On June 28, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq (atezolizumab) plus chemotherapy (Abraxane; nab-paclitaxel) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease (Press release, Hoffmann-La Roche, JUN 28, 2019, View Source [SID1234537324]).

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"This CHMP recommendation marks a breakthrough in the treatment of triple-negative breast cancer, an aggressive type of breast cancer with high unmet medical need," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "With today’s announcement, we hope that people living with PD-L1-positive metastatic triple-negative breast cancer in Europe will soon have a new treatment option with the Tecentriq combination."

The CHMP recommendation is based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (progression-free survival; PFS) by 38% compared with nab-paclitaxel alone (median PFS=7.5 vs 5 months; HR=0.62, 95% CI: 0.49–0.78, p<0.0001) in people who were tested positive for PD-L1 expression on tumour-infiltrating immune cells (IC). The Tecentriq combination showed a clinically meaningful overall survival (OS) improvement of seven months vs nab-paclitaxel alone in the PD-L1-positive population (median OS=25.0 vs 18.0 months; HR=0.71, 95% CI: 0.54–0.93). OS results in the PD-L1-positive population were not formally tested due to the hierarchical design of the study, as statistical significance was not met for OS in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72–1.02, p=0.078). The study will continue until the next planned analysis.

The assessment of PD-L1 on tumour-infiltrating immune cells is essential for identifying the TNBC patients benefiting from this Tecentriq combination. PD-L1 expression status in the IMpassion130 study was assessed by the VENTANA PD-L1 (SP142) assay.

Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual study medicines or underlying disease, and no new safety signals were identified with the combination. Serious adverse events (SAEs) were reported in 23% of people receiving Tecentriq plus nab-paclitaxel, compared with 18% of people receiving chemotherapy alone. Grade 3–4 AEs were reported in 49% of people receiving Tecentriq plus nab-paclitaxel, compared with 42% of people receiving chemotherapy alone.

Currently, Roche has seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease.

About the IMpassion130 study
IMpassion130 is a Phase III, multicentre, randomised, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer. The study enrolled 902 people who were randomised equally (1:1) The co-primary endpoints are PFS per investigator assessment (RECIST 1.1) in the ITT population and in the PD-L1-positive population, and OS in the ITT population and in the PD-L1-positive population. Performing a test for statistical significance for OS in the PD-L1-positive population is dependent upon OS results from all randomised patients. PD-L1 expression status was assessed by the VENTANA PD-L1 (SP142) Assay. Secondary endpoints include objective response rate and duration of response.

About triple-negative breast cancer
Breast cancer is the most common cancer among women, with more than 2 million diagnosed worldwide each year.1 TNBC represents 15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.2,3,4 It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification.5 Patients with metastatic TNBC generally experience rapid progression and shorter OS, compared with other subtypes of breast cancer.3

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.

Our targeted medicines Herceptin, Perjeta and Kadcyla are continuing to transform the treatment of early and advanced HER2-positive breast cancer and, through our Tecentriq and ipatasertib clinical programmes, we hope to bring new treatment combinations to people with breast cancer, ultimately improving outcomes.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy (CIT) that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and/or countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source

On June 28, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported that the Company has strategically expanded its presence in Europe and Latin America to grow its global clinical research and development capacity (Press release, Athenex, JUN 28, 2019, View Source;p=RssLanding&cat=news&id=2402595 [SID1234537323]). The Company believes these initiatives have the potential to enhance Athenex’s capacity to conduct global clinical studies and support its regional marketing decision process. They are part of the Company’s strategy to build on its current strong presence in U.S. and Asia, and help maximize the global potential of its pipeline.

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Athenex’s oncology-focused pipeline currently has nine clinical candidates, including two drug candidates in Phase III development. In line with the Company’s goal to expand its capability and bandwidth to optimize global development and commercialization of its pipeline products, Athenex has been evaluating operational opportunities in Europe and Latin America.

As part of Athenex’s strategy to establish operations in Europe, the second largest healthcare market in the world, the Company has formed a subsidiary in the United Kingdom and established offices in Manchester. The Company is currently conducting clinical studies in the United Kingdom and intends to continue expanding its research and development capabilities in the region.

In Latin America, Athenex recently entered into a definitive agreement to acquire certain assets of CIDAL Limited in exchange for shares of Athenex common stock, subject to customary closing conditions. CIDAL is a contract research organization with headquarters in Guatemala and operations in various countries in Latin America. CIDAL has provided important CRO services and support to Athenex, including for its Phase III study of oral paclitaxel and encequidar for metastatic breast cancer. The asset purchase is expected to strengthen Athenex’s clinical research and operations capabilities and support the Company’s clinical development worldwide.

"These initiatives represent an important step in our ongoing strategic efforts to expand our clinical research and operations for global development, with the potential for increased clinical research efficiencies and cost-effectiveness" said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "Our office in Manchester will enable us to evaluate the best strategy for Europe, an important market for Athenex. We have been engaging with many experienced pharma/biotech specialists who are already contributing to our research programs and look forward to working more closely with these talents. We are also delighted to extend our operations in Latin America through CIDAL, which we believe will increase our bandwidth for clinical research and regulatory development. We believe having a stronger presence in these territories will position us well to evaluate new R&D and commercialization opportunities in Europe and Latin America."

On June 27, 2019 Curve Therapeutics (Curve) a private biotechnology company pioneering a potentially game-changing, functional drug discovery platform, reported a seed investment of £2.25 Mn from Advent Life Sciences, a leading trans-Atlantic venture investor focused on building innovative Life Sciences businesses in the UK, Europe and the USA (Press release, Curve Therapeutics, JUN 27, 2019, View Source [SID1234640603]).

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Curve originated from world-leading Microcycle research conducted by Professor Tavassoli’s group in the Department of Chemistry at the University of Southampton, UK. The company is pioneering a game-changing, functional, drug discovery engine to generate higher quality functional hits and leads with the aim of discovering first-in-class therapeutics against challenging therapeutic targets.

On June 27, 2019 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the fourth quarter and full year of fiscal 2019 ended April 30, 2019 (Press release, Avid Bioservices, JUN 27, 2019, View Source [SID1234539009]).

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Highlights Since January 31, 2019

"Fiscal 2019 was a fundamentally transformative year for Avid, as the team successfully achieved a number of critical goals. Most notably, we converted the losses and negative margins in fiscal 2018 into a sustainable position of financial strength," stated Rick Hancock, interim president and chief executive officer. "Based on our current backlog as well as forecasts from our customers, we believe the company will achieve sustainable growth going forward. Avid is stronger today than it has been at any point in the past.

"With respect to business development, the five new clients signed in late fiscal 2018 contributed significantly to revenue diversification in fiscal 2019. These projects substantially increased capacity utilization, which drove a meaningful improvement in margins during the year.

"Of particular note is the new business we continue to win from existing customers. While some of this business results from the expansion of current projects, many of these projects are completely new, requiring development and/or manufacture of a new molecule. These ‘repeat business’ wins are particularly valuable to Avid as each offers the opportunity for later stage and commercial production, they generally onboard very efficiently and as a result are more profitable, and they provide strong testimonials as to the quality of our work and product."

"Avid finished the year with a strong fourth quarter, growing revenue to $17.1 million while increasing gross margins to 21 percent," said Dan Hart, chief financial officer. "During the fourth quarter we generated $5.6 million in operating cash flow increasing our net cash and cash equivalents by $4.6 million to $32.4 million. Looking ahead, we are encouraged by the forecasted increase in demand which we expect to strengthen the company’s overall financial standing and position us for profitability."

Financial Highlights and Guidance

The company is providing revenue guidance for the full fiscal year 2020 of $64 million – $67 million (ASC 606).

Revenue was $17.1 million for the fourth quarter of fiscal 2019, a 146% increase compared to $6.9 million for the fourth quarter of last fiscal year. This increase is primarily due to growing demand from a more diversified client base. Revenue for the full fiscal year 2019 met guidance at $53.6 million, and was flat compared to full fiscal year 2018.

As of April 30, 2019, revenue backlog was approximately $46 million, the majority of which is expected to be recognized in fiscal year 2020.

Gross margin for the fourth quarter of fiscal 2019 was 21%, and gross margin for full fiscal year 2019 was 13%, both representing significant improvements compared to gross margins of negative 28% during the fourth quarter of fiscal 2018 and negative 5% for full fiscal year 2018. The improvements in gross margins for both fiscal 2019 periods were primarily attributed to our product mix, increased capacity utilization and a reduction in direct manufacturing costs.

Selling, general and administrative expenses ("SG&A") for the fourth quarter of fiscal 2019 were $3.6 million, or 21% of revenue, compared to $4.2 million, or 60% of revenue, for the fourth quarter of last year. For full fiscal year 2019, total SG&A expenses were $12.8 million, or 24% of revenue compared to $16.5 million last fiscal year, or 31% of revenue. The decrease in SG&A was primarily due to a reduction in payroll and related costs, legal fees and other professional consulting fees, and facility costs, which were partially offset by increases in bonuses related to certain achievement levels of corporate goals and stock-based compensation.

During the fourth quarter of fiscal 2019 we generated income from continuing operations of $0.2 million compared to a net loss from continuing operations of $6.1 million for the fourth quarter of fiscal 2018. Fiscal year 2019 loss from continuing operations was $5.1 million compared to a prior year loss from continuing operations of $20.6 million. The decrease during the full fiscal year was primarily due to reductions in both cost of revenues and SG&A resulting in higher profitability margins.

For the fourth quarter of fiscal 2019, the company recorded consolidated net loss attributable to common stockholders of $1.1 million or $0.02 per share, compared to a consolidated net income attributable to common stockholders of $1.6 million or $0.03 per share, for the fourth quarter of fiscal 2018. For full fiscal year 2019, the company recorded a consolidated net loss attributable to common stockholders of $8.9 million or $0.16 per share, compared to a consolidated net loss attributable to common stockholders of $26.5 million or $0.56 per share, for full fiscal year 2018. For both the fourth quarter and full fiscal year 2018, net income and loss were favorably impacted by the sale of the company’s legacy R&D assets to Oncologie, Inc. for $8.0 million and the associated discontinued operations.

Avid reported $32.4 million in cash and cash equivalents as of April 30, 2019, compared to $42.3 million on April 30, 2018.
More detailed financial information and analysis may be found in Avid Bioservices’ Annual Report on Form 10-K, which will be filed with the Securities and Exchange Commission today.

Recent Developments

Signed project expansion orders and new manufacturing projects related to new molecules with current clients during the fourth quarter of fiscal 2019 representing future revenue in the amount of $19.7 million.

Completed a second process validation campaign during fiscal 2019. Completion of a process validation campaign is a critical step in the regulatory product approval process, and is likely to result in future commercial production at Avid.

The first process validation campaign of fiscal 2020 is in progress.
Conference Call

Avid will host a conference call and webcast this afternoon, June 27, 2019, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

On June 27, 2019 Vivoryon Therapeutics AG, (Euronext Amsterdam: currently PBD, to be changed to VVY, ISIN: DE0007921835) reported that they have entered into a research collaboration with University Medical Center Schleswig-Holstein, Campus Kiel, to discover and develop first-in-class therapeutics in cancer immunotherapy (Press release, Vivoryon Therapeutics, JUN 27, 2019, View Source [SID1234537422]). Professor Thomas Valerius and his group will qualify Vivoryon’s broad portfolio of small molecule QPCTL inhibitors for their use as modulators of the CD47/SIRP-alpha myeloid immune checkpoint. These inhibitors, some of which have already been clinically tested, originated from the Company’s Alzheimer’s disease drug development program which remains to be a core focus for Vivoryon Therapeutics. Besides, these inhibitors also offer interesting therapeutic options in immuno-oncology.

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Recently published and internal research has shown that the Glutaminyl-peptide cyclotransferase-like (QPCTL) enzyme is a powerful therapeutic target to silence the "do not eat me" signal provided by the interaction of CD47 (expressed on cancer cells), with the protein SIRP-alpha (expressed on macrophages and other myeloid cells). Tumor immunotherapy that targets this interaction is a current focus of innovation in cancer drug development. Combining a therapeutic tumor-targeted antibody of choice with the inhibition of the CD47/SIRP-alpha interaction is expected to lead to significant therapeutic improvements. By possessing the broadest portfolio of small molecule QPCTL inhibitors and the clinically most advanced compounds in that field, Vivoryon Therapeutics is uniquely positioned. QPCTL inhibitors are expected to have considerable therapeutic advantages compared to antibody approaches that are currently explored in clinical studies to silence the CD47/SIRP-alpha interactions.

Dr. Michael Schaeffer, CBO of Vivoryon Therapeutics said: "We are very pleased to partner with the University Medical Center Schleswig-Holstein, who is -like us- truly dedicated to accelerating innovative cures for cancer. Professor Valerius is a renowned expert in the field of myeloid effector cells in immunotherapy. This collaboration allows us to engage multiple targets and fully exploit our unique patent position. Undoubtedly, we are now entering into one of the most exciting fields of current drug development."

Within this collaboration Vivoryon Therapeutics will fund focused research with the clear goal of further qualifying its QPCTL inhibitors in cellular cancer models. Vivoryon’s highly active compounds will be tested individually and in combination with therapeutic antibodies.

Prof. Dr. Thomas Valerius, Senior Physician at the Department of Internal Medicine II – Hematology, Oncology of the University Hospital Schleswig-Holstein, added: "Our partnership with Vivoryon Therapeutics fits well with our goal of advancing early-stage therapeutic innovation. We are delighted that we are working on some of the most exciting compounds in myeloid checkpoint inhibition today and are convinced that these molecules could lead to significant improvements in cancer immunotherapy."

The development partners confirm that the cooperation has no effect on sales transactions of the University Medical Center Schleswig-Holstein – in particular procurement processes – and there are no expectations in this connection.

For more information, please contact:

Vivoryon Therapeutics AG
Dr. Ulrich Dauer, CEO
Email: [email protected]

Universitätsklinikum Schleswig-Holstein, Campus Kiel
Medizinische Klinik II, Sektion für Stammzell- und Immuntherapie
Prof. Dr. med. Thomas Valerius
Email: [email protected]

MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: [email protected]