1stOncology™: Cancer Intelligence Service – Page 4 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

China’s First mRNA-Based In Vivo CAR-T Candidate! Medicilon Supports Regenelead RGL-208 IND Approval

On November 13, 2026 RGL-208 Injection, a dual-target in vivo CAR-T candidate independently developed by Regenelead, reported it has received implied clinical trial approval from the NMPA. It is intended for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma. RGL-208 marks China’s first mRNA in vivo CAR-T product to enter clinical development, as well as Regenelead’s first in vivo CAR-T candidate advancing into the clinic.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

As a partner of Regenelead, Medicilon provided pharmacokinetic and safety assessment studies for RGL-208, satisfying regulatory requirements for the NMPA, FDA and OECD, and enabling the candidate’s smooth transition into clinical testing.
Unmet Clinical Needs: Limitations of Current CAR-T Therapies
Conventional CAR-T therapies involve complex manufacturing and lengthy lead times, creating major barriers to patient access.
Relapsed/refractory B-cell hematological malignancies are highly heterogeneous and prone to recurrence, with poor outcomes for patients after multiple lines of treatment, representing a substantial unmet medical need. While several approved CAR-T products have offered curative potential, these existing therapies rely on ex vivo personalized manufacturing. The cumbersome workflows, long production cycles and high costs, paired with relapse risks driven by antigen loss and CAR-T cell exhaustion in single-target designs, severely limit accessibility. Expanding access so that more patients can rapidly receive CAR-T treatment remains one of the core challenges in cell therapy.
Dual-Target, Off-the-Shelf In Vivo CAR-T
Generating In Vivo CAR-T cells to advance cell therapy toward off-the-shelf solutions
RGL-208 Injection is a dual-target in vivo CAR-T candidate discovered and developed by Regenelead. As China’s first mRNA in vivo CAR-T product cleared for clinical investigation, it opens a new route to address key pain points of traditional CAR-T therapies and improve access to cell therapy.
mRNA-LNP delivery platform: mRNA encoding the CAR construct is specifically delivered to patients’ T cells to generate functional in vivo CAR-T cells, which recognize and eliminate tumor cells.

Dual-target design to mitigate relapse: By targeting two antigens simultaneously, RGL-208 helps reduce tumor escape caused by the loss or downregulation of a single antigen..

Off-the-shelf format without individualized manufacturing: Patients can be treated by a single intravenous administration — no leukapheresis, no waiting for in vitro manufacturing, drastically cutting waiting time.

Lower barriers for manufacturing and access: The mRNA-LNP platform offers the potential for standardized, large-scale manufacturing, which could reduce production costs and extend cutting-edge cell therapy to a broader patient population.

The IND approval of RGL-208 represents a landmark breakthrough for Regenelead in in vivo CAR-T research, placing the company among China’s front-runners for clinical translation of in vivo CAR-T programs. It further demonstrates the innovative strength and translational capacity of Regenelead’s proprietary technology platforms.

Platform-Driven Preclinical Support

Medicilon’s CGT platform powers preclinical development for cell and gene therapies

During RGL-208’s preclinical development, Medicilon deployed a suite of analytical platforms including flow cytometry, ELISA, PCR and LC-MS/MS to conduct systematic in vivo efficacy and toxicity evaluations. For the cynomolgus monkey toxicology program tailored to RGL-208, our team established immune-related response monitoring and emergency-response plans tailored to the product’s characteristics. In pharmacology studies using humanized immunodeficient mouse models, Medicilon precisely constructed the animal models and carefully controlled for model-related background lesions during data interpretation, delivering a scientifically rigorous and complete assessment of RGL-208’s efficacy and safety.

(Press release, Shanghai Medicilon, NOV 13, 2026, View Source [SID1234674753])

Rezolute Announces Positive Results from the Phase 3 upLIFT Study in Tumor Hyperinsulinism

On November 13, 2026 Rezolute, Inc. (Nasdaq: RZLT) (Rezolute or the Company), a late-stage ultra-rare, metabolic disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), reported positive results from the ongoing open-label Phase 3 upLIFT study of ersodetug in tumor HI, in which the primary efficacy endpoint has been achieved, based on preliminary results from a November 5th data evaluation.

The primary efficacy endpoint in the upLIFT study is the proportion of patients able to achieve at least a 50% reduction from baseline in glucose infusion rate (GIR), a measure of intravenous glucose dependency for underlying hypoglycemia. To achieve statistical significance for the endpoint, the lower bound of the 95% confidence interval for percent of patients responding must exceed 30%, which equates to at least 9 responders (≥56%), based on enrollment of 16 participants. To date, 13 participants have met the responder criterion, including 12 who also achieved a complete discontinuation of IV glucose. Three participants are still in the pivotal period of the study, including two who have not yet met the responder criterion. As previously reported, one participant discontinued the study early and chose to enter home hospice care, and died one week later due to cancer progression. This participant has been classified as a non-responder for purposes of the primary endpoint. Results for the completed study, including statistical analysis of the primary endpoint, are expected by mid-December 2026.

"We are thrilled with this outcome and what it means for individuals living with tumor hyperinsulinism," said Nevan Charles Elam, Founder and Chief Executive Officer of Rezolute. "Notably, these results substantially mirror the powerful outcomes that we have observed over the last few years in our expanded access program. We believe that we are well positioned to advance both congenital HI and tumor HI into the approval process next year and we look forward to discussions with FDA in the first quarter of 2027."

The 16 enrolled participants include four with non-islet cell tumors and 12 with insulin-secreting malignant islet cell tumors (insulinomas). Ersodetug has been well-tolerated to date in the pivotal and extension phases of the study, with no drug-related safety findings attributed to ersodetug.

About upLIFT

The upLIFT Phase 3 registrational study is a single-arm, open-label, pivotal trial in approximately 16 participants with insulinoma or non-islet cell tumors who have uncontrolled hypoglycemia caused by tumor hyperinsulinism (HI). Eligible participants requiring continuous intravenous (IV) glucose receive ersodetug 9 mg/kg per week for 8 weeks, as an add-on to standard of care. Following this 8-week pivotal treatment period, all participants may receive ersodetug at a reduced dosing frequency in long-term extension. The primary endpoint is the proportion of participants able to achieve at least a 50 percent reduction from baseline in GIR, a measure of intravenous glucose dependency for underlying hypoglycemia. Additional endpoints include the number of participants achieving complete discontinuation of GIR and time to discontinuation, time to discharge from the hospital as applicable, extent of hypoglycemia events and hypoglycemia time in the outpatient setting by self-monitored blood glucose and continuous glucose monitor, respectively, and patient reported quality of life.

About Tumor Hyperinsulinism

Tumor hyperinsulinism (HI) is a rare disease that may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs), both of which lead to hypoglycemia because of over-activation of the insulin receptor. Insulinomas are the most common type of ICT and cause hypoglycemia via the overproduction of insulin. A variety of different NICTs, including hepatocellular carcinoma and soft tissue malignancies (e.g. sarcomas), can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances, such as variants of IGF-2, that bind to and activate the insulin receptor. With high morbidity and mortality rates within tumor HI, there remains a significant unmet need for new therapies directed at hypoglycemia treatment. Ersodetug has shown real-world benefit in patients with insulinoma and NICTs.

About Ersodetug

Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from pancreatic insulin or paraneoplastic IGF-2 secretion, and from entero-incretin pathways, it has the potential to be universally effective at treating refractory hypoglycemia due to any form of HI, including congenital HI, tumor HI (insulinoma, non-islet cell tumors) or bariatric/non-bariatric gastrointestinal surgery hypoglycemia. Ersodetug for the treatment of HI is investigational. Statements about safety and efficacy have not been approved by any health authority.

(Press release, Rezolute, NOV 13, 2026, View Source [SID1234674752])

PDS Biotech Reports Third Quarter 2026 Financial Results

On November 13, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a business and clinical programs update and reported financial results for the quarter ended September 30, 2026.

"During our third quarter, we continued to execute our strategic prioritization of PDS0301, our investigational tumor-targeted IL-12 immunocytokine, as our lead development program," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We believe the ongoing clinical trials of PDS0301 at the NCI, along with those of our cancer vaccine platform, support our view that targeted T cell immunotherapy has the potential to change how solid tumors are treated. We are pleased to have the support of Dr. Soon-Shiong and NantWorks, who share our belief in the promise of our immunotherapy platforms and led our PIPE financing of up to $22.3 million, the initial closing of which we completed this quarter."

Clinical and Corporate Update

•
Announced the initial closing of a PIPE financing of up to $22.3 million led by Nant Capital, LLC with additional participation from current investors.

o
The PIPE includes a contingent milestone closing triggered by the Company’s submission to the FDA of a registrational Phase 3 clinical trial protocol for PDS0301 designed in collaboration with NantWorks, subject to the satisfaction or waiver of applicable closing conditions.

o
In connection with the PIPE, the Company entered into an option agreement granting NantWorks, LLC a one-year exclusive right to negotiate an exclusive license for the PDS0101 program.

o
Dr. Patrick Soon-Shiong, founder of NantWorks, and James Banaag appointed to the Company’s Board of Directors as Nant Capital designees.

•
Appointed three pharma veterans to the Company’s Board of Directors, effective October 18, 2026:

o
John Dawson CBE, Deborah Ramsdell, and Bruce Wendel bring deep corporate development, commercialization, and regulatory expertise to the Company.

•
Hosted a Key Opinion Leader (KOL) event discussing PDS0301 Phase 2 trials and projected clinical progress.

o
The event featured Jonathan M. Hernandez, M.D., an investigator with the Surgical Oncology Program at the National Cancer Institute’s Center for Cancer Research. Dr. Hernandez joined company management to discuss clinical outcomes from PDS0301 in the treatment of advanced liver-associated cancers, with a focus on the metastatic colorectal cancer (mCRC) cohort.

o
A replay of the event is available here.

•
Announced publication of VERSATILE-002 Phase 2 clinical trial results of PDS0101 with pembrolizumab in HPV16-positive recurrent and/or metastatic (R/M) head and neck cancer in JAMA Oncology.

•
Received issuance of a Japanese patent, JP Patent No.7909860, titled Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes. The patent broadly covers compositions and use of the Versamune technology platform broadly for use as a T cell activating immunotherapy. A related US patent, US Patent No. 12,551,460, issued earlier in 2026.

•
Received issuance of patents titled HPV16 Non-HLA Restricted T Cell vaccines, Compositions and Methods of Use Thereof in both India and Israel, IN Patent No. 603830 and IL Patent No. 265833. The patents cover the composition and use of PDS0101 being developed to treat HPV16-positive cancers. A related US patent, US Patent No. 11,401,306, issued in 2022.

Third Quarter 2026 Financial Results

The Company’s cash and cash equivalents as of September 30, 2026 were $15.2 million.

Reported net loss was $7.6 million, or $0.11 per basic and diluted share, for the three months ended September 30, 2026, compared to $9.0 million, or $0.19 per basic and diluted share, for the three months ended September 30, 2025.

Research and development expenses were $2.1 million for the three months ended September 30, 2026, compared to $4.6 million for the three months ended September 30, 2025. The decrease of $2.5 million was primarily attributable to decreases of $1.6 million in clinical trial costs, $0.6 million in personnel costs and $0.3 million in manufacturing costs.

General and administrative expenses increased to $3.8 million for the three months ended September 30, 2026 from $3.6 million for the three months ended September 30, 2025. The increase of $0.2 million was primarily attributable to an increase of $0.3 million in professional fees, an increase of $0.1 million in personnel costs offset by a decrease of $0.2 million in stock based compensation costs.

Total operating expenses were $5.9 million for the three months ended September 30, 2026, compared to $8.1 million for the three months ended September 30, 2025.

Net interest expenses were $1.7 million for the three months ended September 30, 2026, compared to $0.9 million for the three months ended September 30, 2025.

(Press release, PDS Biotechnology, NOV 13, 2026, View Source [SID1234674751])

Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) in Combination With Lenvatinib for Adults With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC) Following Treatment With an Anti-PD-1/PD-L1 Therapy

On November 13, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of WELIREG (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus lenvatinib, the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, for the treatment of adult patients with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway. A final decision is expected in the next two months.

"Patients with advanced renal cell carcinoma in the European Union have limited treatment options if their disease progresses following anti-PD-1 or anti-PD-L1 therapy," said Dr. Christina Derleth, vice president, global oncology clinical development, Merck Research Laboratories. "This positive opinion is a meaningful step toward potentially bringing this first-of-its-kind regimen to patients in need in the European Union and underscores the important role of WELIREG plus lenvatinib as a new option in the treatment of renal cell carcinoma."

The recommendation is based on results from the Phase 3 LITESPARK-011 trial. In the study, WELIREG in combination with lenvatinib demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), one of the study’s dual primary endpoints, reducing the risk of disease progression or death by 26% (HR=0.74 [95% CI, 0.61-0.89]; p=0.001) in patients with advanced ccRCC whose disease progressed on or after treatment with a PD-1 or PD-L1 inhibitor compared to cabozantinib. Initial results for the trial were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium. At the final analysis, overall survival (OS), the study’s other dual primary endpoint, did not meet statistical significance for patients who received WELIREG in combination with lenvatinib compared to cabozantinib. WELIREG in combination with lenvatinib reduced the risk of death by 15% (HR=0.85 [95% CI, 0.70-1.03]) in these patients compared to cabozantinib. Additionally, at the final analysis, the combination showed a continued benefit in objective response rate (ORR), a key secondary endpoint, of 53.1% for WELIREG plus lenvatinib versus 40.2% for cabozantinib. Similarly, WELIREG in combination with lenvatinib improved duration of response (DOR), another secondary endpoint, compared to cabozantinib, with a median DOR of 22.0 months versus 11.9 months, respectively. These results were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026.

In September 2026, WELIREG in combination with LENVIMA (lenvatinib) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced ccRCC following a PD-1 or PD-L1 inhibitor, based on results from the Phase 3 LITESPARK-011 trial.

About LITESPARK-011
LITESPARK-011 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04586231) evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced ccRCC. Eligible patients include participants with locally advanced or metastatic ccRCC who have progressed on or after a PD-1 or PD-L1 inhibitor, or within 6 months of completing adjuvant therapy with a PD-1 inhibitor. The trial enrolled 747 patients who were randomized to receive WELIREG (120 mg orally once daily) plus LENVIMA (20 mg orally once daily) or cabozantinib (60 mg orally once daily). The major efficacy endpoints were PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by blinded independent central review (BICR) and OS. Objective response rate per RECIST v1.1 as assessed by BICR, DOR per RECIST v1.1 as assessed by BICR and safety were additional endpoints.

About renal cell carcinoma
Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2024, there were an estimated 442,570 new cases of kidney cancer and 144,871 deaths from the disease worldwide. Renal cell carcinoma is about twice as common in men as in women. Cases of RCC might be discovered incidentally during imaging tests for other reasons. Approximately 32% of patients with kidney cancer are diagnosed at a regional or metastatic stage. Clear cell renal cell carcinoma, which accounts for about 70% of RCC diagnoses, is the most common subtype.

(Press release, Merck & Co, NOV 13, 2026, View Source [SID1234674750])

Incyte provided update on Phase 3 MAESTRA-3 study

On November 13, 2026 Incyte Corporation (the "Company") reported it has decided not to proceed with the planned Phase 3 MAESTRA-3 study evaluating INCB123667, the Company’s selective CDK2 inhibitor, in combination with bevacizumab as first-line maintenance therapy in patients with ovarian cancer, which had been expected to begin in the fourth quarter of 2026.

The Company’s determination was based on the prioritization of its clinical development portfolio and was not based on any safety or efficacy findings from the INCB123667 clinical program. The Company does not expect this determination to affect its financial guidance or its previously disclosed long-term outlook.

(Press release, Incyte, NOV 13, 2026, View Source [SID1234674749])