On July 2, 2025 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, reported the publication of a paper entitled, "A CXCR4 Partial Agonist, Improves Immunotherapy by Targeting Immunosuppressive Neutrophils and Cancer-Driven Granulopoiesis,"1 in the peer-reviewed journal Cancer Cell, that represents a collaboration between scientists at Tonix and Columbia University’s Medical School and presents data demonstrating that treatment with murine TNX-1700 (mTNX-1700) increased survival and decreased metastases in animal models of gastric cancer (Press release, TONIX Pharmaceuticals, JUL 2, 2025, View Source [SID1234654223]). The manuscript can be accessed here: http://bit.ly/3I7Wcvu.

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"Addressing the root causes of resistance to immunotherapy in solid tumors is a hurdle for the successful application of immuno-oncology to anti-PD-1 resistant cancers," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "The combination therapy of mTFF2-MSA with anti-PD1 treatment shows significant promise in reducing the ability of tumors to evade anti-PD-1 therapy in animal models. We believe the published data support further development of TNX-1700 as an approach to overcome resistance to anti-PD-1 immunotherapy in the treatment of gastric cancer and other tumors."

The published studies examined mTNX-1700, which is a fusion protein of murine trefoil factor-2 (mTFF2) and murine serum albumin (MSA). The human version, TNX-1700 is a fusion protein of human TFF2 (hTFF2) and human serum albumin (HSA) that is under development for the treatment of gastric and colorectal cancers.

Dr. Lederman added, "The study showed that in several mouse models, mTNX-1700 plus anti-PD-1 shrank primary tumors, cut liver and lung metastases, and increased survival compared to anti-PD-1 alone. These data show that fine-tuned modulation of CXCR4 can dismantle neutrophil-driven immune suppression and revive checkpoint efficacy without compromising normal myelopoiesis. We are excited, through our collaboration with Columbia University, to continue studies to identify potential clinical biomarkers through preclinical models while enhancing our understanding of the relationship between the role of TFF2 in overcoming resistance to anti-PD1 therapy in the tumor microenvironment (TME)."

Immunosuppressive neutrophils, also known as polymorphonuclear myeloid-derived suppressor cells (PMN-MDSCs), are a major component in solid tumors that significantly hinder anti-tumor activity2,3. Despite being short-lived, the continuous replenishment of PMN-MDSCs from the bone marrow sustains their potent immunosuppression in the TME4. Stromal cells in the TME promote immunosuppression by recruiting MDSCs via secretion of CXCL12. Trefoil Factor 2 (TFF2), a secreted peptide of the trefoil factor family, has displayed activity as a partial agonist of CXCR45,6. The Cancer Cell publication describes data demonstrating that TFF2-MSA selectively reduces immunosuppressive neutrophils and cancer-driven granulopoiesis. Treatment with TFF2-MSA, in combination with an anti-PD1 antibody, induced robust anti-tumoral CD8+ T cell responses, inhibiting tumor invasion. This combination of the mTNX-1700 with anti-PD1 therapy has been shown to reduce tumor size and increase survival in these animal models. TFF2 reduction correlated with elevated PMN-MDSCs in gastric cancer patients, highlighting the potential negative correlation between TFF2 and PMN-MDSCs levels while promoting a T-cell rich microenvironment and inducing an increase in CD8+ T cells in the tumor.

About Trefoil Factor Family Member 2 (TFF2)

Human TFF2 is a secreted protein, encoded by the TFF2 gene in humans, that is expressed in gastrointestinal mucosa where it functions to protect and repair mucosa. TFF2 is also expressed at low levels in splenic immune cells and is now appreciated to have intravascular roles in the spleen and in the tumor microenvironment. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms. Tonix is developing TNX-1700 for the treatment of gastric and colorectal cancers under a license from Columbia University. The inventor of the core technology at Columbia is Dr. Timothy Wang, who is an expert in the molecular mechanisms of carcinogenesis whose research has focused on the carcinogenic role of inflammation in modulating stem cell functions. Dr. Wang demonstrated that knocking out the mTFF2 gene in mice leads to faster tumor growth and that overexpression of TFF2 markedly suppresses tumor growth by curtailing the homing, differentiation, and expansion of MDSCs to allow activation of cancer-killing CD8+ T cells. He went on to show that a novel engineered form of recombinant murine TFF2 (mTFF2-CTP) had an extended half-life in vivo and was able to suppress MDSCs and tumor growth in an animal model of colorectal cancer. Later, he showed in gastric cancer models that suppressing MDSCs using chemotherapy enhances the effectiveness of anti-PD1 therapy and significantly reduces tumor growth. Dr. Wang proposed the concept of employing recombinant TFF2 in combination with other therapies in cancer prevention and early treatment.

On July 2, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody (Press release, Regeneron, JUL 2, 2025, View Source [SID1234654222]). Lynozyfic was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody that can be dosed every two weeks starting at week 14, and every four weeks if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy. The regimen includes hospitalization for safety during the step-up dosing period (one 24-hour period after the first step-up dose, and another 24-hour period after the second step-up dose).

"The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community. Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients, which I saw firsthand in clinical trials," said Sundar Jagannath, M.D., Network Director of the Center of Excellence for Multiple Myeloma at Mount Sinai in New York City and a trial investigator. "Lynozyfic has a convenient response-adapted dosing regimen, which provides the potential to extend time between doses. This is a significant patient-centric advancement that could help reduce treatment burden."

The FDA approval is based on results from the pivotal Phase 1/2 LINKER-MM1 trial investigating linvoseltamab in R/R MM in which patients (n=80) experienced a:

70% objective response rate (ORR), with 45% achieving a complete response (CR) or better, as determined by an independent review committee.
0.95 month median time to first response (range: 0.5 to 6 months).
Median duration of response (DoR) that was not reached (95% Confidence Interval [CI]: 12 months to not estimable). The estimated DoR was 89% at 9 months (95% CI: 77 to 95 months) and 72% at 12 months (95% CI: 54 to 84 months) among responders who had a median follow-up of 13 months.

The prescribing information for Lynozyfic has a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity – including immune effector cell-associated neurotoxicity syndrome – in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity. The most common adverse reactions (≥20%) in the safety population of LINKER-MM1 (n=117) were musculoskeletal pain, CRS, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache and dyspnea. The most common Grade 3 or 4 laboratory abnormalities (≥30%) were decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin and decreased white blood cell count. Lynozyfic is available only through a restricted program called the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS). Details of the Important Safety Information are included below.

"The FDA approval of Lynozyfic reinforces the strength of our bispecific antibody program as well as our commitment to delivering critical medicines to the cancer community," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. "With a 70% overall response rate in heavily pre-treated patients, we believe Lynozyfic is poised to potentially become a new standard of care for multiple myeloma. Furthermore, given the strength of the data, we are rapidly advancing our broad clinical development program for Lynozyfic – exploring its use in earlier lines of therapy as monotherapy and in novel combinations – as we aim to meaningfully advance care for patients."

Regeneron is committed to helping patients who have been prescribed Lynozyfic access their medication. The company has launched Lynozyfic Surround, which offers financial and educational resources to help support patients throughout their treatment journey. For more information, patients can call 1-844-RGN-HEME (1-844-746-4363).

"Even though the number of treatment options for multiple myeloma has expanded in recent years, it remains an incurable disease with considerable unmet need, especially among patients who have undergone multiple lines of treatment," said Diane Moran, R.N., M.A., Ed.M., Chief Executive Officer (Interim) and Senior Vice President of Strategic Planning at the International Myeloma Foundation. "The FDA approval of Lynozyfic is a welcome milestone. It provides appropriate multiple myeloma patients and their care teams with a novel patient-centric treatment option that includes a dosing schedule that can be adapted based on patient response. We appreciate Regeneron’s continued research to further advance treatment for this community."

About Multiple Myeloma

As the second most common blood cancer, there are over 187,000 new cases of MM diagnosed globally every year, with more than 36,000 diagnosed and 12,000 deaths anticipated in the U.S. in 2025. In the U.S., there are approximately 8,000 people who have MM that has progressed after three lines of therapy, and 4,000 whose disease has progressed after four or more therapies.

The disease is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Despite treatment advances, MM is not curable and while current treatments are able to slow progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.

About Lynozyfic (linvoseltamab-gcpt)

Lynozyfic was invented using Regeneron’s VelocImmune technology and is a fully human BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Linvoseltamab is administered with an initial step-up dosing regimen followed by the full 200 mg dose administered weekly. At week 14, patients transition to every two-week dosing. A response-adapted regimen further enables patients to shift to every four-week dosing if they achieve and maintain a VGPR or better after having completed at least 24 weeks of therapy. Patients should be hospitalized for 24 hours after administration of the first step-up dose and for 24 hours after administration of the second step-up dose, with the potential for additional hospitalization if patients experience certain adverse events.

The generic name for Lynozyfic in its approved U.S. indication is linvoseltamab-gcpt with gcpt as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Outside of the U.S., the generic name of Lynozyfic in its approved indications is linvoseltamab. Lynozyfic is also approved in the European Union to treat adults with R/R MM after at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu in due course.

About the Linvoseltamab Clinical Development Program

The ongoing, open-label, multicenter Phase 1/2 dose-escalation and dose-expansion LINKER-MM1 trial is investigating linvoseltamab in more than 300 enrolled patients with R/R MM. The Phase 1 intravenous dose-escalation portion of the trial – which is now complete – primarily assessed safety, tolerability and dose-limiting toxicities across nine dose levels of linvoseltamab and explored different administration regimens. A subcutaneous Phase 1 portion is ongoing. The Phase 2 intravenous dose expansion portion is ongoing and assessing the safety and anti-tumor activity of linvoseltamab, with the primary endpoint of ORR. Key secondary endpoints include DoR, progression-free survival, rate of minimum residual disease negative status and overall survival.

Linvoseltamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens across different lines of therapy in MM, including earlier lines of treatment, as well as MM precursor and other plasma cell disorders. This includes evaluating linvoseltamab in a Phase 1b trial (LINKER-MM2) in combination with other cancer treatments in R/R MM as well as a Phase 3 confirmatory trial (LINKER-MM3) as a monotherapy in R/R MM. For more information on Regeneron’s clinical trials in blood cancer, visit the clinical trials website, or contact via [email protected] or 1-844-734-6643.

On July 2, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported the signature of a license and commercial agreement with Clinigen, a global specialty pharmaceutical services group and a leading European player in hospital distribution and market access, to streamline the pathway for ensuring access to this medicine across Europe (Press release, MaaT Pharma, JUL 2, 2025, View Source [SID1234654220]). With this partnership, MaaT Pharma demonstrates its capability to supply products to pharmaceutical companies, including those specializing in rare diseases while ensuring scale-ups for commercial and extending its cash runway into January 2026.

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Hervé Affagard, CEO and co-founder of MaaT Pharma says: "This deal is a pivotal step in bridging MaaT Pharma’s innovation with healthcare professionals who care for patients with aGvHD. Clinigen’s hemato-oncology expertise and leading European position in hospital distribution and market access make this team the ideal fit to bring this therapy to patients and we’re confident that this new relationship will maximize the full revenue generation potential of full revenue generation potential of Xervyteg (MaaT013). I look forward to working closely with the Clinigen team as we prepare for a successful launch."

Jerome Charton, CEO of Clinigen, says: "Following the EMA’s acceptance of MaaT Pharma’s submission of an application for assessment for MaaT013 in June, we are very excited about this new relationship. This collaboration brings a novel technology to the forefront of rare disease and oncology care. We’re proud to play a leading role in ensuring access across Europe to this innovative therapy, and we look forward to working closely with MaaT Pharma as we prepare for potential launch."

Transaction Terms

Under the terms of the agreement, MaaT Pharma will grant Clinigen exclusive European rights to distribute this medicine for the treatment of patients with aGvHD, if approved by the EMA. MaaT Pharma will receive an upfront payment of €10.5 million and additional eligible payments of up to €18 million depending on the achievement of pre-specified regulatory and sales milestones. MaaT Pharma will also be eligible to receive royalty payments on net sales of a percentage in the mid-thirties and regular cash flow as per the supply agreement.

The hematology community has expressed interest in this medicine and this class of medicines to treat patients with aGvHD, as evidenced by the growing requests of Early Access Program between 2023 and 2024 (+75%). This program has been active in Europe since 2019. Under the terms of the agreement, Clinigen will take over this activity to meet the growing expectations of physicians while allowing MaaT Pharma to optimize its internal resources. This transition enhances MaaT Pharma’s capacity to focus on clinical development, regulatory milestones, and industrial scale-up.

MaaT Pharma management will host a conference call and webcast tomorrow Thursday, July 3nd, 2025, at 3:00pm CET/ 9:00am EDT/ 6:00am PT/ 9:00pm CST. To register, please click here. Participants can also attend the conference by phone by dialing the following number: +33 1 78 42 94 76 + and using the PIN code 43 92 58

On July 2, 2025 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported the clearance of an Investigational New Drug (IND) application for AXN-2510 ("’2510") by the U.S. Food and Drug Administration (Press release, Instil Bio, JUL 2, 2025, View Source [SID1234654219]).

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Instil expects to initiate a phase 1 trial of ‘2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025. The trial is designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of ‘2510 in patients with solid tumors. Additionally, Instil continues to anticipate that initial safety and efficacy results from the ongoing phase 2 study of ‘2510 in combination with chemotherapy in first-line NSCLC in China will be shared in the second half of 2025 by ImmuneOnco.

"We are pleased to announce the clearance of the ‘2510 IND by the FDA," said Jamie Freedman, M.D., Ph.D., Chief Medical Officer of Instil. "Evaluating ‘2510 in a global population will be a critical milestone in the clinical development of ‘2510."

On July 2, 2025 I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported the presentation of positive Phase 1b combination data for givastomig, in combination with nivolumab and mFOLFOX6, at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) in Barcelona (abstract #388MO) (Press release, I-Mab Biopharma, JUL 2, 2025, View Source [SID1234654218]). Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB. I-Mab plans to host a virtual investor event on Tuesday, July 8th (register here) to review these data.

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The Phase 1b data (NCT04900818) show a confirmed objective response rate (ORR) of 71% across all doses (12/17), and 83% (10/12) at doses selected for the ongoing dose expansion study (8 mg/kg and 12 mg/kg). Responses occurred in tumors with low levels of PD-L1 expression and/or Claudin 18.2 (CLDN18.2) expression, with favorable overall tolerability. There were no Grade 3 or greater events for nausea and vomiting, and only one Grade 3 TRAE for increased liver enzymes. The data are based on the results of the dose escalation part of a Phase 1b study evaluating the givastomig combination as first line therapy (1L) in patients with Claudin 18.2-positive gastric cancers (≥1+ IHC staining intensity in ≥1% of tumor cells). The primary endpoint is safety. The study enrolled only patients in the U.S.

"The positive Phase 1b combination data presented at ESMO (Free ESMO Whitepaper) GI bolster our confidence in givastomig’s potential to be a best-in-class Claudin 18.2 directed therapy. Givastomig has been well tolerated when combined with immuno-oncology and chemotherapy, has shown a high objective response rate, with rapid onset and durable responses that have deepened over time, supported by consistent pharmacokinetic data and soluble 4-1BB induction," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "In addition, we are optimistic about the results from the 8 mg/kg and 12 mg/kg doses. These doses showed an ORR of 83%, with consistent responses across PD-L1 and Claudin 18.2 expression levels, and a favorable overall safety profile. These data further our conviction in the ongoing Phase 1b dose expansion study. We believe givastomig has broad potential in a number of gastric cancer settings and look forward to continued advancement of the program."

"I am encouraged by the response rates, as well as the deepening of responses over time, demonstrated by the givastomig combination regimen in the Phase 1b dose escalation study that we presented today at ESMO (Free ESMO Whitepaper) GI. Despite approved therapies, targeted treatment options for gastric cancers continue to be limited. While the data are early, givastomig combination therapy demonstrates a high response rate across Claudin18.2 and PD-L1 expression levels," said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. "In addition, I have been pleased to observe that givastomig has a favorable overall tolerability profile with a low level of gastrointestinal side effects — especially important for patients with gastric cancer. I look forward to participating in the ongoing givastomig clinical development program, and hope we may be able to expand the population of patients who may benefit from Claudin 18.2 directed agents."

Virtual Investor Event:

Register (here) for the Post-ESMO GI 2025 Investor Event to be held on Tuesday, July 8th at 2:00 PM EDT. A replay of the webinar will be accessible on the Events page of the I-Mab website for 90 days.

Fireside Chat Event with Lucid Capital Markets to Recap the Presentation:

Tune in (here) for a fireside chat sponsored by Christopher Liu, PharmD, Managing Director at Lucid Capital Markets that will be accessible today at 2:00pm EDT on the Events page of the I-Mab website. A replay of the fireside chat will be available for 90 days.

ESMO GI Presentation Details:

A full copy of the ESMO (Free ESMO Whitepaper) GI presentation is available on the Publications and Presentations page of the I-Mab website here.

Givastomig Phase 1b Dose Escalation Data Summary in 1L Gastric Cancers

•
17 advanced metastatic gastric cancer patients were treated with givastomig across the 5 mg/kg (n=5), 8 mg/kg (n=6), and 12 mg/kg (n=6) dose levels as of the May 15, 2025 data cutoff. All patients were efficacy evaluable

Patient Characteristics:

•
The 17 patients enrolled in the study were treatment naïve metastatic gastric, esophageal or gastroesophageal adenocarcinomas
•
Patients were HER2-negative, Claudin 18.2-positive (defined as ≥1+ IHC staining intensity in ≥1% of tumor cells), regardless of PD-L1 expression levels
•
All patients were enrolled at sites within the United States

Efficacy Results:

•
Confirmed Objective Response Rates (ORRs):
o
71% of patients (12/17) achieved a partial response (PR) per RECIST v1.1
▪
5 mg/kg (2/5)
▪
8 mg/kg (5/6)
▪
12 mg/kg (5/6)
o
At the doses selected for dose expansion (8 and 12 mg/kg), 83% (10/12) of patients achieved PRs
o
80% of patients (4/5) with CLDN18.2 expression below 75% (CLDN-Low) achieved a PR. The CLDN-Low response rate increased to 100% of patients (3/3) in the doses selected for expansion (8 and 12 mg/kg)
•
The disease control rate (DCR) was 100% across the three dose levels
•
Dose-dependent pharmacokinetics (PK) were observed, similar to monotherapy PK
•
Patients also experienced a dose dependent induction of soluble 4-1BB, a positive indicator of T cell activation and engagement

ORR: % (n)

All

(n=17)

Cohorts Chosen for Expansion

(8 and 12 mg/kg)

(n=12)

PD-L1

Any

71 (12/17)

83 (10/12)

≥5

82 (9/11)

89 (8/9)

<5

50 (3/6)

67 (2/3)

≥1

73 (11/15)

82 (9/11)

<1

50 (1/2)

100 (1/1)

CLDN18.2

≥75

67 (8/12)

78 (7/9)

<75

80 (4/5)

100 (3/3)

ORR: % (n)

PD-L1 ≥ 5

PD-L1 < 5

CLDN18.2 ≥ 75

80 (8/10)

0 (0/2)

CLDN18.2 < 75

100 (1/1)

75 (3/4)

Durability:

•
8 of 17 patients remained on study treatment and the longest treatment duration was 13.3 months as of the data cutoff
•
Median follow-up was 9.0 months across all dose levels as of the data cutoff

Safety:

•
Treatment-related adverse events (TRAEs) leading to discontinuation of any treatment were 12% (two patients), five patients had progressive disease, two patients withdrew from the study for social reasons
•
No dose limiting toxicities (DLT) were observed and a maximum tolerated dose (MTD) was not reached
•
Common TRAEs (≥10% of patients) were generally Grade 1 or Grade 2 including nausea, vomiting, infusion related reaction, fatigue, decreased appetite, diarrhea, abdominal pain, chills, dyspepsia and gastritis
•
Grade 3 TRAEs attributed to givastomig were rare, with single cases of abdominal pain, ALT/AST increases, gastritis, and infusion related reaction
•
Four cases of Grade 3 and two cases of Grade 4 treatment-related neutropenia were observed driven by an early restriction on prophylaxis use of G-CSF, which has been subsequently lifted. The neutropenia cases were primarily attributed to mFOLFOX6 in the 8 mg/kg cohorts
•
No Grade 5 TRAEs were reported

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 first line (1L) metastatic gastric cancers, with further potential in other solid tumors. 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.

An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data.

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.