On December 2, 2019 Samyang Biopharm USA, Inc. (View Source) a global biotech subsidiary of the Samyang Pharmaceuticals Corp. (View Source), reported that the company has entered into a worldwide licensing agreement with CanCure LLC. Financial terms of the agreement were not disclosed (Press release, Samyang Biopharmaceuticals, DEC 2, 2019, View Source [SID1234551836]).

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Under the terms of the agreement, CanCure grants Samyang worldwide rights for the development, manufacturing and commercialization of SYB-010 (formerly CuraB-10), a first-in-class compound currently engaged in Investigational New Drug (IND)-enabling studies. CanCure will collaborate with Samyang to complete nonclinical studies to support an IND Application to regulatory authorities and initiation of the phase 1 clinical program; after which Samyang will be responsible for all activities related to CuraB-10. CanCure will receive an upfront payment and is eligible for future clinical, regulatory and sales milestone payments, as well as royalties on net sales worldwide. Samyang Biopharm USA plans to file an IND in 2021, with a goal of starting SYB-010 clinical trials shortly after IND approval.

"We are thrilled to establish this alliance with CanCure, an innovative biotechnology company who has made great strides in the development of its lead oncology compound to reach IND-enabling studies," said Helen Hyun Jung Lee M.D., President/CEO, Samyang Biopharm USA, Inc. "CanCure shares Samyang’s passion and commitment to discovering breakthrough medicines that may improve the lives of cancer patients worldwide and this transformational collaboration provides our company with a promising clinical candidate that will enable us to advance our capabilities and programs."

In recent years, immune checkpoint inhibitors have proven to be a critical advancement in cancer treatment and those programs have achieved modest success in targeting the T lymphocyte arm of the immune system. In cancer model systems, SYB-010 potently activates both the T lymphocyte and NK (natural killer) cell arms of the anti-tumor immune response, and when combined with inhibitors of PD-1, PD-L1 or CTLA4 in models that are not responsive to those therapies alone has broadened the potential for an immune attack on cancer.

"CanCure is very -enthusiastic with the prospect of Samyang’s research and development team advancing the SYB-010 program and feel that Samyang has the proper mix of science and business acumen to give birth to a medicine with great promise," said Jennifer Wu, PhD, Founder and President of CanCure. "We look forward to the exploration of this compound and the uncovering of its potential as it advances towards the beginning of clinical studies."

About SYB-010

SYB-010 is a first-in-class immune stimulatory monoclonal antibody targeting a tumor-released immune suppressive molecule, soluble MHC class I chain-related protein (sMIC). In preclinical animal studies, monotherapy with the murine version of SYB-010 effectively reduces tumor size and prolongs overall survival. This innovative antibody also enhances tumor response to immune checkpoint blocking therapies when used in combination, and elicits a positive response even in tumors that failed to respond to these therapies.

On December 2, 2019 Novocure (NASDAQ: NVCR) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) reported their 2nd Annual AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research program (Press release, NovoCure, DEC 2, 2019, View Source [SID1234551835]). The program represents a joint effort to promote and support innovative research on Tumor Treating Fields to help deepen the understanding of the mechanism of action and to accelerate the development of new treatment strategies. The program includes research grants and career development awards totaling more than $2 million over the next three years.

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"Our partnership with Novocure continues to break new ground toward the advancement of cancer science," said Mitch Stoller, Chief Philanthropic Officer and Vice President of Development of the AACR (Free AACR Whitepaper) Foundation. "We are grateful for Novocure’s visionary support of the AACR (Free AACR Whitepaper)’s Grants Program, and we look forward to witnessing the innovative research that will result from these important grants."

Recipients of the research grants will receive a total of $250,000 over two years. Recipients of the career development awards will receive a total of $225,000 over three years. Novocure and the AACR (Free AACR Whitepaper) encourage applicants to focus their proposals on translational approaches, promoting the transition of in vitro work into in vivo systems; combination therapies involving Tumor Treating Fields; and bringing treatments involving Tumor Treating Fields to the clinic. The application deadline is December 11. Recipients will be announced at the AACR (Free AACR Whitepaper) Annual Meeting 2020 in San Diego.

"Deepening our understanding of the mechanism of action of Tumor Treating Fields can potentially advance our efforts to extend survival in some of the most aggressive forms of cancer," said Dr. Uri Weinberg, Novocure’s Vice President of Clinical Development. "We are excited to continue our partnership with the AACR (Free AACR Whitepaper) to offer this important research program and look forward to the announcement of recipients at the AACR (Free AACR Whitepaper) Annual Meeting."

To apply for the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research, visit www.aacr.org/funding.

On December 2, 2019 Aleta Biotherapeutics, a privately held immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, reported that Paul Rennert, Ph.D., President and Chief Scientific Officer, will deliver an oral presentation at the 61st ASH (Free ASH Whitepaper) Annual Meeting & Exposition, December 7 – 10, 2019, Orange County Convention Center, Orlando, FL (Press release, Aleta Biotherapeutics, DEC 2, 2019, View Source [SID1234551834]).

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"The 61st ASH (Free ASH Whitepaper) Annual Meeting will be an important opportunity to present mechanistic studies and extensive in vitro and in vivo results from our novel CD19-anti-CD20 bridging protein technology," said Paul Rennert, Ph.D., President and Chief Scientific Officer of Aleta Biotherapeutics. "We look forward to advancing the development of this novel therapy based on the data we will be presenting on December 7."

Oral Presentation Details
Title: 252 A Novel CD19-Anti-CD20 Bridging Protein Prevents and Reverses CD19-Negative Relapse from CAR19 T Cell Treatment in vivo
Session Name: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Mechanisms
Presenter: Paul Rennert, Ph.D.
Session Date: Saturday, December 7, 2019
Session Time: 2:00 PM – 3:30 PM
Presentation Time: 3:15 PM
Location: Orange County Convention Center, Valencia A (W415A)

On December 2, 2019 Acceleron Pharma Inc. (Nasdaq:XLRN) reported it will host a webcast and conference call on Tuesday, December 10, 2019 at 6:00 a.m. EST to review highlights from its presentations at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, Florida, on December 7-10, 2019 (Press release, Acceleron Pharma, DEC 2, 2019, View Source [SID1234551833]).

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Guest Presenters:

Rami Komrokji, M.D., Senior Member & Professor of Oncologic Sciences, Section Head- Leukemia and MDS, Vice Chair-Malignant Hematology Department, Moffitt Cancer Center, Tampa, Florida
Thomas Coates, M.D., Professor of Pediatrics and Pathology, Division of Hematology / Oncology, Children’s Hospital Los Angeles, University of Southern California
Srdan Verstovsek, M.D., Ph.D., Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas
The webcast will be accessible under "Events & Presentations" in the Investors & Media page of the company’s website at www.acceleronpharma.com. Individuals can participate in the conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and refer to the "Acceleron ASH (Free ASH Whitepaper) 2019 Conference Call."

The archived webcast will be available for replay on the Acceleron website approximately two hours after the event.

On December 2, 2019 Provectus (OTCQB: PVCT) reported that data from an ongoing clinical trial of lysosomal-targeting cancer immunotherapy PV-10 (rose bengal disodium) as a single-agent for the treatment of primary or metastatic tumors of the liver (NCT00986661) will be presented at the upcoming Society of Interventional Radiology (SIR) 2020 Annual Scientific Meeting, to be held March 28-April 2, 2020, in Seattle, Washington (Press release, Provectus Biopharmaceuticals, DEC 2, 2019, View Source [SID1234551832]). The accepted abstract is:

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"Oncolytic immunotherapy of hepatic tumors with intralesional rose bengal disodium."
PV-10 is administered percutaneously when targeting primary or metastatic tumors of the liver, such as hepatocellular carcinoma, metastatic colorectal cancer, metastatic neuroendocrine tumors, and metastatic uveal melanoma. Intralesional (aka intratumoral) injection with PV-10 can yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells.1-4

About PV-10

Provectus has shown that PV-10 selectively accumulates in the lysosomes of only cancer cells upon contact, disrupts them, and causes the cancer cells to die.1,5 This lysosomal targeting and destruction mechanism has been reproduced by external collaborators.6 Provectus, external collaborators, and independent researchers have further shown that PV-10 treatment (RB application) can trigger each of the three primary lysosomal cell death pathways of apoptosis, autophagy, and necrosis, and do so in a disease-dependent manner.2,3,6-9

PV-10 causes acute oncolytic destruction of injected tumors (i.e., cell death), mediating several identified immune signaling pathways to date, such as the release of danger-associated molecular patterns (DAMPs) and tumor antigens that initiate an immunologic cascade where local response by the innate immune system facilitates systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. Other mediated immune signaling pathways that have been identified include poly-ADP ribose polymerase (PARP) cleavage, and a third pathway currently being investigated that plays an important role in innate immunity. PV-10 is the first cancer drug that may facilitate multiple, temporally-distinct, immune system signaling pathways.10

PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver (including metastatic neuroendocrine tumors and metastatic uveal melanoma), and preclinical study for pediatric solid tumor cancers (like neuroblastoma5, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma) and pediatric blood cancers (like leukemia).

Orphan drug designation status has been granted to PV-10 by the U.S. Food and Drug Administration for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

PV-10 is an injectable formulation of rose bengal disodium (RB) (4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein disodium salt), which is a small molecule halogenated xanthene and PV-10’s active pharmaceutical ingredient. PV-10 drug product is a bright rose red solution containing 10% w/v RB in 0.9% saline for injection, which is supplied in single-use glass vials containing 5 mL (to deliver) of solution and administered without dilution to solid tumors via intratumoral injection.

Provectus’ intellectual property (IP) includes a family of US and international patents that protect the process by which pharmaceutical grade RB and related xanthenes are produced, reducing the formation of previously unknown transhalogenated impurities that exist in commercial grade RB in uncontrolled amounts. The requirement to control these impurities is in accordance with International Conference on Harmonisation (ICH) guidelines for the manufacturing of an injectable pharmaceutical. US patent numbers are 8,530,675, 9,273,022, and 9,422,260, with expirations ranging from 2030 to 2031.

The Company’s IP also includes a family of US and international patents that protect the combination of PV-10 and systemic immunomodulatory therapy (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers. US patent numbers are 9,107,887, 9,808,524, 9,839,688, and 10,471,144, with expirations ranging from 2032 to 2035.