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:

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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

Adhera Therapeutics Appoints Nancy Phelan as Chief Executive Officer

On April 4, 2019 Adhera Therapeutics, Inc. (OTCQB: ATRX), a specialty pharmaceutical company leveraging technology to commercialize unique therapies and improve patient outcomes, reported that its Board of Directors has appointed Nancy R. Phelan to serve as Chief Executive Officer of the Company (Press release, Marina Biotech, APR 4, 2019, View Source [SID1234535015]). Ms. Phelan has served as a member of the Board of Directors since October 2018.

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"I am excited to assume the role of Chief Executive Officer of Adhera Therapeutics," Ms. Phelan said. "Adhera has been focused on its sales efforts for its first commercial product – PRESTALIA – for the past three fiscal quarters, and I look forward to growing the patient-centric success that Adhera has achieved. I want to express gratitude to my colleagues on the Board for this opportunity and I look forward to working collaboratively to grow the company, expand sales and increase shareholder value."

"I am pleased to welcome Nancy as the new CEO of Adhera Therapeutics," Uli Hacksell, Ph.D., the Chairman of the Board of Directors of Adhera, said. "Given her deep experience commercializing pharmaceutical products, and the successes that she has enjoyed in her career, and having gotten to know Nancy over the past several months on the Adhera Board, I am confident that she will be an effective leader of the company."

Ms. Phelan is an accomplished senior executive and thought leader with over 20 years’ success in the healthcare and biotech industries. She is a passionate and compassionate leader of high performing teams with deep expertise in designing effective customer marketing strategies and building commercial capabilities that drive performance. For the past several years, Ms. Phelan has served as a Board member and/or advisor to various entities and organizations involved in the health care and technology sectors. Previously, she held roles of increasing responsibility for Bristol-Myers Squibb Company (BMS) and Wyeth, including Head of Worldwide Commercial Operations for BMS and Executive Director in Commercial Development for Wyeth. Ms. Phelan received a BA with Honors from Franklin & Marshall College and completed coursework in Villanova University’s MBA program.

In connection with the appointment of Ms. Phelan as Chief Executive Officer of Adhera, Robert C. Moscato, Jr. resigned from such position, as well as from his position as a member of the Board of Directors, effective immediately.

"We would like to thank Rob for his service to Adhera during a critical time in the company’s development as it launched its commercial efforts for Prestalia and completed a strategic reorganization, and we wish him well as he pursues other ventures," Dr. Hacksell said.

Theodora Harold to be appointed new CEO at Crescendo Biologics

On April 4, 2019 Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T-cell enhancing therapeutics, reported that Theodora Harold, the current CFO, will be appointed as CEO (Press release, Crescendo Biologics, APR 4, 2019, View Source [SID1234534982]). She will be succeeding Peter Pack who will be stepping down from the position of CEO on 1 May 2019.

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Theodora joined Crescendo in October 2016 and has worked in close partnership with Peter in the day-today running of the Company ever since. She was central to the recent $70 million fund raising and has had responsibility not only for finance and operations but also, more recently, for business development. She has established strong relationships with Crescendo’s development partners.

Before joining the Company, she held both industry and corporate finance roles with private and listed biotech SMEs including PsiOxus Therapeutics Ltd, MISSION Therapeutics Ltd, OrthoMimetics Ltd and Cytomyx Holdings plc. Prior to this, Theodora qualified as a Chartered Accountant with PricewaterhouseCoopers and read Classics at Trinity College, Cambridge.

Peter remains in his executive position until 1 May 2019 to allow for an orderly succession between him and Theodora, and with the Company. He will continue to support Crescendo as a senior advisor.

Kevin Johnson, Non-Executive Chairman of Crescendo Biologics, said:
"Theodora has been a driving force for the Company since she joined. Not only has she made a significant difference to the day-to-day running of the Company, but she has been a major contributor to the corporate, business development and operational strategies.

"The decision to appoint Theodora to succeed Peter was a straightforward and a unanimous one because of her in-depth knowledge of the business and industry as a whole. She has worked tirelessly to build the business so far and she has exciting ambitions for the Company in the longer term."

Kevin added: "On behalf of the Board, I would like to thank Peter for his significant contribution to Crescendo over the years, both as an investor advising the Board and as CEO, where he successfully transitioned the Company from a platform company to a developer of multifunctional therapeutics and also steered the $790 million deal with Takeda. In that time, he has built a strong team around him – with one of the key elements being Theodora – and he has transformed the business. We wish him the best for the future."

Theodora Harold, incoming CEO, commented: "We have made strong progress over the past few years, with the successful Series B fundraising, rapid advancements in the Takeda collaboration and progress of our lead programme CB307 towards the clinic. We are on track to enter Phase I next year and have a number of programmes following behind. I am excited to be working with such an experienced Board and management team to take Crescendo to the next stage of its development."

Peter Pack said: "I have been extremely fortunate to work at such an extraordinary Company and with the great team at Crescendo. It is now a very different business to the one I joined back in 2015 and I am very proud of what we have achieved together. I believe the time is right to step down but I will keep tight links with the British biotech industry. It is now my pleasure to hand over the stewardship of the Company to Theodora who has been a significant driver of the business since she joined."

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]).

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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

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