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Iovance Biotherapeutics to Host Fourth Quarter and Full Year 2019 Financial Results Conference Call and Webcast on Tuesday, February 25, 2020

On February 19, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its fourth quarter and full year 2019 financial results on Tuesday, February 25, 2020 (Press release, Iovance Biotherapeutics, FEB 19, 2020, View Source [SID1234554512]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. EST.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 4693108. The live webcast can be accessed in the Investors section of the Company’s website at www.iovance.com. The archived webcast will also be available for one year in the Investors section at www.iovance.com.

NantHealth and NantOmics Announce GPS Cancer® Platform May Improve Clinical Trial Design of Combination Strategies by Identifying Previously Unrecognized Cancer Type Specific Associations between Immunoregulatory Molecules and Genomic Mutations

On February 19, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company and NantOmics, LLC, the leader in molecular analysis, reported Real-world data for differential expression of immunoregulatory molecules and targetable cancer genes may provide therapeutic insights into agnostic-driven trial designs during an oral presentation at the Real World Evidence in Immunotherapy Session at the Clinical Immuno-Oncology Symposium, sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) (Press release, NantHealth, FEB 19, 2020, View Source [SID1234554509]).

The Symposium, held at Rosen Shingle Creek in Orlando, FL from February 6-8, 2020 provides cutting-edge translational science and relevant clinical results to a diverse audience of leaders in oncology education, doctors and care teams.

"Our analysis shows that commonly evaluated mutations are associated with therapeutic targets for immunotherapy," said Sandeep "Bobby" Reddy, MD, Chief Medical Officer, NantHealth. "For example we saw high IDO expression in in patient samples with FBXW7 mutations. IDO has failed in clinical trials in the past but perhaps the wrong patient population was assessed. This data may help design better clinical trials which match the molecular phenotype with the best possible combination of therapies."

IDO1 (i.e. IDO) is the molecular target for several immunotherapy drugs (e.g. Epacadostat) that have failed in trials that selected patients based on tissue-type. FBXW7 mutants are significantly higher in IDO1 expression regardless of which tissue they show up in, and FXBW7 mutations are found in many tissue types. Agnostic-driven clinical trial designs using strategies to identify FBXW7 tumors that have higher expression of IDO1 may be a good strategy for these types of drugs.

In the study, authors utilized TCGA data and data collected from NantHealth’s GPS Cancer database on whole exome (WES) DNA tumor and paired normal and matched deep whole transcriptomic sequencing (RNA-Seq) to identify novel associations between oncogenic mutations and immune checkpoint therapeutic targets.

"CDKN2A mutation status was identified as associated with increased PD1 and CTLA4 expression while KRAS and APC mutations were assessed as associated with decreased PDL1/2 expression," said Christopher Szeto, Director of Machine Learning. "These mutation associations remained significant after accounting for tissue-specific expression patterns."

Title: "Real-world data validation for differential expression of immunoregulatory molecules and targetable cancer genes may provide therapeutic insights into agnostic-driven trial designs," Abstract #10
Authors: Jacob J. Adashek, Christopher Szeto, Sandeep K. Reddy, Philippe E. Spiess
Poster Session and Number:
Who: NantHealth, Inc. and NantOmics, LLC
What: Real World Evidence in Immunotherapy Session
When: February 6-8, 2020
Location: Rosen Shingle Creek

NantOmics and NantHealth Announce Results of Proprietary Machine Vision AI Software Study Demonstrating the Ability to Identify Aggressive Subtypes of Breast Cancer From Digital Pathology Images

On February 19, 2020 NantOmics, LLC, the leader in molecular analysis, and NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company, reported the publication of a peer-reviewed study in Breast Cancer Research, a Springer Nature journal, on a novel AI technique in breast cancer (Press release, NantHealth, FEB 19, 2020, View Source [SID1234554508]). The study reports on a novel deep-learning system of digital pathology images and omics data used together to more precisely identify mechanisms of therapy resistance.

NantOmics scientists trained a deep-neural network on diagnostic slide images from 443 breast tumors that had previously undergone PAM50 subtyping to classify patches of the tumor images into four major molecular subtypes of breast cancer (basal-like, HER2-enriched, luminal A, and luminal B). The algorithm was then validated and demonstrated the capability to establish accurate breast cancer sub-typing in 222 samples from a retained set of tumors. By focusing the neural-network’s attention on cancer-rich regions in the diagnostic images, this deep-learning algorithm identifies patient biopsies that are a mixture of different molecular subtypes, a classification that is less definable from molecular pathology techniques. Patients with heterogeneous biopsies such as mixtures of basal-like and luminal disease have a different survival profile than patients with homogeneous disease, and may potentially benefit from a more tailored therapy regimen.

"Breast cancer can be subtyped into at least five distinct disease-types with very different prognoses and responses to therapy. These subtypes are characterized as clinically important, yet are typically only achievable by RNA expression profiling," Dr. Patrick Soon-Shiong, MD, Chairman and CEO of NantHealth explained. "With this AI technique we achieved 87 percent accuracy rate in detecting which patients had basal-like breast cancer (i.e., triple negative breast cancer), one of the most aggressive subtypes," he said.

"Our analysis builds on our breadth of advanced machine learning technologies to better support providers in therapeutic decision-making and to improve the capabilities of the underlying molecular analysis technology platforms that we use at NantHealth and NantOmics," said Soon-Shiong. "Through the advances of machine vision and augmented intelligence, we have developed a rapid and cost-effective deep-learning technique to unlock the rich information in readily-available diagnostic slide images to define subtypes concordant with their underlying molecular designations."

Breast Cancer Research, a Springer Nature journal, is an international, peer-reviewed online journal publishing original research, reviews, editorials and reports in breast cancer. Breast Cancer Research is published by BMC, an open access publisher that produces over 250 scientific journals and according to its website, is "the highest ranked breast cancer focused title in the field."

Molecular Templates, Inc. Announces Dosing of First Subject in Phase I Study of TAK-169 in Relapsed/Refractory Multiple Myeloma

On February 19, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates" or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer and other serious diseases, reported the initiation of dosing in a Phase I study investigating TAK-169 in patients with relapsed/refractory multiple myeloma (Press release, Molecular Templates, FEB 19, 2020, View Source [SID1234554507]). Co-developed with Takeda Pharmaceutical Company Limited ("Takeda"), TAK-169 is a potential first-in-class CD38-targeting ETB. As a result of achieving this milestone, MTEM will receive a $10 million payment from Takeda.

"TAK-169, which leverages MTEM’s second generation, de-immunized ETB technology, represents a promising therapeutic approach for multiple myeloma patients with significant unmet medical needs. We are pleased that dosing is underway in the Phase I study," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "This product candidate is designed to deliver a potent, direct, cell-killing mechanism to cells that express CD38, a receptor that is known to be central to myeloma disease."

This study is a Phase 1, open-label, dose-escalation, multicenter study to evaluate TAK-169 in patients with relapsed or refractory multiple myeloma. The primary endpoints are to evaluate safety and tolerability. Secondary endpoints include preliminary efficacy, pharmacokinetic, pharmacodynamic, and immunogenicity measures. Patients will be followed up for 30 days after the last dose of study drug for a follow-up assessment. For more information, refer to ClinicalTrials.gov identifier: NCT04017130.

"TAK-169 has advanced to clinical development by pairing Takeda’s multiple myeloma expertise with Molecular Templates’ novel ETB technology," said Chris Arendt, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. "This program is a prime example of Takeda’s emphasis on working with world-class partners to discover and develop transformational new therapies for multiple myeloma and other hematologic malignancies."

About TAK-169
TAK-169 is an ETB consisting of a single chain variable fragment (scFv) with affinity for CD38, fused to the enzymatically active de-immunized Shiga-like toxin-A subunit (SLTA). TAK-169 is designed to bind and kill CD38 expressing cells in a manner consistent with SLTA mediated cellular cytotoxicity. TAK-169 has been specifically designed to avoid competition with and to overcome the primary mechanisms of tumor resistance to daratumumab, the first approved monoclonal antibody targeting CD38. In preclinical investigation TAK-169 has been shown to be active in the presence of daratumumab. As such, TAK-169 may have the potential to be combined with approved CD38 targeted therapies. TAK-169 mediated ribosomal inhibition and cell death take place intracellularly so changes in the tumor microenvironment, such as CD55/59 upregulation, which inhibit immune-mediated mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC) or complement dependent cytotoxicity (CDC) are not expected to inhibit TAK-169 activity.

About the CD38 Co-Development Partnership with Takeda
On September 19, 2018, MTEM announced an agreement with Takeda for the joint development of CD38-targeted ETBs for the treatment of multiple myeloma. TAK-169, the lead development candidate, is a CD38-targeted ETB that resulted from a previous discovery collaboration between the two companies. Under the terms of the agreement, Takeda made an upfront payment of $30 million and Molecular Templates is eligible to receive development, regulatory and commercial milestone payments of up to $632.5 million if Molecular Templates exercises its co-development option or $337.5 million if Molecular Templates does not exercise or opts out of its co-development option. Takeda has also agreed to pay royalties on sales of the commercial product developed through the collaboration. Molecular Templates and Takeda will share equally in the development costs. MTEM has been awarded a $15.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to fund development and manufacturing of CD38-targeted ETBs including TAK-169.

Maverick Therapeutics Corporate Presentation

On February 19, 2020 Maverick Therapeutics Presented the Corporate Presentation (Presentation, Maverick Therapeutics, FEB 19, 2020, View Source [SID1234554506]).