On July 28, 2025 AstraZeneca’s Chief Executive Officer, Pascal Soriot, reported on the results and said (Press release, AstraZeneca, JUL 28, 2025, View Source [SID1234654581]):

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"Our strong momentum in revenue growth continued through the first half of the year and the delivery from our broad and diverse pipeline has been excellent, with 12 positive key Phase III trial readouts including for baxdrostat, gefurulimab, and Tagrisso in just the past few weeks.

As we enter our next phase of growth, we have pledged $50 billion to continue to grow in the US, which includes the largest manufacturing investment in AstraZeneca’s history, set for Virginia. This landmark investment reflects not only America’s importance but also our confidence in our innovative medicines to transform global health and power AstraZeneca’s ambition to deliver $80 billion revenue by 2030."

On July 28, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that it has secured a €37.5 million, 4-tranche financing from the European Investment Bank (EIB) (Press release, MaaT Pharma, JUL 28, 2025, View Source [SID1234654565]). The financing will support the advancement of its late-stage hemato-oncology clinical programs including the lead-asset Xervyteg, recently partnered with Clinigen in Europe, and currently under regulatory review by the European Medicines Agency (EMA) for the treatment of acute Graft-versus-Host Disease (aGvHD) and the second drug candidate, MaaT033, currently being evaluated in a Phase 2b randomized controlled trial in improving survival for patients receiving allogeneic stem cell transplants.

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With robust cGMP manufacturing, proprietary therapies, and a development platform, MaaT Pharma is a global leader in microbiome-based oncology, pioneering full-ecosystem therapies to improve survival in oncology. Since completing enrollment in the ARES trial for Xervyteg (MaaT013) in October 2024, MaaT Pharma has steadily advanced its roadmap, reporting topline results in January 2025, submitting the Marketing Authorization Application with the European Medicines Agency in June 2025, and signing an exclusive agreement for marketing and distribution in Europe with Clinigen in July 2025.

The €37.5 million financing from the EIB follows a rigorous due diligence process by the EIB and further confirms MaaT Pharma’s innovation, strategic vision and operational maturity. This funding is part of a global financial strategy to support the Company’s development that combines various non-dilutive and dilutive sources to best preserve shareholder value.

Eric Soyer, Chief Financial Officer, MaaT Pharma, said: "We are grateful for the confidence shown in MaaT Pharma and the support from the EIB, which is a further foundation towards the next phase of MaaT Pharma’s growth on bringing the potential first microbiome-based therapy to market in Europe. Each operational and financing step strengthens our track record. Following the regulatory submission to the EMA for Xervyteg(MaaT013) and our recent partnership with Clinigen for its commercialization, the EIB financing represents another step in reinforcing the Company’s financial position. As previously announced, MaaT Pharma intends to fund its plans and development programs while preserving shareholder value in the best manner possible with a mix of non-dilutive and dilutive financial sources, and the recent announcements of both partnership financing with the Clinigen agreement and debt financing with the EIB agreement, are benchmarks to reflect that strategy."

Summary of the main terms and conditions of the Loan and Warrants

The loan would be available in four (4) tranches, respectively of €3.5 million for Tranche A, €6.0 million for Tranche B, €8.0 million for Tranche C, and €20.0 million for Tranche D, each tranche with Warrants attached. Disbursement of Tranches 2 to 4 are subject to operational and financing conditions. All Tranches are redeemable after a grace period of 4 years from the date of drawing, with reimbursement over a period of 2 years (Tranche A, B and C, i.e. a maturity of 6 years) to 4 years (Tranche D, i.e. a maturity of 8 years). Each tranche will bear interests at 7%, it being provided that some interests will be deferred and paid at maturity and for Tranche C and Tranche D part of the interest will be paid quarterly.

MaaT Pharma will issue warrants to the benefit of EIB at the time of (and subject to) disbursement of each tranche in a number depending, for each relevant tranche, on the amount of the relevant tranche and the average price per share paid by investors in the context of equity injection made prior to disbursement of the relevant tranche (except for tranche A where the average price per share over the last trading days preceding the date of execution of the financing agreement). Each warrant will give right to subscribe to one share at a price per warrant equal to 99% of the average price over a period of 5 trading days preceding the issuance of each Warrant. The Warrants may be exercised at any time following maturity of Tranche A. The Warrants will have a 20-year term.

EIB and MaaT Pharma have also agreed on (i) a put option to the benefit of EIB under which MaaT Pharma undertook to acquire from EIB all or part of the Warrants upon occurrence of certain events and (ii) a call option to the benefit of MaaT Pharma under which EIB undertook to sell all its Warrants, upon occurrence of a public tender offer over the securities issued by MaaT Pharma.

The Warrants are not transferable, except to affiliates of EIB or except in case of occurrence of certain events (including maturity date of Tranche D). In case of transfer of Warrants to third party, MaaT Pharma shall benefit from a preemptive right to acquire the Warrants first.

MaaT Pharma was assisted in this transaction by Mr. Eric Briole and by Van Lanschot Kempen as Financial Advisors and McDermott Will & Emery as Legal Advisor.

On July 28, 2025 Servier reported that Blood Advances published long-term data from the Phase 3 AGILE trial evaluating TIBSOVO (ivosidenib) in combination with azacitidine versus placebo-azacitidine in patients with newly diagnosed mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML) who were unfit to receive intensive chemotherapy (Press release, Servier, JUL 28, 2025, View Source [SID1234654582]). The post-hoc analysis reports positive long-term follow-up results from the pivotal Phase 3 AGILE trial and continues to demonstrate the sustained survival benefit reported in the previous analysis published in the New England Journal of Medicine (NEJM).

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"The clear and robust clinical benefit demonstrated by these long-term analyses – including prolonged overall survival and hematologic recovery – support TIBSOVO as a standard of care treatment for patients with IDH1-mutated AML," said Susan Pandya, M.D., Vice President Clinical Development and Global Head of Oncology LS/LCM, Servier. "These data are a testament to Servier’s industry-leading research in IDH1-mutated cancers, including AML, and demonstrate our steadfast commitment to improving outcomes for patients."

As of data cutoff in June 2022, median follow-up was 28.6 months. Key findings from the newly published analysis include:

Median overall survival (OS) was significantly longer in patients treated with the TIBSOVO combination (29.3 months; 95% CI, 13.2 – not reached) than placebo-azacitidine (7.9 months; 95% CI, 4.1-11.3; hazard ration [HR]=0.42 [0.27, 0.65]; p<.0001).
Hematologic recovery was generally faster and lasted longer in patients in the TIBSOVO arm compared to placebo-azacitidine. Conversion to transfusion independence was more common with TIBSOVO (53.8%) than placebo-azacitidine (17.1%; p=.0004).
Ten (30.3%) of the 33 molecular measurable-residual disease (MRD)-evaluable patients in the TIBSOVO arm converted to an MRD-negative response by Day 1 of Cycle 14, all of whom had a complete response (CR). Seven (70%) of these patients converted to an MRD-negative response by Day 1 of Cycle 7. Of the 23 patients who remained MRD-positive, 19 had a CR and four had a CR with incomplete hematologic recovery (CRi). Two patients (20%) had an MRD-negative response in the placebo-azacitidine arm.
The long-term safety profile of TIBSOVO with azacitidine was consistent with previously reported data. The most commonly reported Grade ≥3 hematologic adverse events (AEs) were anemia (26.4%), neutropenia (30.6%), and febrile neutropenia (27.8%). The most common Grade ≥3 nonhematologic AEs were electrocardiogram QT prolonged (11.1%), pneumonia (22.2%), nausea, (2.8%), hypokalemia (2.8%), and pyrexia (2.8%). There were no new or unexpected safety signals or additional treatment discontinuations due to AEs compared with the primary analysis.
"Long-term results from the AGILE trial underscore the power of TIBSOVO to improve outcomes for patients with IDH1-mutated AML unfit for intensive chemotherapy, a group who historically has had a poor long-term prognosis," said Hartmut Döhner, MD, Professor of Medicine and Director of the Department of Internal Medicine III at the University Hospital Ulm in Germany and Director of the National Center for Tumor Diseases SouthWest (NCT-SW; Ulm site). "These results continue to emphasize the importance of early systematic genetic testing to guide treatment selection for patients – which may lead to improved overall survival rates and a reduction in the risk of death as seen in this study."

TIBSOVO was approved by the U.S. Food and Drug Administration (FDA) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, in May 2022 under Priority Review. The supplemental New Drug Application (sNDA) for TIBSOVO was reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.

On July 28, 2025 CStone Pharmaceuticals reported it will announce the latest clinical data from its 2.0 blockbuster product, CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody), as well as the design of the global, multicenter Phase Ib study for CS5001 (a ROR1 ADC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), one of the world’s most influential oncology conferences, will be held in Berlin, Germany from October 17 to 21, 2025 (Press release, CStone Pharmaceauticals, JUL 28, 2025, View Source [SID1234656217]).

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CS2009 is a potential first-in-class/best-in-class trispecific antibody. Its global multicenter Phase I dose escalation and dose expansion study is actively recruiting patients in Australia and China, and plans to expand to the United States for Phase II enrollment. CStone Pharmaceuticals will announce the Phase Ia clinical study data of CS2009 at the ESMO (Free ESMO Whitepaper) Congress , which will also become the first globalClinical data report of PD-1/VEGF/CTLA-4 trispecific antibody.
CS5001 is the first known ROR1 ADC to demonstrate clinical efficacy in both lymphoma and solid tumors, and its clinical development progress ranks among the top two globally. Currently, a global, multicenter Phase Ib clinical trial of CS5001 is progressing simultaneously in the United States, Australia, and China. CStone Pharmaceuticals will unveil the design of the ongoing Phase Ib study at the ESMO (Free ESMO Whitepaper) Congress.

The following are the key messages presented by the company at the ESMO (Free ESMO Whitepaper) conference:

CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced solid tumors: an open-label, multicenter, phase I first-in-human study

【Category】 Investigational immunotherapy

【Format】 Poster

【Exhibition Number】 1545P

A phase Ib trial of CS5001 (ROR1-ADC) as a single agent and in combination with systemic therapies in patients with advanced solid tumours and lymphomas

【Category】 Haematological malignancies

【Format】 Electronic poster

【Exhibition Number】 1316eTiP

About CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody)

CS2009 is a novel trispecific antibody targeting PD-1, VEGFA, and CTLA-4, independently developed by CStone Pharmaceuticals from the molecular design perspective. It achieves multi-dimensional anti-tumor effects through synergistic action and holds first-in-class/best-in-class potential. CS2009’s differentiated molecular design combines three clinically validated targets, enabling the reactivation of near-exhausted tumor-infiltrating T cells and demonstrating comparable VEGF neutralization to existing anti-VEGF antibodies. It targets a broad range of diseases, including but not limited to non-small cell lung cancer, liver cancer, gastric cancer, endometrial cancer, ovarian cancer, renal cell carcinoma, and cervical cancer.

About the CS5001 (ROR1 ADC)

CS5001 is an antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). The drug utilizes a unique design, combining a tumor-specifically activated pyrrolobenzodiazepine (PBD) protoxin payload and a linker. This "dual-control" mechanism of linker plus protoxin effectively mitigates the toxicity issues associated with traditional PBD payloads and significantly extends the safety window. CS5001 has demonstrated complete tumor inhibition in multiple preclinical cancer models and exhibited favorable serum half-life and pharmacokinetic properties, demonstrating its significant clinical development potential and broad application prospects in the treatment of various solid and hematological tumors. Furthermore, CS5001 utilizes targeted conjugation technology to achieve a precise drug-to-antibody ratio (DAR), ensuring homogeneous production and large-scale manufacturing.

In October 2020, CStone Pharmaceuticals and LigaChem Biosciences, Inc. (LCB) entered into a licensing agreement for the development and commercialization of CS5001. CS5001 was originally co-synthesized by LCB and ABL bio, two leading Korean biotech companies. Under the terms of the agreement, CStone Pharmaceuticals obtained exclusive development and commercialization rights for CS5001 worldwide, excluding Korea.

On July 28, 2025 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported its entry into a definitive agreement for the sale of TECELRA, lete-cel, afami-cel, and uza-cel cell therapies to US WorldMeds (Press release, Adaptimmune, JUL 28, 2025, View Source [SID1234654566]). Consummation of the sale is expected to occur before the end of the week.

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "Adaptimmune has been at the forefront of solid tumor cell therapy and delivering groundbreaking treatments to patients for more than a decade. We were the first company to obtain a marketing authorization for an engineered TCR T-cell therapy, TECELRA, and we have a second cell therapy, lete-cel, with approval anticipated in 2026. However, given the financial situation of the Company, it is clear that securing the right strategic option was critical to maximize value for all of our stakeholders and importantly ensure our patients continue to receive TECELRA. After an extensive review of all strategic alternatives available to Adaptimmune we are convinced that this transaction represents the best path forward for Adaptimmune, our patients and stakeholders."

Breck Jones, US WorldMeds Chief Executive Officer: "Anchored by a first-in-class commercial therapy and a promising pipeline, this acquisition is a meaningful step forward in our mission to bring hope and innovation to patients who need it most. US WorldMeds deeply respects the strong foundation Adaptimmune has built in the cell therapy space and is committed to carrying that work forward – advancing and delivering these important therapies to the people and families who are counting on them."

Under the terms of the asset purchase agreement, US WorldMeds will purchase the TECELRA, uza-cel, afami-cel and lete-cel cell therapy assets of Adaptimmune (the "Assigned Assets") and all intellectual property rights exclusively relating to such Assigned Assets. In return, Adaptimmune will receive $55 million in cash upon consummation of the sale. In addition, US WorldMeds has agreed to make future payments of up to $30 million to Adaptimmune upon the achievement of certain milestones. Adaptimmune and US WorldMeds will also enter into a license agreement pursuant to which, among other things, US WorldMeds will be exclusively licensed residual intellectual property rights necessary for the manufacture and commercialization of the Assigned Assets and non-exclusively licensed intellectual property rights in Adaptimmune’s vector manufacturing process. Adaptimmune will also provide certain transition services to US WorldMeds pursuant to a transition services agreement on terms specified therein.

US employees involved in the development and commercialization of the Assigned Assets will be offered employment with US WorldMeds to ensure the ongoing success and ability to supply those Assigned Assets. Following the transaction Adaptimmune intends to restructure to support the continued development by US WorldMeds of lete-cel, TECELRA and uza-cel and to maximise value from its remaining assets including its PRAME and CD70 directed T-cell therapies.

TD Cowen acted as financial advisor, and Ropes & Gray LLP provided legal counsel, to Adaptimmune.

Gibson, Dunn & Crutcher LLP provided legal counsel to US WorldMeds.

The transaction will be financed by debt financing led by funds managed by Oaktree Capital Management, L.P. ("Oaktree"), with participation from funds managed by Athyrium Capital Management, LP ("Athyrium").