Xencor Announces Extension of U.S. Patent Term on Certain Xtend™ Antibodies

On December 9, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported the issuance of U.S. Patent 12,492,253, which covers Xencor’s Xtend Fc domain for extending the half-life of antibodies targeting C5, with a term that extends into December 2028. The new patent term is approximately three years longer than the previous latest-to-expire U.S. patent covering the Xtend Fc domain.

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Xencor now anticipates receiving low-single digit royalties on net sales of Ultomiris (ravulizumab-cwvz), an anti-C5 antibody engineered with a licensed Xtend Fc domain, into December 2028 in the United States. Ultomiris is a drug being developed and commercialized by Alexion Pharmaceuticals, Inc., and is a registered trademark of Alexion. Xencor has also previously secured regulatory extensions of exclusivity in several EU countries, Japan and Australia.

"Xencor’s Xtend antibody half-life extension technology is one of several modular XmAb Fc domains that power Xencor’s XmAb medicines and drug candidates across internal and partner portfolios," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Importantly, this patent term extension also extends the U.S. royalty term for Ultomiris by approximately three years. We anticipate the resulting additional revenue will support our internal pipeline as it advances into later stages of clinical development and will drive further innovation across our portfolio, continuing to fuel the cycle of value creation that has been central to our strategy."

In 2023, OMERS, one of Canada’s largest defined benefit pension plans, acquired royalties due to Xencor on global Ultomiris sales subject to annual caps beginning in 2026. For potential sales related to Ultomiris occurring between 2026 and 2028, OMERS is entitled to receive up to $35 million annually with excess reverting to Xencor. For the nine-month period ending September 30, 2025, Xencor recognized non-cash royalty revenue of $51.0 million. Based upon consensus sales forecasts of Ultomiris, Xencor estimates recognizing potential royalty revenue in excess of the caps in the range of $100 million to $120 million in aggregate for the extended patent term through 2028.

(Press release, Xencor, DEC 9, 2025, View Source [SID1234661320])

Natera Highlights New Findings in Lymphoma at the ASH Annual Meeting

On December 9, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the results from two oral presentations that were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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Real-world Signatera Analysis: Oral Presentation on December 6

A real-world analysis of personalized circulating tumor DNA (ctDNA) detection in lymphoma evaluated 144 patients across 14 lymphoma subtypes, including aggressive and indolent lymphomas and patients undergoing chimeric antigen receptor T-cell (CAR-T) therapy. Signatera was used clinically to assess baseline ctDNA detection, track molecular clearance during first-line (1L) therapy, and evaluate end-of-treatment (EOT) ctDNA status and post-CAR-T response. Key findings included:

Across 14 subtypes of lymphoma, 94% of patients had detectable ctDNA in a pre-treatment sample.
ctDNA clearance during treatment was highly predictive of CAR-T response (p = 0.0028).
Rapid ctDNA clearance after one cycle of chemotherapy was more predictive of positive outcomes vs. delayed clearance after two cycles of therapy (HR: 20.95 vs. 7.45).
Signatera status at the end of 1L therapy was highly prognostic of event-free survival (HR: 49.77, p<0.0001), outperforming standard of care PET-CT response assessment across lymphoma subtypes.
HOVON Study: Oral Presentation on December 7

The HOVON study was conducted by Foresight Diagnostics, a subsidiary of Natera, in collaboration with Amsterdam University Medical Centers, the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON) and the Netherlands Comprehensive Cancer Organization (IKNL). The study evaluated longitudinal molecular residual disease (MRD) surveillance in 166 patients with diffuse large B-cell lymphoma. The study provided one of the most detailed evaluations to date of ctDNA-MRD dynamics over a two-year surveillance period using the CLARITY ctDNA assay. Key findings included:

The CLARITY ctDNA assay showed early molecular response was associated with improved clinical outcomes, demonstrating its utility as an early risk-stratification marker.
Following any negative ctDNA test during surveillance, the probability of remaining relapse-free was 99% at 6 months and 97% at 12 months.
Early on-treatment molecular response could serve as a dynamic marker for therapy de-escalation or escalation trials, enabling adaptive trial designs.
"These presentations highlight the value of ctDNA in assessing treatment response and long-term risk across lymphoma subtypes, including diffuse large B-cell lymphoma," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "The findings reinforce how the detection of disease at the molecular level can support more personalized treatment and surveillance strategies for patients with cancer."

(Press release, Natera, DEC 9, 2025, View Source [SID1234661336])

Alligator Bioscience comments on Henlius receiving regulatory approval in China to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer

On December 9, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported on the announcement by Shanghai Henlius Biotech, Inc. that applications for Phase 2/3 clinical trials of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) in combination with HLX87 (an antibody-drug conjugate targeting HER2) have been approved by China’s National Medical Products Administration (NMPA). The trials are intended for first-line treatment of HER2-positive breast cancer and for neoadjuvant treatment of HER2-positive breast cancer.

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HLX22 is an anti-HER2 monoclonal antibody being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

"Shanghai Henlius regulatory approvals to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer represent continued progress for this programme and broaden its clinical development," said Søren Bregenholt, CEO of Alligator Bioscience. "While Alligator is not directly involved in the development, we follow HLX22 closely as it represents an opportunity for future revenue streams from milestones and royalties upon potential approval."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius. For further information and the latest updates on HLX22’s clinical development, please refer to Henlius’ announcement available on HKEXnews.

(Press release, Alligator Bioscience, DEC 9, 2025, View Source [SID1234661305])

Aptevo Therapeutics Highlights Compelling Safety and Strong Remission Rates for Mipletamig in Frontline AML at ASH 2025

On December 9, 2025 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported preliminary results from its ongoing Phase 1b/2 RAINIER study evaluating mipletamig, a CD123 x CD3 bispecific molecule, in combination with azacitidine and venetoclax (AZA/VEN) for newly diagnosed acute myeloid leukemia (AML) patients who are unfit for intensive chemotherapy. The data were presented on December 8, 2025, in a poster session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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Across dose-optimization Cohorts 1-3, mipletamig combined with AZA/VEN demonstrated high remission rates and a compelling safety/tolerability profile, reinforcing the potential of T-cell engagement in frontline AML when safety can be effectively managed. Aptevo’s proprietary use of the CRIS-7-derived CD3 binding domain differentiates mipletamig in the category.

Key Findings

100% of treated patients remained free of cytokine release syndrome (CRS) across cohorts to date

93% overall response rate (ORR) among evaluable patients

87% achieved CR/CRi*

73% achieved CR

60% of MRD evaluable CR/CRi patients achieved minimum residual disease negative status, a result that is typically associated with stronger, more durable responses

43% of ORR patients had a TP53 genetic mutation, a marker that is typically associated with poor prognosis in AML patients

*Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered (CRi).

Median patient age was 75, reflecting a population that is underserved by intensive therapies. In the RAINIER trial to date, the triplet regimen was generally well tolerated. Infusion-related reactions and hematologic events were the most common adverse events, consistent with expectations for this patient population. Importantly, no CRS was seen, supporting the molecule’s differentiated safety profile in combination therapy.

"These data, particularly the remission rates and absence of CRS, underscore the promise of mipletamig as part of a frontline AML regimen," said Dirk Huebner, MD, Chief Medical Officer. "We are encouraged by the safety and efficacy profile we are seeing across cohorts, and we look forward to advancing the program into later-stage evaluation."

The RAINIER study continues to enroll patients across additional dose levels. Mipletamig’s design leverages Aptevo’s ADAPTIR platform to deliver targeted T-cell engagement with the goal of minimizing systemic immune activation-an important factor in realizing the full therapeutic potential of T-cell engagers in AML.

About the RAINIER Trial
RAINIER, a frontline AML study, is a Phase 1b/2 dose optimization, multi-center, multi-cohort, open label study. Subjects are adults aged 18 or older, newly diagnosed with AML who are not eligible for intensive induction chemotherapy. RAINIER will be conducted in two parts. First, a Phase 1b dose optimization study in frontline AML patients followed by a Phase 2 study. The Phase 1b trial consists of 28-day cycles of treatment across multiple, sequential cohorts.

About Mipletamig
Aptevo’s wholly owned lead proprietary drug candidate, mipletamig, being evaluated for the treatment of AML, is differentiated by design to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts. This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. Mipletamig is purposefully designed to reduce the likelihood and severity of CRS by use of the CRIS-7-derived CD3 binding pathway an approach that differentiates Aptevo from competitors. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. Orphan drug designation provides key advantages-including the opportunity to seek U.S. market exclusivity for a specific period of time upon approval, FDA fee reductions, and access to development and tax credits. Mipletamig has been evaluated in more than 100 patients over three trials to date.

(Press release, Aptevo Therapeutics, DEC 9, 2025, View Source [SID1234661321])

Study Establishes Molecular Link Between Tumor Metabolism and Drug Engagement in Cancer Cells

On December 9, 2025 Promega reported a new study published in Nature Communications reveals technological advances that accelerate breakthroughs in precision medicine. Conducted as a collaboration between Promega, the Center for Advanced Study of Drug Action at the State University of New York at Stony Brook, and the Centre for Medicines Discovery at the University of Oxford, the work leverages bioluminescent NanoBRET Target Engagement (TE) technology developed by Promega to characterize inhibitors that selectively target cancer cells without harming noncancerous cells. Their results demonstrate a connection between drug efficacy and tumor metabolic state, offering a mechanistic bridge between cancer metabolism and precision oncology.

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"To our knowledge, this is the first time anyone has characterized this type of uncompetitive inhibitor mechanism directly in live cells." -Ani Michaud, Sr Research Scientist at Promega

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"The methods in this study enable us to characterize inhibitors that bind much more tightly in tumor cells with specific mutations," says Ani Michaud, Sr Research Scientist at Promega and co-first author of the Nature Communications paper. "To our knowledge, this is the first time anyone has characterized this type of uncompetitive inhibitor mechanism directly in live cells."

PRMT5: Top Target for Drug Discovery

The published study focuses on a gene-regulating protein called PRMT5, which has long been considered a top target for drug discovery. In normal cells, PRMT5 interacts with a molecule called SAM. However, in the tumor cells of approximately 10-15% of cancers, a deletion of the MTAP gene leads to PRMT5 interacting with the molecule MTA instead, reducing its function. This difference creates a key vulnerability for targeting cancer cells with a mutation to MTAP while leaving normal cells unaffected.

The University of Oxford team designed and developed CBH-002, a cell-permeable BRET probe that binds to a genetically encoded PRMT5-NanoLuc biosensor to report drug target engagement in live cells.

Dr Elisabeth Mira Rothweiler, Postdoctoral Researcher, Centre for Medicines Discovery, University of Oxford and co-first author, says: "CBH-002 could measure various PRMT5 inhibitor types in live cells, prompting us to test its sensitivity to the cofactor SAM. When we discovered the probe’s ability to sense metabolite levels, it established its utility as a metabolic biosensor. Through collaboration with Promega, we demonstrated how MTA influences drug selectivity, revealing why certain inhibitors are so effective in MTAP-deleted cancers."

Dr Rothweiler’s research further enables a strategy for developing molecules that exploit the metabolic vulnerabilities specific to MTAP-deleted cancers, potentially offering highly targeted treatments with minimal effects on healthy tissue.

Uncompetitive Binding in Live Cells

While past studies have characterized this mechanism-of-action (MoA) in biochemical assays, this is the first to use NanoBRET TE technology to characterize uncompetitive, or cooperative, binding in live cells. Biochemical assays can reveal uncompetitive MoAs, but there is often a discrepancy between biochemical data and functional assays like selective cell killing. The NanoBRET TE assay used in this study bridges the two modalities, showing binding MoA in a cellular context that aligns with functional assay results.

Professor Kilian Huber, Associate Professor, Centre for Medicines Discovery, University of Oxford and co-senior author of the study, says, "The biosensor lets us examine, in living cells, how different PRMT5 inhibitors behave under the specific metabolic conditions that make some tumors uniquely vulnerable. This provides unprecedented insight into why certain inhibitors are much more effective in cancers lacking MTAP and paves the way for highly targeted cancer treatment in the future. It’s like turning on the lights inside the cell so we can finally see which key actually fits the lock."

"Selectivity is one of the most critical challenges in cancer therapy, as most treatments also damage healthy cells, leading to dose-limiting toxicities and reduced therapeutic effectiveness," says Peter Tonge, distinguished professor of chemistry and director of the Center for Advanced Study of Drug Action at the State University of New York at Stony Brook and visiting professor at the University of Rochester. "A new class of tumor-specific drugs addresses this by acting uncompetitively with a metabolite that accumulates only in cancer cells, limiting activity to tumor tissue. We have now developed the first technology to quantify the activity of these drugs directly in live cells, providing a foundation for optimizing and advancing next-generation precision oncology therapeutics."

Collaboration Between Academia and Industry

This study was the result of collaboration between Promega, the Center for Advanced Study of Drug Action at the State University of New York at Stony Brook, and the Centre for Medicines Discovery at the University of Oxford, with additional contributions from researchers at Boston University and the Structural Genomics Consortium at the University of Toronto.

"This work underscores the value of research collaborations between academia and industry," says Matt Robers, Associate Director of R&D at Promega and co-senior author of the study. "By combining our complementary expertise in chemical biology and assay design, we were able to dissect how cooperativity can drive cancer cell selectivity. These findings have real potential to guide the development of future precision medicines."

Read the paper "A BRET biosensor for measuring uncompetitive engagement of PRMT5 complexes in cells" in Nature Communications here: View Source

(Press release, Promega, DEC 9, 2025, View Source [SID1234661337])