Pulse Biopharma announced that the ADC drug PRO1184, targeting FRα, has completed the dosing of the first subject

Pufang, a clinical-stage biopharmaceutical company focused on the development of next-generation macromolecule-targeted anti-cancer drugs, announced that its ADC drug PRO1184 (clinical trial number NCT05579366) has completed the first subject administration of the Phase I clinical trial, and the clinical trial application for the ADC drug PRO1160 has been approved
by the US Food and Drug Administration (FDA).

       PRO1184

PRO1184 is an antibody conjugate drug targeting folic acid receptor α (FRα), exeitcan as the payload, and using a novel hydrophilic linker independently developed by Pushang
.
The Phase I clinical trial will evaluate the safety, activity, and pharmacokinetics
of PRO1184 in patients with ovarian, endometrial, breast, non-small cell lung cancer, and mesothelioma.
The trial is actively recruiting patients
at multiple clinical trial centers in the United States.

       PRO1160

The PRO1160 is a CD70 target that uses the same payload and hydrophilic linker
as the PRO1184.
Its Phase I trial will evaluate the safety, activity, and pharmacokinetics
of PRO1160 in patients with metastatic renal cell carcinoma, metastatic or recurrent nasopharyngeal carcinoma, and advanced non-Hodgkin lymphoma.
Preclinical data show that PRO1160 has a wide therapeutic window and is expected to become the best ADC drug
in class.

"We have taken a major step
forward in the development of next-generation ADC drugs.
" Naomi Hunder, MD, Chief Medical Officer of Pulse Biologics, said
.
"Preclinical data show that the combination of novel hydrophilic linkers and esiteccan as payloads allows our ADC candidate to demonstrate better safety and activity
than previous drugs targeting FRα and CD70.
We are excited to bring these advances to the clinic, making it possible to target moderate, low, and heterogeneously expressed tumor antigens, helping more patients
with potentially wider treatment windows.
" ”

"We look forward to clinically validating the new ADC technology platform with independent intellectual property rights and bringing a series of best- and first-in-class ADC drugs
to patients with urgent medical needs.
" Dr.
Zhao Baiteng, co-founder, CEO and chairman of Pufang Biologics, said
.
"In 2022, we achieved several important achievements, including the submission of INDs for two programs to the US FDA and successful clinical trial approval, and the completion of a $70 million Series A+ financing
.
I am very excited about this momentum and look forward to further advances in clinical program development in 2023, advancing more projects into the preclinical/clinical stage, and making further breakthroughs
in ADC technology.
" ”