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• First patient dosed in France, expanding the DOMISOL study beyond Australia
  
• DT‑7012 is being evaluated as monotherapy and in combination with pembrolizumab in a global clinical development program

Montreal, Canada – Strasbourg, France – Boston, United States, April 9, 2026: Kainova Therapeutics ( “the Company” ), a key player for breakthrough treatments in immuno-oncology and inflammation, today announced dosing of the first patient in the European expansion of its DOMISOL Phase I / II clinical trial evaluating DT‑7012, a proprietary Treg‑depleting anti‑CCR8 monoclonal antibody, in patients with advanced solid tumors.

This dosing follows the initiation of the DOMISOL Phase I / II study in Australia, announced in October 2025, marking a significant milestone in the global clinical development of DT‑7012, Kainova Therapeutics’ lead immuno-oncology program. The European expansion ( NCT06819735 ) includes leading oncology centers in France, led by renowned early-phase clinical investigators, including Dr Lauriane Eberst at Hôpitaux Universitaires de Strasbourg, Professor Antoine Italiano at Institut Gustave Roussy in Paris, and Dr Maxime Brunet at Institut Bergonié Bordeaux.

Professor Antoine Italiano, MD PhD, Head of Precision Medicine at Institut Gustave Roussy and member of Kainova Therapeutics’ Scientific Advisory Board, said: “This study brings together strong clinical expertise and advanced translational capabilities, creating an important opportunity to explore how targeted Treg depletion may translate into meaningful benefit for patients with advanced solid tumors. DT‑7012 offers a novel, differentiated approach to precisely address CCR8 biology and reshape the tumor microenvironment.”

Dr Jean‑Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics, commented: “Dosing of the first patient in Europe marks an important step in the clinical maturation of our flagship program, DT‑7012. The DOMISOL study has been designed to generate a comprehensive clinical and biological profile for DT‑7012 across both monotherapy and combination settings, including paired biopsies to directly assess the intra tumoral Treg depletion. These data will be essential to inform dose selection and support the next phases of development.”

The Phase I / II multicenter, open‑label DOMISOL clinical study is evaluating DT‑7012 as monotherapy in a Phase I dose-escalation, in combination with the immune checkpoint inhibitor pembrolizumab in a Phase Ib dose-escalation in patients with advanced solid tumors, and in selected tumor types in a Phase II component focused on clinical efficacy. The primary objectives include determining the maximum tolerated dose ( MTD ) or maximum administered dose ( MAD ) of DT‑7012 as monotherapy and assessing the safety and tolerability of DT‑7012 in combination with pembrolizumab.

The study also includes a translational research program with paired tumor biopsies to evaluate intratumoral Treg depletion induced by DT‑7012, providing a direct demonstration of DT-7012’s mechanism of action to turn the immunosuppressive tumor microenvironment into an immunocompetent one.

Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics, added: “As our flagship program, DT‑7012 is central to Kainova Therapeutics’ strategy and reflects our commitment to advancing breakthrough GPCR‑modulating therapies in immuno‑oncology and inflammation. With multiple high‑value milestones ahead, 2026 is a pivotal year for Kainova Therapeutics. We are excited to expand the DOMISOL trial into Europe and we look forward to sharing compelling data in the coming quarters.”

ENDS

For more information, please contact:
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Elena Bates, Nellie Stephens
+44 (0) 203 882 9621
kainova@optimumcomms.com

For French media:
communication@kainovatx.com

• Phase I / II DOMISOL study design for DT-7012, a Treg-depleting anti-CCR8 antibody
• Comprehensive preclinical characterization of DT-7012, highlighting its differentiated binding and effector-function properties
• Biomarker analyses from the completed Phase I EPRAD study of DT-9081, an EP4 receptor antagonist

Montreal, Canada – Strasbourg, France – Boston, United States, March 26, 2026: Kainova Therapeutics ( “the Company” ), a key player for breakthrough treatments in immuno-oncology and inflammation, today announced that it will present clinical and preclinical updates from its oncology pipeline at the American Association for Cancer Research ( AACR ) Annual Meeting 2026, taking place April 17-22 in San Diego, California.

The presentations reflect the breadth of the Company’s GPCR-modulating programs, from preclinical mechanism of action studies to clinical trial design and translational biomarker evaluation.

Poster Presentation Details:

Poster Title: Comprehensive characterization of DT-7012, a highly differentiated anti-CCR8 depleting antibody
Session: Monoclonal Antibodies and Antibody-Cytokine Platforms
Date & Time: April 21, 2026, 9:00 AM -12:00 PM PST
Location: Poster Section 9
Poster Board Number: 27
Abstract Presentation Number: 4356

DT-7012 is a Phase I / II differentiated anti-CCR8 monoclonal antibody candidate designed to selectively deplete highly immunosuppressive regulatory T cells ( Tregs ). This poster will describe the preclinical characterization of DT-7012, including its unique CCR8 binding profile, effector-function potency, and selectivity compared with other clinical-stage CCR8-targeting antibodies.

Poster Title: Design and rationale of DOMISOL, a first-in-human Phase I / II study of
DT-7012 ( NCT06819735 ) in advanced solid tumors
Session: Phase I and Phase II Clinical Trials in Progress
Date & Time: April 21, 2026, 2:00-5:00 PM PST
Location: Poster Section 51
Poster Board Number: 19
Abstract Presentation Number: CT285

This poster will outline the design and scientific rationale of DOMISOL, the ongoing first-in-human, multicenter, open-label Phase I/II trial evaluating safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of DT-7012 in patients with advanced solid tumors.

Poster Title: Biomarker dynamics in the completed Phase I study of DT-9081: An analysis of ex vivo cytokine stimulation, urinary PGEM, and tumoral biomarkers in advanced solid tumors
Session: Biomarkers Predictive of Therapeutics Benefit 5
Date & Time: April 21, 2026, 9:00 AM -12:00 PM PST
Location: Poster Section 42
Poster Board Number: 5
Abstract Presentation Number: 5239

This poster will present integrated biomarker analyses from the completed Phase I EPRAD study of DT-9081, an oral EP4 receptor antagonist, including ex vivo cytokine stimulation, urinary PGEM, tumor-based biomarkers, and plasma cytokine dynamics.

Stephan Schann, Chief Scientific Officer of Kainova Therapeutics said: “We look forward to sharing these insights with the scientific community at AACR, as they reflect the scientific foundation of our GPCR-modulating programs and the thoughtful approach guiding their advancement. These learnings across preclinical, translational, and clinical contexts are essential to understanding where GPCR modulation may meaningfully shape therapeutic development.”

ENDS

For more information, please contact:
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Elena Bates, Nellie Stephens
+44 (0) 203 882 9621
kainova@optimumcomms.com

For French media:
communication@kainovatx.com

• Phase I results demonstrate favorable safety, sustained target engagement, and early signs of anti-tumor activity

• Reinforce EP4 receptor antagonism as a validated, high-value strategy to overcome immunotherapy resistance

Montreal, Canada – Strasbourg, France – Boston, United States: Kainova Therapeutics (“the Company”), a key player for breakthrough treatments in immuno-oncology and inflammation, today announced positive topline results from its Phase I EPRAD study evaluating DT-9081, a proprietary, oral small molecule EP4 receptor (EP4R) antagonist in patients with advanced, recurrent, and metastatic solid tumors.

The study, conducted across four sites in France and Belgium, met all primary objectives. Results demonstrated a favorable safety profile, robust pharmacokinetic (PK) and pharmacodynamic (PD) characteristics with dose-proportional exposure, and sustained EP4 receptor engagement across all tested doses, with early signs of anti-tumor activity.

No dose-limiting toxicities were reported at any dose level, confirming DT-9081’s clinical tolerability and validating its mechanism of action. The Phase I findings further support DT-9081’s potential to improve responses to immune checkpoint inhibitors (ICIs). Full Phase I study details are available on clinicaltrials.gov under identifier NCT05582850.

Professor Jean-Pascal Machiels, Principal Investigator of the EPRAD study, commented:“The results of the study not only validate EP4 receptor antagonism as a powerful mechanism to counteract PGE2-driven immune suppression, but also demonstrate the clinical potential of DT-9081 across a range of tumor types. Since chemotherapy and other standard treatments often trigger PGE2 production by cancer cells, restoring competence through selective EP4 inhibition offers a rational and versatile strategy to overcome resistance. It was my honor to contribute to the advancement of DT-9081 through the clinic.”

Dr Jean-Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics, said:“The Phase I EPRAD study generated a clear and coherent dataset that precisely characterizes DT-9081’s clinical profile. Across all dose levels, we observed consistent safety findings together with robust PK/PD readouts. The high-quality clinical and translational data obtained in this study are essential for understanding how EP4 antagonism behaves in patients with advanced solid tumors in a clinical setting.”

Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics, added:“The successful completion of this Phase I study represents an important step for Kainova Therapeutics, highlighting the strength of our innovative approach to targeting the EP4 receptor to overcome tumor-induced immunosuppression. The favorable safety and early efficacy signals observed with DT-9081 provide meaningful insight into EP4 biology and its role in immuno-oncology. These findings reflect the depth of expertise within our team and reinforce the relevance of GPCR-modulating strategies in addressing complex immune pathways.”

ENDS

For more information, please contact:
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Elena Bates, Nellie Stephens
+44 (0) 203 882 9621
kainova@optimumcomms.com

For French media:
communication@kainovatx.com

About Kainova Therapeutics

Kainova Therapeutics is a clinical-stage biopharmaceutical company, headquartered in Montreal, Canada, driving a robust pipeline of breakthrough therapies that precisely modulate G protein-coupled receptors (GPCRs) with a focus on immuno-oncology and inflammation. Kainova Therapeutics’ key programs include a unique clinical-stage Treg-depleting anti-CCR8 antibody with differentiated competitive features and a first-in-modality pre-IND stage biased antagonist of PAR2.

By unlocking challenging and unexploited GPCR targets through its integrated discovery-to-clinic approach that integrates deep biological knowledge, Kainova Therapeutics delivers highly differentiated therapies grounded in rigorous science and designed to improve therapeutic efficacy. Recognized for a solid track record of collaborations with major pharma, physicians and KOLs worldwide, Kainova Therapeutics brings scientific excellence to the development of GPCR-modulating therapies.

Operating in North America, France, and Australia, Kainova Therapeutics applies smart trial designs, capital efficiency, and operational rigor across its programs. As GPCRs gain renewed attention as next-generation drug targets, Kainova Therapeutics is uniquely positioned to lead this evolving field. For more information, please visit www.kainovatx.com

About DT-9081

DT-9081 is a best-in-class oral EP4 receptor antagonist designed to reverse Prostaglandin E2 (PGE2)-mediated immunosuppression within the tumor microenvironment. Preclinical studies have shown significant anti-tumor effects in triple-negative breast cancer, sarcoma, and colorectal cancer models, both as a monotherapy and in combination with chemotherapy or immune checkpoint inhibitors. PGE2, produced by COX-2 positive tumors, promotes tumor progression. By selectively inhibiting EP4 receptor, DT-9081 aims at restoring an immunocompetent environment and supporting immune reactivation, with the goal of improving the effectiveness of anticancer treatments, including chemotherapy and certain ICIs. The candidate is supported by a comprehensive biomarker strategy, enabling precise monitoring of EP4 receptor engagement during treatment and helping inform clinical positioning, de-risk development, and ensure an efficient, informative clinical trial strategy.

About GPCRs

G Protein-Coupled Receptors (GPCRs) are at the top of complex signaling cascades and are responsible for translating extracellular messages into intracellular actions, making them critical for various biological processes and attractive for therapeutic intervention. Despite being the most validated drug target family, with 30-35% of all marketed drugs acting on them, they remain challenging to drug, with existing drugs targeting only 10% of the total potential GPCR targets. While most efforts in GPCR drug discovery and development have traditionally focused on central nervous system and cardio-metabolic disorders, Kainova Therapeutics recognizes the substantial untapped potential of GPCRs in immuno-oncology and inflammatory diseases, areas where GPCRs have not been as extensively explored.

• Internationally Financing led by Investissement Québec with continued support from long-standing investors

• Plans include the acceleration of clinical development of breakthrough GPCR targeting treatments for patients

Montreal, Canada – Strasbourg, France – Boston, United States: Kainova Therapeutics (“the Company”), a key player for breakthrough treatments for patients in immuno-oncology and inflammation, today announced the successful first close of its Series B financing round totaling $32 million CAD. This financing round was led by Investissement Québec and was supported by existing investors CTI Life Sciences, Panacea Venture, 3B Future Health Fund, Seventure Partners, Viva BioInnovator, Turenne Capital, Schroders Capital, adMare BioInnovations, and Seido Capital.

The investment demonstrates strong confidence in Kainova Therapeutics’ strategic direction and supports the clinical advancement of its GPCR-targeting therapies. Lead asset DT-7012, a Treg-depleting anti-CCR8 antibody, is progressing in the ongoing Phase I/II DOMISOL trial for the treatment of solid tumors. The Company is also advancing other GPCR-targeting therapies, including DT-9081, an EP4 antagonist for solid tumors and DT-9046, a small molecule biased antagonist of PAR2 for inflammatory conditions, further positioning Kainova Therapeutics as a leader in global precision medicine.

Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics, said: “I am delighted to welcome Investissement Québec as a new investor in the Company and deeply appreciate the continued commitment from our investors. This financing is a strong endorsement of our distinctive scientific strategy, our leadership in GPCR innovation, and our well-defined pipeline of high-value programs with significant commercial potential. Securing this investment is especially significant given the current challenging fundraising environment, but exceptional science is still rewarded, and Kainova Therapeutics remains focused on advancing its robust clinical pipeline of GPCR targeting therapies and delivering breakthrough treatments for patients worldwide.”

Laurence Rulleau, Chair of the Board, and Managing Partner, CTI Life Sciences Fund, commented: “This financing marks a crucial moment in the realization of Kainova Therapeutics’ clinical roadmap and corporate growth. The team achieved significant clinical milestones during 2025, positioning the company at the forefront of GPCR innovation and demonstrating potential of value creation. We look forward with enthusiasm and are pleased to welcome Investissement Québec and Louis-Etienne Fortier to the Board of Directors to achieve the Company’s potential and vision of transforming patients’ lives.”

Bicha Ngo, President and Chief Executive Officer of Investissement Québec, added: “Investissement Québec is pleased to support the research and development of innovative solutions in a critical industry like life sciences. Through our participation in this significant financing effort, we are contributing to the relocation of the Company’s headquarters to Québec and laying the groundwork for a team with unique expertise in pharmaceutical development. Working in cooperation with the team at Kainova Therapeutics, we will deliver essential support to drive growth and foster further innovation.”

ENDS

For more information, please contact:
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Elena Bates, Nellie Stephens
+44 (0) 203 882 9621
kainova@optimumcomms.com

For French media:
communication@kainovatx.com

About Kainova Therapeutics

Kainova Therapeutics is a clinical-stage biopharmaceutical company, headquartered in Montreal, Canada, driving a robust pipeline of breakthrough therapies that precisely modulate G protein-coupled receptors (GPCRs) to transform patient outcomes, particularly in immuno-oncology and inflammation. Kainova Therapeutics’ key programs include a unique clinical stage Treg-depleting anti-CCR8 antibody with differentiated competitive features and a first in-class pre-IND stage biased antagonist of PAR2.

By unlocking challenging and unexploited GPCR targets through its validated approach that integrates deep biological knowledge, Kainova Therapeutics delivers highly differentiated therapies designed to address unmet medical needs and improve therapeutic efficacy. Grounded in scientific excellence and recognized for a solid track record of collaborations with major pharma, physicians and KOLs worldwide, Kainova Therapeutics creates long-term value in competitive and fast-expanding markets.

Operating in North America, France, and Australia, Kainova Therapeutics is progressing with clinical momentum towards global commercialization. As GPCRs gain renewed attention as next-generation drug targets, Kainova Therapeutics is uniquely positioned to lead the field, combining deep biological insight with commercial maturity to drive global impact. For more information, please visit https://www.kainovatx.com

About Investissement Québec

Investissement Québec's mission is to actively participate in the economic development of Quebec by stimulating innovation in businesses, entrepreneurship and takeover as well as the growth of investment and exports. Active in all administrative regions of Quebec, the Company supports the creation and development of businesses of all sizes through investments and adapted financial solutions. Investissement Québec also supports businesses through advisory services and other support measures, notably through the Impulsion PME program, an initiative of the Government of Quebec (MEIE). For more information, please visit https://www.investquebec.com