Phases of clinical research

Transgene Reports Business Update And Q3 2022 Financial Position

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Monday, November 7, 2022
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Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces its business update and its financial position for the quarter ending September 30, 2022.

Key Points: 
  • Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces its business update and its financial position for the quarter ending September 30, 2022.
  • In a previous single-arm Phase Ib/II, Transgene generated strong clinical data in advanced HPV16-positive cancer patients who received TG4001 + avelumab.
  • Transgene plans to communicate an update on these potentially landscape changing trials at a scientific conference in the first half of 2023.
  • AstraZeneca will present a poster at SITC 2022 (November 812, 2022), on a construct that was designed within the frame of its collaboration with Transgene.

Preliminary Results from Two Clinical Studies of Selinexor to be Presented at 2022 ASH Annual Meeting

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Monday, November 7, 2022
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SHANGHAI and HONG KONG, Nov. 6, 2022 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, today announced that it will present updated results from the Phase Ib TOUCH study of selinexor for treatment of R/R T and NK-cell lymphoma in a poster at the upcoming 2022 American Society of Hematology (ASH) Annual Meeting. In addition, preliminary results from the investigator-initiated LAUNCH trial will be published in an on-line abstract. The 2022 ASH Annual Meeting will be held virtually and in person in New Orleans, Louisiana, the United States, from December 10-13, 2022.

Key Points: 
  • In addition, preliminary results from the investigator-initiated LAUNCH trial will be published in an on-line abstract.
  • The 2022 ASH Annual Meeting will be held virtually and in person in New Orleans, Louisiana, the United States, from December 10-13, 2022.
  • "The data to be presented at ASH 2022 highlights the broad clinical potential and manageable side effect profile of selinexor in patients with well-defined T-cell lymphomas and R/R MM," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO.
  • "It is our great pleasureto share these updates with the hematology/oncology community at ASH 2022."

Fate Therapeutics to Present Clinical and Preclinical Data for iPSC Product Platform at the 2022 ASH Annual Meeting

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Thursday, November 3, 2022
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SAN DIEGO, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today announced that fourteen presentations for the Company’s induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition being held in New Orleans, Louisiana, or virtually, December 10-13, 2022.

Key Points: 
  • The Company will also highlight multiple novel strategies to eliminate the need for patient conditioning for off-the-shelf cell therapy.
  • Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.
  • Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer.
  • The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform.

Akeso Announces Oral Presentation of Ivonescimab (PD-1/VEGF Bi-Specific) in First-line Treatment of ES-SCLC on ACLC 2022

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Monday, October 31, 2022
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HK) ("Akeso") released the Phase Ib clinical results of Ivonescimab (PD-1/VEGF bi-specific, AK112) in combination with etoposide and carboplatin in first-line treatment of extensive-stage small-cell lung cancer(ES-SCLC), in an oral presentation at the IASLC 2022 Asia Conference on Lung Cancer.

Key Points: 
  • HK) ("Akeso") released the Phase Ib clinical results of Ivonescimab (PD-1/VEGF bi-specific, AK112) in combination with etoposide and carboplatin in first-line treatment of extensive-stage small-cell lung cancer(ES-SCLC), in an oral presentation at the IASLC 2022 Asia Conference on Lung Cancer.
  • Compared to the data from marketed PD-L1 inhibitors in combination with chemotherapy, AK112 in combination with chemotherapy demonstrated superior antitumor efficacy and survival benefit.
  • As of June 1, 2022, all patients had received at least one dose of AK112.
  • Median progression-free survival (PFS) was 6.9 months, with a 6-month PFS rate of 52.1%,
    Overall survival (OS) data are not mature.

Ascletis Announces U.S. IND Filing of Oral Antiviral ASC10 for Monkeypox Indication

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Wednesday, October 26, 2022
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HANGZHOU and SHAOXING, China, Oct. 26, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces that the Investigational New Drug (IND) application of ASC10, an oral antiviral drug candidate targeting viral polymerase of monkeypox virus, has been filed with the U.S. Food and Drug Administration (FDA).

Key Points: 
  • ASC10 is an orally bioavailable and broad antiviral spectrum double prodrug which has a new and differentiated chemical structure from the single prodrug molnupiravir.
  • Ascletis has filed multiple patent applications globally for ASC10 and its use in viral diseases including monkeypox virus infection.
  • The data from the in vitro antiviral cellular assay with infectious monkeypox virus demonstrated that ASC10-A has potent antiviral activity against monkeypox virus, suggesting that ASC10 has the potential to be an effective treatment of monkeypox virus infection.
  • This IND filing of ASC10 for monkeypox in the U.S. will further broaden Ascletis' pipeline portfolio in viral diseases, and may provide a solution to monkeypox virus infections."

Personalis Forms Research Collaboration to Better Predict Immunotherapy Response for Gastroesophageal Cancer

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Tuesday, October 4, 2022
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Personalis, Inc. (Nasdaq: PSNL) has joined with Duke University and Olink Proteomics AB to form a research collaboration to study the effects of immunotherapy on advanced gastroesophageal cancer.

Key Points: 
  • Personalis, Inc. (Nasdaq: PSNL) has joined with Duke University and Olink Proteomics AB to form a research collaboration to study the effects of immunotherapy on advanced gastroesophageal cancer.
  • Gastroesophageal cancer is the fourth most common cancer worldwide, with nearly 50% of patients having developed unresectable or metastatic disease at the time of diagnosis.
  • Fortunately, pembrolizumab, an immunotherapeutic targeting PDL1/PD1, has been approved by the FDA for use in patients with chemorefractory gastroesophageal cancer.
  • Personalis, Inc. is a leader in advanced cancer genomics, enabling the next generation of precision cancer therapies and diagnostics.

Positive Readouts for Transgene’s Clinical Stage Candidates Generated by its Two Innovative Platforms, with Further Clinical Data Expected in the Second Half of 2022

Retrieved on: 
Wednesday, September 7, 2022
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Additional data from the two ongoing Phase I trials (ovarian cancer and head and neck cancers) are expected in the second half of 2022.

Key Points: 
  • Additional data from the two ongoing Phase I trials (ovarian cancer and head and neck cancers) are expected in the second half of 2022.
  • A clinical collaboration and supply agreement for KEYTRUDA (pembrolizumab) was signed with MSD (Merck & Co) at the end of June 2022.
  • The Phase Ib part of the clinical trial (combination with pembrolizumab) is expected to start in the second half of 2022.
  • In particular, Transgene will disclose new data on TG4050 and provide insights on the progress of the Invir.IO platform.

SpectrumX Confirms Scientific Advice Meeting With MHRA, Proposed Timeline for Human Clinical Trials for Ground-Breaking Medicine SPX-001

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Monday, August 8, 2022
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The MHRA meeting provides an opportunity for the Company to receive further guidance on SPX-001, the broad-spectrum anti-pathogenic medicine produced using the SPC-069 drug substance.

Key Points: 
  • The MHRA meeting provides an opportunity for the Company to receive further guidance on SPX-001, the broad-spectrum anti-pathogenic medicine produced using the SPC-069 drug substance.
  • Following completion of the scientific advice meeting, SpectrumX anticipates it will submit a CTA to the MHRA in which formal authorisation will be sought from the MHRA and UK ethics committee to conduct the proposed clinical trial.
  • This will be conditional upon satisfactory review and evaluation of the information submitted by SpectrumX in the CTA.
  • Contingent upon MHRA approval of the CTA, SpectrumX expects to conduct its first human clinical trial in Q1 2023.

Ascletis Announces FDA Clearance of Oral RdRp Inhibitor ASC10 to Conduct a Randomized, Placebo Controlled Phase Ib Study in Mild-to-Moderate COVID-19 Patients

Retrieved on: 
Wednesday, August 3, 2022
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HANGZHOU and SHAOXING, China, Aug. 3, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ASC10, an oral drug candidate targeting RNA-dependent RNA polymerase (RdRp) for COVID-19, to conduct the Phase Ib clinical trial in mild-to-moderate COVID-19 patients. Ascletis will immediately initiate the clinical trial in patients to collect ASC10's clinical safety, pharmacokinetics and preliminary efficacy data.

Key Points: 
  • Ascletis will immediately initiate the clinical trial in patients to collect ASC10's clinical safety, pharmacokinetics and preliminary efficacy data.
  • ASC10 is an orally bioavailable double prodrug which has a new and differentiated chemical structure from the single prodrug molnupiravir.
  • ASC10 oral tablet formulation for the clinical study was developed with in-house proprietary technology of Ascletis.
  • FDA recommended that Ascletis directly conduct the first clinical study of ASC10 in mild-to-moderate COVID-19 patients rather than in healthy subjects.

Recce Pharmaceuticals Announces Positive Safety Data from Sixth Cohort of Phase I Clinical Trial Evaluating Healthy Subjects Intravenously Dosed with RECCE® 327

Retrieved on: 
Wednesday, June 22, 2022
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SYDNEY Australia, June 22, 2022 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the company developing a new class of synthetic anti-infectives, is pleased to report that in cohort six of a Phase I clinical trial, RECCE® 327 (R327) demonstrated a good safety and tolerability profile among 10 healthy male subjects intravenously dosed at 4,000mg (an 80-fold increase from cohort one at 50mg). A review of the data will be conducted by an Independent Safety Committee with an expected recommendation to commence recruiting for cohort seven.

Key Points: 
  • A review of the data will be conducted by an Independent Safety Committee with an expected recommendation to commence recruiting for cohort seven.
  • The Phase I trial is an ascending dose, randomized, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide's CMAX clinical trial facility.
  • The study is evaluating the safety and pharmacokinetics of R327 in 7-10 healthy subjects per dose across eight sequential dosing cohorts (Trial ID ACTRN12621001313820).
  • RECCE 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.