On October 8, 2026 Bristol Myers Squibb (NYSE: BMY) reported positive topline results from the Phase 3 EXCALIBER-RRMM study, evaluating ZENBEXUSTM (iberdomide) in combination with daratumumab and dexamethasone (ZDd) in 800 patients with multiple myeloma (MM), as early as first relapse. Results showed ZDd demonstrated a statistically significant improvement in the dual-primary endpoint of progression-free survival (PFS), with median PFS of 42 months for ZDd vs. 20 months for daratumumab, bortezomib and dexamethasone (DVd) [HR:0.49, p<0.000001], representing a 51% reduction in the risk of disease progression or death. Median follow-up was 23 months. The safety profile of ZENBEXUS in combination with standard therapies remained consistent with previously reported safety findings from the study.

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These results build on the previously reported improvement in minimal residual disease (MRD)-negative complete response vs. DVd, the other dual-primary endpoint, which supported the U.S Food and Drug Administration approval of ZENBEXUS for RRMM. Detailed MRD results were presented at the International Myeloma Society 23rd annual meeting and simultaneously published in Lancet Oncology.

"The results from EXCALIBER-RRMM reinforce the clinical value of ZENBEXUS in combination with daratumumab and dexamethasone as a treatment approach for relapsed or refractory multiple myeloma, demonstrating the strong benefit observed for minimal residual disease negativity translated to a meaningful improvement in progression free survival for patients," said Cristian Massacesi, MD, chief medical officer and head of development at Bristol Myers Squibb. "These findings further underscore the value of ZENBEXUS as an effective oral treatment option that can be easily used in diverse care settings, including community settings, where many patients receive their care. We look forward to sharing full results from the study."

This data will be presented at the 68th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in New Orleans, L.A. Bristol Myers Squibb thanks the patients and investigators who participated in the EXCALIBER-RRMM clinical trial.

About EXCALIBER-RRMM

EXCALIBER-RRMM (NCT04975997) is a Phase 3, multicenter, two-stage, randomized, open-label study evaluating the efficacy and safety of ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma (RRMM). The study included a dose optimization stage and was designed to assess dual-primary endpoints of minimal residual disease (MRD) negativity and progression-free survival (PFS), with additional secondary endpoints including overall survival (OS), overall response rate (ORR), safety and sustained MRD negativity. Eligible participants included adults with 1 to 2 prior lines of anti-myeloma therapy and progressive disease. The PFS confirmatory analysis population included all 800 patients randomized to ZDd (n=400) or DVd (n=400). Treatment in both arms was administered until disease progression or unacceptable toxicity.

Indication

ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM

EMBRYO-FETAL TOXICITY

ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment.

Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS treatment.

Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS REMS.

SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM

Increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. Anti-thrombotic prophylaxis is recommended.

CONTRAINDICATIONS

Based on the mechanism of action and findings in animal studies, ZENBEXUS can cause birth defects or embryo-fetal death in humans. ZENBEXUS is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity

Females of Reproductive Potential: Must avoid pregnancy while taking ZENBEXUS and for at least 4 weeks after completing therapy. Advise females of reproductive potential of the potential risk to a fetus and to use 2 methods of effective contraception for at least 4 weeks before beginning ZENBEXUS therapy, during therapy, during dose interruptions and for at least 4 weeks after the last dose of ZENBEXUS therapy. Refer patients who can become pregnant to a qualified provider of contraceptive methods, if needed.

Two negative pregnancy tests with a sensitivity of at least 25 mIU/mL must be obtained prior to initiating therapy. Pregnancy testing should be performed weekly during the first 4 weeks of treatment. Thereafter, testing should occur every 4 weeks in patients with regular menstrual cycles, or every 2 weeks in patients with irregular menstrual cycles.

Females of reproductive potential taking ZENBEXUS must not donate eggs during treatment and for 4 weeks after completion.

Males: ZENBEXUS may pass into human semen. Advise patients who can impregnate partners to use effective contraception during treatment and for 4 weeks following the discontinuation of ZENBEXUS therapy. Male patients taking ZENBEXUS must not donate sperm during treatment and for 4 weeks after completion.

Blood Donation: Patients must not donate blood during treatment with ZENBEXUS and for 4 weeks following discontinuation of ZENBEXUS therapy.

ZENBEXUS REMS

ZENBEXUS is available only through a restricted program called ZENBEXUS REMS, because of the risk of embryo-fetal toxicity. Prescribers must be certified with and patients must be enrolled in the ZENBEXUS REMS Program and comply with ongoing monitoring and contraception requirements. Further information about ZENBEXUS REMS, including information for pharmacies, wholesalers, and distributors, is available at www.ZENBEXUSREMS.com or by telephone at 1-888-423-5436.

Serious Venous and Arterial Thromboembolism

ZENBEXUS can cause serious and life-threatening venous thromboembolic events (DVT and PE) and arterial thromboembolic events (myocardial infarction and stroke). In the EXCALIBER-RRMM study (N=204), venous thromboembolic events occurred in 6.4% of patients treated with ZENBEXUS combined with daratumumab and hyaluronidase-fihj and dexamethasone (IberDd) despite mandatory thromboembolism prophylaxis. The incidence of DVT was 3.4% and the incidence of PE was 1.5%.

Arterial thromboembolic events occurred in 3.4% of patients. The incidence of myocardial infarction was 2.0%, and the incidence of stroke (CVA) was 1.5%.

Monitor patients for signs and symptoms of thromboembolic events during treatment with ZENBEXUS. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors. In patients who develop a thromboembolism, interrupt ZENBEXUS and initiate anticoagulant therapy according to guidelines.

Neutropenia

ZENBEXUS can cause severe neutropenia. In the EXCALIBER-RRMM study, all-grade neutropenia was reported in 90.2%, Grade 3 in 30.9%, and Grade 4 in 53.4% of patients in the IberDd arm. Febrile neutropenia occurred in 5.4% of patients.

Monitor complete blood count throughout treatment with ZENBEXUS. Interrupt, reduce dosage, or discontinue ZENBEXUS, as necessary. Initiate granulocyte colony-stimulating factor (GCSF) as appropriate per guidelines.

Infections

ZENBEXUS can cause serious infections, including life-threatening or fatal infections. Patients with active or uncontrolled infection should not start ZENBEXUS treatment until the infection is controlled. In the EXCALIBER-RRMM study, infections, including opportunistic infections, were reported in 78.9%, Grade 3 in 35.8%, Grade 4 in 3.4%, and fatal infections in 2% of patients receiving IberDd. Serious infections occurred in 40% of patients. Discontinuations due to infections occurred in 1.5% of patients.

Monitor patients for signs and symptoms of infection prior to and during treatment with ZENBEXUS and treat appropriately. Withhold or reduce the dose based on severity.

Consider prophylactic anti-infective medications according to current practice guidelines.

Second Primary Malignancies

In the EXCALIBER-RRMM study, at a median follow-up time of 16 months, second primary malignancies (SPM) occurred in 6.9% of patients in the IberDd arm and 4.9% of patients in the daratumumab and hyaluronidase-fihj, bortezomib, and dexamethasone (DVd) arm.

Monitor patients for the development of SPM.

ADVERSE REACTIONS

Serious adverse reactions occurred in 58.3% of patients receiving ZENBEXUS. Serious adverse reactions in ≥2% of patients included pneumonia (26%), upper respiratory tract infection (6.4%), SPM (5.9%), neutropenia (4.9%), febrile neutropenia (3.9%), COVID-19 (4.4%), and sepsis (2.9%). Fatal adverse reactions occurred in 10 patients (4.9%) who received ZENBEXUS. Sepsis (1.5%) was the only fatal drug reaction that occurred in more than 1 patient. The following fatal adverse reactions occurred in 1 patient each: listeria encephalitis, influenza, lung adenocarcinoma, cardiac arrest, large intestine perforation, metabolic acidosis, and respiratory failure.

The most common adverse reactions (≥20%) in the IberDd arm and DVd arm, respectively, were upper respiratory tract infection (54% and 52%), fatigue (36% and 33%), musculoskeletal pain (35% and 33%), pneumonia (34% and 17%), diarrhea (33% and 36%), motor dysfunction (26% and 17%), rash (26% and 15%), sleep disorder (25% and 28%), hypogammaglobulinemia (24% and 12%), COVID-19 (23% and 16%), and constipation (20% and 22%).

The most common Grade 3 to 4 laboratory abnormalities (≥30%) in the IberDd arm and DVd arm, respectively, were neutropenia (77% and 11%), leukopenia (69% and 18%), and lymphopenia (62% and 51%).

DRUG INTERACTIONS

Effects of Other Drugs on ZENBEXUS

Strong or Moderate CYP3A Inhibitors: Coadministration of ZENBEXUS with strong or moderate CYP3A inhibitors should be avoided. If a strong or moderate CYP3A inhibitor must be used in combination with ZENBEXUS, reduce the ZENBEXUS dose. Concomitant use with strong or moderate CYP3A inhibitors may increase the risk of adverse reactions.

Strong or Moderate CYP3A Inducers: Coadministration of ZENBEXUS with strong or moderate CYP3A inducers should be avoided. Concomitant use with a strong or moderate CYP3A inducer may decrease the efficacy of ZENBEXUS.

SPECIFIC POPULATIONS

Pregnancy (See the BOXED WARNINGS)

There is a pregnancy exposure registry that monitors outcomes in patients exposed to ZENBEXUS during pregnancy. See the ZENBEXUS REMS WARNINGS AND PRECAUTIONS section.

Lactation

Advise women not to breastfeed during treatment with ZENBEXUS. Refer to the Prescribing Information for daratumumab hyaluronidase-fihj or dexamethasone for additional information.

Females and Males of Reproductive Potential

ZENBEXUS can cause fetal harm when administered during pregnancy.

Pregnancy Testing, Females of Reproductive Potential, and Males: See the Embryo-Fetal Toxicity WARNINGS AND PRECAUTIONS section.

Geriatric Use

In patients treated with IberDd, the incidence of serious adverse reactions was 53%, 56%, and 74% in adult patients younger than 65 years of age, 65 years of age to younger than 75 years of age, and 75 years of age and older, respectively.

Renal Impairment

Reduce the ZENBEXUS dose in patients with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 not on dialysis. If dose modification is needed due to adverse events, reduce the ZENBEXUS dose to 1 mg every other day on Days 1 to 21 of a 28-day cycle.

Please see full Prescribing Information for ZENBEXUS including Boxed WARNINGS.

About Targeted Protein Degradation and CELMoD

Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered difficult to address. BMS is the only company that has successfully developed and commercialized protein degrader agents for the treatment of multiple myeloma. These agents, known as immunomodulatory drugs (IMiDs), helped establish the current standard of care in the treatment of this disease, which remains without a cure. BMS is building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including cereblon E3 ligase modulators (CELMoDs), ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach enables matching the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provides more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology. Learn more about the science behind TPD at Bristol Myers Squibb here.

About Ongoing Trials

Zenbexus is also being evaluated in the EXCALIBER Maintenance study.

(Press release, Bristol-Myers Squibb, OCT 8, 2026, View Source;Standard-of-Care-in-Relapsed-and-Refractory-Multiple-Myeloma-in-Phase-3—/default.aspx [SID1234673280])

On October 8, 2026 Alpha-9 Oncology Inc. ("Alpha-9"), a clinical-stage radiotherapeutic company developing targeted, next-generation treatments to meaningfully improve the lives of those living with cancer, reported an upcoming oral presentation supporting the use of 68Ga-A9-6217 PET/CT imaging in patients with gastrin-releasing peptide receptor ("GRPR") expressing tumors at the European Association of Nuclear Medicine 2026 Annual Congress, taking place in Vienna, Austria, from October 17-21, 2026.

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Alpha-9 is currently enrolling a Phase 1 clinical trial evaluating safety, tolerability, and recommended dose for expansion of 225Ac-A9-0642 and 177Lu-A9-0631 in patients with GRPR-positive solid tumors, including locally advanced, unresectable or metastatic HR+/HER2- breast cancer and other solid tumors. Alpha-9 is currently using its GRPR imaging agent, 68Ga-A9-6217, for patient selection.

Oral Presentation Details:

Title: A Phase 1 Study Investigating the Safety, Biodistribution, and Dosimetry of [68Ga]Ga-A9-6217 in Participants with Select Advanced or Metastatic Solid Tumors: Case series of selected patients
Presentation Number: OP-877
Date/Time: Wednesday, October 21, 2026, 9:45 – 11:15 AM CEST, Hall C

Full abstracts are available online in the EANM’26 Abstract Book.

(Press release, Alpha9 Oncology, OCT 8, 2026, View Source [SID1234673279])

On October 8, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that the recruitment target of the Cohort Expansion (Main Group) of the Phase I/IIa SECuRE trial has been achieved. The enrolled sixteen participants with metastatic castration-resistant prostate cancer (mCRPC) are being evaluated for the efficacy and safety of up to six cycles of 8 GBq of 67Cu-SAR-bisPSMA. Recruitment remains ongoing for additional participants in the Cohort Expansion to be treated with the combination of 8 GBq 67Cu-SAR-bisPSMA with enzalutamide (an androgen receptor pathway inhibitor [ARPI]).

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The Cohort Expansion aims to assess the efficacy and safety of 67Cu-SAR-bisPSMA in 24 mCRPC patients prior to receiving taxane or radioligand-based therapies, with or without the concomitant administration of enzalutamide (approximately 8 and 16 participants, respectively). 67Cu-SAR-bisPSMA continues to demonstrate a favourable safety profile and promising efficacy in the SECuRE trial. Based on the recent data from 19 participants reported on the 5th of August 20261, a median of 2 cycles (range: 1-4) of 67Cu-SAR-bisPSMA at 8 GBq led to substantial declines in prostate-specific antigen (PSA), with 74% of evaluable participants achieving PSA25 (i.e., ≥25% reduction in PSA from baseline), 63% PSA50, 53% PSA75 and 26% PSA90. Among 16 radiographically evaluable participants treated at the 8 GBq dose level, 81% achieved disease control (50% with stable disease and 31% with complete response [assessed by Response Evaluation Criteria in Solid Tumors 1.1, RECIST] or undetectable disease [assessed by bone scan and/or PSA]). Across the entire 67Cu-SAR-bisPSMA clinical development program, seven participants have achieved complete response/undetectable disease. Most related adverse events were mild or moderate and transient. More updates from the Cohort Expansion Phase will be released in the coming months as data from the most recently enrolled participants continue to mature.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Our SAR-bisPSMA programs continue to generate an impressive evidence base in clinical trials and real-world case profiles. As our two registrational diagnostic trials are nearing readouts early next year, we look forward to further leveraging the benefits of the bivalent PSMA molecule as well as of the "perfect pairing" of copper isotopes to explore the positive impact our product could make in the treatment of mCRPC, an area of focus for us as we look to develop a product with key advantages over standard-of-care. Reaching the recruitment target in the Main Group of the SECuRE study is a significant milestone in the development of this promising theranostic product.

"With a total of 16 patients enrolled in the main group of the Cohort Expansion (multi-dose), as well as 21 participants treated in the Dose Escalation phase, we have observed strong efficacy with a favourable safety profile of 67Cu-SAR-bisPSMA. We are inspired and motivated to progress our theranostic program as almost a third of all evaluable patients treated at the 8 GBq dose level had achieved undetectable levels of disease and/or complete response across the 67Cu-SAR-bisPSMA program at the date of the last assessment (20 July 2026). While we continue to collect data from the enrolled participants and to recruit into the enzalutamide arm to explore the potential further benefits of this combination with 67Cu-SAR-bisPSMA, we are already in planning for a registrational theranostic Phase III trial based on the preliminary results.

"We look forward to providing a further update on the SECuRE trial shortly as our team and collaborators continue to generate a compelling body of high-quality data, advancing SAR-bisPSMA towards commercialisation, as we believe this unique molecule could improve the outcomes for prostate cancer patients across multiple stages of disease, from accurate lesion detection in the pre-prostatectomy and biochemical recurrence (BCR) settings through to treatment in mCRPC."

About the SECuRE trial
The SECuRE trial (NCT04868604)2 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm study, planning to enroll approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion at an 8 GBq dose level as per the Safety Review Committee (SRC) recommendation (up to 6 cycles per patient in total)3. The Cohort Expansion Phase will include 24 participants (Figure 1) with a subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (ARPI), in line with the positive results from the ENZA-p trial4 and previous discussions with and advice from key global medical experts in the field of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic platform that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

(Press release, Clarity Pharmaceuticals, OCT 8, 2026, View Source [SID1234673256])

On October 7, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA" or the "Company"), a leading developer of next-generation antibody-based cancer therapies, reported an update on its strategy and progress to implement a suite of U.S. Food and Drug Administration (FDA) aligned New Approach Methodologies (NAMs) across its preclinical research and development programs, potentially enabling faster clinical advancement while significantly reducing animal testing. This strategic implementation positions VERAXA ahead of the FDA’s 2025 roadmap, which encourages the phased reduction and ultimate replacement of animal testing in favor of human-relevant, non-animal and non-clinical test methods for developing safe and effective therapies.

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NAMs encompass a range of technologies, including cell-based assays, organ-on-chip systems, computational modeling and ex vivo tissue models, designed to more accurately predict human biological responses while reducing dependence on animal models. Beyond this regulatory alignment, the shift toward more sustainable and ethical research practices is also expected to reduce development costs and timelines, for example, by bypassing certain non-human primate (NHP) toxicology studies traditionally required ahead of clinical development.

"We see NAMs as not just a regulatory obligation, but also as a scientific opportunity," said Christoph Erkel, Ph.D., Chief Scientific Officer of VERAXA. "We’ve been investing in translational, human-relevant model systems well ahead of the FDA’s 2025 roadmap, and we see this shift as beneficial and a win-win situation for both science and sustainability. Reducing our reliance on animal studies, particularly NHP toxicology testing, allows us to generate more clinically predictive data, move faster, and do so more efficiently and sustainably."

VERAXA has been building a multi-layered panel of NAMs to characterize and de-risk its pipeline of BiTAC (bi-targeted tumor-associated cytotoxicity) based T cell engagers (BiTAC-TCEs), BiTAC-based antibody drug conjugates (BiTAC-ADCs) and bispecific antibody-drug conjugates (bsADCs) technologies. At the AACR (Free AACR Whitepaper) Annual Meeting 2026, the Company presented initial data on its most advanced BiTAC-TCE program. In those studies, the candidate performed as intended in vitro and in vivo, attacking cancer cells that displayed both target molecules while sparing cells expressing only one of the two, with a safety profile that was superior, and efficacy that matched, a more traditional TCE, pointing to the possibility of a meaningfully improved therapeutic index. The in vitro results came from three-dimensional, cell line-derived spheroid models, which recapitulate solid tumor architecture more closely than two-dimensional culture. VERAXA has since generated new spheroid data demonstrating consistent predictivity of T cell engagement specificity across diverse cancer cell lines and validating the model for IND-enabling studies, further reinforcing this model’s translational value ahead of clinical development.

VERAXA further evaluated its lead BiTAC-TCE and bsADC candidates in an ex vivo panel of ten low-passage patient-derived xenograft models of non-small cell lung cancer, models that closely preserve the molecular characteristics, heterogeneity, and therapeutic response of the original tumors. Because these assays draw on tumor material from a small number of donor mice and can be split into many parallel patient samples, the panel required only about ten mice in total, versus an estimated 200 or more for comparable in vivo efficacy studies.

Across the panel, the combined BiTAC consistently induced potent T cell-mediated killing, while relevant controls, including commercial T cell engagers against non-expressed targets, showed only minimal activity, providing strong evidence that VERAXA’s dual-targeting approach extends beyond cell line models into clinically meaningful anti-tumor activity, validating the need for simultaneous dual-target engagement and reinforcing BiTAC as a next-generation approach to T cell redirection. This ex vivo platform demonstrates how VERAXA’s NAM strategy reduces both animal use and preclinical cycle time without compromising clinical relevance.

(Press release, Veraxa Biotech, OCT 7, 2026, View Source [SID1234673278])

On October 7, 2026 Byondis B.V., a private biopharmaceutical company engineering antibody-drug conjugates (ADCs) to tackle the cancers that current therapies cannot reach, reported it will share progress from its platform technology portfolio at World ADC San Diego, the world’s largest ADC conference, being held from 12-15 October in San Diego, USA.

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With more than 20 years of in-house ADC expertise, Byondis is evolving the ADC field with novel payload platforms, advanced masking technology and optimized linker and conjugation strategies. These enable ADC solutions that can overcome the critical limitations of current and next-generation therapies with the potential for superior efficacy, duration of response and safety, to improve clinical outcomes in patients with difficult-to-treat tumor types.

Overcoming ADC Resistance
The company is advancing an IND-enabling (regulatory non-clinical) package to completion for its lead proprietary ADC candidate, BYON14156, marking a key step towards clinical trial authorization. Harnessing the company’s first-in-class antifolate payload and targeting an antigen highly expressed across multiple tumor types, BYON14156 is engineered to overcome the major challenge seen in current and next-generation ADCs with payload resistance. Dose range-finding toxicity studies in non-human primates have shown a benign toxicity profile and a favorable therapeutic window. Earlier studies have demonstrated efficacy across a range of tumor models in vitro and in vivo, including topoisomerase and tubulin inhibitor-resistant models.

Wim Dokter, PhD, Chief Scientific Officer at Byondis, will share a presentation at World ADC entitled Spotlighting Comprehensive Preclinical Development of Antifolate ADCs to Enter IND Phase for a Novel Drug-Linker Mechanism on Wednesday 14 October at 11.00am PDT, in which he will profile the development of BYON14156, ahead of its advancement into the clinic, anticipated in 2027.

The advancement of BYON14156 is a key part of the company’s strategy to establish itself as a leader in the development of ADCs, through its platform technologies and the modular, end-to-end capabilities that underpin the company.

A Universal Solution to Reduce Off-Tumor Toxicity
Byondis’ best-in-class steric masking technology, ByonGuard, which is designed to improve the therapeutic index of ADCs, T cell engagers and other antibody-based therapies, and provide a universal solution to reduce off-tumor toxicity, will be highlighted on Monday 12 October at 10.30am PDT in the presentation, Introducing ByonGuard: Conditional Activation Technology that Improves the Safety Profile & Therapeutic Index of ADCs. Wim Dokter will explore the rationale to develop conditionally active ADCs to overcome challenges with target-mediated toxicity and improve therapeutic index, and share safety and efficacy findings from Byondis’ latest research.

Christoph Korpus, PhD, MBA, Chief Executive Officer of Byondis, said: "The progress of our first-in-class antifolate payload ADC candidate towards the clinic is a clear demonstration of the strength of our platform technologies in action. It reflects the focused strategy we have built over the past year: prioritizing the proprietary platforms with the greatest potential to address the limitations of current and next-generation ADCs, while pursuing partnerships that can accelerate the impact of our technologies for patients. This candidate brings forward Byondis’ most advanced platform technology, and its progress reinforces our conviction as we continue to engage with potential partners across our platform portfolio."

Under the leadership of Christoph Korpus, PhD, MBA, who was appointed as Chief Executive Officer in April 2026, Byondis has sharpened its focus on the continued development of its proprietary technology platforms, each of which are engineered to work independently or in combination to address multiple hallmarks of cancer, alongside the pursuit of partnering, licensing and co-development opportunities to maximize value.

Byondis’ fully integrated discovery, development and manufacturing capabilities give the company the flexibility to advance its proprietary pipeline independently, while its modular platform approach enables broad partnering flexibility through co-development, licensing and strategic collaboration. The company continues to actively engage with prospective partners across its antifolate, immunostimulatory phosphonate and dual payload platforms, and its steric masking technology.

(Press release, Byondis, OCT 7, 2026, View Source [SID1234673277])