On October 7, 2020 Brainlab, the digital medical technology company, reported the planned delivery of 10 new ExacTrac Dynamic systems to GenesisCare, offering US cancer patients and physicians access to the latest treatment technologies on the market (Press release, GenesisCare, OCT 7, 2020, View Source [SID1234568198]). This follows GenesisCare’s acquisition of major integrated cancer care provider, 21st Century Oncology, increasing access to advanced cancer care for patients across US communities.

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ExacTrac Dynamic, a patient positioning and position monitoring device, received FDA 510(k) clearance in July 2020 and supports the delivery of precision radiotherapy with surface and thermal tracking combined with real-time X-Ray monitoring. ExacTrac Dynamic will allow GenesisCare physicians to deliver stereotactic radiosurgery, a non-invasive form of radiation therapy which delivers precisely targeted radiation in fewer high-dose treatments than traditional therapies.

Australian-headquartered GenesisCare is one of the largest networks of integrated oncology care in the world, with treatment centers and clinics across Australia, the UK, Spain and now the US. ExacTrac Dynamic systems have already been rolled out in Australia and the UK, providing patients access to the latest advancements in radiation therapy, including stereotactic radiosurgery and tattoo-free treatment.

"During COVID-19, we have remained steadfastly committed to ensuring all cancer patients in local communities across the United States and globally receive rapid access to world-class cancer care. Our investment in these cutting-edge ExacTrac Dynamic systems will help us deliver on our vision to ensure as many cancer patients as possible are able to receive the right treatment, at the right time, closer to home. Our partnership with Brainlab will allow our physicians in the US to automate precise patient monitoring during the delivery of faster, more personalized radiotherapy treatments in our 290 centers across the country," said Dan Collins, Founder and Global Chief Executive Officer, GenesisCare."

Building upon the first generation ExacTrac X-Ray, the new ExacTrac Dynamic system expands clinical workflows beyond traditional stereotactic capabilities with new surface-guided and thermal technology. These high-precision tracking and verification capabilities enable the delivery of effective prescription target doses, with less radiation to normal healthy tissues, for a wide range of treatment locations in the body. The system allows for:

Surface guided patient setup without tattoos or markings
Submillimetric patient monitoring using integrated surface, thermal, and X-Ray imaging at all couch angles
Real-time motion management with automatic beam-hold enabling future applications such as Deep Inspiration Breath Hold (DIBH) gated treatments*
"It’s exciting for Brainlab to continue to work with GenesisCare as they expand their presence in the United States," said Stefan Vilsmeier, President and CEO, Brainlab. "We have long partnered with GenesisCare in Australia and the UK and share their vision to make precision radiotherapy more accessible on a global scale."

First deliveries are planned for November 2020.

On October 7, 2020 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that The Lancet Oncology published results of the company’s Phase 2 trial cohorts evaluating TAZVERIK (tazemetostat) for the treatment of epithelioid sarcoma and relapsed/refractory follicular lymphoma (Press release, Epizyme, OCT 7, 2020, View Source [SID1234568197]). Data included in these publications supported the accelerated approval of TAZVERIK by the U.S. Food and Drug Administration (FDA) for the treatment of epithelioid sarcoma in January 2020, and the accelerated approval of TAZVERIK by the FDA for the treatment of relapsed/refractory follicular lymphoma in June 2020.

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"The two publications in such a highly regarded, peer-reviewed journal as the Lancet are the culmination of years of hard work by our team, and the significant contributions by the patients and physicians who participated in our clinical trials," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "In our Phase 2 trials, TAZVERIK demonstrated durable clinical responses in both patient populations, including in patients with advanced disease who had previously received multiple therapeutic regimens. In addition, we observed consistently favorable safety with TAZVERIK, which we view as one of its most attractive features. These publications provide important support for TAZVERIK’s novel epigenetic approach, and I am very proud that we are able to offer it as an approved therapy for both patient populations."

"Based on its compelling clinical data and first-in-class mechanism, we believe TAZVERIK has a pipeline in-a-product opportunity that we hope may offer benefit to patients with a wide range of cancers," said Robert Bazemore, president and chief executive officer of Epizyme. "The two FDA accelerated approvals this year highlight the therapeutic impact TAZVERIK could have for patients, and we look forward to continuing to explore its potential in additional tumor types and combinations to reach as many patients as possible."

The publications can be accessed at the following link:
https://www.thelancet.com/journals/lanonc/onlinefirst

About TAZVERIK

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

Dosage and Administration

The recommended dosage of TAZVERIK is 800 mg taken orally twice daily with or without food.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 729 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.7% of patients. One pediatric patient developed T-cell lymphoblastic lymphoma (T LBL). Monitor patients long-term for the development of secondary malignancies.
Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0-45h]) at the 800 mg twice daily dose.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.
Adverse Reactions

Epithelioid Sarcoma

In 62 clinical study patients with epithelioid sarcoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 37% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥3% were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress. The most common (≥20%) adverse reactions were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%), and constipation (21%).
Relapsed or Refractory Follicular Lymphoma

In 99 clinical study patients with relapsed or refractory follicular lymphoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥2% were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).
Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.
Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.
Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.
Lactation

Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child, advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.

On October 7, 2020 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States, reported that in recognition of its successes in leading edge life science innovations and advancements and in support of its R&D and product commercialization efforts, AnPac Bio has obtained three grants and one rental award from various local authorities in China with a portion of the funding subject to milestone achievements (Press release, Anpac Bio, OCT 7, 2020, View Source [SID1234568196]). In total, these grants and award reached approximately US$8 million. Grant and award payments or benefits are expected to be received over a few years starting from this quarter and will help AnPac Bio fund R&D and new product commercialization.

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Dr. Chris Yu, AnPac Bio’s Chairman and CEO commented: "We are pleased and thankful for the grant and award recognitions. We believe that we are well positioned to successfully execute our goals this year and in 2021, during which we will accelerate our R&D, cancer detection product commercialization in China (class III medical device) and US (Laboratory Developed Tests (LDT)), and increase our revenue."

On October 7, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the FDA has granted Orphan Drug Designation ("ODD") and Rare Pediatric Disease Designation ("RPDD") for its leading bispecific antibody program nivatrotamab for the treatment of neuroblastoma (Press release, Y-mAbs Therapeutics, OCT 7, 2020, View Source [SID1234568195]).

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Nivatrotamab, a humanized bispecific anti-GD2 antibody, is currently in Phase 1 clinical development in collaboration with Memorial Sloan Kettering Cancer Center ("MSK") in patients with relapsed/refractory neuroblastoma, as well as high grade osteosarcoma and other GD2(+) solid tumors, where patients have relapsed or refractory disease that is resistant to standard therapy.

"We are very pleased with the ODD granted for nivatrotamab, as this potentially would give us seven years of market exclusivity upon market approval. The RPDD makes us eligible for a Priority Review Voucher ("PRV") upon potential approval of the biologics license application for this rare pediatric cancer. Among our leading compounds, four now have RPDDs, and this designation further increases our chances of ultimately receiving multiple PRVs," said Thomas Gad, Founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, further notes, "We are very pleased by this recognition by the FDA, and plan to expand the ongoing study with nivatrotamab into two separate Phase 2 arms in neuroblastoma and osteosarcoma, respectively, as well as a separate Phase 2 multicenter study in small cell lung cancer. We expect to submit an IND for the lung cancer study during the fourth quarter of 2020, and we are thrilled to widen nivatrotamab’s clinical reach to include adult indications."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed nivatrotamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.

On October 7, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that abstracts submitted for two of its drug candidates have been selected for presentation at the Molecular Targets and Cancer Therapeutics virtual symposium hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) on Oct. 24-25 (Press release, Turning Point Therapeutics, OCT 7, 2020, View Source [SID1234568193]).

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The abstracts include a late-breaker submission selected for an oral presentation by David Hong, M.D., Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, of early clinical data for Turning Point’s novel MET/SRC/CSF1R inhibitor, TPX-0022; and two poster presentations of preclinical data for lead drug candidate repotrectinib demonstrating first, an increase in the effectiveness of a KRAS-G12C inhibitor via the simultaneous inhibition of SRC, FAK and JAK2 kinases; and second to be presented in a poster discussion session, potent anti-tumor activity as a monotherapy and in combination with chemotherapy in neuroblastoma cell lines and pediatric patient derived xenograft models.

Details for the presentations are as follows:

Title: First-in-human safety, pharmacokinetics, and preliminary efficacy of TPX-0022, a novel inhibitor of MET/SRC/CSF1R in patients with advanced solid tumors harboring genetic alterations in MET
Session: Plenary Session 1, Late Breaking and Best Proffered Papers
Date and Time: Saturday, 24 October 2020 – 15:05 CET (9:05 a.m. ET)

Title: Repotrectinib Increases KRASG12C Inhibitor Effectiveness Via Simultaneous Inhibition of SRC, FAK, and JAK2
Session: Drug Resistance and Modifiers
Date: Saturday, 24 October 2020, Session Code 310

Title: Repotrectinib, a next-generation ALK/ROS1/NTRK 1-3 inhibitor, has potent antiproliferative and anti-tumor activity as monotherapy and in combination with chemotherapy in neuroblastoma cell lines and pediatric patient derived xenograft models
Session: Next Generation Targeted Therapies A
Date and Time: Saturday, 24 October 2020 – 22:00 – 23:20 CET (4:00 p.m. – 5:30 p.m. ET)