On May 15, 2025 Eisai reported financial results and business update for the full year 2024 (Presentation, Eisai, MAY 15, 2025, View Source [SID1234653940]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On May 15, 2025 Merck, a leading science and technology company, reported the company continued to grow across all three business sectors in the first quarter of 2025 (Press release, Merck KGaA, MAY 15, 2025, View Source [SID1234653543]). In the Life Science sector, Process Solutions reclaimed its position as the main growth driver amid noticeably recovering demand. The Healthcare sector saw strong sales in the Cardiovascular, Metabolism, and Endocrinology franchise. And Electronics continued to benefit from steady and strong demand for semiconductor materials.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On May 15, 2025 Novartis reported it will present data from 60 company or investigator sponsored abstracts that have the potential to change clinical practice, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (Press release, Novartis, MAY 15, 2025, View Source [SID1234653249]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The breadth of our oncology and hematology portfolio – anchored by Kisqali, Pluvicto, Scemblix and Fabhalta – demonstrates our leadership in both solid tumors and hematologic diseases," said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. "At ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper), we will present new data on these priority medicines as well as updates from our pipeline and our industry-leading radioligand therapy research."

Novartis will also highlight its US partnerships with the National Football League (NFL), Alliance for Breast Cancer Policy, and ZERO Prostate Cancer, which encourage people to make proactive decisions about their health and advance patient-centered policy solutions to help improve outcomes.

"We’re witnessing a profound shift in how people move through their cancer journey, with cancer diagnoses occurring at younger ages and, simultaneously, older patients living longer and approaching aging with new vigor," said Victor Bultó, President, US, Novartis. "As a leader in driving medical advances in oncology, we have the responsibility to also make a difference in areas beyond treatment innovation. By partnering across the ecosystem, our goal is to advance the conversation around earlier detection and meet the evolving needs of this next generation of cancer patients."

Key highlights of data accepted by ASCO (Free ASCO Whitepaper) include:

Medicine Abstract Title Abstract Number/ Presentation Details
Kisqali
(ribociclib)* Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in NATALEE: Analysis across menopausal status and age Abstract #516
Rapid Oral
June 1, 8:00 – 9:30am CDT
Kisqali
(ribociclib) Real-world (RW) analysis of characteristics and risk of recurrence (ROR) in Black patients (pts) with HR+/HER2− early breast cancer (EBC) eligible for NATALEE Abstract #527
Poster Presentation
June 2, 9:00am – 12:00pm CDT
Kisqali
(ribociclib) Adjuvant WIDER: A phase 3b trial of ribociclib (RIB) + endocrine therapy (ET) as adjuvant treatment (tx) in a close-to-clinical-practice patient (pt) population with HR+/HER2− early breast cancer (EBC) Abstract #TPS617
Poster Presentation
June 2, 9:00am – 12:00pm CDT
Kisqali
(ribociclib) First-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in clinically aggressive hormone receptor (HR)+/HER2− advanced breast cancer (ABC): A subgroup analysis of patients (pts) with or without liver metastases (mets) from RIGHT Choice Abstract #1069
Poster Presentation
June 2, 9:00am – 12:00pm CDT
Scemblix
(asciminib) Efficacy and safety of asciminib (ASC) in patients (pts) with chronic-phase chronic myeloid leukemia (CML-CP) after 1 tyrosine kinase inhibitor (TKI): Interim analysis (IA) of the phase 2 ASC2ESCALATE trial Abstract #6516
Rapid Oral
May 30, 1:00 – 2:30pm CDT
Scemblix
(asciminib) Primary endpoint results of the phase 3b ASC4START trial of asciminib (ASC) vs nilotinib (NIL) in newly diagnosed chronic phase chronic myeloid leukemia (CML-CP): Time to treatment discontinuation due to adverse events (TTDAE) Abstract #6501
Oral Presentation
June 2, 3:00 – 6:00pm CDT
Pluvicto
(lutetium Lu 177 vipivotide tetraxetan) Clinical outcomes of prompt versus deferred 177Lu-PSMA-617 initiation for metastatic castration-resistant prostate cancer (mCRPC) based on prior androgen receptor pathway inhibitor (ARPI) and taxane chemotherapy exposure: a real-world PRostatE Cancer dISease observatION (PRECISION) data platform analysis Abstract #e17030
Online Publication
Pluvicto
(lutetium Lu 177 vipivotide tetraxetan) Real-world outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) receiving guideline-recommended therapies after treatment with 177Lu-PSMA-617: a real-world PRostatE Cancer dISease observatION (PRECISION) data platform analysis Abstract #e17035
Online Publication
Pluvicto
(lutetium Lu 177 vipivotide tetraxetan) PSMA-delay castration (DC): An open-label, multicenter, randomized phase 3 study of [177Lu]Lu-PSMA-617 versus observation in patients with metachronous PSMA-positive oligometastatic prostate cancer (OMPC) Abstract #TPS5127
Poster Presentation
June 2, 9:00am – 12:00pm CDT
Key highlights of data accepted by EHA (Free EHA Whitepaper) include:

Medicine Abstract Title Abstract Number/ Presentation Details
Fabhalta
(iptacopan) APPULSE-PNH: Oral iptacopan monotherapy demonstrates clinically meaningful hemoglobin (Hb) increases in patients (pts) with paroxysmal nocturnal hemoglobinuria (PNH) and Hb ≥10 g/dL on anti-C5 therapy Abstract #S183
Oral Presentation
June 13, 5:00 – 6:15pm CEST

Fabhalta
(iptacopan) The 2-year safety and efficacy of iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria (PNH) from APPLY- and APPOINT-PNH studies who entered the roll-over extension program (REP) Abstract #PF660
Poster Presentation
June 13, 6:30 – 7:30pm CEST

Scemblix
(asciminib) Asciminib (ASC) shows superior tolerability vs nilotinib (NIL) in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): Primary endpoint results of the phase (Ph) 3b ASC4START trial Abstract #S166
Oral Presentation
June 13, 5:00 – 6:25pm CEST

Scemblix
(asciminib) Improved patient-reported outcomes (PROs) with asciminib (ASC) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST wk 48 analysis Abstract #PS1588
Poster Presentation
June 14, 6:30 – 7:30pm CEST

Scemblix
(asciminib)

Interim analysis (IA) results from ASC2ESCALATE support asciminib (ASC) as a treatment (Tx) option in chronic-phase chronic myeloid leukemia (CML-CP) after 1 tyrosine kinase inhibitor (TKI) Abstract #PF595
Poster Presentation
June 13, 6:30 – 7:30pm CEST

Pelabresib
(DAK539) Pelabresib in combination with ruxolitinib for janus kinase inhibitor-naive patients with myelofibrosis: 72-week follow-up with long-term efficacy outcomes of the phase III MANIFEST-2 study Abstract #S223
Oral Presentation
June 12, 5:00 – 6:15pm CEST

Ianalumab
(VAY736) A Phase 2 Study of Ianalumab in patients with primary immune thrombocytopenia previously treated with at least two lines of therapy (VAYHIT3) Abstract #S312
Oral Presentation
June 15, 11:00am – 12:15pm CEST

Rapcabtagene autoleucel
(YTB323) Rapcabtagene Autoleucel (YTB323) in patients with relapsed/refractory diffuse large B-cell lymphoma: A phase II trial clinical update Abstract #PF1152
Poster Presentation
June 13, 6:30 – 7:30pm CEST

On May 15, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2025 and provided a corporate update (Press release, Akari Therapeutics, MAY 15, 2025, View Source [SID1234653207]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We remain laser focused on becoming a key player in the ADC space and advancing our novel ADC platform built around immuno-oncology payloads and our lead asset AKTX-101, an ADC targeting Trop2 with our immuno-oncology payload, PH1. We continue to develop and execute a clear path forward for our ADC pipeline and support these efforts with ongoing activities and building the team that we believe positions us for success in the near and long term," commented Abizer Gaslightwala, President and Chief Executive Officer of Akari. "In particular, we were pleased to recently welcome Mark Kubik, a seasoned leader in the Antibody Drug Conjugate space, as Head of Business Development, Oncology and believe his expertise will be invaluable as we continue to advance our novel ADC platform technology."

Leveraging its innovative payload platform, the Company is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates across a wide range of cancer tumor targets. These initial candidates have shown significant tumor-killing activity in preclinical models with the ability to robustly activate the immune system to drive durable, and sustained outcomes.

Upcoming Expected Value-Driving Milestones

Novel ADC’s With Immuno-Oncology Payloads

Anticipate presenting preclinical data showing that a proof-of-concept ADC with PH1 payload exhibits robust immuno-oncology activity, at a scientific conference in second half of 2025.
Complete additional preclinical studies for novel PH1 payload exploring activity in prostate cancer cell lines.
Explore preclinical activity for AKTX-101 in different solid tumor indications including lung, as single agent and in combination with other approved agents.
Continue to focus on operational excellence and efficient capital allocation to advance novel payload ADC platform.
Ongoing efforts to seek strategic partners for research collaborations on PH1 immuno-oncology payload across customized tumor targets. Continued discussions with partners on advancing AKTX-101 ADC (Trop2/PH1 payload) through additional IND-enabling activities.
Non-Core Asset Out Licensing

Continue efforts to out-license non-core assets across inflammation, ophthalmology, and rare diseases as a source of non-dilutive capital to invest into ADC platform.
Summary of Financial Results for First Quarter 2025

The net loss from operations for the three months ended March 31, 2025 was approximately $3.7 million compared to $5.6 million for the same period in 2024.

The Company reported research and development expenses of $0.8 million for the three months ended March 31, 2025 compared to approximately $2.3 million for the same period in 2024. The decrease was primarily due to our decision to suspend our HSCT-TMA clinical stage program with nomacopan in May 2024.

General and administrative expenses were approximately $2.7 million for the three months ended March 31, 2025 compared to approximately $3.7 million for the same period in 2024. The decrease was primarily due to (i) decreases in legal and professional fees (primarily related to the Merger) and (ii) a decrease in directors’ and officers’ insurance.

As of March 31, 2025, the Company had cash of approximately $2.6 million. The net proceeds from the Company’s March 2025 offering, after deducting placement agent fees and other offering expenses, were approximately $6.0 million, of which $4.0 million was received in April 2025.

On May 15, 2025 Tsingke Biotech reported that it has proudly participated in the AACR (Free AACR Whitepaper) Annual Meeting 2025, held this April in Chicago, USA (Press release, Tsingke Biotech, MAY 15, 2025, View Source;advancing-global-cancer-research-with-integrated-synthesis-solutions-302456314.html [SID1234653204]). As one of the world’s premier events in oncology research, AACR (Free AACR Whitepaper) gathered global leaders from academia and industry to explore the future of cancer diagnostics and therapeutics.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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At Booth #3255, Tsingke presented its comprehensive synthesis and expression service portfolio, offering essential support from early-stage discovery to preclinical development. Our platform drew attention for its capabilities in gene synthesis, oligonucleotide production, mRNA technologies, and protein expression.

What Tsingke Offers for Oncology Research

High-Throughput Nucleic Acid Synthesis
Custom DNA/RNA oligos, siRNA, ASO
Complex modifications: LNA, phosphorothioate, dual-labeled probes
qPCR and NGS-grade primer/probe production
mRNA Synthesis & Raw Materials Supply
IVT template synthesis with 5’/3′ modifications and Poly(A) tails
High-purity enzymes, capping reagents, modified nucleotides, and buffers
Ready to support LNP formulation workflows
Protein Expression & Antibody Tools
Gene synthesis, vector construction, and expression validation
Fast-turnaround expression services in HEK293/CHO systems
Custom R&D Support for Novel Therapies
sgRNA libraries, gene editing tools, and RNAi constructs
Building a Global Synthesis Engine for Cancer Innovation

Tsingke is committed to enabling biotech companies, CDMOs, and academic researchers with a one-stop synthesis platform—from molecular design and synthesis to expression and functional validation. By supporting critical steps in target discovery, validation, and preclinical development, we help accelerate the path from lab to clinic.