Denovo Biopharma

DB102: Anti-tumor Drug Enzastaurin

Lilly conducted many clinical studies with enzastaurin in a variety of tumor indications, including Phase 3 clinical trials in diffuse large B cell lymphoma (DLBCL) and glioma (GBM), and has received orphan drug certification in the U.S. and Europe. Denovo acquired global rights to enzastaurin from Lilly, including development, production and commercialization. Denovo has completed the identification of the biomarker, which is significantly correlated with the expected therapeutic effects on DLBCL and GBM patients, and has filed international patent applications. Denovo initiated a pivotal Phase 3 global DLBCL clinical trial in 2018 with data readout expected in mid-2021. In 2018 Denovo licensed the rights to use DB102 for Pulmonary Arterial Hypertension (PAH) from Stanford University.

DB103: Psychiatric Drug Pomaglumetad

Currently the drugs used in the clinical treatment of psychosis mainly work on dopamine (DA) D2 receptors in the central nervous system. DB103 selectively acts on the glutamic acid mGlu2/3 receptor and has no cross-reaction with other receptors in the central nervous system, and hence can avoid some usual side effects of psychiatric drugs currently on the market. Lilly completed 37 clinical trials with more than 3,800 subjects. DB103 showed significant efficacy in Phase 2 clinical trials (p-value < 0.05) but failed to achieve the desired effect in the Phase 3 pivotal trials. March 2015, Denovo licensed DB103 development rights from Lilly. After completion of a Phase 2I clinical trial by Denovo, Lilly has priority repurchase right. Financial terms have been defined in the agreement. If Lilly repurchases DB103, Denovo will receive a success fee, back milestone and future sales royalties. Denovo is currently conducting biomarker discovery, and progress to date is encouraging. Initiation of a Phase 2 clinical study is planned in 2019.

DB104: Psychiatric Drug Liafensine

DB104, or liafensine, is a potential first-in-class drug targeting treatment resistant depression (TRD). AMRI was the first developer of liafensine and licensed the drug to Bristol-Myers Squibb (BMS). In a number of Phase 2 clinical trials conducted by BMS in the treatment of TRD, liafensine showed high tolerance in TRD patients. Denovo acquired the global rights to liafensine in April 2017, including global R & D, production and marketing. Liafensine is the third potential first-in-class drug candidate in Denovo’s pipeline. Technical transfer is ongoing and biomarker discovery has been initiated.

DB105: Psychiatric drug ORM-12741

In-licensed from Orion Corporation/JNJ, DB105 modulates neurotransmitters in addition to the noradrenergic system and is being developed for Alzheimer’s Disease (AD). Most AD programs target beta amyloid and tau, whereas DB105 offers a distinct mechanism of action. Orion Corporation completed two Phase 2 clinical trials in patients with AD. In these trials DB105 demonstrated positive effects on quality of memory but not for aggression/agitation in patients with AD. DB105 has a reduced side-effect potential compared to non-specific Alpha2 adrenoceptor antagonism. A total of 540 subjects exposed to DB105 across 13 studies and a good safety and tolerability profile were observed.

DB106: Anti-tumor Drug Vosaroxin

Vosaroxin is a potent, first-in-class quinolone derivative, nonanthracycline topoisomerase II inhibitor that may be useful for oncology indications such as acute myeloid leukemia (AML) and solid tumors. More than 1,200 patients across 16 clinical studies have been dosed with vosaroxin, which has shown a manageable safety profile and variable efficacy. In the 711-patient Phase 3 VALOR clinical study there were significant improvements in OS and CR rates in certain sub-populations, specifically in patients with the poorest prognosis such as patients over the age of 60 with relapsed and refractory AML.