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Oncology_icon.jpgDB102: 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.



Psychiatric_icon.jpgDB103: 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. Eli 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. In March 2015, Denovo licensed DB103 development rights from El Lilly. After completion of a Phase 2 clinical trial by Denovo, Lilly has priority repurchase rights. If Eli Lilly repurchases DB103, Denovo will receive a success fee, back-end milestones and future sales royalties. Denovo is currently conducting biomarker discovery for this program.

Psychiatric_icon.jpgDB104: 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, including global R & D, production and marketing. Liafensine is the third potential first-in-class drug candidate in Denovo’s pipeline. A biomarker was discovered in 2020.

Psychiatric_icon.jpgDB105: 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.

Oncology_icon.jpgDB106: 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.

Oncology_icon.jpgDB107: Anti-tumor Gene Therapy Based Drug Toca-511

DB107, acquired from Tocagen, is a two-part cancer-selective immunotherapy comprising an investigational gene therapy treatment and an investigational small molecule. The gene therapy treatment is a retroviral replicating vector that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. The small molecule is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing. The DB107 regimen has been tested clinically in recurrent high-grade glioma, most recently in a 403-patient Phase 3 trial. Although the Phase 3 trial results were negative overall, there were patients identified who demonstrated significant survival benefit in pre-planned subgroup analyses.

Expanded Access Policy

Expanded access, also called compassionate use, enables patients with serious or immediately life-threatening diseases who do not meet the enrollment criteria for clinical trials in progress to gain access to investigational treatments. At this time, Denovo does not offer an expanded access program and does not accept expanded access requests. We believe that investigational drugs should be studied in patients as part of clinical trials designed to produce data on safety and efficacy that may be used to support approval of the product, thereby leading to its broader availability for patients in need of treatment. Denovo strongly encourages patients to speak with their treating physicians and when possible to participate in clinical trials. Denovo is aware that in rare cases patients with serious life-threatening diseases are unable to participate in clinical trials and may have exhausted all available therapies. In these rare cases, Denovo may consider providing an investigational product outside of a clinical trial. However, we currently do not have an expanded access program that allows patients to have access to our investigational products prior to FDA approval. As authorized by the 21st Century Cures Act, Denovo may revise this expanded access policy at any time. Additionally, the posting of this policy by Denovo shall not serve as a guarantee of access to any specific investigational drug by any individual patient. In the event Denovo decides to consider expanded access, we will evaluate and respond to each request that it receives on a case-by-case basis. Reference information about our investigational drugs and ongoing clinical trials can be found on https://www.denovobiopharma.com and https://clinicaltrials.gov. If you have additional questions, please speak with your physician or contact us at info@denovobiopharma.com.

About Us

Denovo Biopharma is a privately held biotech company providing a novel biomarker solution to personalize drug development. Our platform can be broadly applied to biomarker discovery in many therapeutic areas, such as oncology, metabolic, cardiology, immunology and neurology.

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