Replimune to Host Virtual Investor Event on June 3, 2021

On April 28, 2021 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that it will host an investor event to present updated data from its Phase 2 skin cancer cohorts combining RP1 with Opdivo and data from its Phase 1 study of RP2 alone and in combination with Opdivo (Press release, Replimune, APR 28, 2021, View Source [SID1234578745]). The event will include presentations by Philip Astley-Sparke, Chief Executive Officer of Replimune, Robert Coffin, Ph.D., President and Chief Research & Development Officer of Replimune, and Mark Middleton, Professor of Experimental Cancer Medicine in the Department of Oncology, consultant Medical Oncologist at the Oxford Cancer and Haematology Centre and Head of the Department of Oncology at the University of Oxford.

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The event will begin at 8:00 a.m. Eastern Time on Thursday, June 3, 2021. The webcast and slides will be accessible live under "Events & Presentations" on the Investors page of the Company’s website at www.replimune.com or by clicking here. A replay of the event will be available on Replimune’s website.

Opdivo (nivolumab) is a registered trademark of Bristol-Myers Squibb Company.

Zenocutuzumab Clinical Data Selected for Oral Presentation at the 2021 American Society of Clinical Oncology Annual Meeting

On April 28, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the company’s selection for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held virtually June 4-8, 2021 (Press release, Merus, APR 28, 2021, View Source [SID1234578824]).

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The presentation highlights updated interim clinical data for the targeted bispecific antibody, zenocutuzumab (Zeno), in NRG1 fusion positive (NRG1+) cancers. Merus is currently recruiting patients into the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers.

Oral Presentation:

Title: Efficacy and safety of zenocutuzumab in advanced pancreas cancer and other solid tumors harboring NRG1 fusions
Lead Author: Alison Schram, MD, Memorial Sloan Kettering Cancer Center, NY
Abstract #: 3003
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: June 4, 2021, 11:00 AM-2:00 PM EDT

The abstract will be available on May 19 at 5:00 pm. ET and the presentation, with an updated interim analysis of the currently enrolled population, will be broadcasted during the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology session on June 4 from 11:00-2:00 ET, both on the ASCO (Free ASCO Whitepaper) Meeting Library. It will also be available on the Merus website shortly after the live presentation.

About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancers. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.

Learn more about Zeno Dock & Block at View Source

ImmunoPrecise To Attend Alliance For Cancer Gene Therapy Summit 2021

On April 28, 2021 ImmunoPrecise Antibodies reported to be attending the Alliance For Cancer and Gene Therapy Summit 2021 (Press release, ImmunoPrecise Antibodies, APR 28, 2021, View Source [SID1234578618]). The summit is being held virtually April 29th 2021, containing multiple panels led by industry leaders to discuss the latest innovations in cancer drugs and therapies.

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Learn more: Alliance For Cancer and Gene Therapy Summit 2021

ORIC Pharmaceuticals to Present Initial Data from Ongoing Phase 1b Study of ORIC-101 in Combination with Nab-paclitaxel at the 2021 ASCO Annual Meeting

On April 28, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that two abstracts highlighting preliminary results from the Phase 1b study of ORIC-101 in combination with nab-paclitaxel have been accepted for poster presentations during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4 – 8, 2021 (Press release, ORIC Pharmaceuticals, APR 28, 2021, View Source [SID1234578637]).

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"We are pleased to participate in the 2021 ASCO (Free ASCO Whitepaper) program and report initial data from the ongoing Phase 1b study of ORIC-101, our glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors," said Jacob Chacko, M.D., president and chief executive officer. "This represents the first of two data readouts from our two ongoing Phase 1b trials of ORIC-101. We expect to report initial data from the second trial, ORIC-101 in combination with enzalutamide in prostate cancer, in the second half of this year."

Poster Presentations:

Presentation Title: Initial results from a Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors
Date and Time (On-Demand): June 4, 2021 (6:00 am PT)
Abstract Number: 2553

Presentation Title: Biomarker results supporting selection of RP2D from a Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors
Date and Time (On-Demand): June 4, 2021 (6:00 am PT)
Abstract Number: 3110

The posters will be available at www.oricpharma.com/publications following presentation at the meeting.

GSK delivers Q1 sales of £7.4 billion -18% AER, -15% CER Total EPS 21.5p, -32% AER, -25% CER; Adjusted EPS 22.9p -39% AER, -33% CER

On April 28, 2021 GSK reported that Q1 sales of £7.4 billion -18% AER, -15% CER Total EPS 21.5p, -32% AER, -25% CER; Adjusted EPS 22.9p -39% AER, -33% CER (Press release, GlaxoSmithKline, APR 28, 2021, View Source [SID1234578654])

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Highlights
Strong growth in new pharmaceutical products offset by stocking and pandemic disruption
Pharmaceuticals £3.9 billion -12% AER, -8% CER, with growth in new and specialty products (+3% CER) including: Respiratory +24% CER; Immuno-inflammation +26% CER; and Oncology +38% CER partly offsetting decline in Established Products -17% CER. HIV -11% CER impacted by 2020 stocking and tender phasing; HIV two-drug regimen sales +41% CER
Vaccines £1.2 billion -32% AER, -30% CER (Shingrix -47% CER) reflecting government prioritisation of COVID-19 vaccinations. Continue to expect strong growth from Shingrix in H2
Consumer Healthcare £2.3 billion -19% AER, -16% CER (-9% excluding divestments/brands under review) reflecting year-on-year "pantry-loading" comparison and weak cold/flu season
Effective cost control supports delivery of adjusted earnings per share of 22.9p
Total Group operating margin 22.8%. Total EPS 21.5p -32% AER, -25% CER
Adjusted Group operating margin 25.4%. Adjusted EPS 22.9p -39% AER, -33% CER
Q1 net cash flow from operations £331 million. Free cash outflow £3 million
Continued R&D delivery and strengthening of Biopharma pipeline
Launch of Cabenuva, the world’s first and only long-acting HIV treatment
Approvals of Rukobia and Jemperli (dostarlimab) and positive regulatory opinion for Benlysta
Phase III trial starts for RSV older adults vaccine and GSK ‘294 for severe asthma
Positive data for antibody treatment VIR-7831 with EUA filed in US and EU
Phase III trial start with Medicago for adjuvanted COVID-19 vaccine
On track to create New GSK and standalone Consumer Healthcare company in 2022
Consumer Healthcare JV commercial integration broadly complete; separation activities advancing
Pharmaceutical portfolio rationalisation continues with cephalosporin divestment announced
New GSK Investor Update on 23 June to outline strategy, growth outlooks (2022-2031), capital allocation priorities and timing and approach to separation
Reconfirming full-year 2021 EPS guidance and 2022 outlook
Continue to expect 2021 Adjusted EPS to decline by a mid to high-single digit percentage in CER
2022 outlook unchanged with meaningful improvements expected in revenues and margins
Dividend of 19p declared for Q1 2021. Continue to expect 80p/share for 2021

Emma Walmsley, Chief Executive Officer, GSK said:
"Our first quarter results are in line with our expectations and reflect the anticipated impacts of COVID-19. We continue to expect a significant improvement in performance over the remainder of the year and reconfirm our guidance for 2021 and 2022 outlook. The launch of Cabenuva for HIV and Phase III starts for our RSV vaccine and a new long-acting treatment for severe asthma are key milestones as we continue to strengthen our growth prospects. Separation plans are also well underway and we look forward to sharing our strategy and growth outlook for New GSK with investors in June."