On April 23, 2026 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported the initiation of a Phase III clinical study of its proprietary Nectin-4-targeting ADC (R&D code: 9MW2821) for the treatment of triple-negative breast cancer (TNBC). 9MW2821 is the world’s first Nectin-4 ADC to enter Phase III clinical study for TNBC. This marks the fourth pivotal trial initiated for 9MW2821.

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This is a randomized, open-label, controlled, multicenter Phase III clinical study designed to evaluate the efficacy of 9MW2821 compared with investigator’s choice of chemotherapy in patients with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload.

Currently, topoisomerase inhibitor-based ADCs (TOPi-ADCs) are among the standard treatment options for patients with advanced TNBC. For TNBC patients who have failed prior TOPi-ADC therapy, treatment remains primarily based on chemotherapy, representing a significant unmet medical need.

9MW2821 is the world’s first Nectin-4‑targeting ADC to report efficacy data in triple-negative breast cancer. It has received Fast Track Designation (FTD) from the FDA for the treatment of locally advanced or metastatic Nectin-4‑positive TNBC. TNBC is the third tumor type for which 9MW2821 has entered Phase III pivotal trial, following urothelial carcinoma (UC) and cervical cancer (CC). 9MW2821 has also initiated a clinical study in the United States for ADC-treated TNBC, with the first patient dosed in August 2025.

About Triple-Negative Breast Cancer (TNBC)

Triple-negative breast cancer is a subtype of breast cancer characterized by the absence of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) expression. Accounting for approximately 15‑20% of global breast cancer cases, TNBC is generally considered the most aggressive subtype due to the lack of clear therapeutic targets. It is more commonly diagnosed in younger and premenopausal women.

The global incidence of TNBC increased from 320.1 thousand in 2019 to 364.9 thousand in 2024, and is expected to further increase to 382.4 thousand in 2028 and 405.9 thousand in 2032, representing a CAGR of 1.2% and 1.5% respectively. In China, the incidence of TNBC increased from 49.5 thousand in 2019 to 55.9 thousand in 2024, and is expected to further increase to 58.6 thousand in 2028 and 60.4 thousand in 2032, representing a CAGR of 1.2% between 2024 and 2028 and 0.7% between 2028 and 2032.

(Press release, Mabwell Biotech, APR 23, 2026, View Source [SID1234664731])

On April 23, 2026 CREATE Medicines, Inc., ("CREATE"), a clinical-stage biotechnology company pioneering in vivo immune cell programming, reported the dosing of the first patient in the Phase 1/2 clinical trial of MT-304, an investigational in vivo HER2-targeted multi-immune CAR therapy. The study is evaluating MT-304 in patients with HER2-positive breast cancer and other HER2-positive solid tumors, including gastric cancer. MT-304 is the first of CREATE’s multi-immune in vivo CAR therapies to enter clinical development and represents an important step in expanding the company’s platform into NK and T cells.

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"HER2-positive cancers remain an area of high unmet need for patients whose disease has progressed on available targeted therapies," said Matthew Maurer, M.D., Chief Medical Officer of CREATE. "Dosing the first patient with MT-304 reflects our ability to rapidly iterate on our mRNA-LNP platform to meet the clinical urgency. We are now engaging multiple arms of immunity simultaneously, an approach we believe can unlock durable responses where single lineage therapies have fallen short."

"Patients with HER2-positive cancers who have progressed beyond current options have very few paths forward," said Dr. Jordan Cohen, Medical Oncologist and Principal Investigator, Calvary Mater Newcastle, NSW, Australia. "Engaging both NK and myeloid cells simultaneously to coordinate multiple arms of the immune system to attack at the same time has not been possible in the clinic before now. That makes MT-304 both scientifically compelling and potentially meaningful for the patients who need it most."

Daniel Getts, Ph.D., CEO of CREATE, added "MT-304 is proof of what our platform can do, and what our team can execute. Our mRNA-LNP leadership enables us to move from concept to clinic with remarkable speed. Just last weekend at AACR (Free AACR Whitepaper), we presented compelling preclinical data across our in vivo CAR T, CAR NK, and CAR myeloid programs, and introduced RetroT, our all-RNA genome integration platform for stable, durable cell engineering without viral vectors. Both are on track to enter the clinic within 12 months, highlighting a platform designed to consistently convert innovation into clinical outcomes."

About MT-304

MT-304 is an investigational in vivo HER2-targeted NKp44-CAR therapy that programs NK and myeloid cells using CREATE’s redosable mRNA-LNP system. MT-304 is designed to produce:

CAR expression in NK and myeloid cells through DAP12-mediated signaling
Potent NK-mediated tumor lysis and myeloid-driven tumor remodeling
Enhanced antigen spreading and coordination of adaptive immunity
Repeat-dose capability with sustained pharmacodynamic activity, requiring no lymphodepletion or ex vivo manufacturing
HER2 is highly expressed across a majority of HER2-positive breast and gastric cancers and represents an established oncology target. Preclinical data demonstrate superior activity over CD89-based CAR constructs, tumor regression in models refractory to CAR T and checkpoint inhibitors, enhanced immune infiltration, and durable tumor clearance through combined NK and myeloid programming.

About the Phase 1/2 Study of MT-304

The Phase 1/2 clinical study (ClinicalTrials.gov Identifier: NCT07334119) is a multi-center, open-label, dose-escalation trial evaluating MT-304 in adults with HER2-positive breast cancer and HER2-positive solid tumors. The study will assess safety, tolerability, pharmacokinetics, pharmacodynamics, CAR expression kinetics, immune activation, and preliminary antitumor activity. Data generated from this trial will inform recommended Phase 2 dose selection, expansion cohorts, and broader clinical development strategies.

About HER2-Positive Cancer

HER2-positive cancers arise from overexpression of the epidermal growth factor receptor HER2, driving aggressive tumor growth. While targeted therapies have improved outcomes, many patients relapse, and limited durability of response and eventual resistance remain major challenges. HER2-positive breast cancer remains a significant cause of global cancer mortality, and HER2-positive gastric and other solid tumors present additional therapeutic challenges. Novel treatment modalities capable of delivering durable, multi-lineage immune activation are urgently needed. By unlocking coordinated immune activation through NK and myeloid programming, MT-304 aims to offer a new therapeutic paradigm that may overcome resistance patterns and deliver more sustained disease control.

(Press release, Create Medicines, APR 23, 2026, View Source [SID1234664730])

On April 23, 2026 Servier, an independent international pharmaceutical group governed by a foundation, reported the successful completion of the tender offer to acquire all of the issued and outstanding shares of common stock of Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, for $21.50 per share. The acquisition strengthens Servier’s leadership in low-grade glioma and expands the Group’s position in oncology with the addition of a marketed product and pipeline focused on rare cancers.

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"This acquisition represents a significant step forward for Servier as part of our 2030 ambition to strengthen our position in rare cancers, and more specifically in pediatric low-grade glioma," said Olivier Laureau, President of Servier. "Integrating Day One’s scientific and clinical capabilities will enhance our Group’s ability to support long-term innovation and translate science into meaningful medicines for children and families affected by rare cancers."

Day One’s portfolio includes OJEMDATM (tovorafenib), an FDA-approved medicine in pediatric low-grade glioma, the most common form of childhood brain tumor. Day One already markets the product in the United States and has licensed the rights outside the U.S. to Ipsen.

The transaction also strengthens Servier’s oncology pipeline from early clinical to Phase 3. In addition to tovorafenib, which is being investigated in additional indications, Day One’s pipeline includes Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate (ADC) and DAY301, a targeted therapy in rare cancers.

"Welcoming Day One to Servier marks an important next chapter in how we are expanding our presence in oncology in the U.S. and strengthening our ability to deliver for patients," said David K. Lee, Executive Vice President, USA, and CEO, Servier Pharmaceuticals. "Day One is joining us with strong science, an approved medicine, and a team that knows how to turn innovation into real outcomes for patients. This is about combining focus with execution to deliver for patients with rare cancers."

(Press release, Servier, APR 23, 2026, View Source [SID1234664729])

On April 23, 2026 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, reported an oral presentation and two poster presentations on its preclinical immuno-oncology portfolio at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, held April 17-22, 2026, in San Diego, California.

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"We are pleased to report encouraging preclinical data on our TFF2-albumin fusion protein (TNX-1700) and our anti-BTLA monoclonal antibody (mAb) (TNX-4700) at AACR (Free AACR Whitepaper)," said Bruce Daugherty, PhD, MBA, Executive Vice President of Research at Tonix Pharmaceuticals. "TNX-1700 and TNX-4700 are investigational immuno-oncology candidates in pre-clinical development. TNX-1700 is in development for the treatment of gastric and colorectal cancer in combination with PD-1 inhibitors. TNX-4700 is in development for the treatment of potentially several cancers since its ligand HVEM is expressed and/or upregulated in the tumor microenvironment and generally correlates with reduced overall survival."

Abstract #: 6822 Oral Presentation: "TFF2 Deficiency Amplifies IL-1β–Driven Inflammation and Promotes Aging-Associated Gastric Tumor Progression"

Presenting author: Shuang Li, MD, PhD, Postdoctoral Research Scientist in the Timothy C. Wang, MD, Laboratory at the Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center

Aging is a major risk factor for gastric cancer, but the underlying mechanisms remain poorly defined. The stomach undergoes profound epithelial and immune remodeling during aging. TFF2 is a mucosal protective factor implicated in epithelial repair and immune regulation. However, whether TFF2 regulates age-associated inflammation and tumor progression remains unknown.

TFF2-expressing epithelial cells were reduced in the stomachs of aged mice compared to young mice, with corresponding reductions in tissue and circulating TFF2 levels. Decline of TFF2 led to elevated IL-1β and promoted gastric inflammaging. The murine version of TNX-1700 (mTNX-1700 or TFF2-MSA) treatment reversed aging-associated inflammation. The aged stomach exhibited increased susceptibility to tumor progression. Myeloid-derived stem cells (MDSCs) accumulated and overexpressed IL-1β, interacting with IL-1R1⁺ cancer associated fibroblasts (CAFs). mTNX-1700 attenuated tumor progression in the aged gastric microenvironment.

Poster Presentation #7940: "Pharmacokinetics of TNX-1700 in Non-Human Primates and Human FcRn/Serum Albumin Transgenic Mice"

Presenting author: Bruce Daugherty, PhD, MBA, Executive Vice President of Research, Tonix

TNX-1700 was evaluated in double-transgenic mice expressing human FcRn and human serum albumin (HSA) and in non-human primates. All animals survived without clinical signs or greater than 10% body-weight loss. TNX-1700 exhibited dose-independent, linear pharmacokinetics, with comparable pharmacokinetic profiles and exposure observed across species and doses. TNX-1700 substantially extends the half-life of TFF2 and achieves durable systemic exposure, supporting its potential as a therapeutic candidate for gastric cancer.

Poster Presentation #6550: In Vitro Characterization of Fully Human Antagonistic Anti-BTLA Monoclonal Antibodies

Presenting author: Bruce Daugherty, PhD, MBA, Executive Vice President of Research, Tonix

B and T Lymphocyte Attenuator (BTLA) is a promising target in immuno-oncology since its ligand HVEM (herpesvirus entry mediator) is expressed in and upregulated in the tumor microenvironment of many cancers and generally correlates with reduced overall survival. Targeting BTLA offers opportunities for cancer immunotherapy and may demonstrate additive or synergistic activity when combined with other checkpoint antagonists, potentially overcoming resistance mechanisms and improving clinical outcomes.

Tonix studied several anti-BTLA mAbs, which demonstrated potent, high-affinity binding and functional antagonism of BTLA in vitro. Antagonists with reduced FcgRI binding and no binding to FcgRIIB may improve pharmacokinetics and confer a reduced risk of FcR-dependent adverse events, such as cytokine release syndrome or other immune-mediated toxicities.

Copies of the two poster presentations are available under the Scientific Presentations tab on the Tonix website at www.tonixpharma.com.

About Trefoil Factor Family Member 2 (TFF2)
Human TFF2 is a secreted protein expressed in gastrointestinal mucosa where it functions to protect and repair the mucosal lining. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms, including its activity as a partial agonist of CXCR4 that modulates myeloid cell trafficking to reduce accumulation of immunosuppressive neutrophils.

About TNX-1700
TNX-1700, a fusion protein of TFF2 and albumin, is in preclinical and pre-Investigational New Drug (IND) stage of development as a treatment of gastric and colorectal cancer in combination with PD-1 blockade.1 The Company in-licensed TFF2 technology from Columbia University. TNX-1700 is an immunotherapy being developed to treat gastric and colorectal cancers in combination with PD-1 blockers. Results of preclinical testing demonstrated that a mouse version of TNX-1700 was able to evoke an increase in anti-tumor immunity in combination with anti-PD-1 in several mouse models of gastric cancer by reducing immunosuppressive neutrophils and activating anti-tumoral CD8+ T cell responses. TNX-1700 administered as both monotherapy and in combination with anti-PD-1 dramatically reduced metastasis and increased survival in these models; these findings were recently published.1 TNX-1700 addresses a central mechanism of therapeutic resistance to anti-PD-1 therapy in gastric cancer by targeting the CXCR4-driven myeloid axis to normalize cancer-induced myelopoiesis and reprogram the tumor microenvironment.

About BTLA
BTLA (B and T lymphocyte attenuator) is a protein on the surface of tumor infiltrating lymphocytes. Targeting BTLA is a promising target in immuno-oncology since its ligand HVEM is expressed and/or upregulated in the tumor microenvironment of many cancers including melanoma, non-small cell lung cancer, colorectal cancer, gastric cancer, glioblastoma, and prostate cancer and generally correlates with reduced overall survival. Targeting BTLA offers opportunities for cancer immunotherapy and may demonstrate additive or synergistic effects when combined with other checkpoint antagonists, potentially overcoming resistance mechanisms and improving clinical outcomes.

About TNX-4700
Tonix is developing TNX-4700 (anti-BTLA) mAb for immuno-oncology indications. The mAb technology was licensed from Curia.

(Press release, TONIX Pharmaceuticals, APR 23, 2026, View Source [SID1234664728])

On April 23, 2026 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the first quarter ended March 28, 2026.

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First Quarter Highlights

•First quarter revenue grew 6% to $11.01 billion.
•First quarter GAAP diluted earnings per share (EPS) grew 11% to $4.43.
•First quarter adjusted EPS grew 6% to $5.44.

•Delivered excellent performance in the first quarter, demonstrating the strength of our proven growth strategy, the power of our PPI Business System, and the continued active management of our company.

•Advanced our proven growth strategy, launching a range of high-impact, innovative new products during the quarter. This included the Thermo Scientific Glacios 3 Cryo-TEM, a next-generation cryo-transmission electron microscope designed to enable installation in a broader range of lab spaces, democratizing access to cryo-EM for use in structural biology; the Thermo Scientific TSQ Certis triple quadrupole mass spectrometer, which enhances productivity and reliability by delivering faster, high-quality results to support analytical testing across pharmaceutical and applied laboratories; the Thermo Scientific Niton XL5e Handheld XRF Analyzer, which enables industrial and applied customers to improve the speed and accuracy of identifying materials in the field; and the Gibco CTS Compleo Fill and Finish System, which increases productivity and reliability in cell therapy manufacturing, supporting scalable production of advanced therapies.

•Strengthened our industry-leading commercial engine and deepened our trusted partner status with customers. During the quarter, we announced a strategic collaboration with NVIDIA, combining our leadership in laboratory technologies with NVIDIA’s AI capabilities to advance scientific instrumentation, improve laboratory performance and accelerate scientific breakthroughs. We also announced a strategic collaboration with SHL Medical to deliver fully integrated sterile fill-finish and device assembly solutions, advancing our U.S. drug product manufacturing capabilities and helping pharma and biotech customers accelerate development and commercialization of important medicines.

•Continued to successfully execute our capital deployment strategy. During the quarter, we completed the acquisition of Clario, an industry-leading provider of endpoint data solutions, repurchased $3.0 billion of stock and increased our dividend by 10%.

"We delivered a strong start to the year, reflecting excellent execution by our team, as we leveraged the PPI Business System to drive operational excellence and enable our customers’ success," said Marc N. Casper, chairman and chief executive officer of Thermo Fisher Scientific. "We continued to make great progress executing our strategy, further strengthening our capabilities with the addition of Clario."

Casper added, "Looking ahead, we are well positioned to deliver a strong year. As the trusted partner to our customers, we are uniquely equipped to help them accelerate their innovation and enhance their productivity. Through our global scale and the power of the PPI Business System, we will continue to actively manage the company to create value for our stakeholders and build an even brighter future for our company."

First Quarter 2026

Revenue for the first quarter of 2026 grew 6% to $11.01 billion, versus $10.36 billion in the same quarter of 2025. Organic revenue growth was 1%.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2026 was $4.43, 11% growth versus the first quarter of 2025. GAAP operating income for the first quarter of 2026 was $1.86 billion, 9% higher than the year-ago quarter. GAAP operating margin was 16.9%, compared with 16.6% in the first quarter of 2025.

Non-GAAP Earnings Results

Adjusted EPS for the first quarter of 2026 was $5.44, 6% growth versus the first quarter of 2025. Adjusted operating income for the first quarter of 2026 was $2.40 billion, 6% higher than the year-ago quarter. Adjusted operating margin was 21.8%, compared with 21.9% in the first quarter of 2025.

Annual Guidance for 2026

The company will provide updated 2026 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern Time.

(Press release, Thermo Fisher Scientific, APR 23, 2026, View Source [SID1234664727])