MONROVIA, Calif .– (COMMERCIAL THREAD) – Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing monoclonal antibodies and modified cytokines for the treatment of cancer and autoimmune diseases, today announced the priorities of the undertaking for 2022 and the planned stages of clinical development and research.
“The plug-and-play nature of Xencor’s XmAb® The Fc domains and our expertise in protein engineering have enabled a broad portfolio of bispecific antibodies and modified cytokine drug candidates, as well as a multitude of partnerships, which have so far produced three commercialized products, ”said Bassil Dahiyat, Ph.D., President and CEO of Xencor. “In 2022, we anticipate that emerging clinical data will continue to support our own mid-term development plans for vudalimab and plamotamab, and we will continue to launch new studies that may present new data that may define a path forward. registration for these programs. Additionally, we remain excited about the opportunities to use our technological competitive advantage to tackle challenging areas of biology and continually grow our portfolio, now with several lower potency cytokines and CD3 and CD28 T cell engageers in development, at both internally at Xencor and with our partners. ”
Execute development plans for XmAb at mid-term® bispecific antibody programs
Vudalimab (PD-1 x CTLA-4), designed to activate intra-tumor T cells
Xencor presented updated phase 1 extension cohort data in November 2021 and is enrolling a phase 2 study in patients with metastatic castration-resistant prostate cancer (mCRPC), where vudalimab is evaluated as monotherapy or in combination according to the molecular subtype of the tumor. Xencor plans to:
Initiate a second phase 2 study, evaluating vudalimab in patients with advanced pelvic tumors, including clinically defined high-risk mCRPC and certain gynecologic malignancies.
Present the initial data from the phase 2 study in mCRPC, in the second half of 2022.
Plamotamab (CD20 x CD3), for malignant B cell tumors
Xencor presented updated Phase 1 dose escalation data in December 2021 and is currently enrolling patients with non-Hodgkin lymphoma in extension cohorts of plamotamab monotherapy at the recommended phase 2 dose. Xencor has concluded a global collaboration and licensing agreement with Janssen Biotech, Inc., one of Johnson & Johnson’s Janssen pharmaceutical companies, to expand the company’s strategy to develop plamotamab in multiple highly active drug regimens without chemotherapy against B cell cancers. Xencor plans to:
Launch a phase 2 study that can allow registration, evaluating plamotamab in combination with tafasitamab and lenalidomide, in patients with relapsed or refractory LDGCB.
Incorporate subcutaneous administration into the ongoing Phase 1 monotherapy study.
Present data from phase 1 expansion cohorts, in the second half of 2022.
To develop CD28 bispecific antibodies targeted at B cells to selectively enhance the cytotoxic activity of T cells in combination with plamotamab.
Multiple reduced power advanced XmAb® cytokine programs in oncology and autoimmune diseases
Xencor’s modified and reduced potency cytokines are designed to expand selected immune cell populations, to have a longer circulating half-life, and to be tolerable, active and easy to administer. XmAb cytokines incorporate the Xtend ™ extended half-life technology.
XmAb306, IL15 / IL15Rα-Fc fusion protein at reduced potency
Recently, Xencor announced encouraging initial dose escalation data from an ongoing Phase 1 study in patients with advanced solid tumors, in which the preliminary safety profile, laboratory activity and signs of Anti-tumor activity provides initial validation for the company’s approach to therapeutic engineering of cytokines. . Xencor plans to:
Announce new clinical studies of XmAb306 in combination with other agents, such as NK or T cell recruitment therapies in collaboration with the Company’s co-development partner.
XmAb564, reduced potency IL2-Fc fusion targeting regulatory T cells in autoimmune diseases
Xencor plans to:
To present the tolerability, durability and biomarker data from the ongoing Phase 1 single-dose escalating study in healthy volunteers.
Identify indications for development and initiate a multi-dose escalating study in selected patient populations.
XmAb662, reduced potency IL12-Fc fusion protein designed to increase tumor immunogenicity
Xencor plans to:
Submit an Investigational New Drug Application (IND) in 2022 and initiate a Phase 1 study in patients with advanced solid tumors in 2023.
Xencor plans to present preclinical data from additional cytokine-Fc programs in 2022.
Expanding the Company’s Portfolio with the First Internally Developed XmAb® 2 + 1 CD3 and XmAb® CD28 Bispecific Antibodies Advance in Phase 1 Clinical Studies
XmAb819 (ENPP3 x CD3), XmAb 2 + 1 bispecific antibody for renal carcinoma (RCC)
The multivalent XmAb 2 + 1 bispecific antibody format allows greater selectivity for tumor cells compared to normal cells, which also express ENPP3 at lower levels. Xencor plans to:
Initiate a phase 1 study evaluating XmAb819 in patients with RCC during the first half of 2022.
XmAb808 (B7-H3 x CD28), CD28 bispecific antibody selective tumor stimulator
CD28 is a key immunostimulatory receptor on T cells; however, ligands which activate T cells via CD28 are generally not expressed on tumor cells. Targeted CD28 bispecific antibodies can provide conditional co-stimulation of T cells, for example, to T cells recognizing neoantigens or in concert with bispecific antibodies engaging CD3 T cells. XmAb808 targets the widely expressed tumor antigen B7-H3. Xencor plans to:
Submit an IND application in the first half of 2022 and launch a phase 1 study in patients with advanced solid tumors in the second half of 2022.
Cash position and financial orientation
Xencor ended the fourth quarter of 2021 with cash, cash equivalents, receivables and unaudited marketable debt securities totaling approximately $ 660 million. Based on current operating plans, Xencor expects to have sufficient cash resources to fund research and development programs and operations through 2025.
About Xencor, Inc.
Xencor is a clinical-stage biopharmaceutical company developing monoclonal antibodies and modified cytokines for the treatment of cancer and autoimmune diseases. Currently, 22 candidates designed with Xencor’s XmAb® are under clinical development internally and with partners. Xencor’s XmAb antibody engineering technology enables small changes in protein structure resulting in novel mechanisms of therapeutic action. For more information, please visit www.xencor.com.
Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact and can generally be identified by the use of words such as “potential”, “may”, “will”, “plan”, “may”, ” could “,” could “,” “‘”, but not limited to statements regarding additional clinical trials planned, quotes from the President and CEO of Xencor and other statements which are not purely statements of historical fact. Such statements are made based on the current beliefs, expectations and assumptions of Xencor’s management and are subject to significant risks, uncertainties and other known and unknown factors that may cause results, performance or actual accomplishments and timing of events to be materially different from those implied by such declarations ations, and therefore, these statements should not be read as guarantees of future performance or results. These risks include, but are not limited to, risks associated with the process of discovering, developing, manufacturing and marketing drugs which are safe and effective for use as human therapeutics and other risks, including the ability of publicly disclosed preliminary clinical trial data to support further clinical trials. development and regulatory approval for specific treatments, in each case, as described in Xencor’s government securities filings. For a discussion of these and other factors, please refer to Xencor’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 as well as to Xencor’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This disclaimer is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor assumes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as may be required by law. ‘required.