On July 23, 2020 Roche reported first half yearly report for 2020 (Press release, Hoffmann-La Roche, JUL 23, 2020, View Source [SID1234562238]). Group sales increase 1%1 at constant exchange rates and decline 4% in Swiss francs as a result of continued appreciation of the Swiss franc against most currencies
COVID-19 pandemic has a negative impact on sales during the second quarter; since June sales are recovering
Pharmaceuticals Division sales up 1%, driven by newly launched medicines (+37%),2 including Tecentriq, Hemlibra, Ocrevus and Perjeta, compensating for the impact of competition from biosimilars
Diagnostics Division sales grow 3%, with COVID-19 testing as the main contributor; routine testing declining as COVID-19 causes delays of patients visiting physicians
Approvals for medicines in the second quarter:
in the US: Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer; Tecentriq in combination with Avastin for people with the most common form of liver cancer; Phesgo for HER2-positive breast cancer
in Japan, Canada and Switzerland: Enspryng (satralizumab) for the treatment of a rare neurodegenerative disease (neuromyelitis optica spectrum disorder)
in Europe: Ocrevus with shorter infusion time
Completion of phase III trial enrolment for pivotal studies in Alzheimer’s and Huntington’s disease and start of four important phase III studies in oncology
Diagnostic launches in the second quarter: several tests for COVID-19 diagnosis; cobas prime, a pre-analytical system for automation in molecular labs; digital pathology algorithms for non-small cell lung cancer and breast cancer
Core earnings per share up 2%
On IFRS basis, net income increases 3%
Outlook for 2020 confirmed
Roche’s contributions to the fight against the COVID-19 pandemic in the second quarter:
Launches of several new diagnostic tools for COVID-19, including the Elecsys Anti-SARS-CoV-2 test, Roche v-TAC digital algorithm and the Elecsys IL-6 test
Production capacity for SARS-CoV-2 tests ramped up significantly
Six different medicines in 28 clinical trials for COVID-19 infections
Read-out of Covacta study with Actemra/RoActemra expected soon

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Commenting on the Group’s performance in the first half of the year, Roche CEO Severin Schwan said: "The corona pandemic continues to pose an enormous challenge worldwide. I am grateful that, in close collaboration with health authorities, we have been able to make a number of SARS-CoV-2 tests available and start several global Actemra/RoActemra phase III studies in COVID-19 pneumonia. At the same time, Roche’s regular business was significantly impacted by the pandemic in the second quarter. But we now see clear signs of recovery. Furthermore, the uptake of our recently introduced medicines and diagnostic tests continues to be strong. Based on our current assessment of the impact of the pandemic, we can confirm the outlook for the full year."

Outlook confirmed for 2020
Based on the current assessment of the COVID-19 impact, sales are expected to grow in the low- to mid-single digit range, at constant exchange rates. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to increase its dividend in Swiss francs further.

Group results
In the first half of 2020, Group sales rose 1% to CHF 29.3 billion and core EPS grew 2%, ahead of sales. IFRS net income increased 3% at constant exchange rates, due to the strong underlying core results. As a result of the continued appreciation of the Swiss franc against most currencies, the IFRS net income expressed in Swiss francs decreased 5% to CHF 8.5 billion.

Sales in the Pharmaceuticals Division increased 1% to CHF 23.2 billion. The COVID-19 pandemic had an overall negative impact on the division’s sales, especially in May. Hospitalisations and out-patient visits decreased, which particularly impacted sales of Ocrevus, Hemlibra, Lucentis and MabThera/Rituxan. Key growth drivers were the cancer medicine Tecentriq, the haemophilia medicine Hemlibra, the multiple sclerosis medicine Ocrevus, Actemra/RoActemra in immunology and Perjeta in breast cancer. The new medicines (+37%) generated sales of CHF 8.9 billion and grew by CHF 2.5 billion at constant exchange rates over 2019, more than offsetting the impact of the competition from biosimilars (CHF 2.1 billion at constant exchange rates).3

Within the Roche Group’s sales growth of 1% in the first half of 2020, there was 7% year-on-year growth in the first quarter and 4% decline in the second quarter. Especially in May, Roche’s business was impacted by the COVID-19 pandemic.
In the US, overall sales decreased 4%. While sales of Hemlibra, Ocrevus, Tecentriq and Actemra/RoActemra increased, competition from biosimilars for Herceptin, Avastin and MabThera/Rituxan impacted this growth as expected. Hemlibra sales increased 80%, resulting from the ongoing rollout in the US. Ocrevus sales increased by 19% and were driven by both new and returning patient demand. Sales of both Hemlibra and Ocrevus were partly impacted by COVID-19 effects. Tecentriq sales increased by 52%, driven by the growth in the new indications ES-SCLC and triple-negative breast cancer. In the US, as well as in other countries, an increased use of Actemra/RoActemra in patients with severe COVID-19 pneumonia can be observed as countries included it in their treatment guidelines. Actemra/RoActemra is not currently approved for this use; Roche is conducting several phase III clinical studies in severe COVID-19 pneumonia. Results from the Covacta study are expected soon.

In Europe, sales increased (+5%) as the strong demand for Tecentriq, Ocrevus, Hemlibra, Kadcyla, Perjeta and Actemra/RoActemra was able to offset the impact of lower sales of Herceptin (-33%) and MabThera/Rituxan (-34%). The first biosimilar versions of Avastin could come to market in Europe in the second half of 2020.

In the International region (+11%), growth was mostly driven by Russia and China. Growth in China resulted from a strong uptake of Perjeta and Alecensa, partially offset by the National Reimbursement Drug List price cut and COVID-19 impact for Herceptin, MabThera/Rituxan and Avastin.

Sales decreased in Japan 2%, resulting from considerable competition from biosimilars, generics and government price cuts. This decline was partially compensated by recently launched products including Tecentriq, Hemlibra and Perjeta.

Diagnostics Division sales increased 3% to CHF 6.1 billion. The business area Molecular Diagnostics (+61%) was the main growth contributor. Sales of the recently developed cobas SARS-CoV-2 PCR tests could offset the negative impact of the COVID-19 pandemic on products for routine diagnosis. Growth was reported in North America (+13%), EMEA4 (+5%), Latin America (+6%) and Japan (+1%). In the Asia-Pacific region (-9%), sales were strongly impacted by the COVID-19 pandemic shutdown in China. Overall, demand was impacted by COVID-19 in all regions in the second quarter. Routine testing decreased significantly due to a decline in regular health checks while emergency and SARS-Co-V-2 testing increased significantly.

The core operating profit increased 2% in the Pharmaceuticals Division and 9% in the Diagnostics Division.

Roche’s response to the COVID-19 pandemic
Ever since the early phase of the COVID-19 pandemic, we have been partnering with healthcare providers, laboratories, authorities and organisations to provide patients with the tests, treatments and care they need.

The portfolio of our recently developed SARS-Co-V-2 tests as well as our existing diagnostics menu for critical care have become a significant factor in supporting patient management during the COVID-19 pandemic. Roche is working closely with healthcare providers around the world, and has significantly increased production to provide tests globally.

To date no major manufacturing supply chain issues have been identified and the Group’s planned drug launches, filings, pivotal phase III trial readouts and pivotal trial starts are largely on track. The Group is continuously monitoring the situation.

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About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

On July 23, 2020 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that the European Medicines Agency (EMA) has granted access to the PRIME initiative to the Company for ADP-A2M4 for the treatment of synovial sarcoma (Press release, Adaptimmune, JUL 23, 2020, View Source [SID1234562431]). PRIME access provides enhanced scientific and regulatory support by the EMA to developers of medicines with the potential to significantly address unmet medical needs.

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"We are thrilled that the EMA has acknowledged the potential of ADP-A2M4 to address an unmet medical need for more effective treatment options for patients with advanced synovial sarcoma," said Dennis Williams, PharmD, Adaptimmune’s Senior Vice President, Late Stage Development. "Access to the enhanced EMA support and guidance offered in the PRIME scheme will facilitate the development of ADP-A2M4 to ensure this important medicine reaches patients with sarcoma as early as possible."

Access to the PRIME initiative for ADP-A2M4 was granted based on clinical data from the Phase 1 trial demonstrating compelling efficacy and early promising durability, with tolerable safety in patients with synovial sarcoma. Based on these data the Company initiated the SPEARHEAD-1 trial with ADP-A2M4, enrolling people with advanced synovial sarcoma and myxoid/ round cell liposarcoma (MRCLS) at clinical sites in Canada, France, Spain, the United Kingdom, and the United States (US). The SPEARHEAD-1 trial is intended to support the registration of ADP‑A2M4 for the treatment of advanced synovial sarcoma and MRCLS.

In recent months, the US Food and Drug Administration granted Orphan Drug Designation (ODD) to SPEAR T-cells targeting MAGE-A4 for the treatment of soft tissue sarcomas and Regenerative Medicine Advanced Therapy designation for the treatment of synovial sarcoma. In addition, The EMA’s Committee for Orphan Medicinal Products adopted a positive opinion for ODD for ADP-A2M4 for the treatment of soft tissue sarcomas.

The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. The PRIME designation is awarded by the EMA to promising medicines that target an unmet medical need. To be eligible and accepted for PRIME, a medicine must show potential to benefit patients with unmet medical needs based on early clinical data coupled with non-clinical data. Through the PRIME program, the EMA offers enhanced support to medicine developers including early interaction and dialogue, and a pathway for accelerated evaluation by the agency. The program is intended to optimize development plans and expedite the review and approval process so that these medicines may reach patients as early as possible.

About Synovial Sarcoma
Soft tissue sarcomas can develop from soft tissues like fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues. There are approximately 50 types of soft tissue sarcomas, including synovial sarcoma, which accounts for approximately 6% to 10% of all soft tissue sarcomas. There remains a large unmet medical need for synovial sarcoma, and approximately one-third of synovial sarcomas occur in childhood and the peak incidence is in the third decade of life. The most common locations for this cancer are the hip, knee, ankle, and shoulder.

On July 23, 2020 UNC Lineberger Comprehensive Cancer Center reported that CAR-T immunotherapy, which attacks cancer cells using a person’s reprogrammed immune cells, has been used to treat Hodgkin lymphoma with remarkable success for the first time, according to the results of an early phase clinical trial led by researchers at UNC Lineberger Comprehensive Cancer Center and Baylor College of Medicine in Houston (Press release, Lineberger Comprehensive Cancer Center, JUL 23, 2020, View Source [SID1234562376]).

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The clinical trial, whose results are published in the Journal of Clinical Oncology, was designed to determine the treatment’s safety and efficacy for patients with relapsed Hodgkin lymphoma. Researchers demonstrated that the treatment was safe, but perhaps more importantly, that the treatment was highly active in patients with relapsed/refractory Hodgkin lymphoma. The treatment led to the complete disappearance of tumor in the majority of patients treated at the highest dose level of therapy with almost all patients having clinical benefit after treatment.

Barbara Savoldo
UNC Lineberger’s Barbara Savoldo, MD, PhD.
"This is particularly exciting because the majority of these patients had lymphomas that had not responded well to other powerful new therapies," said study senior author Barbara Savoldo, MD, PhD, professor in the UNC Department of Microbiology and Immunology at the UNC School of Medicine and a UNC Lineberger member.

"Everyone worked tirelessly on the study and I am proud of the collaborative work it fueled between UNC Lineberger and Baylor," Savoldo said.

Chimeric antigen receptor (CAR) T-cells are human T-cells – a powerful type of immune cell – that have been harvested from a patient and genetically re-engineered to recognize proteins found on the patient’s cancer cells. They are reinfused into the patient to circulate in the blood for months as a "living drug" to attack the patient’s cancer cells. In some cases, patients are infused with CAR-T cells made from T-cells provided by other donors.

CAR-T therapies in the past decade have had striking successes in some clinical trials, and so far have been approved by the U.S. Food and Drug Administration for treating two blood cancers, acute lymphoblastic leukemia and diffuse large B-cell lymphoma. These CAR-T therapies are designed to target the protein CD19, which is found on malignant cells in these cancers. Inspired by the success of CAR-T cell therapies against these cancers, researchers have been developing the technology for use against cancers that express other cancer-associated proteins.

Savoldo and her colleagues in recent years have been exploring the use of CAR-T against Hodgkin lymphoma, a blood cancer that afflicts more than 200,000 people in the United States. While about 85 percent of Hodgkin lymphoma patients are cured or have many cancer-free years following standard chemotherapy and/or radiation regimens, the rest either don’t respond to standard therapy or do respond but experience a cancer relapse within a few years. Many of these "refractory/relapsing" patients go through years of further treatments without success, and end up with no good options.

In a pilot study in seven refractory/relapsing Hodgkin lymphoma patients, published in 2017, Savoldo and Baylor colleagues found that a CAR-T therapy targeting Hodgkin cell-associated protein CD30 appeared safe but brought about only modest responses.

In the new study, which included 41 patients treated at Baylor and UNC, the researchers used the same anti-CD30 CAR-T strategy, but added a preconditioning regimen in which patients’ existing lymphocytes – a broad family of white blood cells including T-cells – were greatly depleted with chemotherapy drugs prior to the addition of the CAR-T cells.

Natalie Grover
UNC Lineberger’s Natalie Grover, MD.
"Lymphodepletion prior to CAR-T cell infusion seems to produce a more favorable environment for the CAR-T cells to proliferate and attack their cancerous targets," said study co-first author Natalie Grover, MD, assistant professor in the UNC Department of Medicine and a UNC Lineberger member.

Carlos Ramos, MD, at Baylor College of Medicine is the paper’s other co-first author.

Side effects of the lymphodepletion plus CAR-T treatment were common and included flu-like symptoms due to an immune chemical storm called cytokine release syndrome, but these events were generally modest. None of the patients experienced the more serious, life-threatening complications, such as brain swelling, that have been seen in CAR-T trials against other blood cancers.

Even more promising, the study showed that this anti-CD30 CAR-T therapy appeared to be very active even against refractory/relapsing Hodgkin lymphoma.

As the trial progressed, the researchers settled on fludarabine as a key element of the pre-therapy lymphodepletion regimen, since patient outcomes seemed better when it was used. The researchers found that among the 32 patients with active cancer who received fludarabine for lymphodepletion before their CAR-T cells, 19 patients (59 percent) had a complete response.

Of the patients in the study who had a complete response, 61 percent still had no evidence of recurrence a year later. Overall, 94 percent of the treated patients were still alive a year after their treatment.

"This treatment showed remarkable antitumor activity without significant toxicity, and we think it should be considered for patients in earlier stages of refractory/relapsing Hodgkin lymphoma," Savoldo said.

"The activity of this new therapy is quite remarkable and while we need to confirm these findings in a larger study, this treatment potentially offers a new approach for patients who currently have very limited options to treat their cancer," said Jonathan Serody, MD, the Elizabeth Thomas Professor of Medicine, Microbiology and Immunology at UNC School of Medicine, director of the bone marrow transplant and cellular therapy program at UNC, and a UNC Lineberger member. "Additionally, unlike other CAR-T cell therapies, clinical success was not associated with significant complications from therapy. This means this treatment should be available to patients in a clinic setting and would not require patients to be hospitalized, which is critical in our current environment."

The researchers hope to do further studies of the CAR-T therapy alone and in combination with other new immune-modulating anticancer drugs.

On July 23, 2020 Cancer researchers Alex Huang, Reshmi Parameswaran and Yamilet Huerta reported that have been awarded $315,000 in grants from the St. Baldrick’s Foundation to conduct research of new immunotherapy treatments for pediatric cancers (Press release, Case Western Reserve University, JUL 23, 2020, View Source [SID1234562373]).

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Huang, professor of pediatrics at Case Western Reserve University School of Medicine and co-leader of the Hematopoietic and Immune Cancer Biology Program of the Case Comprehensive Cancer Center (CCCC), received both a research grant and funding support for a summer research fellow in his laboratory.

Huang was awarded a one-year grant to begin development of a novel biomarker that would predict clinical response for advanced muscle tumor, Rhabdomyosarcoma, using immunotherapy through cryoablation—a procedure during which ultra-cold liquid nitrogen is used to kill tumor cells and activate the patient’s immune system.

"Treatment for Rhabdomyosarcoma is aggressive, but patient outcomes are the least improved in childhood cancer," said Huang. "With this grant, we hope to find the data we need to rapidly move from the lab to a clinical trial, making an impact for patients in the near future."

Melissa Bonner, a second-year Medical Scientist Training Program (MSTP) student who started her PhD thesis work in Huang’s laboratory this summer, received a summer fellowship to investigate a class of novel drugs that targets a tumor-specific carbonic anhydrase and disrupts a sarcoma tumor’s ability to manipulate its tissue environment, thereby making immunotherapy more effective.

Parameswaran and Huerta each received funding to continue projects to create better treatments for acute myeloid leukemia (AML), the second-most common form of acute leukemia in children.

Parameswaran is an assistant professor in the Division of Hematology and Oncology at the School of Medicine and member of the Hematopoietic and Immune Cancer Biology Program at the CCCC. She received a fifth year of funding for her St. Baldrick’s Scholar Award to continue to develop a new immunotherapy strategy using Natural Killer (NK) cells, a type of white blood cells with potential to kill cancer cells. Parameswaran in developing a new potential therapy where NK cells from a patient are isolated in a lab and expanded to enhance cancer-fighting potential, then injected back into the patient to kill childhood AML cells.

Photo of Reshmi Parameswaran
Reshmi Parameswaran
"Successful completion of this research will lead to new clinical trials using activated NK cells as an adoptive immunotherapy for pediatric AML," said Parameswaran.

Huerta, an instructor of pediatrics at the School of Medicine, a member of the Huang lab and a pediatric hematology/oncology fellow at University Hospitals Rainbow Babies & Children’s Hospital, was awarded additional fellow funding to continue her study of the use of targeted immunotherapy in future clinical trials to treat AML. She is engineering T-cells that are capable of binding to a specific target on AML cells while "engaging" neighboring T-cells, mounting an immune response and killing cancer cells.

Photo of Yamilet Huerta in the lab
Yamilet Huerta
Huerta said prognosis of a child with AML can remain poor even with chemotherapy and stem-cell treatment, but she sees promise in manipulating T-cells that are naturally part of the body’s immune system to eradicate chemo-resistant tumor cells.

The St. Baldrick’s Foundation is a volunteer-driven charity committed to funding the most promising research to find cures for childhood cancers and give survivors long and healthy lives. The Foundation is the largest private funder of childhood cancer research grants and awarded new grants totaling more than $12.9 million in its summer grant cycle to support the brightest minds in the pediatric cancer field. The round of grants supports the best research at 36 institutions nationally. The Foundation has given the School of Medicine and University Hospitals Rainbow Babies & Children’s Hospital more than $5.4 million to support childhood cancer research.

On July 23, 2020 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it is scheduled to report second quarter results on August 6, 2020 at 4:00 PM Eastern Time (Press release, Cytokinetics, JUL 23, 2020, View Source [SID1234562348]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 5588711.

An archived replay of the webcast will be available via Cytokinetics’ website until August 20, 2020. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 5588711 from August 6, 2020 at 7:30 PM Eastern Time until August 20, 2020.