On December 9, 2025 Daiichi Sankyo reported first patient has been dosed in the randomization phase of the DESTINY-Ovarian01 phase 3 trial evaluating ENHERTU (trastuzumab deruxtecan) in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer following treatment with first-line platinum-based chemotherapy in combination with bevacizumab.

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DESTINY-Ovarian01 is being conducted in collaboration with the European Network of Gynecological Oncological Trial Groups (ENGOT), with the Spanish cooperative group (GEICO) as the lead ENGOT group, The GOG Foundation, Inc. (GOG-F) and Asia-Pacific Gynecologic Oncology Trials Group (APGOT).

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The prognosis for patients with ovarian cancer is poor with an estimated five-year survival rate of 31.8% for those with advanced disease.1 Approximately 70% to 80% of patients with advanced ovarian cancer (Stage 3 or 4) will experience disease recurrence following standard treatment with surgery and platinum-based chemotherapy regimens.2 Maintenance therapy may be given to delay relapse and current recommended treatment strategies include bevacizumab or PARP inhibitor monotherapy or bevacizumab/PARP inhibitor combination treatment, depending on the biomarker status of the tumor. 3 There currently are no HER2 directed medicines approved as maintenance therapy despite HER2 expression being present in up to 55% of ovarian cancers.

"Results from the ovarian cancer cohort of DESTINY-PanTumor02 demonstrated clinically meaningful and durable responses in previously treated patients with HER2 expressing advanced ovarian cancer, supporting the development of ENHERTU in earlier lines of therapy," said Abderrahmane Laadem, MD, Head, Late- 2 Stage Oncology Clinical Development, Daiichi Sankyo. "Given the important role first-line maintenance therapy can play in disease control, we have initiated this first phase 3 trial in ovarian cancer to evaluate whether ENHERTU combined with bevacizumab could become a new maintenance strategy for patients with HER2 expressing advanced high-grade epithelial ovarian cancer."

About DESTINY-Ovarian01

DESTINY-Ovarian01 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer following treatment with first-line platinum-based chemotherapy in combination with bevacizumab. The randomized period of the trial was preceded by a non-randomized safety run-in phase to evaluate the safety of ENHERTU in combination with bevacizumab

The primary endpoint is progression-free survival (PFS) as assessed by blinded independent central review (BICR) in the HER2 IHC 3+/2+ population. The key secondary endpoint is overall survival (OS) in the HER2 IHC 3+/2+ population. Additional secondary endpoints include PFS as assessed by BICR and OS in the HER2 IHC 3+/2+/1+ population as well as PFS as assessed by investigator in both the HER2 IHC 3+/2+ and HER2 IHC 3+/2+/1+ populations.

DESTINY-Ovarian01 will enroll approximately 580 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

(Press release, Daiichi Sankyo, DEC 9, 2025, View Source [SID1234661322])

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])

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])

On December 9, 2025 Pulse Biosciences, Inc. (Nasdaq: PLSE)(the "Company" or "Pulse Biosciences"), a company leveraging its novel nPulse technology using its proprietary Nanosecond Pulsed Field Ablation (nanosecond PFA or nsPFA) energy, reported a research collaboration with The University of Texas MD Anderson Cancer Center to examine the use of the Company’s nPulse Vybrance Percutaneous Electrode System for treatment of thyroid cancers. The Investigational Device Exemption (IDE) submitted for this first-in-human clinical feasibility study has been approved by the FDA.

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Under the agreement, MD Anderson researchers led by Victoria Banuchi, M.D., Associate Professor of Head & Neck Surgery, will conduct a clinical study to assess the safety and effectiveness of using nPulse technology to treat papillary thyroid microcarcinoma, a common cancer affecting hundreds of thousands of US patients. The trial is planned to commence early in 2026. The study will be conducted at two sites and is planned to enroll 30 subjects. Under an existing material transfer agreement, preclinical studies with MD Anderson researchers are ongoing to assess the effect of nsPFA energy on anaplastic thyroid carcinoma. With a five-year survival rate of less than 5%, anaplastic thyroid carcinoma is one of the deadliest types of cancer.

"We believe the nonthermal mechanism of action of nsPFA, which limits scarring, fibrosis, and damage to critical surrounding structures, positions our nPulse technology as potentially the ideal treatment for benign and malignant thyroid tumors. We look forward to carrying this collaborative work forward to evaluate how our game-changing technology may benefit these patients," said Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences.

About the Company’s nPulse Vybrance Percutaneous Electrode System

The Company’s nPulse Vybrance Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company’s proprietary nPulse Console. The novel electrode is designed to harness and deliver the key advantages of nsPFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The system has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. This proprietary system is designed for non-cardiac applications.

(Press release, Pulse Biosciences, DEC 9, 2025, View Source [SID1234661319])

On December 9, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that the Japan Patent Office has issued Patent No. 7783866 for PDS0101 granting broad composition of matter and methods of use claims. The new patent expands previously granted patents in Japan, and adds to the Company’s robust intellectual property estate, which includes previously granted patents in the United States, China, Australia, and Hong Kong. The Company has additional patent applications pending in several other countries. Together with anticipated biologics exclusivity in the United States, the Company has patent and market protections for PDS0101 into the 2040s.

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The incidence of HPV16-related cancers is rapidly increasing in the US and Europe and also increasing globally.* PDS0101 is currently being studied in the Company’s Phase 3 trial for PDS0101 + pembrolizumab in HPV16-positive recurrent/metastatic head and neck cancer.

"The issuance of an additional patent for PDS0101 in Japan further strengthens our global IP portfolio and reinforces the robust intellectual property position supporting our growth. This marks an important step in protecting the value of our innovative immunotherapies as we advance our pipeline worldwide." said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotechnology.

The Company intends to continue to advance broad intellectual property protections for PDS0101 and its other investigational agents in development.

(Press release, PDS Biotechnology, DEC 9, 2025, View Source [SID1234661318])