Exelixis Announces Initiation of First-in-Man Phase 1 Trial Evaluating XL114 Monotherapy in Patients With Non-Hodgkin’s Lymphoma | national company

ALAMEDA, Calif.–(BUSINESS WIRE)–April 14, 2022–

Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of the dose escalation stage of the first-in-human Phase 1 trial of XL114, a novel cancer compound that inhibits the CARD11-BCL10-MALT1 complex, as monotherapy in non-Hodgkin’s lymphoma (NHL) patients who have received prior standard treatments. The objectives of the study are to determine the recommended dose and/or maximum tolerated dose of XL114 and to assess the safety and preliminary efficacy of XL114 in patients with NHL.

“The launch of the dose-escalation stage of our first-in-human Phase 1 trial of XL114 marks an important milestone in our early efforts to identify treatments for people with blood cancers, such as lymphoma. non-Hodgkinian, which have exhausted the known lifetime. -prolong treatment options and therefore face poor prognoses,” said Vicki L. Goodman, MD, executive vice president, product development and medical affairs, and chief medical officer of Exelixis. “Based on preclinical data demonstrating activity in therapy-resistant lymphoma cell lines that inhibit Bruton’s tyrosine kinase, we are encouraged by the potential uptakes of XL114 and look forward to expanding to stage one. once the appropriate dose has been identified.”

The dose escalation step will determine the recommended dose of XL114 in patients with advanced B- and T-cell NHL. In the cohort expansion phase, the safety and preliminary efficacy of XL114 will be further evaluated in B-cell NHL-specific expansion cohorts, including patients with diffuse large B-cell lymphoma. (DLGCB) activated type B, mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocyte lymphoma. The primary endpoint of the expansion stage will be objective response rate based on lymphoma-specific response criteria as assessed by the investigator.

Like announcement Last year, Exelixis acquired XL114 under license from Aurigene Discovery Technologies Limited under the company’s July 2019 Collaboration, Option and License Agreement. Exelixis has assumed responsibility for the future clinical development, commercialization and global manufacturing of XL114.

More information about this trial is available at ClinicalTrials.gov.

About the NHL

According to the American Cancer Society, more than 80,000 people will be diagnosed with NHL in 2022, making it the seventh most common cancer in the United States. population ages. 1,2 NHL has over 60 subtypes, with DLBCL being the most common. 3 Approximately 85% of NHL cases in the United States affect B cells, and the remainder affect T cells or Nature Killer (NK) cells. 3,4 NHL can also be classified by how quickly the cancer grows; about 40% of cases, including chronic lymphocytic leukemia, are “indolent” or slowly growing, while 60%, including DLBCL, are “aggressive” or rapidly progressing. 3,5 Although standard first-line therapy may be curative, up to 50% of patients with DLBCL may be treatment refractory or relapse. 6 The overall five-year survival rate for NHL is 73%. 7

About XL114

XL114 is a novel anti-cancer compound that inhibits the CARD11-BCL10-MALT1 complex, a key signaling component downstream of B and T cell receptors, which promotes the survival and proliferation of B and T lymphomas. In preclinical studies, the compound has been shown to have activity in models of lymphoma resistant to Bruton’s tyrosine kinase inhibitor treatment and in subsets of B-cell lymphomas in which Bruton’s tyrosine kinase inhibitors are not assets. XL114 is currently under development for the NHL.

OnExelixis

Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful oncology-focused biotechnology company dedicated to accelerating the discovery, development and commercialization of new drugs for difficult-to-treat cancers. Following early work on model systems genetics, we have established an extensive drug discovery and development platform that has served as the foundation for our ongoing efforts to bring new cancer therapies to the patients who need them. Our discovery efforts have resulted in four commercially available products, CABOMETYX ® (cabozantinib), COMETRIQ ® (cabozantinib), COTELLIC ® (cobimetinib) and MINNEBRO ® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies plan to bring these important medicines to patients around the world. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We complement our existing therapeutic assets with targeted commercial development and in-house drug discovery activities, all to deliver the next generation of Exelixis drugs and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 Index, which measures the performance of profitable mid-sized companies. For more information on Exelixis, please visit www.exelixis.comto follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

Forward-looking statements

This press release contains forward-looking statements, including, but not limited to, statements regarding: the clinical and therapeutic potential of XL114 monotherapy for patients with NHL; and Exelixis’ plans to reinvest in its business to maximize the potential of the Company’s pipeline, including through focused business development activities and in-house drug discovery. All statements referring to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based on Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties, which include, but are not limited to: the potential failure to demonstrate the safety and/or efficacy in the phase 1 trial and in future trials; uncertainties inherent in the product development process; the complexity and unpredictability of regulatory review and approval processes in the United States and elsewhere; Exelixis’ continued compliance with applicable legal and regulatory requirements; the continued COVID-19 pandemic and its impact on Exelixis’ research and development operations, including Exelixis’ ability to initiate new clinical trials and clinical trial sites, recruit patients for trials clinical trials, to conduct per-protocol trials and to conduct research, drug discovery and related operations Activities; the costs of conducting clinical trials; Exelixis’ dependence on third-party suppliers for the development, manufacture and supply of XL114; Exelixis’ ability to protect its intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting Exelixis and its development programs discussed under “Risk Factors” in Exelixis’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 18, 2022, and in future documents filed by Exelixis with the second. All forward-looking statements contained in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained in this press release, except as required by law.

Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are US registered trademarks of Exelixis.

COTELLIC is a registered trademark of Genentech, Inc.

MINNEBRO is a registered trademark of Daiichi Sankyo Company, Limited.

1 Cancer Facts and Figures 2022. American Cancer Society website. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures. pdf. Accessed April 2022.

2 Risk factors for non-Hodgkin’s lymphoma. American Cancer Society website. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/causes-risks-prevention/risk-factors.html. Accessed April 2022.

3 Lymphoma – non-Hodgkin’s: subtypes. Cancer.Net website. Available at: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes. Accessed April 2022.

4 types of B-cell lymphoma. American Cancer Society website. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html. Accessed April 2022.

5 NHL subtypes. Leukemia & Lymphoma Society website. Available at: https://www.lls.org/lymphoma/non-hodgkin-lymphoma/nhl-subtypes. Accessed April 2022.

6 Crump, M., Neelapu, SS, Farooq, U., et al. Results in refractory diffuse large B-cell lymphoma: results of the international SCHOLAR-1 study. Blood. October 2017; 130(16):1800-1808.

7 Lymphoma – Non-Hodgkin’s: Statistics. Cancer.Net website. Available at: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/statistics. Accessed April 2022.

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CONTACT: Investors:

Susan Hubbard

EVP, Public Affairs and

Investor Relations

Exelixis, Inc.

(650) 837-8194

[email protected]:

Lindsay Treadway

Executive Director, Public Affairs

and advocacy relationships

Exelixis, Inc.

(650) 837-7522

[email protected]

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

SECTOR KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH ONCOLOGY

SOURCE: Exelixis, Inc.

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PUBLISHED: 04/14/2022 08:00 / DISK: 04/14/2022 08:02

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Elna M. Lemons