On May 22, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, reported publication of cell therapy NXC-201 Abstract #7508, selected for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2025) being held in Chicago, Illinois (Press release, Immix Biopharma, MAY 22, 2025, View Source [SID1234653306]). The abstract summarizes positive results from the U.S. multi-site NEXICART-2 trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis with a data cutoff of January 28, 2025.

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On June 3, 2025 Heather Landau, MD of Memorial Sloan-Kettering Cancer Center in New York will present further updated results at ASCO (Free ASCO Whitepaper) oral presentation in Chicago, IL. A Key Opinion Leader (KOL) event to discuss the significance will be held Tuesday, June 3, 2025 3:00pm ET with live Q&A (register here to participate).

"We are beyond thrilled with the strength of these results. I believe these results could transform the paradigm of relapsed/refractory AL Amyloidosis treatment," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "Recent NXC-201 FDA RMAT designation and ASCO (Free ASCO Whitepaper) interim readout demonstrate our progress toward completion of NEXICART-2 enrollment and BLA submission."

Immix’s Phase 1/2 NEXICART-2 clinical trial is a U.S. multi-site, single-arm study to evaluate the efficacy and safety of NXC-201 in patients who are refractory to, or relapse on treatment for relapsed/refractory AL Amyloidosis.

ASCO Abstract Results
Prior to NXC-201 treatment, the median lines of therapy was 4 (range: 2-9). All patients had baseline relapsed/refractory AL Amyloidosis organ involvement. After NXC-201 treatment, all patients normalized pathological disease markers. Complete responses (CRs) were observed in 71% (5 out of 7) of patients treated with NXC-201. The remaining 2 patients are bone marrow minimum residual disease (MRD) negative (10-6), predicting future CR (Immix believes remaining two MRD negative (10-6) patients could be confirmed as CRs in the coming weeks and months). Downstream clinical improvement, including cardiac and renal organ responses, were recorded after CRs. There have been no relapses recorded to-date and no safety signals identified. No neurotoxicity has been observed. Only low-grade cytokine release syndrome has been observed, lasting less than 24 hours. The ASCO (Free ASCO Whitepaper) abstract contains clinical data as of January 28, 2025.

Current treatments typically result in a lower than 10% complete response (CR) rate in relapsed/refractory AL Amyloidosis according to Zanwar, et al 2024, indicating a high unmet medical need.

Updated NXC-201 results with a later data cutoff, including endpoint analysis, will be presented on June 3, 2025 by lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center:

Upcoming ASCO (Free ASCO Whitepaper) Presentation

Title "Safety and efficacy data from NEXICART-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201"
Presentation
Date/Time
Session Date: Tuesday, June 3, 2025 at 12:09pm CT (1:09pm ET)
Abstract Number: 7508
Session Name: 652. Oral Abstract Session – Hematologic Malignancies-Plasma Cell Dyscrasia
KOL Event to Discuss NXC-201 ASCO (Free ASCO Whitepaper) Clinical Data Presentation
A Key Opinion Leader (KOL) event with lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center, Shahzad Raza, MD of Cleveland Clinic and Jeffrey Zonder, MD of Karmanos Cancer Center will be held subsequently Tuesday, June 3, 2025 at 3:00 pm ET to discuss these results. Register here: View Source

About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. U.S. Phase 1/2 study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

About AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that circulate in the blood, then build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading to high mortality rates.

The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

On May 22, 2025 Genmab A/S (Nasdaq: GMAB) reported that it will present new research from its comprehensive development program evaluating its late-stage portfolio at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 30 to June 3 in Chicago, Illinois (Press release, Genmab, MAY 22, 2025, View Source [SID1234653305]).

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The presentations will include the first disclosure of results from a Phase 1/2 trial evaluating rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRa)-targeted, TOPO1-inhibor antibody-drug conjugate (ADC), in patients with recurrent/advanced endometrial cancer. Additionally, results from an analysis of the Phase 1/2 EPCORE NHL-1 study of epcoritamab, a T-cell–engaging bispecific antibody administered subcutaneously, including long-term follow-up in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who remain in complete response (CR) at 2 years, will be presented.

"Our presence at ASCO (Free ASCO Whitepaper) reflects our commitment to advancing our antibody science for patients in need of alternative treatment options, including women with endometrial cancers that have progressed following treatment with existing available therapies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We’re particularly encouraged by Rina-S as a potential treatment option for endometrial cancer, one of the few cancers with rising mortality rates and few treatment options. Additionally, together with AbbVie, we are continuing our commitment to evaluating epcoritamab as a potential core therapy across B-cell malignancies."

Investor Update at ASCO (Free ASCO Whitepaper) 2025
On Monday, June 2 at 4:00 PM CDT (5:00 PM EDT/11:00 PM CEST), Genmab will host a review of the Rina-S data presented at ASCO (Free ASCO Whitepaper). The event will be virtual and webcast live. Details, including the webcast link and registration, will be available on View Source This meeting is not an official program of the ASCO (Free ASCO Whitepaper) Annual Meeting.

All abstracts accepted for presentation have been published and may be accessed online via the ASCO (Free ASCO Whitepaper) Meeting Library. Abstracts accepted for presentation at ASCO (Free ASCO Whitepaper) include:

Rinatabart sesutecan (Rina-S)

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
3039 Winer et al. Rinatabart sesutecan (Rina-S) for patients with advanced endometrial cancer: First disclosure from dose expansion cohort B2 of the GCT1184-01 study. Poster June 2; 1:30 p.m.-4:30 p.m. CDT

TPS5627 Secord et al. A phase 3, open-label, randomized study of rinatabart sesutecan (Rina-S) vs investigator’s (IC) of chemotherapy in patients with platinum-resistant ovarian cancer Poster June 1, 9:00 a.m.-12:00 p.m. CDT
Epcoritamab

Abstract
Number Abstract Title Type of Presentation Date/Time of Presentation
7043 Karimi et al. Novel analysis of 3-y results from the pivotal EPCORE NHL-1 study: Outcomes in patients with relapsed/refractory large B-cell lymphoma and complete response at 2 y with epcoritamab monotherapy Poster June 1; 9:00 a.m.-12:00 p.m. CDT
e19001 Zhao et al. First data from phase 1b/2 EPCORE NHL-4: epcoritamab (epcor) in Chinese patients (Pts) with relapsed or refractory diffuse large B-cell lymphoma Publication NA
Non-Asset

Abstract
Number Abstract Title Type of Presentation Date/Time of Presentation
6046 Maghsoudi et al. Fusion of Radiomic, Pathomic, and Clinical Biomarkers Reveals Multi-scale Tumor Biology, Improves OS
Stratification in HNSCC receiving Standard of Care (SOC) Poster June 2; 9:00 a.m.-12:00 p.m. CDT
The safety and efficacy of investigational products and uses have not been established.

About Rinatabart Sesutecan (Rina-S; GEN1184)
Rinatabart sesutecan (Rina-S; GEN1184) is a FRα-targeted, TOPO1 ADC, currently being evaluated for the potential treatment of ovarian cancer and other FRα-expressing cancers. A Phase 3 trial (RAINFOLTM-02, NCT06619236) evaluating Rina-S in patients with platinum resistant ovarian cancer compared to treatment of investigator’s choice is ongoing. In January 2024, the U.S. Food and Drug Administration granted Fast Track designation to Rina-S for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

The safety and efficacy of rinatabart sesutecan has not been established. Please visit www.clinicaltrials.gov for more information.

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemoimmunotherapy in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

On May 22, 2025 Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications, reported financial results for the three months ended March 31, 2025 and recent developments (Press release, Galmed Pharmaceuticals, MAY 22, 2025, View Source [SID1234653304]).

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Key Recent Developments

Announced First Time Results in Oncology Studies: Aramchol Significantly Enhances Bayer’s Regorafenib Effect in GI Cancer Models
Signed Term Sheet for the Development of Novel Semaglutide Sublingual Formulation
Raised $6.5 million since the beginning of 2025. Company’s current cash balance is $20.1 million
Financial Summary – First Quarter 2025 vs. First Quarter 2024*:

Cash and cash equivalents, short term deposits, restricted cash and marketable debt securities totaled approximately $15.9 million as of March 31, 2025, compared to approximately $15.4 million at December 31, 2024. During May 2025, the Company raised an additional $5.0 million. As a result, as of the date hereof, the Company’s current cash balance is approximately $20.1 million.
Net loss amounted to approximately $1.1 million, or $0.62 per share, for the three months ended March 31, 2025, compared to a net loss of approximately $1.3 million, or $2.76 per share, for the three months ended March 31, 2024.
Research and development expenses amounted to approximately $0.6 million for the three months ended March 31, 2025, compared to approximately $0.6 million for the three months ended March 31, 2024.
General and administrative expenses amounted to approximately $0.6 million for the three months ended March 31, 2025, compared to approximately $0.8 million for the three months ended March 31, 2024. The decrease in general and administrative expenses for the three months ended March 31, 2023 resulted primarily from a decrease in professional services expenses.
Financial income, net amounted to approximately $0.2 million for the three months ended March 31, 2025, compared to financial income of $0.1 million for the three months ended March 31, 2024.

On May 22, 2025 FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, reported a $38 million Series D-2 financing (Press release, Fore Biotherapeutics, MAY 22, 2025, View Source [SID1234653303]). For this initial close of the Series D-2, leading healthcare dedicated investors participated, including SR One, Medicxi, OrbiMed, HBM Healthcare Investments, Wellington Management, Novartis Venture Fund, Cormorant Asset Management, and 3B Future Health Fund. This $38 million adds to the $75 million raised as part of the earlier Series D and D-1 financings, for an aggregate total to date of $113 million for this Series D financing.

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"At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need," said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. "Fore Bio is focused on resetting the standard in BRAF driven tumors with a potential first in class paradox breaker with compelling early clinical data that support the potential of plixorafenib monotherapy to address the well-known treatment gaps oncologists face with first- and second-generation BRAF inhibitors. We are impressed with the team’s progress to date, excited about the multiple near term data readouts, and are proud to support the continued advancement of plixorafenib."

"This financing is a testament to the hard work of our team in developing plixorafenib, a differentiated, rationally designed BRAF inhibitor for both V600 and non V600 mutations that has already generated compelling data to date. We believe plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors, representing a multi-billion-dollar market opportunity," said William Hinshaw, Chief Executive Officer of Fore. "We are grateful for the continued support of this highly regarded investor syndicate and their confidence in both the Fore Bio team and plixorafenib. With their backing, we are well positioned to continue our capitally efficient execution and make significant strides in delivering the ongoing FORTE Master Protocol as we look to multiple anticipated interim analyses and clinical data supporting potential registration under the accelerated approval pathway with FDA submissions potentially at the end of next year."

Proceeds from the financing will be used to advance the registration-intended FORTE Master Protocol, a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are BRAF V600 Recurrent Primary Central Nervous System (CNS) Tumors, Rare BRAF V600 Mutated Solid Tumors and Solid Tumors with BRAF Fusions.

2025 Strategic Objectives and Anticipated Milestones

Fore Bio is anticipating interim analyses to occur in 2025 across three monotherapy indications being evaluated in the FORTE Master Protocol:

BRAF V600 Primary Recurrent CNS Tumors: In this cohort, up to approximately 50 patients with BRAF V600 primary recurrent CNS tumors will be treated with plixorafenib. The primary endpoints of the study are overall response rate (ORR) and median duration of response (mDOR). An interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the third quarter of 2025. Pending a positive recommendation from the data monitoring committee, topline data from this trial would be anticipated in the second half of 2026. The company anticipates that this trial, with sufficient demonstration of safety and efficacy, would enable the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) under the Accelerated Approval pathway. In a previously conducted Phase 1/2 study of patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated a 67% ORR and a mDOR of 13.9 months, along with a favorable tolerability profile.

Rare BRAF V600 Mutated Solid Tumors: In this cohort, up to approximately 75 patients with rare BRAF V600 mutated solid tumors will be treated with plixorafenib. The primary endpoints of the study are ORR and median duration of response mDOR. An interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the fourth quarter of 2025. In a previously conducted Phase 1/2 study of patients with MAPK inhibitor naïve BRAF V600 mutated solid tumors (n=24), plixorafenib monotherapy demonstrated a 42% ORR and a mDOR of 17.8 months, along with a favorable tolerability profile.

Advanced Solid Tumors with BRAF Fusions: In this cohort, up to approximately 75 patients with advanced solid tumors with non-V600 BRAF fusions will be treated with plixorafenib. The primary endpoints of the study are ORR and median duration of response mDOR. An interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the fourth quarter of 2025. In a previously conducted Phase 1/2 study of adults with advanced solid tumors with BRAF fusions (n=14), plixorafenib monotherapy results in one complete response (with a DOR of 67.4 months), one partial response and 7 stable disease, along with a favorable tolerability profile.

Recent and Upcoming Medical Meeting Presentations

AACR 2025: In April 2025, Fore presented new circulating tumor DNA (ctDNA) results from a previously completed plixorafenib clinical trial and presented the basket study design for the ongoing global Phase 2 FORTE clinical trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. Results from the plasma ctDNA analysis of over 70 plixorafenib-treated patients demonstrated a high concordance between changes in ctDNA and tissue biopsy of several BRAF mutations. The correspondence shown between changes in ctDNA and tumor size across tumor types suggests that ctDNA may be a viable surrogate marker for monitoring disease. Compared to acquired mutations driving resistance to early generation BRAF inhibitors, no new mutations in MAPK pathway genes were found following plixorafenib treatment, supporting the dimer–breaker property and novel mechanism of action of plixorafenib from the early generation BRAF inhibitors.

ASCO 2025: At the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 – June 3 in Chicago, Fore will present the master protocol design of the ongoing global Phase 2 FORTE clinical trial.

On May 22, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported results from an expansion cohort of the phase 1b/2 STELLAR-002 trial evaluating zanzalintinib in combination with either nivolumab (Opdivo) or a fixed-dose combination of nivolumab and relatlimab (Opdualag) in patients with previously untreated advanced clear cell renal cell carcinoma (RCC) (Press release, Exelixis, MAY 22, 2025, View Source [SID1234653302]). These findings, as well as data from multiple dose-escalation cohorts from STELLAR-002, will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"We are pleased to present these preliminary findings from the phase 1b/2 STELLAR-002 study, including early signs of promising activity for zanzalintinib in combination with immune checkpoint inhibitors," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "Data emerging from this ongoing study are important to help inform further evaluation of zanzalintinib-based regimens in advanced solid tumors, including renal cell carcinoma."

Abstract 4515: Zanzalintinib + Nivolumab ± Relatlimab in Patients with Previously Untreated Clear Cell Renal Cell Carcinoma: Results from an Expansion Cohort of the Phase 1b STELLAR-002 Study
Lead Author: Jad Chahoud, M.D., M.P.H., Moffitt Cancer Center, Tampa, Fla., USA
Session Title: Genitourinary Cancer—Kidney and Bladder
Saturday, May 31, 1:15-2:45 p.m. CDT

This expansion cohort of STELLAR-002 included patients with advanced clear cell RCC who received zanzalintinib in combination with either nivolumab (n=40) or fixed-dose nivolumab and relatlimab (n=40) in two non-randomized treatment arms. Patients had unresectable advanced or metastatic disease for which they received no prior systemic therapy. Intermediate- or poor-risk disease, per the International Metastatic RCC Database Consortium, accounted for 75% of patients receiving zanzalintinib in combination with nivolumab and 70% of patients receiving zanzalintinib in combination with fixed-dose nivolumab and relatlimab.

At a median follow-up of 20.1 months for those receiving zanzalintinib in combination with nivolumab and 15.9 months for those receiving zanzalintinib in combination with fixed-dose nivolumab and relatlimab, the objective response rates were 63% (95% confidence interval [CI]: 46-77%) and 40% (95% CI: 25-57%), respectively. Disease control rates were 90% (95% CI: 76-97%) for both arms. The 12-month duration of response was 73.4% (95% CI: 50.0-87.1%) and 74.1% (95% CI: 39.1-90.9%), respectively. Median progression-free survival was 18.5 months (95% CI: 9.5 months-not estimable [NE]) and 13.0 months (95% CI: 7.4 months-NE), respectively.

"While significant progress has been made in advanced clear cell renal cell carcinoma, many patients still experience disease progression, and more effective therapies earlier in the treatment landscape are needed," said Jad Chahoud, M.D., M.P.H., Associate Member, Department of Genitourinary Oncology and Medical Director of the Inpatient/Outpatient (IPOP) service at Moffitt Cancer Center in Tampa, Fla., who is presenting the findings. "The high rate of durable responses and long progression-free survival observed for zanzalintinib in combination with nivolumab are encouraging and support further evaluation of this regimen."

Treatment-emergent adverse events (TEAEs) of any grade were reported in all patients. Grade 3/4 TEAEs occurring in at least four patients receiving zanzalintinib in combination with nivolumab included hypertension (n=13), diarrhea (n=6), aspartate aminotransferase increase (n=5), alanine aminotransferase increase (n=5) and palmar-plantar erythrodysesthesia (n=4). Grade 3/4 TEAEs occurring in at least four patients receiving zanzalintinib in combination with fixed-dose nivolumab and relatlimab included hypertension (n=6), rash (n=6), lipase increase (n=4) and pulmonary embolism (n=4). There were two grade 5 TEAEs in each arm; none were considered related to study treatment. Three patients (8%) in the zanzalintinib in combination with nivolumab arm and eight patients (20%) in the zanzalintinib in combination with fixed-dose nivolumab and relatlimab arm discontinued all study drugs for treatment-related AEs as assessed by investigator.

Abstract 3101: Zanzalintinib + Nivolumab ± Relatlimab in Patients with Advanced Solid Tumors: Results from Two Dose-Escalation Cohorts of the Phase 1b STELLAR 002 Study
Lead Author: Benjamin Garmezy, M.D., Sarah Cannon Research Institute, Nashville, Tenn., USA
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Monday, June 2, 1:30-4:30 p.m. CDT

This analysis of STELLAR-002 included multiple cohorts of patients with advanced solid tumors who received zanzalintinib 100 mg in combination with nivolumab (n=19); zanzalintinib 60 mg in combination with fixed-dose nivolumab and relatlimab (n=24); or zanzalintinib 100 mg in combination with fixed-dose nivolumab and relatlimab (n=25). The most common cancer types for those receiving zanzalintinib in combination with nivolumab were colorectal and prostate cancers, followed by lung cancer and RCC. The most common tumor types in the zanzalintinib in combination with fixed-dose nivolumab and relatlimab cohorts were RCC, followed by prostate cancer, melanoma and colorectal cancer.

The findings showed that the toxicity profile of these combinations was manageable and consistent with each monotherapy agent. Preliminary safety, efficacy and pharmacokinetic results supported selection of the 100 mg dose for zanzalintinib for the ongoing expansion cohorts.

About STELLAR-002
STELLAR-002 (NCT05176483) is a global, open-label phase 1b/2 study of zanzalintinib as a single agent or in combination with nivolumab, fixed-dose nivolumab and relatlimab or nivolumab and ipilimumab in advanced solid tumors. The objective of the study is to evaluate the safety, tolerability and efficacy of zanzalintinib alone and in these combinations. The trial is divided into two parts: a dose-escalation stage and an expansion cohort stage. Expansion cohorts include patients with clear cell RCC, non-clear cell RCC, castration-resistant prostate cancer, urothelial carcinoma, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer and head and neck squamous cell carcinoma. Exelixis is sponsoring STELLAR-002, and Bristol Myers Squibb is providing nivolumab, ipilimumab and a fixed-dose combination of nivolumab and relatlimab for use in the trial. More information about the trial is available at ClinicalTrials.gov.

About Zanzalintinib
Zanzalintinib is a third-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis and resistance to multiple therapies, including immune checkpoint inhibitors. With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including neuroendocrine tumors, genitourinary, colorectal and head and neck cancers.

About RCC
Kidney cancer is among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.1 Nearly 81,000 Americans will be diagnosed with kidney cancer in 2025.1 Clear cell RCC is the most common type of kidney cancer in adults.2 Non-clear cell RCC represents about 25% of RCC cases, with fewer treatment options available and poorer outcomes compared with clear cell RCC.3 Advanced or metastatic RCC occurs when the cancer has spread beyond the kidney.4 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%.5 In 2025, approximately 33,700 patients with advanced kidney cancer will require systemic therapy in the U.S., with over 21,400 patients receiving first-line treatment.