On December 8, 2021 Hoffmann-La Roche reported that invite investors and analysts to participate in our virtual event on Wednesday, 15 December, 2021, highlighting Roche data presented at the virtual American Society of Hematology (ASH) (Free ASH Whitepaper) 63rd Annual Meeting, from 11-14th December (Press release, Hoffmann-La Roche, DEC 8, 2021, View Source [SID1234596593]).

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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

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16:00 – 17:30 CET / 15:00 – 16:30 GMT
10:00 – 11:30 am EST / 7:00 – 8:30 am PST

The webinar will start with a presentation, followed by a Q&A session (live access to the speakers).

Agenda:

Welcome
Karl Mahler, Head of Investor Relations

Hematology franchise overview
Peter Ahnesorg, Franchise Head Hematology

Review of key clinical data presented at ASH (Free ASH Whitepaper): Hemlibra, mosun, glofit, cevostamab
Charles Fuchs, Senior Vice President – Global Head Of Oncology And Hematology Product Development

Presentation of POLARIX data
Franck Morschhauser, MD, PhD, Professor of Hematology, University of Lille; President of LYSA, LYSARC

Q&A

The slides will be available for download at 15:00 CET on the day of the event. > click here

Should you be unable to register for the webinar due to your company IT policy, please send an email to investor.relations@roche.com.

On December 8, 2021 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported the presentation of new data at the 2021 San Antonio Breast Cancer Symposium (SABCS) supporting the clinical value of the Oncotype DX Breast Recurrence Score test (Press release, Exact Sciences, DEC 8, 2021, View Source [SID1234596592]). New analyses presented at the meeting include an oral presentation of updated data from the RxPONDER study led by the independent SWOG Cancer Research Network, and sponsored by the National Cancer Institute (NCI).

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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

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Exact Sciences announced new data at the 2021 SABCS, supporting the clinical value of the Oncotype DX test.
"New findings presented at SABCS 2021 add to the wealth of data highlighting the role of the Oncotype DX test in providing critical information to personalize and improve the quality of breast cancer treatment decisions," said Rick Baehner, M.D., chief medical officer of Precision Oncology at Exact Sciences. "Additionally, we are encouraged by results from a study validating our new 16-gene genomic radiation therapy signature in development, showing promise in identifying women with early-stage breast cancer who may be able to forgo irradiation following breast conserving surgery. Like the critical chemotherapy answer we are providing women with the Oncotype DX test, being able to offer clear guidance to radiotherapy benefit enables patients to avoid over- or under-treatment and further personalize their treatment plans."

New data from RxPONDER confirm and strengthen previous findings
Following the recent publication of initial study results in The New England Journal of Medicine[i], updated data were presented in an oral session[ii] at SABCS by Dr. Kevin Kalinsky, study lead investigator. In an analysis with longer follow-up (median 6.1 years), the investigators reported that postmenopausal women with 1-3 positive nodes and Recurrence Score results 0-25 continue to not benefit from adjuvant chemotherapy. In addition, a new analysis of distant recurrence-free interval (defined as time to distant recurrence or death from breast cancer) showed that premenopausal women with Recurrence Score results 0-13 received a modest 2.3% absolute benefit at five years. For those with Recurrence Score results 14-25 the benefit was 2.8%.

Approximately one-third of patients diagnosed with hormone receptor (HR)-positive, HER2-negative early breast cancer have a tumor that has spread to their lymph nodes. The vast majority of these patients currently receive chemotherapy[iii] even though approximately 85% of them have Recurrence Score results 0 to 25.[iv] In addition, approximately two out of three early-stage breast cancer patients are postmenopausal.[v]

Use of a 16-gene radiation therapy signature to identify patients with HR-positive, HER2-negative early-stage breast cancer who may skip radiotherapy
The study, presented at SABCS in a poster session[vi], applied the 16-gene radiation therapy signature to 132 patients enrolled in the Princess Margaret Trial, which randomized patients ages 50 or older to radiotherapy and tamoxifen or tamoxifen alone after breast conserving surgery. The results, in a treatment cohort in line with the current standard of care, support previous validation study data[vii] suggesting that the 16-gene radiation therapy signature may be used to identify patients with a low risk of locoregional recurrence who will not experience significant benefit from adjuvant radiotherapy. The 16-gene radiation therapy signature was developed by PFS Genomics, a company acquired by Exact Sciences earlier this year.

Additional Oncotype DX data presented at SABCS 2021
Other data featured in Poster Sessions and Spotlight Poster Discussions at SABCS 2021 include the following:

Poster #P1-08-28: Real world use of Oncotype DX testing in the management of breast cancer. The North East England experience
Authors: Gault, A., et al.
Date/Time: Wednesday, December 8, 7:00-9:30 a.m. CT

Poster #P2-15-02: Using Oncotype DX Breast Recurrence Score (RS) assay to define the role of neoadjuvant endocrine therapy (NET) in early-stage hormone receptor positive (HR+) breast cancer (BC)
Authors: Taylor, C., et al.
Date/Time: Wednesday, December 8, 5:00-6:30 p.m. CT

Spotlight Poster #PD9-01: Expanding downstaging criteria in AJCC pathologic prognostic staging using Oncotype DX Recurrence Score assay in T1-2N0 hormone-receptor positive patients enrolled in the TAILORx Trial
Authors: Kantor, O., et al.
Date/Time: Thursday, December 9, 7:00-8:30 a.m. CT

Spotlight Poster #PD15-05: Assessment of estrogen receptor (ESR1) mRNA expression for prediction of extended aromatase inhibitor benefit in HR-positive breast cancer using NRG Oncology/NSABP B-42
Authors: Mamounas, E., et al.
Date/Time: Friday, December 10, 7:00-8:30 a.m. CT

About the Oncotype DX and Oncotype MAP Portfolio of Tests
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 risk of distant 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. For patients with advanced and metastatic cancer, the company offers the Oncotype MAP Pan-Cancer Tissue test, a rapid, comprehensive tumor profiling panel, which provides results in three to five business days[viii] and allows physicians to understand a patient’s tumor profile and recommend actionable targeted therapies or clinical trials. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX and Oncotype MAP tests, visit www.OncotypeIQ.com/

On December 8, 2021 EpiAxis Therapeutics reported it is commencing a pre-clinical collaboration focused on inhibiting Protein Kinase C theta (PKC theta), which could provide a potential new approach to treating cancer (Press release, EpiAxis Therapeutics, DEC 8, 2021, View Source;utm_medium=rss&utm_campaign=epiaxis-expands-pkc-theta-pre-clinical-program [SID1234596591]).

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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

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PKC theta is upregulated in a variety of solid and haematological cancers and is associated with promoting tumour aggressiveness, metastasis, and resistance to therapy. PKC theta also plays an important role in immune regulation.

EpiAxis is collaborating with Dr Hanna Y Irie, MD, PhD, Associate Professor of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai and a leading research scientist in the PKC theta cancer sector. Under the collaboration, EpiAxis will provide Dr. Irie with its PKC theta inhibitors for evaluation in breast cancer models.

Mt Sinai oncology

"This is an important collaboration for EpiAxis as we expand our pre-clinical program to advance our PKC theta assets," said EpiAxis CEO Dr Jeremy Chrisp. "We are delighted to be collaborating with Dr Irie’s team at the Icahn School of Medicine as this complements and strengthens our existing focus on LSD1 in breast cancer."

"This is an exciting opportunity to validate novel inhibitors against a promising therapeutic target for triple negative breast cancer, a particularly aggressive subtype that we have been studying for many years," said Mount Sinai’s Dr Irie about the partnership with EpiAxis.. "Once validated, we hope to translate these inhibitors for the benefit of patients."

Dr Irie (above) is a physician-scientist at Mount Sinai’s Tisch Cancer Institute whose research program is focused on identifying, validating, and translating novel therapeutic targets for high-risk breast cancers, especially drug-resistant and metastatic disease. While maintaining an active clinical practice as a breast medical oncologist, she has led translational efforts at Mount Sinai’s Dubin Breast Center, including the creation of the Breast Tumor Biorepository and generation of patient-derived xenograft (PDX) models of high risk and metastatic breast cancers, particularly triple negative, from diverse populations. Dr Irie’s research team has used phenotypic, genetic, and pharmacologic screening strategies to identify novel candidate therapeutic targets for breast cancer cells that are resistant to current standard-of-care treatments.

Dr Irie has published research papers in Nature Communications, Cell Reports, Cancer Research, NPJ Breast Cancer, Breast Cancer Research and Oncotarget, and her research on PKC theta has been supported by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the Breast Cancer Research Foundation.

She received her MD and PhD degrees from Harvard Medical School, where she also completed her post-doctoral research fellowship. Dr Irie completed her clinical fellowship in Medical Oncology at the Dana-Farber Cancer Institute and Massachusetts General Hospital.

On December 8, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) ("Corcept") a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it has extended the expiration of its previously announced tender offer for shares of its common stock from one minute after 11:59 P.M., New York City time, on December 7, 2021 until one minute after 11:59 P.M., New York City time, on December 15, 2021 (unless further extended or earlier terminated) (Press release, Corcept Therapeutics, DEC 8, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-extension-previously-announced [SID1234596589]).

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Based on information provided by Continental Stock Transfer & Trust Company, the depositary for the tender offer, to date, 8,282,336 shares have been tendered for purchase in the tender offer. Stockholders who have validly tendered and not withdrawn their shares do not need to re-tender their shares or take any other action in response to the extension of the tender offer.

The tender offer is contingent upon at least three million shares being tendered. The tender offer is also subject to terms and conditions, which are described in detail in the offer to purchase. Except for the extension of the expiration of the tender offer as set forth above, the terms and conditions of the tender offer remain the same.

None of Corcept, the members of its Board of Directors, the dealer manager, the financial advisor, the information agent or the depositary for the tender offer makes any recommendation as to whether or not any stockholder should participate in the tender offer or as to the purchase price or purchase prices at which stockholders may choose to tender their shares.

The sole dealer manager for the tender offer is Truist Securities, Inc. D.F. King is serving as the information agent for the tender offer and Continental Stock Transfer & Trust Company is serving as the depositary. Canaccord Genuity LLC is serving as a financial advisor. For all questions relating to the tender offer, please contact the information agent, D.F. King & Co., Inc. at cort@dfking.com or call toll-free at 1 (800) 431-9646, or call the dealer manager, Truist Securities, Inc. at 1 (404) 926-5832.

On December 8, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported the initiation of the CONTERNO study, a global, randomized Phase 3 trial of cosibelimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC) (Press release, Checkpoint Therapeutics, DEC 8, 2021, View Source [SID1234596588]). The primary endpoint for the CONTERNO Phase 3 trial is overall survival (OS), and the study is designed to support full regulatory approvals worldwide.

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, "We are excited to develop this combination in NSCLC, with the goal of extending the lives of patients with lung cancer and providing expanded access and fewer obstacles to potentially life-saving immunotherapy treatment." Mr. Oliviero continued, "Our strategy since our founding has been to enter the largest markets in this class with a focus on highly competitive pricing, and there is no more impactful indication to execute on this approach than NSCLC with approximately 1.7 million new worldwide cases reported in 2020."

About the CONTERNO Study
The CONTERNO study (ClinicalTrials.gov, NCT04786964) is a Phase 3, open-label, multi-center, randomized trial investigating cosibelimab (1200mg every three weeks) combined with pemetrexed and investigator’s choice of platinum chemotherapy (either carboplatin or cisplatin) versus pemetrexed and platinum chemotherapy alone in patients with previously untreated stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations. The primary endpoint is OS. Key secondary endpoints include progression-free survival, objective response rate and safety. Approximately 560 subjects will be randomized in a 2:1 ratio to receive cosibelimab in combination with chemotherapy or chemotherapy alone.

About Non-Small Cell Lung Cancer
Lung cancer is the most common cancer worldwide according to the World Health Organization, accounting for more than 2 million new cases diagnosed each year. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer diagnoses, resulting in approximately 1.7 million new cases each year. Currently, the five-year survival rate for lung cancer is less than 20%, decreasing further when the disease is diagnosed at later stages. The majority of people with NSCLC are diagnosed with advanced or Stage III or IV disease. Lung cancer is by far the leading cause of cancer death among both men and women, making up almost 25% of all cancer deaths.