On April 20, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its first quarter 2021 financial results on Tuesday, May 4, 2021 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, APR 20, 2021, View Source [SID1234578251]).

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To access the conference call and webcast, please register at the link below:
View Source

Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

The live webcast of the call and slide deck, may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to [email protected].

On April 20, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported a new supply agreement with Israel for 2022 (Press release, Moderna Therapeutics, APR 20, 2021, View Source [SID1234578267]). Under the terms of this agreement, Israel also retains an option to purchase doses of one of Moderna’s variant-specific vaccine candidates subject to regulatory approval. Today’s announcement follows two earlier agreements between Israel and Moderna to supply a total of 10 million doses of the COVID-19 Vaccine Moderna. The Israeli Ministry of Health authorized COVID-19 Vaccine Moderna for use on January 4, 2021.

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"We appreciate the continued confidence and collaboration with the Israel Ministry of Health with this new agreement," said Stéphane Bancel, Chief Executive Officer of Moderna. "This is an important moment for our company as the first firm order for 2022 supply and for the supply of our variant-specific booster vaccine candidates against COVID-19, currently being studied in human clinical trials. Recent preclinical results have shown that our variant-specific booster candidates were effective against COVID-19 variants of concerns, and we hope to continue to see positive results from the clinical studies."

About the COVID-19 Vaccine Moderna

The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar and Taiwan. Additional authorizations are currently under review in other countries and by the World Health Organization.

Preclinical data on the Company’s variant-specific booster vaccine candidates have been submitted as a preprint to bioRxiv and will be submitted for peer-reviewed publication. These variant-specific vaccine candidates include mRNA-1273.351, which is more specifically targeted against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa, and a multivalent booster candidate, mRNA-1273.211, which combines mRNA-1273 (Moderna’s authorized vaccine against ancestral strains) and mRNA-1273.351 in a single vaccine. The Company’s Phase 2 study to evaluate three approaches to boosting is ongoing.

Authorized Use

Moderna has received approval to import and market COVID-19 Vaccine Moderna in Israel under Regulation 29 (A)(9). COVID-19 Vaccine Moderna is approved as a two-dose series for patients 18 years of age and older.

On April 20, 2021 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous formulation (sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 1,365 million in the first quarter of 2021 (Press release, Genmab, APR 20, 2021, View Source [SID1234578236]). Net trade sales were USD 691 million in the U.S. and USD 674 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX and DARZALEX FASPRO under the exclusive worldwide license to Janssen Biotech, Inc. (Janssen) to develop, manufacture and commercialize daratumumab. As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.

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About DARZALEX(daratumumab)
DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone. It is also approved in the U.S. for the treatment of adult patients with multiple myeloma: in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology. .DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma and the first and only approved treatment for patients with AL amyloidosis in the U.S.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,4,5,6,7

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On April 20, 2021 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2021 (Press release, Abbott, APR 20, 2021, View Source [SID1234578252]).

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First-quarter sales of $10.5 billion increased 35.3 percent on a reported basis and 32.9 percent on an organic basis, which excludes the impact of foreign exchange.
First-quarter GAAP diluted EPS was $1.00 and adjusted diluted EPS, which excludes specified items, was $1.32, reflecting 103.1 percent growth versus the prior year.1
Abbott projects full-year 2021 diluted EPS from continuing operations on a GAAP basis of at least $3.74. Projected full-year adjusted diluted EPS from continuing operations of at least $5.00 remains unchanged and reflects growth of more than 35 percent versus the prior year.2
Global COVID-19 testing-related sales were $2.2 billion in the first quarter, led by combined sales of $1.8 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms.
First-quarter sales increased 7.6 percent on a reported basis and 5.7 percent on an organic basis, excluding COVID-19 testing-related sales.
In January, the U.S. Centers for Medicare & Medicaid Services expanded reimbursement coverage eligibility for Abbott’s revolutionary MitraClip device, which significantly increases the number of people who can benefit from this market-leading, minimally invasive heart device.
In March, Abbott announced the U.S. launch of NeuroSphere Virtual Clinic, a first-of-its-kind technology that allows patients to communicate with physicians, ensure proper settings and functionality, and receive new treatment settings remotely as needed.
In April, Abbott announced U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) of its BinaxNOW COVID-19 Ag Self Test for individuals with or without symptoms and without the need of a prescription.
"We’re off to a very strong start to the year, with all four of our major businesses achieving strong growth," said Robert B. Ford, president and chief executive officer, Abbott. "We’re particularly pleased with the growing momentum of several recently launched products and continue to forecast more than 35 percent EPS growth for the year."

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 impact of foreign exchange.

Following are sales by business segment and commentary for the first quarter 2021

* Total Q1 2021 Abbott sales from continuing operations include Other Sales of approximately $16 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
foreign exchange rates.

First-quarter 2021 worldwide sales of $10.5 billion increased 35.3 percent on a reported basis and 32.9 percent on an organic basis.

Worldwide Nutrition sales increased 6.9 percent on a reported basis and 6.4 percent on an organic basis in the first quarter. Strong performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global Adult Nutrition sales growth of 18.9 percent on a reported basis and 18.3 percent on an organic basis. In Pediatric Nutrition, sales growth was negatively impacted by a difficult comparison versus the first quarter of 2020 when consumers increased purchases in advance of stay-at-home directives as a result of COVID-19.

Worldwide Diagnostics sales increased 119.8 percent on a reported basis in the first quarter and increased 114.8 percent on an organic basis. Strong growth in the quarter was driven by demand for Abbott’s portfolio of COVID-19 diagnostics tests across its rapid and lab-based platforms. Global COVID-19 testing-related sales were $2.2 billion in the first quarter, led by combined sales of $1.8 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms.

Excluding COVID-19 testing-related sales, Core Laboratory Diagnostics sales increased 10.7 percent and Molecular Diagnostics sales increased 31.5 percent on an organic basis in the first quarter.3

Established Pharmaceuticals sales increased 2.5 percent on a reported basis in the first quarter and increased 6.2 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 increased 1.0 percent on a reported basis in the quarter and increased 6.7 percent on an organic basis. Organic sales growth was led by strong growth across several geographies, including China, India and Brazil.

Other sales increased 7.8 percent on a reported basis in the quarter and increased 4.2 percent on an organic basis.

Worldwide Medical Devices sales increased 13.1 percent on a reported basis in the first quarter and increased 8.8 percent on an organic basis. Strong growth in the quarter was driven by continued recovery from the COVID-19 pandemic. In Diabetes Care, sales of FreeStyle Libre and Libre Sense were $829 million in the quarter. FreeStyle Libre now has more than 3 million users worldwide.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects 2021 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of at least $3.74. Abbott forecasts specified items for the full-year 2021 of $1.26 primarily related to intangible amortization, expenses associated with acquisitions, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be at least $5.00 for full-year 2021.

ABBOTT DECLARES 389TH CONSECUTIVE QUARTERLY DIVIDEND
On Feb. 19, 2021, the board of directors of Abbott declared the company’s quarterly dividend of $0.45 per share. Abbott’s cash dividend is payable May 17, 2021 to shareholders of record at the close of business on April 15, 2021.

Abbott has increased its dividend payout for 49 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.

On April 20, 2021 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that results from four clinical studies of the company’s three apoptosis-targeted drug candidates have been selected for presentations at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Ascentage Pharma, APR 20, 2021, View Source [SID1234578268]). These include two oral presentations: one based on a global Phase I clinical study of the Bcl-2 inhibitor lisaftoclax (APG-2575); and the other based on a global Phase II clinical trial of the MDM2-p53 inhibitor alrizomadlin (APG-115) in combination with the PD-1 checkpoint inhibitor pembrolizumab.

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Convening on June 4 to 8, 2021, the ASCO (Free ASCO Whitepaper) Annual Meeting showcases the most cutting-edge research in clinical oncology and the most advanced cancer therapies, and is the world’s most influential and prominent scientific gathering of the clinical oncology community.

"This year marks the fourth consecutive year in which our clinical study results were selected for presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting, and we are pleased to have an opportunity to share multiple progress from our clinical development programs," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We are thrilled that the results from two of our clinical studies have been selected for oral presentations at the meeting this year. Through these oral presentations, we will release the data from the Phase I study of lisaftoclax at a prominent scientific event for the first time. This signifies the drug candidate’s therapeutic potential and the global research community’s strong interest in this novel therapeutic, and shows Ascentage Pharma’s capability in the global research and development of apoptosis-targeted cancer therapies. We look forward to sharing detailed results during the meeting. Moving forward, we will strive to accelerate our clinical development programs to hopefully soon provide cancer patients with more treatment options."

At this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, Ascentage Pharma will present results from four clinical studies of the company’s three apoptosis-targeted drug candidates as follows:

The novel Bcl-2 inhibitor lisaftoclax (APG-2575)

Lisaftoclax is a novel, orally administered small-molecule Bcl-2‒selective inhibitor being developed by Ascentage Pharma. Lisaftoclax is designed to treat hematologic malignancies and solid tumors by selectively blocking antiapoptotic protein Bcl-2 to restore the normal apoptosis process in cancer cells. Lisaftoclax is the first China-developed Bcl-2 inhibitor entering clinical development in China.

Selected study: A global Phase I clinical study of lisaftoclax, a novel Bcl-2 inhibitor, in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and other hematologic malignancies (HMs)
Format: Oral Presentation
This global multi-center, single-agent, open-label Phase I clinical study is designed to assess the safety, pharmacokinetics (PK), pharmacodynamic (PD), and efficacy of lisaftoclax, and to determine its maximum tolerated dose (MTD)/recommended Phase II dose (RP2D) in patients with R/R CLL and other HMs.

In the preliminary data released by Ascentage Pharma in December 2020, lisaftoclax has demonstrated an objective response rate (ORR) of 70%, with favorable tolerability and manageable safety profiles in patients with R/R CLL. Detailed updated results will be released in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting during June 4 – 8, 2021.

The novel MDM2 inhibitor alrizomadlin (APG-115)

Being developed by Ascentage Pharma, alrizomadlin is an orally administered, selective, small-molecule inhibitor of the MDM2 protein. Alrizomadlin has strong binding affinity to MDM2 and is designed to activate tumor suppression activity of p53 by blocking the MDM2-p53 protein-protein interaction. Alrizomadlin is the first MDM2-p53 inhibitor entering clinical development in China, and is currently being investigated in multiple Phase Ib/II clinical studies in solid tumors and HMs in China, Australia and the US.

Selected study: A Phase II study of alrizomadlin in combination with pembrolizumab in patients with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic drugs
Format: Oral Presentation
This study is designed to evaluate the efficacy and safety of alrizomadlin in combination with pembrolizumab in patients with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic drugs.

The results of this Phase Ib study released at the 2020 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrated that alrizomadlin in combination with pembrolizumab is well-tolerated, with preliminary antitumor activity in advanced solid tumors.

Selected study: A Phase I/II trial of alrizomadlin, with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma
Format: Poster Presentation
This multi-center, open-label Phase I/II study in the US is designed to evaluate the efficacy of alrizomadlin, with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma.

The Bcl-2/Bcl-xL inhibitor pelcitoclax (APG-1252)

Pelcitoclax is a novel, highly potent, small molecule drug designed to restore apoptosis through selective inhibition of Bcl-2 and Bcl-xL proteins.

Selected study: A multi-center Phase Ib/II study of pelcitoclax plus paclitaxel in patients with relapsed/refractory small-cell lung cancer (R/R SCLC)
Format: Poster Presentation
This multi-center, open-label Phase Ib/II study is designed to evaluate the safety and preliminary efficacy of combination therapy with pelcitoclax plus paclitaxel in patients with R/R SCLC.