Xencor Regains CD20 x CD3 Bispecific T-Cell Engager
Xencor (NASDAQ: XNCR) announced it will regain exclusive worldwide rights to plamotamab, a CD20 x CD3 bispecific T-cell engager, after Janssen Biotech terminated its rights under their collaboration agreement. Xencor had advanced plamotamab through Phase 1 clinical trials targeting hematologic cancers. Despite Janssen's withdrawal, it retains rights to develop and commercialize other B-cell targeting CD28 bispecific antibodies, JNJ-9401 and JNJ-1493, which are in Phase 1 clinical trials for prostate cancer and B-cell malignancies respectively.
Xencor emphasizes that plamotamab is Phase 2 ready and subcutaneously administered, highlighting its potential to address unmet medical needs. The company remains eligible for milestone payments and royalties from Janssen's ongoing projects and has the option to co-fund development costs for increased royalty benefits.
- Xencor regains full rights to plamotamab, potentially increasing its control over the drug's future development and commercialization.
- Plamotamab has completed Phase 1 trials and is ready for Phase 2, indicating significant progress in development.
- Potential to address unmet medical needs with a subcutaneously administered antibody.
- Ongoing collaborations with Janssen on CD28 bispecific antibodies could yield milestone payments and royalties.
- Xencor retains options to co-fund development to increase its share of future royalties.
- Janssen's termination of rights to plamotamab may indicate a lack of confidence in its commercial potential.
- Xencor will bear the full development and commercialization costs of plamotamab, which could be financially burdensome.
- Dependence on milestone payments and royalties from Janssen's projects introduces uncertainty and reliance on external outcomes.
Insights
The decision by Janssen Biotech to terminate its rights to develop and commercialize plamotamab may have mixed implications for Xencor financially. On one hand, Janssen's withdrawal might suggest that the Phase 1 results of plamotamab did not meet their strategic priorities or expectations. This could potentially raise concerns about the drug's efficacy or market potential. However, Xencor regains the worldwide rights to plamotamab and can now leverage its development without sharing revenues. This provides Xencor with greater control and the ability to pursue different strategic partners or continue development independently. Future revenues from plamotamab depend on successful further trials and ultimately gaining market approval, factors that involve substantial uncertainty and risk.
Furthermore, the ongoing collaboration on CD28 bispecific antibodies with Janssen, including the advancements of JNJ-9401 and JNJ-1493 into clinical development, suggests strong continuing potential in other areas of Xencor's pipeline. The tiered royalties and milestone payments from these collaborations could provide a significant revenue stream, offering a cushion and potentially offsetting some of the risks associated with plamotamab.
From a clinical perspective, regaining control of plamotamab could allow Xencor to re-align its research priorities and strategies to more tightly focus on their existing knowledge and resources. The drug has already reached Phase 2 readiness, indicating a certain level of progress in demonstrating its safety and potential efficacy. However, the shift in strategy by Janssen may highlight potential challenges or limitations observed during Phase 1, necessitating a thorough re-evaluation by Xencor to determine the best path forward clinically.
Moreover, the continuing collaborations on CD28 bispecifics offer promising avenues in oncology, likely benefiting from the resources and expertise of Janssen. Targeting CD28 is a notable strategy in immuno-oncology, aiming to activate T-cells and enhance their ability to attack cancer cells. These collaborations could contribute to innovative treatments and provide substantial clinical and market value if successful.
Market dynamics for bispecific antibodies, particularly in oncology, are highly competitive. Regaining rights to plamotamab allows Xencor to directly control its commercialization strategy, including exploring alternative partnerships or internal development paths. The market for CD20-targeting therapies is well-established, with competitors like Roche's Rituxan setting high efficacy and safety benchmarks. Xencor’s Phase 2 readiness for plamotamab suggests it has potential, but differentiation in efficacy, safety, or administration (e.g., subcutaneous vs. intravenous) will be key to capturing market share.
The continued partnership with Janssen on CD28 bispecifics could also strategically position Xencor within the immuno-oncology market, which is expanding rapidly due to the demand for novel cancer therapies. Success in these areas can significantly impact Xencor’s market valuation and attractiveness as a potential acquisition target or collaborator, enhancing its long-term market positioning.
Xencor has been notified that Janssen will terminate its rights to plamotamab under the collaboration and license agreement. Janssen has retained its rights to develop and commercialize B-cell targeting CD28 bispecific antibodies, including JNJ-9401 (PSMA x CD28) and JNJ-1493 (CD20 x CD28).
“Plamotamab is a Phase 2 ready, subcutaneously administered immune-cell directed cytotoxic antibody, and we will review its potential for addressing unmet medical needs,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “Xencor’s CD28 platform remains the subject of two collaborations with Janssen. JNJ-9401 and JNJ-1493 are clinical-stage CD28-targeting bispecific antibodies that J&J is currently developing in prostate cancer and B-cell malignancies, respectively, and both entered clinical development during the fourth quarter of 2023.”
Under Xencor’s two collaboration agreements with Janssen, Xencor and Janssen conducted joint research activities to discover XmAb® bispecific antibodies against CD28 and select targets, with Janssen maintaining exclusive worldwide rights to develop and commercialize licensed products identified from the research activities. Janssen has advanced JNJ-9401and JNJ-1493 into Phase 1 clinical studies.1,2
Xencor is eligible to receive additional development, regulatory and sales-based milestone payments, and tiered royalties on approved products in the high-single to low-double digit percent range of net sales. Upon clinical proof-of-concept for each program, Xencor has the right to opt-in to fund
References
- ClinicalTrials.gov Identifier NCT06095089. “A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer.”
- ClinicalTrials.gov Identifier NCT06139406. “A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer.”
About Plamotamab
Plamotamab is an investigational XmAb® bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing cells.
Data presented from a Phase 1 clinical study of plamotamab in patients with B-cell malignancies indicated intravenously administered plamotamab was generally well tolerated and demonstrated encouraging clinical activity.
About Xencor
Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and other serious diseases. More than 20 candidates engineered with Xencor's XmAb® technology are in clinical development, and three XmAb medicines are marketed by partners. Xencor's XmAb engineering technology enables small changes to a proteins structure that result in new mechanisms of therapeutic action. For more information, please visit www.xencor.com.
Forward-Looking Statements
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,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding the future evaluation of any product, potential future milestone and royalty payments, the quotations from Xencor's president and chief executive officer, and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks, including the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, in each case as described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2023 as well as 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 caution 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 undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
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Source: Xencor, Inc.
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