Toxicity

Privo Technologies, Inc. Announces Positive Results From Phase 1/2 Clinical Trial for PRV111 in Head and Neck Squamous Cell Carcinoma

Friday, October 22, 2021 - 6:39pm

PRV111 showed a favorable safety profile with no severe adverse events (SAEs).

Key Points: 
  • PRV111 showed a favorable safety profile with no severe adverse events (SAEs).
  • Reported treatment emergent adverse events (TEAEs) were mild or moderate in severity, and no dose-limiting toxicities (DLTs) were observed.
  • The clinical trial design was Open-Label, Single-Arm Safety, Tolerability, Anti-Tumor Effects, Systemic Exposure, and Device Technical Effects of PRV111 in subjects with Head and Neck Squamous Cell Carcinoma.
  • Squamous cell carcinoma (SCC) is cancer of the squamous cells - thin and flat cells that line the epithelia.

Theratechnologies Announces Publication in Frontiers in Oncology Journal Highlighting SORT1+ Technology™ for Targeting SORT1-Mediated Vasculogenic Mimicry

Friday, October 22, 2021 - 2:15pm

The formation of microvascular channels by deregulated cancer cells leads to aggressive, metastatic and resistant cancer cells and is known as vasculogenic mimicry.

Key Points: 
  • The formation of microvascular channels by deregulated cancer cells leads to aggressive, metastatic and resistant cancer cells and is known as vasculogenic mimicry.
  • VM is believed to be associated with tumor growth, resistance and poor prognosis in many types of aggressive cancers including ovarian and TNBC.
  • Theratechnologies is currently developing a platform of new proprietary peptides for cancer drug development targeting SORT1 receptors called SORT1+ TechnologyTM.
  • TH1902 is currently Theratechnologies lead investigational PDC candidate for the treatment of cancer derived from its SORT1+ Technology.

Humanigen announces preparation of Phase 1b study of ifabotuzumab in solid tumors following presentation of Phase 1 study results at EANM‘21

Friday, October 22, 2021 - 12:00pm

EANM is the largest organization dedicated to nuclear medicine in Europe and represents more than 9,000 specialists from 41 different countries.

Key Points: 
  • EANM is the largest organization dedicated to nuclear medicine in Europe and represents more than 9,000 specialists from 41 different countries.
  • Our preclinical studies with antibody-drug conjugate forms of ifabotuzumab have shown promising results.
  • The Olivia Newton-John Cancer Research Institute plans to conduct a Phase 1b dose-escalation and imaging study in non-CNS solid tumors that is scheduled to begin in early 2022.
  • We look forward to supporting our valued partners in Australia as they advance research of ifabotuzumab into solid tumors.

Masked Antibodies & Cytokines as Prodrugs: A Landscape Analysis of Stakeholders, Technologies, Pipelines, Business and Financing - ResearchAndMarkets.com

Friday, October 22, 2021 - 10:17am

The "Masked Antibodies & Cytokines as Prodrugs: A Landscape Analysis of Stakeholders, Technologies, Pipelines, Business and Financing from An Industry Perspective" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Masked Antibodies & Cytokines as Prodrugs: A Landscape Analysis of Stakeholders, Technologies, Pipelines, Business and Financing from An Industry Perspective" report has been added to ResearchAndMarkets.com's offering.
  • However, systemic administration of monoclonal antibodies or cytokines may induce severe adverse events with mechanism-of-action effects, meaning off-tumor on-target toxicity in healthy tissue.
  • In order to increase the selectivity of antibodies and cytokines at the disease site, antibodies should ignore the target antigen and cytokines the receptor in normal healthy tissue and be preferentially active in the disease region.
  • The prodrug concept of masking technologies is an elegant approach to address the selectivity limitations of conventional therapeutic antibodies and cytokines.

SARC Appoints Dr. Jonathan Fletcher To New Role of Chief Scientific Officer

Friday, October 22, 2021 - 5:01am

SARC (Sarcoma Alliance for Research Through Collaboration) appoints Jonathan Fletcher, M.D.

Key Points: 
  • SARC (Sarcoma Alliance for Research Through Collaboration) appoints Jonathan Fletcher, M.D.
  • Dr. Fletcher also serves on the SARC Board of Directors and on its Scientific Steering, Career Development, and Discovery/Translation Committees.
  • As CSO, Dr. Fletcher will expand SARC commitments in sarcoma biology, discovery science, and biomarkers, thereby strengthening SARC's portfolio of clinical trials.
  • Dr. Fletcher will also serve as chief spokesperson for SARC's scientific strategy, translating sarcoma science for diverse audiences such as the NIH, patient advocates, sarcoma clinicians, and SARC industry partners.

Adial Announces Positive Pre-Clinical Data for Purnovate’s PNV-5030 as a Drug Candidate for the Treatment of Pain

Thursday, October 21, 2021 - 3:13pm

CHARLOTTESVILLE, Va., Oct. 21, 2021 (GLOBE NEWSWIRE) --  Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced positive data in a pre-clinical model of pain reduction. Based on this positive data, Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, Inc., has selected PNV-5030 as the lead compound for its program to develop a drug for the treatment of pain.

Key Points: 
  • Based on this positive data, Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, Inc., has selected PNV-5030 as the lead compound for its program to develop a drug for the treatment of pain.
  • However, PNV-5030 has demonstrated solubility more than 50 times greater than other known selective adenosine compounds of the same class.
  • PNV-5030 alone exhibited a significant pain reduction as compared to the control group and a similar effect to 1mg/kg morphine.
  • Interestingly, when combined with 1 mg/kg morphine, PNV-5030 achieved a similar level of pain reduction to the reduction obtained with 2mg/kg morphine.

Adial Announces Positive Pre-Clinical Data for Purnovate’s PNV-5030 as Drug Candidate for the Treatment of Pain

Thursday, October 21, 2021 - 2:45pm

CHARLOTTESVILLE, Va., Oct. 21, 2021 (GLOBE NEWSWIRE) --  Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced positive data in a pre-clinical model of pain reduction. Based on this positive data, Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, Inc., has selected PNV-5030 as the lead compound for its program to develop a drug for the treatment of pain.

Key Points: 
  • Based on this positive data, Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, Inc., has selected PNV-5030 as the lead compound for its program to develop a drug for the treatment of pain.
  • However, PNV-5030 has demonstrated solubility more than 50 times greater than other known selective adenosine compounds of the same class.
  • PNV-5030 alone exhibited a significant pain reduction as compared to the control group and a similar effect to 1mg/kg morphine.
  • Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders.

Ligand and CR Double-Crane Enter Collaboration Agreement to Develop an Oral COVID-19 Therapeutic Using Ligand’s BEPro Technology™

Thursday, October 21, 2021 - 2:00pm

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced the signing of a collaboration agreement granting China Resources Double-Crane Pharmaceutical Co., Ltd. (CRDC) exclusive Asia territorial rights to develop a novel investigational oral COVID-19 antiviral therapeutic compound using Ligands BEPro technology.

Key Points: 
  • Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced the signing of a collaboration agreement granting China Resources Double-Crane Pharmaceutical Co., Ltd. (CRDC) exclusive Asia territorial rights to develop a novel investigational oral COVID-19 antiviral therapeutic compound using Ligands BEPro technology.
  • BEPro is a proprietary prodrug technology that is specifically applicable to nucleotides and nucleotide analogs for the development of compounds with improved product profiles.
  • Ligand has filed multiple patents globally on the BEPro technology and potential antiviral compounds.
  • Ligands OmniAb technology platform is a patent-protected technology stack used in the discovery of fully human mono- and bispecific therapeutic antibodies.

BeyondSpring Announces First Patient Treated in Phase 2 Study with Plinabulin Combined with Nivolumab + Ipilimumab in Patients in 3rd Line Recurrent Small-Cell Lung Cancer Patients Who Failed Checkpoint Inhibitors

Thursday, October 21, 2021 - 12:00pm

NEW YORK, Oct. 21, 2021 (GLOBE NEWSWIRE) -- BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, announced the first patient has been treated in an investigator-initiated, open-label Phase 2 study with lead asset plinabulin in combination with nivolumab + ipilimumab in patients with 3rd line recurrent small-cell lung cancer (SCLC) who failed checkpoint inhibitors and platinum-based chemotherapy. Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. This Phase 2 study, to be conducted through the Big Ten Cancer Research Consortium in 7 U.S. clinical centers, comes after the successful completion of the Phase 1 dose escalation study portion of this Phase 1/2 study.

Key Points: 
  • In the Phase 1 study, plinabulin combination was able to induce tumor responses in patients who had progressed on platinum and checkpoint inhibitors, with 43% ORR (3 partial responses with tumor reduction >50%).
  • This Phase 2 study, to be conducted through the Big Ten Cancer Research Consortium in 7 U.S. clinical centers, comes after the successful completion of the Phase 1 dose escalation study portion of this Phase 1/2 study.
  • For patients with extensive stage SCLC who failed chemo and checkpoint inhibitors, effective treatment options are limited.
  • In the Phase 1 study, the addition of plinabulin to nivolumab + ipilimumab was able to induce tumor responses in patients who failed chemotherapy and checkpoint inhibitors with ORR at 43%, double the ORR of nivolumab + ipilimumab in Checkmate 032.

Matinas BioPharma Initiates Dosing in Phase 1 Study of Potential First Oral Aminoglycoside Antibiotic Drug MAT2501

Thursday, October 21, 2021 - 12:00pm

MAT2501 is being developed to potentially become the first oral aminoglycoside, with the application of Matinas proprietary LNC platform technology to the broad-spectrum antibiotic drug amikacin.

Key Points: 
  • MAT2501 is being developed to potentially become the first oral aminoglycoside, with the application of Matinas proprietary LNC platform technology to the broad-spectrum antibiotic drug amikacin.
  • Our goal with MAT2501 is to develop the first oral aminoglycoside, which could transform the use of this important class of drugs, stated Jerome D. Jabbour, Chief Executive Officer of Matinas.
  • This Phase 1 study is a double-blind, placebo-controlled, SAD study designed primarily to evaluate the safety, tolerability and pharmacokinetics of single ascending oral doses of MAT2501 in healthy adult subjects.
  • MAT2501 is an oral, LNC formulation of the broad-spectrum aminoglycoside antibiotic amikacin, primarily used to treat chronic and acute bacterial infections.