib in combination with Tecentriq® and Abraxane® in front-line TNBC and in combination with Tecentriq and Avastin® in front-line RCC and MARIO-1; a Phase 1/1b study evaluating eganelisib as a monotherapy and in combination with Opdivo (nivolumab) in patients with advanced solid tumors.
Infinity Pharmaceuticals (NASDAQ: INFI)
Market Cap: $297.83M; Current Share Price: 3.36 USD
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In addition to eganelisib, Infinity’s pipeline consists of a Phase 2 front-line Triple-Negative-Breast Cancer (TNBC) evaluation of eganelisib in combination with Tecentriq and Abraxane that is being conducted in collaboration with Roche (RHHBY) and Genentech. The Company presented data from the study at the San Antonio Breast Cancer Symposium (SABCS) held in December 2020 and intends to provide an update in the first half and second half of 2021. The results from the MARIO-3 trial, which is evaluating eganelisib’s contribution over Tecentriq and Abraxane, demonstrates that of the 13 patients 100% of patients had a reduction in the tumor volume and 69% had either a partial response or a complete response with 100% of the PD-L1 high patients responding and 50% of the PD-L1 low patients responding.
The Company has entered into a collaboration with Arcus Biosciences (NYSE: RCUS) to evaluate checkpoint inhibitor-free, novel combination regimen of eganelisib plus AB928 (dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients. Infinity is currently enrolling patients for the trail and has presented data at the San Antonio Breast Cancer Symposium (SABCS) held in December 2020.
Bladder cancer, the 6th most common form of cancer, occurs when the cells lining the walls of the uterus grow controllably, forming a tumor. A hollow organ located in the lower pelvis, the bladder stores urine and releases it through a tube called uretha. The most common form of bladder cancer is Urothelial carcinoma, also known as transitional cell carcinoma (TCC). The disease is further categorized into squamous cell carcinomas, adenocarcinomas, small cell carcinoma and sarcoma.
Based on the extent to which it has spread, bladder cancer is further segmented into Non-invasive cancers that are only in the inner layers of cells and invasive cancers that spread to the inner layers and other parts of the body. Non-muscle invasive cancers include both non-invasive and invasive tumors that have not permeated into the main muscle layer of the bladder according to cancer.org. Smoking, workplace exposure, arsenic exposure, chemotherapy or radiation, race and ethnicity and age are some of the risk factors. The average of diagnosis is 73 years with 90 percent of cases being diagnosed in people older than 55 years of age. Furthermore, more than 83,730 adults (64,280 men and 19,450 women) will be diagnosed with bladder cancer and nearly 17,200 (12,260 men and 4,940 women) will succumb to the disease in the U.S in 2021.
Treatment is usually dependent on the stage of the cancer and is usually a combination of different therapies such as surgery, intravesical therapy, chemotherapy, radiation and immunotherapy. According to a report by Global Data, the bladder cancer therapeutics market is expected to reach approximately $1.17 billion by 2025, growing at a CAGR of 12.5%, from $360 million in 2015. Increasing research and development, rising awareness and development of innovative therapies will drive the growth in the market.
Breast cancer is the most common form of cancer in women with an estimated one in eight women and one in 1,000 men being diagnosed with breast cancer during their lifetime. According to data made available by centers for disease control and prevention (CDC) over 237,000 cases of breast cancer are diagnosed in women and about 2,100 in men in the U.S alone. Approximately 41,000 women and 450 men in the U.S. succumb to this malady every year.
The breast cancer therapeutics industry is likely to reach US$16.21 billion by 2023 growing at a CAGR of 8.4% CAGR from 2015 to 2023 according to a report by Transparency Market Research. Lifestyle changes such as rise in age of childbearing, high intake of oral contraceptive pills, reduced breast-feeding, and undergoing estrogen modifying drug treatments are leading to increased incidences of breast cancer according to the report. The increasing spending on mergers and acquisition, strategic collaborations and the rise in research and development efforts to stay ahead of competitors will drive the growth in the market. Onslaught of generics could hamper the market from reaching its full growth potential though
Full Year 2020 Financial Results
The Company closed the year with cash, cash equivalents and available-for-sale securities of $34.1 million as of 31 December 2020, as compared to $42.4 million at the end of the previous year. Infinity reported $1.7 million in revenue, realized from royalties on net sales of Copiktra® from Verastem, Inc. and Secura Bio, Inc., who obtained the rights to Copiktra® in 2020.
For the Financial year 2021, the Company expects to end the year with $70 million to $80 million in cash, cash equivalents and available for sale securities. Furthermore, Infinity is likely to receive a $5 million milestone payment from BVF for positive patidegib Phase 3 data in Gorlin Syndrome and expects to receive additional funds from milestone payments or sale of equity interest in PellePharm.
In February 2021, Infinity closed a public offering of approximately $86 million in net proceeds that will to be used for clinical development of eganelisib and fund its operations and working capital requirements.
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