Amgen And Molecular Partners Announce Strategic Collaboration In Immuno-Oncology

On December 18, 2018 Amgen (NASDAQ: AMGN) and Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin therapeutics, reported a collaboration and license agreement for the clinical development and commercialization of MP0310 (FAP x 4-1BB) (Press release, Amgen, DEC 18, 2018, View Source [SID1234532127]). MP0310 is a preclinical molecule designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator).

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 terms of the agreement, Amgen obtains exclusive global development and commercial rights for MP0310. The parties will jointly evaluate MP0310 in combination with Amgen`s oncology pipeline products, including its investigational BiTE (bispecific T cell engager) molecules. Under the collaboration, Molecular Partners retains certain rights to develop and commercialize its proprietary DARPin pipeline products in combination with MP0310.

Molecular Partners will receive an upfront payment of $50 million and is eligible to receive up to $497 million in development, regulatory and commercial milestone payments, as well as double-digit, tiered royalties up to the high teens. The parties will share the clinical development costs in defined percentages for the first three indications subject to certain conditions. For all additional clinical trials, Amgen is responsible for all development costs.

"MP0310 is the first candidate out of our portfolio of localized and multi-specific immune-cell agonists. This collaboration with Amgen will allow us to test multiple combinations of MP0310 with other agents, leveraging the potential of MP0310. We anticipate MP0310 to enter the clinic in 2019," said Dr. Patrick Amstutz, chief executive officer of Molecular Partners. "The partnership with Amgen underlines the potential of MP0310 and the DARPin platform to deliver novel therapeutic designs."

"The field of immuno-oncology continues to rapidly evolve, and it’s our belief that combination treatments will have a major role to play in the future of cancer care," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to collaborating with Molecular Partners to combine MP0310 with certain oncology assets, including BiTE molecules, to deliver improved outcomes for patients."

Conference call and audio webcast
Molecular Partners will host a conference call and audio webcast on Dec. 19, 2018, at 2 p.m. CET (1 p.m. GMT, 5 a.m. PT).

In order to register for the conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:

Switzerland / Europe

+41 (0) 58 310 5000

UK

+44 (0) 207 107 0613

USA

+1 (1) 631 570 5613

Interested parties can access a corresponding audio webcast of the presentation. The webcast will be accessible, both live and as a replay, on the investors section of the company’s website, along with the accompanying presentation slides.

About DARPin Therapeutics
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates contain multiple designed ankyrin repeat binding domains and can engage more than five targets, offering potential benefits over conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and high production yields. DARPin is a registered trademark owned by Molecular Partners AG.

Portola Pharmaceuticals to Webcast Corporate Update on January 8, 2019

On December 18, 2018 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported that Scott Garland, Portola’s president and chief executive officer, will provide a corporate update on Tuesday, January 8, at 7 a.m. PT (10 a.m. ET) (Press release, Portola Pharmaceuticals, DEC 18, 2018, View Source;p=RssLanding&cat=news&id=2381016 [SID1234532144]). The live webcast will be available on the Company’s website at www.portola.com.

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!

Webcast Details
To access the live investor webcast on Tuesday, January 8, at 7 a.m. PT (10 a.m. ET), go to the Investor Relations section of the company’s website at View Source A replay will be available for 30 days.

Delcath Announces 4th Independent Safety Review of Registration Trial Data for Metastatic Ocular Melanoma: Recommended Continuation with no Trial Modification

On December 18, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that the independent Data Safety Monitoring Board (DSMB) of the Registration trial for Patients with Hepatic Dominant Ocular Melanoma (The FOCUS Trial) completed another pre-specified review of safety data for treated patients in the trial (Press release, Delcath Systems, DEC 18, 2018, View Source;p=RssLanding&cat=news&id=2381000 [SID1234532112]). This review was conducted on data collected from both the prior randomized protocol and the amended single-arm protocol for the FOCUS Trial. The DSMB again recommended continuation of the study without modification.

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!

In July, the Company announced that it has amended the protocol for the FOCUS trial, which is now enrolling as a single-arm, multi-center open label study. Safety data collected have not been modified as a result of the amendment, and safety data from both the randomized and single-arm protocols will be pooled in any analyses submitted to the Food & Drug Administration as part of a New Drug Application.

The FOCUS trial, now entitled A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma (The FOCUS Trial), is enrolling a minimum of 80 patients with ocular melanoma metastatic to the liver. Patients previously enrolled under the prior randomized protocol continue to be treated and evaluated as part of the amended trial, and periodic DSMB reviews will continue to be conducted.

Commenting on the announcement, Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath, said, "We are pleased with the safety profile observed by our therapy in the trial thus far, and the trial remains on track to complete enrollment by June 2019."

Regeneron Announces Presentation at the 37th Annual J.P. Morgan Healthcare Conference

On December 18, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast its presentation at the 37th Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2019 (Press release, Regeneron, DEC 18, 2018, View Source [SID1234532128]). The presentation is scheduled for 10:30 a.m. Pacific Time (1:30 p.m. Eastern Time) and may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A breakout session will immediately follow the formal presentation and can also be accessed on our website. An archived version of the presentation and the breakout session will be available for 30 days.

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!

Qualigen obtains exclusive license to novel cancer drug technology from Advanced Cancer Therapeutics

On December 18, 2018 Qualigen, Inc., and Advanced Cancer Therapeutics, LLC (ACT) reported that Qualigen has licensed certain ACT patents, intellectual property and know-how associated with the antiproliferative activity of G-rich oligonucleotides ACT-GRO-777 (also known as AS1411) and methods of using these to bind to nucleolin, a protein that is present on the surface of tumor cells (Press release, Qualigen, DEC 18, 2018, View Source [SID1234532129]). AS1411 is a novel aptamer-based anticancer technology and a key component of Qualigen’s anti-nucleolin agent-conjugated nanoparticle drug (AS1411-GNP) that can be used to treat virtually any type of cancer. The AS1411 aptamer has been tested as a drug in over 100 patients and is well tolerated with no evidence of severe side effects, with at least 7 patients having long-lasting clinical responses, where their cancers either disappeared or shrank substantially. Under this License Agreement, Qualigen will obtain the exclusive rights to develop and commercialize ACT-GRO-777/AS1411 and related compounds. In return, ACT will receive potential equity in Qualigen, along with cash payments on the achievement of certain milestones and royalties on future drug sales.

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!

"We are delighted to add ACT-GRO-777/AS1411 to our portfolio of anticancer drug technologies. This is a unique opportunity to continue development of a compound that has already undergone extensive preclinical characterization and shown promise in prior clinical studies. We believe that Qualigen’s new AS1411-GNP formulation will lead to a significant improvement in potency and absorption in humans, enabling the drug to fulfill the promise seen in the earlier studies," noted Michael S. Poirier, Chairman, CEO and President of Qualigen.

"We are excited to work with Qualigen on the product development of our aptamer-based drug to fight cancer," said Randall Riggs, Board Member of ACT.