Imugene gets FDA IND approval for Phase-1 trial of PD1-Vaxx
Category: #healthcare  By Mateen Dalal  Date: 2020-11-02
  • share
  • Twitter
  • Facebook
  • LinkedIn

Imugene gets FDA IND approval for Phase-1 trial of PD1-Vaxx

Imugene Ltd., a biotechnology firm that specializes in cancer immunotherapy, has recently bagged an investigational new drug (IND) approval from the US Food and Drug Administration (FDA) to commence the Phase-1 clinical study of PD1-Vaxx, one of its major immunotherapy candidates, in the United States.

As per reports, the approval enables Imugene to begin patient dosing and recruitment for its US Phase-1 clinical trial in non-small cell lung cancer (NSCLC) patients. Reportedly, New Jersey’s Hackensack University Medical Center will be the first hospital in the country to commence patient dosing for this trial.

Other US clinical sites will follow Hackensack University later this year. These clinics include Ohio State University Medical Center and Mayo Clinic in Phoenix, Arizona. The main goal of this Phase-1 study is to establish safety along with an ideal biological dose as a monotherapy and to measure immune response and efficacy.

Speaking on the move, Leslie Chong, CEO and Managing Director, said that receiving an IND approval from the FDA for PD1-Vaxx comes as a crucial step forward for the company. Moreover, commencing of the US study marks as a substantial milestone for the company as well as for the clinicians treating severe lung cancer in the country. Accomplishing this goal adds to Imugene’s dedication and perseverance as it continues to strengthen its commercial and clinical potential.

As of now, Imugene has enough funds to proceed with its human studies for PD1-Vaxx and CF33 treatments in the near-term. It will also be able to continue with the enrolment of patients for the HER-Vaxx Phase 2 trial.

Back in September, Imugene had published its balance sheet along with a $5.7 million option underwriting deal which offers holders an option to buy shares in the firm at a price of 2.6 cents per share. This agreement supports Imugene’s financial position and strengthens its existing cash balance of $30.1 million.

Source Credit: https://www.proactiveinvestors.com/companies/news/932862/imugene-receives-fda-ind-approval-for-phase-1-clinical-trial-of-new-checkpoint-immunotherapy-pd1-vaxx-in-usa-932862.html

About Author

Mateen Dalal    

Mateen Dalal

Despite working as a professional testing engineer, Mateen Dalal always held a liking for content creation. Following his passion, he now pens down articles for itresearchbrief.com and a couple of similar portals. Mateen is a qualified electronics and telecommunicat...

Read More>>

More News By Mateen Dalal

Mercedes Benz India planning to launch 15 new vehicles in 2021
Mercedes Benz India planning to launch 15 new vehicles in 2021
By Mateen Dalal

According to reliable sources, luxury car manufacturer Mercedes Benz India Pvt. Ltd. is planning on ...

AltPep Corporation raises USD 23.15 million in Series A funding round
AltPep Corporation raises USD 23.15 million in Series A funding round
By Mateen Dalal

According to reliable sources, U.S.-based privately held biomedical organization AltPep Corporation ...

Volvo to triple EV production volume at its Belgium facility from 2022
Volvo to triple EV production volume at its Belgium facility from 2022
By Mateen Dalal

Swedish luxury car manufacturer, Volvo AB has announced plans to triple electric vehicle production ...