VERAXA Biotech Presents in vivo Proof-of-Concept Data for BiTAC®-ADC Technology at World ADC Congress

On October 13, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"), an emerging leader in designing novel cancer therapies, reported first in vivo proof-of-concept data and additional in vitro data validating its novel BiTAC-ADC technology platform at the 17th World ADC Congress in San Diego, CA, USA. The in vivo data demonstrate that a systemically applied, single dose of the two-component BiTAC-ADC selectively triggered a tumor-specific response resulting in a significant reduction in tumor volume, while continuing to show differentiated safety features and the potential to overcome systemic toxicity, the primary limitation of current ADCs.

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 in vivo data presented at the World ADC Congress showed that treatment with BiTAC-ADCs resulted in strong tumor regression in a xenograft breast cancer model even at a single dose of 3 mg/kg. As intended, BiTAC-ADCs utilizing one non-targeted component, thereby only delivering one component to the tumor, showed no significant effect. A control ADC, engineered by VERAXA using the same conjugation and linker-payload technology and with the same drug-antibody ratio (DAR) as its BiTAC-ADC counterpart, performed similarly. In the BiTAC-ADC treatment arm, no decrease in body weight could be observed.

"These novel datasets on the BiTAC-ADC platform underline the rapid progress our team has made in demonstrating the potentially transformative safety benefits of BiTAC-ADCs compared to conventional ADCs," said Christoph Erkel, Ph.D., Chief Scientific Officer at VERAXA. "While BiTAC-TCEs remain our priority, the rapid validation of our BiTAC-ADC concept bodes well for establishing a second pillar in our R&D and partnering strategy towards safer drugs for solid tumor patients."

"Demonstrating that BiTAC-ADCs can reach the tumor site following intravenous administration, induce a specific effect only upon arrival of both BiTAC components, and shrink the tumor in a living organism is a significant platform milestone and validates its underlying concept," added Paul Sauter, Ph.D., Senior Director and Department Head ADC Tech & Chemistry at VERAXA.

The poster presented at the World ADC congress also expanded on previously published in vitro studies and shows that BiTAC-ADCs can discriminate between cancer and healthy cells, require both BiTAC-ADC constructs to be co-targeted to the tumor site and do not release active toxins in the periphery. The BiTAC-ADC concept was also successfully evaluated across a wide range of cancer cell lines and against several validated ADC targets. Taken together, the data sets underline the potential for this novel therapeutic concept with comparable efficacy to a conventional ADC, but a mechanistically highly differentiated safety profile.

The BiTAC therapeutic strategy is designed to unlock a new level of precision in cancer treatment via dual-targeting using two complementary precursors and enabling a tumor-restricted activation of the desired therapeutic effect. Applied to the development of antibody drug conjugates (ADCs), the technology delivers a systemically inactive prodrug and a cell-impermeable proactivator through two separate antibodies, each addressing a defined tumor-associated antigen. While the single BiTAC-ADC precursors are therefore not toxic by design, the selective internalization of both components into the same cancer cell leads to dose-dependent cytotoxicity.

(Press release, Veraxa Biotech, OCT 13, 2026, View Source [SID1234673374])

Prelude Announces Clinical Trial Collaboration and Supply Agreement with Lilly to Evaluate KAT6A Selective Degrader PRT13722 in Combination with Verzenio® and Inluriyo® in Patients with HR+/HER2- Breast Cancer

On October 13, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, reported a clinical trial collaboration and supply agreement with Eli Lilly and Company ("Lilly") for supply of its CDK4/6 kinase inhibitor, abemaciclib and its oral estrogen receptor antagonist, imlunestrant. The agreement supports the evaluation of Prelude’s clinical development candidate PRT13722, an oral KAT6A selective degrader, in combinations with abemaciclib and imlunestrant in a Phase 1 trial in patients with HR+/HER2- breast cancer.

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 U.S. Food and Drug Administration (FDA) recently cleared the Company to proceed with the Phase 1 study under its Investigational New Drug (IND) Application for PRT13722. The Company expects to begin enrolling patients in the fourth quarter of 2026 beginning with monotherapy dose escalation and rapidly advancing to various combination cohorts.

"This collaboration with Lilly enables us to evaluate the potential of PRT13722 in combinations with abemaciclib and imlunestrant in patients with HR+ breast cancer," stated Sean Brusky, Chief Business & Strategy Officer of Prelude. "We are taking a highly differentiated approach to this clinically validated target. Our preclinical data demonstrate that selectively degrading KAT6A has the potential to improve upon the efficacy and hematologic toxicity seen with dual KAT6A/B inhibitors, thereby enabling combination approaches that could advance the standard of care in earlier lines of therapy. We are pleased to be partnering with Lilly, recognized global leaders in breast cancer, to generate these important data for patients."

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting in April of this year, Prelude presented preclinical data that demonstrated PRT13722, by selectively degrading KAT6A, drives more complete disruption of the KAT6A regulatory pathways than dual KAT6A/B inhibitors, resulting in more robust depth and breadth of efficacy across HR+/HER2- breast cancer models. Additionally, PRT13722 drove durable complete tumor regressions in HR+/HER2- CDX and PDX xenograft models (both endocrine therapy naive and experienced) at well tolerated doses, as a monotherapy. In combinations with endocrine therapy, CDK4/6 inhibitors and PI3K inhibitors, PRT13722 demonstrated synergy while maintaining monotherapy and combination activity across HR+ breast cancer models, including ESR1 mutated and acquired therapy-resistant cancer cells. PRT13722 also demonstrated preclinically an improved hematological safety profile compared to the KAT6A/B dual inhibitor prifetrastat, which may enable combinations with standard of care agents used in the frontline treatment of metastatic and early-stage HR+/HER2- breast cancer.

Prelude maintains full global development and commercial rights to PRT13722 as a wholly owned program.

Highly selective KAT6A oral degrader program
KAT6 is an emerging and clinically validated target in the treatment of HR+ breast cancer. Prelude discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A degraders. Prelude believes that selectively degrading KAT6A and sparing KAT6B has the potential for improved efficacy, tolerability and combinability with other agents relative to dual inhibitors of KAT6A/B.

(Press release, Prelude Therapeutics, OCT 13, 2026, View Source [SID1234673373])

Rgenta Therapeutics Announces RGT-61159 Poster Presentation at the European Society for Medical Oncology (ESMO) Congress 2026

On October 13, 2026 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, reported that an abstract highlighting clinical data from the ongoing Phase 1a/b study of RGT-61159, an oral MYB splicing modulator, in patients with adenoid cystic carcinoma (ACC) has been accepted as a poster at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23-27, 2026, in Madrid, Spain.

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!

Poster presentation details:

Title: RGT-61159, an Oral MYB Splicing Modulator, Demonstrates Exposure-Dependent Target Engagement and Early Clinical Activity in Advanced Adenoid Cystic Carcinoma
Presentation Number: 1582P
Session Date & Time: Monday, October 26, 2026; 12:00 – 12:45 p.m. CET
Session Title: Head and neck cancer, excluding thyroid

The full abstract will be available for public viewing via the ESMO (Free ESMO Whitepaper) Congress website on Monday, October 19, 2026, here. The full poster will be available for public viewing via the ESMO (Free ESMO Whitepaper) Congress website on October 23, 2026.

About RGT-61159
RGT-61159 is an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB resulting in the inhibition of oncogenic MYB protein production, which has the potential to inhibit proliferation or induce cell death of cancer cells that overexpress MYB protein. MYB acts as a master regulator of cell proliferation differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemias (AML), T-cell acute lymphoblastic leukemias (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer.

About Adenoid Cystic Carcinoma (ACC)
It is estimated that approximately 200,000 people are living with ACC throughout the world including 11,000 in the US. While it is a rare cancer, ACC is the second most common cancer type arising in the salivary gland and is an aggressive malignancy with a tendency to infiltrate surrounding nerves and metastasize to distant sites. Overactivation of the MYB oncogene has been described as a hallmark of ACC and is noted in over 90% of ACC. Treatment for ACC is extremely challenging and may include surgery and/or radiation, which often fails to control local tumor recurrence and distant metastases. There are no effective targeted therapies available for patients with recurrent and/or metastatic disease. There is thus an unmet medical need for new therapeutic targets and treatment strategies for patients with this fatal cancer.

(Press release, Rgenta Therapeutics, OCT 13, 2026, View Source [SID1234673372])

Envisagenics Awarded $2M+ NCI SBIR Grant to Expand AI-Driven RNA Splicing Analysis Capabilities Across Oncology Portfolio

On October 13, 2026 Envisagenics, Inc., an AI-driven RNA splicing therapeutics company, reported that it has been awarded a Small Business Innovation Research (SBIR) Direct to Phase II grant from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH).

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 award will provide more than $2 million over two years to support further development and commercialization of SpliceCore, including SpliceDisco, a new machine learning algorithm designed to connect cancer-specific therapeutic targets with the splicing mechanisms that drive disease. With this capability, Envisagenics can prioritize targets with strong biological rationale and therapeutic potential.

"We believe SpliceDisco will be a critical tool in helping us identify and prioritize novel cancer targets most prevalent in patient populations, and more specifically those directly linked to pathological splicing mechanisms," said Martin Akerman, CTO and Co-Founder of Envisagenics. "By deploying SpliceDisco across our oncology programs, we aim to strengthen the biological rationale behind our targets and accelerate the development of differentiated cancer therapies."

Alternative RNA splicing is a fundamental biological process that enables a single gene to produce multiple distinct proteins. In many cancers, this process becomes dysregulated, generating protein isoforms found only in tumor cells. These tumor-specific isoforms represent a significant and largely untapped opportunity to develop precision therapies that spare healthy tissue.

Envisagenics’ proprietary SpliceCore AI software platform combines artificial intelligence, large-scale transcriptomic analysis, and experimental validation to systematically identify and prioritize these therapeutic opportunities. Built on one of the industry’s most comprehensive RNA splicing resources, SpliceCore predicts critical characteristics, including disease specificity, patient prevalence, and therapeutic suitability, to enable the development of highly differentiated precision medicines.

The project funded with this grant will support the development of SpliceDisco. By combining AI-driven prioritization with experimental validation, the project is designed to generate cancer-specific, partner-ready therapeutic target opportunities with defined disease relevance, patient prevalence, and modality fit across Envisagenics’ internal oncology pipeline and external collaboration programs.

"This award represents an important milestone in our mission to unlock the therapeutic potential of RNA splicing biology in oncology," said Maria Luisa Pineda, Ph.D., Chief Executive Officer and Co-Founder of Envisagenics. "With support from the NCI, we will further advance our platform capabilities and accelerate the discovery of first-in-class therapeutic programs that have the potential to address significant unmet medical needs for patients."

This award builds on Envisagenics’ track record of innovation and prior support from the NIH, including previous SBIR grants focused on advancing AI-driven RNA splicing analytics and therapeutic target discovery for precision medicines.

"We are grateful for the NIH’s continued support of innovative technologies and for recognizing the transformative potential of AI-enabled RNA splicing analysis," said Dr. Pineda. "This support will help us expand SpliceCore for both our internal pipeline and external partnerships. As oncology drug developers seek more precise and disease-specific targets, alternative splicing represents a differentiated source of therapeutic opportunities."

(Press release, Envisagenics, OCT 13, 2026, View Source [SID1234673371])

Teiko Will Collaborate With University of Utah Health on Developing a Series of Immune Profiling Tests, Starting With Acute Myeloid Leukemia

On October 13, 2026 Teiko reported a collaboration with the University of Utah’s U of U Health and the Huntsman Cancer Institute to develop a series of breakthrough immune profiling tests, starting with Acute Myeloid Leukemia (AML). This first study marks the start of a broader, long-term collaboration between the two organizations, with plans to extend the work across multiple disease areas where stabilized samples and high-resolution immune profiling make a difference for patients. As part of this initiative, University of Utah Health Innovations will become an investor in Teiko.

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!

AML is an aggressive blood cancer. Patients with measurable residual disease (MRD) after treatment roughly have a five-year overall survival rate of approximately 34%, compared with 68% for patients without detectable MRD.

Multiparameter flow cytometry is used in 60%+ of AML MRD assessments, but it must reliably identify leukemic cells present at frequencies as low as 0.01–0.1% of total cells. Guidelines recommend acquiring at least 500,000–1,000,000 CD45+ events with adequate cell viability to achieve this limit of detection.

Acquiring this amount of cells depends heavily on sample quality. With current workflows, bone marrow must be processed within 24-72 hours of collection. Even within that window, storage and transit time degrade sample quality. As a result, high-quality MRD testing is largely limited to specialized laboratories capable of rapid processing. This barrier means patients who receive care in a community or rural setting often do not have access to MRD testing. Teiko and University of Utah aim to change that.

In initial testing, Teiko’s stabilization kit fixes bone marrow at the point of collection, extending the processing window from 72 hours to 90 days, thereby allowing community hospitals to ship samples to a central laboratory and for biobanking. In collaboration with the U, Teiko will be developing a high-parameter spectral flow panel on bone marrow that will measure disease burden before and after treatment.

AML is the first of several disease areas that Teiko and the University of Utah plan to pursue together to advance precision diagnostics, with more details to come as the collaboration progresses.

(Press release, University of Utah, OCT 13, 2026, View Source [SID1234673370])