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Lilly to acquire Orna Therapeutics to advance cell therapies

On February 9, 2026 Eli Lilly and Company (NYSE: LLY) and Orna Therapeutics, Inc., a biotechnology company dedicated to engineering immune cells in vivo, reported entry into a definitive agreement for Lilly to acquire Orna.

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Orna is advancing a new class of therapeutics utilizing engineered circular RNA paired with novel lipid nanoparticles to allow the patient’s own body to generate cell therapies that can treat underlying disease. Orna’s lead program is ORN-252, a clinical trial-ready, CD19 targeting in vivo Chimeric Antigen Receptor T-cell (CAR-T) therapy designed to treat B cell-driven autoimmune diseases. Experiments to date suggest that Orna’s circular RNA platform may deliver more durable expression of therapeutic proteins and therefore unlock treatments that are not feasible with current RNA or cell therapy platforms.

"Early autologous CAR-T studies have shown the promise of cell therapy for patients with autoimmune diseases, but the complexity, cost, and logistics of ex vivo approaches make it challenging to deliver these breakthroughs to the broader population of patients who need them," said Francisco Ramírez-Valle M.D., Ph.D., Senior Vice President, Head of Immunology Research and Early Clinical Development. "We look forward to working with Orna colleagues to potentially unlock an entirely new class of genetic medicines and cell therapies for patients who today have limited or no treatment options."

"At Orna, we believe our circular RNA technology paired with our best-in-class LNP delivery platform have the potential to unlock in vivo CAR-T therapies for patients across a wide range of B cell-driven autoimmune diseases. We are excited to join forces with Lilly, an industry leader in the development of patient-centric therapeutics to realize the full potential of these technologies," said Joe Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics."

Under the terms of the agreement, Lilly will acquire Orna, and Orna shareholders could receive up to $2.4 billion in cash, inclusive of an upfront payment and subsequent payments upon achievement of certain clinical development milestones.

Lilly will determine the accounting treatment of this transaction in accordance with Generally Accepted Accounting Principles (GAAP) upon closing. This transaction will thereafter be reflected in Lilly’s financial results and financial guidance.

Paul, Weiss, Rifkind, Wharton & Garrison LLP is acting as legal counsel to Lilly. Lazard is acting as financial advisor to Orna. Goodwin Procter LLP is acting as legal counsel to Orna.

(Press release, Eli Lilly, FEB 9, 2026, View Source [SID1234662543])

Anixa Biosciences Reports Encouraging Patient Survival Observations in Ovarian Cancer CAR-T Trial; Achieves Regulatory Approval Enabling Major Dose Escalation

On February 9, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported an update on patient outcomes observed in its ongoing Phase 1 ovarian cancer CAR-T clinical trial, following regulatory approval of a protocol amendment that enables substantial dose escalation.

The ongoing Phase 1 trial is enrolling adult women with recurrent ovarian cancer, who have failed standard of care chemotherapy, and progressed after two or more prior therapies. To date, twelve patients have been treated in the trial at four dosage levels. Of these patients, seven have lived beyond their expected median survival of approximately three to four months, based on disease stage and prior therapy history. One patient survived 28 months following treatment, three patients have survived greater than one year following treatment (17, 15 and 14 months, respectively) and three patients have survived 11, 8 and 8 months, respectively. Three patients that have reached 15, 14 and 8 months remain alive, and one additional patient who was treated more recently, is also currently alive.

While the study is designed to primarily demonstrate safety, Anixa believes this pattern of extended survival represents encouraging, albeit anecdotal, evidence of clinical activity in a patient population with limited therapeutic options. These survival observations have been accompanied by a clean safety profile. Importantly, no dose-limiting toxicities (DLTs) have been observed to date, prompting Anixa’s partner, Moffitt Cancer Center ("Moffitt"), to obtain Institutional Review Board (IRB) approval for a protocol amendment that permits significant dose escalation.

Under the amended protocol, dosing may increase from the original range of 1×10⁵ to 1×10⁷ CAR-positive cells per kilogram of body weight ("cells/kg") to as high as 1×10⁹ cells/kg, representing a two-order-of-magnitude increase. If no DLTs are observed at this level, additional escalation may be pursued at the discretion of the principal investigator.

Anixa and Moffitt believe the favorable safety profile observed to date is partially attributable to the direct intra-peritoneal delivery of CAR-T cells, which differs from conventional intravenous administration and may reduce systemic toxicity while enhancing localized tumor targeting.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "Although these patients were treated at doses we believe are below the optimal therapeutic range, we are encouraged by the number of individuals who have lived far longer than expected."

As part of the amended study design, the next patient cohort will receive 1×10⁷ cells/kg following treatment with cyclophosphamide and fludarabine, a preparatory regimen known as lymphodepletion. Lymphodepletion reduces competing immune cells, creating a more favorable environment for CAR-T expansion, persistence, and activity. While lymphodepletion is routinely used in CAR-T therapies for hematologic cancers, its role in solid tumors remains investigational. Anixa, Moffitt, and the U.S. Food and Drug Administration view this addition as an important opportunity to assess whether lymphodepletion can further enhance efficacy in a localized solid tumor setting, particularly when combined with intra-peritoneal CAR-T delivery.

Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt and principal investigator of the trial, added, "The absence of dose-limiting toxicities observed thus far has given us the flexibility to safely explore higher dose levels than originally planned. With regulatory approval now in place, the program is positioned to advance into higher-dose evaluation under the amended protocol. This amendment allows us to further evaluate both safety and potential therapeutic benefit as the study advances."

Dr. Kumar will further discuss the observations in the clinical trial, as well as provide updates on Anixa’s plans for 2026, in the upcoming Water Tower Research Fireside Chat Series taking place on Tuesday, February 10, 2026, at 11:00am ET. Interested parties can register for the event at: Fireside Chat Registration.

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer

Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

(Press release, Anixa Biosciences, FEB 9, 2026, View Source [SID1234662542])

Innovent Announces Strategic Collaboration with Lilly to Develop New Medicines Globally in Oncology and Immunology

On February 8, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, reported a strategic collaboration with Eli Lilly and Company ("Lilly") to advance novel medicines in oncology and immunology. This agreement marks the seventh collaboration between the two companies, deepening a longstanding and productive partnership to deliver new medicines for patients worldwide. The collaboration’s unique structure also establishes a new model for Innovent to accelerate the global development of its innovative pipeline.

Under the collaboration, the companies will leverage their complementary strengths to accelerate global development of novel medicines. Innovent, drawing on its robust antibody technology platforms and efficient clinical execution, will lead the development of programs from concept through clinical proof-of-concept (Phase 2 clinical trial completion) in China. The agreement grants Lilly an exclusive license to develop and commercialize the programs worldwide outside Greater China, while Innovent retains rights in Greater China.

"We’re delighted to partner with Lilly, our trusted global pharmaceutical partner for over 10 years, to pursue novel medicines to improve treatment outcomes for patients with cancer and immune disorders," said Dr. Michael Yu, Founder, Chairman of the Board, and CEO of Innovent. "This alliance moves beyond traditional licensing to create a seamless, end-to-end innovation ecosystem that combines our agile discovery and early-stage development engine with Lilly’s extensive global scale and creates a highly efficient model for cross-border synergy. This partnership validates Innovent’s R&D capabilities and allows us to accelerate the translation of scientific discoveries into impactful global medical solutions together with our partner, with the ultimate goal of bringing world-class medicines to patients across the globe."

Under the terms of the agreement, Innovent will receive a $350 million upfront payment and is eligible to receive development, regulatory and commercial milestone payments totaling up to approximately $8.5 billion contingent upon the achievement of certain future events. Additionally, Innovent will be eligible for tiered royalties on net sales of each product outside of Greater China.

(Press release, Innovent Biologics, FEB 8, 2026, View Source [SID1234662537])

PharmaResearch Receives U.S. FDA Clearance to Initiate Phase 1 Clinical Trial of Nano Anticancer Drug, PRD-101

On February 6, 2026 PharmaResearch Co., Ltd. (CEO: Jihoon Sohn) reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PRD-101, enabling the initiation of a Phase 1 clinical trial in the United States.

PRD-101 is a next-generation nano anticancer drug candidate formulated using nucleotide fragments produced through PharmaResearch’s proprietary DOT (DNA Optimizing Technology). The drug leverages the company’s nucleotide-based Advanced DOT drug delivery platform, designed to enable efficient loading of therapeutics and improve pharmacokinetics.

The Phase 1 clinical trial will be conducted across up to seven clinical sites in the United States and is expected to enroll approximately 90 patients with locally advanced or metastatic solid tumors. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of PRD-101.

"The FDA clearance of our IND application marks an important milestone for PRD-101. Through this Phase 1 trial, we aim to further characterize PRD-101 and continue advancing our oncology pipeline," PharmaResearch stated.

About PharmaResearch’s PRD-101

PRD-101 represents a significant advancement in cancer treatment, utilizing nucleotide fragments produced through PharmaResearch’s proprietary DNA optimizing technology (DOT) in nanoparticle anticancer formulations. Collaborative efforts between PharmaResearch and the University of California Irvine (UCI) researchers, along with support from organizations like the U.S. NCL, have propelled the development of PRD-101. PharmaResearch holds patents and exclusive licenses associated with PRD-101, marking a milestone in the company’s innovative endeavors.

Traditional anticancer drugs often face limitations due to high toxicity, which restricts patient eligibility and necessitates careful dosage management. PharmaResearch anticipates that PRD-101 will address these unmet medical needs in anticancer therapy.

(Press release, PharmaResearch, FEB 6, 2026, View Source [SID1234662532])

Kelun-Biotech Announces Fourth Indication for Sacituzumab Tirumotecan (sac-TMT) Approved by NMPA in HR+/HER2- Breast Cancer

On February 6, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that a new indication application for its TROP2-directed ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱) has been approved by the National Medical Products Administration (NMPA) of China for treatment of adult patients with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer (BC) who have received prior endocrine therapy (ET) and at least one line of chemotherapy in advanced setting. This approval for HR+/HER2- BC after at least one prior line of chemotherapy marks the fourth indication for sac-TMT approved for marketing in China.

The approval is based on the positive results from the Phase III OptiTROP-Breast02 study which was selected as a Late-Breaking Abstract (LBA) and presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

The OptiTROP-Breast02 study evaluated the efficacy and safety of sac-TMT monotherapy compared to investigator’s choice of chemotherapy in patients with unresectable or metastatic HR+/HER2- BC. Of the patients enrolled in this Phase III study, 95.7% had visceral metastases, 75.9% had liver metastases; 52.9% were HER2-zero (IHC 0), while 47.1% were HER2-low (IHC 1+ or IHC 2+/ISH-). All patients had received prior CDK4/6 inhibitor and taxane therapy; 56.6% had received ≥2 lines of prior chemotherapy in the advanced or metastatic setting.

Results showed that sac-TMT demonstrated a statistically significant and clinically meaningful increase in progression-free survival (PFS) as assessed by the Blinded Independent Central Review (BICR) compared to chemotherapy (8.3 vs. 4.1 months; hazard ratios (HR), 0.35; 95% CI: 0.26-0.48; p<0.0001). Consistent PFS benefits were observed across all pre-specified subgroups, including HER2-zero and HER2-low, number of chemotherapy lines received in the advanced or metastatic setting, presence of baseline visceral and liver metastases and previous CDK4/6 inhibitor use. According to BICR-assessed PFS results, the hazard ratios in the HER2-zero and HER2-low (IHC 1+ or IHC 2+/ISH-) subgroups were 0.39 (95% CI: 0.26-0.57) and 0.31 (95% CI: 0.20-0.48), respectively. A trend towards overall survival (OS) benefit and a significantly higher objective response rate (ORR) (41.5% vs. 24.1%) were also observed compared with chemotherapy. [1]

Currently, Phase III clinical studies of sac-TMT with or without pembrolizumab (KEYTRUDA[2]) for the treatment of chemotherapy-naïve HR+/HER2- BC who have received prior ET have been initiated globally (NCT06312176) and in China (NCT07071337).

About HR+/HER2- Breast Cancer

Breast cancer is one of the most common malignant tumors that seriously threaten women’s health worldwide. In 2022, there were about 2,297,000 new cases of breast cancer and 666,000 deaths worldwide. Among them, HR+/HER2- breast cancer is the most common subtype, accounting for about 70% of all breast cancer cases, and advanced HR+/HER2- breast cancer has a poor prognosis. This subtype is typically sensitive to hormonal therapy, and therefore, endocrine therapy combined with a CDK4/6 inhibitor constitutes the standard treatment. However, for patients with HR+/HER2- advanced breast cancer whose disease progresses on endocrine therapy, chemotherapy is widely used in clinical while it is associated with low response rate (ORR approximately 14%-22.9%) and limited survival benefit (mPFS approximately 4.0-4.9 months).

About Sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) BC who have received prior ET and at least one line of chemotherapy in advanced setting. The first two indications listed above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinical benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating16 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, FEB 6, 2026, View Source;breast-cancer-302681155.html [SID1234662531])