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PANTHERx® Rare Pharmacy Selected by Blueprint Medicines to Distribute GAVRETO™ (pralsetinib) for the Treatment of Adults with Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC)

On September 14, 2020 PANTHERx Rare Pharmacy reported that it has been selected by Blueprint Medicines as a limited distribution partner for new drug GAVRETO (pralsetinib), which was granted accelerated approval for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test (Press release, PANTHERx Rare Pharmacy, SEP 14, 2020, View Source [SID1234565118]). Developed by Blueprint Medicines, GAVRETO is a once-daily oral precision therapy designed to selectively and potently target oncogenic RET alterations.

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RET activating fusions and mutations are key disease drivers in many cancer types, including NSCLC. RET fusions are implicated in approximately 1 to 2 percent of patients with NSCLC.

"PANTHERx is honored to be chosen by Blueprint Medicines to deliver this breakthrough oncology therapy to people living with RET fusion-positive metastatic NSCLC," said Dr. Gordon Vanscoy, Chairman and CEO of PANTHERx. "As a partner, we are proud to do our part in advancing rare oncology by providing award-winning white-glove services to this previously underserved patient population as part of our innovative RxARECARE model."

For more information about the symptoms, diagnosis, and treatment of RET fusion-positive NSCLC, please click here.

Neogene Therapeutics Raises $110 Million Series A Financing to Develop Next-Generation Fully Personalized Neo-Antigen T Cell Receptor (TCR) Therapies

On September 14, 2020 Neogene Therapeutics, Inc., a pre-clinical stage biotechnology company pioneering a new class of fully personalized neo-antigen T cell therapies to treat cancer, reported that it has raised $110 million in a Series A financing (Press release, Neogene Therapeutics, SEP 14, 2020, View Source [SID1234565116]). The financing was co-led by EcoR1 Capital, Jeito Capital and Syncona, with participation from Polaris Partners and Pontifax. Seed investors Vida Ventures, TPG and Two River also participated in the round.

Neogene, a Two River company, was founded in 2018 by a team of world-class cell therapy experts to advance the development of neo-antigen T cell therapies. Carsten Linnemann, Ph.D., Chief Executive Officer of Neogene, and Ton Schumacher, Ph.D., Principal Investigator at the Netherlands Cancer Institute, Oncode Institute and 2020 recipient of the Dutch Research Council’s Stevin Award co-founded the Company with individual investments by cell therapy industry veterans Arie Belldegrun, M.D. FACS, founder of Kite Pharma, Inc. and Co-Founder and Executive Chairman of Allogene Therapeutics, Inc. and David Chang, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of Allogene. Dr. Linnemann and Dr. Schumacher previously co-founded T-Cell Factory B.V., a company acquired by Kite Pharma in 2015.

Dr. Schumacher, an internationally leading immunologist in the areas of neo-antigen biology and T cell engineering, developed the seminal concepts of Neogene’s proprietary technology. Neogene’s platform allows for the isolation of neo-antigen specific TCR genes from tumor biopsies that are routinely obtained from cancer patients during treatment. The tumor-infiltrating lymphocytes (TIL) obtained by these tumor biopsies frequently express TCRs specific for mutated proteins found in cancer cells (neo-antigens). The Company’s proprietary technology uses state-of-the-art DNA sequencing, DNA synthesis and genetic screening tools to identify such neo-antigen specific T cell receptor genes within tumor biopsies with high sensitivity, specificity and at scale. The isolated TCR genes are subsequently engineered into T cells of cancer patients to provide large numbers of potent T cells for therapy.

"Neogene is committed to forging a path for new fully personalized engineered T cell therapies in solid cancer that are redirected towards neo-antigens found on cancer cells," said Dr. Linnemann. "While engineered T cell therapies have transformed the treatment paradigm for patients with hematologic malignancies, the industry has struggled to translate this success to the enormous unmet need in patients with advanced solid tumors. We believe that through a fully individualized approach using patient-specific TCRs to target neo-antigens, engineered T cell therapy can become broadly accessible to these patients. We are excited that our vision is shared by an outstanding syndicate of marquee investors, who have a deep understanding of and commitment towards the development of novel cell therapies in oncology."

"Neo-antigens represent ideal targets for cancer therapy, as they inevitably arise from DNA mutations that enable tumor development in the first place. Further supporting this concept is clear, correlative evidence linking T cell reactivity against neo-antigens with tumor regression in several patients," said Dr. Schumacher. "The Neogene platform makes it possible to exploit the neo-antigen reactive TCRs that are present in TIL without a requirement for viable tumor material. In addition, its syn-bio based approach offers major advantages with respect to standardization and scalability and will be critical to achieve our goal of bringing personalized engineered T cell therapies to patients."

In this Series A financing, Neogene expands its distinguished investor base with leading health-care investors from both the U.S. and Europe. For the seed-investors Vida Ventures, TPG and Two River, Neogene marks the second major collaboration in the cell therapy space after the launch of Allogene Therapeutics in 2018. Neogene’s seed-financing in 2019 enabled the Company to achieve proof-of-concept for its neo-antigen technology platform and built on the respective expertise of Vida Ventures, Two River and TPG in the gene and cell therapy space.

"We believe that Neogene’s technology and therapeutic approach has the potential to become a game changer for the treatment of cancer," said Oleg Nodelman, Founder and Managing Director of EcoR1 Capital. "We are impressed by the bold vision of the management team and are thrilled to support Neogene as it advances its mission of developing novel therapies for cancer patients in need."

"Neogene’s approach perfectly aligns with Jeito’s mission. Jeito was launched recently to support new and established entrepreneurs aspiring to help patients in need by pioneering novel, ground-breaking medicines underlined by highest quality innovation," said Rafaèle Tordjman, Founder and Chief Executive Officer at Jeito Capital. "We are delighted to welcome Neogene as the first investment into our new portfolio."

"We are excited to partner with the outstanding Neogene team," said Martin Murphy, Chief Executive Officer of Syncona. "Neogene’s technology offers a radically innovative approach to utilize the therapeutic potential of TIL cells by employing state-of-the-art TCR engineering and synthetic biology technologies." Facilitated by the Series A, Neogene intends to further develop its technology with growing offices in Amsterdam and the U.S. with the goal to initiate Phase I clinical studies in 2022.

Pfizer Hosts Virtual Investor Day

On September 14, 2020 Pfizer Inc. (NYSE: PFE) reported that it will host its virtual Investor Day today and tomorrow: Monday, September 14, 2020 from 1:00 p.m. EDT to 3:45 p.m. EDT and Tuesday, September 15, 2020 from 10:00 a.m. EDT to 1:30 p.m. EDT (Press release, Pfizer, SEP 14, 2020, View Source [SID1234565115]). Pfizer business executives and scientific leadership will provide updates on the company’s progress in advancing its R&D pipeline, specifically on product candidates with blockbuster potential that are expected to launch by 2025.

The agenda for Pfizer’s Investor Day is as follows:

DAY 1

Monday September 14, 2020 | 1:00 p.m. – 3:45 p.m. ET

DAY 2

Tuesday September 15, 2020 | 10:00 a.m. – 1:30 p.m. ET

1:00 p.m.

Welcome & Introduction to Day 1

Speaker: Chuck Triano

10:00 a.m.

Welcome & Introduction to Day 2

Speaker: Chuck Triano

1:05 p.m.

Executive Leadership Team Plenary Session

Pfizer "Big Picture"
Speaker: Albert Bourla
R&D Turnaround Story
Speaker: Mikael Dolsten
Productivity of Clinical Change
Speaker: Rod MacKenzie
Pfizer Biopharmaceuticals Group Core Therapeutic Area Overview
Speaker: Angela Hwang
10:05 a.m.

Inflammation & Immunology Triad Presentation and Q&A

Speakers: Richard Blackburn, Michael Corbo, Michael Vincent & Tamas Koncz

10:50 a.m.

Rare Disease Triad Presentation and Q&A

Speakers: Suneet Varma, Brenda Cooperstone & Seng Cheng

10 Minute Break

2:15 p.m.

Internal Medicine Triad Presentation and Q&A

Speakers: Michael Gladstone, James Rusnak & Morris Birnbaum

11:45 a.m.

Oncology Triad Presentation and Q&A

Speakers: Andy Schmeltz, Chris Boshoff, Jeff Settleman & Nicholas Saccomano

3:00 p.m.

Vaccines Tetrad Presentation and Q&A

Speakers: Nanette Cocero, Luis Jodar, Kathrin Jansen & William Gruber

5 Minute Break

12:35 p.m.

Updates on COVID-19 Programs and Q&A

Speakers: Mikael Dolsten, Kathrin Jansen & Angela Hwang

1:20 p.m.

Closing Remarks

Speaker: Albert Bourla

To access the live webcast, including audio, video and presentation slides, visit our web site at www.pfizer.com/investors. The webcast can also be accessed directly at www.PfizerInvestorDay.virtualeventsite.com. Participants are advised to register in advance.

Investors and analysts will also have an opportunity to ask questions in live Q&A sessions with speakers. Those participants who would like to ask a question can dial either (833) 711-4985 in the United States and Canada or (916) 637-9673 outside of the United States and Canada. The password is "Pfizer2020". Members of the media are invited to monitor the call by dialing (833) 711-4985 in the United States and Canada or (916) 637-9673 outside of the United States and Canada with the password "Pfizer2020". Journalists who wish to ask questions are requested to contact a member of Pfizer’s Media Relations team.

Interested parties unable to watch the live webcast will be able to view and listen to an archived copy of the webcast, which will be available on www.pfizer.com/investors following the conclusion of the event.

Diaceutics Unveils Expert Advisory Panel Powering its Industry-Changing Diagnostic Network DXRX

On September 14, 2020 Diaceutics PLC, (AIM: DXRX), reported the establishment of a dedicated Advisory Panel of experts to support and inform the development and rollout of its revolutionary DXRX platform – the world’s first diagnostic network for precision medicine (Press release, Diaceutics, SEP 14, 2020, View Source [SID1234565114]).

The panel consists of key opinion leaders from the areas of oncology, including lung cancer research and colorectal research; pathology, including tissue pathology and uropathology; molecular diagnostics; digital image analysis; telemedicine and informatics; external quality assessment (EQA); and FDA-expertise. They are providing insights and recommendations to help drive the future direction of DXRX, as well as other solutions developed by Diaceutics to better support the treatment of patients across the world and transform the healthcare industry.

Endorsed and shaped by these industry leaders with over 120 years of collective experience, DXRX will help to unlock the power of precision medicine, drive standardization of diagnostic testing and ensure that every eligible patient gets access to the right treatment at the right time. The end-to-end solution will not only enhance Diaceutics’ service offering but also offer a secure platform for pharmaceutical companies, laboratories and diagnostic companies to collaborate more effectively.

Currently, the Diaceutics Advisory Panel consists of Dr Anthony Magliocco of Protean BioDiagnostics Inc. (Founder and CEO, Consultant Pathologist) in the USA, Keith Kerr from Aberdeen University School of Medicine in Scotland (Professor, Consultant Pathologist), US-based Kenneth J. Bloom of Invicro and Ambry Genetics (CMO, MD, FCAP), Markus Eckstein from University Hospital Erlangen in Germany (MD) and Dr Fotios Loupakis from the Institute of Oncology at Veneto in Italy (Medical Oncologist, MD, MS, Ph.D).

To date, Diaceutics′ Advisory Panel has undertaken extensive research into the inefficiencies in precision medicine testing which are preventing patients from getting the treatment they need, when they need it. For example, this research – which was published in four abstracts and one poster at this year′s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference – revealed the economic burden of not testing for the FLT3 biomarker to treat Acute Myeloid Leukemia (AML), which could cost up to $445 million in the United States alone.

Alongside the establishment of the panel – Diaceutics has invested in building the world’s largest repository of diagnostic testing data consisting of 227 million patient records to power its DXRX platform. The platform has been purpose built to enable access to a global flow of testing data integrating 2500+ laboratories into one secure network. Diaceutics is also building partnerships with industry-leading service providers in areas such as test access and reimbursement, pathology training, health economics, reference standards and EQA including Targos Molecular Pathology and HistoCyte Laboratories earlier this year. The company is currently onboarding laboratory partners to the network with pharmaceutical companies gaining access to the solution in Q4 2020.

Derek Hosty, Head of Innovation, Diaceutics, commented: "It is an honour to have such well-renowned experts joining our ever-expanding network and helping to shape our future service offering. This dynamic group of advisors will enhance the value we deliver to pharmaceutical companies, laboratories and diagnostic companies via our DXRX platform. In turn, this will help to overcome the obstacles currently present in the field of precision medicine and, more importantly, greatly benefit patients by getting them the treatment they deserve.

"DXRX has been designed to give global laboratories a voice, so that they are no longer the forgotten stakeholder in precision medicine, and the very best in the sector are ensuring its success. Together with the industry-leading service providers and partners with whom we are collaborating, the DXRX Advisory Panel will help to transform the broken testing ecosystem and has the potential to transform the entire business model of precision medicine for patients."

Kenneth J. Bloom, CMO, Invicro and Ambry Genetics, said: "I am honored to be part of what is very much an unprecedented approach to bringing stakeholders on to one secure platform to collaborate around diagnostic testing. I see there being a huge appetite for this technology not only with pharma, labs and diagnostic companies but also with clinicians and any service provider involved in the process of getting patients treated."

Keith Kerr, Professor and Consultant Pathologist, Aberdeen University School of Medicine, added: "There is today an unmet need in the testing ecosystem for labs to be much more supported at ground level through in-lab services such as EQA, test standardization and industry training to ensure that more patients get the right treatment at the right time. I am glad to be part of a network which has the potential to deliver on those needs and look forward to what we can achieve together going forward."

LAVA Therapeutics, Amsterdam UMC and Monash University Announce Publication of a Novel Cancer Immunotherapy Approach in Nature Cancer

On September 14, 2020 LAVA Therapeutics B.V., a biotech company pioneering bispecific gamma-delta T cell engagers for cancer, Amsterdam UMC and the Monash Biomedicine Discovery Institute in Australia, reported that Nature Cancer has published their co-authored paper titled, "A single domain bispecific antibody targeting CD1d and the NKT T cell receptor induces a potent antitumor response," detailing a novel immune-oncology approach for the potential treatment of cancer (Press release, Lava Therapeutics, SEP 14, 2020, View Source [SID1234565113]).

Findings in the paper highlight the potential for a LAVA-derived antibody fragment, known as a single domain antibody, that acts as a bridge to link together two key immune cell receptors – the CD1d receptor and the T cell receptor of natural killer T (NKT) cells – in order to enhance the body’s immune response to cancer. The CD1d receptor is frequently expressed by tumor cells and NKT cells are positioned at the interface between the innate and adaptive immune system and play an important role in the host-rejection of both tumors and virally infected cells. Preclinical research through the companies’ collaboration demonstrates that a CD1d-NKT cell targeting antibody resulted in significant activation of NKT cells and the subsequent killing of CD1d-expressing tumor cells in multiple tumor samples, including multiple myeloma and acute myeloid leukemia.

"These data underscore the potential of LAVA’s bispecific antibody approach to target and activate NKT cells for the treatment of cancer," said Hans van der Vliet, professor in medical oncology at Amsterdam UMC and chief scientific officer of LAVA Therapeutics. "By targeting and boosting natural immune cells that are inherent in all humans, such as NKT and gamma-delta T cells, for an enhanced therapeutic effect, our approach could translate into a broadly applicable immunotherapeutic strategy for treating a range of cancer indications."

"Using the Australian Synchrotron, the team at Monash University provided detailed atomic insight into how the single domain antibodies exerted their effect on immune cells in a cancer model. Through this, we were able to precisely visualize how the single domain antibody simultaneously recognized CD1d and the NKT T cell receptor, thereby providing a molecular basis for their anti-tumor properties," professor Jamie Rossjohn, Australian Research Council Laureate Fellow at Monash University stated. "The collaboration with LAVA Therapeutics on this ground-breaking approach was very effective."

Instrumental to the study were joint first authors Dr. Roeland Lameris from Amsterdam UMC and Dr. Adam Shahine from Monash University.