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HOOKIPA to Present Complete HB-200 Phase 1 Results and Recommended Phase 2 Dose for HB-202/HB-201 for the Treatment of Advanced HPV16+ Cancers at ASCO

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목요일, 5월 26, 2022 - 10:15pm

We look forward to sharing the full Phase 1 data results on our HB-200 program at ASCO.

Key Points: 
  • We look forward to sharing the full Phase 1 data results on our HB-200 program at ASCO.
  • The final analysis shows that HB-201 and 2-vector HB-202/HB-201 were generally well tolerated and showed anti-tumor activity in these difficult-to-treat patients.
  • The primary endpoint of Phase 1 is a recommended Phase 2 dose.
  • In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead.

Elevar Therapeutics Announces Rivoceranib Demonstrated Clinical Effectiveness in Patients with Progressive Recurrent or Metastatic Adenoid Cystic Carcinoma in a Phase 2 Trial

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목요일, 5월 26, 2022 - 10:00pm

SALT LAKE CITY, May 26, 2022 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced its Phase 2 clinical trial (Study RM-202) evaluating rivoceranib, an orally administered tyrosine kinase inhibitor (TKI), demonstrated clinical effectiveness in patients with progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC). Elevar will present topline findings at the American Society of Clinical Oncology (ASCO)’s annual meeting on June 6.

Key Points: 
  • Elevar will present topline findings at the American Society of Clinical Oncology (ASCO)s annual meeting on June 6.
  • It is also gratifying that rivoceranib demonstrates a favorable safety profile, reflecting adverse events consistent with other VEGFR TKIs.
  • Rivoceranib, co-developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (JHP) in China and Elevar Therapeutics globally, with the exception of China.
  • Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and hepatocellular carcinoma (U.S.).

PDS Biotech Announces Presentation of Data from NCI-Led Triple Combination Phase 2 Clinical Trial in Advanced, Refractory HPV-Positive Cancers at ASCO 2022

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목요일, 5월 26, 2022 - 10:01pm

The triple combination is being studied in CPI-nave and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy.

Key Points: 
  • The triple combination is being studied in CPI-nave and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy.
  • Early data from the study suggests that the triple combination is preferentially active in HPV16-positive cancer.
  • Data from 30 cancer patients (9 cervical, 2 vaginal/vulvar, 6 anal, 13 oropharyngeal) are included in the poster.
  • PDS Biotech is presenting a second abstract #6041 from a non-NCI clinical study which presents clinical results for a PDS0101-KEYTRUDA combination in HPV16-positive head and neck cancer.

PDS Biotech Announces Presentation of Efficacy and Safety Data from VERSATILE-002 Phase 2 Clinical Trial in Recurrent or Metastatic Head and Neck Cancer at ASCO 2022

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목요일, 5월 26, 2022 - 10:02pm

VERSATILE-002 is a single-arm Phase 2 study evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotechs proprietary Versamune technology, in combination with Mercks anti-PD-1 therapy KEYTRUDA (pembrolizumab).

Key Points: 
  • VERSATILE-002 is a single-arm Phase 2 study evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotechs proprietary Versamune technology, in combination with Mercks anti-PD-1 therapy KEYTRUDA (pembrolizumab).
  • The combination is being evaluated in checkpoint inhibitor (CPI) -nave and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).
  • The data being presented at ASCO will detail preliminary safety and efficacy data for CPI-nave patients at a prespecified interim analysis point.
  • These data continue to strengthen our confidence that PDS0101 in combination with KEYTRUDA could potentially improve patient outcomes.

Affimed Highlights Trial Designs of Three AFM24 Ongoing Clinical Studies at the Annual Meeting of the American Society of Clinical Oncology (ASCO)

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목요일, 5월 26, 2022 - 10:05pm

We are very excited to have these trial designs showcased at ASCO illustrating why we believe AFM24 can provide a promising alternative to current treatments.

Key Points: 
  • We are very excited to have these trial designs showcased at ASCO illustrating why we believe AFM24 can provide a promising alternative to current treatments.
  • Preclinical studies showed AFM24 induced killing of EGFR+ tumor cell lines independent of EGFR expression level and independent of mutations in the EGFR signaling pathway.
  • An ongoing phase 1/2a, first-in-human study is evaluating AFM24 in patients with locally advanced or metastatic, treatment refractory solid tumors that are known to express EGFR.
  • The starting dose and at least two planned dose escalations are based on results from the ongoing AFM24 monotherapy trial.

IO Biotech Announces Two Presentations at the American Society of Clinical Oncology Annual Meeting 2022

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목요일, 5월 26, 2022 - 10:00pm

The meeting will be held in-person and virtually June 3-7, 2022 in Chicago.

Key Points: 
  • The meeting will be held in-person and virtually June 3-7, 2022 in Chicago.
  • IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform.
  • IO Biotech is advancing in clinical studies its lead immuno-oncology candidate, IO102-IO103, targeting IDO and PD-L1, and through clinical and preclinical development its other pipeline candidates.
  • Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.

Repligen Appoints Dr. Konstantin Konstantinov to Board of Directors

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목요일, 5월 26, 2022 - 9:30pm

WALTHAM, Mass., May 26, 2022 (GLOBE NEWSWIRE) -- Repligen Corporation (NASDAQ:RGEN) today announced the appointment to its Board of Directors of Konstantin Konstantinov, Ph.D., a life sciences and bioprocessing industry expert.

Key Points: 
  • WALTHAM, Mass., May 26, 2022 (GLOBE NEWSWIRE) -- Repligen Corporation (NASDAQ:RGEN) today announced the appointment to its Board of Directors of Konstantin Konstantinov, Ph.D., a life sciences and bioprocessing industry expert.
  • Dr. Konstantinov has been directly involved in the development and commercialization of multiple biotherapeutic modalities, including monoclonal antibodies, blood factors, gene therapy vectors and exosomes.
  • We are delighted to welcome Dr. Konstantinov to our board, said Karen A. Dawes, Chairperson of the Board of Directors for Repligen.
  • We are thrilled to have Konstantin on our Board as we continue on our journey to transform the bioprocessing industry as an innovation leader.

Rubius Therapeutics to Present Trials in Progress Poster for the Phase 1/2 Clinical Trial of RTX-224 in Select Advanced Solid Tumors at the 2022 American Society of Clinical Oncology Annual Meeting

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목요일, 5월 26, 2022 - 10:00pm

The trial will also assess pharmacodynamic changes in immune cell populations relative to baseline and anti-tumor activity.

Key Points: 
  • The trial will also assess pharmacodynamic changes in immune cell populations relative to baseline and anti-tumor activity.
  • The study will include a monotherapy dose escalation phase followed by an expansion phase in specified tumor types during the Phase 2 portion of the trial.
  • Rubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics.
  • We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

Cue Biopharma to Present at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

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목요일, 5월 26, 2022 - 10:00pm

Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO) is committed to making a world of difference in cancer care.

Key Points: 
  • Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO) is committed to making a world of difference in cancer care.
  • As the worlds leading organization of its kind, ASCO representsnearly 45,000 oncology professionalswho care for people living with cancer.
  • The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules.
  • This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation.

Galera Announces Oral Presentation at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting Detailing Results from Phase 3 ROMAN Trial of Avasopasem

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목요일, 5월 26, 2022 - 10:00pm

MALVERN, Pa., May 26, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced data from its Phase 3 ROMAN trial of avasopasem for severe oral mucositis will be highlighted in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on Friday, June 3, 2022 from 2:45 p.m. – 5:45 p.m. CDT during the Head and Neck Cancer session. Topline data was announced in December 2021. Abstracts are currently available in the ASCO digital program.

Key Points: 
  • We are pleased that our Phase 3 trial of avasopasem was selected for an oral presentation at ASCO, where details of the clinically meaningful and statistically significant results will be shared, said Mel Sorensen, M.D., Galeras President and CEO.
  • Exploratory analyses, such as time to SOM onset and SOM incidence at various landmarks of radiotherapy delivered, also demonstrated clinical benefit of avasopasem in reducing the burden of SOM.
  • These results are consistent with those from the positive 223-patient Phase 2b trial (Anderson, J Clin Oncol, 2019) that was the basis for Breakthrough Therapy Designation.
  • Galeras selective dismutase mimetic product candidate avasopasem manganese (GC4419, also referred to as avasopasem) is being evaluated for radiotherapy-induced toxicities.