On December 9, 2020 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported that it will be presenting at the 13th annual LD Micro Main Event investor conference on Monday, December 14 at 9:40 AM PST / 12:40 PM EST (Press release, Biolase Technology, DEC 9, 2020, https://www.prnewswire.com/news-releases/biolase-to-present-at-the-13th-annual-ld-micro-main-event-conference-301189336.html [SID1234572557]). President and CEO Todd Norbe and Executive Vice President, CFO and COO John Beaver will be presenting to a live, virtual audience.

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Register to attend the event here: ve.mysequire.com/

The Main Event will feature a new and unique format, with companies presenting for 10 minutes, followed by 10 minutes of Q&A by a panel of investors and analysts.

"The time has finally come to do something different in the virtual conference world. Let’s see if we can pull off something that can be enjoyed by both executives and investors alike," stated Chris Lahiji, Founder of LD, now a wholly owned subsidiary of SRAX, Inc.

The Main Event will take place on December 14th and 15th, exclusively on the Sequire Virtual Events platform.

On December 9, 2020 Exact Sciences Corp. (NASDAQ: EXAS) reported that data from the Rx for Positive Node, Endocrine Responsive Breast Cancer, or RxPONDER, trial successfully defined the benefit of chemotherapy in early-stage, node-positive breast cancer patients with Oncotype DX Breast Recurrence Score results of 0 to 25. First results from the study, led by the independent SWOG Cancer Research Network, and sponsored by the National Cancer Institute (NCI), identified the majority of women with 1-3 positive nodes who received no benefit from chemotherapy (Press release, Exact Sciences, DEC 9, 2020, View Source [SID1234572556]).i The data will be presented on December 10 at the 2020 San Antonio Breast Cancer Symposium (SABCS).

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RxPONDER showed a different effect of chemotherapy based on Recurrence Score results for postmenopausal and premenopausal women. Postmenopausal women with Recurrence Score results 0-25 were not observed to show benefit from chemotherapy and may avoid the associated side effects of the treatment. Importantly, no chemotherapy benefit was observed regardless of the number of affected nodes, tumor grade, or size. Two-thirds of the women in the trial were postmenopausal.

The first results also demonstrated, after a median of five years of follow-up, that premenopausal women with Recurrence Score results 0-25 were observed to have a statistically significant chemotherapy benefit, with an average improvement in distant recurrence rates at 5 years of 3%.

Approximately 85% of women with node- positive disease have Recurrence Score results of 0 to 25. ii Postmenopausal and premenopausal women with Recurrence Score results 26-100 were not included in the study because investigators reviewed prior studies and determined that this patient group had chemotherapy benefit. The SWOG investigators intend to publish the detailed RxPONDER results in a peer-reviewed publication.

"Every day in clinics around the world, physicians wrestle with the question of how to best treat women with this common form of breast cancer," said study lead author Kevin Kalinsky, MD, a long-time SWOG investigator and director of the Glenn Family Breast Center at the Winship Cancer Institute of Emory University. "These results are practice changing and demonstrate that the great majority of postmenopausal women can be spared unnecessary chemotherapy and receive only hormone therapy. This should bring more clarity to physicians and some relief for patients."

Approximately 25% of patients diagnosed with hormone receptor (HR)-positive, HER2-negative early breast cancer have tumor that has spread to their lymph nodes and two out of three are postmenopausal.iii The vast majority of these patients currently receive chemotherapy.iv

"With the RxPONDER and TAILORx trials, there is now definitive and undeniable clarity on who does and who does not benefit from chemotherapy among early-stage breast cancer patients, with either node-negative or node positive disease," said Steven Shak, MD, chief medical officer at Exact Sciences. "These long-awaited results, which continue to build on the body of evidence supporting the role of the Oncotype DX test in shaping clinical practice, are estimated to impact tens of thousands of women worldwide."

One of the largest clinical trials in women with node-positive HR+, HER2- early breast cancer, RxPONDER is a prospective, randomized Phase III study conducted at 632 sites in nine countries – the United States, Canada, Mexico, Colombia, Ireland, France, Spain, South Korea, and Saudi Arabia. The study enrolled more than 5,000 women with up to three positive nodes. Women with a Recurrence Score result 0-25 were randomized for treatment with hormone therapy alone or chemotherapy followed by hormone therapy. Randomized patients were stratified based on their Recurrence Score result, menopausal status, and the type of lymph node surgery.

The use of the Oncotype DX test in early-stage breast cancer is supported by prospective outcomes from more than 17,000 patients with node-positive disease and more than 83,000 patients with node-negative disease, including the TAILORx study. Results from TAILORx, published in 2018, showed that the Oncotype DX test identifies the vast majority of women with node-negative disease who receive no substantial benefit from chemotherapy (approximately 80%), as well as the important minority for whom chemotherapy can be life-saving.

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. 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 Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On December 9, 2020 Bolt Biotherapeutics, a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems, reported the presentation of a poster detailing the design of its ongoing Phase 1/2 clinical trial for BDC-1001 in patients with HER2-expressing solid tumors at the San Antonio Breast Cancer Symposium (SABCS) 2020 Virtual Meeting, being held Dec. 8-11, 2020 (Press release, Bolt Biotherapeutics, DEC 9, 2020, View Source [SID1234572555]). The poster will be presented today, Wednesday, Dec. 9, at 8:00 a.m. CT/9:00 a.m. ET.

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The in-progress clinical trial poster titled, "Phase 1/2 study of a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), BDC-1001, as a single agent and in combination with an immune checkpoint inhibitor in patients with advanced HER2-expressing solid tumors," discusses the framework of Bolt’s Phase 1/2 clinical trial. The actively enrolling global clinical study is for patients with refractory HER2-expressing solid tumors and its primary objectives are to evaluate safety, tolerability and to determine the recommended Phase 2 dose for both monotherapy and combination with a checkpoint inhibitor. BDC-1001 is a novel treatment which combines the targeting and antitumor effect of trastuzumab with stimulation of the immune system via TLR 7/8 agonism. Based on initial clinical observations to date, there have been no dose-limiting toxicities and no drug-related severe adverse events.

Edith Perez, M.D., Chief Medical Officer at Bolt, commented, "Preclinical data support that BDC-1001 may enable a patient to recruit their own immune system to fight their cancer with intravenous administration of BDC-1001. We continue to see strong interest in participation in our trial from both investigators and potential patients based on our compelling preclinical data and ongoing clinical observations."

About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody ISAC platform technology harnesses the ability of innate immune agonists to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration as monotherapy in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.

About the Ongoing BDC-1001 Phase 1/2 Study in Patients with HER2-Expressing Solid Tumors
The Phase 1/2, multi-center, open-label study is evaluating the safety, pharmacokinetics, pharmacodynamics and proof of mechanism of BDC-1001 in patients with HER2-expressing solid tumors. The first portion of the study includes a monotherapy dose-escalation phase in which cohorts of patients will receive ascending intravenous doses of BDC-1001 to determine the maximum tolerated dose and/or the recommended dose to advance into expansion cohorts and Phase 2 based on safety and tolerability. The second portion of the study is a dose expansion phase in which patients will receive BDC-1001 monotherapy to further evaluate the safety, tolerability and clinical antitumor activity of the recommended Phase 2 dose. Please refer to www.clinicaltrials.gov NCT04278144 for additional clinical trial information.

On December 9, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported that new data will be presented on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, in an oral presentation on December 10, 2020 at the 2020 European Society for Medical Oncology Immuno-Oncology (ESMO IO) Virtual Congress (Press release, Natera, DEC 9, 2020, View Source [SID1234572554]). The abstract is available to view here.

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The oral presentation will report results from a prospective circulating tumor DNA (ctDNA) analysis of 581 muscle invasive urothelial carcinoma (MIUC) patients who participated in IMvigor010, an open-label, global, randomized and controlled Phase III study that evaluated adjuvant treatment with the PD-L1 inhibitor atezolizumab compared with observation. Results at an interim analysis show that patients who were ctDNA-positive after surgery (37%) had an increase in overall survival (OS) in the treatment arm, with a median of 25.8 months with Tecentriq, compared with 15.8 months for observation (HR=0.59; 95% CI: 0.41–0.86), while those patients who were ctDNA-negative after surgery derived no benefit. The study also shows that ctDNA clearance was higher in the treatment arm vs. the observation arm (p=0.0048).

"In this study, we show that personalized ctDNA analysis is highly accurate not only for identifying molecular residual disease, but also for predicting better outcomes with immune therapy," said Thomas Powles, M.D., Professor, Barts Cancer Institute, and Principal Investigator of the study. "This opens new avenues for patient selection in the future and is an important step in the drive towards personalized cancer therapy."

"We are honored to partner with Genentech on this groundbreaking study," said Alexey Aleshin, M.D., Natera’s Senior Medical Director of Oncology. "This randomized Phase III study demonstrates for the first time, unequivocally, that Signatera can identify which patients are likely to benefit from adjuvant therapy and which are unlikely to benefit. It also highlights the significance of ctDNA clearance as an early endpoint for the evaluation of drug efficacy."

Details about the presentation are as follows:

Presentation #10 | Presenter: Thomas Powles, M.D. | Date and time: Dec 10, 13:50 – 14:02 CET

Clinical outcomes in post-operative ctDNA-positive muscle-invasive urothelial carcinoma (MIUC) patients after atezolizumab adjuvant therapy

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On December 9, 2020 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of fully human antibody therapeutics, reported the presentation of the latest interim data from its ongoing phase Ib combination trial of olinvacimab and pembrolizumab for metastatic triple-negative breast cancer (mTNBC) patients (Press release, PharmAbcine, DEC 9, 2020, View Source [SID1234572553]). The results were presented at the SABCS (San Antonio Breast Cancer Symposium) 2020, currently taking place virtually.

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As of the data cut-off date of September 2020, all 11 mTNBC patients were recruited and received at least one dose of treatment. No DLT (Dose Limiting Toxicity) was observed. Three patients were receiving treatment at the data cut-off date. 4 patients (36%) had partial response (PR) as best overall response, and 5 patients (45%) had clinical benefit (PR+SD≥24weeks). In the high-dose cohort, 3 patients (50%) showed PR and 4 patients (67%) received clinical benefit. 1 patient in PR showed complete response in the target lesion but was included in PR because a tumor was found in a non-target lesion.

The number of PR and SD remains the same from our previous interim results whose cut-off date was June 2020. The same 3 patients who were receiving treatment as of the previous cut-off date continued to receive treatment as of September 2020. As such, PFS (Progression Free Survival) and OS (Overall Survival) are likely to improve for the final results. Adverse events were similar to those shown in the previous interim results.

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 10-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

"The early activity signals for olinvacimab in combination with pembrolizumab for mTNBC patients are highly encouraging. We believe these findings provide an encouraging safety profile and evidence of clinical activity of the combo therapy," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We are particularly thrilled by the efficacy data from the high-dose cohort, heightening our expectation for its continued clinical development or future planned clinical studies."

About San Antonio Breast Cancer Symposium

San Antonio Breast Cancer Symposium (SABCS) is the world’s largest breast cancer conference held annually. Nearly 10,000 researchers and medical experts participate event every year. The core mission of this event is to provide the latest research data in breast oncology to all participants around the globe. For the safety and security of all members in the COVID-19 global pandemic, the SABCS executive committee has decided to hold this year’s event virtually.