On April 20, 2018 Heat Biologics, Inc. presented investor presentation (Presentation, Heat Biologics, APR 20, 2018, View Source [SID1234525815]).

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On April 20, 2018 Dr. Michael Rosenblum and his team at MD Anderson Cancer Center, Houston, TX, reported that presented updated data on TGI (Targeted Granzyme B immunotherapy) at the 2018 American Association of Cancer Research Annual Meeting (AACR) (Free AACR Whitepaper) (Press release, Mirata BioPharma, APR 20, 2018, View Source [SID1234525564]). The research was supported by Mirata Biopharma LLC and conducted by the Clayton Foundation for Research ("Clayton Foundation").

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Dr. Rosenblum’s team developed a fusion protein, GrB-Fc-IT4 (MRT-101), that contains a humanized scFv binding domain targeting the cell surface receptor Fn14, an antigen highly expressed in a variety of solid tumors, and containing the human serine protease granzyme B (GrB) as the cytotoxic payload. The construct includes the IgG hinge Fc domain linker for efficient dimerization and an overall high molecular weight, thereby designed to provide a prolonged serum half-life (~40 h in mice). This unique format mimics human immune effector cell function and induces target cell death through the activation of a variety of well described pro-apoptotic cascade signals.

The poster, entitled "Molecular mechanistic and in vivo efficacy studies of Fn14-targeted fusion constructs containing human granzyme B," demonstrated that Western blot studies on human TNBC cells (MDA-MD-231) have shown that intact MRT-101 is translocated into the cytosol in less than 1 hour after exposure and is detectable in the cytosol for at least 8 hours. The free GrB component is also detected by the Western blot 4 hours after treatment and persists for up to 8 hours. Both of these agents trigger apoptotic cascades through activation of various caspases and induction of mitochondrial damage. Studies demonstrating cytochrome C release and mitochondrial depolarization are ongoing and will be reported. Incubation with the lysosomotropic agent chloroquine did not alter the IC50 of MRT-101, suggesting that the fusion protein is not appreciably held in the endosomal compartment.

In vivo studies have shown that MRT-101 is well tolerated in BALB/c mice after intravenous administration of 5 doses at 20 mg/kg/dose. This dose level showed no evidence of toxicity in any of the major organs such as liver and kidneys. In vivo efficacy studies conducted on NSGNOD scid mice demonstrated significant tumor growth inhibition of established orthotopic breast tumors (MDA-MB-231), with no tumor growth for up to 30 days after implantation. Treatment of nude mice bearing lung PDX tumors showed a 60% tumor growth inhibition when compared to the vehicle control group. These results, in combination with previous in vitro and in vivo studies, demonstrate that the completely human MRT-101 construct is a selective, highly potent, non-toxic and effective antigen-driven drug with significant potential for the treatment of Fn14 positive tumors that acts through a new and unique mechanism of action.

Full poster from the AACR (Free AACR Whitepaper) can be accessed via Mirata Biopharma website: View Source

On April 19,2018 The Medicines Company (NASDAQ:MDCO) reported that it will host a conference call and audio webcast on Wednesday, April 25, 2018, at 8:30 a.m., Eastern Time, to discuss first-quarter 2018 financial results and operational developments (Press release, Medicines Company, APR 19, 2018, View Source [SID1234525526]).

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The conference call may be accessed by telephone as follows:

U.S./Canada: (877) 359-9508
International: (224) 357-2393
Conference ID: 5683598

A taped replay of the conference call will be available after the call concludes, and may be accessed by telephone as follows:

U.S./Canada: (855) 859-2056
International: (404) 537-3406
Conference ID: 5683598

A live audio webcast of the conference call may be accessed in the Investors section of The Medicines Company website. An archived webcast will be available after the call concludes.

In the organization’s own words, "The American Society of Breast Surgeons, the primary leadership organization for general surgeons who treat patients with breast disease, is committed to continually improving the practice of breast surgery by serving as an advocate for surgeons who seek excellence in the care of breast patients (Press release, Dune Medical Devices, APR 19, 2018, View Source [SID1234525547]). This mission is accomplished by providing a forum for the exchange of ideas and by promoting education, research, and the development of advanced surgical techniques. Founded in 1995, the Society has grown to more than 3000 members in the United States and 35 countries throughout the world."

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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

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The Society’s Annual Meeting, May 2-6, 2018 in Orlando, is the breast cancer community’s greatest opportunity to connect, collaborate and collectively advance the standard of care for tens of thousands of breast cancer patients.

We want physicians interested in reducing positive margins and improving the patient experience to visit us at booth #101 to discuss MarginProbe’s ability to detect microscopic cancer intraoperatively and review the latest clinical data supporting its use. We want attendees to appreciate the value of MarginProbe in significantly reducing the risk of positive margins thereby preventing additional surgeries. As a result, patients avoid disruption to their adjuvant care plan, reduce the risks and costs associated with additional surgeries and return to their lives prior to their cancer diagnosis.

MarginProbe will also be discussed in the Wednesday May 2nd 7am – 4pm: Beginner and Intermediate Oncoplastic Breast Surgery Skills Courses with Cadaver Lab with Drs. Dennis Holmes and Julie Reiland.

You can find the MarginProbe team throughout ASBrS 2018 at booth #101.

On April 19, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has received Orphan Drug Designation from the U.S. FDA for Oraxol for the treatment of angiosarcoma (Press release, Athenex, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343439 [SID1234525530]). Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel orally non-absorbable gastrointestinal tract P-glycoprotein pump inhibitor).

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Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "We are pleased to receive Orphan Drug Designation for Oraxol for the treatment of angiosarcoma, a form of malignant blood vessel cancer. This designation represents our commitment to expand the use of Oraxol, in which the active pharmaceutical ingredient is paclitaxel, to additional clinical indications based on the known efficacy of paclitaxel and the observed improved pharmacokinetic profile of Oraxol. This is a parallel development with our clinical studies in metastatic breast cancer and gastric cancer, in which Oraxol has already shown promising efficacy and safety profile. We will be initiating the angiosarcoma clinical study soon."

The FDA grants Orphan Drug status to support development of medicines for the treatment of diseases that that affect fewer than 200,000 people in the United States. Orphan Drug Designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

Athenex previously announced that it had met its enrollment target for the second interim analysis for the Oraxol Phase III clinical trial for metastatic breast cancer and is scheduled to conduct this interim analysis in the third quarter of 2018. Additionally, the Company announced the receipt of the Promising Innovative Medicine designation for Oraxol by the United Kingdom Medicines and Healthcare products Regulatory Agency on December 27, 2017, qualifying Athenex to apply for Step II of the Early Access to Medicines Scheme to provide patients early access to Oraxol prior to receiving marketing authorization. Athenex also recently announced that the Chinese FDA has allowed the Investigational New Drug application for Oraxol on January 8, 2018. Athenex also announced initial results of a clinical study in Taiwan in patients with metastatic breast cancer, as well as results of the first cohort of patients in a study in Taiwan on the combination with ramucirumab (Cyramza, Eli Lilly’s monoclonal antibody against VEGFR2) in patients with gastric cancer.

Oraxol was initially discovered by Hanmi Pharmaceuticals and licensed to Athenex, in territories including North and Latin Americas, Europe, Japan, greater China and Southeast Asia, Australia and New Zealand. Athenex is leading the registration effort from IND and clinical studies.