On October 22, 2025 I-Mab (NASDAQ: IMAB) (I-Mab or the Company), is a global biotechnology platform company committed to accelerating access to innovative medicines for patients worldwide, reported that updated data from the Phase 1 study (NCT04900818) of givastomig as a monotherapy in heavily pre-treated patients (n=45) with gastroesophageal carcinoma (GEC) will be presented as a "short-talk" at the Triple Meeting on October 23, 2025 in Boston, Massachusetts (Presentation #B016). Givastomig is a bispecific antibody targeting CLDN18.2 (Claudin 18.2) and 4-1BB.

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"The Phase 1 givastomig monotherapy data that will be shared at the Triple Meeting continue to demonstrate impressive safety and efficacy, with an 18% ORR in heavily pre-treated gastric cancer patients, with favorable overall safety. These data, showing responses over a dose range from 5 mg/kg Q2W to 18 mg/kg Q3W, further enrich givastomig’s emerging product profile and bolster our confidence that givastomig has the potential to be a best-in-class Claudin18.2-directed therapy across a broad range of CLDN18.2 expression. In Q1 2026, we expect to report topline results from the fully-enrolled Phase 1b dose expansion immune-chemotherapy combination study and initiate a global, randomized Phase 2 combination study. We believe the data from these studies will clearly demonstrate givastomig’s potential to significantly improve the standard of care in the treatment of first line GEC patients with a broad range of Claudin 18.2 expression levels," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab.

"In our experience, givastomig integrates well into the workflow at our center. Based on the monotherapy efficacy across a range of doses and Claudin 18.2 expression levels, and excellent overall safety, givastomig has the potential to be the best-in-class Claudin-directed therapy and combination partner for the treatment of frontline gastric cancer. These follow-up data, plus encouraging initial results from the Phase 1b immune-chemotherapy frontline combination studies, presented earlier this year, give us hope that givastomig treatment can lead to improved treatment outcomes for patients with gastric cancers. We are eager to move forward with the planned Phase 2 study and continue to advance this program," said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital.

AACR-NCI-EORTC "the Triple Meeting" Conference Information:

Title: Updated Safety, Efficacy and Biomarker Analysis from the Phase I Study of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Claudin 18.2 Positive Advanced Gastroesophageal Carcinoma (GEC)

Session: Concurrent Session 2: Bispecifics/T-cell Engagers

Speaker: Samuel J. Klempner, MD, Associate Professor of Medicine, Massachusetts General Hospital

Presentation Number: B016

Date and Time: Thursday, October 23, 2025, 6:20 – 6:35 PM ET

Location: Hynes Convention Center

A copy of the Triple Meeting presentation and poster will be available on the Publications and Presentations page of the I-Mab website on October 23, 2025.

Givastomig Phase 1 Monotherapy Updated data Summary GEC (per June 10, 2025 data cut-off):

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Givastomig was well tolerated up to 15 mg/kg Q2W and 18 mg/kg Q3W and continues to show monotherapy activity in heavily pre-treated GEC patients with a wide range of CLDN18.2 expression
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Givastomig may have the ability to target patients with lower CLDN18.2 expression compared with other CLDN18.2 agents
Patients Characteristics:

•
45 GEC patients were dosed with givastomig every two weeks (Q2W) across dose levels of: 5mg/kg (n=7), 8 mg/kg (n=5), 12 mg/kg (n=21), 15 mg/kg (n=6) and 18 mg/kg Q3W (n=6) as of the June 10, 2025 data cutoff
•
Patients had received a median of 3 prior therapies including 74% with a prior PD-L1 inhibitor
Efficacy Results:

•
Confirmed Objective Response Rate (ORR):
o
18% of patients (8/45) achieved a partial response (PR)
▪
5 mg/kg (1/7)
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8 mg/kg (1/5)
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12 mg/kg (4/21)
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15 mg (0/6)
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18 mg/kg Q3W (2/6)
o
Claudin 18.2 expression in responders ranged from 11% (1+, 10%; 2+, 1%) to 100% (2+, 10%; 3+, 90%)
•
The Disease Control Rate (DCR) was 49%, including stable disease (SD) in 14 patients
Follow-up and Biomarker Data:

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2 patients are ongoing (4%), with 1 PR (8 mg/kg) at 33 months (mo), and 1 PR (18 mg/kg Q3W) at 10 mo
•
The median progression free survival (mPFS) and median overall survival (mOS) are 2.96 mo (95% CI 1.71-3.91) and 7.49 mo (95% CI 4.96-12.5), respectively

No statistical difference in ORR, DCR, PFS or OS, between CLDN18.2-high (n=21) and CLDN18.2-low patients (n=24): ORR 19% v. 17% (p=1.00), DCR 57% v. 42% (p=0.46), mPFS 3.68 mo v. 1.84 mo, PFS hazard ratio (HR) 0.87 (p=0.67), and mOS 7.49 mo v. 7.49 mo, OS HR 0.88 (p=0.74), respectively
Safety:

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There were no new safety signals identified with longer follow-up
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No dose limiting toxicities were observed
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Common TREAEs (≥15%, any grade/grade 3) included anemia (27%/9%), white blood cell count decrease (22%/7%), nausea (20%/2%), ALT increase (16%/2%) and AST increase (16%/4%)
About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

(Press release, I-Mab Biopharma, OCT 22, 2025, View Source [SID1234656898])

On October 22, 2025 Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, and the University Hospitals Birmingham NHS Foundation Trust, reported new overall survival (OS) insights from the PROCLIPI (PROgnostic Cutaneous Lymphoma International Prognostic Index) Study aligning with previous findings that suggest mogamulizumab may offer meaningful OS benefit for patients living with mycosis fungoides (MF) and Sézary syndrome (SS), two rare conditions and subtypes of cutaneous T-cell lymphoma (CTCL).

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Key findings2:

For patients with advanced-stage MF and SS (n=371), the median overall survival from the onset of treatment was higher for patients treated with mogamulizumab (n=72) at 64 months compared with those not receiving mogamulizumab (n=175) at 54 months (p<0.01).
Patients treated with mogamulizumab showed a trend toward improved OS compared to those not receiving mogamulizumab across risk-stratified groups according to the new Cutaneous Lymphoma International Prognostic Index (CLIPI).
For a subset of patients with SS (n=96), the median OS is around 6.5 years for patients treated with mogamulizumab (n=46) compared with around 3 years for systemic treatment but not mogamulizumab (n=50) (p<0.01).
This research was presented as part of the Scientific Proceedings at this year’s European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) Annual Meeting in Athens, Greece.2 The data contributes to a growing body of evidence suggesting potential OS benefits with mogamulizumab, 4,5 highlighting the importance of collaboration across the CTCL community in advancing understanding of survival outcomes and helping to shape the future of patient care.

"The PROCLIPI Study demonstrates the power of global collaboration in rare diseases. By bringing together data from across the world, we can generate insights that simply wouldn’t be possible in isolation," says Professor Julia Scarisbrick, Chief Investigator of the PROCLIPI Study and Honorary Professor of Dermatology, University Hospitals Birmingham NHS Foundation Trust. "We are proud to coordinate this initiative as we’re working to build rigorous scientific evidence while giving patients and their families a better understanding of what long-term survival looks like."

The PROCLIPI Study, now in its tenth year, aims to develop prognostic indices for MF and SS. The study collects comprehensive data, including clinical, haematological, pathological, imaging, treatment with responses, quality of life and survival data.1 Recently, a new prognostic index (CLIPI) for advanced CTCL was published to enable precise patient risk stratification.6

"For those of us in the CTCL community, survival isn’t just about numbers on a chart – it’s about being able to spend more time with our families, plan for the future, and live life with dignity", says Susan Thornton, CEO, Cutaneous Lymphoma Foundation. "That’s why initiatives like PROCLIPI are important, as the data collected reflects real lived experiences and can help inform future improvements in care for patients."

The independent international PROCLIPI Study aligns with Kyowa Kirin International’s commitment to generating real-world insights that advance the understanding of CTCL and turn these clinical insights into meaningful improvements in access, policy, and patient care.

Cutaneous T-cell lymphoma is a rare disease7, and innovation in this environment can be challenging due to the rarity of this disease.8 Yet despite these challenges, mounting evidence continues to emerge4,5 to help strengthen our collective understanding of potential treatment benefits.

"These insights into improved overall survival for patients living with CTCL mark an important step forward, providing a stronger clinical evidence base and reinforcing the value of international networks in rare disease research," says Dr Nick Kronfeld, Head of Medical Affairs, Kyowa Kirin International. "By working alongside scientific and patient communities in CTCL, we can gain a better understanding of real-world outcomes, enabling us to bring life-changing value to patients and families, not just today but over the long term."

Note to editors

The OS data from the PROCLIPI Study was presented as an oral presentation during the EORTC CTCL Annual Group Meeting 2025.2 KKI did not sponsor the PROCLIPI study or OS analysis.
The median OS for patients (n=72) receiving mogamulizumab compared to those not receiving mogamulizumab (n=175) was 64 months versus 54 months.2
Median OS data amongst risk stratifications according to CLIPI: 2,6
Low-risk: 67 months vs. ‘not reached’ for mogamulizumab versus those who had not received mogamulizumab
Medium-risk: 64 vs. 48 months for mogamulizumab versus those who had not received mogamulizumab
High-risk: 26 vs. 13 months for mogamulizumab and for those who had not received mogamulizumab

(Press release, Kyowa Hakko Kirin, OCT 22, 2025, View Source [SID1234656914])

On October 22, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines in oncology and autoimmune disease, reported the initiation of the DAYBreak clinical trial, a pivotal single-arm Phase 2 study of bexobrutideg (NX-5948) in patients with relapsed or refractory chronic lymphocytic leukemia.

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DAYBreak and the planned Phase 3 confirmatory study of bexobrutideg will evaluate the 600 mg dose taken once daily (QD). The selection of the 600 mg dose follows the completion of the analysis of data from a randomized cohort within the Phase 1b study comparing 200 mg and 600 mg in accordance with Project Optimus and reflects alignment with global regulators including the U.S. Food and Drug Administration, the U.K Medicines and Healthcare products Regulatory Agency, and the European Medicines Agency.

In an investor webcast at 8:00 a.m. ET, today, Wednesday, October 22, 2025, Nurix will provide a program update including a review of new preclinical data supporting the potential best-in-class BTK degrader profile of bexobrutideg and discuss the DAYBreak and planned Phase 3 confirmatory studies.

"The initiation of the DAYBreak study marks Nurix’s transition to a pivotal-stage company and a major milestone for bexobrutideg, which our data demonstrate has a potential best-in-class profile," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "With the DAYBreak study underway, we are advancing the development of bexobrutideg and are one step closer to registration and commercialization."

The DAYBreak study will enroll patients with r/r CLL who have experienced disease progression following treatment with a covalent BTK inhibitor (cBTKi), a BCL-2 inhibitor (BCL-2i), and a non-covalent BTK inhibitor (ncBTKi). The DAYBreak study aims to evaluate bexobrutideg’s potential to address an unmet medical need in this patient population and generate data to support a potential Accelerated Approval submission.

Nurix plans to initiate a randomized confirmatory Phase 3 trial in the first half of 2026 in r/r CLL patients whose disease has previously progressed while receiving a cBTKi. This global Phase 3 confirmatory trial in patients treated in the second line or later setting will compare bexobrutideg monotherapy to an investigator’s choice of pirtobrutinib monotherapy (a ncBTKi), bendamustine + rituximab, or idelalisib + rituximab.

"The favorable safety profile observed at the 600 mg bexobrutideg dose allows us to optimize its therapeutic effect, providing patients the opportunity to regain control of CLL that has progressed or has failed to respond to other therapies," said Paula O’Connor, M.D., chief medical officer of Nurix. "With regulatory alignment, we are advancing a global registrational program intended to address a large unmet need for patients with relapsed or refractory CLL. We look forward to completing this pivotal Phase 2 study and our confirmatory Phase 3 trial as part of our comprehensive development plan designed to provide patients with a much-needed therapeutic alternative.

As an innovator in the field of targeted protein degradation, Nurix has generated significant data to support bexobrutideg’s potential best-in-class BTK degrader profile.

"During our upcoming conference call, we will share highlights from our latest, unpublished preclinical data demonstrating superior degradation potency, broad coverage of clinically relevant BTK mutations, and exquisite selectivity, which together set a high bar for this class of medicines," said Gwenn Hansen, Ph.D., chief scientific officer of Nurix. "These superior attributes strengthen our conviction that bexobrutideg may prove to be a clinically superior medicine for the treatment of patients with CLL and other B-cell driven diseases."

Investor webcast
Nurix will host an investor webcast today, October 22, 2025, at 8:00 a.m. EDT. A live webcast and replay of today’s event will be available on the Investors section of the Nurix website at View Source A copy of the materials to be presented at the Investor Update will be filed in an accompanying Form 8-K filing and may be found at View Source

(Press release, Nurix Therapeutics, OCT 22, 2025, View Source [SID1234656899])

On October 22, 2025 GemPharmatech, a global leader in preclinical research solutions and genetically-engineered mouse models, reported a collaboration with Memorial Sloan Kettering Cancer Center (MSK) to accelerate the discovery of new therapeutic antibodies.

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Through the non-exclusive agreement, researchers at Memorial Sloan Kettering will have access to GemPharmatech’s extensive preclinical service capabilities and resources, utilizing the NeoMab platform — a next-generation transgenic mouse model designed for rapid, efficient discovery of fully human therapeutic antibodies. The collaboration will help scientists at Memorial Sloan Kettering who are already tapping a wide range of leading-edge preclinical resources to further accelerate the development of fully human therapeutic antibodies against high-value targets and address urgent, unmet needs in cancer treatment.

"Our mission has always been to enable transformative biomedical research through innovative mouse models and technologies," said Dr. Xiang Gao, founder of GemPharmatech. "Collaborating with MSK on antibody discovery represents a powerful opportunity to combine scientific excellence with cutting-edge mouse models such as NeoMab. Together, we can accelerate the development of novel therapeutics that address some of the most urgent challenges in cancer treatment."

Part of the world’s largest library of genetically engineered mouse models (GEMMs), the immunoglobulin gene-humanized mouse model- NeoMab, carries the full variable gene repertoire of human heavy and kappa light chains, and regulatory elements, in a BALB/c background. This innovative design enables the rapid generation of diverse, high-affinity fully human antibodies without the need for time-consuming sequence humanization steps. By skipping this process, the collaboration aims to shorten antibody development timelines and reduce immunogenicity risks.

"This collaboration underscores our mission to provide the global research community with advanced platforms to accelerate innovations in drug discovery," said Dr. Brandy Wilkinson, Chief Executive Officer of GemPharmatech. "We are excited to be supporting MSK’s pioneering work in oncology research with the NeoMab platform. It is an honor to contribute to their scientific mission and to help advance antibody programs with the potential to transform therapies and improve patient outcomes worldwide."

(Press release, Memorial Sloan-Kettering Cancer Center, OCT 22, 2025, View Source [SID1234656915])

On October 22, 2025 Onco3R Therapeutics, a clinical-stage immunology and oncology biotech company dedicated to transforming patients’ lives with best-in-class medicines, reported that it will present preclinical data from its FGFR3, SMARCA2 and P53 Y220C small molecules programs in 3 posters at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place October 22-26, 2025, in Boston.

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"First generation precision medicines are often suboptimal in the clinic due to low target coverage, off-target toxicity and emergence of resistance. At Onco3R, our vision is to design best-in-class medicines to address the unmet needs left by first generation drugs and unlock the full potential of therapeutic targets" said François Gonzalvez, PhD, CSO and co-Founder of Onco3R Therapeutics.

"We are thrilled to present the first preclinical data from our lead oncology programs FGFR3, SMARCA2 and P53 Y220C. Each program has identified best-in-class molecules which offer the potential to deliver transformational efficacy and improved tolerability for patients. Our FGFR3 and SMARCA2 candidates, G-012 and G-141 respectively, have reached the optimum potency and selectivity profile to mitigate dose-limiting toxicities while maintaining maximum target coverage. This has translated into robust anti-tumor activity in vivo. The poster presentations will highlight data supporting the advancement of these two candidates towards the clinic, as well as the discovery of unique small molecule P53 reactivators."

"These compelling preclinical results further validate our patient-centric drug discovery approach, which integrates deep translational science with rational, structure-based and AI-augmented drug design", Pierre Raboisson, PhD, CEO and co-Founder of Onco3R Therapeutics said. "We look forward to advancing these two candidates and remain on track to initiate IND-enabling studies in mid-2026. The identification of these candidates, alongside the continued clinical progress of our SIK3 inhibitor O3R-5671 in autoimmune indications, reinforces Onco3R’s strong strategic position. With a robust pipeline and clear execution momentum, we are confidently advancing toward our next value-driving milestones."

Presentation details

Title: Discovery of Best-in-Class FGFR3 small molecule inhibitors with high isoform selectivity and activity against gatekeeper mutations

Session: Poster Session C

Session Date and Time: Saturday, October 25, 12:30-4pm

Presenting author: Sandrine Vendeville, PhD

Key findings from preclinical studies include:

G-012 demonstrated best-in-class potency and selectivity with favorable drug-like properties.

Based on translational modelling, the compound reached the optimal selectivity against other FGFR isoforms to mitigate off-target toxicity and maintain maximal target coverage.

G-012 showed robust anti-proliferative activity in FGFR3-driven cancer cells and induced significant tumor regression in vivo.

G-012 is currently advancing in 14 days toxicology studies.

IND-enabling studies are anticipated in mid-2026.

Title: Discovery of novel SMARCA2 small molecule inhibitors with best-in-class potency and selectivity for the treatment of SMARCA4-mutant cancers

Session: Poster Session C

Session Date and Time: Saturday, October 25, 12:30-4pm

Presenting author: Lijs Beke, PhD

Key findings from preclinical studies include:

G-141 combined best-in-class cellular potency and selectivity to allow optimal target coverage and unlock the full therapeutic potential of SMARCA2 inhibition.

The compound showed synthetic lethality in SMARCA4-deficient cells and induced robust anti-tumor activity in vivo without signs of SMARCA4-related toxicity.

G-141 showed favorable drug-like properties and is currently advancing in 14 days toxicology studies.

IND-enabling studies are anticipated in mid-2026.

Title: Discovery of a Best-in-Class small molecule p53 Y220C reactivator: Breaking through the potency ceiling

Session: Poster Session C

Session Date and Time: Saturday, October 25, 12:30-4pm

Presenting author: François Gonzalvez, PhD

Key findings from preclinical studies include:

Onco3R patient-centric drug discovery approach identified unique small molecule P53 reactivators with best-in-class cellular potency.

Onco3R leads exhibit the optimal potency and residence time to induce deep and sustain target engagement and fully unlock the tumor suppressive function of P53 in cells.

This translated into robust anti-proliferative activity in P53 Y220C mutant cancer cell lines (single digit nanomolar IC50s) and tumor regression in a Y220C P53 mutant xenograft model.

Further characterization of the lead candidates is ongoing.

(Press release, Onco3R Therapeutics, OCT 22, 2025, View Source [SID1234656951])