On February 12, 2025 AVEO Oncology, an LG Chem company ("AVEO"), is a biopharmaceutical company that is trying to provide differentiated solutions to improve cancer patients lives, reported two poster presentations at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) 2025 meeting this February 13-15, 2025, in San Francisco, CA (Press release, AVEO, FEB 12, 2025, View Source [SID1234650222]).

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"We are excited to be presenting the latest tivozanib data at ASCO (Free ASCO Whitepaper) GU," said Edgar Braendle, AVEO’s Chief Medical Officer, "and we look forward to sharing this important data with the genitourinary community and continue to build on the extensive tivozanib clinical story."

Presentation Details

Title: Integrated efficacy and safety exposure response (ER) analysis of tivozanib (TIVO) for the treatment of renal cell cancer (RCC)
First Author: Bradley McGregor, MD, Dana-Farber Cancer Institute
Abstract Number: 461
Poster Session: Poster Session C: Renal Cell Cancer; Penile, Testicular and Urethral Cancers
Poster Board: D29
Date and Time: Saturday, February 15, 2025, 7:10-8:10 AM PT and 11:30 AM-12:45 PM PT
Location: Level 1, West Hall

Title: Patient-reported outcomes (PROs) for tivozanib (TIVO) + nivolumab (NIVO) vs TIVO monotherapy in patients with renal cell carcinoma (RCC) following an immune checkpoint inhibitor (ICI): results of the phase 3 TiNivo-2 study
First Author: Katy Beckermann, MD, PhD, Vanderbilt University
Abstract Number: 459
Poster Session: Poster Session C: Renal Cell Cancer; Penile, Testicular and Urethral Cancers
Poster Board: D27
Date and Time: Saturday, February 15, 2025, 7:10-8:10 AM PT and 11:30 AM-12:45 PM PT
Location: Level 1, West Hall

About FOTIVDA (tivozanib)
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Hypertension was reported in 45% of patients (22% ≥ Grade 3). Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac failures were reported in 1.6% of patients (1% ≥ Grade 3); 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure during treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac ischemia were reported in 3.2% of patients; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of patients, including death due to ischemic stroke (0.1%). Closely monitor patients at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events (VTE) were reported in 2.4% of patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue in patients who develop serious VTEs.

Hemorrhagic Events were reported in 11% of patients; 0.2% of events were fatal. Use FOTIVDA with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria was reported in 8% of patients (2% = Grade 3). Monitor during treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment. Discontinue in patients who develop nephrotic syndrome.

Gastrointestinal (GI) Perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of GI perforation or fistula formation periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening GI perforation.

Thyroid Dysfunction events were reported in 11% of patients (0.3% ≥ Grade 3). Monitor thyroid function before and during treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing is observed.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS
Common adverse reactions include fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.

Serious adverse reactions include bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS
Avoid coadministration with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS
Advise women not to breastfeed during treatment and for at least 1 month after the last dose.

The recommended dosage for patients with end-stage renal disease has not been established.

Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA (tivozanib).

On February 12, 2025 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported financial results for its fiscal third quarter ended December 31, 2024 and provided an update on recent developments (Press release, Aethlon Medical, FEB 12, 2025, View Source [SID1234650221]).

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Company Updates

During the third quarter, and subsequently, the company made significant progress in its oncology trial efforts in Australia while executing cost-cutting measures to enhance operational efficiency. Management is pleased to highlight the following key developments:

Clinical Trials:

Steady progress in our Australian Oncology trial of the Hemopurifier in patients with solid tumors was made. To date, three patients have been enrolled. Two patients did not advance to the treatment phase due to pre-specified stopping criteria during the run-in period – one showed a clinical response to anti PD-1 therapy, while the other experienced toxicity related to anti-PD-1 therapy. The third patient, who did not respond to anti-PD-1 therapy, successfully underwent a single 4-hour Hemopurifier treatment at Royal Adelaide Hospital on January 29, 2025. The treatment was completed with no device-related issues or complications. Samples collected before and after treatment will be analyzed to assess extracellular vesicle removal and changes in anti-tumor T cell activity. This data will be available once all 3 patients in this patient cohort are treated.

Following the investigator meeting with the three clinical sites, Aethlon received valuable feedback suggesting protocol modifications that could possibly improve enrollment speed, reduce screen failures, and shorten the time to Hemopurifier treatment and time to data. In response, the Aethlon team swiftly developed a protocol amendment incorporating these recommendations.

Key changes include enrolling patients only after they have been confirmed not to be responding to anti-PD-1 therapy. This adjustment eliminates the need to identify patients within the first 2 weeks of starting anti-PD-1 therapy and removes the two-month run-in period previously required to assess response to therapy. Additionally, restrictions on commonly prescribed concomitant medications that do not impact patient safety have been lifted. The amended protocol also broadens eligibility to include patients receiving all approved dosing regimens of Pembrolizumab and Nivolumab, rather than limiting enrollment to specific schedules.

The company is pleased to announce that the Human Research Ethics Committees (HREC) and Research Governance Offices (RGO) have approved this amendment at all three clinical sites. The two currently active clinical sites, Royal Adelaide Hospital and Pindara Private Hospital, can enroll under the amended protocol. The third site, Genesis Care/ Royal North Shore Hospital, can begin enrollment under this amendment following a Site Initiation Visit (SIV) on February 14, 2025.

The company continues to pursue approval of a similar clinical trial in India. HREC approval has been obtained at Medanta Medicity Hospital, and we are currently awaiting approval from the regulatory agency CDSCO in India. Recent regulatory changes in India have introduced additional documentation requirements that were previously not necessary. Aethlon is actively responding to CDSCO’s queries through the company’s India CRO, Qualtran.

Operational Efficiency:

Aethlon has implemented strategic cost-cutting measures to optimize company resources, enabling it to maintain a strong focus on the high-impact oncology trials in both Australia and India. These initiatives are designed to improve resource allocation, reduce operational expenses, and support the continued advancement of our clinical programs.

"During the third fiscal quarter and subsequent period, we continued to advance our oncology trials, including treatment of the first patient at Royal Adelaide Hospital in late January. We are pleased to report that the patient tolerated the procedure without complications, making a critical milestone for the safety, feasibility and dose-finding trials of the Hemopurifier in patients with solid tumors who have not responded to anti-PD-1 antibodies," stated James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. "We currently have two clinical sites activated and open for enrollment in Australia, with a third site expected to be activated in February 2025. In addition, we have received ethics committee approval from a site in India. We also anticipate continued enrollments in our Hemopurifier cancer trial as these sites progress.

"While two previously recruited patients were withdrawn from the study due to outcomes related to their anti-PD-1 therapies, we believe that the recent protocol amendment will shorten trial timelines and support improved patient enrollment. As previously announced, we believe these studies will help inform future oncology efficacy trials. Furthermore, we have implemented strategic cost-cutting measures to optimize company resources, enabling us to maintain a strong focus on the high-impact oncology trials in both Australia and India."

As a reminder, the primary endpoint of the approximate nine to 18-patient, safety, feasibility and dose-finding trials, is safety. The trials will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda or Opdivo monotherapy. Patients who do not respond to the PD-1 antibody therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of subsequent efficacy and safety trials, including a Premarket Approval (PMA) study required by the FDA and other regulatory agencies.

Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.

The company is closely monitoring developments related to Bird Flu in the United States, Marburg virus in Rwanda and Ebola virus in Uganda. Aethlon has direct experience with these viruses, having previously generated in vitro viral binding data for all three viruses and treated an Ebola patient in Germany under Emergency Use conditions. Aethlon will continue to monitor these situations carefully and be poised to respond if currently available treatment strategies are deemed ineffective.

Financial Results for the Fiscal Third Quarter Ended December 31, 2024

As of December 31, 2024, Aethlon had a cash balance of approximately $4.8 million.

Consolidated operating expenses for the fiscal quarter ended December 31, 2024, decreased by approximately $1.8 million, or approximately 50%, to $1.8 million compared to $3.6 million for the fiscal quarter ended December 31, 2023. This reduction was driven by a $1.3 million decrease in payroll and related expenses, a $300,000 decrease in professional fees, and a $200,000 decrease in general and administrative expenses.

The approximate $1.3 million decrease in payroll and related expenses was primarily attributable to a reduction of $900,000 in separation expenses related to the Separation Agreement with the former Chief Executive Officer that had been recorded in the December 2023 period, as well as a decrease of approximately $400,000 due to a reduction in headcount. Of the approximate $900,000 of separation expenses related to the departure of the former CEO, approximately $400,000 related to the acceleration of vesting of stock options.

The approximate $300,000 decrease in professional fees was primarily due to an approximate reduction of $200,000 in legal fees resulting from the transition to a new legal firm, and a decrease of $200,000 in scientific and operational consulting fees largely attributable to completed projects. These decreases were partially offset by an approximate $100,000 increase in investor relations and accounting fees.

The approximate $200,000 decrease in general and administrative expenses was primarily driven by a $300,000 reduction in supplies, largely related to the raw materials and components used in the manufacturing of the Hemopurifier, with no comparable purchases during the current period. Additionally, there was an approximate $100,000 decrease in insurance expenses associated with a reduced headcount and various other operating expenses. These reductions were partially offset by a $200,000 increase in expenses related clinical trial expenses related to our ongoing oncology clinical trials in Australia and India.

As a result of the factors noted above, the company’s net loss decreased to approximately $1.8 million in the fiscal quarter ended December 31, 2024, from approximately $3.5 million in the fiscal quarter ended December 31, 2023.

The consolidated balance sheet for December 31, 2024, and the consolidated statements of operations for the three- and nine-month periods ended December 31, 2024 and 2023 follow at the end of this release.

Conference Call

Management will host a conference call today, Wednesday, February 12, 2025, at 4:30 p.m. ET to review the company’s financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference call by navigating to View Source Please note that registered participants will receive their dial-in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741

PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through March 12, 2025. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 7828175.

On February 12, 2025 Akeso, Inc. (9926. HK) ("Akeso" or the "Company") reported the recent completion of the first patient enrollment in the Phase 3 randomized, double-blind, multicenter clinical trial (COMPASSION-30/AK104-309) for its independently developed PD-1/CTLA-4 bispecific antibody, cadonilimab (Press release, Akeso Biopharma, FEB 12, 2025, View Source [SID1234650220]). This study is evaluating the efficacy of cadonilimab compared to sugemalimab (PD-L1) as a consolidation therapy for patients with locally advanced, non-resectable, non-small cell lung cancer (NSCLC) who have not experienced disease progression following concurrent or sequential chemoradiotherapy.

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The COMPASSION-30/AK104-309 study is led by Prof. Jinming Yu, Academician of the Chinese Academy of Engineering and Director of the Oncology Hospital at Shandong First Medical University.

Currently, consolidation therapy with immune checkpoint inhibitors following concurrent or sequential chemoradiotherapy is the standard of care for patients with unresectable NSCLC. The use of immune checkpoint inhibitors as consolidation therapy has demonstrated a modest improvement in overall survival for patients. However, despite these advancements, there continues to be a significant unmet clinical need within this patient population, underscoring the urgent demand for more effective treatment options.

As a global first-in-class bispecific antibody targeting both PD-1 and CTLA-4, cadonilimab is anticipated to enhance the efficacy of immunotherapy compared to PD-1/PD-L1 single-target antibodies. Cadonilimab exerts its effects through multiple mechanisms that contribute to the "normalization" of the tumor microenvironment. Its unique tetravalent symmetric structure, combined with Fc modifications, facilitates targeted accumulation in tumor tissues. These distinctive features enable cadonilimab to potentially improve the effectiveness of cancer immunotherapy while minimizing the risk of adverse effects.

About Cadonilimab
Cadonilimab is a novel global first-in-class PD-1/CTLA-4 bi-specific immuno-therapy drug independently developed by Akeso. In June 2022, cadonilimab was granted marketing approval by the NMPA for the treatment of recurrent/metastatic cervical cancer patients who have progressed on or after platinum-based chemotherapy, and became the world’s first approved PD-1/CTLA-4 bi-specific antibody. In September 2024, cadonilimab as a first-line treatment of unresectable locally advanced, recurrent or metastatic G/GEJ adenocarcinoma was approved in China. Currently, the Company is conducting more than 23 clinical trials of cadonilimab combination therapies covering 16 indications including but not limited to cervical cancer, gastric cancer, liver cancer and lung cancer.

On February 12, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd （"Kelun-Biotech" reported that it will present efficacy and safety results from the Phase 1/2 KL264-01/MK-2870-001 study (NCT04152499) of its anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB-264/MK-2870) as monotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (UC) who progressed on or after prior anti-cancer therapies at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium 2025, to be held in San Francisco, USA, from Feb. 13-15, 2025 (Press release, Kelun, FEB 12, 2025, View Source [SID1234650219]).These findings will be presented in a poster session on February 14, 2025, local time (Abstract #796).

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The abstract for the above study was also published on the official website of the ASCO (Free ASCO Whitepaper) GU Cancers Symposium 2025 on February 10, 2025, local time.

UC

Eligible participants had histologically/cytologically confirmed locally advanced or metastatic UC, had experienced progression of disease on ≥1 prior line of platinum-based therapy and had received prior anti-PD-(L)1 therapy; platinum-ineligible patients were eligible if they received prior anti-PD-(L)1 therapy (prior neoadjuvant/adjuvant therapy counted as a line of therapy if patients progressed within 12 months). Patients had Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1 and measurable disease by CT/MRI. Patients received sac-TMT 5 mg/kg every two weeks (Q2W) until progression of disease, unacceptable toxicity or withdrawal of consent.

As of data cutoff on June 30, 2024, 49 treated patients had a minimum follow-up of ≥9 weeks. Eleven patients received sac-TMT as 2L treatment; 38 received sac-TMT as 3L+ treatment. Median age was 62 and 61 years old, respectively; most patients were Asian (82%; 100%). Median (range) follow-up was 9.5 (7.5-16.2) months and 11.7 (7.8-17.4) months, respectively. Among all patients, objective response rate (ORR) was 31%. Efficacy data are shown below:

Outcome

UC 2L

sac-TMT 5 mg/kg

(n=11)

UC 3L+

sac-TMT 5 mg/kg

(n=38)

Confirmed ORRa n (%)

5 (45)

10 (26)

95% CI

16.7-76.6

13.4-43.1

CR n (%)

1 (9)

0

PR n (%)

4 (36)

10 (26)

SD n (%)

3 (27)

17 (45)

PD n (%)

2 (18)

10 (26)

Not evaluable n (%)

1 (9)

1 (3)

Median DoRb, months (range)

NE (3.5+ to 13.9+)

NE (2.1 to 15.0+)

Median PFSb, months (95% CI)

5.8 (1.7-NE)

5.0 (3.5-7.4)

Median OSb, months (95% CI)

NE (2.0-NE)

11.5 (8.9-NE)

CI=Confidence interval, CR=Complete response, PR=Partial response, SD=Stable disease, PD=Progression of disease, DoR=Duration of response, PFS=Progression-free survival, OS=Overall survival, NE=Not evaluable.

"+" No progressive disease or death as of last disease assessment.

a Includes all patients as-treated.

b Kaplan-Meier method for censored data.

By safety data cutoff (May 21, 2024), grade ≥3 treatment-related adverse events (TRAEs) occurred in 59% of patients. The most common Grade 3-4 TRAEs were anemia (39%), neutrophil count decreased (29%), white blood cells count decreased (16%), stomatitis (12%), and platelet count decreased (8%), which were generally reversible with dose modifications and/or supportive care. No Grade 5 TRAEs occurred; TRAEs led to sac-TMT discontinuation in one patient.

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 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 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.

Previously, the National Medical Products Administration (NMPA) has approved the marketing of sac-TMT in China for 2L+ advanced triple negative breast cancer (TNBC), and accepted two supplemental new drug applications (sNDA) seeking the approvals of sac-TMT monotherapy for 2L/3L EGFR-mutant non-small cell lung cancer (NSCLC).

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).

On February 12, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported that BOT/BAL will be featured in two presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) IO Annual Meeting that will take place on February 23-26 in Los Angeles, California (Press release, Agenus, FEB 12, 2025, View Source [SID1234650218]). An oral presentation will highlight interim data from the ongoing Phase 2 study of botensilimab and balstilimab (BOT/BAL) in combination with MiNK Therapeutics’ iNKT cell therapy, AgenT-797, in patients with refractory (2L+) gastric cancer (NCT06251973). A Trial-in-Progress (TiP) poster will feature data from the ongoing Phase 1/2 study of BOT/BAL in first-line MSS colorectal cancer (NCT05627635).

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Presentation Details:

Abstract Title: First-line botensilimab and balstilimab optimization in microsatellite stable colorectal cancer (MSS-CRC) without liver metastasis (BBOpCo)

Session : Poster Session A

Session Date and Time: Monday, February 24th , 1:45-4:45 p.m. PST

Abstract Title: Biomarker analysis from phase 2 study of AgenT-797 (invariant natural killer T-cells), botensilimab (a Fc-enhanced CTLA-4 Inhibitor) with balstilimab (anti-PD-1) in PD-1 refractory gastroesophageal cancer (GEC)

Session : Proffered Papers, Session 2

Session Date and Time: Tuesday, February 25th , 1:00-1:45 p.m. PST