Fresenius Kabi, TQ Therapeutics Announce Cell Therapy Technology Agreement

On January 14, 2026 Fresenius Kabi, an operating company of Fresenius, and TQ Therapeutics, reported they have entered into a strategic-development agreement under which Fresenius Kabi has an exclusive license to develop, manufacture, and distribute products that incorporate TQ Therapeutics’ proprietary cell selection technology. The goal of the agreement is to advance cell and gene therapy accessibility by enabling scalable and efficient cell therapy manufacturing.

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Fresenius Kabi is a leading provider of essential medicines and medical technologies. TQ Therapeutics specializes in proprietary cell selection technology and following therapeutic applications. Under the agreement, TQ Therapeutics’ affinity and column-based cell isolation technology will be integrated into Fresenius Kabi’s Cue Cell Processing System. By combining these technologies, the companies aim to create an automated and robust system that can isolate T cells from whole blood and apheresis products in less than two hours for cell and gene therapy manufacturing applications. The goal is to quickly, easily and consistently produce high purity T cells, helping therapeutic developers work more efficiently and potentially bring treatments to patients faster.

"With this collaboration, we are reinforcing our commitment to innovation in cell and gene therapy technology," said Saurabh Bhasin, Head of Portfolio, Cell Therapies & Contract Manufacturing Operations at Fresenius Kabi. "By integrating TQ Therapeutics’ novel selection technology into our Cue system, our aim is to improve manufacturing success and scalability—key steps toward supporting the advancement of cell and gene therapies."

TQ Therapeutics’ goal is to leverage the Cue system and its integrated cell selection column technology to develop extracorporeal, ultra-short cell and gene therapy processes for clinical applications creating faster steps that can be performed closer to the point of care to help simplify and accelerate treatment workflows.

"This agreement with Fresenius Kabi allows us to bring our proprietary technology to a broader audience with the goal of accelerating the development of next-generation cell therapies," said Christian Eckert, chief executive officer of TQ Therapeutics. "With Fresenius Kabi’s expertise in cell and gene therapy device technologies development and commercialization, and TQ Therapeutics’ focus on developing ultra-short processes for clinical cell therapies from manufacturing to in vivo applications, we are creating a novel value proposition for scaling and enabling the supply of cell therapies for broader patient populations."

Cell and gene therapy is an emerging segment of medicine that has shown promise in treating certain cancers and other conditions.

Phacilitate Advanced Therapies Week 2026

Fresenius Kabi and TQ Therapeutics will debut the Cue Cell Processing System and the in-development cell selection module at Booth #623 on February 10-12 during Phacilitate ATW 2026 in San Diego, CA. Attendees are invited to visit the booth to learn more about the technology and its development.

(Press release, Fresenius, JAN 14, 2026, View Source [SID1234662052])

C4 Therapeutics Outlines Strategic Milestones to Advance Cemsidomide as a Potential Best-in-Class IKZF1/3 Degrader and Discovery Strategy Focused on Novel Targets in Clinically Validated Pathways

On January 14, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported milestones through 2028 and highlighted recent achievements.

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"We begin 2026 with compelling opportunities ahead, anchored by cemsidomide’s path to become a foundational medicine for multiple myeloma by reaching patients across multiple lines of therapy. As we prepare to initiate two cemsidomide trials in the coming months, we believe the emerging data exploring the class in combination with BiTE therapies derisks our strategy to rapidly advance cemsidomide through registrational development," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "We are equally excited about our new discovery strategy that leverages a decade of learnings in the TPD field as well as the strengths of our platform to address unmet needs for inflammation, neuro-inflammation and neuro-degenerative diseases by degrading novel targets that modulate validated inflammatory pathways. Our strong balance sheet provides cash runway through key inflection points, keeping us positioned to advance our portfolio and create transformative medicines for patients."

Anticipated Key Strategic Milestones
C4T’s vision is to become a fully integrated biopharmaceutical company leveraging the benefits of targeted protein degradation across drug discovery, clinical development and commercialization to create and deliver breakthrough therapies for patients. To achieve this vision, C4T’s strategy centers around rapidly advancing cemsidomide to become the IKZF1/3 degrader of choice across lines of therapy and progressing its early portfolio of high-value degraders pursuing novel targets. The following anticipated key strategic milestones through 2028 support this strategy.

Cemsidomide
Relapsed/Refractory Multiple Myeloma: Fourth Line or Later

In Q1 2026, initiate the Phase 2 MOMENTUM trial of cemsidomide and dexamethasone and complete enrollment within 12 months.
In mid-2026, present further analysis of the data from the ongoing Phase 1 trial of cemsidomide and dexamethasone.
In 2H 2027, present initial overall response rate (ORR) data for the MOMENTUM trial.
In mid-2028, present efficacy and safety for the MOMENTUM trial.
By year-end 2028, submit new drug application evaluating cemsidomide and dexamethasone for potential accelerated approval in fourth line or later.
Relapsed/Refractory Multiple Myeloma: Second Line or Later

In Q2 2026, initiate the Phase 1b trial of cemsidomide in combination with elranatamab and provide incremental updates throughout dose escalation.
In mid-2026, share the plan to initiate an additional Phase 1b trial to evaluate cemsidomide in combination with other anti-myeloma agents.
In mid-2027, present Phase 1b data from all cohorts evaluating cemsidomide in combination with elranatamab.
By early 2028, initiate the Phase 3 trial evaluating cemsidomide in combination with a BCMA BiTE.
Early Portfolio: CFT8919

In Q1 2026, utilize data from the Phase 1 dose escalation trial to inform ex-China clinical development.
Early Portfolio: Internal Discovery Projects Focused on Inflammation, Neuro-inflammation and Neuro-degenerative Diseases

By year-end 2028, deliver up to three investigational new drug applications.
Early Portfolio: Discovery Collaborations

Earn additional research milestones and potential licensing fees from collaborations with Merck KGaA, Darmstadt, Germany, Roche and Biogen.
By year-end 2026, deliver at least one development candidate to a collaboration partner.
By year-end 2026, advance existing collaborations toward key milestones.
2025 Achievements
Cemsidomide

Completed enrollment in the Phase 1 trial of cemsidomide and dexamethasone and presented data demonstrating that the two highest dose levels (75 µg and 100 µg) achieved a 40% and 53% ORR, respectively. This compelling anti-myeloma activity in a heavily pretreated patient population reinforces cemsidomide’s potential best-in-class profile.
Developed a regulatory path incorporating FDA feedback that positions cemsidomide to potentially receive two distinct accelerated approvals in (1) fourth line or later for cemsidomide and dexamethasone, and (2) second line or later for cemsidomide in combination with a BCMA BiTE.
Selected 100 µg dose for the MOMENTUM trial as the recommended Phase 2 dose after discussions with FDA.
CFT8919

Advanced the Phase 1 dose escalation trial in China with partner Betta Pharmaceuticals to generate data that will inform C4T’s next steps.
Internal Discovery Pipeline

Implemented new discovery strategy focused on developing degrader medicines for five novel targets that modulate three clinically validated pathways for inflammation, neuro-inflammation and neuro-degenerative diseases to potentially deliver new therapies with enhanced efficacy for patients with unmet needs. This strategy leverages C4T’s expertise in developing highly catalytic orally bioavailable degraders that penetrate the blood brain barrier to achieve high central nervous system exposures and compelling efficacy in central nervous system models as well as C4T’s ability to control targeted protein levels through finely tuned degrader kinetics.
Extended capabilities to identify molecular glue degraders for targets with and without G- and RT-loops by utilizing DNA-encoded library (DEL) technology.
About Cemsidomide
Cemsidomide is an investigational, orally bioavailable molecular glue degrader of IKZF1/3, transcription factors that drive multiple myeloma. Data from the Phase 1 trial, which has completed enrollment, show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that support the potential for durable outcomes.

About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).

About Cemsidomide in Combination With Elranatamab (ELREXFIO)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).

About Multiple Myeloma
Multiple myeloma (MM) is a rare blood cancer affecting plasma cells. Approximately 36,000 people in the United States are diagnosed with MM each year. Despite advances in treatment, MM remains incurable. Treatment combinations include IKZF1/3 degraders, which are established backbone therapies, across lines of therapy.

(Press release, C4 Therapeutics, JAN 14, 2026, View Source [SID1234662035])

Celltrion presents innovative drug pipeline and U.S. manufacturing and R&D expansion strategy at the 44th Annual J.P. Morgan Healthcare Conference

On January 13, 2026 Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, reported key strategic priorities and clinical development updates for its innovative drug pipelines including antibody-drug conjugates (ADCs) and multi-specific antibodies (msAbs) at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California. The company also highlighted plans to expand its manufacturing and R&D capabilities to support long-term growth, enhance supply resilience and reinforce its long-term commitment to the U.S. market.

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The presentation, composed of two sections— ‘From Biosimilar Excellence to Next-Gen Innovative Therapeutics’ and ‘Scaling Our U.S. Presence with a Next-Gen Manufacturing and R&D Hub’—was delivered on the conference’s Main Track. Celltrion’s Chief Executive Officer Jin-Seok Seo and Senior Executive Vice President Hyuk-Jae Lee outlined the company’s innovative drug pipeline, with plans to submit up to 16 investigational new drug (IND) applications by 2028, including up to 10 ADCs, 4 msAbs, 1 recombinant protein, and 1 peptide. In its biosimilar business, Celltrion aims to commercialize up to 18 products by 2030 and 41 products by 2038.

The company’s ADC candidates are designed to target solid tumor cancers; with IND applications for CT-P70, CT-P71 and CT-P73 accepted by the U.S. Food and Drug Administration (FDA) in 2025. CT-P70, a novel ADC candidate being developed for the treatment of non-small cell lung cancer (NSCLC), recently received Fast Track designation from the U.S. FDA, enabling expedited interactions throughout the development process and the potential for accelerated regulatory review.

Celltrion is advancing a portfolio of msAbs that are designed to selectively target cancer cells or are activated only under specific conditions. Celltrion received an IND approval from the U.S. FDA for CT-P72, a tetravalent bispecific antibody being developed to target human epithelial growth factor receptor 2 (HER2) and cluster of differentiation 3 (CD3).

"We have made significant progress and see compelling opportunities ahead. Building on our company’s global footprint in biosimilar excellence, Celltrion is accelerating its transition toward next-generation innovative therapeutics," said Jin-Seok Seo, Chief Executive Officer at Celltrion. "Our expanding pipeline of ADCs and msAbs, grounded in deep antibody expertise, underscores our commitment to delivering meaningful value to patients worldwide. We aim to redefine the standard of care in oncology and beyond, while creating long-term sustainable value through scientific excellence and bold innovation."

To reinforce the company’s U.S. manufacturing capabilities, Celltrion recently completed the strategic acquisition of a former Eli Lilly manufacturing facility located in Branchburg, New Jersey, securing 66,000L of drug substance (DS) capacity. The company plans to sequentially increase capacity to a total of 132,000L by 2030, while also extending its capabilities to include drug product (DP) facilities. Through this acquisition, Celltrion plans to ensure long-term supply chain resilience eliminating the tariff and trade risks, ultimately strengthening its competitiveness in the U.S. market.

"The acquisition of the U.S. manufacturing facility represents a pivotal step in strengthening our global supply chain and solidifying our presence in the U.S. market," said Hyuk-Jae Lee, Senior Executive Vice President at Celltrion. "By securing large-scale DS capacity in the U.S., we are enhancing supply stability, mitigating trade and tariff risks, and establishing a solid foundation for expanded R&D collaboration and innovation in the region."

(Press release, Celltrion, JAN 13, 2026, View Source [SID1234662022])

Rakuten Medical and LOTTE Biologics Sign Manufacturing Agreement to Support Biopharmaceuticals in Global Oncology Program

On January 13, 2026 Rakuten Medical, Inc. and LOTTE Biologics reported that they have signed a biopharmaceutical contract manufacturing agreement during the J.P. Morgan Healthcare Conference in San Francisco to strengthen Rakuten Medical’s production capabilities for its innovative oncology therapy, Alluminox platform-based photoimmunotherapy.

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Under the agreement, LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates, supporting Rakuten Medical’s global clinical development and future commercialization.

Rakuten Medical’s proprietary photoimmunotherapy technology is designed to selectively target cells in solid tumors, by combining cell-targeting moieties, such as antibodies, with light-activatable agents, enabling focal and selective destruction of solid tumor cells upon light exposure.

In Japan, the therapy is approved for recurrent head and neck cancer, and its footprint has expanded steadily, through broader site adoption and sustained year–over–year growth in treatment numbers. In parallel, a global Phase 3 clinical trial is underway in the United States, Taiwan region and Japan, with plans to start treatment in Ukraine and Poland soon.

Rakuten Medical also plans to initiate a Phase 1 clinical trial in Japan for other solid tumors beyond head and neck cancer this year. These clinical and commercial dynamics are driving increased demand for Rakuten Medical’s bioconjugates.

LOTTE Biologics has been expanding its capabilities as a global contract development and manufacturing organization (CDMO), particularly in the field of monoclonal and multispecific antibodies, antibody-drug conjugates (ADCs), and advanced bioconjugation services. LOTTE Biologics will support the production of monoclonal antibody intermediates and their conjugates for Rakuten Medical’s programs, through its specialized ADC manufacturing facility at the Syracuse Bio Campus in New York. The facility is equipped with dedicated ADC production capabilities and advanced bioconjugation technologies, enabling the company to deliver high-quality manufacturing services while meeting global regulatory requirements and ensuring stable supply for customers worldwide.

(Press release, Rakuten Medical, JAN 13, 2026, View Source [SID1234662023])

Applied Cells and Immuneel Therapeutics announce strategic collaboration to advance affordable CAR-T therapies

On January 13, 2026 Applied Cells Inc. reported a strategic collaboration framework with Immuneel Therapeutics Private Limited to jointly evaluate the application of Applied Cells’ MARS Atlas platform and GoFast CAR-T workflow for future CAR-T therapy development and manufacturing.

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Under this collaboration, the two companies will work together to integrate the MARS Atlas platform and GoFast workflow into selected Immuneel CAR-T programs. The shared objective is to significantly improve the affordability and accessibility of CAR-T therapies, beginning in India, with the potential for broader global adoption.

A key focus of the collaboration is achieving manufacturing costs that enable truly affordable CAR-T therapy for the majority of eligible patients in India, while maintaining therapeutic efficacy comparable to currently approved CAR-T treatments. ‘We are thrilled to partner with Immuneel, a pioneer in bringing cutting‑edge cell therapies to India,’ said Yuchen Zhou, CEO of Applied Cells. ‘The combination of MARS Atlas and the GoFast workflow with Immuneel’s clinical and regulatory capabilities has the potential to transform the CAR‑T landscape by making these life‑saving treatments accessible to millions who currently cannot afford them.’

‘At Immuneel, our mission is to make advanced cell therapies accessible and affordable for patients who need them the most,’ said Amit Mookim, CEO of Immuneel Therapeutics. ‘This collaboration represents an important step in evaluating innovative technologies that could strengthen our manufacturing capabilities and support development of scalable, cost‑effective CAR‑T solutions. We look forward to jointly exploring how platforms like MARS Atlas and the GoFast workflow could contribute to expanding access to high‑quality cell therapies in India and beyond.’

Both companies have commenced collaborative activities and will share updates as the programs progress.

(Press release, Applied Cells, JAN 13, 2026, https://appliedcells.com/immuneel-cart-collaboration/ [SID1234662008])