PR94320

Denovo Biopharma LLC Announces FDA Approval of IND to Initiate First Biomarker–Guided Global CNS Clinical Trial for Treatment-Resistant Depression (TRD)

SAN DIEGO, Feb. 1, 2022 /PRNewswire=KYODO JBN/--

Denovo Biopharma LLC ("Denovo"), a pioneer in applying precision medicine to

the development of innovative therapies, today announced that the FDA has

authorized the company's investigational new drug (IND) application of DB104

(liafensine) for treatment-resistant depression (TRD) to proceed, which enables

Denovo to start a global Phase 2b clinical trial to assess the safety and

efficacy of liafensine in patients with TRD. This will be the third potentially

pivotal global trial that Denovo is conducting, and more importantly, may be

the first ever genetic biomarker-guided clinical trial conducted for central

nervous system (CNS) diseases.

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Xiao-Xiong Lu, PhD, Denovo's Chief Technical Officer, said, "CNS diseases are

notoriously difficult to treat, and lack of precision medicines may contribute

to the modest success in developing innovative drugs in this area. Denovo used

its unique biomarker platform to identify a novel predictive biomarker named

Denovo Genomic Marker 4 (DGM4(TM)), which is highly associated with clinical

response to liafensine in patients with TRD. We are excited to launch this

biomarker-guided TRD trial that may provide a scientific, personalized medicine

approach rather than the trial-and-error method that is typically used today.

This could potentially be a game–changer for the field of CNS drug development."

About Treatment-Resistant Depression

Major depressive disorder (MDD) afflicts more than 15 million people in the US

in any given year. Approximately one-third of people with MDD do not respond

adequately to at least two different antidepressants of adequate dose and

duration in the current depressive episode and are considered to have

treatment-resistant depression (TRD). TRD is a chronic condition that places an

ongoing emotional, functional, and economic burden on the individual, their

loved ones, and society.

About Denovo Biopharma

Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses

novel biomarker approaches to executes efficient clinical trials in targeted

patient populations to optimize the probability of successful trials. Denovo

has 8 late clinical stage drugs in its pipeline addressing major unmet medical

needs in oncology and CNS diseases, most of which are first–in–class drugs with

global rights. Its first biomarker-guided trial for its lead asset DB102

(enzastaurin) has completed enrollment of patients with diffuse large B-cell

lymphoma (DLBCL) in a Phase 3 clinical trial in the US and China, and

enrollment is ongoing in a Phase 3 trial in glioblastoma (GBM). In addition to

Denovo-discovered biomarkers for DB102 and DB104, Denovo also announced

recently the discovery of a novel biomarker for its gene therapy program DB107

(Toca 511/Toca FC) for recurrent high-grade glioma. For additional information,

please visit: www.denovobiopharma.com.

Contact: Michael F. Haller

         Chief Business Officer

         Denovo Biopharma LLC

         mhaller@denovobiopharma.com

SOURCE:  Denovo Biopharma LLC