On March 18, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that they will present three posters from their ongoing Phase 2 clinical trial with spevatamig (PT886), a first-in-class bispecific antibody targeting CLDN18.2 and CD47, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) held on April 17-22 in San Diego, CA. All three posters will be presented under the Phase II and Phase III Clinical Trials Session. Details of each presentation are below:

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Title: Pharmacokinetics of spevatamig (PT886), a bispecific antibody targeting CLDN18.2 and CD47, in patients with advanced gastrointestinal cancers as monotherapy or combination therapy

Date/Time: 4/20/2026 | 2:00-5:00 PM PST
Location: Poster Section 52
Poster Board Number: 8
Abstract Presentation Number: CT144
First Author: Anwaar Saeed, MD, University of Pittsburgh Medical Center

Title: Reducing nausea and vomiting while maintaining the full potential for efficacy with spevatamig, a CLDN18.2xCD47 bispecific antibody

Date/Time: 4/20/2026 | 2:00-5:00 PM PST
Location: Poster Section 52
Poster Board Number: 6
Abstract Presentation Number: CT142
First Author: Michael Overman, MD, University of Texas MD Anderson Cancer Center

Title: Resolved hematological toxicities associated with anti-CD47 agents using a bispecific design involving an optimized anti-CD47 arm: A clinical proof of concept study

Date/Time: 4/20/2026 | 2:00-5:00 PM PST
Location: Poster Section 52
Poster Board Number: 7
Abstract Presentation Number: CT143
First Author: Harshabad Singh, MD, Mass General Brigham

ABOUT SPEVATAMIG
Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

The US multi-center Phase 1/2 clinical trial of spevatamig (NCT05482893) is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal or biliary tract adenocarcinomas. The Phase 2 study of spevatamig has begun in China (CTR20241655).

(Press release, Phanes Therapeutics, MAR 18, 2026, View Source [SID1234663711])

On March 18, 2026 Totus Medicines, a clinical stage, precision medicine company leveraging a novel covalent DNA-encoded library + AI-powered small molecule drug discovery platform to advance a differentiated pipeline of therapeutics against high-value, historically difficult to drug targets in multiple therapeutic areas, reported the presentation by Dr. Antonio Giordano of Dana Farber Cancer Center of new clinical data for TOS-358, its lead oral covalent PI3Ka inhibitor, in an oral presentation at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress in Paris, France.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"TOS-358 was designed to overcome the limitations of currently available PI3Ka inhibitors by delivering sustained and specific, >90% covalent inhibition of the target combined with a best-in-class safety profile," said Zelanna Goldberg, M.D., Chief Medical Officer of Totus Medicines. "We are very encouraged by the early clinical efficacy data, which demonstrate durable tumor control and class-leading tolerability in heavily pretreated patients, including those who had previously progressed on other PI3K pathway therapies.

"TOS-358 is amongst the most interesting agents in this class to emerge. It appears to be a well-tolerated and straightforward drug to give for PI3Ka mutant disease with early data suggesting the potential for meaningfully durable tumor control. This may help inhibit tumor growth and maintain quality of life, which is a promising combination for our patients" said Dr. Antonio Giordano.

TOS-358 is an oral, highly selective, pan-mutant, covalent PI3Ka inhibitor that achieves >95% continuous target engagement for deep and durable inhibition of PI3K-AKT signaling which is required for optimal efficacy and durability.

Phase 1a Key Clinical Findings:

Clinical results from the efficacy cohort demonstrated encouraging anti-tumor activity and durability of response:

Overall efficacy profile:

CBR: 50%
DCR: 75%
ORR: 15%
≥20% tumor shrinkage: 40%
Patients on therapy for ≥24 weeks: 45%

Clinically meaningful disease control in heavily pre-treated patients:

DCR in PAM-resistant patients: 67%
DCR in PAM-intolerant patients: 100%

Class-leading Safety & Tolerability Profile:

TOS-358 demonstrated a favorable and differentiated safety profile, with minimal gastrointestinal or epithelial toxicities.

Key observations included:

No bone marrow toxicity
No hepatic toxicity
No renal toxicity
No ocular symptoms
No rash
No stomatitis or mucositis
<5% of patients required medication for nausea or diarrhea

Hyperglycemia, an expected on-target effect of PI3Ka inhibition, was primarily low grade and manageable with oral medications. Only 3.6% (2/54 pts) required ongoing insulin, which is similar to, or lower than, other PI3Ka inhibitors in development including mutant selective and/or allosteric compounds.

Phase 1b study design:

TOS-358 is currently being evaluated in an ongoing Ph1b study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of TOS-358 in combination with fulvestrant and in combination with fulvestrant and CDK inhibitors in patients with PI3Ka-mutated, HR+/HER2- metastatic breast cancer. Initial data from these combination cohorts are expected to be presented at future medical and scientific conferences.

(Press release, Totus Medicines, MAR 18, 2026, View Source [SID1234663728])

On March 18, 2026 STADA reported that in 2025 again demonstrated the success of its three-segment strategy, that provides patients and healthcare professionals with a broad range of medicines and healthcare products across Consumer Healthcare, Generics and Specialty, including innovative medicines.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Adjusted, constant-currency (adj. cc) Group revenues increased by 6% to €4.3 billion in the financial year ended 31 December 2025. Group earnings before interest, tax, depreciation and amortization (EBITDA) ̵ adjusted for special items and at constant exchange rates ̵ improved by 8% to €961 million.

"All our regions ̵ Western Europe, Central & Eastern Europe, Germany and Middle East & Asia ̵ are contributing nicely to our growth. Key drivers for our above-industry growth were several great launches across all our three segments. On top of this, we in-licensed in 2025 alone 110 new products securing an even stronger pipeline for a successful future," commented STADA CEO Peter Goldschmidt.

(Press release, Stada, MAR 18, 2026, View Source [SID1234670887])

On March 18, 2026 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported an oral presentation and multiple poster presentations of five abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22 in San Diego.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Presentation Details:

Title: Preclinical assessment of BT5528 anti-tumor activity in cell-line-derived xenograft (CDX) models of head and neck squamous cell carcinoma (HNSCC)
Type: Oral Presentation
Session: Advanced Antibody, Conjugate, and Targeted Therapeutic Platforms
Date and Time: Sunday, April 19, 4:05-4:20 p.m. PT
Abstract Number: 1325
Lead Author: Lukas Stanczuk, Ph.D., Bicycle Therapeutics

Title: EphA2 expression across molecular and histological subtypes in muscle-invasive bladder cancer (MIBC) and its association with Nectin-4 and HER2
Type: Poster Presentation
Session: Clinical Research 1
Date and Time: Sunday, April 19, 2-5 p.m. PT
Abstract Number: LB012
Lead Author: Markus Eckstein, M.D., University Hospital Erlangen (FAU Erlangen -Nürnberg)

Title: An EphA2-targeting Bicycle Drug Conjugate (BDC), BT5528, in combination with nivolumab in patients (pts) with advanced solid tumors: results from a Phase 1/2 study
Type: Poster Presentation
Session: First-in-Human Phase I Clinical Trials
Date and Time: Monday, April 20, 9 a.m.-12 p.m. PT
Abstract Number: CT063
Lead Author: Babar Bashir, M.D., Thomas Jefferson University

Title: Preclinical assessment of BT5528 anti-tumor activity in patient-derived xenograft (PDX) models of pancreatic ductal adenocarcinoma (PDAC)
Type: Poster Presentation
Session: Hematologic Malignancies and Novel Therapeutic Modalities
Date and Time: Tuesday, April 21, 9 a.m.-12 p.m. PT
Abstract Number: 4518
Lead Author: Lukas Stanczuk, Ph.D., Bicycle Therapeutics

Title: Development and first clinical experiences of a phage display derived bicyclic peptide for EphA2-specific PET imaging
Type: Poster Presentation
Session: Diagnostic Biomarkers 2
Date and Time: Tuesday, April 21, 2-5 p.m. PT
Abstract Number: 6520
Lead Author: Ann-Christin Eder, Ph.D., University of Freiberg and German Cancer Consortium (DKTK)

The presentations will be made available in the Publications section of the Bicycle Therapeutics website at the beginning of the poster session.

(Press release, Bicycle Therapeutics, MAR 18, 2026, View Source [SID1234663696])

On March 18, 2026 Biotheryx, Inc., a biopharmaceutical company focused on the discovery and development of first-in-class protein degraders for cancer and inflammatory diseases, reported that the first patient has been dosed in the dose expansion phase of its clinical trial evaluating BTX-9341, a potent and selective CDK4/6 degrader, in combination with fulvestrant for the treatment of HR+/HER2- breast cancer in patients who have previously received CDK4/6 inhibitor therapy in the advanced and/or metastatic setting.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The dose expansion portion of the trial is a randomized study designed to evaluate the efficacy and safety of BTX-9341 in combination with fulvestrant. The trial is being conducted at multiple sites in the United States and is expected to enroll approximately 80 patients across two treatment arms based on the recommended dose identified in the earlier dose escalation phase. This dose expansion study builds on the recently completed dose escalation phase that evaluated the safety, tolerability, pharmacokinetics and pharmacodynamic activity of BTX-9341. The primary endpoint of this study is the Overall Response Rate (ORR), with key secondary endpoints including the measurement of investigator-assessed Clinical Benefit Rate (CBR) and Progression Free Survival (PFS).

"We are pleased to have dosed the first patient in the dose expansion portion of our clinical trial evaluating BTX-9341 in combination with fulvestrant." said Dr. Leah Fung, Chief Executive Officer of Biotheryx. "The encouraging safety, pharmacokinetics, and preliminary activity observed in the earlier dose escalation portion of the study support advancing BTX-9341 into this next stage of clinical evaluation. We believe the differentiated mechanism of targeted CDK4/6 degradation has the potential to address resistance seen with currently available CDK4/6 inhibitors, and we look forward to further assessing BTX-9341 in combination with fulvestrant to improve outcomes for patients with HR+/HER2- breast cancer who have previously received CDK4/6 inhibitor therapy."

About BTX-9341

BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated superiority to CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of CDK2 and Cyclin E transcription, cell cycle arrest, and ultimately superior in vivo efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that limit the impact of inhibitors in second line HR+/HER2- metastatic breast cancer.

(Press release, BioTheryX, MAR 18, 2026, View Source;breast-cancer-302716705.html [SID1234663712])