Genmab Announces Data to be Presented at 2019 ASCO Annual Meeting

On April 17, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that 14 industry sponsored abstracts regarding Genmab programs were accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago from May 31 to June 4, 2019 (Press release, Genmab, APR 17, 2019, View Source [SID1234535166]). The titles of the abstracts are currently available on the ASCO (Free ASCO Whitepaper) iPlanner website, with the full abstracts scheduled to be published on May 15, 2019. A list of accepted industry sponsored abstracts is provided below, and includes ten daratumumab abstracts, two of which were accepted for oral presentations, one abstract on enapotamab vedotin, and two abstracts on tisotumab vedotin (Trial in Progress abstracts).

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"We are pleased that once again a wide selection of abstracts concerning Genmab proprietary and partnered programs was selected for presentation at the prestigious ASCO (Free ASCO Whitepaper) Annual Meeting. We are especially looking forward to the first full presentations of data from the COLUMBA and CASSIOPEIA daratumumab Phase III trials," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are equally excited to begin sharing with the oncology community early data from enapotamab vedotin and ongoing trials in progress for tisotumab vedotin."

Representatives from Genmab will be in attendance at ASCO (Free ASCO Whitepaper), booth #24159.

List of Industry Sponsored Abstracts:

Daratumumab (Submitted by Janssen Biotech, Inc.):
Phase 3 Randomized Study of Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) Vs VTd in Transplant-eligible Newly Diagnosed Multiple Myeloma: CASSIOPEIA Part 1 Results – Oral presentation, Sunday, June 2, 10:45 AM – 10:57 PM CDT

Efficacy and Safety of the Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA – Oral presentation, Sunday, June 2, 11:09 AM – 11:21 AM CDT

Efficacy of Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) in Transplant-eligible Newly Diagnosed Multiple Myeloma Based on Minimal Residual Disease Status: Analysis of the CASSIOPEIA Trial –Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Stem Cell Yield and Transplantation Results from Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Receiving Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) in the Phase 3 CASSIOPEIA Study –Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Impact of age on efficacy and safety of daratumumab in combination with lenalidomide and dexamethasone (D-Rd) in patients with transplant-ineligible newly diagnosed multiple myeloma: MAIA – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Faster and sustained improvement in health-related quality of life for newly diagnosed multiple myeloma patients ineligible for transplant treated with daratumumab, lenalidomide, and dexamethasone (D-Rd) vs Rd alone: MAIA – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Efficacy and safety of daratumumab, bortezomib, and dexamethasone (D-Vd) in relapsed or refractory multiple myeloma based on cytogenetic risk: updated subgroup analysis of CASTOR – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Efficacy and safety of daratumumab, lenalidomide, and dexamethasone (D-Rd) in relapsed or refractory multiple myeloma: updated subgroup analysis of POLLUX based on cytogenetic risk – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Bortezomib, lenalidomide, and dexamethasone (VRd) ± daratumumab in patients with transplant-eligible newly diagnosed multiple myeloma: a multicenter, randomized, phase 3 study (PERSEUS) – Poster, Monday, June 3, 8:00 AM – 11:00 AM CDT

Bortezomib, lenalidomide, and dexamethasone (VRd) ± daratumumab in patients with newly diagnosed multiple myeloma for whom transplant is not planned as initial therapy: a multicenter, randomized, phase 3 study (CEPHEUS) – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Tisotumab vedotin (Submitted by Seattle Genetics):
SGNTV-001: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or
Metastatic Disease in Solid Tumors – Poster presentation, Saturday, June 1, 2019, 8:00 AM – 11:00 AM CDT

Phase 2 Trial of Tisotumab Vedotin in Platinum-Resistant Ovarian Cancer (innovaTV 208) – Poster presentation, Saturday, June 1, 2019, 1:15 PM – 4:15 PM CDT

Enapotamab vedotin:
First-in-human, dose-escalation, phase 1 trial to evaluate safety of anti-Axl antibody–drug conjugate enapotamab vedotin in solid tumors – Poster presentation, Saturday, June 1, 2019, 8:00 AM – 11:00 AM CDT

Ofatumumab (Submitted by Novartis):
Long-term follow-up of previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) treated with ofatumumab and chlorambucil: Final analysis of the phase 3 COMPLEMENT 1 trial –Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

ImaginAb to Present at Upcoming Investor and Scientific Conferences in April and May 2019

On April 17, 2019 ImaginAb Inc., a clinical stage immuno-oncology imaging company, reported that it is scheduled to present at the following investor and scientific conferences in April and May 2019 (Press release, ImaginAb, APR 17, 2019, View Source [SID1234535165]).

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AIM at Melanoma

April 26-28, 2019, Hotel L’Echiquier Opera Paris, 38 Rue De L Echiquier, Paris

Dr. Anna Wu, Founder, and Board Director, and Ivan Plavec, CBO will be attending and making a presentation on ImaginAb at the 26th International Myeloma Working Group meeting in Paris.

Anglo-Nordic Life Science Conference

May 9, 2019, The County Hall, Belvedere Road, London

Ian Wilson, CEO, will be a panelist at the ‘Technologies and Treatments – What’s on the horizon’ discussion at 13.30 BST.

Bio€quity Europe 2019

May 20-21, 2019, Crowne Plaza Fira Center, Barcelona

Ian Wilson, CEO, and Ivan Plavec, CBO, will be attending and hosting meetings.

2019 ASCO (Free ASCO Whitepaper) Annual Meeting

May 31-June 4, 2019, McCormick Place, Chicago

Ian Wilson, CEO, Ivan Plavec, CBO, and Ron Korn CMO, will be attending and hosting meetings.

Inquiries:

ImaginAb

Ian Wilson

Email: [email protected]

Phone: +1 310 645 1211

Optimum Strategic Communications

Mary Clark, Supriya Mathur

Email: [email protected]

Phone: +44 20 3950 9144

OncoSec Announces Collaborative Research Agreement in HER2+ Breast Cancer Evaluating the Use of TAVO™ in Combination with Plasmid DNA Vaccines with a World Leading Academic Medical Center

On April 17, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, and Duke University School of Medicine, reported that they have entered into a collaborative research agreement to evaluate the use of OncoSec’s proprietary TAVOPLUS (enhanced IL-12 DNA-plasmid) in combination or sequence with a HER2-plasmid vaccine administered with OncoSec’s novel intratumoral delivery system (Press release, OncoSec Medical, APR 17, 2019, View Source [SID1234535161]). The research will be led by Herbert Kim Lyerly, M.D., George Barth Geller Professor, Professor of Immunology, Surgery and Pathology at Duke University School of Medicine.

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"We are eager to expand our immunotherapy research in breast cancer through this collaboration with OncoSec. We have previously demonstrated, in a variety of breast cancer models, that local delivery of IL-12 stimulates an anti-breast cancer immune response with applicability beyond end-stage cancer. This delivery system has the potential to be a foundational therapeutic in the treatment of early-stage disease," said Dr. Lyerly. "The translational work with TAVOPLUS has been very encouraging and we are excited to explore the potential of OncoSec’s IL-12 plasmid delivery technology to enhance immune responses targeting HER2+ tumors and to elicit superior T-cell and B-cell responses to HER2 in a variety of preclinical breast cancer models."

Under the terms of the agreement, OncoSec will provide its proprietary TAVO (IL-12 plasmids) and its new electroporation generator, APOLLO, using lower voltage and a longer pulse width which greatly increased DNA-plasmid cellular transfection rates, to Duke University’s Center for Applied Therapeutics. Duke University investigators will conduct preclinical studies using plasmid vaccines targeting HER2 in combination with plasmid vaccines and TAVO in a newly developed endogenous mouse model of HER2+ breast cancer. Additionally, Duke investigators will use TAVO with their high-intensity ultrasound tumor ablation models to explore the impact of IL-12 delivery on the development of systemic immunity.

Abbott Reports First-Quarter 2019 Results

On April 17, 2019 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2019 (Press release, Abbott, APR 17, 2019, View Source [SID1234535159]).

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First-quarter worldwide sales of $7.5 billion increased 2.0 percent on a reported basis and 7.1 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.38 in the first quarter.
Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.63, above the previous guidance range.
Abbott projects full-year 2019 diluted EPS from continuing operations on a GAAP basis of $1.95 to $2.05. Projected full-year adjusted diluted EPS from continuing operations remains unchanged at $3.15 to $3.25, reflecting double-digit growth at the mid-point.
During the quarter, Abbott received U.S. FDA approval for a new, expanded indication for its market-leading MitraClip device to treat clinically significant secondary mitral regurgitation, a leaky heart valve resulting from advanced heart failure.
In January, Abbott announced U.S. FDA approval of its TactiCath Contact Force Ablation Catheter, Sensor Enabled, which is designed to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.
In March, Abbott obtained CE Mark for its Alinity m (molecular) diagnostics system and testing assays, providing market-leading speed and accuracy to help laboratories meet the growing demand for infectious disease testing.
"We’re right on track with our expectations to start the year," said Miles D. White, chairman and chief executive officer, Abbott. "All of our key long-term growth drivers are performing well and we’re targeting another year of strong sales and earnings growth."

* See note on organic growth below.

FIRST-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

Organic sales growth:

Excludes the prior year first-quarter results for a non-core business within U.S. Adult Nutrition, which was discontinued during the third quarter 2018; and
Excludes the impact of foreign exchange.
Following are sales by business segment and commentary for the first quarter:

* Total Q1 2019 Abbott sales from continuing operations include Other sales of $15 million.

n/a = Not Applicable.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

First-quarter 2019 worldwide sales of $7.5 billion increased 2.0 percent on a reported basis. On an organic basis, worldwide sales increased 7.1 percent. Refer to table titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 2.0 percent on a reported basis in the first quarter. On an organic basis, sales increased 6.7 percent. Refer to table titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 3.5 percent on a reported basis in the first quarter, including an unfavorable 3.2 percent effect of foreign exchange, and increased 6.7 percent on an organic basis. International Pediatric Nutrition sales increased 5.4 percent on a reported basis and 11.2 percent on an organic basis in the first quarter. Sales performance in the quarter was led by strong growth in Asia and Latin America, including broad-based growth across Abbott’s portfolio of infant and toddler brands.

Worldwide Adult Nutrition sales increased 0.1 percent on a reported basis in the first quarter, and increased 6.8 percent on an organic basis. International Adult Nutrition sales increased 3.9 percent on a reported basis and 11.1 percent on an organic basis in the first quarter. Sales performance in the quarter was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Worldwide Diagnostics sales increased 0.2 percent on a reported basis in the first quarter, including an unfavorable 4.2 percent effect of foreign exchange, and increased 4.4 percent on an organic basis.

Core Laboratory Diagnostics sales increased 4.1 percent on a reported basis and 9.9 percent on an organic basis in the first quarter. Sales performance in the quarter was led by above-market growth in the U.S. and internationally, where Abbott is achieving continued strong adoption of its Alinity family of innovative and highly differentiated diagnostic instruments.

Molecular Diagnostics sales decreased 8.4 percent on a reported basis in the first quarter, including an unfavorable 3.3 percent effect of foreign exchange, and decreased 5.1 percent on an organic basis. International sales growth in Molecular and Rapid Diagnostics was negatively impacted in the quarter by certain non-governmental organization (NGO) purchasing patterns in Africa. During the quarter, Abbott obtained CE Mark for its Alinity m (molecular) diagnostics system and several testing assays, providing market-leading speed and accuracy to help laboratories meet the growing demand for infectious disease testing.

Point of Care Diagnostics sales decreased 4.8 percent on a reported basis in the first quarter, including an unfavorable 0.6 percent effect of foreign exchange, and decreased 4.2 percent on an organic basis.

Rapid Diagnostics sales decreased 4.0 percent on a reported basis in the first quarter, including an unfavorable 2.6 percent effect of foreign exchange, and decreased 1.4 percent on an organic basis. Strong sales growth in several areas of the business, including cardio-metabolic testing and Abbott’s ID-NOW TM infectious disease testing platform, was offset by a difficult comparison versus the first-quarter of 2018 when sales were abnormally high due to a strong flu season.

Established Pharmaceuticals sales decreased 4.9 percent on a reported basis in the first quarter, including an unfavorable 10.3 percent effect of foreign exchange, and increased 5.4 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 5.2 percent on a reported basis in the first quarter, including an unfavorable 12.5 percent effect of foreign exchange, and increased 7.3 percent on an organic basis led by growth in several markets.

Other sales decreased 4.2 percent on a reported basis in the first quarter, including an unfavorable 3.3 percent effect of foreign exchange, and decreased 0.9 percent on an organic basis. As expected, Other sales growth was negatively impacted in the quarter by the recent discontinuation of a non-core, low-margin supply agreement.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Worldwide Medical Devices sales increased 5.5 percent on a reported basis in the first quarter and increased 9.5 percent on an organic basis, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.

In Electrophysiology, in January, Abbott announced U.S. FDA approval of its TactiCath Contact Force Ablation Catheter, Sensor Enabled, which is designed to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

In Heart Failure, growth was driven by rapid U.S. market adoption of Abbott’s HeartMate 3 left ventricular assist device following FDA approval as a destination (long-term use) therapy in late-2018. In March, Abbott announced data from its MOMENTUM 3 clinical study, the largest randomized controlled trial to assess outcomes in patients receiving a heart pump to treat advanced heart failure, which demonstrated HeartMate 3 improved survival and clinical outcomes in this patient population.

Growth in Structural Heart was broad-based across several areas of the business, including MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation (MR), a leaky heart valve. During the quarter, Abbott received U.S. FDA approval for a new, expanded indication for MitraClip to treat clinically significant secondary MR as a result of underlying heart failure. This new indication significantly expands the number of people with MR that can be treated with the MitraClip device.

In Diabetes Care, sales increased 34.4 percent on a reported basis and 42.0 percent on an organic basis in the first quarter. Sales growth in the quarter was led by FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system, with worldwide sales of $379 million, an increase of 70.2 percent on a reported basis and 80.1 percent on an organic basis versus the prior year. During the quarter, Abbott released real-world data from nearly 500,000 users that shows higher rates of scanning with its FreeStyle Libre system improves glucose control for people living with diabetes.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE

Abbott projects 2019 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $1.95 to $2.05. Abbott forecasts net specified items for the full year 2019 of $1.20 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $3.15 to $3.25 for the full year 2019.

Abbott is issuing second-quarter 2019 guidance for diluted earnings per share from continuing operations under GAAP of $0.47 to $0.49. Abbott forecasts specified items for the second quarter 2019 of $0.32 per share primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.79 to $0.81 for the second quarter.

ABBOTT DECLARES 381ST CONSECUTIVE QUARTERLY DIVIDEND

On Feb. 22, 2019, the board of directors of Abbott declared the company’s quarterly dividend of $0.32 per share. Abbott’s cash dividend is payable May 15, 2019, to shareholders of record at the close of business on April 15, 2019.

Abbott has increased its dividend payout for 47 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

PureTech Health Announces Collaboration with Boehringer Ingelheim to Advance Immuno-oncology Product Candidates using its Lymphatic Targeting Platform

On April 17, 2019 PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, reported that it has entered into a research collaboration with Boehringer Ingelheim to develop novel product candidates for an undisclosed number of targets by leveraging PureTech’s proprietary lymphatic targeting technology for immune modulation (Press release, PureTech Health, APR 17, 2019, View Source [SID1234535154]). Under terms of the agreement, PureTech Health will receive up to $26 million, including upfront payments, research support, and preclinical milestones, and is eligible to receive more than $200 million in development and sales milestones, in addition to royalties on product sales. The collaboration will initially focus on applying PureTech’s lymphatic targeting technology to an immuno-oncology product candidate designated by Boehringer Ingelheim.

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"We see great promise in leveraging PureTech’s platform to target the lymphatic system and deliver therapeutic candidates directly to the lymph nodes responsible for priming, educating and proliferating immune cells," said Clive Wood, PhD, global head of discovery research at Boehringer Ingelheim. "The approach is a potentially powerful tool for modulating the immune system and may allow us to improve efficacy and reduce systematic toxicities through precise targeting."

The partnership leverages the potential of the proprietary lymphatic targeting platform that PureTech Health is developing through its internal R&D division. The approach harnesses the gut’s lipid transport mechanisms to enable oral administration and transport of drug candidates directly through the gut-draining lymphatic vasculature, also bypassing first pass metabolism in the liver. More specifically, the therapeutic candidates are directed to the mesenteric lymph nodes, which program as many as 70 percent of circulating adaptive immune cells. By targeting the lymphatic system directly, the technology has the potential to achieve more effective and precise immunomodulation of local tissues, while sparing the patient from the risks of extensive systemic exposure to the drug. PureTech’s lymphatic targeting approach, which is based on the research of Chris Porter, PhD, Director of the Monash Institute of Pharmaceutical Sciences (MIPS) at Monash University, can potentially be applied to therapeutic molecules across a range of physiochemical properties and holds promise for the development of novel therapeutics for gastrointestinal, central nervous system, and autoimmune diseases as well as cancer.

"This collaboration signals the exciting potential of another proprietary platform from our internal R&D to enable novel immunotherapy approaches by harnessing the lymphatic system’s capacity for immune cell trafficking and immunomodulation," said Daphne Zohar, co-founder and chief executive officer of PureTech Health. "We look forward to working with the excellent scientific teams at Boehringer Ingelheim to advance this important program, which has the potential to greatly expand therapeutic options for patients with cancer."

The research collaboration with Boehringer Ingelheim will focus first on using this approach to administer an immuno-oncology candidate for gastrointestinal (GI) cancers directly to the gut lymphatics. About 70 percent of immune cells reside in lymphatic tissues associated with the GI tract, so targeting immunomodulatory agents with this approach could potentially tune both systemic and local immunity. Once the product candidates enter the development stage, Boehringer Ingelheim will assume full responsibility for development and PureTech Health will be eligible for various developmental and sales milestones in addition to royalties on product sales.

About PureTech’s Lymphatic Targeting Platform
PureTech’s proprietary lymphatic targeting platform is designed to the body’s natural lipid transport mechanisms to enable the transport of drug molecules directly into the lymphatic system when administered orally. This pathway facilitates entry into the mesenteric lymph nodes, which are crucial centers for immune cell priming, education and proliferation in the GI tract. Targeting the lymphatic vasculature enables rational design of therapeutics to modulate immunity in a tissue-specific manner and minimize systemic toxicity due to global immunosuppression. Preclinical data suggest PureTech’s lymphatic targeting platform could potentially enable more efficacious and less toxic therapeutics addressing cancer and inflammatory and autoimmune diseases. This technology is based on the pioneering research of Professor Chris Porter and his team at the Monash Institute of Pharmaceutical Sciences, Monash University, who continue to collaborate with PureTech Health on the program. All the relevant intellectual property associated with his work on this technology is exclusively licensed to PureTech and is supported by additional PureTech Health patents.