Core Points - AIM ImmunoTech Inc. will participate in the 2025 Maxim Growth Summit on October 22-23, 2025, in New York, NY, which focuses on industry trends and advancements [1] - Management will be available for in-person one-on-one meetings with registered investors during the conference [2] - AIM ImmunoTech is an immuno-pharma company developing therapeutics for cancers, immune disorders, and viral diseases, with its lead product being Ampligen, currently in Phase 2 clinical trials for metastatic pancreatic cancer in collaboration with AstraZeneca [4] Company Information - AIM ImmunoTech Inc. specializes in research and development of therapeutics targeting multiple diseases, including COVID-19 [4] - The company's lead product, Ampligen (rintatolimod), is a first-in-class investigational drug that acts as a dsRNA and TLR3 agonist [4] - AIM ImmunoTech is focused on broad-spectrum activity in clinical trials, particularly in combination therapies for cancer treatment [4] Event Information - The Maxim Growth Summit is organized by Maxim Group LLC, a full-service investment banking and wealth management firm based in New York [3] - The summit will feature industry leaders and innovators discussing the latest trends across various sectors [1] - For more details on the summit agenda and AIM's presentation, interested parties can visit the respective websites [2]

HARMONi-6 Trial Results (Ivonescimab + Chemotherapy vs Tislelizumab + Chemotherapy in Advanced Squamous NSCLC) - Ivonescimab plus chemotherapy demonstrated a statistically significant improvement in Progression-Free Survival (PFS) compared to tislelizumab plus chemotherapy, with a Hazard Ratio (HR) of 0.60, representing a 4.2-month improvement in median PFS (mPFS)[19, 21] - The median PFS (mPFS) was 11.14 months in the ivonescimab plus chemotherapy arm compared to 6.90 months in the tislelizumab plus chemotherapy arm[21] - Subgroup analysis of PFS by IRRC showed that the PFS benefit favored ivonescimab plus chemotherapy across all key subgroups, including PD-L1 TPS <1% (HR=0.55) and PD-L1 TPS ≥1% (HR=0.66)[29, 31] - The Overall Response Rate (ORR) was higher in the ivonescimab plus chemotherapy arm (75.9%) compared to the tislelizumab plus chemotherapy arm (66.5%), with a p-value of 0.008[37, 38] - The median Duration of Response (mDoR) was 11.20 months in the ivonescimab plus chemotherapy arm compared to 8.38 months in the tislelizumab plus chemotherapy arm, with a p-value of 0.0219[41] - The safety profile of ivonescimab plus chemotherapy was manageable in squamous NSCLC, with Grade ≥ 3 Treatment-Related Adverse Events (TRAEs) occurring in 63.9% of patients in the ivonescimab arm and 54.3% in the tislelizumab arm[46, 47] AK112-206 Trial Results (Ivonescimab + Chemotherapy in Colorectal Cancer) - In the AK112-206 study, the investigator-assessed ORR for ivonescimab + FOLFOXIRI was 81.8% (95% CI: 59.7-94.8) and for ivonescimab + ligufalimab + FOLFOXIRI was 88.2% (63.6-98.5)[97] - The investigator-assessed Disease Control Rate (DCR) was 100% for both ivonescimab + FOLFOXIRI (95% CI: 84.6-100) and ivonescimab + ligufalimab + FOLFOXIRI (95% CI: 80.5-100)[97] - Treatment-emergent adverse events (TEAEs) with Grade ≥3 occurred in 68.2% of patients in the ivonescimab + FOLFOXIRI arm and 66.7% in the ivonescimab + ligufalimab + FOLFOXIRI arm[102] Ongoing and Planned Trials - HARMONi-3, a Phase 3 study of Ivonescimab + Chemo vs Pembrolizumab + Chemo in 1L Metastatic Non-Small Cell Lung Cancer (NSCLC), is ongoing globally with expected enrollment of 600 squamous and 1,000 non-squamous patients[59, 74, 77] - A Phase 3 study of Ivonescimab + Chemo vs Bevacizumab + Chemo in 1L Unresectable Metastatic Colorectal Cancer (CRC) is planned with an enrollment of 600 patients[81, 83]

Core Insights - Johnson & Johnson announced promising results from the Phase 1b/2 OrigAMI-4 study, which evaluated the efficacy and safety of subcutaneous amivantamab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after prior treatments [1][5][6] Study Results - The study reported an overall response rate of 45% in patients with HPV-unrelated R/M HNSCC, with a median time to first response of 6.4 weeks and a median duration of response of 7.2 months [3][4] - Tumor shrinkage was observed in 82% of patients after 8.3 months of follow-up, with a median progression-free survival of 6.8 months [3][4] - The safety profile of subcutaneous amivantamab was consistent with previous studies, with common adverse events including fatigue (31%), hypoalbuminemia (31%), and stomatitis (23%) [4][5] Treatment Context - Patients with R/M HNSCC have limited treatment options and poor outcomes after disease progression on PD-1 or PD-L1 inhibitors and platinum-based chemotherapy, with response rates typically ranging from 10% to 24% [2] - RYBREVANT, the bispecific antibody targeting EGFR and MET, is positioned as a potential treatment option for these patients, highlighting the role of EGFR and MET as key tumor drivers [2][4] Future Directions - Based on the positive results from the OrigAMI-4 study, Johnson & Johnson is initiating the Phase 3 OrigAMI-5 study to further evaluate subcutaneous amivantamab in combination with pembrolizumab and carboplatin [5][6] - The findings support the broader potential of RYBREVANT-based therapies across multiple solid tumors, including non-small cell lung cancer and colorectal cancer [4][6]

Core Insights - Pfizer Inc. announced updated follow-up results from the Phase 2 PHAROS trial for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in treating adults with metastatic non-small cell lung cancer (mNSCLC) with a BRAF V600E mutation [1] Group 1 - In treatment-naïve patients, the median overall survival (OS) was reported at 47.6 months with a 95% confidence interval of 31.3 months, not estimable after a median follow-up of 52.3 months [1]

Core Insights - Regeneron Pharmaceuticals announced new data from the Phase 3 C-POST trial for Libtayo (cemiplimab), focusing on a patient-centric every 6-week dosing regimen for high-risk cutaneous squamous cell carcinoma (CSCC) [1][2] Group 1: Clinical Data and Trial Results - The C-POST trial data will be presented at the ESMO 2025 Meeting, highlighting the efficacy and safety of Libtayo as an adjuvant treatment for CSCC [1][2] - Patients in the trial initially received 350 mg of Libtayo every 3 weeks for 12 weeks, with most switching to every 6-week dosing thereafter, while the safety profile remained consistent with previous findings [2] Group 2: Regulatory and Approval Status - The new data supports the FDA approval of Libtayo as the first immunotherapy for adjuvant treatment of adult patients with high-risk CSCC following surgery and radiation [2] Group 3: Company Overview and Pipeline - Regeneron is focused on developing therapies for over 30 types of solid tumors and blood cancers, with nearly half of its pipeline dedicated to oncology assets [6][26] - Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint, approved in over 30 countries for various indications, including advanced CSCC and non-small cell lung cancer [8][9]

Core Insights - Cellectar Biosciences presented positive preclinical data for CLR 225, an actinium-based radio conjugate, at the AACR Special Conference on Pancreatic Cancer Research, indicating its potential to inhibit tumor growth and improve survival in pancreatic cancer models [1][2] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [6][7] Product Development - CLR 225 has completed IND-enabling studies and is positioned to advance into Phase 1 studies, demonstrating robust anti-tumor activity and selective biodistribution in preclinical models [1][3] - The studies involved three pancreatic cancer xenograft models (PANC-1, MIA PaCa-2, and BxPC-3), showing meaningful inhibition of tumor growth and potential survival benefits [2][3] Mechanism of Action - CLR 225 targets lipid rafts to deliver treatment directly to tumor cells, addressing the dense extracellular matrix characteristic of pancreatic cancer, which is a significant barrier to effective treatment [2][5] Market Context - Pancreatic ductal adenocarcinoma (PDAC) is a severe disease with less than 10% five-year survival rate, accounting for approximately 90% of pancreatic cancer cases in the U.S. [4]

Core Insights - The article discusses the promising interim clinical data for petosemtamab, a bispecific antibody, in combination with standard chemotherapy regimens FOLFOX/FOLFIRI for metastatic colorectal cancer (mCRC) and as a monotherapy for later lines of treatment [1][2] Clinical Trial Data - As of April 28, 2025, 36 patients with microsatellite stable mCRC received petosemtamab 1500 mg Q2W, either in combination with FOLFOX/FOLFIRI or as monotherapy [2] - In the 1L treatment group, 7 patients were treated, with 3 being efficacy evaluable, showing 1 unconfirmed complete response and 2 partial responses [2] - In the 2L treatment group, 10 patients were treated, with 8 being efficacy evaluable, resulting in 4 partial responses and 3 stable diseases [2] - In the 3L+ monotherapy group, 19 patients were treated, with 14 being efficacy evaluable, showing 1 unconfirmed partial response and 6 stable diseases [2] Safety Profile - No fatal treatment-related adverse events (TEAEs) were observed across all cohorts [2] - Common TEAEs for petosemtamab plus FOLFOX included dermatitis acneiform (71%), constipation (43%), fatigue (43%), and peripheral neuropathy (43%) [2] - Common TEAEs for petosemtamab plus FOLFIRI included diarrhea (70%), mucosal inflammation (50%), and fatigue (40%) [2] - For petosemtamab monotherapy, frequent TEAEs included rash (58%) and nausea (26%) [7] Upcoming Presentations - The updated clinical data will be presented in a plenary session on October 24, 2025, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics [3]

Core Insights - AB Science has released initial data on the combination of AB8939 and Venetoclax for treating refractory or relapsed acute myeloid leukemia (AML), showing positive responses in the first three patients with unfavorable genetic profiles [1][2][5] Group 1: Clinical Trial Details - AB8939 is currently in a Phase 1 clinical trial (study AB18001, NCT05211570) targeting refractory and relapsed AML [3][4] - The trial has completed its first two stages, determining the maximum tolerated dose (MTD) at 21.3 mg/m² after 3 and 14 days of monotherapy [4] - The third stage is evaluating the combination of AB8939 and Venetoclax, with initial results showing a 100% disease control rate and a 100% partial response rate among the three patients [5][6] Group 2: Patient Profiles and Responses - The three patients involved in the trial have very difficult-to-treat cytogenetic profiles, including TP53 mutations and complex karyotypes, which are typically associated with poor prognosis [5][6] - Notably, one patient achieved complete remission after the first cycle of treatment, which lasted 14 days [5][6] Group 3: Future Directions - Following the initial encouraging results, the trial will continue with an expansion phase involving about 15 patients with a more homogeneous profile, specifically targeting those in their second or third line of treatment with poor prognostic factors [6] - The ongoing research aims to confirm the initial promising clinical data before initiating a registration clinical trial [6] Group 4: Company Background - AB Science is a pharmaceutical company founded in 2001, specializing in the research, development, and commercialization of protein kinase inhibitors (PKIs) [12][13] - The company focuses on diseases with high unmet medical needs, often lethal or rare, and has developed a proprietary portfolio of molecules [12][13]

Core Insights - CytomX Therapeutics is developing two biologics targeting various cancers, with one already showing promising phase 1 data and the other expected to release phase 1 data soon [1] Company Overview - CytomX Therapeutics is listed on NASDAQ under the ticker CTMX [1] - The company focuses on biopharmaceuticals with potential applications in oncology [1] Clinical Development - One of the biologics has produced compelling results in phase 1 trials, indicating potential efficacy [1] - The second biologic is anticipated to generate phase 1 data shortly, which could provide further insights into its therapeutic potential [1]

Kickoff was extra special for one NFL team this weekend. The Jacksonville Jaguars had an honorary captain at the coin toss, Wesley Hines Allen, son of defensive end Josh Hines Allen. The 8-year-old was diagnosed with leukemia at the end of the 2024 season.>> And they told us that he had leukemia and I was just like it just it just kind of like hit me and then nothing else mattered after that. >> The duo sharing a special father-son moment on the field. Hines Allen reacting to it during an interview with Jac ...