On November 2, 2021 Medivir reported that (Press release, Medivir, NOV 2, 2021, View Source;interim-report-january–september-2021-301415069.html [SID1234594159])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Positive MIV-818 data presented at ESMO (Free ESMO Whitepaper). New positive data and renegotiated agreement for remetinostat

July – September
Financial summary for the quarter

Net turnover amounted to SEK 0.8 (1.1) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -11.7 (5.2) million. Basic and diluted earnings per share amounted to SEK -0.26 (0.19) and SEK -0.26 (0.19) respectively.
Cash flow from operating activities amounted to SEK -20.0 (-17.1) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 225.9 (82.7) million.
Significant events during the quarter

In July, Malene Jensen was appointed Vice President Clinical Development. She took on her position in early September.
In August, the positive results from the phase II study with remetinostat against basal cell carcinoma (BCC) were published in the scientific journal Clinical Cancer Research.
In August, it was announced that Medivir, through a renegotiated multi-party agreement, strengthens the business development potential for remetinostat.
End of August, Medivir received regulatory approval from the British UK Medicines & Healthcare products Regulatory Agency (MHRA) for the upcoming phase 1b/2a combination study with MIV-818 against liver cancer.
At the ESMO (Free ESMO Whitepaper) Congress in September, the results from the completed dose escalation part of the phase 1b monotherapy study with MIV-818 were presented. Medivir presented the data at a conference call on the same day.
January – September
Financial summary for the period

Net turnover amounted to SEK 11.6 (12.5) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -36.0 (-27.9) million. Basic and diluted earnings per share amounted to SEK -0.80 (-1.30) and SEK -0.80 (-1.30) respectively.
Cash flow from operating activities amounted to SEK -43.3 (-57.1) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 225.9 (82.7) million.
Significant events after the end of the period

In October, the Board of Directors appointed Jens Lindberg as new CEO of Medivir. Jens Lindberg has extensive experience from the pharmaceutical industry and the field of Oncology. He joins from Sedana Medical where he has been VP Commercial Operations and acting CEO.
Conference call for investors, analysts and the media
The Interim Report January – September 2021 will be presented by Medivir’s interim CEO, Magnus Christensen.

Time: Wednesday, November 3, 2021, at 15.00 (CET).
Phone numbers for participants from:
Sweden + 46 8 505 583 69
Europe +44 33 3300 9032
US +1 646 722 4904

The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir’s website after completion of the conference.

CEO’s message
Our development strategy to reach the market remains unchanged and we have received the first approval for the upcoming phase 1b/2a combination study with MIV-818. Positive data from the dose escalation part of the monotherapy study presented at ESMO (Free ESMO Whitepaper). New positive data and renegotiated agreement for remetinostat.

Despite a number of new treatments for hepatocellular carcinoma (HCC), the most common form of primary liver cancer, there is still a great need for pharmaceuticals with new mechanisms of action. Our candidate drug MIV-818 represents a new and unique mechanism that can be combined with the most common therapies for HCC. Among the drugs that are already approved or under development, the most common mechanisms are: stimulation of the immune system and blockage of the blood supply. We have therefore chosen to study MIV-818 in combination with two products representing these two different mechanisms, Keytruda (anti-PD-1 checkpoint inhibitor) and Lenvima (tyrosine kinase inhibitor). The goal is to develop a better therapy as second-line treatment for HCC patients.

The third quarter has been characterized by continued work to ensure the start of the next study in the MIV-818 clinical program. This spring, we announced positive data with a good safety and tolerability profile from the first part of the phase 1b study with MIV-818. These data were further strengthened in September when data from the final dose escalation part of the phase 1b study were presented at the leading scientific conference, ESMO (Free ESMO Whitepaper).

A total of nine patients with various types of advanced cancer in the liver were included and evaluated. These patients had exhausted all possible approved treatments prior to being included in the study. The study evaluated safety and tolerability in patients with different types of cancer in the liver, and a positive sign of efficacy was that four patients with HCC showed stable liver disease over an extended period of time. Furthermore, liver biopsies from patients demonstrated delivery of MIV-818 to the liver, and a selective effect of MIV-818 on cancer cells.

The purpose of our next study in patients with HCC is to evaluate safety, tolerability and to also get an indication of the efficacy of MIV-818 in combination with two approved drugs.

At the end of August, we received regulatory approval from MHRA, the regulatory authority in UK, for the upcoming phase 1b/2a combination study with MIV-818. The study will include patients with hepatocellular carcinoma (HCC) who have progressed on, or are intolerant of, first line standard therapy. The study is an open-label phase 1b/2a study starting with a dose escalation part to establish the recommended phase 2 dose (RP2D).

Once the RP2D has been established for the combinations, further cohorts of up to 30 patients with HCC will be enrolled in the expansion part (phase 2a). The study will start in the UK and is planned later to include centers in Spain and South Korea. The first patient is expected to be enrolled before year-end and we look forward with optimism to conducting the study.

Medivir has two more drug development projects in the clinical development phase, remetinostat, and MIV-711. Medivir does not conduct clinical development of these projects on its own, but instead seeks partners for further development.

In August, positive results from a phase II study with remetinostat against Basal Cell Carcinoma (BCC) were published in the scientific journal Clinical Cancer Research. The study was conducted at the Stanford University School of Medicine in California, USA, and the results are very promising and provide further support for the potential of remetinostat as a treatment for a number of skin cancers in addition to cutaneous T-cell lymphoma (CTCL).

In August, the remetinostat agreement was renegotiated to create significantly improved conditions for a potential outlicensing or sale in our continued business development work.

Early this year, the global and exclusive rights to develop Medivir’s project birinapant, were outlicensed to the American company IGM Biosciences. We are looking forward to the start of the clinical study with birinapant in combination with IGM’s antibody IGM-8444 later this year.

In October, we announced that Jens Lindberg has been appointed new CEO of Medivir. Jens, who joins us from his role as VP Commercial Operations at Sedana Medical, has extensive experience from the pharmaceutical industry and the oncology area. We look forward to taking Medivir forward under Jens’ leadership.

The further we advance the clinical program with MIV-818, the more I am impressed by the determination and commitment that prevails at Medivir. We are convinced that MIV-818 has the potential to become an effective drug for liver cancer. Our goal is that it would make a big difference for patients and for healthcare and thus also for the company’s shareholders.

On November 2, 2021 Dunad Therapeutics ("Dunad"), a biopharmaceutical company focusing on the development of next-generation targeted protein degradation therapies, reported that it has entered a strategic collaboration and license agreement with Novartis to generate orally bioavailable covalent and protein degrading small molecule drugs (Press release, Novartis, NOV 2, 2021, View Source [SID1234594197]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Dunad will apply its tunable and highly selective platform to generate novel covalent and targeted protein degrading small molecule drugs focusing on up to four drug targets agreed with Novartis. Dunad will also be responsible for program execution up to lead optimization. Novartis will contribute target and ligand knowledge as well as access to unique assays and models and will fully fund the research collaboration.

Novartis has an exclusive option to develop and commercialize products resulting from the research programs directed against up to four drug targets. Upon exercise of this option, Novartis will assume responsibility for future development, manufacturing and global commercialization of the small molecule therapeutic products generated against the agreed targets.

Dunad’s unique platform uses mono-valent small molecules to induce selective degradation of disease-causing and often undruggable proteins via direct modification of the target. The Company’s novel molecular approach is fully tunable to be selective and is underpinned by a target-class agnostic mechanism of action that is clearly differentiated from other targeted protein degradation technologies.

Dunad’s platform has the potential to generate orally bioavailable degrader therapeutics that significantly expand the frontiers of protein degradation targets.

Under the terms of the agreement, Dunad will receive $24 million in an upfront payment and equity investment, as well as significant research funding. Dunad will also be eligible for milestone payments that could aggregate to up to $1.3 billion and royalties.

Alongside the equity investment of Novartis, and the founding investor Epidarex Capital, BioGeneration Ventures (BGV) is joining Dunad as a new investor. Oskar Slotboom, General Partner at BGV, has joined Dunad’s Board of Directors.

Prof. Patrick Gunning, Dunad’s co-founder, acting Chief Executive Officer and Chief Scientific Officer commented: "We are thrilled to have entered this collaboration with Novartis, which has already established a world leading position in the protein degradation space. This deal highlights the clear benefits our platform promises for the development of next-generation targeted protein degrader therapeutics. We are confident that with our approach of inducing degradation via direct modulation of target proteins with mono-valent small molecules, we can significantly expand the boundaries of targeted protein degraders as a therapeutic modality."

Dr. Diana Kraskouskaya, co-founder and Chief Operating Officer of Dunad, commented: "This collaboration is an important milestone for Dunad. It allows us to rapidly expand the impact of our platform technology to additional target classes and therapeutic areas, beyond Dunad’s own internal target pipeline. Our growing team is committed to advancing our internal pipeline and partnered programs directed against the most sought-after and previously intractable targets."

Dr. Elizabeth Roper, Partner at Epidarex Capital, Dunad’s founding investor, and board director of Dunad, commented: "We are delighted to see Dunad’s growth continue with such a significant deal with Novartis. This collaboration provides validation of Dunad’s differentiated protein degradation technology and explores the full potential of this new modality as a therapeutic approach. We are also excited to welcome BGV and Novartis as investors to the syndicate and look forward to our continued collaboration with the team."

On November 2, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the third quarter ended September 30, 2021 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, NOV 2, 2021, View Source [SID1234594101]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our strong 2021 performance continued in the third quarter fueled by 145% growth over the prior year period in revenue from royalties. We continue to project that full year royalty revenue in 2021 will be more than double 2020 royalty revenue. Our topline growth in turn resulted in strong profitability for the quarter," said Dr. Helen Torley, president and chief executive officer. "We look forward to additional study starts before year-end as our partners continue making progress in the clinic developing products utilizing our ENHANZE technology, with the goal of providing patients with additional treatment options."

Recent Partner Highlights:

In July 2021, Janssen elected the target HIV reverse transcriptase, representing the third target selected by Janssen for development with ENHANZE.
In July 2021, Janssen received U.S. Food and Drug Administration approval for DARZALEX FASPRO in combination with pomalidomide and dexamethasone for patients with multiple myeloma after first or subsequent relapse.
In October 2021, Janssen’s DARZALEX FASPRO was approved by the China National Medical Products Administration (NMPA) for the treatment of primary light chain amyloidosis, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) in newly diagnosed patients. This followed a similar approval Janssen Pharmaceutical K.K. received in August 2021 from Japan’s Ministry of Health, Labour and Welfare (MHLW) for DARZQURO (Daratumumab SC) for the additional indication of systemic AL amyloidosis.
Recent Corporate Highlights:

During the third quarter, the Company repurchased approximately 1.6 million shares of common stock for $64.7 million at an average price per share of $41.40. Year-to-date through the third quarter of 2021, Halozyme has repurchased a total of 4.4 million shares of common stock for $189.7 million at an average price of $43.35. In October 2021, the Company repurchased an additional 0.3 million shares of common stock for $10.3 million, resulting in a total of $200.0 million in share repurchases in 2021 and completing the Board-authorized three-year share repurchase plan that began in November 2019. Under the program a total of 22.3 million shares were repurchased for $550.0 million at an average price per share of $24.72.
Third Quarter Financial Highlights

Revenue for the third quarter was $115.8 million compared to $65.3 million for the third quarter of 2020. The year-over-year increase was primarily driven by an increase in royalty revenue primarily attributable to subcutaneous DARZALEX (daratumumab) and an increase in product sales. Revenue for the quarter included $58.6 million in royalties, an increase of 145% compared to $23.9 million in the prior year period.
Cost of product sales for the third quarter was $18.6 million, compared to $5.6 million for the third quarter of 2020. The year-over-year increase was primarily driven by higher product sales, principally the sales of bulk rHuPH20 to the Company’s partners.
Research and development expenses for the third quarter were $8.5 million, compared to $7.7 million for the third quarter of 2020. The increase is primarily due to an increase in compensation expense, including stock-based compensation, for personnel to support additional ENHANZE targets entering clinical development.
Selling, general and administrative expenses for the third quarter were $13.2 million, compared to $11.7 million for the third quarter of 2020. The increase was primarily due to an increase in compensation expense, including stock-based compensation, for personnel to support additional ENHANZE targets entering clinical development.
Operating Income: On a GAAP basis in the third quarter of 2021, operating income was $75.6 million, compared to an operating income of $40.3 million in the third quarter of 2020.
Net Income: On a GAAP basis in the third quarter of 2021, net income was $216.6 million, compared with net income of $36.2 million in the third quarter of 2020. Non-GAAP net income was $80.5 million in the third quarter of 2021, compared with Non-GAAP net income of $44.0 million in the third quarter of 2020.1
Earnings per Share: On a GAAP basis in the third quarter of 2021, diluted earnings per share was $1.48, compared with $0.25 in the third quarter of 2020. On a Non-GAAP basis diluted earnings per share was $0.55, compared with diluted earnings per share of $0.31 in the third quarter of 2020.1
Third quarter financial results include the reversal of substantially all of the valuation allowance recorded against the Company’s deferred tax assets. This reversal resulted in the recognition of a non-cash income tax benefit during the quarter of $142.5 million, or $0.97 earnings per diluted share. The Company maintains a full valuation allowance on its deferred tax assets (DTAs) until there is sufficient evidence to support the reversal of all or some portion of these allowances. On a periodic basis, the Company reassesses the valuation allowance of its DTAs, weighing all positive and negative evidence, to assess if it is more-likely-than-not that some or all of the Company’s DTAs will be realized. As of the third quarter, the Company has demonstrated profitability and cumulative pretax income as well as forecasting revenue growth. After assessing both the positive and negative evidence, the Company determined that it was more likely than not that its DTAs would be realized and released substantially all of the valuation allowance related to federal and state DTAs as of September 30, 2021.
Cash, cash equivalents and marketable securities were $815.9 million on September 30, 2021, compared to $368.0 million on December 31, 2020.
During the third quarter, the Company repurchased 1.6 million shares of common stock for $64.7 million at an average price of $41.40. In October 2021, the Company repurchased an additional 0.3 million shares of common stock for $10.3 million, completing its Board-authorized three-year share repurchase plan that began in November 2019. Under the program a total of 22.3 million shares were repurchased for $550.0 million at an average price per share of $24.72.
Financial Outlook for 2021

The Company is increasing the lower end of revenue and operating income guidance ranges to reflect strong third quarter results. In addition, the Company is increasing GAAP diluted earnings per share guidance to reflect an income tax benefit related to the release of a valuation allowance for its deferred tax assets, and increasing the lower end of Non-GAAP diluted earnings per share guidance. The Company now expects:

Revenues of $430 million to $445 million, increased from prior guidance of $425 million to $445 million, representing year-over-year growth of 61%-66%;
GAAP Operating Income of $265 million to $280 million, increased from prior guidance of $260 million to $280 million, representing year-over-year growth of 84%-94%;
GAAP Net Income of $380 million to $395 million, up from prior guidance of $235 million to $255 million due to the income tax benefit recorded in Q3 2021; and Non-GAAP Net Income of $285 million to $300 million, compared to prior guidance of $280 million to $300 million;1
GAAP Diluted Earnings per Share of $2.60 to $2.70, up from prior guidance of $1.55 to $1.70 due to the income tax benefit recorded in Q3 2021; and
Non-GAAP Diluted Earnings per Share of $1.90 to $2.00, compared to prior guidance of $1.85 to $2.00, representing year-over-year growth of 70%-79%.1
Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the third quarter of 2021 today, Tuesday, November 2, 2021 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, please register a day in advance or at minimum 10 minutes before the start of the call.

On November 2, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $456.4 million for the third quarter ended September 30, 2021, compared to $408.4 million for the same period of 2020 (Press release, Exact Sciences, NOV 2, 2021, View Source [SID1234594124]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Exact Sciences is entering an exciting period for its pipeline, generating evidence to support innovative tests that will help defeat cancer through earlier detection," said Kevin Conroy, chairman and CEO. "Our powerful commercial engine will help us achieve our mission by getting more people tested with Cologuard, Oncotype DX, and our future tests."

Third quarter 2021 financial results

For the three-month period ended September 30, 2021, as compared to the same period of 2020 (where applicable):

Total revenue was $456.4 million, an increase of 12 percent
Screening revenue was $280.4 million, an increase of 31 percent
Precision Oncology revenue was $145.4 million, an increase of 59 percent
COVID-19 testing revenue was $30.6 million, a decrease of 70 percent
Gross margin including amortization of acquired intangible assets was 70%, and non-GAAP gross margin excluding amortization of acquired intangible assets was 75%
Intangible asset impairment of $20.2 million was related to a supply agreement asset recorded as part of the combination with Genomic Health
Net loss was $166.9 million, or $0.97 per share, compared to a net loss of $202.5 million, or $1.35 per share
EBITDA was $(119.9) million, and adjusted EBITDA was $(16.3) million
Cash, cash equivalents, and marketable securities were $1.22 billion at the end of the quarter
Screening includes laboratory service revenue from Cologuard tests and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype products and laboratory service revenue from Ashion.

2021 outlook

The company anticipates revenue of $1,722-$1,737 million during 2021, including Screening revenue of $1,050-$1,055 million, Precision Oncology revenue of $547-$552 million, and COVID-19 testing revenue of $125-$130 million.
Updated revenue guidance has been narrowed toward the high end of our previously expected range of $1,705-$1,745 million, which included Screening revenue of $1,100-$1,125 million, Precision Oncology revenue of $530-$540 million, and COVID-19 testing revenue of $75-$80 million.
Screening revenue expectations are lower due to the rapid rise in Delta variant cases starting in late July, causing in-person sales calls to significantly decrease in August and September.
Non-GAAP disclosure
In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and non-GAAP gross profit. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations."

Third quarter conference call & webcast
Company management will host a conference call and webcast on Tuesday, November 2, 2021, at 5 p.m. ET to discuss third quarter 2021 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-952-1519 and international callers should dial +1-236-714-2125. The access code for both domestic and international callers is 2782364.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or +1-416-621-4642 internationally. The access code for the replay of the call is 2782364. The webcast, conference call and replay are open to all interested parties.

About Cologuard
The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated. The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit www.cologuardtest.com.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. The Oncotype MAP Pan-Cancer Tissue test is a rapid, comprehensive tumor profiling panel that aids therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer. With more than 1 million patients tested in more than 90 countries, the Oncotype tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On November 2, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that three abstracts highlighting the company’s immuno-oncology offerings for biopharmaceutical researchers will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place in Washington, DC and virtually, November 10-14, 2021 (Press release, Veracyte, NOV 2, 2021, View Source [SID1234594143]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This is especially important in the immuno-oncology field where the micro-environment of the tumor plays a key role in cancer progression and response to therapy."

"It is exciting to have the opportunity to present new data on our Brightplex assays and be able to provide to clinical researchers innovative solutions designed to help them better understand the mechanism of action for therapeutics," said Corinne Danan, Veracyte’s general manager, Biopharma. "This is especially important in the immuno-oncology field where the micro-environment of the tumor plays a key role in cancer progression and response to therapy."

Veracyte acquired the novel Brightplex technology – which combines information from multiplex immunohistochemistry (IHC) and advanced digital pathology analysis to provide a comprehensive picture of the tumor micro-environment – through its acquisition of HalioDx in August 2021.

The following posters will be presented at the SITC (Free SITC Whitepaper) meeting:

Poster Title: "Assessment of the spatial distribution of B cells subpopulations in the tumor microenvironment and tertiary lymphoid structures by Brightplex, a sequential chromogenic multiplex assay"
Abstract number: 57
Session Date/Time: Nov. 12, 7:00 a.m. – 8:00 p.m. ET (on-site) and Nov. 12, 7:00 a.m. ET (ePoster)

Poster Title: "Assessment of the spatial distribution of CD4+ T cells subpopulations in the tumor microenvironment by Brightplex, a sequential chromogenic multiplex assay"
Abstract number: 41
Session Date/Time: Nov. 12, 7:00 a.m. – 8:00 p.m. ET (on-site) and Nov. 12, 7:00 a.m. ET (ePoster)

Poster Title: "Spatial distribution of infiltrating T lymphocytes with Immunoscore CR T Cells Exhaustion test helps stratification of NSCLC patients treated with PD1/L1 inhibitors in the PIONeeR project"
Abstract number: 460
Session Date/Time: Nov. 13, 7:00 a.m. – 8:00 p.m. ET (on-site) and Nov. 12, 7:00 a.m. ET (ePoster)