On April 25, 2018 Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, reported that Cancer Research UK has released the first cGMP (current Good Manufacturing Practice) clinical grade lot of AST-VAC2 to be used to dose subjects enrolling into the first clinical study evaluating AST-VAC2 in non-small cell lung cancer (Press release, Asterias Biotherapeutics, APR 25, 2018, View Source;date=April+25%2C+2018&title=Asterias+Announces+Clinical+Grade+Lot+Released+to+Support+Dosing+of+First+Subjects+in+First+Clinical+Study+of+AST-VAC2 [SID1234525669]).

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"With the release of the first clinical grade lot of AST-VAC2 the first-in-human clinical trial of AST-VAC2 is expected to be initiated soon," stated Mr. Michael Mulroy, President and Chief Executive Officer. "With its potential as a ready-to-administer, off-the-shelf cancer immunotherapy, AST-VAC2 represents an exciting opportunity for Asterias to be more fully recognized as a participant in the rapidly evolving immuno-oncology sector."

Investigational therapies intended for human clinical applications must be manufactured in accordance with cGMP standards designed to help assure the safety and potency of drug products. To achieve cGMP standards, a product must be manufactured and released according to rigorous systems designed to ensure appropriate control of manufacturing facilities, equipment, raw materials, processes and testing procedures. Under the company’s agreement with Cancer Research UK, Asterias has transferred its innovative laboratory scale AST-VAC2 manufacturing process to Cancer Research UK’s Biotherapeutics Development Unit, which has developed, optimized and validated the process for cGMP manufacture and is responsible for producing cGMP AST-VAC2 for use in the upcoming Phase 1 clinical study in non-small cell lung cancer.

With the release of the clinical lot of AST-VAC2, the Company anticipates three sites opening for this study shortly and the first subjects to be dosed in the first half of 2018. As currently designed, the study will enroll up to 24 subjects into one of two cohorts, depending on the stage of each subject’s non-small cell lung cancer.

AST-VAC2 is a "first-in-class" allogeneic cancer immunotherapy that is composed of mature dendritic cells which are designed to kill tumor cells by stimulating immune responses to telomerase, a tumor antigen expressed by over 85% of malignant tumor cells. AST-VAC2 is intended to be available for "on demand" patient use because it is produced from allogeneic pluripotent stem cells that can be manufactured in scale and then cryopreserved.

AST-VAC2 is a platform cancer immunotherapy that could be investigated as a potential therapeutic for many cancer indications and for targeting of many antigens. The results from the Phase 1 clinical trial sponsored by Cancer Research UK could be used to support advanced clinical studies in one or more of the following areas:

Non-small cell lung cancer
Other indications showing high levels of telomerase activity and susceptibility to immunotherapy
In combination with check point or immune pathway inhibitors
In combination with additional antigens, including those arising from the exciting new field of tumor neoantigens
About AST-VAC2

AST-VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) AST-VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumor cells, but rarely found in normal cells. The modified form of telomerase invokes enhanced stimulation of immune responses to the protein. Similar to an earlier, Asterias-sponsored, hematological cancer program which provided proof-of-concept data, the AST-VAC2 dendritic cells instruct the immune system to generate responses against telomerase and, through this mechanism, target tumor cells. AST-VAC2 is based on a specific mode of action that is complementary to and potentially synergistic with other immune therapies such as checkpoint inhibitors or other immune pathway inhibitors.

About Non-Small Cell Lung Cancer and the AST-VAC2 Trial

Lung cancer (both small cell and non-small cell) is the leading cause of cancer-related death, accounting for about one-quarter of all cancer deaths and more than colorectal, breast, and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of lung cancers, according to the American Cancer Society. The three main types of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The American Cancer Society’s estimates for lung cancer in the United States for 2017 are: about 222,500 new cases of lung cancer, and about 155,870 deaths from lung cancer. Despite the large number of people afflicted by non-small cell lung cancer, patients remain vastly underserved due to a scarcity of effective treatments. According to statistics published by Cancer Research UK, the five year survival rate for lung cancer patients in England and Wales is less than 10%.

As currently designed, the AST-VAC2 Phase 1 clinical trial will enroll up to twenty-four subjects into one of two cohorts, depending on the stage of their non-small cell lung cancer. The first cohort will evaluate AST-VAC2 in up to 12 subjects with advanced non-small cell lung cancer. Subjects in this cohort, who carry the major histocompatibility gene, HLA-A2, will receive six weekly injections of AST-VAC2 and will be followed for safety, immune responses to telomerase and overall clinical survival. These survival results will be compared directly to a control group who meet all of the other inclusion/exclusion criteria but do not possess the HLA-A2 gene. Assuming safety is demonstrated in the first cohort, enrollment will advance to a second cohort. In the second cohort, early stage subjects who have had successful resection of their tumor with no evidence of metastasis will be enrolled. Up to 12 subjects in this second cohort who carry the major histocompatibility allele HLA-A2 will receive six, weekly injections of AST-VAC2 and will be followed for safety, immune responses to telomerase, overall clinical survival and time to relapse. These survival results will again be compared directly to a control group who meet all of the inclusion/exclusion criteria of cohort 2 but are not HLA-A2+. Subjects will be followed for one year for immune response to telomerase and for 2 years for the survival endpoints. Asterias and Cancer Research UK are exploring the combination of AST-VAC2 with an immune pathway inhibitor.

On April 25, 2018 LabCorp (or the Company) (NYSE: LH) reported results for the first quarter ended March 31, 2018, and updated 2018 guidance (Press release, LabCorp, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344448 [SID1234525667]).

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"We delivered another outstanding quarter, with strong results from each of our businesses demonstrating the power of our multi-faceted platform for growth," said David P. King, chairman and CEO. "The Drug Development business had terrific performance, highlighted by organic revenue growth, robust margin improvement, and continued strength in book-to-bill. The Diagnostics business generated industry-leading organic volume growth despite adverse weather, and expanded key partnerships. As we have highlighted, our Diagnostics and Drug Development businesses are individual market leaders and, as an enterprise, we offer a unique ‘beyond-lab, beyond-CRO’ combination to our business partners. We continue to grow as a global leader in life sciences, positioning us to deliver long-term growth and substantial shareholder value."

Adoption of ASC 606

Effective January 1, 2018, the Company adopted the FASB-issued converged standard on revenue recognition (ASC 606), using the full retrospective method. Unless otherwise indicated, all financial results in 2017 and comparisons to financial results in 2017 have been restated in this press release as if the Company had adopted ASC 606 on January 1, 2017. This accounting change affects the Company’s Diagnostics and Drug Development businesses differently, as explained in this press release; for the enterprise, the accounting change increases revenue, lowers earnings, and has no impact on cash flow. Tables comparing the full-year financial results in 2017 as well as the first quarter financial results in 2018 and 2017 under ASC 606 to the Company’s results for the applicable periods under the prior revenue recognition accounting standard (ASC 605) appear at the end of this press release. In addition, the Company furnished a Supplemental Financial Information presentation on Form 8-K dated April 25, 2018, which includes quarterly financial results in 2017 and full-year financial results in 2016 under ASC 606.

Consolidated Results

First Quarter Results

Revenue for the quarter was $2.85 billion, an increase of 18.0% compared to $2.41 billion in the first quarter of 2017. The increase in revenue was due to growth from acquisitions of 13.4%, organic growth of 3.2%, and the benefit from foreign currency translation of approximately 150 basis points.

Operating income for the quarter was $305.4 million, or 10.7% of revenue, compared to $318.1 million, or 13.2%, in the first quarter of 2017. The decrease in operating income and margin were primarily due to higher restructuring charges, special items, and amortization which together totaled $130.3 million in the quarter, compared to $58.6 million during the same period in 2017. This change was primarily due to acquisition-related costs, and the payment of a one-time bonus to non-bonus-eligible employees following the implementation of the Tax Cuts and Jobs Act of 2017 (TCJA). Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $435.7 million, an increase over last year’s $376.7 million primarily due to acquisitions, organic revenue growth, and the Company’s LaunchPad business process improvement initiative. Adjusted operating margin for the quarter was 15.3% of revenue, down from 15.6% in the first quarter of 2017, due to acquisition mix.

Net earnings in the quarter were $173.2 million, compared to $183.0 million in the first quarter of 2017. Diluted EPS were $1.67 in the quarter, a decrease of 4.6% compared to $1.75 in the same period in 2017. Adjusted EPS (excluding amortization, restructuring charges and special items) were $2.78 in the quarter, an increase of 30.5% compared to $2.13 in the first quarter of 2017.

Operating cash flow for the quarter was $154.7 million, compared to $225.9 million in the first quarter of 2017. The reduction in operating cash flow was driven by the one-time bonus payment related to tax reform and higher working capital to support growth, partially offset by higher cash earnings. Capital expenditures totaled $72.5 million, compared to $72.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $82.2 million, compared to $153.7 million in the first quarter of 2017.

At the end of the quarter, the Company’s cash balance and total debt were $361.8 million and $6.8 billion, respectively. During the quarter, the Company repurchased $75.0 million of stock representing approximately 0.4 million shares. On April 24, 2018, the board authorized an increase in the Company’s share repurchase program to a total of $1.0 billion.

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The following segment results have been restated in this press release as if the Company had adopted ASC 606 on January 1, 2017, and exclude amortization, restructuring charges, special items and unallocated corporate expenses.

First Quarter Segment Results

LabCorp Diagnostics

Revenue for the quarter was $1.77 billion, an increase of 8.0% over $1.64 billion in the first quarter of 2017. The increase in revenue was primarily driven by acquisitions, organic volume (measured by requisitions), and the benefit from foreign currency translation of approximately 30 basis points, partially offset by lower Medicare reimbursement as a result of the implementation of the Protecting Access to Medicare Act (PAMA), and the impact from adverse weather. Total volume (measured by requisitions) increased by 6.9%, of which organic volume was 3.0% and acquisition volume was 3.9%. Revenue per requisition increased by 0.7%.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $364.0 million, or 20.6% of revenue, compared to $341.8 million, or 20.8%, in the first quarter of 2017. The increase in operating income was primarily due to strong revenue growth, as the negative impact of adverse weather was largely offset by a favorable legal settlement. The decline in operating margin was due to the negative impact from PAMA, partially offset by strong revenue growth.

Covance Drug Development

Revenue for the quarter was $1.08 billion, an increase of 39.3% over $0.77 billion in the first quarter of 2017. The increase was primarily due to acquisitions, as well as organic growth and the benefit from foreign currency translation of approximately 390 basis points.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $108.0 million, or 10.0% of revenue, compared to $68.1 million, or 8.8%, in the first quarter of 2017. The increase in operating income was due to organic demand, LaunchPad savings and acquisitions. The Company remains on track to deliver $150 million of net savings from LaunchPad and $30 million of cost synergies from the integration of Chiltern by the end of 2020.

Net orders and net book-to-bill during the trailing twelve months were $4.84 billion and 1.29, respectively. Backlog at the end of the quarter was $9.17 billion, and the Company expects approximately $3.7 billion of this backlog to convert into revenue in the next twelve months.

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Outlook for 2018

In the following guidance, all financial results in 2017 and comparisons to financial results in 2017 have been restated in this press release as if the Company had adopted ASC 606 on January 1, 2017. The guidance assumes foreign exchange rates effective as of March 31, 2018 for the remainder of the year, and includes capital allocation.

Revenue growth of 10.0% to 12.0% over 2017 revenue of $10.31 billion, which includes the benefit of approximately 90 basis points of foreign currency translation. This is higher than the prior guidance of 9.5% to 11.5% due to strong organic growth, and a favorable change in currency translation.
Revenue growth in LabCorp Diagnostics of 3.5% to 5.5% over 2017 revenue of $6.86 billion, which includes the negative impact of PAMA as well as the benefit of approximately 20 basis points of foreign currency translation. This is higher than the prior guidance of 3.0% to 5.0% primarily due to strong organic growth.
Revenue growth in Covance Drug Development of 21.0% to 25.0% over 2017 revenue of $3.45 billion, which includes the benefit of approximately 230 basis points of foreign currency translation. This is higher than the prior guidance of 20.0% to 24.0% due to a favorable change in currency translation.
Adjusted EPS of $11.30 to $11.70, an increase of approximately 22.2% to 26.5% over 2017 adjusted EPS of $9.25. This guidance is unchanged from prior guidance, but now includes the projected negative impact of $0.20 to $0.30 for the full year in 2018 from ASC 606, offset by strong first quarter results and an improved outlook for the remainder of the year.
Free cash flow (operating cash flow less capital expenditures) of $1.1 billion to $1.2 billion, compared to $1.1 billion in 2017, unchanged from prior guidance.
Use of Adjusted Measures

The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted EPS, adjusted operating income, free cash flow, and certain segment information. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is furnishing a Current Report on Form 8-K that will include additional information on its business and operations. This information will also be available in the investor relations section of the Company’s website at www.labcorp.com. Analysts and investors are directed to the Current Report on Form 8-K and the website to review this supplemental information.

A conference call discussing LabCorp’s quarterly results will be held today at 9:00 a.m. Eastern Time and is available by dialing 844-634-1444 (615-247-0253 for international callers). The access code is 3095857. A telephone replay of the call will be available through May 9, 2018 and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 3095857. A live online broadcast of LabCorp’s quarterly conference call on April 25, 2018, will be available at View Source or at View Source beginning at 9:00 a.m. Eastern Time. This webcast will be archived and accessible through April 19, 2019.

Takeda’s current bid implies an equivalent value of around £49 per Shire ordinary share, comprised of around £27.26 in new Takeda shares and £21.75 in cash (Press release, Shire, APR 25, 2018, View Source,_takeda_move_closer_to_merger_deal_1233173 [SID1234525666]).

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At completion, Shire shareholders would own around 50 percent of the new group, with shares listed in Japan and in the US through an ADR programme.

Shire noted that the making of any firm offer by Takeda would be subject to agreement of certain other terms of the latest proposal, completion of a due diligence review by Takeda, the unanimous recommendation of the Board of Shire, and final approval by the Japanese drugmaker.

On April 25, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported that the abstract highlighting new data from the Company’s adaptive Phase 1 clinical trial for ZW25 has been selected for an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held in Chicago from June 1 through 5, 2018 (Press release, Zymeworks, APR 25, 2018, View Source [SID1234525665]).

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The oral presentation, entitled "Single Agent Activity of ZW25, a HER2 Targeted Bispecific Antibody, in Heavily Pretreated HER2 Expressing Cancers," is scheduled for Friday June 1, 2018 at 2:45 pm CT during the session on Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics in room S406.

"We look forward to sharing the updated ZW25 data and are honored that it has been selected by ASCO (Free ASCO Whitepaper) for an oral presentation at their annual meeting," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "With over 35,000 oncology professionals from around the world anticipated to attend, it is an excellent opportunity to share an update of the data and to establish new relationships to realize the full potential of this therapeutic candidate."

Phase 1 Testing of ZW25

Zymeworks’ adaptive Phase 1 study is divided into three parts. Enrollment in the first portion of the study (the dose-escalation phase) has been completed. The Company has previously reported preliminary results from this part of the trial showing encouraging tolerability and anti-tumor activity in heavily pretreated patients with HER2-expressing cancers, including breast and gastric cancers.

In the second part of the study, which is now ongoing, expansion cohorts are being enrolled to further assess ZW25’s tolerability and single agent anti-cancer activity. The five cohorts include patients with HER2 high breast, HER2 high gastric, HER2 intermediate breast, HER2 intermediate gastric, and other HER2-expressing cancers.

The third part of the study, which is also ongoing, is evaluating the safety and anti-tumor activity of ZW25 in combination with selected chemotherapy agents in patients with HER2 low to high-expressing breast cancer or HER2 intermediate to high-expressing gastric cancers.

About ZW25

ZW25 is being evaluated in a Phase 1 clinical trial in the United States and Canada. It is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function and has led to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2.

On April 25, 2018 INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported that it will release its first quarter 2018 financial results on Tuesday, May 8, after the U.S. financial markets close (Press release, Insys Therapeutics, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344410 [SID1234525664]).

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Following the release, Saeed Motahari, president and chief executive officer, and Andrew Long, chief financial officer, will host a conference call at 5:00 p.m. Eastern Daylight Time to discuss the results.

Interested parties can listen to the call live as it occurs via the company’s website, View Source, on the Investors section’s Presentations & Events page; or by dialing 844-263-8304 (from inside the U.S.) or 213-358-0958 (from outside the U.S.), and using the Conference ID 6338979. A webcasted replay of the call will be available on the site a few hours after the event.