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Mallinckrodt to Present at Morgan Stanley 17th Annual Global Healthcare Conference

On August 21, 2019 Mallinckrodt Pharmaceuticals (NYSE: MNK), a global biopharmaceutical company, reported that it will present on Tuesday, Sept. 10, 2019, at the Morgan Stanley 17th Annual Global Healthcare Conference at the Grand Hyatt, 109 E. 42nd St., New York (Press release, Mallinckrodt, AUG 21, 2019, View Source [SID1234538921]).

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Bryan Reasons, Executive Vice President and Chief Financial Officer, and Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, will represent the company in a fireside chat at 8:00 a.m. Eastern.

Individuals who cannot attend the meeting in person can find webcast information at: http://www.mallinckrodt.com/investors. A replay will also be available following the meeting.

GO2 Foundation for Lung Cancer Partners with eHealth App Belong Beating Cancer Together to Improve Treatment Management

On August 21, 2019 The GO2 Foundation for Lung Cancer, the United States’ leading lung cancer organization, reported that it has partnered with Belong.Life, which operates the world’s largest interactive social network for cancer patients, caregivers and healthcare professionals (Press release, GO2 Foundation, AUG 21, 2019, View Source [SID1234538920]).

To join the new GO2 Foundation Members Area on Belong, go to this link and enter the code: go2lung.

GO2 Foundation will have both a community forum and a membership area on the Belong eHealth app for its community of nearly 100,000 individuals. Within the membership area, GO2 Foundation’s social workers, clinical trial specialists, and survivor-volunteers will provide hope, education, and support to those living with lung cancer and their caregivers.

Members will get the latest treatment updates, access to GO2’s suite of educational materials, an appointment tracker, an area to store medical documents, and peer-to-peer support. Through the partnership, GO2 Foundation and Belong will also study members’ experiences to better address the needs of the lung cancer community.

"We’re delighted to introduce our community to the Belong social network," said Laurie Fenton Ambrose, Co-Founder, President and CEO of the GO2 Foundation for Lung Cancer. "Open communication is such a meaningful way to share information, inspire action, and spread comfort. The Belong platform has been impressive in both its user engagement and ability to analyze real-world data. This partnership will allow us to both support and learn from more patients and caregivers as we transform lung cancer survivorship."

Belong’s free and anonymous app uses machine learning and AI to deliver highly personalized and relevant information to people with cancer and their caregivers. It also includes forums for the many different aspects of cancer recovery such as emotional support, nutrition, pain and symptoms and radiation. The app boasts a very high average engagement rate of 90 minutes per user per month.

"Belong’s community has always set out to include as many cancer patients as possible," said Eliran Malki, Co-founder and CEO of Belong. "The more people we can connect with caregivers, doctors and each other, the more we can help those who need it most. Each ‘Belonger’s’ journey provides amazing actionable insights into the struggles and needs of other cancer patients. GO2 Foundation is the world’s largest lung cancer organization and our partnership will lead to more people getting the support they need. At the same time, it will increase what we know about lung cancer treatment and survivorship as we share resources."

GO2 Foundation for Lung Cancer is a newly formed organization created by the merger of the Lung Cancer Alliance and the Bonnie J. Addario Lung Cancer Foundation. The organization provides access to life-changing patient information and support services, advances research that spans the continuum of care, and grassroots advocacy to increase funding and access to high-quality care.

CMAB and Kintor Announce a New Comprehensive Collaboration to Develop and Manufacture the ALK-1 Monoclonal Antibody

On August 21, 2019 CMAB Biopharma (Suzhou) Inc. ("CMAB"), a pure-play CDMO business in biologics and Suzhou Kintor Pharmaceuticals, Inc. ("Kintor"), an innovative biopharmaceutical enterprise, reported a comprehensive strategic cooperation agreement for the development and manufacturing of Kintor’s ALK-1 mAb (Press release, CMAB Biopharma, AUG 21, 2019, View Source [SID1234538919]).

ALK-1 mAb has been studied in two Phase-I clinical trials in the United States, Italy, South Korea and Japan from 2007 to 2014. In these two clinical studies, ALK-1 mAb demonstrated favorable PK and safety profile and reasonable clinical benefits, which suggest that this novel therapeutic antibody has a potential to be a first-in-class in targeting ALK-1, an angiogenesis target. Kintor has been granted the exclusive and worldwide rights to develop, manufacture and commercialize this novel anti-angiogenic drug, and has initiated a Phase II clinical trial in combination with nivolumab in patients with hepatocellular carcinoma (HCC) in Taiwan. This is the first time Pfizer has licensed a Chinese company to develop a new antibody drug for oncology indications, which is expected to become the first fully human therapeutic monoclonal antibody that targets ALK-1 in the world.

According to the agreement, CMAB will provide a full range of CMC research and manufacturing services that meet the IND application requirements of China and the United States. This strategic cooperation will support the clinical development of ALK-1 antibody worldwide by Kintor. Importantly, this collaboration is based upon CMAB’s sophisticated CMC process development and manufacturing platform, experienced R&D team in IND applications in both China and the United States, and an impeccable product quality system.

"We are delighted and greatly honored that a comprehensive strategic cooperation agreement can be launched with Kintor. Kintor has been an outstanding player for the development of innovative anti-tumor drugs in China and recruited a top leadership team with drug discovery experience from multinational pharmaceutical companies. This well recognized innovative drug discovery company has delivered a strong portfolio across pre-clinical development to Phase-III clinical trials. ALK-1 MONOCLONAL ANTIBODY, a blockbuster large molecule clinical asset, is now in a critical stage of clinical development. To support Kintor’s clinical development plan, CMAB will not only provide professional CMC technology and manufacturing services for Kintor, but also make full use of its team’s expertise in IND application both in China and the United States. CMAB is also excited to support the commercialization and marketing of ALK-1 antibody in the future. In addition, CMAB wants to work with more and more innovative biopharmaceutical companies in China, like Kintor, to help shorten R&D cycles and speed up marketing of biopharmaceutical products. CMAB’s high quality service should enable these excellent drug discovery leaders who have committed to the research and development of new drugs being competitive to the world classes of innovative anti-tumor therapies," said by Dr. Yongzhong Wang, CMAB CEO.

"During the discussion of this collaboration agreement, we have been very impressed with the expertise of CMAB’s biotechnology team, the world-class production equipment and facilities and the customer-centered attitude toward cooperation. We, therefore, have decided to work together for the development manufacturing of ALK-1 antibody with CMAB," said by Dr. Youzhi Tong, Kintor’s President and CEO. "With the extensive and comprehensive discussions about this collaboration project, we have felt very confident in choosing CMAB as our long-term partner. Now we have every reason to believe that CMAB has top-class production equipment and facilities in the world and the capacity in technology integration and mature CDMO expertise. CMAB’s technical team with a strong experience in IND application both in China and the United States and a suite of core technologies and a rigorous IP protection system, will help us successfully launch ALK-1 mAb’s IND application in China and United States. We believe this productive collaboration will provide cancer patients the novel therapeutic agents with clinical benefits in China and in the world."

Penumbra, Inc. to Present at the 2019 Wells Fargo Healthcare Conference

On August 21, 2019 Penumbra, Inc. (NYSE: PEN) reported that its management team is scheduled to present at the 2019 Wells Fargo Healthcare Conference in Boston, MA on Wednesday, September 4, 2019 (Press release, Penumbra, AUG 21, 2019, View Source [SID1234538918]).

Event: 2019 Wells Fargo Healthcare Conference
Date: Wednesday, September 4, 2019
Time: 3:00pm ET / 12:00pm PT

A webcast of the presentation will be available by visiting the investors’ section of the company’s website at www.penumbrainc.com. The webcast will be available on the company’s website for at least two weeks following the event.

Updated Clinical Results and New Translational Research Data for Daiichi Sankyo’s ADCs U3-1402 and DS-1062 to be Presented at the 2019 World Conference on Lung Cancer

On August 21, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that updated results and new translational research data from two phase 1 studies evaluating investigational antibody drug conjugates (ADCs) U3-1402 and DS-1062 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) will be presented at the 2019 IASLC World Conference on Lung Cancer (#WCLC19), to be held September 7-10, 2019 in Barcelona, Spain (Press release, Daiichi Sankyo, AUG 21, 2019, https://www.prnewswire.com/news-releases/updated-clinical-results-and-new-translational-research-data-for-daiichi-sankyos-adcs-u3-1402-and-ds-1062-to-be-presented-at-the-2019-world-conference-on-lung-cancer-300904719.html [SID1234538917]).

The oral presentations will feature updated safety and efficacy results for U3-1402, a potential first-in-class HER3 targeting ADC being evaluated in patients with EGFR mutated metastatic NSCLC that has become resistant to TKI therapy, and for DS-1062, a TROP2 targeting ADC being evaluated in patients with advanced NSCLC who have progressed on standard treatments or for whom no standard treatment is available. Translational research findings from both studies, including biomarker expression and genomic alterations, will be presented alongside patient response data.

"As we continue to report our progress in clinical development of U3-1402 and DS-1062 in NSCLC, we also will begin to showcase some of the advanced translational research being conducted in the trials," said Antoine Yver, MD, MSc, EVP and Global Head, Oncology Research and Development, Daiichi Sankyo. "We are using cutting-edge tools to assess biomarker expression, genomic alterations and tumor burden; analyzing their relationships to treatment response; and pushing the boundaries of current science to fully leverage the potential of our ADCs in a precision medicine approach."

Both U3-1402 and DS-1062 are designed using Daiichi Sankyo’s proprietary DXd ADC technology, which consists of a monoclonal antibody attached by a tetrapeptide-based linker to a novel topoisomerase I inhibitor payload. Each ADC is constructed to target and deliver chemotherapy inside cancer cells that express a specific cell surface antigen, and each has a customized drug to antibody ratio (DAR) designed to attain the intended safety and efficacy for the target under investigation.

U3-1402 and DS-1062 are Daiichi Sankyo’s second and third ADCs in clinical development for NSCLC, following [fam-] trastuzumab deruxtecan (DS-8201), which is being co-developed and co-commercialized globally in collaboration with AstraZeneca. U3-1402 also is being evaluated in a phase 1/2 trial in patients with HER3 positive metastatic breast cancer.

Following are details of the Daiichi Sankyo presentations at WCLC:

"Preliminary Phase 1 Results from U3-1402—a Novel HER3 Targeted Antibody Drug Conjugate – in EGFR TKI resistant, EGFR mutant NSCLC" (Abstract #1720. Mini Oral Session MA21: Non EGFR/MET Targeted Therapies. Tuesday, September 10, 2019. 14:30 – 16:00 CEST)
"First-in-Human Phase 1 Study of DS-1062a (TROP2 Antibody Drug Conjugate) in Patients with Advanced Non-Small Cell Lung Cancer" (Abstract #3854. Mini Oral Session MA25: Precision Medicine in Advanced NSCLC. Tuesday, September 10, 2019. 14:30 – 16:00 CEST)
U3-1402, DS-1062 and DS-8201 are investigational agents that have not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.