On April 21, 2021 Scientists at City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that have developed a novel, noninvasive liquid biopsy test for detecting lymph node metastasis in individuals with high-risk T1 colorectal carcinoma (Press release, City of Hope, APR 21, 2021, View Source [SID1234578314]). Research on the development of the blood test was reported in a new study published in Gastroenterology, a journal of the American Gastroenterological Association.

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This blood-based test is an example of the theranostic (a term that combines "therapeutic" and "diagnostic") approach at City of Hope, whose goal is to help every patient receive personalized treatment appropriate for their specific disease. Development of blood-based biopsies to detect and monitor tumors is one of the leading-edge technologies under investigation to help patients with cancer.

Most individuals suspected of having T1 colorectal cancer with lymph node metastasis undergo radical surgery to remove affected parts of the colon. Unfortunately, only 5-10% of these individuals actually had lymph node metastasis after final examination of the removed colon, indicating that surgery was not necessary for the majority of these people.

"Since radical surgery dramatically reduces quality of life for patients, improving the success rate of identification of high-risk individuals with lymph node metastasis remains the challenge in T1 colorectal cancer diagnosis," said Ajay Goel, Ph.D., M.S., chair of the Department of Molecular Diagnostics and Experimental Therapeutics at City of Hope, and the study’s senior author. "In the future, we hope to improve our confidence in identifying which individuals truly have lymph node metastasis via this novel biomarker-based liquid biopsy test for T1 colorectal cancer, in combination with clinical and pathological criteria."

The publication by Goel and colleagues focused on translating their previous findings of identifying lymph node metastasis with T1 colorectal cancer in a tissue-based assay into a blood-based assay. After refining and validating the panel of RNA biomarkers, the blood test was found to accurately identify lymph node metastasis with high sensitivity (83.3%; a higher value means fewer cases of disease are missed), and specificity (76.2%; a higher value means the test can accurately identify those without disease).

"Obtaining results with more than 80% accuracy (sensitivity) in finding lymph node metastasis in the blood was a completely unexpected finding and is a complete game changer," Goel said.

City of Hope researchers are excited about the potential of this new liquid biopsy test to complement current risk assessment for lymph node metastasis for individuals with early stage T1 colorectal cancer. The technology is patent pending.

Goel indicated that further work will be done to optimize the blood-based assay to improve sensitivity and continue to validate the assay in prospective clinical trials. "There are several steps between where we are now and where we want to go — detecting lymph node metastasis in colon cancer from a blood sample — but without doubt this is an encouraging first step."

Support for this study was provided by grants from the National Cancer Institute, and the National Institutes of Health (CA72851, CA181572, CA184792, CA202797 and CA187956).

On April 21, 2021 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that the Board of Directors has approved the Company’s financial statements for 2020 (Press release, Vaccibody, APR 21, 2021, View Source [SID1234578297]).

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The Company’s annual accounts for the financial year 2020, including the financial statements and annual report, are together with the auditor’s report attached to this announcement. Vaccibody’s annual report 2020 contains the first annual accounts where the financial statements have been prepared in accordance with IFRS (International Financial Reporting Standards). The financial statements are presented in United States dollar (USD). The annual report 2020 is also available at the Company’s website, View Source

On April 21, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its first quarter 2021 financial results after the market closes on Wednesday, May 5, 2021 (Press release, Personalis, APR 21, 2021, View Source [SID1234578315]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 6587766. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On April 21, 2021 BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTC:BVAXF) ("BioVaxys"), the world leader in haptenized antigen vaccines for antiviral and cancer applications, reported that effective today it has been assigned a new US OTC trading symbol of BVAXF (Press release, BioVaxys Technology, APR 21, 2021, View Source [SID1234578298]). This replaces the prior US OTC trading symbol of LMNGF.

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BioVaxys has also applied for a OTCQB listing and anticipates approval in the upcoming weeks. The OTCQB is the mid-tier OTC equity market, which lists primarily early-stage and developing companies in the U.S. and international markets. OTCQB companies must meet certain minimum reporting standards, pass a bid test, and undergo annual verification.

On April 21, 2021 Roche reported that solid results in the first quarter of 2021 (Press release, Hoffmann-La Roche, APR 21, 2021, View Source [SID1234578282])

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Group sales increase 3%1 at constant exchange rates (CER); 1% decline in Swiss francs, as a result of the appreciation of the Swiss franc
Pharmaceuticals Division sales:
Continued strong growth of new medicines (+20%)
As expected, significant impact from biosimilars (CHF -1.6 billion)
Base effect from the strong first quarter 2020 (negative impact of the pandemic only since April 2020)
Overall, this results in a 9% decline in sales.
Diagnostics Division sales:
All businesses contribute to very strong growth of 55%
Roche’s contributions to the fight against the COVID-19 pandemic in the first quarter:
SARS-CoV-2 Rapid Antigen Test Nasal to quickly identify people with the highest risk to be infectious (using simple nasal swabs) receives CE mark and special approvals for self-testing in several countries
Research-use cobas SARS-CoV-2 Variant Set 1 Test launched to help monitor coronavirus mutations
Continued ramp-up of production capacity for COVID-19-related diagnostics and medicines
Partnership with Regeneron: Antibody combination casirivimab/imdevimab is now benefitting patients in an increasing number of countries, incl. the US, Germany, Italy, France and Switzerland
Positive results of phase III studies in both COVID-19 prevention (reduction of symptomatic infections by 81%) and treatment (reduction of hospitalisation or death by 70%)
Positive phase III results for Tecentriq in early lung cancer and for eye medicine faricimab
Important approvals for medicines in the first quarter:
USA: Actemra/RoActemra for a rare lung disease; Xolair as a pre-filled syringe (eg, allergic asthma)
Europe: Evrysdi for spinal muscular atrophy
Roche signs definitive merger agreement with GenMark Diagnostics
Outlook for 2021 confirmed
Commenting on the Group’s performance in the first quarter, Roche CEO Severin Schwan said: "In 2021, Roche remains strongly committed to the fight against COVID-19. The uptake of our recently introduced diagnostic tests and medicines remains strong, while we continue to see the expected impact from biosimilars on sales of our established medicines. Our broad product pipeline keeps making good progress. I am particularly pleased about the highly encouraging study results of our immunotherapy Tecentriq in early lung cancer and of faricimab in ophthalmology. The upcoming acquisition of GenMark underlines our commitment to help control infectious diseases and antibiotic resistance. Based on the results of the first quarter of 2021, we confirm the outlook for the full year."

Outlook confirmed for 2021
Despite the continued strong impact of biosimilars, 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 quarter of the year, Group sales rose 3% (-1% in CHF) to CHF 14.9 billion. The appreciation of the Swiss franc against many currencies had a negative impact on the results expressed in Swiss francs compared to constant exchange rates.

Sales in the Pharmaceuticals Division decreased 9% to CHF 10.6 billion, mainly because of the continued biosimilars competition and the COVID-19 pandemic. As expected, the first quarter of 2021 was particularly challenging due to base effects, as the pandemic only started to have a significant business impact at Roche as of April 2020.

The impact of biosimilars on sales of the established cancer medicines MabThera/Rituxan, Avastin and Herceptin remained significant (combined sales reduction of CHF 1.6 billion), especially in the US.

Moreover, the pandemic continued to have a negative impact overall on the division’s sales, especially for medicines where regular visits to hospitals or health practices are needed (ie, for infusions). This was partly compensated by additional sales of medicines used to treat COVID-19 (Actemra/RoActemra +22%, mostly for treating patients with severe COVID-19-associated pneumonia2, plus the recently launched antibody combination casirivimab/imdevimab).

The new medicines (launched since 20123) grew by 20% (or CHF +880 million) and generated sales of CHF 5.2 billion. Overall, demand continued to grow encouragingly, though here too the impact of the lower number of doctor’s visits was clearly noticeable.

In the United States, sales decreased by 14%, as a result of the continued competition from biosimilars for the above mentioned cancer medicines (combined CHF -1.0 billion). This decline was partially compensated for by the new products (mainly Evrysdi, Ocrevus, Hemlibra and Tecentriq) and Actemra/RoActemra for COVID-19-associated pneumonia.

In Europe, sales decreased by 6%, as demand for the new products (including the antibody combination casirivimab/imdevimab) was only partly able to offset the impact of lower sales for the established cancer medicines (mainly Avastin) and impacts of the COVID-19 pandemic.

In Japan, sales decreased by 7%. This decline was mainly driven by the osteoporosis medicine Edirol and the competition from biosimilars. This was partially offset by sales of cancer immunotherapy Tecentriq.

In the International region, sales were stable. The impact of biosimilars was compensated by new products (Perjeta, Tecentriq and Ocrevus) and COVID-19 related Actemra/RoActemra sales.

The Diagnostics Division reported very strong sales growth of 55% to CHF 4.3 billion, mainly due to Roche’s comprehensive and growing portfolio of COVID-19 tests. The Point of Care and Molecular Lab businesses made the largest contributions (+281% and +86%, respectively) with COVID-19 testing.

Routine diagnostic testing, which was also greatly affected by the COVID-19 pandemic during 2020, recorded strong growth.

Additional product launches in the first quarter, such as a research-use PCR test to help monitor SARS-CoV-2 mutations, further strengthened Roche’s position as the world’s leading supplier of COVID-19 tests.

All regions reported very strong sales growth: EMEA4 and Asia-Pacific (both +62%), North America (+34%) and Latin America (+71%).

In March, Roche signed a definitive merger agreement with GenMark Diagnostics for approx. USD 1.8 billion5. Acquiring GenMark will give Roche access to a novel technology that can test a wide range of pathogens with one patient sample. It will broaden Roche’s molecular lab portfolio, including tests for COVID-19. The transaction is expected to close in the second quarter of 2021.