GSK delivers strong Q1: sales £9.1 billion +19% AER, +19% CER (Proforma +10% CER*)

On April 29, 2020 GSK reported strong Q1: sales £9.1 billion +19% AER, +19% CER (Proforma +10% CER*) (Press release, GlaxoSmithKline, APR 29, 2020, View Source [SID1234556759])

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Financial highlights
Reported Group sales £9.1 billion +19% AER, +19% CER (Proforma +10% CER*). Pharmaceuticals £4.4 billion +6% AER, +6% CER; Vaccines £1.8 billion +19% AER, +19% CER; Consumer Healthcare £2.9 billion
+44% AER, +46% CER (Proforma +11% CER*)
Sales growth reflects strong underlying performance and additional impact from increased demand including stock building for many products
Total Respiratory sales £871 million +38% AER, +38% CER. Trelegy sales £193 million +>100% AER,
+>100% CER. Nucala sales £210 million +38% AER, +38% CER
Total HIV sales £1.2 billion, +8% AER, +8% CER. Two-drug regimen sales £186 million
Shingrix sales £647 million +81% AER, +79% CER
Total Group operating margin 22.2%. Adjusted Group operating margin 29.4%, reflecting strong operating leverage (Pharmaceuticals 26.9%; Vaccines 47.5%; Consumer Healthcare 26.8%)
Total EPS 31.5p +87% AER, +89% CER reflecting good operating performance and an increase in the value of shares in Hindustan Unilever relating to the disposal of Horlicks in India
Adjusted EPS 37.7p +25% AER; +26% CER reflecting operating performance and lower tax rate resulting from
a non-recurring revaluation of deferred tax assets
Q1 net cash flow from operations £965 million. Free cash flow £531 million
19p dividend declared for the quarter
Guidance
Based on current assessment of COVID-19, guidance for 2020 Adjusted EPS maintained; to be updated if needed as more information becomes available

Pipeline highlights
Zejula submission accepted by FDA and EMA in first-line maintenance treatment for women with ovarian cancer
Belantamab mafodotin granted FDA priority review for patients with relapsed or refractory multiple myeloma based on data from the pivotal DREAMM-2 study. PDUFA date set for August 2020
Cabenuva, first long-acting regimen for HIV, approved in Canada. Expect submission of reply to FDA Complete Response Letter mid-year
Fostemsavir submitted for approval to EMA for the treatment of HIV in adults
Multiple collaborations underway to develop adjuvanted vaccines for use against COVID-19, including with Sanofi
Agreement with Vir Biotechnology to research and develop solutions for coronaviruses, including using their monoclonal antibody platform technology

Emma Walmsley, Chief Executive Officer, GSK said:
"Responding to the COVID-19 pandemic is at the heart of our purpose as a company and GSK’s portfolio is both highly relevant and needed. We have mobilised efforts across the company and I want to thank all the GSK teams for their outstanding work to make sure our vital medicines, vaccines and everyday health products continue to be available to the people who need them. We have also taken action to deploy our science and technologies. Our primary aim is to develop multiple adjuvanted COVID-19 vaccines, and we are working with companies and institutions across the world to do so.

"Our business performed strongly in the quarter with growth in sales and earnings reflecting good underlying performance and increased demand, including stock-building, for many of our products. Looking ahead, we clearly face a period of considerable uncertainty, but we remain confident in the resilience and sustainability of GSK’s business and our ability to deliver on our long-term priorities of Innovation, Performance and Trust."

Genmab Announces Data to be Presented at ASCO20 Virtual Scientific Program

On April 29, 2020 Genmab A/S (Nasdaq: GMAB) reported that six industry sponsored abstracts regarding Genmab and Genmab partnered programs were accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program, taking place from May 29 to 31, 2020 (Press release, Genmab, APR 29, 2020, View Source [SID1234556758]). The titles of the abstracts are currently available on the ASCO (Free ASCO Whitepaper) Meeting Library, with the full abstracts scheduled to be published on May 13, 2020. A list of the abstracts is provided below, and includes one on epcoritamab, one on tisotumab vedotin (Trial in Progress) and four on daratumumab. Beginning Friday, May 29, 2020 at 8:00 AM EDT, poster sessions will be available on demand.

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"Although this year’s ASCO (Free ASCO Whitepaper) will be a virtual conference due to the difficult and unprecedented circumstances, we are pleased that data on our proprietary pipeline and partnered programs has been accepted for presentation at this prestigious conference. We are particularly looking forward to the data presentation that will demonstrate continued solid progress in our development of epcoritamab (DuoBody-CD3xCD20)," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

List of Industry Sponsored Abstracts:

Epcoritamab:
Epcoritamab (GEN3013; DuoBody-CD3×CD20) to induce complete response in patients with relapsed/ refractory B-NHL: Complete dose escalation data and efficacy results from a phase I/II trial – Virtual poster presentation

Tisotumab Vedotin:
Phase Ib/II trial of tisotumab vedotin ± bevacizumab, pembrolizumab, or carboplatin in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8/GOG-3024) – Virtual poster presentation

Daratumumab (Submitted by Janssen Biotech, Inc.):
Corticosteroid Tapering in Patients with Relapsed or Refractory Multiple Myeloma Receiving Subcutaneous Daratumumab: Part 3 of the Open-label, Multicenter, Phase 1b PAVO Study – Virtual poster presentation

Daratumumab + Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma: Baseline slimCRAB-based Subgroup Analysis of CASSIOPEIA – Virtual poster presentation

Efficacy and Safety of Carfilzomib, Dexamethasone, Daratumumab Twice-Weekly at 56 mg/m2 and Once-Weekly at 70 mg/m2 in Relapsed or Refractory Multiple Myeloma: Cross-study Comparison of CANDOR and MY1001 – Virtual poster presentation

Subcutaneous Daratumumab in Patients with Multiple Myeloma who have been Previously Treated with Intravenous Daratumumab: A Multicenter, Randomized, Phase 2 Study (LYNX) – Virtual poster presentation

Forbius to Report Phase 1 Oncology Clinical Trial Results with AVID200, First-in-Class Selective TGF-beta Inhibitor, at ASCO 2020

On April 29, 2020 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported that it will report complete safety and biomarker data from its Phase 1 oncology trial with AVID200 in a virtual poster presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting 2020 (Virtual Format, May 29 – Jun. 2) (Press release, Forbius, APR 29, 2020, View Source [SID1234556757]).

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The Phase 1 clinical study (AVID200-03, NCT03834662) in patients with advanced solid tumor malignancies was designed to assess the safety, PK and pharmacodynamic response of escalating doses of AVID200 administered intravenously q3w as a monotherapy.

Doses of 5 – 30 mg/kg were well tolerated, led to peripheral target engagement, TGF-beta pathway biomarker modulation as well as immune activation.

The Phase 1 results serve as a proof-of-principle that AVID200-mediated selective inhibition of TGF-beta 1 & 3 is feasible in the clinic and support the company’s strategy to develop AVID200 across a broad range of immune-oncology and fibrosis indications.

Details of the Presentation:

Title: AVID200, First-in-Class TGF-beta 1 & 3 Selective and Potent Inhibitor: Safety and Biomarker Results of a Phase 1 Monotherapy Dose Escalation Study in Patients with Advanced Solid Tumors

Presenter: Dr. Timothy Yap, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center

Poster Viewing: Available on demand beginning May 29 at 8:00 AM ET

About TGF-beta 1 & 3
TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis and resistance to anti-PD-(L)1 therapies such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

About AVID200 and the AVID200-03 Trial (NCT03834662)
AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3 undergoing Phase 1 clinical testing in solid tumors and fibrotic diseases. TGF-beta 1 & 3 are the principal disease-driving isoforms, while TGF-beta 2 is responsible for normal cardiac function and hematopoiesis.

AVID200’s selectivity for TGF-beta 1 & 3 was designed to achieve optimal efficacy while circumventing cardiac and other safety issues that have limited the applicability of earlier-generation, non-selective TGF-beta inhibitors. Therefore, AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings, including in combination with anti-PD-(L)1 therapy.

AVID200-03 (NCT03834662) is an open label, multicenter, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor effects of AVID200 in patients with advanced or metastatic solid tumor malignancies.

STAND UP TO CANCER HAILS FDA APPROVAL OF ENCORAFENIB + CETUXIMAB COMBINATION FOR PATIENTS WITH BRAF V600E-MUTANT METASTATIC COLORECTAL CANCER

On April 29, 2020 Stand Up To Cancer (SU2C) reported the recent Food and Drug Administration (FDA) approval this month of encorafenib in combination with cetuximab for patients with advanced BRAF-mutated colorectal cancer (Press release, SU2C, APR 29, 2020, View Source [SID1234556756]). Research by the SU2C-Dutch Cancer Society (KWF) Translational Research Team: Prospective Use of DNA-Guided Personalized Cancer Treatment contributed to the development of this treatment.

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"This is the seventh FDA approval for a new cancer therapy supported by SU2C research," said Nobel Laureate Phillip A. Sharp, PhD, chair of the SU2C Scientific Advisory Committee, and Institute professor, David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology. "The work of this team demonstrates how SU2C’s research accelerates development of new effective treatments showing promise in patients."

BRAF-mutant colorectal cancer is a hard to treat type of colorectal cancer that affects 10 to 15 percent of colorectal patients. Across the US and Canada, approximately, this new treatment could potentially help between 17,500-26,000 patients each year.

"Colorectal cancer is the second leading cause of cancer death in men and women combined," stated SU2C CEO Sung Poblete, PhD, RN. "Stand Up To Cancer is proud to have contributed to the development of this new targeted treatment option for people with the historically difficult to treat colorectal cancer whose cancer has progressed, despite receiving prior therapy."

The SU2C-KWF Research Team participated in a Phase 1b/ Phase 2 multi-institutional dose escalation clinical trial (NCT01719380) which studied the effects of encorafenib, alpelisib and cetuximab in BRAF-mutated colorectal cancers. The study compared a two-drug combination of encorafenib and cetuximab; and a triple-drug combination of encorafenib, alpelisib, and cetuximab. Both combinations showed promise for treating metastatic colorectal cancer characterized by BFAF mutations and were well tolerated by the patients. The team made an important observation that patients carrying key mutations in genes associated with the MAP kinase signaling pathway were more responsive to the combination.

Supported by the team’s findings, the FDA granted Breakthrough Therapy Designations for both the combination of encorafenib, binimetinib, and cetuximab and the combination of encorafenib and cetuximab for patients with BRAF V600E-mutant metastatic colorectal cancer, which sped regulatory review.

"We now have clinical proof that science can guide smart treatment combinations which will further stimulate intelligent use of combinations of targeted anti-cancer drugs," said Emile Voest, MD, PhD, professor of Medical Oncology, medical director of the Netherlands Cancer Institute, and leader of the SU2C-KWF Translational Research Team: Prospective Use of DNA-Guided Personalized Cancer Treatment.

"These results highlight how novel insights gained from basic research can lead to novel therapeutic options for cancer patients," said Rene Bernards, PhD, Netherlands Cancer Institute, and co-leader of the Research Team.

This Research Team engaged just over a dozen scientists from the Netherlands Cancer Institute, Erasmus Medical Center, University Medical Center Utrecht in the Netherlands, and University of California San Diego and UC San Francisco.

CytomX Therapeutics Announces Presentations at the 2020 American Society of Clinical Oncology Virtual Scientific Program

On April 29, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported the selection of seven presentations to be featured as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program taking place from May 29 – May 31, 2020 (Press release, CytomX Therapeutics, APR 29, 2020, View Source [SID1234556755]).

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The titles of the abstracts are currently available on ASCO (Free ASCO Whitepaper)’s 2020 Digital Scientific Program, with full abstracts, including the dates and times of presentations, scheduled for publication on May 13, 2020.

A list of accepted abstracts by CytomX and its partners is provided below.

ASCO 2020 Clinical Highlights From Across the CytomX Probody Portfolio

Preliminary Data from Phase 1/2 Trial of CX-2029, a CD71 Targeting Probody Drug Conjugate, Partnered with AbbVie
Preliminary Phase 1 Clinical Data Presented by Bristol Myers Squibb from the Ongoing First-in-Human Phase 1/2a trial of BMS-986249, a Probody Version of the anti-CTLA-4 Antibody ipilimumab
Updated Data from the Phase 1/2 Trial of CX-2009, an Anti-CD166 Probody Drug Conjugate
Updated Clinical Data from the Phase 1/2 Trial of CX-072, an Anti-PD-L1 Probody Therapeutic, as Monotherapy, in Selected Tumor Types and in Combination with ipilimumab
"Our presence at ASCO (Free ASCO Whitepaper) this year highlights the strong clinical progress made by CytomX and our partners in exploring the broad potential of the novel Probody technology platform," said Amy Peterson, M.D., chief development officer of CytomX Therapeutics. "We look forward to updating the oncology community on this progress and on next steps towards our vision of transforming the lives of patients with cancer."

CX-2029, An Anti-CD71 Probody Drug Conjugate

Presentation Title: CX-2029, a PROBODY Drug Conjugate Targeting CD71 (Transferrin Receptor): Results from a First-in-Human Study (PROCLAIM-CX-2029) in Patients (Pts) With Advanced Cancer
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 3502
Session Type: Oral Presentation

CX-072, An Anti-PD-L1 Probody Therapeutic

Presentation Title: PROCLAIM-CX-072: Analysis of Patients With Advanced Solid Tumors Receiving Long-Term Treatment With CX-072, a PD-L1 PROBODY Therapeutic, as a Single Agent or in Combination With Ipilimumab.
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 2005
Session Type: Oral Presentation

Presentation Title: Evidence of Intratumoral Localization, Activation, and Immunomodulatory Effect of CX-072, a PROBODY Therapeutic Targeting PD-L1, in a Phase 1/2 Trial
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 3108
Session Type: Poster Presentation (Poster #172)

Presentation Title: Preliminary Population Pharmacokinetics Supports Phase 2 Dose Selection for Masked Anti–PD-L1 Antibody CX-072
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 3602
Session Type: Poster Presentation (Poster #332)

CX-2009, An Anti-CD166 Probody Drug Conjugate

Presentation Title: CX-2009, A CD166-Directed PROBODY Drug Conjugate (PDC): Results From the First-in-Human Study in Patients With Advanced Cancer Including Breast Cancer
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 526
Session Type: Poster Presentation (Poster #18)

Presentation Title: Preliminary Clinical Pharmacokinetics and Dose-Response to Support a Phase 2 Dose Selection for CX-2009: A Masked PROBODY Drug Conjugate to CD166
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 3599
Session Type: Poster Presentation (Poster #329)

BMS-986249, An Anti-CTLA-4 Probody Therapeutic

Presentation Title: Anti–CTLA-4 probody BMS-986249 Alone or in Combination with Nivolumab in Patients with Advanced Cancers: Initial Phase 1 Results
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 3058
Session Type: Poster Presentation (Poster #122)