RECIST

Scholar Rock Presents New Data from Phase 1 DRAGON Trial Showing Promising Anti-Tumor Activity in Anti-PD-1 Resistant Metastatic ccRCC Patients and Supporting SRK-181 Continued Tolerability

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Friday, November 3, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Society for Immunotherapy of Cancer, Neoplasm, Patient, FRCP, MDSC, PRS, NSCLC, Poster, PD, Aes, UC, Publication, Vomiting, DCR, Diarrhea, Pembrolizumab, Metastasis, Associate professor, Safety, Conference, Doctor of Philosophy, MBBS, Data, Nausea, CD8, Rash, Cancer immunotherapy, Immunotherapy, Rock, SD, DRAGON, SITC, San Diego Convention Center, Biopsy, Annual general meeting, ORR, University, RECIST, Biomarker, Melanoma, Lung cancer, Society, Therapy, AE, Carcinoma, Spectrochimica Acta Part B, Dermatitis, PR, Toxic epidermal necrolysis, Pharmaceutical industry, Medical imaging, Nightclub, Part

The second poster focuses on preliminary biomarker data from part B of the trial in patients with multiple tumor types.

Key Points: 
  • The second poster focuses on preliminary biomarker data from part B of the trial in patients with multiple tumor types.
  • Data presented continues to support proof of concept for SRK-181 in 28 heavily pretreated patients with ccRCC resistant to anti-PD-1.
  • In the biomarker analysis for ccRCC, levels of circulating granulocytic myeloid-derived suppressor cells (gMDSC) correlated with clinical activity in ccRCC patients treated with SRK-181 in combination with pembrolizumab.
  • “The DRAGON trial has successfully delivered on its objective of demonstrating proof of concept for SRK-181 by showing promising anti-tumor activity.

Tallac Presents First Clinical Data for TAC-001 at SITC 2023

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Friday, November 3, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Patient, PD, CD22, Mount Tallac, TLR9, Poster, Multimedia, SITC, Immunotherapy, Immunity, MOA, RECIST, Melanoma, Immunology, Cancer, Therapy, Partial agonist, TRAAC, Vaccine, Pharmaceutical industry, Pharmacokinetics

“These TAC-001 clinical data provide evidence that systemic administration of a TLR9 immune agonist targeting and activating B cells is generally well tolerated and induces immune activation consistent with preclinical studies.

Key Points: 
  • “These TAC-001 clinical data provide evidence that systemic administration of a TLR9 immune agonist targeting and activating B cells is generally well tolerated and induces immune activation consistent with preclinical studies.
  • TAC-003 has completed pre-clinical testing, including exploratory toxicological studies in cynomolgus monkeys, and has been selected as the Company’s third clinical candidate.
  • “We are excited to see these initial clinical data with TAC-001, the first program from Tallac’s TRAAC platform,” said Dr. Hong I. Wan, president, CEO and co-founder of Tallac Therapeutics.
  • Tallac Therapeutic’s TRAAC platform is designed to deliver a potent and differentiated TLR9 agonist (T-CpG) for targeted immune activation via systemic administration.

Fulgent Shares Data from Two Poster Presentations at SITC 2023 Annual Meeting

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Friday, November 3, 2023
Technology, Genetics, Health Technology, Software, Biotechnology, Health, Pharmaceutical, General Health, Oncology, SNV, Taxane, Plasma, Stomach, Paclitaxel, Bladder cancer, Research, Cancer, Poster, HNSCC, Pharmacokinetics, SITC, Immunotherapy, Drug discovery, Biopsy, Annual general meeting, Head and neck cancer, RECIST, Biliary tract, Society, Therapy, Liquid biopsy, Patient, Neoplasm, Prostate, PR, Pharmaceutical industry, Medical imaging, Illumina

Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today announced data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.

Key Points: 
  • Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today announced data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.
  • The study calls for the involvement of certified labs, highlighting the need for stringent quality management and regulatory alignment.
  • The poster titled, “FID-007: Nanoencapsulated Paclitaxel Derived from a Novel Nano-Drug Delivery Platform,” highlights progress for Fulgent Pharma’s lead therapeutic oncology candidate, FID-007, in various cancers.
  • Preliminary clinical data suggests FID-007 may have anti-tumor activity in heavily pre-treated patients across various tumor types.

IDRx Presents Preliminary Clinical Data from Ongoing Phase 1 StrateGIST Study at CTOS 2023 Supporting Best-in-Class Potential of IDRX-42 in Patients with GIST

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Thursday, November 2, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, TKI, Patient, KIT, PRS, MTD, MPH, Physician, BID, Exon, Poster, Strategist, UZ Leuven, Annual general meeting, GIST, RECIST, Stromal cell, Therapeutic index, Pharmaceutical industry, MD

“Importantly, these preliminary data will help guide our discussions with physicians regarding development strategies for IDRX-42 in patients with GIST in early lines of therapy to prevent the emergence of genomically-driven resistance mutations.

Key Points: 
  • “Importantly, these preliminary data will help guide our discussions with physicians regarding development strategies for IDRX-42 in patients with GIST in early lines of therapy to prevent the emergence of genomically-driven resistance mutations.
  • Median duration on treatment was 16 weeks and continuing, with 70% (23/33) of patients remaining on treatment at time of data cutoff.
  • 4/28 patients are on study for
  • Title: Phase 1 Study of IDRX-42 in Patients with Advanced Gastrointestinal Stromal Tumors Resistant to Prior Systemic Therapy: Early Results
    Session: CTOS Poster Reception 5:30-6:30 p.m. GMT, Thursday, November 2nd

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

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Wednesday, November 1, 2023
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Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.

Key Points: 
  • Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • For gemcitabine, treatment could be continued beyond eight cycles, while for cisplatin, treatment could be administered for a maximum of eight cycles.
  • There was a difference of ≥5% incidence in laboratory abnormalities between patients who received KEYTRUDA plus chemotherapy versus placebo plus chemotherapy for decreased lymphocytes (69% vs. 61%).

Moleculin Presents Positive Preliminary Efficacy Findings from Phase 1B/2 Clinical Trial Demonstrating 64% Stable Disease Rate Through Two Cycles of Annamycin for the Treatment of Soft Tissue Sarcomas (STS) Lung Metastases

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Monday, November 6, 2023
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HOUSTON, Nov. 6, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced the presentation of preliminary efficacy findings from the Phase 2 portion of the Company's ongoing U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107).

Key Points: 
  • Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107).
  • We look forward to further data readouts from this trial and understanding the full potential of Annamycin for the treatment of STS lung mets."
  • The other subject maintained SD through 8 cycles prior to progressing ~6.9 months after initiating treatment with Annamycin.
  • Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107) visit clinicaltrials.gov and reference identified NCT04887298.

Deciphera Pharmaceuticals Announces Positive Top-line Results from MOTION Pivotal Phase 3 Study of Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT) and Updated Results from Phase 1/2 Study of Vimseltinib in TGCT

Retrieved on: 
Monday, October 30, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Week, IRR, TGCT, Neoplasm, ITT, CSF1R, Leiden University Medical Center, Caregiver, Medicine, Stiffness, ORR, RECIST, Part, Safety, Cancer, Patient, Pharmaceutical industry

“TGCT has a significant negative impact on the daily life of patients who face substantial pain, stiffness, and impaired mobility.

Key Points: 
  • “TGCT has a significant negative impact on the daily life of patients who face substantial pain, stiffness, and impaired mobility.
  • Success across both the primary and all key secondary endpoints in MOTION underscores vimseltinib’s ability to help TGCT patients feel and function better.
  • “The totality of data shown today demonstrate the potential for vimseltinib to offer a new and differentiated treatment option for patients with TGCT.
  • The open-label Part 2 portion of MOTION, in which patients from both the vimseltinib and placebo arms receive treatment with vimseltinib, remains ongoing.

LianBio Announces Presentation of Data from Phase 2a Study of Infigratinib in Patients with Gastric Cancer at ESMO Congress 2023

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Wednesday, October 25, 2023
Gene amplification, Corr, Stomach, NMPA, ESMO, Trae tha Truth, FGFR2, ATP, DOR, DCR, MOS, FGFR, Congress, Safety, National Medical Products Administration, Disease, Oncology, Hepatotoxicity, RECIST, European Society for Medical Oncology, GC, GEJ, Death, Pharmaceutical industry, Patient

1527P)

Key Points: 
  • 1527P)
    The study enrolled 21 GC and GEJ patients with FGFR2 gene amplification.
  • Among 20 evaluable patients who had post-baseline assessments, cORR was 25.0% (95% CI: 8.7–49.1) and DCR was 80.0% (95% CI: 56.3–94.3).
  • “China has an acute need for new effective treatment options as there is a disproportionately higher number of patients with gastric cancer in the region.”
    FGFR pathway aberrations are common in multiple cancer types, including gastric cancer.
  • Infigratinib received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the treatment of gastric cancer.

Ambrx Announces ARX517, a PSMA-Targeted ADC, Demonstrates a Promising 52% PSA50 (≥50% Reduction) and a Highly Differentiated Safety and PK Profile in Patients with mCRPC, who Progressed on Multiple FDA-Approved Treatments

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Monday, October 23, 2023
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SAN DIEGO, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx, (NASDAQ: AMAM), today announced that in biomarker unselected patients ARX517 monotherapy demonstrated a strong antibody-drug conjugate (ADC) safety profile at all doses tested with promising early efficacy signals that included PSA50 declines, ctDNA reductions, and RECIST v1.1 tumor response. The ESMO clinical posters present updated safety, efficacy and PK data from Ambrx’s on-going trial, APEX-01 (NCT04662580).   Posters were made available as part of the 2023 European Society for Medical Oncology (ESMO) Congress 2023 meeting, taking place in Madrid, Spain, October 20-24, 2023, and are summarized below.

Key Points: 
  • The ESMO clinical posters present updated safety, efficacy and PK data from Ambrx’s on-going trial, APEX-01 ( NCT04662580 ).
  • APEX-01 is a Phase 1 / 2, first-in-human, open label dose escalation and dose expansion trial enrolling patients with metastatic castration-resistant prostate cancer (mCRPC).
  • APEX-01 opened for enrollment in July 2021 and is the only on-going clinical trial in the United States targeting PSMA with an ADC.
  • The two primary objectives of APEX-01 are to analyze the safety and tolerability of ARX517 and establish a recommended Phase 2 dose.

Merus’ Zeno Interim Data Continues to Demonstrate Robust and Durable Responses in NRG1+ Cancer

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Monday, October 23, 2023
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UTRECHT, The Netherlands and CAMBRIDGE, Mass., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced interim clinical data, as of a July 31, 2023 data cutoff date, from the phase 1/2 eNRGy trial and Early Access Program (EAP) of the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) cancer presented by Principal Investigator, Dr. Alison Schram* of Memorial Sloan Kettering Cancer Center at the European Society for Medical Oncology (ESMO) Congress 2023.

Key Points: 
  • “I’ve been impressed by the consistency of the Zeno clinical data and am convinced Zeno has the potential to be both a first and best in class treatment for NRG1+ cancer,” said Dr. Andrew Joe, Chief Medical Officer at Merus.
  • With Zeno’s durable efficacy and excellent safety profile reported at ESMO, I believe Zeno could be an important, new standard of care for patients with NRG1+ cancer.”
    The reported data are from the phase 1/2 eNRGy trial and EAP which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer.
  • Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)
    Observations in the presentation include:
    As of July 31, 2023 data cutoff date, 105 patients with NRG1+ NSCLC were treated with Zeno.
  • Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC)
    Observations in the presentation include:
    As of July 31, 2023 data cutoff date, 44 patients with NRG1+ PDAC were treated with Zeno.