Trae tha Truth

Merck Announces Findings from Phase 2 KeyVibe-002 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)

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Thursday, December 7, 2023
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Vibostolimab/pembrolizumab alone did not show an improvement in median PFS compared to docetaxel alone (2.7 months vs. 3.2 months; HR=1.40 [95% CI, 0.96-2.02]; p=0.9622).

Key Points: 
  • Vibostolimab/pembrolizumab alone did not show an improvement in median PFS compared to docetaxel alone (2.7 months vs. 3.2 months; HR=1.40 [95% CI, 0.96-2.02]; p=0.9622).
  • Vibostolimab/pembrolizumab plus docetaxel improved OS compared with docetaxel alone, though these results did not reach statistical significance (HR=0.76 [95% CI, 0.50-1.15]).
  • The safety profile of vibostolimab/pembrolizumab was consistent with that observed for vibostolimab and pembrolizumab in previously reported studies, with no new safety signals observed.
  • Ongoing Phase 3 studies in lung cancer include KeyVibe-003 , KeyVibe-006 , KeyVibe-007 and KeyVibe-008 , as well as KeyVibe-010 in melanoma.

Qilu Pharmaceutical Announces Results from Phase I Clinical Study for Its Novel Bispecific Antibody QLS31905 at ESMO Immuno-Oncology Congress

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Tuesday, December 12, 2023
Pancreatic cancer, Trae tha Truth, Safety, Progression-free survival, Gallbladder cancer, PD, Clinical trial, ESMO, Patient, Multimedia, PFS, Bi-specific T-cell engager, Pharmacokinetics, DCR, Index, ORR, Nausea, MTD, Phase, Stomach, Infrared spectroscopy correlation table, Neoplasm, Fever, CD3, Cytokine release syndrome, Pharmaceutical industry

QLS31905, developed by Qilu Pharmaceutical, is a bispecific T cell engager (BiTE) that targets Claudin18.2.

Key Points: 
  • QLS31905, developed by Qilu Pharmaceutical, is a bispecific T cell engager (BiTE) that targets Claudin18.2.
  • The primary objective of this trial was to evaluate the safety, tolerability, and preliminary antitumor activity of QLS31905 in patients with advanced solid tumors.
  • During the dose-escalation phase, 22 participants received QLS31905 at 0.5 μg/kg QW to 350 μg/kg QW.
  • The Phase II clinical trial are now in progress to further assess the efficacy and safety of QLS31905.

Innovent Presents Clinical Data Update of IBI351 (KRAS G12C Inhibitor) Monotherapy in Lung Cancer and Colorectal Cancer at ESMO Asia Congress 2023

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Friday, December 1, 2023
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As data cutoff date (June 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable:

Key Points: 
  • As data cutoff date (June 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable:
    IBI351 demonstrated encouraging antitumor activity.
  • IBI351 as a selective covalent irreversible KRAS G12C inhibitor, its monotherapy has demonstrated outstanding efficacy and manageable safety in advanced colorectal cancer with KRAS G12C mutation.
  • Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2023 ESMO Asia Congress.
  • We will continue to explore the clinical development of IBI351 monotherapy and combination therapy in the fields of lung cancer, colorectal cancer and other solid tumors to benefit more cancer patients ."

Replimune Presents Updated Data on RP2 in Uveal Melanoma during Plenary Session at the 20th International Congress of the Society for Melanoma Research

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Wednesday, November 8, 2023
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The data were presented by Dr. Joseph Sacco during a Plenary Session at the 20th International Congress of the Society for Melanoma Research in Philadelphia.

Key Points: 
  • The data were presented by Dr. Joseph Sacco during a Plenary Session at the 20th International Congress of the Society for Melanoma Research in Philadelphia.
  • The median duration of response (DOR) at the data cutoff was 11.47 months (range of 2.78 to 21.22 with responses ongoing).
  • RP2 was generally well tolerated both as monotherapy and in combination with nivolumab with no additive adverse events observed.
  • “These data from the trial cohort evaluating RP2 as monotherapy and in combination with nivolumab in metastatic uveal melanoma are highly promising,” said Robert Coffin, President and Chief Research & Development Officer at Replimune.

Medicenna Announces Promising Single-Agent Response and Durability of MDNA11 in the Phase 1/2 ABILITY Study During Dose Escalation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

Retrieved on: 
Monday, November 6, 2023
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MDNA11 with uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.

Key Points: 
  • MDNA11 with uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.
  • Following return from a 7 week vacation, a single new lesion was observed and MDNA11 treatment was resumed.
  • Monotherapy expansion part of ABILITY-1 is enrolling patients with metastatic melanoma, non-melanoma skin cancers (CSCC, MCC, and BCC) and MSI-H/dMMR tumors.
  • A copy of the poster and a related slide deck have been posted to the “ Events and Presentations ” page of Medicenna’s website.

Xilio Announces Initial Monotherapy Safety and Anti-Tumor Activity Data for XTX202, a Tumor-Activated, Engineered, Beta-Gamma IL-2, in Late Line Patients with Advanced Solid Tumors

Retrieved on: 
Friday, November 3, 2023
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We observed a disease control rate of 50% at higher doses (≥2.8 mg/kg) and 31% across all dose levels in a variety of advanced and IO refractory solid tumors, including cold tumors.

Key Points: 
  • We observed a disease control rate of 50% at higher doses (≥2.8 mg/kg) and 31% across all dose levels in a variety of advanced and IO refractory solid tumors, including cold tumors.
  • Eight (8) patients were treated in Phase 2 monotherapy at a dose level of 1.4 mg/kg Q3W.
  • As of the data cutoff date, 20 patients were continuing treatment with XTX202 across the Phase 1/2 trial.
  • Based on the initial monotherapy data for XTX202, Xilio also plans to explore opportunities for strategic partnerships to evaluate XTX202 as a combination therapy.

Adagene Presents Data Demonstrating the Best-in-Class Therapeutic Index for Masked Anti-CTLA-4 SAFEbody® ADG126 at SITC 2023

Retrieved on: 
Friday, November 3, 2023
Neoplasm, Bevacizumab, FOLFOX, MSS, Trae tha Truth, FOLFIRI, Society for Immunotherapy of Cancer, Pembrolizumab, Therapeutic index, SITC, Immunotherapy, CRC, Liver disease, Annual general meeting, Tumor microenvironment, Safety, Society, TME, Patient, PR, Pharmaceutical industry, Ipilimumab

SAN DIEGO and SUZHOU, China, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today presented new data on its masked, anti-CTLA-4 SAFEbody ADG126 at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting taking place in San Diego. The poster presentation, Optimal Dose Selection of ADG126 (Masked Anti-CTLA-4 SAFEbody®) with Significantly Widened Therapeutic Index Compared to Ipilimumab in Combination with anti-PD-1 Antibodies Informed by QSP Modeling, is available on the company’s website.

Key Points: 
  • The poster presentation, Optimal Dose Selection of ADG126 (Masked Anti-CTLA-4 SAFEbody®) with Significantly Widened Therapeutic Index Compared to Ipilimumab in Combination with anti-PD-1 Antibodies Informed by QSP Modeling , is available on the company’s website.
  • The data, which integrate clinical results with physiologically based pharmacokinetic and quantitative systems pharmacology modeling, demonstrated that Adagene’s lead SAFEbody candidate, ADG126, is effective at targeting CTLA-4 within the tumor microenvironment (TME).
  • ADG126 SAFEbody is the most advanced clinical stage anti-CTLA-4 candidate integrating masking technology and Treg depletion for superior safety and efficacy profiles.
  • A phase 2 dose expansion cohort is ongoing to evaluate ADG126 plus pembrolizumab in patients with MSS CRC without liver metastases.

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

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Thursday, November 2, 2023
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Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Key Points: 
  • Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.
  • Methods: Doses of BMF-219 are escalated independently for each indication, initially in single-subject cohorts followed by a “3 + 3” design.
  • A subsequent amendment introduced quotas for KMT2Ar (MLL1r), NPM1 and other known menin-dependent mutations: CEBP/A, MLL1-PTD, MN1, NUP98, NUP214, PICALM-AF10, SETBP1.
  • The study was initiated in July 2023 and will enroll ~110 participants at approximately 30 sites.

ORIC Pharmaceuticals to Present Initial Phase 1b Clinical Data for ORIC-533 in Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Pharmacokinetics, First grade, Bone marrow, Safety, CD73, Plasma, Half-life, Patient, Trae tha Truth, Fluoride toxicity, Pharmaceutical industry

The study included a heavily pretreated patient population where all patients were triple-class refractory, 88% were penta-refractory, and 59% also received prior anti-BCMA/CD3 bispecific therapy or anti-BCMA CAR-T therapy.

Key Points: 
  • The study included a heavily pretreated patient population where all patients were triple-class refractory, 88% were penta-refractory, and 59% also received prior anti-BCMA/CD3 bispecific therapy or anti-BCMA CAR-T therapy.
  • ORIC-533 demonstrated good bioavailability and a plasma half-life of ~24 hours.
  • Strong inhibition of soluble CD73 enzymatic activity was seen across all dose levels.
  • Overall, ORIC-533 demonstrated an acceptable safety profile and preliminary evidence of immune activation in this heavily pretreated patient population.

ProfoundBio Presents Promising Data on ADC Programs, Including Early Clinical Results of Rinatabart Sesutecan in Ovarian and Endometrial Cancers, at SITC 2023

Retrieved on: 
Friday, November 3, 2023
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ProfoundBio , a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, today announced multiple data presentations at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC 2023).

Key Points: 
  • ProfoundBio , a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, today announced multiple data presentations at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC 2023).
  • “We are thrilled to present proof-of-concept data from our novel sesutecan ADC platform with the initial clinical results for Rina-S,” said ProfoundBio Chief Medical Officer Naomi Hunder, M.D.
  • Enrolled patients had the following tumor types: ovarian cancer (n=17), endometrial cancer (n=9), breast cancer (n=3), non-small cell lung cancer (n=5), and mesothelioma (n=2).
  • Superior tumor growth inhibition and tolerability relative to the precedent PTK7-directed ADC cofetuzumab pelidotin were observed in head-to-head preclinical studies.