10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Caladrius Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Caladrius Biosciences, 2018, MAR 22, 2018, View Source [SID1234524943]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Celyad Reports 2017 Financial and OperatingResults and Expected Key Milestones for 2018

On March 22, 2018 Celyad Reported 2017 Financial and OperatingResults and Expected Key Milestones for 2018 (Press release, Celyad, MAR 22, 2018, View Source(3).pdf [SID1234532496]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


DAC Selects Evotec as Strategic Partner for a Drug Discovery Collaboration on the HSP90 Cancer Target

On March 22, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX 30) reported that DAC (a wholly owned subsidiary of Genextra SPA) has chosen Evotec as a strategic partner to identify small molecule therapeutics in a pharmaceutical discovery project on the HSP90 target, a key protein involved in a variety of oncogenic pathways in several cancer related diseases (Press release, Evotec, MAR 22, 2018, View Source;announcements/press-releases/p/dac-selects-evotec-as-strategic-partner-for-a-drug-discovery-collaboration-on-the-hsp90-cancer-target-4520 [SID1234525395]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the agreement, DAC will access compound intellectual property that Evotec has generated on this disease target through its internal R&D activities. The aim of the collaboration will be to take compounds identified by Evotec as being active against the target and further optimise them to the point of clinical development.

Using its proprietary fragment screening platform (High Throughput Fragment Screening, HTFS), Evotec identified novel fragments that interact with the HSP90 target from Evotec’s five thousand member fragment library. Active fragments were further characterised by co-crystallisation with the target protein. The X-ray crystal structures of the protein-ligand complexes identified a variety of binding modes some of which will give rise to novel approaches for inhibiting HSP90. Following due diligence DAC has decided to collaborate with Evotec with the aim of improving the potency and selectivity of the identified compounds. In the collaboration, which may run for an initial period of over 2 years, Evotec will use its medicinal chemistry, profiling and ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) expertise to generate lead molecules for further progression into clinical trials.

For its contributions to the discovery project Evotec will potentially receive single digit millions R&D service revenues and will also be eligible for additional preclinical and clinical milestone payments.

"We are delighted that DAC and Genextra, one of the most innovative and active biopharmaceutical companies in Italy, appreciated the value of the HSP90 inhibitors that we had identified using our novel approach to fragment screening and have selected us for this project. We are very excited about the potential for analogues of these compounds to be novel treatments for diseases that require inhibition of the HSP90 protein," said Dr Mark Ashton, Executive Vice President Business Development Services at Evotec. "This project represents another major milestone in our strategy to strengthen our collaborative relationships by providing our partners access to selected promising proprietary drug discovery assets discovered using our state-of-the-art platform."

"This project is an important extension of our lead discovery activities. From existing collaborations with Evotec, we remained positively impressed by Evotec’s medicinal chemistry capabilities and this, together with the results that Evotec had already generated against this disease target, convinced us to collaborate on this exciting project," commented Mr Paolo Fundarò, Chief Executive Officer of Genextra.

Contact: Anne Hennecke, Director, Investor Relations & Corporate Communications, Evotec AG, Phone: +49-40-56081-286, [email protected]

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Provectus Biopharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Provectus Biopharmaceuticals, 2018, MAR 22, 2018, View Source [SID1234524955]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Astellas Receives Orphan Drug Designation from the Japanese MHLW for Gilteritinib

On March 22, 2018 Astellas Pharma Inc. (President and CEO: Yoshihiko Hatanaka, "Astellas" ) reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation to gilteritinib for the treatment of FLT3mut+ Acute Myeloid Leukemia (AML), the drug’s prospective indication (Press release, Astellas, MAR 22, 2018, View Source [SID1234536693]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Orphan drug designation system in Japan aims to support the development of drugs for diseases that, despite there being a significant medical need for treatments, affect only a small number of patients, and for which research and development is virtually nonexistent. As stipulated in Article 77 of the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act of Japan, the designation is granted by the minister of Health, Labour and Welfare for drugs that meet the designation criteria which include the following: the number of patients who may use the drug is less than 50,000 in Japan; there is no alternative appropriate drug or treatment in Japan; high efficacy or safety is expected compared to existing products. Specific measures to support the development of orphan drugs include subsidies for research and development expenditures, prioritized consultation regarding clinical development, reduced consultation fees, tax incentives, priority review of applications, reduced application fees, and extended registration validity period1

AML is a cancer that impacts the blood and bone marrow, and its incidence increases with age. In Japan, approximately 5,500 patients are diagnosed with AML each year2. Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in approximately one-third of patients with AML. Further, gilteritinib has also demonstrated inhibition of the AXL receptor in AML cell lines.

Astellas will continue to develop gilteritinib to provide it to FLT3mut+ AML patients as early as possible.

(1): View Source
(2): KantarHealth. TREATMENT ARCHITECTURE: JAPAN LEUKEMIA, ACUTE MYELOID. CancerMPact Japan, February 2017.