GEMoaB appoints oncology expert Michael Pehl as Chief Executive Officer

On July 16, 2019 GEMoaB GmbH, a biopharmaceutical company focused on the discovery, development, manufacture and commercialization of next-generation immunotherapies for difficult-to-treat cancers, reported the appointment of Michael Pehl to the CEO with effect from 1 July 2019 (Press release, GEMoaB Monoclonals, JUL 16, 2019, View Source [SID1234537560]). This move reflects GEMoaB’s strategy of positioning itself as a fully integrated biotech company over the long term. GEMoaB relies on its strong scientific expertise as well as its solid foundation in research and development.

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"We are pleased that with Michael Pehl, an experienced leader in the field of oncology GEMoaB will be heading into the next phase of growth. Under his leadership, GEMoaB will further develop its proprietary immunotherapy platforms in clinical trials. These include the Affinity-Tailored Adapters for T-Cells (ATAC), such as GEM333 and GEM3PSCA, and cellular immunotherapy (UniCAR / RevCAR). This can significantly improve the prognosis of patients with intractable hematological and solid tumors, "said Professor Dr. Gerhard Ehninger , founder and co-owner of the company." I know Michael Pehlfor many years. He has a strong scientific background, immense experience and is well positioned to lead and develop GEMoaB with its exceptional people, broad pipeline and partnerships. "

Michael Pehl has more than 25 years of leadership experience in the international biotech industry and in oncology in the US and Europe. Prior to joining GEMoaB, as Chief Executive Officer of Immunomedics Inc., he led the implementation of the clinical development plan and regulatory filing for the core product sacituzumab-govetecan for the treatment of metastatic triple-negative breast cancer.

Previously, Michael Pehl was President of Oncology at Celgene, responsible for the Company’s global commercial and clinical development, medical strategy and operational implementation. During this time, he was instrumental in expanding the pipeline and steadily growing global business volume. His responsibility included the clinical development program, and the introduction of drugs such as lenalidomide (Revlimid ), pomalidomide (Pomalyst ; Imnovid ) and Enasidenib (IDHIFA ) for the treatment of hematological malignancies, nab-paclitaxel (Abraxane ) in solid tumors as well as luspatercept in myelodysplastic syndrome (MDS) and beta-thalassemia.

Prior to that, Michael Pehl held senior positions at Celgene as Senior Vice President, Global Marketing and Strategy; Head of Global Marketing; Head of Hematology Europe; Vice President Central and Eastern Europe & Middle East and General Manager Germany .

His biotechnology career began at AMGEN, where he held leadership positions at the German and European levels in oncology and nephrology.

"I am grateful that I have been given the opportunity to lead GEMoaB and work with its excellent team at an exciting time for the company," said Michael Pehl, "with its highly differentiated next-generation immunotherapy platforms and its promising preclinical and GEMoaB’s goal is to make GEMoaB, together with our partners and potential investors, a fully integrated biopharmaceutical company that will help improve the cancer outcomes of cancer patients in indications for which there are currently There are far too few treatment options. "

About the Affinity-Tailored Adapter for T-Cells (ATAC) Platform

The GEMoaB-owned platform of the ‘Affinity-Tailored Adapter for T-Cells’ is due to a high binding affinity for tumor antigens and a lower affinity for the CD3 antigen on the
T-effector cells are characterized, which in preclinical models, the auto-activation of T cells is avoided. In addition, the safety and tolerability of the therapy may be improved by the relatively short serum half-life of only 60 minutes. Using fully humanized antibodies reduces the potential immunogenicity risk even with continuous treatment. The first two compounds from the ATAC platform in clinical trials are GEM333 and GEM3PSCA. GEM333 is an ATAC with specific binding to CD3 and CD33 and is currently in clinical development for the treatment of CD33-positive relapsed / refractory acute myeloid leukemia (AML). (For more information, see View Source). GEM3PSCA is an ATAC with specific binding to CD3 and the PSCA antigen.

About UniCAR / RevCAR

To avoid possible therapy-related toxicities as well as limitations in the efficacy and production of current CAR-T therapies, GEMoaB GmbH has developed universal and modular CAR technologies called UniCAR and RevCAR. These genetically modified T cells can be repeatedly turned on and off by administering a so-called targeting module ("TM") .TMs are bispecific molecules against various antigens that bind UniCAR / RevCAR T cells to the malignant target cells After elimination of the corresponding TM, the UniCAR / RevCAR T cells switch off automatically.

Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer

On July 16, 2019 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (Nasdaq:SGEN) reported submission of a Biologics License Application for accelerated approval to the U.S. Food and Drug Administration for the investigational agent enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting (Press release, Astellas, JUL 16, 2019, View Source [SID1234537545]).

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The submission is based on results from the first cohort of patients in the EV-201 pivotal phase 2 clinical trial that were presented as a late-breaking abstract at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a protein that is highly expressed in urothelial cancers.i

"There are limited treatment options for patients with advanced urothelial cancer, and we are encouraged by the results observed in the pivotal trial for enfortumab vedotin," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas.

"There is an urgent need for new therapies for patients with advanced urothelial cancer, and we look forward to working with our partner Astellas and the FDA on the review of this application," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.

Based on preliminary results from a phase 1 trial (EV-101), the FDA granted enfortumab vedotin Breakthrough Therapy designation for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following checkpoint inhibitor therapy.

A global, randomized phase 3 confirmatory clinical trial (EV-301) is ongoing and is intended to support global registrations. Another ongoing trial, EV-103, is evaluating enfortumab vedotin in earlier lines of treatment for patients with locally advanced or metastatic urothelial cancer, including in combination with pembrolizumab and/or platinum chemotherapy in newly diagnosed patients as well as patients whose cancer progressed from earlier-stage disease.

About the EV-201 Trial

EV-201 is an ongoing single-arm, pivotal phase 2 clinical trial of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy or who are ineligible for cisplatin (cohort 2). In cohort 1, 128 patients were enrolled at multiple centers internationally.ii The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability. EV-201 continues to enroll patients in cohort 2.

More information about enfortumab vedotin clinical trials can be found at clinical trials.gov.

About Urothelial Cancer

Urothelial cancer is the most common type of bladder cancer (90 percent of cases).iii In 2018, more than 82,000 people were diagnosed with bladder cancer in the United States. Globally, approximately 549,000 people were diagnosed with bladder cancer last year, and there were approximately 200,000 deaths worldwide.iv

About Enfortumab Vedotin

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule that is expressed on many solid tumors, and that has been identified as an ADC target by Astellas.

The safety and efficacy of enfortumab vedotin are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval or become commercially available for the uses being investigated.

BioMarin to Host Second Quarter 2019 Financial Results Conference Call and Webcast on Thursday, August 1 at 4:30pm ET

On July 16, 2019 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Thursday, August 1, at 4:30 p.m. ET to discuss second quarter 2019 financial results and provide a general business update (Press release, BioMarin, JUL 16, 2019, View Source [SID1234537561]).

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Dial-in Number
U.S. / Canada Dial-in Number: (866) 502-9859
International Dial-in Number: (574) 990-1362
Conference ID: 6989536

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 6989536

Interested parties may access a live audio webcast of the conference call via the investor section of the BioMarin website, www.biomarin.com. A replay of the call will be archived on the site for one week following the call.

JOHNSON & JOHNSON REPORTS 2019 SECOND-QUARTER RESULTS

On July 16, 2019 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2019. "We delivered solid second-quarter underlying sales growth and strong earnings growth that enables us to make investments in innovation to accelerate performance in each of our businesses," said Alex Gorsky, Chairman and Chief Executive Officer. "Our pipelines continue to progress with the launch of new products and several regulatory submissions and approvals, which positions us well to deliver the next wave of transformational products and solutions. I am proud of our talented colleagues across Johnson & Johnson who continue to deliver significant healthcare advances to improve the lives of patients and consumers around the world."
SEGMENT COMMENTARY:

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Consumer
Consumer worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 2.3%* driven by NEUTROGENA, AVEENO and OGX beauty products, over-the-counter products including ZYRTEC upper respiratory and MOTRIN analgesic products, international LISTERINE mouthwash in Oral Care products and U.S. Baby Care products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures grew 4.4%* driven by DARZALEX (daratumumab), for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with non-metastatic castration-resistant prostate cancer and PREZISTA/PREZCOBIX/REZOLSTA/ SYMTUZA (D/C/F/TAF) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection, partially offset by declines in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer due to biosimilar and generic entrants.

Medical Devices
Worldwide Medical Devices operational sales, excluding the net impact of acquisitions and divestitures grew 3.2%* driven by the growth of electrophysiology products in the Interventional Solutions business, endocutters and international energy products in the Advanced Surgery business. As previously disclosed, the divestiture of the ASP business was completed, resulting in an approximate $2.0 billion pretax gain in the quarter.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the company’s website at news releases.

Pipeline Updates
Regulatory Approvals
IMBRUVICA (ibrutinib) – CHMP Positive Opinions in combination with obinutuzumab in CLL and in combination with rituximab in WM
(press release)
DARZALEX (daratumumab) – Newly diagnosed patients with Multiple Myeloma in combination with Lenalidomide and Dexamethasone (U.S.)
(press release)
Regulatory Submissions
DARZALEX (daratumumab) – Subcutaneous formulation in multiple myeloma (U.S.)1

(press release)
ERLEADA (apalutamide) – Metastatic Hormone-Sensitive Prostate Cancer (EU)
(press release)
ERLEADA (apalutamide) – Metastatic Castration – Sensitive Prostate Cancer (U.S)
(press release)
Rilpivirine and Cabotegravir – Monthly, Injectable, Two-Drug Regimen for Treatment of HIV
(press release)

1 Subsequent to the quarter

FULL YEAR 2019 GUIDANCE:

Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.

Heska Corporation Second Quarter 2019 Financial Results and Earnings Call Scheduled for August 6, 2019

On July 16, 2019 Heska Corporation (NASDAQ: HSKA – News; "Heska" or the "Company"), a provider of advanced veterinary diagnostic and specialty products, reported its second quarter 2019 financial performance in a press release on Tuesday, August 6, 2019 before the market opens and to host an earnings call to discuss the results at 9 a.m. MT / 11 a.m. ET on the same day (Press release, Heska, JUL 16, 2019, View Source [SID1234537562]).

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To access the conference call:

From within the United States, please dial 1-800-289-0438
From outside of the United States, please dial 1-323-794-2423
Reference Conference ID: 7297179

The earnings call will be webcast live from the Company’s website at View Source

A telephonic replay will be available beginning at 2 p.m. ET August 6 and will continue through 11:59 p.m. ET on Tuesday, August 20, 2019. The webcast will be archived on www.heska.com for 90 days.

To access the replay:

From within the United States, please dial 1-844-512-2921
From outside the United States, please dial 1-412-317-6671
Reference Replay Pin Number: 7297179