On April 22, 2020 Alkermes plc (Nasdaq: ALKS) reported the publication of preclinical data demonstrating the selectivity and anti-tumor efficacy of its investigational, immunotherapy candidate, ALKS 4230, in the Journal for ImmunoTherapy of Cancer (JITC) (Press release, Alkermes, APR 22, 2020, View Source [SID1234556504]). ALKS 4230, a novel cytokine, is an investigational, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the interleukin-2 (IL-2)-induced activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex.

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The manuscript, titled "ALKS 4230: a novel engineered IL-2 fusion protein with an improved cellular selectivity profile for cancer immunotherapy," provides an in-depth explanation of the design of ALKS 4230 and includes data from multiple assays that demonstrated that ALKS 4230 selectively activated the intermediate-affinity IL-2 receptor as intended. Additionally, data from a mouse B6F10 lung metastasis model demonstrated that treatment with ALKS 4230 achieved a maximum of 100% inhibition of tumor growth with one of the doses tested, as compared to treatment with recombinant human IL-2 (rhIL-2), which achieved a maximum of 70% inhibition of tumor growth with one of the doses tested. In this model, equivalent anti-tumor activity of ALKS 4230 was observed whether it was administered intravenously or subcutaneously.

"Targeting the IL-2 pathway has shown significant efficacy in renal cell carcinoma and melanoma, however the broader and more prevalent use of this approach in treating cancer has been limited by the toxicity profile and side effects associated with currently available IL-2-based therapy," said Marc Ernstoff, M.D., Roswell Park Comprehensive Cancer Center, and publication co-author. "These preclinical data demonstrated that ALKS 4230 selectively activated and expanded cancer-fighting cells in mice with less toxicity than conventional high-dose IL-2 therapy. These data support further clinical evaluation of ALKS 4230 as a potential novel cytokine-based cancer immunotherapy."

Key findings published in the manuscript include the following:

ALKS 4230 demonstrated a similar potency to rhIL-2 in activating mouse CD8+ T cells and Natural Killer (NK) cells. However, ALKS 4230 was ~ 1000 times less potent than rhIL-2 in activating regulatory T cells (Tregs), which are known to suppress cancer-fighting immune mechanisms.

ALKS 4230 treatment of peripheral blood mononuclear cells (PBMCs) from patients with melanoma or renal cell carcinoma resulted in the selective expansion of CD8+ T cells and NK cells with negligible effects on Treg expansion.

ALKS 4230 showed superior anti-tumor efficacy to rhIL-2 in a mouse B6F10 lung metastasis model and the ability to achieve equivalent anti-tumor efficacy when administered either intravenously or subcutaneously.

In mice, ALKS 4230 treatment induced markedly lower levels of cytokines typically associated with cytokine release syndrome, compared to rhIL-2.
"We leveraged our therapeutic development expertise and protein engineering capabilities to create ALKS 4230, a stable fusion protein. It is designed to minimize toxicity without compromising the proven anti-cancer effects of IL-2-based therapies," said Heather Losey, Ph.D., Director, Program Lead in Immuno-Oncology at Alkermes, and corresponding author of the publication. "We are encouraged by ALKS 4230’s preclinical profile, as discussed in this important peer-reviewed publication, including its selectivity for immune effector cells, pharmacokinetics and preclinical efficacy. We look forward to progressing the ARTISTRY clinical development program and seeing how the data mature for this novel, investigational immunotherapy."

ALKS 4230 is currently being studied in both monotherapy and combination settings as part of the Alkermes-sponsored ARTISTRY clinical development program.

About ALKS 4230
ALKS 4230 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 ALKS 4230 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 ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, an ongoing monotherapy expansion stage, and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with select advanced solid tumors.

ARTISTRY-2 is an ongoing phase 1/2 study in which ALKS 4230 is administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.

On April 22, 2020 Silverback Therapeutics ("Silverback") reported that Laura Shawver, Ph.D., was appointed president, chief executive officer and director of Silverback Therapeutics to lead the next phase of growth utilizing ImmunoTAC therapeutics that are administered systemically, tissue-directed, and locally active with a pipeline of programs in oncology, fibrosis and virology (Press release, Silverback Therapeutics, APR 22, 2020, View Source [SID1234556501]). Dr. Shawver brings more than 25 years of demonstrated success as a scientist, biotech leader and patient advocate to the role.

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"With her range of strategic expertise, demonstrated success raising capital, scientific acumen, and broad drug development experience, Laura is the perfect fit for Silverback," said Peter Thompson, MD, OrbiMed partner, co-founder and chairman of Silverback Therapeutics. "I, along with Silverback’s entire board, look forward to working with Laura and our exceptional leadership team to advance Silverback’s pipeline and deliver on the promise to dramatically improve the lives of patients."

"It’s an amazing opportunity to lead a team creating a new generation of therapies that can modulate previously impossible to treat pathways. Silverback is on the verge of entering clinical development with SBT6050, which maximizes the potential for an anti-tumor immune response in tumors lacking T cells," said Dr. Shawver. "Marrying the curative potential of IO treatment with the precision of targeted drugs is a major advancement. I look forward to marshalling the necessary resources to maximize the value of the ImmunoTAC platform for all the stakeholders."

Most recently, Dr. Shawver was CEO and director of Synthorx, Inc. from 2017 until its acquisition by Sanofi in January 2020 for $2.5 billion. Previously, she has held positions as CEO and director of Cleave Biosciences; entrepreneur-in-residence for 5AM Ventures; CEO and director of Phenomix Corporation; and president of SUGEN Inc. She is currently a director of Relay Therapeutics, as well as board chair of Cleave Therapeutics. She is an active member of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), serving on the Scientific Advisory Committee for Stand Up to Cancer. Dr. Shawver knows firsthand what it is like to be a cancer patient – having survived ovarian cancer, she founded The Clearity Foundation, a nonprofit organization helping women with ovarian cancer improve their treatment options. Dr. Shawver received her Ph.D. in pharmacology and a B.S. degree in microbiology from the University of Iowa.

On April 22, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the first quarter ended March 28, 2020 (Press release, Thermo Fisher Scientific, APR 22, 2020, View Source [SID1234556499]).

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First Quarter 2020 Highlights

•First quarter revenue increased 2% to $6.23 billion.
•First quarter GAAP diluted earnings per share (EPS) decreased 2% to $1.97.
•First quarter adjusted EPS increased 5% to $2.94.

•Announced agreement to acquire QIAGEN N.V. for $11.5 billion, expanding our specialty diagnostics portfolio with attractive molecular diagnostics capabilities and enhancing our life sciences offering with innovative sample preparation technologies. Commenced permanent financing by raising $3.5 billion through U.S. and European bond offerings.

•Responded to global demand for COVID-19 diagnostic testing by developing the Applied Biosystems TaqPath COVID-19 Combo Kit, which received Emergency Use Authorization from the U.S. FDA, the CE mark in Europe and subsequent authorizations worldwide. Also introduced the Thermo Scientific AcroMetrix Coronavirus 2019 RNA Control to validate molecular diagnostic tests.

•Launched new products to support a range of customer applications, including the highly automated Thermo Scientific Vanquish Core HPLC system for increased throughput in pharmaceutical, food and industrial testing, and the Thermo Scientific Labtainer Pro bioprocess container to improve drug and vaccine production.

•Repurchased $1.5 billion of stock and increased our dividend by 16 percent.

Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"We’re clearly living in unprecedented times, and the COVID-19 pandemic has put a spotlight on the importance of the work we do at Thermo Fisher Scientific," said Marc N. Casper, chairman, president and chief executive officer of the company. "Our leading scale and depth of capabilities are key advantages in navigating this environment, and we were pleased to deliver a very good first quarter. Our performance reflects the amazing effort of our teams who continued to meet our customers’ needs and quickly mobilized to provide solutions to analyze, diagnose and protect from the virus globally.

"As you would expect, we’re managing the company appropriately and our guiding principles are to keep our colleagues safe, support our customers’ important work and ensure we come through this period an even stronger industry leader."

Casper added, "We were also very excited to announce our agreement to acquire QIAGEN, which will enhance our customer value proposition in life sciences and specialty diagnostics, including infectious disease testing. QIAGEN’s offerings and expertise are a perfect complement to our capabilities, and we remain on track to complete the transaction in the first half of 2021."

First Quarter 2020

Revenue for the quarter grew 2% to $6.23 billion in 2020, versus $6.12 billion in 2019. Organic revenue growth was 2%; acquisitions, net of a divestiture, increased revenue by 1% and currency translation decreased revenue by 1%.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2020 decreased 2% to $1.97, versus $2.02 in the same quarter last year. GAAP operating income for the first quarter of 2020 was $0.91 billion, compared with $0.92 billion in the year-ago quarter. GAAP operating margin was 14.5%, compared with 15.0% in the first quarter of 2019.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2020 increased 5% to $2.94, versus $2.81 in the first quarter of 2019. Adjusted operating income for the first quarter of 2020 grew 1% compared with the year-ago quarter. Adjusted operating margin was 22.1%, compared with 22.4% in the first quarter of 2019.

2020 Guidance

Thermo Fisher announced on April 6, 2020, that it withdrew its 2020 annual guidance due to the evolving COVID-19 pandemic and related customer impact.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

In the first quarter of 2020, Life Sciences Solutions Segment revenue grew 10% to $1.77 billion, compared with revenue of $1.61 billion in the first quarter of 2019. Segment adjusted operating margin increased to 38.0%, versus 34.9% in the 2019 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue was $1.10 billion in the first quarter of 2020, compared with revenue of $1.32 billion in the first quarter of 2019. Segment adjusted operating margin was 15.5%, versus 21.3% in the 2019 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue was flat at $0.96 billion in the first quarter of 2020, compared with the first quarter of 2019, reflecting the divestiture of the Anatomical Pathology business in June 2019. Segment adjusted operating margin was 24.7%, versus 25.3% in the 2019 quarter.

Laboratory Products and Services Segment

In the first quarter of 2020, Laboratory Products and Services Segment revenue grew 9% to $2.73 billion, compared with revenue of $2.51 billion in the first quarter of 2019. Segment adjusted operating margin was 10.8%, versus 11.3% in the 2019 quarter.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, and the impact of significant tax audits or events. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of 3 to 20 years. Based on acquisitions closed through the end of the first quarter of 2020, adjusted EPS will exclude approximately $3.31 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes or the estimated initial impacts of U.S. tax reform legislation), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans and the early retirement of debt.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher’s results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, April 22, 2020, at 8:30 a.m. Eastern time. To listen, dial (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors."
You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, May 29, 2020.

On April 22, 2020 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported that its first quarter 2020 financial results will be released after market close on Thursday, May 7, 2020 (Press release, Coherus Biosciences, APR 22, 2020, View Source [SID1234556498]). Starting at 4:30 p.m. ET, Coherus’ management team will host a conference call to discuss financial results and provide a general business update.

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After releasing first quarter financial results, the Company will post them on the Coherus website at View Source

Conference Call Information

When: Thursday, May 7, 2020 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (Toll Free) or (765) 507-2587 (International)
Conference ID: 6167564

On April 22, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported that the U.S. Food and Drug Administration (FDA) has approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease (Press release, Immunomedics, APR 22, 2020, View Source [SID1234556497]). Trodelvy is the first ADC approved by the FDA specifically for relapsed or refractory metastatic TNBC and is also the first FDA-approved anti-Trop-2 ADC.1

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Trodelvy, which was granted Breakthrough Therapy Designation and Priority Review, was approved under the FDA’s Accelerated Approval Program based on the objective response rate (ORR) and duration of response (DoR) observed in a single-arm, multicenter Phase 2 study. Continued approval may be contingent upon verification of clinical benefit in the confirmatory Phase 3 ASCENT study, which was recently halted by the independent Data Safety Monitoring Committee (DSMC) for compelling evidence of efficacy across multiple endpoints.

"The approval of Trodelvy, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease," stated Aditya Bardia, MD, MPH, Director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center and Assistant Professor of Medicine at Harvard Medical School. Dr. Bardia was the lead investigator of the Phase 2 study. "In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer."

In the single-arm Phase 2 study, Trodelvy demonstrated an ORR of 33.3 percent (95 percent CI: 24.6, 43.1) and a median DoR of 7.7 months (95 percent CI: 4.9, 10.8), as determined by local assessment, in 108 adult TNBC patients who had previously received a median of three prior systemic therapies in the metastatic setting (range: 2-10).1

"We are proud to bring Trodelvy to patients with metastatic TNBC who are in dire need of new options. Trodelvy has the potential to become a standard of care in in the management of TNBC, and we anxiously await the results of ongoing studies in other types of metastatic breast cancer," said Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics. "This approval highlights the potential of our unique ADC platform and strengthens the premise that the Trop-2 antigen found in many solid cancers is an important target for drug delivery. We are committed to broadening the potential use of Trodelvy in other Trop-2-expressing cancers, especially those with unmet need."

Trodelvy carries a black box warning for severe neutropenia and severe diarrhea. The most common adverse reactions occurring in 25 or more percent of patients included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash and abdominal pain. The most common Grade 3 or 4 adverse events occurring in more than 5 percent of patients were neutropenia, white blood cell count decreased, anemia, hypophosphatemia, diarrhea, fatigue, nausea and vomiting. Two percent of patients discontinued treatment due to adverse events. There were no deaths related to treatment and no severe cases of neuropathy or interstitial lung disease.1

"Trodelvy’s approval is a major milestone in our transformation from a research-based organization to a fully-integrated biopharmaceutical company, underscoring our commitment to bring innovative therapies to patients with hard-to-treat cancers," said Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "We are grateful to all of the patients, their families, physicians, and nurses who participated in our clinical trials and played a significant role in making this moment possible."

The Company recently announced that the Phase 3 confirmatory ASCENT study of Trodelvy in metastatic TNBC, with over 500 patients enrolled, will be stopped early due to compelling efficacy across multiple endpoints, based on the unanimous recommendation of the DSMC. The Company remains on track to achieve topline results from the ASCENT study by mid-2020.

Conference Call

The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss the FDA approval. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 4987526. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

About TRODELVY

Trodelvy (sacituzumab govitecan-hziy) is the lead product and the most advanced program in Immunomedics’ unique antibody-drug conjugate (ADC) platform. Trodelvy is an ADC that is directed against Trop-2, a cell-surface protein expressed in many solid cancers, making it an attractive target for Trodelvy to potentially address multiple types of cancer.2 Trodelvy binds to Trop-2 and delivers the anti-cancer drug, SN-38, to kill cancer cells. Trodelvy is currently being evaluated as a treatment for eight hard-to-treat solid cancers.

About triple-negative breast cancer

Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer, accounting for up to 20 percent of all breast cancers.3 TNBC is diagnosed more frequently in younger and premenopausal women and is highly prevalent in African American and Hispanic women.4 TNBC cells do not have estrogen or progesterone hormone receptors, or very much of the human epidermal growth factor receptor 2 – hence the term triple negative. This means that medicines that target these receptors are not typically effective in TNBC. There is currently no approved standard of care for people with previously-treated mTNBC.3