Liminatus Pharma Engages Synex as Contract Research Organization to Support Phase 1/2a Clinical Development of CD19xCD22 bivalent CAR-T therapy

Rhea-AI Summary

Liminatus Pharma (Nasdaq: LIMN) has engaged Korea-based contract research organization Synex Consulting to support clinical development of IBC101, its autologous CD19xCD22 bivalent CAR-T cell therapy for relapsed or refractory B-cell malignancies. According to Liminatus, Synex will deliver clinical research services under a milestone-based program, with payments tied to key events such as patient enrollment, database lock and completion of the clinical study report.

IBC101 has received MFDS authorization in South Korea for a Phase 1/2a trial in relapsed or refractory diffuse large B-cell lymphoma, with Seoul St. Mary’s Hospital as lead site. The program broadens Liminatus’ immuno-oncology portfolio beyond its IBA101 anti-CD47 antibody, adding a clinical-stage hematologic malignancy pathway.

Positive

• MFDS authorization for Phase 1/2a IBC101 trial in relapsed/refractory DLBCL in Korea
• Engagement of Synex as CRO with milestone-based payments linked to trial execution steps
• Establishment of Seoul St. Mary’s Hospital as lead clinical site for IBC101 study
• IBC101 adds a clinical-stage CAR-T program alongside IBA101, expanding the oncology portfolio

Negative

• None.

Market Context

The only tag-matched clinical-trial precedent recorded -2.46% over 24 hours, giving the platform a n...

Analysis

The only tag-matched clinical-trial precedent recorded -2.46% over 24 hours, giving the platform a negative comparator for this CRO engagement. Current peer data showed DTIL up 1.3559321872889996%, while low short positioning remained a separate risk context.

Key Figures

Clinical study phase: Phase 1/2a Target antigens: 2 antigens

2 metrics

Clinical study phase Phase 1/2a IBC101 study in relapsed or refractory DLBCL

Target antigens 2 antigens CD19 and CD22

Previous Clinical trial Reports

1 past event · Latest: Mar 17 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 17	Phase 1 trial	Positive	-2.5%	Planned IBA101 Phase 1 trial initiation was followed by a -2.46% 24-hour reaction.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

The only tag-matched clinical-trial precedent was followed by a negative 24-hour reaction, diverging from the announcement's positive development milestone.

Key Terms

contract research organization, autologous, bivalent CAR-T, OR-gate, +2 more

6 terms

contract research organization technical

"Synex Consulting Ltd., a Korea-based full-service contract research organization"

A contract research organization (CRO) is an outside company hired to run medical and scientific work for drug, device or biotech developers—like an experienced project manager and lab team that companies rent instead of building in-house. Investors care because CROs influence development speed, quality and cost: delays or successes in trials affect client spending, regulatory risk and ultimately revenues for both the sponsor and the CRO.

autologous medical

"IBC101 is an autologous CD19xCD22 bivalent CAR-T cell therapy"

Autologous describes a medical product or treatment made from a patient’s own cells or tissues rather than from a donor. For investors, autologous approaches matter because they can lower the risk of immune rejection and improve effectiveness, but they often require individualized manufacturing, complex logistics, and higher per-patient costs—factors that affect scalability, pricing, and regulatory hurdles in healthcare businesses.

bivalent CAR-T medical

"IBC101 is an autologous CD19xCD22 bivalent CAR-T cell therapy"

A bivalent CAR-T is a cell therapy in which engineered T cells carry a chimeric antigen receptor designed to recognize two different tumor targets or two parts of the same target. Think of it like a security guard with two keys, able to lock onto either of two markers on cancer cells; that dual-targeting can reduce the chance tumors escape by losing one marker and can broaden the types of tumors the therapy can engage, with implications for clinical effectiveness, safety testing, manufacturing complexity, and regulatory review.

OR-gate technical

"The candidate utilizes an OR-gate approach intended to recognize malignant B cells"

An OR gate is a basic logic element that produces a positive outcome when any one of its inputs is active — like a room light that turns on if any of several switches are flipped. For investors, OR gates matter because they describe how products, chips, control systems, or engineered biological circuits behave under different conditions; a simple OR design can make a product more flexible but may also affect reliability, performance trade-offs, regulatory complexity, and market value.

database lock technical

"including patient enrollment, database lock and completion of the clinical study report"

A database lock is the point in a clinical trial when the collected study data are finalized and no further changes or corrections are allowed, so analysts can run the official statistical tests. For investors this matters because it usually precedes public results or regulatory filings—think of it like sealing and signing off an exam before grading: once locked, the timing and content of the readout become clearer and uncertainty about last-minute data edits is reduced.

clinical study report regulatory

"database lock and completion of the clinical study report"

A clinical study report is a detailed, written account of a medical trial that explains how the study was run, what happened to participants, and the full results on safety and effectiveness. Think of it as the study’s final report card and instruction manual combined: regulators and investors use it to judge whether a drug or device works, what risks it carries, and whether it can move toward approval or commercialization — factors that directly affect a company’s value and prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Engagement advances clinical execution of IBC101, Liminatus’ CD19xCD22 bivalent CAR-T therapy for relapsed or refractory B-cell malignancies

FULLERTON, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- Liminatus Pharma, Inc. (Nasdaq: LIMN) (“Liminatus” or the “Company”), a biotechnology company developing innovative cancer therapies, today announced that it has engaged Synex Consulting Ltd. (“Synex”), a Korea-based full-service contract research organization (“CRO”), to support the clinical development of IBC101, the Company’s CD19xCD22 bivalent CAR-T cell therapy candidate.

The engagement represents an important step in advancing IBC101 toward clinical execution in South Korea. IBC101 has received authorization from the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) for a Phase 1/2a clinical study in patients with relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”), with Seoul St. Mary’s Hospital identified as the lead clinical site.

Under the engagement, Synex will provide clinical research services pursuant to a milestone-based program, with payments linked to key clinical development milestones, including patient enrollment, database lock and completion of the clinical study report.

“Engaging Synex is another important step in moving IBC101 from regulatory authorization toward clinical execution,” said Chris Kim, Chief Executive Officer of Liminatus. “Synex brings extensive experience supporting pharmaceutical clinical development in Korea, and we believe its local regulatory and clinical capabilities will be valuable as we advance the IBC101 Phase 1/2a program.”

IBC101 is an autologous CD19xCD22 bivalent CAR-T cell therapy designed for relapsed or refractory B-cell malignancies. The candidate utilizes an OR-gate approach intended to recognize malignant B cells expressing either CD19 or CD22. By targeting two established B-cell antigens, IBC101 is designed to broaden antigen coverage and potentially address antigen escape and tumor heterogeneity, two mechanisms associated with relapse following single-antigen CAR-T therapy.

The IBC101 program further expands Liminatus’ oncology development portfolio beyond its IBA101 CD47 checkpoint inhibitor program and establishes an additional clinical-stage development pathway focused on hematologic malignancies.

“Following the expansion of our oncology portfolio, our focus is increasingly shifting toward execution across our development programs,” added Mr. Kim. “The Synex engagement provides clinical infrastructure in Korea to support the next stage of IBC101’s development, and we look forward to progressing the program toward patient enrollment.”

About IBC101

IBC101 is an investigational autologous CD19xCD22 bivalent CAR-T cell therapy candidate designed for the treatment of relapsed or refractory B-cell malignancies. The therapy is designed as an OR-gate CAR-T system capable of recognizing tumor cells expressing either CD19 or CD22, with the goal of expanding antigen coverage and reducing the potential for antigen escape associated with single-target CAR-T therapies. IBC101 has received authorization from the MFDS for a Phase 1/2a clinical study in relapsed or refractory DLBCL.

About Liminatus Pharma, Inc.

Liminatus Pharma, Inc. (Nasdaq: LIMN) is a biotechnology company developing innovative immuno-oncology and cell therapy candidates. The Company’s portfolio includes IBA101, a next-generation anti-CD47 monoclonal antibody, as well as oncology-focused cellular therapy programs including IBC101, a CD19xCD22 bivalent CAR-T candidate for B-cell malignancies. Liminatus is focused on advancing differentiated therapeutic approaches designed to address significant unmet needs in cancer treatment.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of applicable federal securities laws. Forward-looking statements include statements regarding the clinical development of IBC101, the timing and initiation of clinical trial activities, patient enrollment, the expected services to be provided by Synex, the potential therapeutic benefits of IBC101, and the Company’s plans for its development programs. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Additional information regarding risks and uncertainties affecting Liminatus is contained in the Company’s filings with the Securities and Exchange Commission. Liminatus undertakes no obligation to update any forward-looking statements except as required by applicable law.

Investor Contact:
Liminatus Pharma, Inc.

Chris Kim, CEO info@liminatuspharma.com (213) 273-5453

FAQ

What did Liminatus Pharma (LIMN) announce about Synex and IBC101 on August 24, 2026?

Liminatus Pharma announced it engaged Korea-based CRO Synex to support clinical development of its CD19xCD22 bivalent CAR-T candidate IBC101. According to Liminatus, Synex will provide milestone-based clinical research services for the authorized Phase 1/2a trial in relapsed or refractory diffuse large B-cell lymphoma.

What is Liminatus Pharma's IBC101 CD19xCD22 bivalent CAR-T therapy?

IBC101 is an investigational autologous CAR-T therapy targeting CD19 and CD22 on malignant B cells. According to Liminatus, it uses an OR-gate design to recognize cells expressing either antigen, aiming to broaden coverage and reduce antigen escape seen with single-target CAR-T therapies.

What regulatory approval has IBC101 received for clinical trials in South Korea?

IBC101 has received authorization from South Korea’s Ministry of Food and Drug Safety (MFDS) for a Phase 1/2a clinical study. According to Liminatus, the trial will enroll patients with relapsed or refractory diffuse large B-cell lymphoma, with Seoul St. Mary’s Hospital as the lead clinical site.

What role will Synex play in Liminatus Pharma's Phase 1/2a trial of IBC101?

Synex will act as the contract research organization providing clinical research services for the IBC101 trial. According to Liminatus, Synex’s work is organized under a milestone-based program, with payments tied to specific steps such as patient enrollment, database lock and final clinical study report completion.

How does the IBC101 program affect Liminatus Pharma's (LIMN) oncology portfolio?

IBC101 expands Liminatus Pharma’s oncology portfolio by adding a clinical-stage CAR-T program for B-cell malignancies. According to Liminatus, this program complements its IBA101 anti-CD47 monoclonal antibody and creates an additional development pathway focused on hematologic cancers and unmet patient needs.

What cancer patients are targeted in Liminatus Pharma's IBC101 Phase 1/2a trial (LIMN)?

The IBC101 Phase 1/2a trial targets patients with relapsed or refractory diffuse large B-cell lymphoma. According to Liminatus, these patients will receive the autologous CD19xCD22 bivalent CAR-T therapy at sites led by Seoul St. Mary’s Hospital under MFDS authorization in South Korea.