Athenex, Inc. to Report First Quarter 2019 Earnings Results on May 9, 2019

On April 25, 2019 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 will release first quarter ended March 31, 2019 financial results on May 9, 2019 before the market opens (Press release, Athenex, APR 25, 2019, View Source;p=RssLanding&cat=news&id=2395677 [SID1234535381]). The Company will host a conference call and live audio webcast on Thursday, May 9, 2019, at 8:00am Eastern Time to discuss the financial results and provide a business update.

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To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13689379. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at View Source

ADC Therapeutics and Adagene Announce License Agreement

On April 24, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), and Adagene Inc., an antibody engineering and discovery company, reported that they have entered into a discovery collaboration and license agreement (Press release, ADC Therapeutics, APR 24, 2019, View Source [SID1234596063]). ADC Therapeutics will use Adagene’s SAFEbody technology to generate a masked antibody that will be combined with ADC Therapeutics’ pyrrolobenzodiazepine (PBD) cytotoxic payload technology for the development of a novel ADC against a solid tumor target.

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Adagene has developed the SAFEbody technology to produce masked antibodies that are activated to bind to an antigen in the tumor microenvironment by factors present in tumor tissues but not in healthy tissues. This enables enhanced specificity for targeting of an ADC and minimizes off-target toxicity on healthy cells, potentially enhancing the therapeutic index of the ADC.

"The SAFEbody technology requires specific conditions within the tumor microenvironment to unleash the ADC’s full therapeutic potential," said Patrick van Berkel, Senior Vice President of Research and Development at ADC Therapeutics. "Combining a SAFEbody with highly potent PBD-based payloads will allow us to develop potent new tumor-specific ADCs that depend on the unique conditions in the local tumor microenvironment for full activation."

ADC Therapeutics has entered into the agreement with Adagene for one exclusive target, with the option to leverage SAFEbody technology for one additional exclusive target. Both potential programs will focus on targets in which healthy tissue expression does not permit development of ADCs incorporating traditional antibodies.

Under the terms of the agreement, Adagene will receive research funding for the discovery phase. Upon success of the discovery collaboration, Adagene will receive an upfront payment, development and commercial milestone payments, and royalties on net sales. ADC Therapeutics has granted Adagene certain commercial rights for Greater China. No other financial terms were disclosed.

"We are very pleased to partner our SAFEbody technology with ADC Therapeutics," said Peter Luo, Chief Executive Officer and Co-Founder of Adagene. "Adagene’s innovative protein engineering ability enables us to tailor-make products to limit their on-target off-tumor toxicity. Together with ADC Therapeutics’ experience in developing ADCs with highly potent PBD payloads, we have the potential to unlock new treatment options for patients with unmet medical needs."

"We’re excited to collaborate with Adagene to work toward the next generation of masked ADCs," said Chris Martin, Chief Executive Officer at ADC Therapeutics. "As we continue evaluating our potent ADCs in ongoing clinical trials, we look forward to exploring how Adagene’s SAFEbody technology incorporated in our ADCs may enable us to further improve anti-tumor activity while minimizing side effects."

ABC2 Awards Grant to Develop Natural Disease History Benchmark for the Development of ONC201 in Midline Gliomas

On April 24, 2020 Oncoceutics reported that Accelerate Brain Cancer Cure (ABC2) has awarded a $116,523 grant to a research team at University of California, Los Angeles to perform a natural disease history study of adult midline gliomas, a certain type of aggressive brain tumors (Press release, Oncoceutics, APR 24, 2019, View Source [SID1234558358]). The study will follow patients from first diagnosis through a series of therapeutic interventions that for a subset of patients will include ONC201, an investigational agent in clinical trials for H3 K27M-mutant gliomas that has induced radiographic regressions in some patients.

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"Novel therapies are desperately needed for treatment of H3 K27M-mutant gliomas," said Max Wallace, Chief Executive Officer of ABC2. "A dedicated natural history study will open up the path to accelerated approval based on radiographic responses to new treatments such as ONC201 in this rare and immediately life-threatening disease."

ONC201 is the first antagonist of D2-like dopamine receptors DRD2/3 to be developed for clinical neuro-oncology. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ONC201 for the treatment of adult recurrent H3 K27M-mutant high-grade glioma. Diffuse midline gliomas harboring the histone H3 K27M mutation have a dismal prognosis with a median survival from diagnosis consistently reported to be between 8 and 11 months. The mutation was chosen by the World Health Organization (WHO) as a criterion for WHO grade IV designation, the most severe grade that is associated with a diffuse and aggressive growth pattern. No drug has been approved for H3 K27M-mutant glioma and no investigational therapy has shown clinically meaningful efficacy in this indication. Radiation is typically used in newly diagnosed patients and associated with some benefit before the tumor progresses, leading to the dismal survival rates.

Despite the increased awareness for the prognostic importance of the H3 K27M mutation, dedicated studies of midline gliomas are sparse, particularly in adults. Response criteria that are often applied, e.g. RANO criteria, were developed for supratentorial glioblastoma that have different radiographic features than midline gliomas, including H3 K27M-mutant gliomas. Consequently, the utility of these criteria for many midline glioma patients are confounded by a number of features often found in this disease: minimal or no contrast enhancement, diffuse growth, multifocal dissemination, and sub-centimeter lesions (not measurable as per some criteria). With the disease classifications that consider phenotypic as well as genotypic disease characteristics (e.g. WHO 2016) and patient registries that collect historical data the disease can be studied in more detail. However, many features of midline gliomas are still poorly understood, including tumor growth rates, dissemination patterns, response to therapies, and the relationship of clinical outcomes to these features.

"The goal of the study is to quantify the dynamics of how midline gliomas change over time on clinical imaging to better understand the natural progression of this disease and if treatments can alter those dynamics," said Timothy F. Cloughesy, MD, Clinical Professor and Director of the Neuro-Oncology Program at the University of California, Los Angeles. "The natural disease history could serve as a benchmark for new therapies such as ONC201 and other agents targeting glioma. We are very thankful to ABC2 for their support that will allow us to research this important and unaddressed topic."

Arrowhead Pharmaceuticals to Webcast Fiscal 2019 Second Quarter Results

On April 24, 2019 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on May 8, 2019, at 4:30 p.m. EDT to discuss its financial results for the fiscal 2019 second quarter ended March 31, 2019 (Press release, Arrowhead Pharmaceuticals, APR 24, 2019, View Source [SID1234535393]).

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Conference Call and Webcast Details Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 5049067.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 5049067.

Aurinia Pharmaceuticals to Present at the 2019 Bloom Burton & Co. Healthcare Investor Conference

On April 24, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (the "Company") reported that members of the management team will present a corporate overview at the 2019 Bloom Burton & Co. Healthcare Investor Conference on Tuesday, April 30, 2019 at 8:30am PT (11:30am ET) in Toronto, Ontario (Press release, Aurinia Pharmaceuticals, APR 24, 2019, View Source [SID1234535380]).

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The presentation will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of the presentation will also be archived on the Company website following the event