On July 20, 2018 TESARO, Inc. (NASDAQ:TSRO) reported that it will announce second-quarter 2018 financial results on Thursday, August 2, 2018, after the close of the U.S. financial markets (Press release, TESARO, JUL 20, 2018, View Source [SID1234527800]). TESARO’s senior management team will host a conference call and live audio webcast at 4:15 p.m. ET on August 2, 2018 to discuss the Company’s operating results for the quarter in greater detail, as well as the status of its development programs.

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This quarterly earnings call will be available via phone and webcast. The conference call dial-in information is listed below. To access the webcast, please log on to the TESARO website at www.tesarobio.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

Targeting the CD47-SIRPα axis is emerging as one of the most promising new cancer immunotherapy approaches seeking to target the innate immune response. A recent analysis reveals just how intense the global interest is and a growing list of stakeholders operating in this field.

Highest Stage Breakdown of CD47/SIRPα Molecules

Most of the identified molecules are either anti-CD47 antibodies or SIRPα-Fc recombinant proteins. In healthy cells, CD47 serves as a “don’t eat me” signal by binding to the transmembrane SIRPα protein on phagocytic cells, preventing the engulfment of “self” by macrophages. In several cancer types, tumor cells overexpress CD47 to elude the immune system. Exploration of this property has been the driving force to attract hundreds of million of dollars in investments to companies like Tioma Therapeutics (now Arch Oncology), Surface Oncology and Forty Seven, the latter of which has just recently completed a $100M+ IPO. Deals in this area include the early adopter move in 2012 by Celgene securing Inhibrx’ anti-CD47 antibody in a $500 million dollar deal to the recent billion dollar plus agreement between OSE Immunotherapeutics and Boehringer Ingelheim.

On the patent front, it is evident that that the Synthon/Sanquin Blood Supply intellectual property rights hold some clout in the CD47 world following Forty Seven’s $47 million settlement and license agreement with Synthon. The license agreement also includes some far reaching concessions by Forty Seven in order for them to obtain freedom to operate. Moreover a recent patent analysis accessible in this product shows several new CD47/SIRPA bispecific/fusion-proteins, CD47 mimetics and additional, previously unknown, combination therapy strategies set forth along with methods for determining responsiveness to anti-cd47 agent

CD47/SIRPα Molecules Are In Development in Thirty Five Different Tumor Types

On the clinical development front, this report identifies fewer than ten molecules targeting the CD47-SIRPα axis which have made it into the clinic. So far with encouraging results, following the early termination of a Phase I/II trial of Tioma’s Ti-061 in late 2017.

Several of these trials also shed light on biomarker- and combination therapies of interest. On the horizon, this field will soon have another injection of candidate therapies with bispecific CD47 antibodies entering the clinic in late 2018 or early 2019.

The CD47/SIRPα Molecules Are Also Targeting Thirteen Other Targets, Including Bispecific Antibodies

Moreover, targeting the CD47-SIRPα axis also has the potential to become the combination therapy of choice as has already been demonstrated via mediating longer survival in mice together with oncolytic virotherapy and enhancing phagocytic capacity when used together with Carisma Therapeutics’ CAR macrophages. Carisma Therapeutics themselves have just announced a $53 million series A round of financing in order to develop its novel CAR macrophage cellular immunotherapy and is estimating that their project(s) will enter into the clinic in 2019.

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On July 19, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that the company has submitted a clinical trial authorization (CTA) application to the relevant regulatory authorities to start a phase I study of its wholly-owned bispecific drug candidate ATOR-1015 (Press release, Alligator Bioscience, JUL 19, 2018, View Source [SID1234527787]).

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The upcoming phase I study with ATOR-1015 is a first-in-human dose escalation study in patients with advanced solid cancer. The study will be conducted at five sites in Sweden and Denmark and will enroll up to 50 patients. The primary aim of the study is to investigate the safety and tolerability of ATOR-1015 and establish the recommended dose for the subsequent phase II studies. ATOR-1015 is intended to be the first CTLA-4 and OX40-binding bispecific antibody to achieve a strong anti-tumor effect, either as a monotherapy or in combination with currently established immunotherapies such as PD-1 and PD-L1 blockers. It is expected to be suitable for treating a large number of different forms of cancer.

"We are very pleased to announce the CTA submission and look forward to starting patient recruitment as fast as possible after regulatory approval. Based on a strong preclinical data package demonstrating that ATOR-1015 localizes to the tumor and selectively activates the immune system in the tumor area, we have high expectations of this first-in-class drug candidate," said Per Norlén CEO of Alligator Bioscience.

As previously communicated, Alligator has appointed Theradex Oncology, a global contract research organization with extensive expertise in oncology clinical development, to conduct the phase I study.

For further information, please contact:

Cecilia Hofvander, Director Investor Relations & Communications

Phone +46 46 286 44 95

E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 4:10 p.m. CEST on July 19, 2018.

About ATOR-1015

ATOR-1015 is a next generation CTLA-4 bispecific antibody developed for tumor-directed immunotherapy with increased capability of regulatory T-cell depletion. It is wholly-owned by Alligator. ATOR-1015 binds to two different immune receptors: the checkpoint receptor CTLA-4 and the co-stimulatory receptor OX40. The immune activation is increased in areas where both target molecules are expressed at high levels, notably in the tumor microenvironment, which is believed to reduce adverse immune reactions.

On July 19, 2018 GT Biopharma Inc. (GTBP) and (Euronext Paris: GTBP.PA) reported a Material Transfer Agreement (MTA) between a Major Pharmaceutical Company and Dr. Daniel Vallera, Director, Section of Molecular Cancer Therapeutics at the Masonic Cancer Center, University of Minnesota (Press release, GT Biopharma , JUL 19, 2018, View Source [SID1234539527]).

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Under the terms of the agreement, this Major Pharmaceutical Company will supply a formulation of their multibillion dollar, widely prescribed oncology drug, which has been approved for use in several hematologic malignancies to Dr. Vallera to be used in this study.

Dr. Vallera is the lead researcher for GT Biopharma’s bispecific antibody drug conjugate (ADC) program, and the innovator of oncology drug candidate DT2219, also known as OXS-1550. OXS-1550 targets two antigens on cancer cells and contains a cytotoxic payload thereby increasing the probability it will kill the cancer cells. OXS-1550 targets cancer cells expressing the CD19 receptor and/or CD22 receptors which includes B-cell leukemias and lymphomas and has a modified form of diphtheria toxin (DT390) as its cytotoxic drug payload. After OXS-1550 binds to cancer cells, it is taken in by the cancer cells and subsequently deploy its cytotoxic diphtheria toxin payload which inhibits protein synthesis and kills the cancer cells.

Initial pre-clinical work performed by Dr. Vallera suggests a much greater effect when OXS-1550 is given in combination with this established oncology drug. Dr. Vallera said: "I am looking forward to conducting these experiments. Early work suggests that these two agents would be a great combination in the treatment of certain cancers. This initial work will assist us in deciding what tumors to target and the doses to employ."

GT Biopharma’s Chairman and Chief Executive Officer (CEO) Dr. Raymond Urbanski said: "This is a tremendous step forward for the OXS-1550 program. Pre-clinical data suggests that the combination of OXS-1550 and this agent is highly potent against certain tumor cell lines. This MTA will allow further studies in animal models to both confirm the effects as well as ascertain which tumor types are the most susceptible to this potent combination."

On July 19, 2018 AskAt reported that Ningbo NewBay Medical Technology Co., Ltd. (headquarters in Ningbo, China, CEO: Zhenhai Shen, "NewBay") received an approval of an IND application for EP4 antagonist AAT-007 (grapiprant) for cancer therapy from China Food and Drug Administration ("CFDA") on July 4, 2018. NewBay is a subsidiary company of Ningbo Tai Kang Co., Ltd. to which AskAt Inc. licensed AAT-007 for cancer therapy in China (Press release, AskAt, JUL 19, 2018, View Source [SID1234535047]). NewBay submitted the IND application to CFDA on January 16, 2018.

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NewBay is planning to start a clinical study of AAT-007 for oncology in China by the end of this year.