Monoclonal antibodies

The Lancet Simultaneously Publishes Two Phase 3 Studies Detailing Comprehensive Efficacy and Safety of TREMFYA®▼ (guselkumab), a First-in-Class IL-23 p19 Subunit Inhibitor, in Psoriatic Arthritis

Monday, April 6, 2020 - 1:06pm

Results published in The Lancet show that, at week 24, the primary endpoints achieved statistical significance in both studies.

Key Points: 
  • Results published in The Lancet show that, at week 24, the primary endpoints achieved statistical significance in both studies.
  • Higher proportions of patients receiving guselkumab q4w or q8w also attained an ACR70 response at week 24, vs the placebo groups.
  • Efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and pharmacogenomics evaluations are being performed in the study on a defined schedule.
  • A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis (DISCOVER-2).

Millendo Therapeutics Announces Topline Results for Pivotal Phase 2b Study of Livoletide in Patients with Prader-Willi Syndrome (PWS)

Monday, April 6, 2020 - 12:00pm

The ZEPHYR study was a two-part, randomized, double-blind, placebo-controlled pivotal Phase 2b/3 study.

Key Points: 
  • The ZEPHYR study was a two-part, randomized, double-blind, placebo-controlled pivotal Phase 2b/3 study.
  • The pivotal Phase 2b study included a three-month double-blind, placebo-controlled period in which patients (N=158) were randomized to either 60 g/kg or 120 g/kg of livoletide, or placebo.
  • Millendo has made the decision to stop all livoletide development efforts in PWS, including the 9-month extension study and initiation of the Phase 3 ZEPHYR study.
  • For more information about Millendos pivotal study of livoletide (ZEPHYR) please visit www.clinicaltrials.gov ( NCT03790865 ) or the Our Patients portion of our website.

First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency IND and Two Patients Have Already Extubated

Monday, April 6, 2020 - 11:00am

This trial is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (drug to placebo ratio).

Key Points: 
  • This trial is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (drug to placebo ratio).
  • Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 14 days.
  • The Company will perform an interim analysis on the data from 50 patients following two weeks of leronlimab therapy.
  • Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease.

Samsung Biologics enters into a development and manufacturing partnership with PharmAbcine for oncology and neovascular treatment

Monday, April 6, 2020 - 1:00am

SONGDO, South Korea, April 5, 2020 /PRNewswire/ --Samsung Biologics (207940.KS) entered into a strategic partnership with PharmAbcine for the development and manufacturing of PMC-402 pipeline, a next generation therapeutic antibody candidate to treat oncology and neovascular disorders.

Key Points: 
  • SONGDO, South Korea, April 5, 2020 /PRNewswire/ --Samsung Biologics (207940.KS) entered into a strategic partnership with PharmAbcine for the development and manufacturing of PMC-402 pipeline, a next generation therapeutic antibody candidate to treat oncology and neovascular disorders.
  • Under this agreement, Samsung will provide the full scope of its CDO services from cell line development, process development, cGMP clinical manufacturing to IND filing support.
  • PharmAbcine is a clinical-stage biotech company developing fully human therapeutic antibodies to treat cancer and neovascular disease.
  • "Offering full range of services in development, manufacturing, and laboratory testing from our state-of-the-art facilities, Samsung Biologics works intimately with our clientsto reach IND and market Faster & Better," said Tae-Han Kim, CEO of Samsung Biologics.

Sanofi: Dupixent® (dupilumab) Phase 3 data show significant improvement in severe atopic dermatitis for children aged 6 to 11 years

Friday, April 3, 2020 - 6:00am

Detailed results will be presented during a session at the 2020 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on April 5.

Key Points: 
  • Detailed results will be presented during a session at the 2020 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on April 5.
  • Additionally, more than three times as many children experienced a significant reduction in itch with Dupixent compared to TCS alone.
  • There are currently no biologic medicines approved for children with severe atopic dermatitis.
  • Dupixent is also being studied in a Phase 3 trial for children with uncontrolled persistent asthma, with results expected later this year.

Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA

Thursday, April 2, 2020 - 4:23pm

A cytokine storm is an overproduction of immune cells and their activating compounds, which can contribute to life-threatening respiratory distress.

Key Points: 
  • A cytokine storm is an overproduction of immune cells and their activating compounds, which can contribute to life-threatening respiratory distress.
  • CytoDyn received rapid approval from the FDA for the emergency treatment of extremely ill COVID-19 patients.
  • As of April 1, CytoDyn reported that a total of 10 patients have received treatment under emergency use.
  • NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.

Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA

Thursday, April 2, 2020 - 1:01pm

A cytokine storm is an overproduction of immune cells and their activating compounds, which can contribute to life-threatening respiratory distress.

Key Points: 
  • A cytokine storm is an overproduction of immune cells and their activating compounds, which can contribute to life-threatening respiratory distress.
  • CytoDyn received rapid approval from the FDA for the emergency treatment of extremely ill COVID-19 patients.
  • As of April 1, CytoDyn reported that a total of 10 patients have received treatment under emergency use.
  • NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.

APEIRON Biologics Initiates Phase II Clinical Trial of APN01 for Treatment of COVID-19

Thursday, April 2, 2020 - 7:12am

The Phase II trial aims to treat 200 severely infected COVID-19 patients, and the first patients are expected to be dosed shortly.

Key Points: 
  • The Phase II trial aims to treat 200 severely infected COVID-19 patients, and the first patients are expected to be dosed shortly.
  • The randomized, double-blind Phase II trial will compare APN01 to placebo in up to 200 patients at 10 sites in Austria, Denmark and Germany.
  • The product candidate is currently in Phase II development by APEIRON Biologics for the treatment of PAH and ALI/ARDS, which is a significant cause of COVID-19-related mortalities.
  • APEIRONs APN01 (rhACE2) is starting a Phase II trial in Europe to treat COVID-19.

Zymeworks Announces First Patient Dosed in Phase 1b/2 Trial of ZW25 in First-Line HER2-Positive Breast Cancer and Gastroesophageal Adenocarcinoma Conducted by BeiGene

Wednesday, April 1, 2020 - 9:15pm

Zymeworks will receive a payment under its collaboration with BeiGene as a result of the achievement of this development milestone.

Key Points: 
  • Zymeworks will receive a payment under its collaboration with BeiGene as a result of the achievement of this development milestone.
  • We look forward to the results of these trials, which have the potential to further expand the population of patients who may benefit from ZW25.
  • Arm one of the trial will evaluate the safety, tolerability, and preliminary antitumor activity of ZW25 in combination with docetaxel in patients with metastatic HER2positive breast cancer.
  • Zymeworks lead clinical candidate, ZW25, is a novel Azymetric bispecific antibody currently in Phase 2 clinical development.

Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA

Wednesday, April 1, 2020 - 2:00pm

The naxitamab BLA is for the treatment of patients with relapsed/refractory high-risk neuroblastoma.

Key Points: 
  • The naxitamab BLA is for the treatment of patients with relapsed/refractory high-risk neuroblastoma.
  • As the father of a long-term high-risk neuroblastoma survivor, I am excited to see Y-mAbs first BLA submission in neuroblastoma completed.
  • Dr. Claus Moller, Chief Executive Officer, continued, With this submission, we look forward to working with the Agency to bring naxitamab to appropriate patients.
  • We are excited to complete this submission and believe naxitamab can address a significant unmet medical need for children with relapsed/refractory high-risk neuroblastoma.