Clinical medicine

Positive Pivotal Data for Libtayo® (cemiplimab) Monotherapy in Locally Advanced Basal Cell Carcinoma Featured as a Late-breaking Presentation at ESMO

Friday, September 18, 2020 - 8:05am

The use of Libtayo to treat advanced BCC is investigational and has not been fully evaluated by any regulatory authority.

Key Points: 
  • The use of Libtayo to treat advanced BCC is investigational and has not been fully evaluated by any regulatory authority.
  • In this ongoing, global Phase 2 trial, two cohorts of patients were studied: locally advanced BCC and metastatic BCC.
  • All patients received Libtayo 350 mg intravenously every three weeks for up to 93 weeks or until disease progression.
  • In skin cancer, this includes trials in adjuvant and neoadjuvant CSCC in addition to the pivotal trial in advanced BCC.

Autolus Therapeutics presents additional data on AUTO3 in DLBCL during the ESMO Virtual Congress 2020

Friday, September 18, 2020 - 8:05am

Today we presented data from our recommended Phase 2 dose cohort from the ALEXANDER trial of AUTO3, a CD19 and CD22 dual targeting CAR T product candidate in DLBCL.

Key Points: 
  • Today we presented data from our recommended Phase 2 dose cohort from the ALEXANDER trial of AUTO3, a CD19 and CD22 dual targeting CAR T product candidate in DLBCL.
  • As of the data cut-off date of August 3, 2020, 35 patients in the ALEXANDER Phase 1/2 clinical trial of AUTO3 have been treated and were evaluable for safety.
  • AUTO3 was well tolerated, with no Grade 3 or higher cytokine release syndrome (CRS) with primary infusion and low rates of neurotoxicity (NT).
  • In terms of efficacy data, of the 35 patients dosed to date, 30 patients were evaluable within their completed cohort.

Helsinn Group and Italfarmaco announce oral presentation of NEPA (netupitant and palonosetron) data at ESMO Virtual Congress 2020

Friday, September 18, 2020 - 8:00am

Whilst generally considered safe, even short-term use of DEX is associated with various side effects, including transient elevations in glucose, insomnia, anxiety, and gastric upset.

Key Points: 
  • Whilst generally considered safe, even short-term use of DEX is associated with various side effects, including transient elevations in glucose, insomnia, anxiety, and gastric upset.
  • There is also evidence to suggest that DEX may reduce the efficacy of most immunotherapies and cellular therapies if used concurrently.
  • Dr Silvia Sebastiani, Helsinn Head of Medical Affairs, commented: Our aim is to always improve the quality of life for cancer patients.
  • Title: Two simplified dexamethasone (DEX)-sparing regimens with NEPA for the prevention of emesis caused by cisplatin (DDP): a phase III, controlled, non-inferiority trial

Immutep Announces Improving Results from Stage I of Phase II TACTI-002 Study

Friday, September 18, 2020 - 1:23am

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada).

Key Points: 
  • TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada).
  • Immutep CSO and CMO, Dr Frederic Triebel said: The combination of efti and pembrolizumab is reporting encouraging progression free survival in patients with HNSCC and NSCLC, improving on the results from separate historical trials.
  • For example, in comparable studies, HNSCC patients receiving pembrolizumab monotherapy had a PFS of 2.1 months, or 2.3 months if given chemotherapy1,2.
  • This compares to a PFS of 4.3 months in HNSCC patients from the TACTI-002 trial, thus far.

Ufovax Announces Its Self-Assembling NanoParticles as the Next-Generation Vaccine Solution for COVID-19

Friday, September 18, 2020 - 12:32am

Ufovax holds an exclusive global license to the Scripps Intellectual Property covering the platform and several vaccines, including COVID-19.

Key Points: 
  • Ufovax holds an exclusive global license to the Scripps Intellectual Property covering the platform and several vaccines, including COVID-19.
  • In a publication submitted Monday, September 14 (now available on the bioRxiv preprint server ), the authors present a systematic study on rational vaccine design and evaluation of vaccine response in mice.
  • In particular, Zhu and his team propose a new spike antigen design (S2GHR2) and displayed it on several SApNPs as COVID-19 vaccine candidates.
  • In practice, we have seen similar performance from the Merck HPV Gardasil vaccine which is essentially a protein nanoparticle vaccine.

Dr. Jennifer Buell Speaks Live at Scientific American Inaugural Fireside Chat Series 18 Minutes With

Thursday, September 17, 2020 - 10:06pm

A replay of the live streaming event 18 Minutes With: Dr. Jennifer Buell is available at https://www.scientificamerican.com/custom-media/cancer-covid-19-and-acce...

Key Points: 
  • A replay of the live streaming event 18 Minutes With: Dr. Jennifer Buell is available at https://www.scientificamerican.com/custom-media/cancer-covid-19-and-acce...
    In the interview with Jeremy Abbate, Dr. Buell discusses Agenus immunotherapies in the fight against COVID-19, the importance of combination therapies and the need for improved patient access, and the rapidly changing I-O landscape.
  • Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer.
  • The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs.
  • Information that may be important to investors will be routinely posted on our website and Twitter.

Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab for the Treatment of Soft Tissue Sarcoma

Thursday, September 17, 2020 - 11:00pm

The FDA has previously granted Orphan Drug designation for Toripalimab for the treatment of mucosal melanoma and nasopharyngeal carcinoma.

Key Points: 
  • The FDA has previously granted Orphan Drug designation for Toripalimab for the treatment of mucosal melanoma and nasopharyngeal carcinoma.
  • Soft tissue sarcoma is a rare heterogeneous tumor with complex pathological types and obvious tumor heterogeneity.
  • The current clinical treatment of soft tissue sarcoma mainly uses cytotoxic anti-tumor drugs, which have significant adverse reactions and poor tolerance.
  • Toripalimab for the treatment of nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the FDA in September 2020.

BeiGene Presents Data at ESMO Virtual Congress 2020 on Phase 3 Trial of Tislelizumab in First-Line Non-Squamous Non-Small Cell Lung Cancer and Phase 2 Trial of Pamiparib in Advanced Ovarian Cancer

Thursday, September 17, 2020 - 11:05pm

Our hope is to advance our broad tislelizumab development program in lung cancer to potentially improve treatment outcomes for the most prevalent cancer, both globally and in China.

Key Points: 
  • Our hope is to advance our broad tislelizumab development program in lung cancer to potentially improve treatment outcomes for the most prevalent cancer, both globally and in China.
  • Pamiparib demonstrated strong antitumor activity in patients with advanced ovarian cancer, having achieved clinically meaningful and durable responses in both platinum-sensitive and platinum-resistant patients with BRCA1/2 mutation.
  • The preliminary results presented at ESMO 2020 were from a Phase 2 dose-expansion portion of a Phase 1/2 trial of pamiparib in patients with advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer (NCT03333915).
  • To learn more about the data presented at the ESMO Virtual Congress 2020 and BeiGenes clinical pipeline, visit our virtual booth at https://beigenemedical.eu/ .

Isoray Announces Fourth Quarter and Full-Year Fiscal Year End 2020 Financial Results

Thursday, September 17, 2020 - 9:05pm

RICHLAND, Wash., Sept. 17, 2020 (GLOBE NEWSWIRE) -- Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in seed brachytherapy powering expanding treatment options throughout the body, today announced financial results for the fiscal fourth quarter and full-year ended June 30, 2020.

Key Points: 
  • RICHLAND, Wash., Sept. 17, 2020 (GLOBE NEWSWIRE) -- Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in seed brachytherapy powering expanding treatment options throughout the body, today announced financial results for the fiscal fourth quarter and full-year ended June 30, 2020.
  • Revenue for the fourth quarter of fiscal 2020 grew 18% to $2.28 million versus $1.92 million in the prior year comparable period.
  • Prostate brachytherapy represented 84% of total revenue for the fourth quarter of fiscal 2020 compared to 89% in the prior year comparable period.
  • Cash, cash equivalents, and certificates of deposits at the end of fiscal 2020 totaled $2.39 million and the Company had no long-term debt.Shareholders equity at the end of fiscal 2020 totaled $5.72 million.

Equillium Presented New Data and Insights on the CD6-ALCAM Pathway in Uncontrolled Asthma at the European Respiratory Society International Congress 2020

Thursday, September 17, 2020 - 9:07pm

Preclinical data has demonstrated that modulating the CD6-ALCAM pathway has the potential to inhibit the activation and trafficking of both Th2 and Th17 effector T cells.

Key Points: 
  • Preclinical data has demonstrated that modulating the CD6-ALCAM pathway has the potential to inhibit the activation and trafficking of both Th2 and Th17 effector T cells.
  • Therefore, Equillium is evaluating itolizumab in uncontrolled moderate to severe asthma, regardless of eosinophilia level, to assess the breadth of its clinical utility.
  • The EQUIP study is a Phase 1b randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of itolizumab in patients with uncontrolled moderate-to-severe asthma ( NCT04007198 ).
  • Equilliums initial product candidate, itolizumab (EQ001), is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway.