About Xencor

Xencor, Inc. (Xencor) operates as a clinical-stage biopharmaceutical company. The company focuses on discovering and developing engineered monoclonal antibody and cytokine therapeutics to treat patients with cancer and autoimmune diseases who have unmet medical needs. The company uses its protein engineering capabilities to increase its understanding of protein structures and interactions and to design new technologies and XmAb drug candidates with improved properties. The company advances these candidates into clinical-stage development, where it is conducting Phase 1 and Phase 2 studies for a broad portfolio of programs, to determine which programs the company advances into later stages of development and potentially commercialization, which programs it partners to access complementary resources to optimize development, or which programs it terminates. The company’s approach to protein design includes engineering Fc domains, the parts of antibodies that interact with multiple segments of the immune system and controls antibody structural architecture. The Fc domain is constant and interchangeable among antibodies, and the company’s engineered XmAb Fc domains can be readily substituted for natural Fc domains. The company’s protein engineering capabilities and Fc technologies enable the company and its partners to develop XmAb antibodies and biotherapeutic drug candidates with improved properties and functionality, which can provide innovative approaches to treating disease and potential clinical advantage over other treatment options. For example, the company has developed an antibody scaffold to rapidly create novel multi-specific antibodies that bind two or more different targets simultaneously, creating entirely new biological mechanisms. Other applications of the company’s protein engineering technologies enhance antibody performance by increasing immune inhibitory activity, improving cytotoxicity, extending circulating half-life and stabilizing novel protein structures, such as engineered cytokines. Three marketed XmAb medicines have been developed with the company’s protein engineering technologies and are generating royalties for the company. Strategy The key elements of the company’s strategy are to advance the clinical development of the company’s XmAb bispecific antibody and cytokine drug candidates; Build and manage a large and diversified portfolio of XmAb drug candidates; Leverage the company’s protein engineering capabilities, XmAb Fc domains, and XmAb drug candidates with partnerships, collaborations, and licenses to generate revenue streams, create new drug candidates and combination treatments, and identify new indications for the company’s pipeline of drug candidates; Broaden the functionality of the company’s XmAb Fc technology platforms; and Continue to expand the company’s patent portfolio protecting the company’s Fc technologies and XmAb drug candidates. XmAb Bispecific Fc Domain and New Multi-Specific Antibody Formats The company’s modular approach to protein engineering is a distinguishing feature of the company’s Fc technologies. This inherent flexibility enables the company to design multiple XmAb bispecific antibody and cytokine drug candidates with distinct and novel mechanisms-of-action and to seek out new applications of the XmAb Bispecific Fc Domain. The company’s business, research, and clinical efforts are to develop and advance the company’s Fc technologies and its portfolio of XmAb bispecific antibody and engineered cytokine drug candidates in oncology and autoimmune diseases. CD3 Candidates: The company has significantly expanded the potential of its CD3 bispecific antibodies with the multi-specific XmAb 2+1 bispecific antibody format, utilizing two identical tumor targeting domains and one CD3 targeting domain. The affinities for antigen binding are engineered to enable selective engagement and killing of high antigen-expressing tumor cells over low antigen-expressing normal cells. In preclinical models, XmAb 2+1 bispecific antibodies bound preferentially to tumor cells compared to normal cells and effectively recruited T cells to kill tumor cells selectively. CD28 Candidates: The company has engineered XmAb bispecific antibodies to provide selective CD28 co-stimulation of T cells, activating them when bound to tumor cells. TME Activator Candidates: The company’s tumor microenvironment (TME) activators have been designed to promote tumor-selective T-cell activation by targeting multiple checkpoints or co-stimulating receptors. These candidates also incorporate the company’s Xtend technology for longer half-life. Cytokine Candidates: The company’s engineered novel cytokine candidates are fusions of XmAb Bispecific Fc Domains and immune signaling proteins. The company engineers its cytokine candidates with reduced potency to improve therapeutic index and with the company’s Xtend technology for longer half-life. The company continues to invest in its protein engineering efforts to identify novel technologies and drug candidates. Other XmAb Fc Domains The company has also created additional XmAb Fc domains, and the company has successfully entered partnerships for these technologies and for XmAb drug candidates that incorporate them. The company continues to seek additional partnering and licensing opportunities for these Fc domains. Additional XmAb Fc domains include: Immune Inhibitor Fc Domain – selective immune inhibition and rapid target clearance, targeting the receptor FcgammaRIIb; Cytotoxic Fc Domain – increased cytotoxicity, targeting the receptors FcgammaRIIIa on natural killer (NK) cells and FcgammaRIIa on other immune system cells; and Xtend Fc Domain – extended antibody half-life, targeting the receptor FcRn on endothelial cells. Approved or Authorized Medicines Engineered with XmAb Fc Domains Three medicines that have been developed with the company’s XmAb Fc domains are marketed or made available by the company’s partners. Sotrovimab: Vir Biotechnology, Inc. and its partner GlaxoSmithKline Plc have made available sotrovimab, an antibody that targets the SARS-CoV-2 virus, and in 2021 they received an emergency use authorization (EUA) from the United States Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 in high-risk adults and pediatric patients. In the first quarter of 2022, the FDA deauthorized sotrovimab in treating patients with COVID-19. Sotrovimab has been granted a marketing authorization in the European Union (EU), approved via Japan’s Special Approval for Emergency Pathway in Japan, and granted conditional, provisional, or temporary authorizations in more than 40 other countries. GSK supplies sotrovimab under the name Xevudy. Sotrovimab incorporates the company’s Xtend Fc domain for longer duration of action. Ultomiris (ravulizumab-cwvz): Alexion’s Ultomiris is approved in the U.S., Europe, and Japan for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). In April 2022, Ultomiris was approved by the FDA for the treatment of adult patients with generalized myasthenia gravis (bMG) who are anti-acetylcholine receptor (AChR) antibody positive. Alexion is also evaluating Ultomiris in a broad late-stage development program across many indications in neurology and nephrology. Alexion used the company’s Xtend Fc Domain to enhance the half-life of Ultomiris to allow for a longer duration of action, less frequent dosing and reduced patient burden of therapy compared to the previous generation therapy, Soliris. Monjuvi (tafasitamab-cxix): In 2020, the FDA approved Monjuvi under accelerated approval. Monjuvi is a humanized Fc-modified CD19 targeting immunotherapy indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In August 2021, the European Commission granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). MorphoSys and Incyte are also conducting studies of tafasitamab in additional B-cell indications. Tafasitamab was created and initially developed by the company. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S. and is marketed by Incyte under the brand name Minjuvi in Europe and Canada. Incyte has exclusive commercialization rights to tafasitamab outside the U.S. Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Drug Candidates in Clinical Development There are 21 clinical-stage drug candidates or marketed medicines that have been developed with one or more of the company’s Fc technologies. A partner is also advancing a drug candidate that incorporates the company’s DN-TNF technology. The company is also supporting investigator sponsored trials evaluating vibecotamab (CD123 x CD3) and XmAb968 (CD38 x CD3). The company regularly evaluates its portfolio of candidates and make additional investments in candidates with promising early-stage clinical data, partner out other candidates, and stop development of candidates where early clinical data does not support further investment. During 2022: The company initiated a second Phase 2 study for its vudalimab program, The company initiated Phase 1 studies for its XmAb819 and XmAb808 programs, The company initiated a Phase1b study for its XmAb564 program, and The company stopped development of the tidutamab and XmAb841 programs and also stopped development of its plamotamab, tafasitamab and lenalidomide combination study. XmAb Bispecific Fc Drug Candidates in Clinical Development 10 XmAb drug candidates that have been engineered with the company’s XmAb bispecific Fc domain are in active clinical development internally or with its partners. Five candidates are wholly owned and are being evaluated by the company in Phase 2 or Phase 1 studies; Two candidates are being co-developed with partners; and Three additional candidates are being advanced by partners. Additional candidates are advancing through the preclinical stages of development. Drug candidates with the company’s bispecific Fc domain, both bispecific antibodies and cytokines, in clinical development include: Wholly Owned Development Candidates Vudalimab is a bispecific antibody that targets PD-1 and CTLA-4, two immune checkpoint receptors, and is designed to promote tumor-selective T-cell activation. The company is conducting a Phase 2 clinical study of vudalimab in patients with mCRPC, as a monotherapy or in combination depending on molecular subtype, and a Phase 2 clinical study in patients with advanced gynecologic malignancies and clinically defined high-risk mCRPC. The company continues to enroll patients into these clinical studies. XmAb104 is a bispecific antibody that targets PD-1 and ICOS, an immune co-stimulatory receptor, and is being developed in multiple oncology indications. The company is conducting a Phase 1 study to assess the safety, tolerability, and preliminary anti-tumor activity of XmAb104 in patients with selected solid tumors. Initial data reported in 2022 indicated XmAb104 was well tolerated and exhibited a distinct safety profile compared to other clinical-stage ICOS programs. The company continues to enroll patients with select solid tumors in the dose expansion portion of the study, evaluating XmAb104 as a monotherapy and in combination with ipilimumab, an anti-CTLA4 antibody. XmAb564 is a monovalent, potency-reduced interleukin-2 Fc (IL-2-Fc) fusion protein, engineered to selectively activate and expand regulatory T cells (Tregs) for the potential treatment of patients with autoimmune diseases. XmAb564 is engineered with reduced binding affinity for IL-2's beta receptor and increased binding affinity for its alpha receptor. In a Phase 1a clinical study of XmAb564, a single dose of XmAb564, administered subcutaneously in healthy volunteers, was well tolerated and generated durable, dose-dependent and selective expansion of Tregs. The company is conducting a randomized, double-blind, placebo-controlled Phase 1b clinical study to evaluate the safety and tolerability of multiple ascending doses of XmAb564, administered subcutaneously in patients with atopic dermatitis or psoriasis. XmAb819 is a first-in-class ENPP3 x CD3 XmAb 2+1 bispecific antibody that the company is developing for patients with renal cell carcinoma (RCC). The XmAb 2+1 multivalent format enables greater selectivity for ENPP3 expressing tumor cells compared to normal cells, which also express ENPP3 at lower levels. The company is conducting a Phase 1 study evaluating XmAb819 in patients with RCC. XmAb808 is a tumor-selective, co-stimulatory XmAb 2+1 bispecific antibody designed to bind to the broadly expressed tumor antigen B7-H3, and selectively to the CD28 T-cell co-receptor only when bound to tumor cells, which was demonstrated in in vitro studies. In vivo studies further demonstrated strong potentiation of checkpoint and CD3 cytotoxic activity. Xencor is conducting a Phase 1 study of XmAb808 in combination with pembrolizumab in patients with advanced solid tumors. Candidates Co-Developed with Partners Plamotamab is a bispecific antibody that targets CD20, an antigen on B-cell tumors, and CD3, an activating receptor on T cells. In October 2021, the company entered into a global collaboration and license agreement with Janssen to advance plamotamab and XmAb CD28 bispecific antibody combinations for the treatment of patients with B-cell malignancies. Janssen received worldwide exclusive development and commercial rights to plamotamab, and the company is collaborating with Janssen on further clinical development of plamotamab. The company is conducting a Phase 1 study of plamotamab in patients with non-Hodgkin's lymphomas, and the company continues enrolling patients into subcutaneous dose escalation cohorts of this study. XmAb306 (RO7310729) is a potency-reduced IL15/IL15-receptor alpha complex fused to the company’s bispecific Fc domain (IL15/IL15Ra-Fc). The Fc domain also incorporates the company’s Xtend technology for extended half-life. Xencor is co-developing the program in collaboration with Genentech, a member of the Roche Group. Genentech is conducting a Phase 1 study of XmAb306 as a single agent and in combination with atezolizumab in patients with advanced solid tumors. Genentech is also conducting two additional Phase 1 studies, evaluating XmAb306 in patients with relapsed/refractory multiple myeloma, either in combination with daratumumab (anti-CD38 antibody) or in combination with cevostamab (FcRH5 x CD3 bispecific antibody). The company continues to support enrollment into these clinical studies. Candidates Advanced by Partners AMG 509 is a STEAP1 x CD3 2+1 bispecific antibody that the company’s partner Amgen is advancing for the treatment of patients with prostate cancer. The XmAb 2+1 multivalent format enables higher binding capability for STEAP1 expressing cells. Amgen is enrolling patients in a Phase 1 study of AMG 509 in patients with mCRPC. In February 2022, Amgen presented encouraging, preliminary pharmacodynamic activity by the induction of percent maximum PSA decline among 30 patients in the study, which provides an early signal of activity and validation of the potential of the XmAb 2+1 format. ASP2138 is a Claudin-18.2 x CD3 2+1 bispecific antibody that the company’s partner Astellas is advancing for the treatment of patients with gastric, gastroesophageal and pancreatic cancers and is being evaluated in a Phase 1 study. The XmAb 2+1 multivalent format enables higher binding capability for Claudin-18.2 expressing cells. Novartis XmAb undisclosed bispecific antibody candidate. Novartis is conducting a Phase 1 clinical study with an undisclosed bispecific antibody candidate that was developed with the company’s bispecific Fc technology under the company’s collaboration with them. XmAb, Xtend, and Cytotoxic Fc Drug Candidates in Clinical Development Two drugs engineered with the company’s Xtend Fc Domain and one drug the company engineered with its XmAb Cytotoxic Fc Domain are marketed commercially by partners. In addition to these approved drugs, the company’s partners are advancing multiple clinical-stage programs with antibodies engineered with XmAb, Xtend, and/or Cytotoxic Fc Domains, including: Vir Biotechnology, Inc.: Vir is advancing two candidates in clinical development. VIR-3434 is being evaluated in a Phase 2 combination study as a potential treatment for patients with hepatitis B virus infection. VIR-2482 is being evaluated in a Phase 2 study as a universal prophylactic for influenza A. Gilead Sciences, Inc.: Gilead is supporting HIV candidates in clinical development that are broadly neutralizing antibodies that incorporate the company’s Fc technologies. The company’s partners are conducting preclinical studies of additional drug candidates engineered with these XmAb Fc domains. Other Clinical Stage Drug Candidates AIMab7195 (XmAb7195) uses the company’s XmAb Immune Inhibitor Fc Domain and is designed to reduce blood levels of IgE, which mediates allergic responses and allergic disease. In February 2020, the company licensed this drug candidate to Aimmune Therapeutics, Inc., now a wholly owned subsidiary of Nestlé S.A., which is advancing the candidate in clinical studies for allergic indications. Obexelimab targets CD19 with its variable domain and uses the company’s XmAb Immune Inhibitor Fc Domain, which is designed to inhibit the function of B cells, an important component of the immune system. In November 2021, the company licensed this drug candidate to Zenas BioPharma, which initiated a Phase 3 study with obexelimab in January 2023 in immunoglobulin G4-related disease (IgG4-RD). Xpro1595 is a proprietary TNF inhibitor candidate, which the company licensed to INmune Bio, Inc., in October 2017. INmune is advancing Xpro1595 through clinical development for patients with Alzheimer’s disease, mild cognitive impairment and treatment-resistant depression. Collaborations, Partnerships and Licensing Arrangements A key part of the company’s business strategy is to leverage the company’s protein engineering capabilities, XmAb technologies, and XmAb drug candidates with partnerships, collaborations, and licenses. Through these arrangements the company generate revenues in the form of upfront payments, milestone payments, and royalties. For partnerships for the company’s drug candidates, the company aim to retain a major economic interest in these candidates through transactions that allow the company to retain major geographic commercial rights, provide for profit-sharing on future sales of approved products, include co-development options, and also the right to conduct independent clinical studies with drug candidates developed in the collaboration. Examples of arrangements the company has entered with its partners include: Product Licenses: Janssen Biotech, Inc., Genentech, MorphoSys AG, Nestlé S.A., Zenas BioPharma, and INmune Bio, Inc. Novel Bispecific Antibody Collaborations: Janssen Biotech, Inc., Astellas Pharma, Inc., Amgen Inc., and Novartis AG. Technology Licensing Agreements: Alexion Pharmaceuticals, Inc., Vir Biotechnology, Inc., Gilead Sciences, Inc., Novartis AG, Omeros Corporation, Viridian Therapeutics, Inc., and Astria Therapeutics, Inc. Strategic Collaborations: Atreca, Inc., The University of Texas MD Anderson Cancer Center, and Caris Life Sciences. Product Licenses Product licenses are arrangements in which the company licenses to third parties partial or full rights to develop and commercialize the company’s internally developed drug candidates. Janssen Biotech, Inc. In October 2021, the company entered into an agreement with Janssen Biotech, Inc. (Janssen) to develop, manufacture, and commercialize plamotamab and pursuant to which we, together, will conduct research and development activities to discover novel CD28 bispecific antibodies against undisclosed B cell tumor targets. Janssen will receive exclusive worldwide rights, subject to certain Xencor opt-in rights, to develop, manufacture and commercialize pharmaceutical products that contain one or more of such CD28 bispecific antibodies. Genentech In February 2019, the company entered into an agreement with Genentech to develop and commercialize novel IL-15 cytokine therapeutics that use the company’s bispecific Fc technology, including XmAb306, declared as a Collaboration Product under the agreement. The company is jointly collaborating on the worldwide development of XmAb306 with Genentech maintaining worldwide commercialization rights, subject to the company having a co-promotion option in the U.S. The company retains the right to perform clinical studies with XmAb306 at the company’s sole expense in combination with other therapeutic agents, subject to certain restrictions. Genentech received a worldwide exclusive license to XmAb306. MorphoSys AG In July 2020, the FDA approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide for treating certain patients with DLBCL, and the European Commission granted conditional marketing authorization to tafasitamab for treating certain patients with DLBCL, which is marketed as Minjuvi in Europe, in August 2021. In 2010, the company licensed exclusive worldwide rights to develop and commercialize tafasitamab to MorphoSys. Tafasitamab, which the company engineered with an XmAb Cytotoxic Fc Domain, is the second XmAb medicine to be approved by the FDA. Nestlé S.A./Aimmune Therapeutics, Inc. In February 2020, the company granted Aimmune Therapeutics, Inc., an exclusive worldwide license to develop and commercialize XmAb7195, which was renamed AIMab7195. Nestlé is responsible for all further development of AIMab7195 and is planning additional studies of the candidate. INmune Bio, Inc. In October 2017, the company entered into an agreement with INmune Bio, Inc., for an exclusive license to the company’s Xpro1595 drug candidate. INmune is planning Phase 2 studies in Alzheimer’s disease, mild cognitive impairment, and treatment-resistant depression, as Xpro1595; Phase 2 studies in patients with non-alcoholic steatohepatitis, as LIVNate; and additional studies in MUC4-positive cancers, as INB03. Zenas BioPharma (Cayman) Limited In November 2020, the company entered into an agreement with Zenas BioPharma (Cayman) Limited (Zenas) to which the company licensed the exclusive worldwide rights to develop and commercialize three preclinical-stage Fc-engineered drug candidates for autoimmune disease: XmAb6755, Xpro9523, and XmAb10171. These programs incorporate an Xtend Fc Domain, a Cytotoxic Fc Domain, or both. In November 2021, the company entered into a second agreement with Zenas to which the company licensed the exclusive worldwide rights to develop and commercialize obexelimab, a bifunctional antibody that targets CD19 with its variable domain and uses the company’s XmAb Immune Inhibitor Fc Domain. Novel Bispecific Antibody Collaborations Novel bispecific antibody collaborations are arrangements in which the company’s partner seeks to create an XmAb bispecific antibody using one or more of the company’s bispecific technologies. The company’s partners provide an antibody or an antigen against tumors, and the company conducts limited research and development activities to create potential bispecific antibody candidates for further development and commercialization by the company’s partners. Janssen Biotech, Inc. In November 2020, the company entered into an agreement, with Janssen Biotech, Inc. (Janssen), to develop XmAb bispecific antibodies against CD28 and an undisclosed prostate tumor target, for the potential treatment of patients with prostate cancer. Under the agreement, the company conducted research activities to develop CD28 bispecific drug candidates for further development by Janssen. Preclinical activities and all clinical development, regulatory and commercial activities will be conducted by Janssen, which has exclusive worldwide rights to develop and commercialize the novel drug candidates developed in the collaboration. Astellas Pharma, Inc. In March 2019, the company entered into an agreement with Astellas Pharma, Inc., under which the company applied its XmAb bispecific Fc technology to an antigen pair provided by Astellas and generated bispecific antibody candidates for further certain characterization and testing. Astellas was granted a worldwide exclusive license, with the right to sublicense products in the field created by the research activities. Astellas has selected a bispecific antibody developed under the collaboration, ASP2138, a CLDN18.2 x CD3 XmAb 2+1 bispecific antibody, for further development to treat patients with gastric, gastroesophageal, and pancreatic cancers. Amgen Inc. In September 2015, the company entered into an agreement with Amgen Inc. to develop and commercialize bispecific antibody product candidates using the company’s proprietary XmAb bispecific Fc technology. Novartis AG In connection with the company’s June 2016 agreement with Novartis, the company applied the company’s XmAb bispecific Fc technology to a target pair antibody selected by Novartis. Novartis is responsible for development and commercialization of the program. Technology Licensing Agreements Alexion Pharmaceuticals, Inc. Ultomiris (ravulizumab-cwvz) was the first antibody incorporating XmAb Fc technology to be approved by the FDA for commercial marketing. It is approved in the U.S. and multiple global markets for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). Ultomiris is commercialized by Alexion Pharmaceuticals, Inc. Vir Biotechnology, Inc. Sotrovimab, an antibody that targets the SARS-CoV-2 virus, has received an emergency use authorization from the FDA and temporary authorizations in multiple global markets for the treatment of mild-to-moderate COVID-19 in high-risk adults and pediatric patients. In March 2020, the company entered into an agreement in which the company provided Vir a non-exclusive license to the company’s Xtend technology to extend the half-life of novel antibodies, including sotrovimab, that Vir is investigating as potential treatments for patients with COVID-19. In August 2019, the company entered into an agreement with Vir Biotechnology, Inc., in which the company provided Vir a non-exclusive license to the company’s Xtend technology for two targets in infectious disease. VIR-2482 is being evaluated in a Phase 2 study as a universal prophylactic for influenza A, and VIR-3434 is being evaluated in a Phase 2 combination study as a potential treatment for patients with hepatitis B virus infection. Gilead Sciences, Inc. In January 2020, the company entered into an agreement with Gilead Sciences, Inc., in which the company provided Gilead an exclusive license to the company’s Cytotoxic Fc and Xtend Fc technologies for broadly neutralizing anti-HIV antibodies. Gilead is responsible for all development and commercialization activities. Omeros Corporation In August 2020, the company entered into an agreement with Omeros Corporation, in which the company provided Omeros a non-exclusive license to the company’s Xtend Fc technology, an exclusive license to apply the company’s Xtend Fc technology to an initial identified antibody, OMS906, and options to apply the company’s Xtend Fc technology to three additional antibodies. Omeros is responsible for all development and commercialization activities. OMS906, a MASP-3 targeted antibody, is being evaluated in a Phase 1 study in patients with PNH and other alternative pathway disorders. Viridian Therapeutics, Inc. In December 2020, the company entered into an agreement with Viridian Therapeutics, Inc., in which the company provided Viridian a non-exclusive license to the company’s Xtend Fc technology and an exclusive license to apply the company’s Xtend Fc technology to antibodies targeting IGF-1R. Viridian is responsible for all development and commercialization activities. In December 2021, the company entered into a second agreement with Viridian for a non-exclusive license to certain antibody libraries developed by the company. Astria Therapeutics, Inc/Catabasis Pharmaceuticals, Inc./Quellis Biosciences, Inc. In May 2018, the company entered into an agreement with Quellis Biosciences, Inc., in which the company provided Quellis a non-exclusive license to the company’s Xtend Fc technology to apply to an identified antibody. Quellis is responsible for all development and commercialization activities. Strategic Collaborations Atreca, Inc. In July 2020, the company entered into an agreement with Atreca, Inc., to research, develop and commercialize novel CD3 bispecific antibodies as potential therapeutics in oncology. In January 2023, the company and Atreca selected a candidate to be developed under the collaboration. The University of Texas MD Anderson Cancer Center In September 2020, the company entered into an agreement with MD Anderson, in which the company will provide funding over a five-year period, and MD Anderson will collaborate to design and execute additional clinical studies with the company’s portfolio of XmAb drug candidates, including novel bispecific antibody and cytokine candidates. The company own all rights to the programs and results generated from these studies. In December 2021, the company extended the agreement for an additional year at the same level of committed funding. MD Andersen is conducting clinical studies with the company’s vudalimab candidate. In December 2020, the company entered into a second agreement with MD Anderson to develop novel CD3 bispecific antibody therapeutics for the potential treatment of patients with cancer. MD Anderson will work to identify and develop potential antibodies, and the company will apply the company’s Fc bispecific technology to create therapeutic candidates. MD Anderson will then conduct and fund all preclinical activities to advance candidates toward clinical studies. The company has certain exclusive options to license worldwide rights to develop and commercialize potential new medicines arising from the collaboration. Caris Life Sciences In July 2022, the company entered into an agreement with Caris Life Sciences (Caris), under which Caris will apply its proprietary end-to-end discover platform to identify novel targets for XmAb bispecific antibody drug candidates for the treatment of patients with cancer. The company received exclusive options to research, develop and commercialize products directed up to three targets. In December 2022, the company expanded its Caris collaboration with a second agreement. Intellectual Property The Xencor logo is a trademark of Xencor, Inc. XmAb and Proteins by Design are also registered trademarks of Xencor. The company’s patent estate, on a worldwide basis, includes over 1,400 issued patents and pending patent applications which the company owns, with claims directed to XmAb Fc domains, all of the company’s clinical and preclinical stage product candidates and the company’s computational protein design methods and platforms. The company also has a large number of issued patents and pending patent applications with claims directed specifically to the company’s XmAb technology and candidates. The company has obtained registrations for the Xencor trademark, as well as certain other trademarks, which the company uses in connection with the company’s pharmaceutical research and development services and the company’s clinical-stage products, including XmAb. The company has registrations for Xencor and XmAb in the United States, Australia, Canada, the European Union, the United Kingdom, and Japan; and for Proteins by Design in the United States, Australia, Canada, and the European Union and the United Kingdom. The U.S. Government Regulation The company’s product candidates are subject to regulation by the FDA as a biologic. Any biologic products for which the company or the company’s collaborators receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, current good manufacturing practice (cGMP) compliance for product manufacture, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, complying with certain electronic records and signature requirements, and complying with FDA promotion and advertising requirements, which include, among others, restrictions on direct-to-consumer advertising, promoting biologics for uses or in patient populations that are not described in the product’s approved labeling (known as ‘off-label use’), industry-sponsored scientific and educational activities, and promotional activities involving the internet. Third Party Vendors and Suppliers KBI Biopharma, Inc. In July 2014, the company entered into a master services agreement (KBI Agreement) with KBI Biopharma, Inc. (KBI). The company has engaged KBI under the KBI Agreement for process development, clinical scale-up, analytical method development, formulation development, and other services related to drug substance and drug product for its bispecific antibody and cytokine development candidates: plamotamab, vudalimab, XmAb104, XmAb306, and XmAb564 in accordance with cGMP regulations. Cell Line Agreements with Selexis In December 2015, the company entered into a master service agreement (Selexis Agreement) with Selexis SA (Selexis) for the manufacture of Selexis cell lines. Under the terms of the Selexis Agreement, Selexis will manufacture cell lines for the antibody candidates provided by the company and upon completion of the cell lines, the company has the option to take an unrestricted commercial license to the cell line. Selexis has manufactured cell lines for certain of the company’s bispecific antibody and cytokine drug candidates, and the company has rights to obtain commercial licenses to the Selexis cell line for the following bispecific antibody and cytokine candidates: plamotamab, vudalimab, XmAb104, XmAb306, XmAb564, and XmAb819. License Agreement with BIO-TECHNE In February 2018, the company entered into an agreement with BIO-TECHNE for a non-exclusive license to a certain recombinant monoclonal antibody reactive with human programmed death protein, PD-1. The company expects to use this protein in certain of its oncology drug candidates. Umbrella Development Services Agreement with Patheon Biologics LLC In September 2018, the company entered into an Umbrella Development Services Agreement (Patheon Agreement) with Patheon Biologics LLC (Patheon). Under the terms of the Patheon Agreement, any of the affiliates within the global network of service sites in Thermo Fisher Scientific Inc.’s Pharma Services Group may perform clinical manufacturing and development services for the company in accordance with cGMP regulations. Patheon is manufacturing drug substance material for the company’s XmAb819 program. Master Services Agreement with WuXi Biologics (Hong Kong) Limited In February 2021, the company entered into a Master Services Agreement (WuXi Agreement) with WuXi Biologics (Hong Kong) Limited (WuXi). Under the terms of the WuXi Agreement, WuXi and its affiliates will perform manufacturing, analytical, development and other services for Xencor in accordance with applicable regulations. The WuXi Agreement includes customary rights to the replacement of non-conforming products. WuXi is manufacturing drug substance and drug product for XmAb808 and XmAb662. Master Clinical Services Agreement with ICON Clinical Research Limited In April 2016, the company entered into a Master Clinical Services Agreement (ICON Agreement) with ICON Clinical Research Limited (ICON). Under the terms of the ICON Agreement, ICON and its affiliates will perform clinical trial services (including site selection, study design, site monitoring, management and training, and patient selection) for Xencor in accordance with applicable regulations. ICON is providing services to the company in connection with ongoing Xencor-sponsored clinical trial that target oncology indications. Master Services Agreement with Innovaderm Research, Inc. In April 2022, the company entered into a Master Services Agreement (Innovadrem Agreement) with Innovaderm Research, Inc. (Innovaderm). Under the terms of the Innovaderm Agreement, Innovaderm will perform clinical trial management and clinical development services (including site selection, study design, site monitoring, management and training, and patient selection) for Xencor in accordance with applicable regulations. Innovaderm is conducting clinical studies for the company’s XmAb564 program. History Xencor, Inc. was founded in 1997. The company was incorporated in California in 1997 and reincorporated in Delaware in 2004.