On October 23, 2026 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported updated data from the Phase 1b/2 study of JK06, a 5T4-targeted antibody drug conjugate (ADC), in patients with unresectable locally advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC) and breast cancer. The data are being presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23-27, 2026, in Madrid, Spain.

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"We are excited to present these updated Phase 1b/2 results, which further underscore the potential benefit JK06 can offer patients across various subtypes of NSCLC, breast cancer, and cervical cancer. Building upon our previously presented results at AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper), we have observed frequent and durable benefit with JK06 treatment among heavily pretreated patients. Data in monotherapy from second-line and later squamous NSCLC support JK06’s advancement to later-stage studies," said Sam Murphy, Chief Executive Officer of Salubris Biotherapeutics. "Additionally, the safety and efficacy profile of JK06 unlocks the potential for combination with immune and targeted therapies in earlier-line settings. We look forward to continuing our Phase 1/2 study of JK06 and deepening our understanding of this treatment as both a monotherapy and combination therapy."

The ongoing Phase 1/2, open-label study (NCT06667960) included a dose escalation stage which has concluded; the study is currently enrolling multiple tumor-specific monotherapy and combination expansion cohorts in NSCLC, breast cancer, cervical cancer, and a basket of other 5T4-expressing tumors. JK06 is administered intravenously once every three weeks (Q3W), with responses assessed per RECIST 1.1. As of September 21, 2026, 249 patients have been treated with JK06, including 42 patients in dose escalation and 207 patients in expansion cohorts. Overall, 230 patients have been treated in the target dose range of 3.7 – 5.2 mg/kg, including 109 NSCLC patients and 68 breast cancer patients.

Key Efficacy Findings in the Target Dose Range (3.7 – 5.2 mg/kg):

On smaller screens, swipe sideways to view all cancer groups.

JK06 NSCLC Breast Cancer Cervical Cancer
Squamous
(n = 41)
Nonsquamous w/o genomic alterations
(n = 23)
EGFR Mutant
(n = 32)
HR+
(n = 28)
(n = 19)
Median Prior Lines of Therapy 2 2 2 5 2
Response Evaluable 32 23 21 27 18
Objective Response Rate (%) 22% 22% 19% 33% 33%
Disease Control Rate (%) 84% 61% 57% 59% 72%
Median Duration of Response, weeks
(95% CI) 22.6
(18.3, NE) 16.4
(9.0, NE) 18.3
(18.3, NE) NE
(9.1, NE) NE
PFS: Number of Events 19 20 15 15 8
Median, weeks
(95% CI) 22.1
(17.3, 31.4) 15.0
(9.1, 19.1) 17.4
(7.1, 30.4) 18.1
(8.6, NE) 17.7
(9.7, NE)
OS: Number of Events 11 6 5 6 2
Median, weeks
(95% CI) 51.3
(18.9, NE) NE
(28.4, NE) 51.9
(19.9, NE) 36.4
(36.4, NE) 25.9
(16.7, NE)

Key Safety Findings in the Target Dose Range (n=230; 3.7 – 5.2 mg/kg):

JK06 at doses of 3.7 – 5.2 mg/kg was generally well-tolerated, with treatment-related adverse events (TRAEs) that were predominantly low grade and manageable.
Median follow-up time was 35 weeks for the target dose range.
The most frequently observed TRAEs (≥ 15% overall) were alopecia (23%), peripheral neuropathy (17%), fatigue (16%), and asthenia (15%).
TRAEs ≥Grade 3 were uncommon, and included keratitis (n=6, 3%), peripheral neuropathy (n=4, 2%), and two cases each of asthenia (1%), fatigue (1%), and neutropenia (1%).
TRAEs ≥Grade 3 were observed in 9% of patients overall, with only two Grade 4 events among 230 patients and no Grade 5 events.
27 patients out of 230 (12%) underwent dose reduction, and 12 out of 230 (5%) patients discontinued due to TRAEs.

Details of the ESMO (Free ESMO Whitepaper) presentation are as follows:

Title: A Phase 1b/2 Study of JK06, a 5T4-Targeted Antibody Drug Conjugate (ADC), in Patients with Unresectable Locally Advanced or Metastatic Cancer
Presenter: Emiliano Calvo, M.D., Ph.D., START Center for Cancer Research, Madrid, Spain
Presentation #: 1013P
Session: Developmental Therapeutics
Date/Time: October 23, 2026 | 15:15 – 16:00 CEST

About JK06
JK06 is a first-in-class quadrivalent, biparatopic ADC that selectively targets 5T4 with a monomethyl auristatin E (MMAE) payload. 5T4 is an oncofetal protein that is overexpressed in a wide range of solid tumors, including non-small cell lung cancer (NSCLC), breast, gastric, and genitourinary cancers, and is associated with more aggressive tumor progression and reduced survival. JK06 has demonstrated picomolar affinity for 5T4 and enhanced internalization resulting from the biparatopic design. Together with stable, site-specific payload conjugation, JK06 has demonstrated the potential for robust efficacy and a favorable safety profile.

(Press release, Salubris Biotherapeutics, OCT 23, 2026, View Source [SID1234673716])

On October 23, 2026 Oric Pharmaceuticals presented its corporate presentation.

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(Presentation, ORIC Pharmaceuticals, OCT 23, 2026, View Source [SID1234673715])

On October 23, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported a trial-in-progress e-Poster highlighting the design and clinical rationale of its randomized Phase 2 Abili-T trial evaluating its lead cancer vaccine candidate, abi-suva (formerly VB10.16) with interim data expected in 2027. The e-Poster will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, held 23 to 27 October in Madrid, Spain.

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Abili-T (NCT06016920) is an open-label, randomized Phase 2 trial of abi-suva, Nykode’s DNA-based therapeutic cancer vaccine targeting the HPV16 E6 and E7 oncoproteins, in combination with pembrolizumab as first-line treatment for patients with HPV16-positive, PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (1L r/m HNSCC).

The trial will enroll approximately 100 patients across approx. 50 sites in Europe and Canada. Patients will be randomized to receive either abi-suva in combination with pembrolizumab or pembrolizumab alone. The primary endpoints are progression-free survival (PFS) and objective response rate (ORR). Secondary endpoints include duration of response (DOR), disease control rate (DCR), and overall survival (OS). Exploratory endpoints include immunogenicity and circulating tumor DNA (ctDNA) kinetics.

The randomized Abili-T trial represents an important step in the development of Nykode’s lead program, abi-suva, building on encouraging results from the earlier trials and the differentiated design of Nykode’s therapeutic cancer vaccine platform. Unlike mRNA-based HPV16 vaccine candidates, abi-suva utilizes a DNA-based approach incorporating Nykode’s proprietary antigen-presenting cell (APC)-targeting technology, designed to direct HPV16 E6 and E7 antigens to APCs and stimulate strong, durable HPV16-specific T-cell responses. In the Phase 1 VB-C-03 study abi-suva combined with pembrolizumab demonstrated a confirmed ORR of 38.5% in 13 patients compared with a reported historical ORR of 19.1% for pembrolizumab monotherapy in a comparable first-line patient population with CPS ≥1 (KEYNOTE-048). The study also demonstrated rapid, strong and durable HPV16-specific T-cell responses. These findings support the rationale for Abili-T, which will evaluate whether adding abi-suva to pembrolizumab improves clinical outcomes compared with pembrolizumab alone.

The protocol has been approved by 8 European regulatory authorities (Norway, France, Spain, Hungary, Poland, Czech, UK and Germany) and was recently approved in Canada. The first patient was dosed in Poland in May 2026, and enrolment has since expanded across additional sites in the UK, Spain, France and Germany.

"Abi-suva is our lead clinical program, and Abili-T is a critical step in establishing its potential to improve treatment outcomes for patients with HPV16-driven head and neck cancer. With the recent approval of the study protocol in Canada we are adding a very important country to the trial," said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. "While checkpoint inhibitors have transformed cancer treatment, too many patients still do not respond. Our earlier clinical findings with abi-suva have been encouraging, and Abili-T is designed to build on those results by evaluating whether our targeted cancer vaccine can enhance the benefit of pembrolizumab. Presenting the trial design at ESMO (Free ESMO Whitepaper) provides an important opportunity to engage with the oncology community as we advance this program toward its first interim efficacy readout in 2027."

Presentation details:

● Title: Abili-T: A phase 2 randomized clinical trial evaluating the therapeutic cancer vaccine abipapogene suvaplasmid in combination with pembrolizumab versus pembrolizumab for first line treatment of patients with HPV16+ PD-L1+ unresectable recurrent or metastatic oropharyngeal cancer
● Presenter: Dr. Åse Bratland, Oslo University Hospital, Norway
● Abstract/Publication number: 1675eTiP
● Date: October 23, 2026

(Press release, Nykode Therapeutics, OCT 23, 2026, View Source [SID1234673714])

On October 23, 2026 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation and immunology (I&I), reported the publication in Nature Medicine of results from STARt-001, the first-in-human Phase 1/2 clinical trial of invikafusp alfa in patients with advanced, heavily pretreated solid tumors. The publication represents the first clinical demonstration that germline-encoded (sequences of DNA naturally present in the body from birth) Vβ T-cell subsets can be selectively activated and expanded as a therapeutic approach in oncology. In patients whose tumors were mostly resistant to prior immune checkpoint blockade (ICB), invikafusp alfa expanded functional effector and memory Vβ6/Vβ10 T cells and generated single-agent antitumor activity across multiple tumor types.

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The article titled "Bispecific dual T cell agonist invikafusp alfa in solid tumors: the Phase 1/2 START-001 trial," reports findings from the completed Phase 1 dose-escalation and initial Phase 2 expansion cohorts. The results demonstrate a manageable safety profile, selective peripheral and intratumoral expansion of Vβ6/Vβ10 T cells, objective responses across multiple difficult-to-treat tumor types and the establishment of a recommended Phase 2 dose.

"These data provide encouraging clinical evidence that selected Vβ6/Vβ10 T-cell populations can be activated and expanded in patients with advanced cancer," said Lillian L. Siu, M.D., Senior Medical Oncologist at UHN’s Princess Margaret Cancer Centre and co-lead author of the publication. "The alignment of target engagement, functional T-cell expansion, a manageable safety profile and objective responses across several refractory tumor types provides a rationale for further investigation of this approach and its potential antitumour activity."

Key findings reported in the publication include:

● Completion of Phase 1 dose escalation without reaching a maximum tolerated dose and selection of a recommended Phase 2 dose based on integrated safety, pharmacodynamic and antitumor activity data.

● Confirmed objective responses in heavily pretreated patients with immune checkpoint blockade-resistant tumors, including microsatellite-stable (MSS) colorectal cancer and PD-L1-negative non-small cell lung cancer, settings that have historically shown limited responsiveness to checkpoint inhibition.

● A manageable safety profile consistent with invikafusp alfa’s mechanism of action, with cytokine release syndrome primarily low grade and no treatment-related deaths, no treatment-related non-laboratory Grade 4 adverse events and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS).

● Selective, dose-dependent expansion of peripheral and intratumoral functional effector and memory Vβ6/Vβ10 T cells, providing evidence of target engagement and the intended biological mechanism.

"Publication of these data in Nature Medicine marks the breakthrough moment at which a novel scientific concept becomes a clinically demonstrated therapeutic approach," said Zhen Su, M.D., President and Chief Executive Officer of Marengo Therapeutics. "For the first time, we show that selected germline Vβ T-cell populations can be activated and expanded in cancer patients, generating antitumor activity across biologically distinct, PD-1-resistant tumors. Invikafusp alfa represents the first clinical application of this biology, and these findings provide proof of concept in humans for our broader platform to activate, redirect or deplete selected T cell populations. As we present updated Phase 2 results at ESMO (Free ESMO Whitepaper) today and advance our next generation IO-ADC strategy, we are applying this biology with precision tailored to the right tumor, the right patient and the right therapeutic solution."

Invikafusp alfa is the lead clinical asset from Marengo’s Vβ-directed platform. Vβ6/Vβ10 T cells are a germline-encoded population expressed consistently across multiple tumor types, regardless of patient age or sex, and enriched among tumor-infiltrating lymphocytes (TILs). Invikafusp alfa therefore has a target that does not depend on any single tumor-specific mutation or antigen. By demonstrating that a selected germline-encoded Vβ subset can be therapeutically modulated in humans, the Nature Medicine publication provides the biological foundation for three complementary approaches: selective activation through STAR, tumor directed redirection through TriSTAR and selective depletion through MSTAR.

Marengo will also present interim Phase 2 results from STARt-002, the first clinical study to combine a Vβ6-selective T-cell agonist with an antibody-drug conjugate in triple-negative and HR-positive/HER2-negative metastatic breast cancer at the SITC (Free SITC Whitepaper) 2026 Annual Meeting. Further analyses are also ongoing, with additional clinical data expected in 2027.

About Invikafusp Alfa (STAR0602)

Invikafusp alfa (STAR0602), the lead candidate from Marengo’s STAR platform, is a first-in class, bispecific dual T-cell agonist. It is designed to selectively activate a common Vβ T-cell subset found in all cancers by combining a non-clonal mode of TCR activation with a T-cell co stimulatory signal in a single molecule. This approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing antitumor immunity and enabling durable tumor clearance. Invikafusp alfa was designed to restore and amplify antitumor immunity in patients who have progressed on, or are insensitive to, prior immune checkpoint blockade.

About the STARt-001 Clinical Study

STARt-001 is a global Phase 1/2 trial evaluating invikafusp alfa monotherapy in patients with advanced, antigen-rich solid tumors that are refractory or resistant to PD-1–directed therapy. The Phase 2 portion uses biomarker-enriched cohorts, including TMB-H and MSI-H, to assess activity across multiple tumor types and help identify patients most likely to benefit. For more information, visit ClinicalTrials.gov (NCT05592626). STARt-001 Phase 2 expansion is ongoing to further investigate invikafusp alfa for the treatment of ICB-resistant tumors.

(Press release, Marengo Therapeutics, OCT 23, 2026, View Source [SID1234673713])

On October 23, 2026 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation and immunology (I&I), reported the presentation of Phase 2 results from the STARt-001 clinical trial of invikafusp alfa at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23–27 in Madrid, Spain.

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The oral presentation, titled "STARt-001: Phase 2 results of invikafusp alfa, a first-in-class T-cell receptor β-chain–targeted bispecific antibody, as monotherapy in patients with TMB-H solid tumors resistant to immune checkpoint blockade," includes clinical and translational findings from the ongoing Phase 2 study.

STARt-001 is a Phase 1/2 study evaluating invikafusp alfa, a first-in-class dual T-cell agonist designed to amplify antitumor immunity, as a single agent in patients with unresectable, locally advanced or metastatic tumor mutation burden-high (TMB-H) solid tumors mostly unresponsive to immune checkpoint blockade (ICB). This population includes patients whose tumors progressed following prior checkpoint inhibition, as well as patients with tumor types for which checkpoint inhibitors are not approved or have historically demonstrated limited benefit.

The results showed tissue-agnostic antitumor activity across multiple heavily pretreated tumor types, providing further clinical evidence that selective activation of Vβ T-cell populations can generate antitumor responses beyond the PD-1 pathway. The findings are consistent with the tissue-agnostic rationale recognized in invikafusp alfa’s second FDA Fast Track Designation, recently granted for TMB-H solid tumors regardless of tissue of origin.

"Patients with tumors that are unresponsive to immune checkpoint blockade continue to face a significant unmet need, whether their disease has progressed following prior checkpoint inhibition or checkpoint therapy is not an established treatment option for their tumor type," said Elena Garralda, M.D., Ph.D., Director of the Research Unit for Molecular Therapy of Cancer

(UITM) – CaixaResearch at Vall d’Hebron Institute of Oncology and principal investigator of the study. "The Phase 2 results presented at ESMO (Free ESMO Whitepaper) show a tissue-agnostic efficacy signal with invikafusp alfa across multiple heavily pretreated tumor types. The translational findings also demonstrate selective expansion of Vβ6-positive T-cell clonotypes, along with an increase in tumor-infiltrating lymphocyte clonotypes, supporting the ability of this novel mechanism to generate antitumor immune responses beyond PD-1 biology."

Highlights from the Phase 2 STARt-001 oral presentation

● Objective responses were observed across eight distinct tumor types, including breast, colorectal, endometrial, gastroesophageal junction, gastric, head and neck, non-small cell lung and bladder cancers.

● Among 62 evaluable patients with heavily pretreated TMB-H solid tumors across these eight tumor types, tumor shrinkage was observed in 56% of patients, with an 18% ORR and 60% DCR.

● Activity was observed in both ICB-experienced and ICB-naïve patients. o ORR and DCR were numerically higher among ICB-experienced patients than among ICB-naïve patients (20% versus 14%, and 68% versus 43%), respectively. o Among ICB-experienced patients, responses were observed in tumors with both primary and secondary resistance, with ORRs of 23% and 28%, respectively.

● Translational analyses showed rapid and reproducible polyclonal expansion of Vβ6 positive T-cell clonotypes following the first infusion, accompanied by increased overlap between blood and tumor clonotypes consistent with trafficking of activated T cells into tumors. These findings further support selective Vβ T-cell activation as a mechanism capable of expanding antitumor immune responses beyond the PD-1 pathway.

● In 104 patients evaluated for safety, invikafusp alfa showed a manageable tolerability profile consistent with selective T-cell activation. Cytokine release syndrome was mainly Grades 1 and 2, with no immune effector cell-associated neurotoxicity syndrome and no Grade 5 treatment-related adverse events observed.

"These Phase 2 results demonstrate the breadth of invikafusp alfa’s single-agent activity across biologically distinct, heavily pretreated tumor types and represent an important efficacy signal for this first-in-class mechanism," said Zhen Su, M.D., M.B.A., President and Chief Executive Officer of Marengo Therapeutics. "STARt-001 was designed as a signal-seeking basket study to evaluate this novel biology across a heterogeneous group of tumors. The activity observed across eight tumor types is now informing a focused, evidence-led development strategy in populations where the biological rationale and unmet need are strongest."

The tissue-agnostic results presented at ESMO (Free ESMO Whitepaper) point to the potential breadth of Vβ-directed immunotherapy. Invikafusp alfa was designed to amplify antitumor immunity and is well suited to complement standard-of-care therapies, with the potential for synergistic antitumor activity. Marengo’s combination strategy aims to build greater depth in prioritized indications by pairing invikafusp alfa with these therapies while also supporting its long-term vision for invikafusp alfa as a potential immuno-oncology backbone that can be tailored to the right tumor, the right patient and the right therapeutic solution.

Additionally, results from the Phase 1 dose-escalation and initial Phase 2 expansion of STARt 001 were published today in Nature Medicine. The publication represents the first clinical report of a Vβ-directed dual T-cell agonist and establishes first-in-human proof that selected germline encoded Vβ T-cell populations can be therapeutically activated and expanded in patients with advanced cancer.

The Nature Medicine publication and ESMO (Free ESMO Whitepaper) presentation collectively provide compelling evidence for invikafusp alfa and Marengo’s broader Vβ-directed immunotherapy strategy.

Marengo is advancing invikafusp alfa through a focused clinical strategy spanning biomarker selected single-agent development and rational combinations in prioritized tumor settings. The company will present interim Phase 2 results from STARt-002, the first clinical study combining a Vβ6-selective T-cell agonist with an antibody-drug conjugate in triple-negative and HR positive/HER2-negative metastatic breast cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting.

Further analyses from STARt-001 are also ongoing, with a more complete clinical dataset expected in 2027.

About Invikafusp Alfa (STAR0602)

Invikafusp alfa (STAR0602), the lead candidate from Marengo’s STAR platform, is a first-in class, bispecific dual T-cell agonist. It is designed to selectively activate a common Vβ T-cell subset shared across most cancers by combining a non-clonal mode of TCR activation with a T cell co-stimulatory signal in a single molecule. This approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing antitumor immunity and enabling durable tumor clearance. Invikafusp alfa was designed to restore and amplify antitumor immunity in patients who have progressed on, or are insensitive to, prior immune checkpoint blockade. Invikafusp alfa has been granted two Fast Track Designations from the U.S. Food and Drug Administration; the first for the treatment of TMB-H colorectal cancer (granted January 2025) and the second designation, which expands invikafusp alfa’s Fast Track status to TMB-H solid tumors regardless of their tissue of origin (granted October 2026).

About the STARt-001 Clinical Study

STARt-001 is a global Phase 1/2 trial evaluating invikafusp alfa monotherapy in patients with advanced, antigen-rich solid tumors that are unresponsive to immune checkpoint blockade, including tumors that progressed on prior PD-1–directed therapy. The Phase 2 portion uses biomarker-enriched cohorts, including TMB-H and MSI-H, to assess activity across multiple tumor types and help identify patients most likely to benefit. For more information, visit ClinicalTrials.gov (NCT05592626). STARt-001 Phase 2 expansion is ongoing to further investigate invikafusp alfa for the treatment of ICB-resistant tumors.

(Press release, Marengo Therapeutics, OCT 23, 2026, View Source [SID1234673712])