On January 8, 2026 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported corporate priorities and 2026 pipeline advancement milestones for its clinical-stage portfolio of novel XmAb drug candidates.

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"Xencor designs proteins that enable potential first-in-class and best-in-class medicines for patients, and we are building on momentum from 2025, when we presented encouraging clinical data from our portfolio of T-cell engagers and TL1A antibodies," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "We are excited to be evaluating a pipeline of five wholly owned clinical-stage XmAb drug candidates and have plans this year to begin the first-in-human study of our TL1A x IL23p19 bispecific antibody for development in inflammatory bowel disease."

"Throughout 2026, we plan to present key clinical data and program updates as we advance our oncology programs toward late-stage development and present clinical proof-of-concept data for our autoimmune programs. We are also starting the year with a strong balance sheet to execute our plans, and we look forward to several updates, potential regulatory achievements and milestones across multiple partner programs."

Four Novel XmAb T-Cell Engagers in Solid Tumor Oncology and B-Cell Depletion for Autoimmune Disease

XmAb819 (ENPP3 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC). Initial results from an ongoing Phase 1 study in advanced ccRCC indicated that XmAb819 demonstrated evidence of anti-tumor activity and an acceptable safety profile that was generally well tolerated. Of the 20 efficacy-evaluable patients treated at the dose levels that were preclinically predicted to be within the target dose range, 25% achieved a partial response (RECIST v1.1) as best response with a 70% disease control rate. The dose-expansion portion of the ongoing Phase 1 study is enrolling patients and dose-escalation continues. We plan to:

Present new clinical data to support a recommended Phase 3 dose in 2H26
Initiate tumor expansion cohorts in colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) during 2026
Initiate a pivotal study of XmAb819 in ccRCC during 2027
XmAb541 (CLDN6 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced gynecologic and germ cell tumors. In 2025, Xencor presented early efficacy data from a cohort in the ongoing Phase 1 dose-escalation study of XmAb541. Nine patients had received XmAb541 in the most recently completed escalation cohort. Confirmed partial responses (RECIST v1.1) were observed in three patients: one patient with ovarian cancer and two patients with germ cell tumors. We plan to:

Present new clinical data to support a recommended Phase 3 dose in 2H26
Initiate a pivotal study of XmAb541 during 2027
Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in development for patients with rheumatoid arthritis (RA). Xencor is evaluating plamotamab in an ongoing Phase 1b proof-of-concept study, for patients with RA who have progressed through prior standard-of-care treatment. We plan to:

Provide an update on progress achieved in the Phase 1b study of plamotamab in RA in 2H26
XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in development for patients with idiopathic inflammatory myopathies (IIM). In the fourth quarter of 2025, Xencor initiated a Phase 1 proof-of-concept study of XmAb657 for patients with IIM. We plan to:

Provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26
Two Differentiated, Potentially Best-in-Class Therapeutic Options for Inflammatory Bowel Disease

XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. Xencor is conducting the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy. Patient enrollment in the study is ongoing. We plan to:

Present final results from the Phase 1 study of XmAb942 in healthy volunteers in 1H26
Provide an update on progress achieved in the XENITH-UC study near year-end 2026
XmAb412 (TL1A x IL23p19), a bispecific antibody for dual targeting of important inflammatory pathways in autoimmune and inflammatory disease, while avoiding the complexities of dosing and formulary access for two separate TL1A and IL23 targeted drugs. XmAb412 was selected as the lead candidate in 2025. We plan to:

Present preclinical characterization of XmAb412 in 1H26
Initiate a first-in-human study of XmAb412 in 2H26
Preliminary Cash Position and Financial Guidance

Xencor’s broad development portfolio is supported by a strong financial position. Xencor ended the fourth quarter of 2025 with unaudited cash, cash equivalents and marketable debt securities expected to be approximately $611 million. Based on current operating plans, Xencor expects to have sufficient cash resources to fund research and development programs and operations through 2028.

(Press release, Xencor, JAN 8, 2026, View Source [SID1234661856])

On January 8, 2026 Enodia Therapeutics, a biotechnology company developing novel small-molecule therapies for targeted protein degradation at the point of synthesis, reported it has raised €20.7 million (US$25 million) in a Seed financing. The round was co-led by Elaia, Pfizer Ventures and Bpifrance, as part of the InnoBio investment strategy, with participation from Wallonie Entreprendre, Argobio Studio, MACSF, The Institut Pasteur, InvestSud, Sambrinvest and Mission BioCapital.

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Enodia’s proprietary discovery platform, built on Institut Pasteur science, uses machine learning to selectively modulate the SEC61 translocon, where secreted and transmembrane proteins are directed into the secretory pathway at the point of synthesis. This enables intervention upstream of disease, without compromising vital physiological functions, and before damage occurs. Leveraging a large chemical space spanning several families of well-characterized inhibitors, together with a tailored library of signal-peptide cell lines, the company integrates machine-learning-driven selectivity, proteomics-based secretome analysis and structural validation to guide rational drug design. This innovative strategy allows Enodia to unlock previously undruggable secreted and membrane protein targets to treat high-unmet-need conditions.

"We are grateful for the strong support and confidence from our investors, which reflects their conviction in our scientific approach and team," said Yves Ribeill, Chief Executive Officer of Enodia Therapeutics. "This financing supports the advancement of our small-molecule approach to modulating the SEC61 translocon, with machine learning enabling greater selectivity in targeted protein degradation than previous approaches. Over the next year, we plan to progress our lead program toward preclinical candidate selection, thereby establishing a key value inflection point and the foundation for subsequent IND-enabling development."

Florian Denis, Partner at Elaia, commented: "Enodia’s rational, proteomics-enabled drug design approach provides strong confidence in the team’s ability to repeatedly translate complex SEC61 biology into truly differentiated drug candidates, supported by a highly experienced management team. Beyond individual programs, the platform unlocks exceptionally deep and expandable therapeutic opportunities across a broad range of disease areas, creating significant long-term pipeline and partnering potential."

"Our investment reflects strong interest in Enodia’s differentiated approach addressing disease by controlling protein secretion and enabling precise targeting of pathogenic proteins," said Irena Melnikova, Partner at Pfizer Ventures. "We are pleased to support Enodia’s efforts to rapidly advance a broad pipeline of SEC61-targeted small-molecule medicines across inflammatory diseases and autoimmune disorders, and beyond."

Enodia Therapeutics was created by Argobio Studio and The Institut Pasteur, with early platform and translational validation further supported by the Mission BioCapital Platinum Program.

"Enodia is tackling a significant unmet medical need by targeting the secretion pathway at the initiation of protein synthesis," said Olivier Martinez, Senior Investment Director at Bpifrance. "Built on strong scientific foundations from the Institut Pasteur and further developed within France’s Argobio ecosystem, the company’s selective approach to pathogenic secreted and membrane-associated proteins illustrates the type of rigorous, translational innovation we want to support."

Valentin Tonnel, Investment Manager, WE Venture Life Sciences on behalf of the Walloon public investor consortium: "This investment in Enodia reflects WE Venture Life Sciences’ strategy to support breakthrough biology at a very early stage, in close collaboration with leading specialized investors. Enodia’s SEC61 platform, selected by Argobio, illustrates how cutting-edge scientific discoveries can be translated into transformative therapeutic solutions. We are pleased to contribute to the development of this program alongside our partners Sambrinvest and InvestSud within the Walloon region, where a mature life sciences ecosystem offers strong conditions for successful execution."

(Press release, Enodia Therapeutics, JAN 8, 2026, View Source [SID1234661872])

On January 8, 2026 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, reported upcoming milestones and recent corporate updates.

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"2025 was marked by robust execution at Xilio as we delivered on key priorities across our deep portfolio of differentiated I-O therapies, demonstrated additional clinical validation of our masking technology and further strengthened our financial position through strategic partnerships and our recent equity financing," said René Russo, Pharm.D., president and chief executive officer of Xilio. "In the year ahead, we have a strong foundation to advance our potential best-in-class bispecific PD-1/IL-2 and T cell engager programs toward the clinic and maximize the value of our vilastobart and efarindodekin alfa programs through strategic partnerships."

Xilio also announced the appointment of Sara Bonstein as chair of the board of directors, following the retirement of Paul Clancy. Dr. Russo continued, "Sara has been an invaluable member of our board since 2021 and brings more than two decades of executive leadership in finance, corporate strategy and business operations in the biotechnology industry, as well as extensive experience advancing novel therapies from discovery through commercialization. I look forward to continuing to partner with Sara as we advance our pipeline of masked immuno-oncology therapies through development. On behalf of the entire board, I’d also like to express my gratitude to Paul for his leadership and contributions as chair, which have been instrumental in helping shape Xilio over the past five years."

Ms. Bonstein added, "During my tenure, Xilio has made significant progress demonstrating validation for its novel masking technology through strategic partnerships with Gilead and AbbVie as well as promising clinical data for its most advanced programs. I am excited to chair the board and look forward to working closely with the management team to advance the company’s deep portfolio of differentiated I-O therapies."

Corporate Updates

In January 2026, Xilio announced the receipt of $35.8 million in gross proceeds from the exercise of Series B warrants, before deducting underwriting discounts and commissions and any offering expenses, including the full exercise of Series B warrants held by Coastlands Capital, Frazier Life Sciences and Gilead Sciences, Inc. The Series B warrants were issued in connection with a follow-on public offering in June 2025.

Xilio today announced:

•
The achievement of a development milestone related to the masked antibody-based immunotherapy program under the company’s collaboration, license and option agreement with AbbVie.
•
The nomination of a development candidate for its masked T cell engager program targeting the tumor-associated antigen for CLDN18.2, which has broad potential as a target for gastric, pancreatic, esophageal and lung cancers.
•
The appointment of Sara M. Bonstein as chair of the board of directors of Xilio. Ms. Bonstein has served as a member of Xilio’s board of directors since August 2021 and succeeds Paul Clancy, who retired from the board of directors on January 6, 2026. Ms. Bonstein has more than 10 years of experience as a chief financial officer for public biotechnology companies, and she currently serves as chief financial officer of Insmed, Inc. where she oversees key financial functions including capital raising, investor relations, accounting, treasury, financial planning and analysis and procurement. Earlier in her career, Ms. Bonstein held finance roles of increasing responsibility at Eli Lilly & Company and Johnson & Johnson. Ms. Bonstein holds a B.S. in finance from The College of New Jersey and an M.B.A. from Rider University.

Anticipated Milestones

Xilio’s anticipated upcoming milestones include:

•
Submit an investigational new drug (IND) application for XTX501 in the middle of 2026
•
Report initial Phase 1 data for XTX501 in the second half of 2027, subject to clearance of the IND by the U.S. Food and Drug Administration
•
Nominate a development candidate for the STEAP1 program (masked T cell engager with co-stimulation) in the first half of 2026
•
Advance at least two masked T cell engager programs into IND-enabling studies and submit IND applications for those programs in 2027
•
Deliver the Phase 1/2 option data package to Gilead for the efarindodekin alfa program in the first half of 2027

Financial Guidance

As of December 31, 2025, Xilio estimates that it had cash and cash equivalents of $137.5 million, including $35.8 million in gross proceeds received in the fourth quarter of 2025 from the exercise of Series B warrants.

Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of December 31, 2025 will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2027.

The cash and cash equivalents information provided above is based on preliminary unaudited information and management estimates for the year ended December 31, 2025, is not a comprehensive statement of the company’s financial results as of and for the fiscal year ended December 31, 2025 and may change. Xilio’s independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, this preliminary estimate.

(Press release, Xilio Therapeutics, JAN 8, 2026, View Source [SID1234661857])

On January 8, 2026 RefleXion Medical, an external-beam theranostic oncology company, reported the U.S. Food and Drug Administration has cleared its next generation, autonomously-guided oncology platform, the RefleXion X2 with SCINTIX therapy, for the treatment of primary and metastatic lung and bone tumors.

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The X2 platform delivers a 20-fold increase in positron emissions tomography (PET) sensitivity, significantly increasing the biological signal for tumor detection. This increased sensitivity aims to expand the number of patients eligible for SCINTIX therapy.

"Clinical outcomes data1 from our first-generation platform showed that SCINTIX biology-guided radiotherapy enables tumors to autonomously direct their own treatment," said Sam Mazin, Ph.D., CTO and co-founder of RefleXion. "The goal of the X2 platform is to scale applicability of SCINTIX therapy to a broader patient population, including those with early-stage or metastatic disease."

The key innovation of the X2 platform is its wide field-of-view PET detector technology, which quadruples the imaging field of view to generate sharper images with less noise and improve visualization of moving tumors. The X2 expands the field of view of the first-generation system from 5 to 20 centimeters, expanding autonomous delivery of SCINTIX therapy to a much larger area.

"We have effectively expanded the ‘eyes’ of the machine to generate more real time data over a larger portion of the patient’s anatomy, thereby covering the expected range of tumor motion during treatment," continued Mazin.

Design advancements also allow upgrades across the existing installed base, enabling current RefleXion customers to transition to the full capabilities of the new X2 platform with minimal disruption.

The company will leverage its participation in the 44th annual J.P. Morgan Healthcare Conference to be held Jan. 12-15 in San Francisco to discuss the newly cleared X2 platform and other commercialization milestones with select investors.

(Press release, RefleXion, JAN 8, 2026, View Source [SID1234661873])

On January 8, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported corporate updates and highlights from its ZYNLONTA clinical program.

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"During 2025, we delivered meaningful progress across our ZYNLONTA clinical program and extended our expected cash runway at least to 2028," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This year, we look forward to multiple clinical catalysts including full results from our LOTIS-5 and LOTIS-7 2L+ DLBCL trials, as well as potentially from the ongoing Phase 2 indolent lymphoma IITs. Assuming positive results, we anticipate potential compendia inclusion for each in the first half of 2027 with LOTIS-5 regulatory approvals to follow. Taken together, we anticipate we will see an acceleration in net product revenue growth beginning in 2027."

Recent Highlights and Developments

Preliminary unaudited 2025 selected financial results. ZYNLONTA net product revenue is expected to be approximately $73 million for full year 2025 compared with $69.3 million for full year 2024. Fourth quarter 2025 ZYNLONTA net product revenue is expected to be approximately $22 million, as compared to $16.4 million in the fourth quarter of 2024, primarily reflecting variability in customer ordering. Underlying demand for ZYNLONTA in the current 3L/3L+ DLBCL indication remained broadly stable year-over-year. The Company ended 2025 with cash and cash equivalents of approximately $261 million which, based on current plans, is expected to provide a cash runway at least to 2028.

Reported updated data from LOTIS-7 in December 2025. Updated data from the LOTIS-7 Phase 1b clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) demonstrated an 89.8% best overall response rate (ORR) and a 77.6% complete response rate across 49 efficacy evaluable patients with a minimum of 6 months follow-up. Enrollment in the LOTIS-7 trial is ongoing, with complete enrollment of approximately 100 patients at the selected 150 µg/kg dose expected during the first half of 2026. The Company plans to share full data at a medical meeting and through publication by the end of 2026. In addition, the Company plans to assess regulatory and compendia strategies in the first half of 2027.

LOTIS-5 topline results anticipated in 2Q 2026. The Company expects to provide topline data in 2Q 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL once the pre-specified number of approximately 262 progression-free survival (PFS) events is reached and data are available. Publication of the full results is anticipated by the end of 2026. Assuming positive results, a supplemental Biologics License Application (sBLA) submission to the U.S. FDA will follow, with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ DLBCL in mid-2027.

Investigator-initiated trials (IITs) of ZYNLONTA in indolent lymphomas ongoing. Initial data from the Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab to treat relapsed or refractory (r/r) follicular lymphoma (FL) and the Phase 2, single-arm, open-label, multicenter trial of ZYNLONTA to treat r/r marginal zone lymphoma (MZL) led by the Sylvester Comprehensive Cancer Center at University of Miami have shown promising efficacy and manageable safety results. The Company anticipates publication of both data sets as early as the end of 2026. Assuming positive data, the Company plans to assess regulatory and compendia strategies.

IND-enabling activities completed for PSMA-targeting ADC. IND-enabling activities for the Company’s exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC were completed at the end of 2025. The Company continues to explore partnership opportunities.

(Press release, ADC Therapeutics, JAN 8, 2026, View Source [SID1234661842])