TC BioPharm Initiates Phase I Trial of Allogeneic Gamma Delta T Cell Therapy in Acute Myeloid Leukemia Patients

On April 24, 2019 TC BioPharm (TCB), a developer of allogeneic CAR-T immuno-oncology products, and leaders in Gamma Delta T (GDT) cell therapies, reported it has initiated a Phase I clinical study of TCB002, an allogeneic cell therapy consisting of activated and expanded gamma delta T cells (Press release, TC Biopharm, APR 24, 2019, View Source [SID1234535362]). The trial, for treatment of patients suffering from Acute Myeloid Leukemia (AML), is being conducted at the Institute of Hematology and Blood Transfusion (ÚHKT) in Prague, Czech Republic. Patient recruitment commenced January 2019 following regulatory approval late 2018. Dose escalation is in progress, with completion of treatment imminent for the first patient cohort. The clinical trial is registered with identifier NCT03790072.

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Developed by TC BioPharm, TCB002 comprises GDT cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. The donors are selected based on criteria designed to ensure that the cells are potent killers of cancer cells, and can be a more effective and consistent treatment compared to the patient’s own cells. GDT cells are a subset of lymphocytes which have both innate and adaptive immune properties and represent an emerging therapeutic option for cancer and other diseases. Use of allogeneic GDT cells from healthy donor cell banks paves the way for development of superior drug products through screening and selection of the highest quality starting material, facilitating preparation of consistent batches capable of treating many patients.

The study in Prague is designed to provide safety data on allogeneic use of GDTs prior to subsequent use of CAR-modified variants later in the year. GDTs are an obvious vehicle for allogeneic cell therapies as they do not elicit ‘graft versus host’ rejection. TCB is developing its proprietary GDT CAR-T (Chimeric Antigen Receptor T Cell) platform in a stepwise manner, evolving the clinical development program from autologous to allogeneic to CAR-modified products.

The first human trial of TCB002 is an ICH GCP compliant, open-label single arm study expected to enroll 9 patients, with three escalating doses of the drug product. Cancer patients in the study are suffering from relapsed or refractory AML and are ineligible or non-consenting to a stem cell transplant. The product is manufactured at TCB’s GMP-compliant manufacturing site in the UK using cells sourced from healthy allogeneic donors. The development of this allogeneic product has been supported by a €4m grant from the European Union’s Horizon 2020 research and innovation program.

Angela Scott, Chief Operating Officer, TC BioPharm, said: "Treatment of the first patients with TCB002 represents the culmination of a concerted collective effort from our in-house product development, quality, manufacturing, regulatory and clinical teams, as well as the expert physicians at ÚHKT. We are now focused on successful completion of this trial and the progression of our CAR-T products to treat further patient groups with unmet clinical needs, as part of our strategic plan of delivering allogeneic CAR-T medicines as mainstream cancer therapies."

Prof. Petr Cetkovský, Director, ÚHKT, added: "Collaborating with TC BioPharm on clinical evaluation of Advanced Therapy Medicinal Products allows us to offer experimental options to patients with acute clinical need, and builds upon our position of expertise with pioneers of cellular immuno-oncology products."

This project has received funding from the European Union’s Horizon 2020 Research and Innovation program.

Bicycle Therapeutics to Present Immune Oncology CD137 Data on Multivalent and Tumour-targeted Bispecific Bicycles at Peptides Congress

On April 24, 2019 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that Punit Upadhyaya, Ph.D., Senior Scientist at Bicycle, will present at the 6th Annual Peptides Congress in London (Press release, Bicycle Therapeutics, APR 24, 2019, View Source [SID1234535361]). The presentation, entitled "Bicycles as T-cell Modulators: Activation of CD137 Using Multivalent and Tumour-targeted Bicycle Peptides," will take place on Thursday, April 25, at 12:00 BST.

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"Our T-cell targeting Bicycles are set apart from other biological approaches because they are fully synthetic and modular, which is designed to enable the rapid creation of molecules with unique drug-like properties," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "We’re looking forward to sharing research showcasing that our multivalent and tumour-targeted bispecific Bicycles robustly activate CD137 positive T-cells in in vivo disease models as well as in patient-derived material."

BioCryst to Report First Quarter 2019 Financial Results on May 8

On April 24, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its first quarter 2019 financial results on Wednesday, May 8, 2019 (Press release, BioCryst Pharmaceuticals, APR 24, 2019, View Source [SID1234535360]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 1777029. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 1777029.

BERGENBIO ASA: INVITATION TO FIRST QUARTER PRESENTATION AND WEBCAST

On April 24, 2019 BerGenBio ASA (OSE:BGBIO), reported that it will announce its results for the first quarter on Wednesday, 8 May 2019 (Press release, BerGenBio, APR 24, 2019, View Source [SID1234535359]). A presentation by BerGenBio’s senior management team will take place at 10:00 am CET at:

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Felix Konferansesenter,
Bryggetorget 3,
0125 Oslo.

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

-Ends-

Contacts
Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Jessica Hodgson, Nicholas Brown, Carina Jurs, Consilium Strategic Communications
[email protected]
+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
[email protected]
+47 995 13 891

Thermo Fisher Scientific Reports First Quarter 2019 Results

On April 24, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the first quarter ended March 30, 2019 (Press release, Thermo Fisher Scientific, APR 24, 2019, View Source [SID1234535358]).

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First Quarter 2019 Highlights

First quarter revenue increased to $6.12 billion.
First quarter GAAP diluted earnings per share (EPS) increased 41% to $2.02.
First quarter adjusted EPS increased 12% to $2.81.
Launched a range of new products, including two Thermo Scientific instruments for materials analysis – the Nicolet Summit FTIR spectrometer and the Helios 5 DualBeam scanning electron microscope – and in specialty diagnostics, received FDA clearance for a new ImmunoCAP test for peanut allergy.
Recently opened new Customer Solution Centers in Beijing and Delhi to help scientists in the food and beverage industry develop advanced analytical workflows that improve food quality and safety.
Announced $150 million expansion of our pharma services sites in Italy and North Carolina to increase capacity and capabilities of our global sterile manufacturing network and meet growing customer demand for biologics development and manufacturing services.
Announced agreement to acquire Brammer Bio, a leader in viral vector manufacturing, for $1.7 billion, significantly expanding our capabilities in the fast-growing gene and cell therapy market.
Repurchased $750 million of stock and increased our dividend by 12 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 pleased to deliver another quarter of excellent growth on the top and bottom line," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Our teams are strengthening our competitive position by successfully executing our growth strategy – a combination of launching great new products, leveraging our scale in high-growth and emerging markets, and enhancing our unique value proposition to be the strongest partner possible for our customers.

"I’m especially excited about our pending acquisition of Brammer Bio, which we announced in March. As a leader in viral vector manufacturing, Brammer Bio helps pharma and biotech customers deliver breakthrough gene and cell therapies to patients with rare diseases. We also continue to deploy capex to expand our pharma services capacity and capabilities in the U.S. and Europe to meet increasing customer demand and ultimately make a difference for countless patients and their families."

Casper added, "We’re off to a strong start, and we’re on track to deliver another outstanding year."

First Quarter 2019

Revenue for the quarter grew 5% to $6.12 billion in 2019, versus $5.85 billion in 2018. Organic revenue growth was 7%; acquisitions increased revenue by 1% and currency translation decreased revenue by 3%.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2019 increased 41% to $2.02, versus $1.43 in the same quarter last year. GAAP operating income for the first quarter of 2019 grew to $0.92 billion, compared with $0.79 billion in the year-ago quarter. GAAP operating margin increased to 15.0%, compared with 13.4% in the first quarter of 2018.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2019 increased 12% to $2.81, versus $2.50 in the first quarter of 2018. Adjusted operating income for the first quarter of 2019 grew 7% compared with the year-ago quarter. Adjusted operating margin was 22.4%, compared with 22.0% in the first quarter of 2018.

2019 Guidance Update

Thermo Fisher is raising its 2019 revenue and earnings guidance to reflect strong operational performance and the acquisition of Brammer Bio, partially offset by a more adverse foreign exchange environment. The company is raising its revenue guidance to a new range of $25.17 to $25.47 billion versus its previous guidance of $24.88 to $25.28 billion. This would result in 3 to 5% revenue growth over 2018. The company is raising its adjusted EPS guidance to a new range of $12.08 to $12.22, versus its previous guidance of $12.00 to $12.20, for 9 to 10% growth year over year.

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 2019, Life Sciences Solutions Segment revenue grew 7% to $1.61 billion, compared with revenue of $1.50 billion in the first quarter of 2018. Segment adjusted operating margin increased to 34.9%, versus 34.5% in the 2018 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 5% to $1.32 billion in the first quarter of 2019, compared with revenue of $1.26 billion in the first quarter of 2018. Segment adjusted operating margin increased to 21.3%, versus 19.6% in the 2018 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue increased 1% to $0.96 billion in the first quarter of 2019, compared with revenue of $0.95 billion in the first quarter of 2018. Segment adjusted operating margin was 25.3%, versus 25.6% in the 2018 quarter.

Laboratory Products and Services Segment

In the first quarter of 2019, Laboratory Products and Services Segment revenue grew 4% to $2.51 billion, compared with revenue of $2.41 billion in the first quarter of 2018. Segment adjusted operating margin was 11.3%, versus 11.6% in the 2018 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, the impact of significant tax audits or events and the results of discontinued operations. 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, and also excludes operating cash flows from discontinued operations 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 2019, adjusted EPS will exclude approximately $3.23 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, the early retirement of debt and discontinued operations.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures, and also excludes operating cash flows from discontinued operations 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 24, 2019, 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 10, 2019.