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Janssen Announces Investigational CAR-T Therapy JNJ-68284528 Granted PRIME Designation by the European Medicines Agency

On April 4, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Medicines Agency (EMA) has granted a PRIME (PRIority MEdicines) designation for the company’s investigational B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, JNJ-68284528 (JNJ-4528) (Press release, Johnson & Johnson, APR 4, 2019, View Source [SID1234535000]). PRIME offers enhanced interaction and early dialogue to optimise development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.1

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"The PRIME designation of this novel BCMA CAR-T therapy highlights the value of regulatory innovation in the European Union," said Sjaak Bot, Vice President, Head EMEA Regulatory Affairs at Janssen Biologics B.V. "We hope to bring this important advance to patients as quickly as possible and this PRIME designation, the first for Janssen, marks an important milestone towards potential market approval."

The PRIME designation is based on results from the Phase 1/2 LEGEND-2 study (NCT03090659) evaluating LCAR-B38M CAR-T cells, sponsored by Nanjing Legend Biotech Co.,2 and the Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating JNJ-4528, sponsored by Janssen and being conducted in collaboration with Legend Biotech USA Inc.3 Results from the LEGEND-2 study were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 annual meeting.4 Results from the CARTITUDE-1 study will be presented in the future.

"CAR-T therapy is an exciting therapeutic platform that harnesses the patient’s immune system to attack tumour cells," said Sen Zhuang, M.D., Ph.D., Vice President, Oncology Clinical Development, Janssen Research & Development, LLC. "We continue to advance this novel BCMA targeted CAR-T therapy through clinical studies globally as we strive to bring it to the patients with multiple myeloma around the world."

JNJ-4528 is currently being investigated for the treatment of patients with multiple myeloma who have received at least three prior regimens, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody, and have documented disease progression within 12 months of starting the most recent therapy, or are double refractory to an IMiD and PI.3 These patients have few available treatment options and are often faced with poor outcomes.5

In December 2017, Janssen entered into a worldwide collaboration and licence agreement with Legend Biotech to jointly develop and commercialise LCAR-B38M in multiple myeloma.6 In China, the Phase 2 CARTIFAN-1 confirmatory trial (NCT03758417), sponsored by Nanjing Legend Biotech Co. Ltd. and registered with the Center for Drug Evaluation (CTR20181007), is actively recruiting to further evaluate LCAR-B38M in patients with advanced relapsed or refractory multiple myeloma.7

About LEGEND-2

LEGEND-2 (NCT03090659) is an ongoing single-arm, open-label Phase 1/2 study being conducted at four participating hospitals in China evaluating the efficacy and safety of LCAR-B38M for the treatment of relapsed or refractory multiple myeloma.2

About CAR-T and BCMA

CAR T-cells are an innovative approach to eradicating cancer cells by harnessing the power of a patient’s own immune system. BCMA is a protein that is highly expressed on myeloma cells.8 By targeting BCMA via this approach, CAR-T therapies may have the potential to redefine treatment for multiple myeloma.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.9 In Europe, more than 48,200 people were diagnosed with multiple myeloma in 2018, and more than 30,800 patients died.10 Almost 40 percent of patients with multiple myeloma do not reach five-year survival.11

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.12 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.13,14 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.15 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.16 Patients who relapse after treatment with standard therapies, including PIs and IMiDs, have poor prognoses and few treatment options available.17

IMV Inc. to Present at the Bloom Burton & Co. Healthcare Investor Conference; Announces Update to Presentation at H.C. Wainwright Investor Conference

On April 4, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company reported that IMV Chief Executive Officer, Frederic Ors will be making an investor presentation at the 2019 Bloom Burton & Co Healthcare Investor Conference, which will be held from April 30 to May 1, 2019 in Toronto, Ontario (Press release, IMV, APR 4, 2019, View Source [SID1234534999]).

IMV’s presentation details include:

Date: Wednesday, May 1, 2019
Time: 11:00 a.m. ET
Location: Metro Toronto Convention Centre, 255 Front St W, Toronto, ON
There will be a live webcast of IMV’s presentation accessible in the ‘Events, Webcasts & Presentations’ page of IMV’s website. The webcast will be archived for 90 days following the live presentation and a copy of the presentation will be available www.imv-inc.com.

April 9 H.C. Wainwright Investor Conference Presentation Update:

IMV also revealed a time change for its participation at the H.C. Wainwright Global Life Sciences Conference. IMV will now present at 1:10 p.m. local time. Full details include:

Venue: H.C. Wainwright Global Life Sciences Conference, being held April 7-9, 2019
Date: Tuesday, April 9, 2019
Time: 1:10 p.m. BST
Location: Stratton Suite, Grosvenor House, A JW Marriott Hotel, London, UK

Seattle Genetics to Host Conference Call and Webcast Discussion of First Quarter 2019 Financial Results on April 25, 2019

On April 4, 2019 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its first quarter 2019 financial results on Thursday, April 25, 2019 after the close of financial markets (Press release, Seattle Genetics, APR 4, 2019, View Source [SID1234534998]). Following the announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

LIVE access on Thursday, April 25, 2019

1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 877-260-1479 (domestic) or +1 334-323-0522 (international); conference ID 6169352
Webcast with slides available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Thursday, April 25, 2019 through 5:00 p.m. PT on Monday, April 29, 2019 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 6169352
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

Oncolytics Biotech® to Host Key Opinion Leader Meeting on the Emerging Role of Biomarkers and Oncolytic Viruses in the Treatment of Cancer

On April 4, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will host a Key Opinion Leader meeting to discuss the emerging role of biomarkers and oncolytic viruses in the treatment of cancer on Thursday, April 11, 2019 at 12 pm EDT in New York City (Press release, Oncolytics Biotech, APR 4, 2019, View Source [SID1234534997]).

The event will feature presentations by company management and Key Opinion Leader Dirk Arnold MD, PhD, Executive Board Member of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) & Chief of Oncology at Asklepios Klinik Altona, who will discuss biomarkers, their importance in trials, their influence on large pharma and their impact in both clinical and commercial settings, as well as recent biomarker data from Oncolytics. This will be followed by a brief outline of how Oncolytics’ biomarker strategy is influencing the Company’s clinical development plan, specifically its phase 3 program in metastatic breast cancer. Dr. Arnold will be available to answer questions at the conclusion of the event.

Oncolytics’ management team will also provide an overview of the ongoing development of pelareorep, the Company’s first-in-class intravenously delivered immuno-oncolytic virus (IOV) for the treatment of solid tumors and hematological malignancies. Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus. It induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers, including metastatic breast cancer, multiple myeloma, and pancreatic cancer.

Dr. Arnold is Professor, Chief Physician, Haematology and Internal Oncology, at Asklepios Klinik Altona. He is the Chairman of the Colorectal Cancer Study Group of the Arbeitsgemeinschaft Internistische Onkologie (AIO) and is a member of the Task Force Colorectal Cancer and the Board of the Gastrointestinal Cancer Study Group of the EORTC. He is a key member of several German and other international cancer societies, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), where he serves as a Board Member and Section Editor for Gastrointestinal Cancers of the Guideline Committee.

He previously served as Professor of Medicine at the University of Hamburg, where he held the position as Medical Director of the University Cancer Center (UCCH) until 2012. Before that, he served as Assistant Professor and Chair of the Gastrointestinal Cancer Unit at the Martin Luther University Halle-Wittenberg, Halle, Germany, where he also received his training as Medical Oncologist, and specialist in Palliative Care. From 2012 to 2015, Dr. Arnold served as Director of the Department of Medical Oncology of the Klinik für Tumorbiologie, University Freiburg. In January 2016, he joined the CUF Hospitals in Lisbon, Portugal, as Director of Oncology services.

This event is intended for institutional investors and sell-side analysts. Please RSVP in advance HERE if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com. Members of the media and the public are invited to participate via the live webcast.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

Puma Biotechnology Expands Cohorts in Phase II SUMMIT Trial of Neratinib in Cancer Patients with Tumors with Activating EGFR or HER2 Mutations

On April 4, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it has expanded two additional cohorts from the Phase II SUMMIT clinical trial investigating its lead drug candidate neratinib in patients with solid tumors who have an activating EGFR or HER2 mutation (Press release, Puma Biotechnology, APR 4, 2019, View Source [SID1234534994]). The cohorts that have been expanded are (i) HER2 mutant patients with metastatic salivary gland cancer and (ii) patients with EGFR exon 18 mutation-positive lung cancer.

The Phase II SUMMIT basket trial is an open-label, multi-center, multi-histology, international study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR, HER2 or HER4 mutations. The salivary gland cancer patients initially entered the study in the "other solid tumors with a HER2 mutation" cohort, and due to the preliminary activity seen in the trial, the Company has expanded a separate salivary gland cancer cohort pursuant to the protocol for the trial. The expanded HER2-mutant salivary gland cancer cohort and the expanded EGFR exon 18 mutant lung cancer cohort will each now enroll approximately 18 patients.

"We are pleased to expand our evaluation of neratinib in metastatic HER2 mutant salivary gland cancer and exon 18 mutated lung cancer from SUMMIT, as they both represent orphan and deadly diseases with few treatment options," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "We believe this once again demonstrates the value of the basket study approach, in particular for developing targeted therapy for rare diseases with clinically-actionable mutations. We look forward to continuing enrollment into these expanded cohorts and presenting updated trial results."