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Roche to present new positive data from its broad cancer immunotherapy programme and across a wide range of cancers at the European Society for Medical Oncology (ESMO) 2018 Congress

On October 9, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new results from a number of studies across its industry leading oncology portfolio of approved and investigational medicines will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place from 19-23 October, in Munich, Germany (Press release, Hoffmann-La Roche, OCT 9, 2018, View Source [SID1234529810]). These data include positive Phase III results from Roche’s cancer immunotherapy development programme across multiple tumour types, positive Alecensa (alectinib) data from the Phase III ALESIA study and new pivotal data for entrectinib, a tumour-agnostic investigational medicine that targets NTRK gene fusion-positive solid tumours.

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"We look forward to presenting the first positive Phase III study of a cancer immunotherapy combination in breast cancer, which showed encouraging results for Tecentriq plus nab-paclitaxel in people with metastatic triple-negative breast cancer, specifically in the PD-L1-positive population," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We will also share new data from our pivotal analysis of entrectinib for people with NTRK gene fusion-positive solid tumours, an example of our continued commitment to developing next-generation personalised treatments."

An audio webcast for analysts and investors to discuss key data presented on the Roche Group’s oncology portfolio and pipeline during the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich, will be held on Monday 22 October 2018 from 6:00 – 7:15 pm CEST. Further details are available here.

Follow Roche on Twitter via @Roche and keep up to date with ESMO (Free ESMO Whitepaper) 2018 Congress news and updates by using the hashtag #ESMO18.

Key Presentations
Breast cancer:
Primary results will be presented from the positive, Phase III, randomised IMpassion130 study investigating Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), an aggressive type of the disease which currently has limited treatment options. Abstract LBA1_PR (Presidential Symposium 1) Saturday, 20 October, 16:30 -16:45 CEST: Hall A2 – Room 18

As reported earlier this year by Roche, the combination of Tecentriq plus chemotherapy (nab-paclitaxel) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) in the intention-to-treat and the PD-L1-positive populations, and showed an encouraging overall survival (OS) improvement at this interim analysis in people whose disease expresses the PD-L1 protein, a subgroup determined by PD-L1 biomarker testing.

Data from the IMpassion130 study will also be featured as part of ESMO (Free ESMO Whitepaper)’s press programme on Saturday, 20 October.

Tumour-agnostic:
Pivotal data from the positive Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA trials will be presented on entrectinib (RXDX-101) for the treatment of people with NTRK gene fusion-positive solid tumours. Abstract LBA17 (oral) – Sunday, 21 October, 11:24 – 11:36 CEST: Hall B3 – Room 22

Molecular profiling and next-generation sequencing will play a critical role in identifying people most likely to benefit from entrectinib. Roche is combining comprehensive genomic profiling with precision medicines, like entrectinib, in order to offer patients more personalised healthcare solutions.

Entrectinib has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA); Priority Medicines (PRIME) designation by the European Medicines Agency (EMA); and Sakigake Designation by the Japan Ministry of Health, Labour and Welfare for the treatment of NTRK gene fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or have no acceptable standard therapies.

Lung cancer:
Key data to be presented at ESMO (Free ESMO Whitepaper) cover advances from Roche’s lung cancer programme, including a combination approach using the cancer immunotherapy Tecentriq with targeted therapies and a range of different chemotherapies.

OS and PFS data will be presented for the first time from the positive Phase III IMpower130 study, a multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and nab-paclitaxel) versus chemotherapy (carboplatin and nab-paclitaxel) alone for advanced non-squamous non-small cell lung cancer (NSCLC). Abstract LBA53 (oral) – Monday, 22 October, 09:15 – 09:30 CEST: Hall A1 – Room 17

PFS data will also be presented for the first time from the positive Phase III ALESIA study, a randomised, multicentre, open-label study evaluating the efficacy and safety of Alecensa versus crizotinib in Asian patients with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. Abstract LBA10 (Presidential Symposium 3) – Monday, 22 October, 17:30-17:45 CEST: Hall A2 – Room 18

Liver cancer:
Updated data will be presented from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin as treatment for patients with unresectable or advanced hepatocellular carcinoma (HCC). HCC is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide. Earlier this summer the US FDA granted BTD for Tecentriq in combination with Avastin as an initial (first-line) treatment for people with advanced or metastatic HCC. Data at ESMO (Free ESMO Whitepaper) include longer follow-up and data from patients with hepatitis B virus, a major driver of the disease. Abstract LBA26 (oral) – Sunday, 21 October, 11:54 – 12:09 CEST: Hall A1 – Room17

Overview of key data featuring Roche medicines at ESMO (Free ESMO Whitepaper) 2018

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Tarceva (erlotinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies

Strong showing for Oncology Drug Developers Among Fierce 15 Award Winners

On October 2nd, 2018 Fierce Biotech disclosed the 15 selected companies for the Fierce 15 Award. This prestigious award has come to symbolize novelty and being at the forefront of biotechnology development among privately held businesses. The winners of this award are aiming at breakthroughs and big things, not at being ‘me-too’.

Since 2010 1stOncology has included the Fierce 15 award in a set of attractive benchmarking parameters to identify and analyze the pipeline of movers and shakers in cancer drug development. Year after year oncology keeps coming back as a dominating therapeutic area among the Fierce 15 awardees and 2018 is no different!
In fact, no less than eleven out of the fifteen 2018 Fierce 15 companies are active in cancer drug development. Three of the companies, Beam Therapeutics, Gossamer Bio and Quentis Therapeutics were all founded in 2018, with another three companies formed in 2017, see table below. Compass Therapeutics is this year oldest recipient founded in 2013.

Fierce pointed to the fact that this years winners have been notable in their success in already raising serious funding. In total they have raised $1.36 billion in funding rounds and capital commitments with four over $100 million and most others between $40 million and $60 million. Notable too was that all eleven of the oncology companies were based out of the US, whereas in previous years the field has been more global.

Our 1stOncology clients can review detailed pipeline analysis of each these Fierce 15 companies via our special analyst report available in the platform. For all others, we are happy to offer a free online demo here, so you can see the actionable information that 1stOncology provides.

List of Oncology Associated Companies Among this Year Recipients of the Fierce 15 Award:

Navidea Biopharmaceuticals to Present at the 2018 BIO Investor Forum

On October 8, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that its Chief Executive Officer, Jed Latkin, will present a corporate overview of the Company at the 2018 BIO Investor Forum, being held October 17-18, 2018 in San Francisco, California (Press release, Navidea Biopharmaceuticals, OCT 8, 2018, View Source [SID1234530337]).

Conference Presentation Details:

Where: The Westin St. Francis Hotel, San Francisco, California
When: Thursday, October 18, 2018 at 11:15AM PDT
Room: Elizabethan C
Conference Website:
View Source

To schedule a meeting, investors can submit meeting requests through the conference one-on-one partnering system.

Affimed Places AFM11 (CD19/CD3-Targeting T cell Engager) Phase 1 Program on Clinical Hold

On October 8, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK and T cells), reported that it has placed AFM11 (CD19/CD3-targeting T cell engager) on clinical hold, and has notified the global health authorities of its decision (Press release, Affimed, OCT 8, 2018, View Source [SID1234530285]). AFM11 is being evaluated in two Phase 1 clinical studies for the treatment of patients with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). The clinical hold was initiated after the occurrence of Serious Adverse Events (SAEs) in three patients, which included a death in the ALL study and two life-threatening events in the NHL study.

The SAEs occurred in patients enrolled in the highest dose cohorts of each study. Thirty-three patients have been treated in total in the two Phase 1 studies, with preliminary signs of clinical activity observed in several patients.

Affimed will be working closely with the global health authorities, the Safety Monitoring Committees, and the studies’ clinical investigators to review the events, carefully assess all of the data and determine next steps for the AFM11 program. Affimed intends to provide an update on AFM11 upon completion of the evaluation.

The clinical hold does not affect the ongoing development of Affimed’s NK cell engager programs, which are based on targeting the NK cell receptor CD16A, a different approach than used for AFM11, which targets T cells through CD3.

Inovio Successfully Develops First DNA-Encoded Monoclonal Antibody (dMAb™) Checkpoint Inhibitor and Demonstrates Tumor Shrinkage in Preclinical Studies

On October 8, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported the successful animal testing of DNA-encoded monoclonal antibodies targeting the immune checkpoint molecule CTLA-4 as published in Cancer Research (Press release, Inovio, OCT 8, 2018, View Source;Monoclonal-Antibody-dMAb-Checkpoint-Inhibitor–and-Demonstrates-Tumor-Shrinkage-in-Preclinical-Studies/default.aspx [SID1234530270]). The breakthrough preclinical study demonstrated that highly optimized dMAbs targeting mouse CTLA-4 protein can be robustly expressed in vivo, and shrank tumors in mice. More importantly, Inovio’s dMAb constructs for anti-human CTLA-4 antibodies ipilimumab (YERVOY) and tremelimumab, achieved high expression levels in mice (approximately 85µg/ml and 58µg/ml, respectively). These dMAbs exhibited long-term expression with maintenance of serum levels >15µg/ml for over a year.

This research publication is significant because it is the first to report on the use of Inovio dMAb technology to develop novel monoclonal antibody-based therapies targeting checkpoint inhibitors. Inovio is developing additional dMAbs targeting other checkpoint molecules including PD-1. When delivered directly into the body, the genetic instructions provided from the dMAb construct enable the patient’s own cells to become the factory which manufactures the therapeutic monoclonal antibody products. Inovio has previously published several papers demonstrating its dMAb product candidate’s ability to treat multiple virus targets such as flu, dengue, chikungunya, and HIV.

Laurent Humeau, Ph.D., Inovio’s Senior Vice President, Research & Development, said, "Even though conventional monoclonal antibodies represent one of the most successful segments of the biotechnology market, accounting for over $50 billion in sales today, manufacturing complexity and repeated dosing may limit a broader use of this technology. Inovio’s dMAb products may improve upon this class using our synthetic design and in vivo production. This newly published study further support that Inovio’s potent dMAb platform can be expanded to target cancer. We plan on advancing the first clinical dMAb candidate into the first-in-human study in 2019. Moreover, we expect to form partnerships to advance several dMAb products targeting cancers and infectious diseases."

David B. Weiner, Ph.D., the paper’s senior author and the W.W. Smith Charitable Trust Professor in Cancer Research at The Wistar Institute, said, "Our work provides the first demonstration that we can use synthetic DNA technology to produce checkpoint inhibitor molecules in vivo to impact tumor growth in a preclinical setting. We showed that dMAbs may represent a valuable addition to the cancer immunotherapy toolbox: In our preclinical studies, dMAbs achieved antitumor activity comparable to that of traditional monoclonal antibodies, while being delivered through a simpler formulation that may provide a bridge to expand target populations for checkpoint inhibitors."

The study highlights that delivery of a synthetic, sequence-optimized DNA plasmid designed to encode anti-mouse CTLA-4 monoclonal antibodies, with the aid of an electroporation device to enhance uptake, resulted in significant and prolonged antibody expression with even a single dose. Importantly, this approach stimulated robust CD8+ T cell infiltration, achieving tumor clearance across multiple mouse tumor models. The researchers then went on to develop human checkpoint inhibitor molecules and demonstrated their production in mice and their ability to stimulate human T cell responses associated with antitumor activity. The study clearly demonstrates how optimized dMAbs encoding the human CPI’s ipilimumab and tremelimumab are potently expressed in vivo and enhance the activation of human effector T cells with the potential to destroy tumors. This strategy provides a novel approach to immune checkpoint therapy, with the potential to expand patient access to this breakthrough immunotherapy to treat cancer.

Funded with over $60 million in R&D support from top agencies like DARPA, NIH, and the Gates Foundation, Inovio dMAb products could extend the medical benefits that marketed monoclonal antibodies have already achieved, and even potentially address diseases that conventional monoclonal antibodies cannot.

About Inovio’s DNA-based Monoclonal Antibody Platform

Traditional monoclonal antibodies are manufactured outside the body in bioreactors, typically requiring costly large-scale manufacturing facility development and laborious production. Inovio’s disruptive dMAb technology has the potential to overcome these limitations by virtue of their simplified design, rapidity of development, product stability, ease of manufacturing and deplorability, and cost effectiveness, thereby providing potential new avenues for treating a range of diseases. Another significant advancement seen in Inovio dMAb technologies is that the optimized genes for a desired monoclonal antibody is encoded in a DNA plasmid, which is produced using very cost effective and highly scalable fermentation techniques. These plasmids are delivered directly into cells of the body using electroporation and the encoded monoclonal antibody is then directly produced by these cells. Previously published studies show that a single administration of a highly optimized DNA-based monoclonal antibody targeting HIV virus produced a high level of expression of the antibody in the bloodstream of mice; Inovio similarly reported data showing that dMAb products against flu, Ebola, chikungunya and dengue protected animals against lethal challenge. Inovio Ebola dMAb product is being developed under a grant from the Defense Advanced Research Projects Agency (DARPA).