On November 5, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company primarily focused on targeting virus-associated malignancies, reported that the Company has entered into a loan and security agreement with Silicon Valley Bank (SVB) and Oxford Finance LLC (Oxford) for up to $50.0 million (Press release, Viracta Therapeutics, NOV 5, 2021, View Source [SID1234594576]). In connection with the $50.0 million credit facility, the Company and SVB agreed to terminate the Company’s prior $15.0 million loan and security agreement and the existing $5.0 million debt balance was refinanced. Under this new $50.0 million credit facility, the remaining $45.0 million is available in two additional tranches of $20.0 million and $25.0 million. The Company is under no obligation to draw funds in the future.

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"This expanded credit facility increases our financial strength and provides the Company with significant strategic and operational flexibility by securing access to a non-dilutive and immediately available financing option that carries an attractive single-digit cost of capital," said Dan Chevallard, Chief Operating Officer and Chief Financial Officer at Viracta. "We appreciate SVB’s continued support, are pleased to welcome the Oxford team to Viracta, and believe broadening the relationship at this time offers external validation in addition to valuable access to capital that could potentially support our future prospects and corporate strategy."

Michael White, National Head of Business Development and Managing Director for SVB’s Life Sciences and Healthcare Practice added, "We are excited to expand our already strong relationship with Viracta and partner with the Oxford team. We believe Viracta is well-positioned to advance towards multiple value-creating inflection points, with the initiations of its pivotal NAVAL-1 trial and its Phase 1b/2 solid tumor trial, as well as the progress of its preclinical pipeline."

"Viracta’s platform technology has enabled broad applicability in a variety of EBV positive cancers and has the potential to create therapies for other virus-related cancers through its inducible, synthetic lethality approach," said Christopher A. Herr, Senior Managing Director at Oxford. "Oxford is happy to enter this partnership with SVB and support Viracta’s focus on advancing new medicines for the treatment of virus-associated malignancies."

On November 4, 2021 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. reported that IMM27M, the newly developed ADCC-enhanced CTLA-4 antibody was approved by NMPA for clinical trial research (Press release, ImmuneOnco Biopharma, NOV 4, 2021, View Source [SID1234655627]). This is another major milestone for ImmueOnco.

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CTLA-4 is the first clinically proven check point for immunotherapy, as the first antibody approved in 2011, Ipilimumab is still the only approved drug in the global market. Three weeks ago, the first prescription came out priced at￥28,000 per dose in China.

The IMM27M is an IgG1 antibody targeting CTLA-4. It has been genetically modified to enhance ADCC activity. In the preclinical research, IMM27M appeared to be more efficacious than that of Ipilimumab since it completely removes tumors at a lower dose (0.3 mg/kg) in animal models.

Dr. Tian, Wenzhi, the founder and chairman of ImmueOnco said, "We are pleased that our next-generation CTLA-4 antibody program has been approved by NMPA for clinical trial research. Repeatable in vivo studies have demonstrated that IMM27M has robust anti-tumor activity and also, can be used in combination with a variety of drugs in the company’s pipeline for clinical research. We believe that the IMM27M has great value for clinical development. "

"We will make our best to develop IMM27M to benefit more patients."

On November 4, 2021 Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, reported that an abstract has been accepted for presentation at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 11-14, 2021 in Atlanta, GA (Press release, Advaxis, NOV 4, 2021, View Source [SID1234595577]).

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Title: Aspacytarabine (BST-236) As Monotherapy Is Safe, Well-Tolerated and Effective for the Treatment of Adults with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Therapy. Results of a Phase 2 Study

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I

Date: Saturday, December 11, 2021

Time: 5:30 PM – 7:30 PM

Location: Hall B5
The above abstract was published today and is now available on the ASH (Free ASH Whitepaper) website at www.hematology.org.

About Aspacytarabine (BST-236)

Aspacytarabine is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. Cytarabine serves as the backbone of AML therapy for over 45 years due to its superior efficacy, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities, which significantly limit its use, especially in older and medically compromised patients. Due to its unique pharmacokinetics and metabolism, aspacytarabine enables high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues. As such, aspacytarabine may serve as a new therapy for AML and other hematological malignancies and disorders, including for older adults who are unfit for intensive therapy.

Aspacytarabine was granted FDA Fast Track Designation for treatment of AML patients unfit for standard chemotherapy, and FDA and EMA Orphan Drug Designations, which entitle Biosight to seven and ten years of market exclusivity in the U.S. and Europe, respectively, upon aspacytarabine marketing approval for the treatment of AML in each territory.

Interim results from an ongoing Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and single-agent activity, and additional studies are ongoing to evaluate aspacytarabine as a second line treatment for patients with relapsed or refractory MDS or AML. For more information regarding the Phase 2b clinical study of BST-236, please visit www.clinicaltrials.gov.

On November 4, 2021 Orion Biotechnology Canada Ltd., a clinical stage company unlocking the therapeutic potential of G Protein-Coupled Receptors (GPCRs) with a novel drug modality, proven discovery platform and best-in-class molecules, reported that it is receiving advisory services and conditional funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) (Press release, Orion Biotechnology, NOV 4, 2021, View Source [SID1234595541]). The funding will support the development of Orion’s lead compound, OB-002, a GPCR analog of CCL5 with best-in-class potency and broad applicability across a range of serious diseases including cancer and neuroinflammation. Working in collaboration with NRC’s Human Health Therapeutics Research Centre, the objectives of the project will be to further expand the translational research of OB-002, including an assessment of the molecules’ ability to cross the blood brain barrier (BBB).

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"We are very pleased to receive advisory services and this funding from NRC IRAP," said Mark Groper, President and CEO of Orion Biotechnology. "Their support will help accelerate development of OB-002 as a potentially important therapy for the treatment of serious illnesses".

"GPCRs are implicated in a wide range of human physiological processes and we are interested in expanding our knowledge of OB-002’s pharmacological profile and mechanism of action," commented Ian McGowan, Orion’s Chief Medical Officer. "This project, supported by NRC IRAP and our collaborators, will prove important as we continue to progress OB-002 into the clinic"

Regeneron has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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