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Surface Oncology Resets Portfolio Priorities, Extends Cash Runway Through 2021

On December 18, 2018 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported updates related to its product pipeline, notably the significant reduction of the investment in and scope of its SRF231 program, the planned filing of two Investigational New Drug applications (INDs) in 2019 and extension of its cash runway (Press release, Surface Oncology, DEC 18, 2018, View Source [SID1234532130]).

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"A disciplined approach to both drug development and portfolio prioritization is central to our mission to develop truly innovative immunotherapies to help those affected by cancer," said Jeff Goater, chief executive officer of Surface Oncology. "The decision to significantly reduce the scope of our SRF231 program was driven by initial data from our ongoing phase 1 trial, the CD47 competitive landscape, as well as the continued emergence and prioritization of our CD39 and IL-27 programs."

The company is conducting a multi-center, open-label phase 1 trial of SRF231 designed to assess safety and tolerability in multiple ascending doses. To date, 18 patients have been treated with SRF231 on an every-three-week schedule. During the dose escalation portion of the phase 1, two hematologic dose-limiting toxicities (DLTs) were seen at a lower dose (12 mg/kg) than anticipated and resolved without long-term toxicity. Surface will explore additional dose administration schedules but will not open expansion cohorts in the phase 1 study.

"While the early biological activity observed in the clinic with SRF231 potentially represents novel biology, specifically a lack of hemagglutination and differential effects on white blood cells, it does not meet our standard for pursuing additional clinical expansions at this time," said Rob Ross, M.D., chief medical officer of Surface Oncology. "In the coming months we will focus on identifying a potential dose and schedule, while exploring key insights about SRF231."

This outlined activity may support business development opportunities for SRF231. The company anticipates presenting additional SRF231 data in the second half of 2019.

Surface believes the reprioritization of its programs will extend the company’s projected cash runway through 2021 based upon its current operating plan, which includes advancing its next two preclinical programs SRF617 and SRF388 into clinical studies and through initial clinical data. Phase 1 clinical work for the company’s Novartis-partnered CD73 program, NZV930, is ongoing. Based on the reallocation of capital, the company now anticipates that the SRF388 program will accelerate and be ready for IND filing before the end of 2019. Cash and cash equivalents at year end 2018 is projected to be approximately $160 million.

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.

"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.

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.

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).

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

+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.

Propanc Biopharma Selects LaVoieHealthScience as Integrated Communications Partner

On December 18, 2018 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc"), a clinical stage biopharmaceutical company focused on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that Propanc has selected LaVoieHealthScience ("LHS") as its communications agency of record (Press release, Propanc, DEC 18, 2018, View Source [SID1234532126]). LHS is an integrated investor and public relations agency focused on advancing health and science innovations. Propanc is partnering with LHS to develop corporate awareness of Propanc as a health science innovator as it transitions its lead technology into human clinical trials.

Propanc is developing new cancer treatments targeting high-risk patients, particularly cancer survivors, who need a follow-up, non-toxic, long-term therapy designed to prevent cancer from returning and spreading. Its lead product, PRP, is an enhanced proenzyme formulation designed to enhance the anti-cancer effects of multiple enzymes acting synergistically. The company’s initial target patient populations include pancreatic, ovarian and colorectal cancers. Propanc’s treatment for pancreatic cancer received Orphan Drug Designation by the U.S. Food and Drug Administration in 2017. For more information on PRP’s Mechanism of Action, view this video at: View Source

"As we move closer to the clinical trials stage, it’s critically important to build the right reputation amongst key stakeholders. LHS, with its proven track record in providing integrated communications to global health science innovators, will be a great long-term partner as we continue to drive PRP forward with our drug discovery efforts," said James Nathanielsz, CEO and Executive Chairman of Propanc. "LHS stood out with its deep understanding of our value proposition across targeted channels and audiences, its team of high-touch senior communicators, and proprietary approach to creating targeted messaging mapped to stakeholders as the underpinning of a strategic communications program. We are looking forward to a long and productive relationship."

Donna L. LaVoie, President & CEO of LHS commented, "We are delighted to be working with the Propanc Biopharma team to bring attention to their pioneering work targeting cancer stem cells. We look forward to supporting Propanc Biopharma as it brings novel therapies into the clinical trials stage to provide new hope for patients suffering from metastatic cancer."