On April 27, 2021 Alkermes plc (Nasdaq: ALKS) reported the initiation of ARTISTRY-6, a global phase 2 trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin alfa (nemvaleukin) monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy (Press release, Alkermes, APR 27, 2021, View Source [SID1234578573]). The study will evaluate intravenously administered (IV) nemvaleukin in patients with mucosal melanoma and subcutaneously administered (SC) nemvaleukin in patients with advanced cutaneous melanoma. Nemvaleukin, Alkermes’ lead immuno-oncology candidate, is a novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy. Nemvaleukin was granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA) in March 2021.

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"The initiation of the ARTISTRY-6 study represents a significant milestone in the nemvaleukin development program, building on the early signals of anti-tumor activity observed with IV nemvaleukin in melanoma," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President at Alkermes. "Consistent with our strategy to study nemvaleukin in difficult-to-treat cancers with clear unmet need, we look forward to further evaluating the potential clinical utility of nemvaleukin monotherapy in mucosal melanoma, a rare and aggressive form of melanoma that has very limited treatment options. We recently discussed with the FDA a potential filing pathway in mucosal melanoma, pending review of data that emerge from ARTISTRY-6."

ARTISTRY-6 is designed to evaluate the anti-tumor activity, safety and tolerability of IV nemvaleukin in patients with mucosal melanoma. The study also includes a cohort of patients with advanced cutaneous melanoma who will receive SC nemvaleukin with intent to establish monotherapy proof-of -concept with SC dosing. The primary endpoint of ARTISTRY-6 is centrally-assessed overall response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, to be evaluated separately for patients with mucosal or cutaneous melanoma. The secondary endpoints include safety and tolerability, duration of response, progression-free survival, disease control rate and time to response based on RECIST 1.1. Additionally, the phase 2 study will assess health-related quality of life, and pharmacokinetic and pharmacodynamic effects of IV and SC nemvaleukin monotherapy. The study is planned to enroll approximately 110 patients. Patients will be enrolled into one of two cohorts: patients with advanced mucosal melanoma will receive 6 µg/kg/day IV nemvaleukin for 5 consecutive days every 3 weeks, and patients with advanced cutaneous melanoma will receive 3 mg SC nemvaleukin once every 7 days.

More information can be found at www.clinicaltrials.gov, identifier: NCT04830124.

About Nemvaleukin alfa ("nemvaleukin", formerly ALKS 4230)
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin alfa as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.

On April 27, 2021 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that it will present data detailing a new robotics technology to aid in multi-tumor-associated antigen (mTAA)-specific T cell therapy manufacturing at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place virtually May 11-14, 2021 (Press release, Marker Therapeutics, APR 27, 2021, View Source;cell-therapy-asgct-annual-meeting-301278520.html [SID1234578589]). The data will be presented by lead author Anastasiya Smith, Ph.D.

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The presentation details how the robotic assistant prototype, co-designed by Marker Therapeutics and ABB Robotics, could in the future be integrated in a standard biosafety cabinet to collaborate with a human operator during mTAA-specific T cell manufacturing. The researchers found that the robotic assistant prototype was more precise and accurate than human operators in pipetting liquid and was more consistent in the number of cycles performed over a 1-hour test period, while the human operator’s performance deteriorated over time. The authors conclude that the future combination of process simplification with robotic automation may be able to address some of the challenges associated with cell therapy and make this therapy readily available to a larger patient population.

Presentation Details

Title: "Robotic Automation of T Cell Generation for the Treatment of Acute Myeloid Leukemia (AML)"
Authors: Anastasiya Smith, Ph.D., et al.
Session Type: Digital Poster Presentation
Session Date/Time: Tuesday, May 11, 2021, 8:00 a.m. – 10:00 a.m. ET
Session Title: Cell Therapies
Abstract: 772

The abstract is available on ASGCT (Free ASGCT Whitepaper)’s website and in an online supplement to the ASGCT (Free ASGCT Whitepaper) journal. The poster presentation will be available to ASGCT (Free ASGCT Whitepaper) registrants beginning May 11, 2021.

On April 27, 2021 INOVIO (NASDAQ: INO) reported that first quarter 2021 financial results will be released after the market close on May 10, 2021 (Press release, Inovio, APR 27, 2021, View Source [SID1234578539]). Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update regarding its DNA Medicines Platform, including the company’s ongoing vaccine developments for COVID-19.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

On April 27, 2021 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the first quarter of fiscal year 2021 (Press release, Illumina, APR 27, 2021, View Source [SID1234578558]).

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"Illumina achieved its first billion-dollar revenue quarter in company history and delivered a very strong start to 2021, exceeding our expectations"

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First quarter results reflect record revenue:

Revenue of $1,093 million, a 27% increase compared to the prior year period
GAAP net income for the quarter of $147 million, or $1.00 per diluted share, compared to $173 million, or $1.17 per diluted share, for the prior year period
Non-GAAP net income for the quarter of $278 million, or $1.89 per diluted share, compared to $243 million, or $1.64 per diluted share, for the prior year period. Non-GAAP net income excludes acquisition-related expenses, primarily the Continuation Payments paid to GRAIL (see the "Reconciliation Between GAAP and Non-GAAP Net Income" table for a reconciliation of these GAAP and non-GAAP financial measures)
Cash flow from operations of $282 million compared to $281 million in the prior year period
Free cash flow (cash flow from operations less capital expenditures) of $240 million for the quarter compared to $241 million in the prior year period
"Illumina achieved its first billion-dollar revenue quarter in company history and delivered a very strong start to 2021, exceeding our expectations," said Francis deSouza, Chief Executive Officer. "Orders during the first quarter of 2021 reached an all-time high demonstrating strength in our core business across all regions, reflecting growth in both clinical and research customers. We are seeing tremendous progress in clinical market access and reimbursement for genomic applications increasing access to genomic testing for patients worldwide. We are proud of the significant contributions our customers, partners, and employees are making to the creation of a genomic epidemiology infrastructure to combat COVID-19, as well as monitor for future pathogen outbreaks for the benefit of global public health."

Gross margin in the first quarter of 2021 was 69.9% compared to 72.1% in the prior year period. Excluding amortization of acquired intangible assets and expenses related to COVID-19, non-GAAP gross margin was 70.5% for the first quarter of 2021 compared to 73.0% in the prior year period.

Research and development (R&D) expenses for the first quarter of 2021 were $197 million compared to $156 million in the prior year period. Non-GAAP R&D expenses as a percentage of revenue were 18.0% compared to 18.3% in the prior year period.

Selling, general and administrative (SG&A) expenses for the first quarter of 2021 were $374 million compared to $274 million in the prior year period. Excluding acquisition-related expenses and expenses and income related to COVID-19, non-GAAP SG&A expenses as a percentage of revenue were 20.4% compared to 21.1% in the prior year period.

Depreciation and amortization expenses were $48 million and capital expenditures for free cash flow purposes were $42 million during the first quarter of 2021. At the close of the quarter, the company held $4.6 billion in cash, cash equivalents and short-term investments, compared to $3.5 billion as of January 3, 2021.

Updates since our last earnings release:

Announced TSO 500 partnership with Kartos Therapeutics to advance comprehensive genomic profiling for blood cancers
Published positive economic study results in partnership with Harvard Pilgrim Health Care demonstrating the cost-effectiveness of offering non-invasive prenatal testing (NIPT) to all pregnant women
Illumina was selected among the top 100 influential global companies by Time magazine
Published our second annual Corporate Social Responsibility report that highlights our commitment to society, our employees and the environment
Completed a senior unsecured investment grade bond offering for an aggregate principal amount of $1 billion and finalized a $750 million 5-year unsecured revolving credit facility
Announced Jay Flatley will step down from the Board of Directors and John W. Thompson will be appointed as the new Chair of the Board effective May 26, 2021
Received medical device registration in Russia for NextSeq 550Dx and associated reagent kits
Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2021, the company expects year-over-year revenue growth in the range of 25% to 28%, and now expects GAAP earnings per diluted share of $4.72 to $4.97 and non-GAAP earnings per diluted share of $5.80 to $6.05. Except for acquisition-related expenses and bridge facility fees incurred during Q1 2021, this guidance excludes the potential impact from the pending acquisition of GRAIL, which we expect to close in the second half of 2021.

Conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, April 27, 2021. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597 or 1 (647) 689-6853 outside North America, both using conference ID 4359912.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On April 27, 2021 DURECT Corporation (Nasdaq: DRRX) reported that it will report its first quarter 2021 financial results and host a conference call after the market close on Tuesday, May 4, 2021 (Press release, DURECT, APR 27, 2021, https://investors.durect.com/news-releases/news-release-details/durect-corporation-announce-first-quarter-2021-financial-results [SID1234578574]).

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Tuesday, May 4 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

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