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Onco-This-Week
25th June , 2019
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MedNess This Week
Highlights
Drug Approvals
EU approves Talazoparib in gBRCA 1/2-mutated HER2 neg locally advanced or metastatic breast cancer patients based on Ph III EMBRACA trial data
“Today’s approval of TALZENNA for certain patients with advanced-stage breast cancer and an inherited BRCA mutation is the latest example of our successful precision medicine approach to drug development,” said Andreas Penk, M.D., Regional President, Oncology International Developed Markets at Pfizer. “This important milestone builds on Pfizer’s decades-long legacy of developing therapies that improve outcomes for patients with breast cancer. We are thrilled that we can now offer these patients in Europe, who are often diagnosed at a younger age and have limited treatment options, an effective, once-daily, alternative treatment to chemotherapy.”
Japan approves entrectinib for adult and paediatric pts with NTRK fusion +ve, advanced recurrent solid tumors based on data from Ph II STARTRK-2, Ph I STARTRK-1, Ph I ALKA-372-001 trials, and Ph I/II STARTRK-NG study in pediatric patients
“Today’s approval of Rozlytrek represents a new chapter in personalised healthcare, applying advanced diagnostics to deliver precision medicines that target cancers based on their molecular drivers instead of their location in the body,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are proud to be at the forefront of personalised medicine with this novel treatment approach, and we look forward to working with regulatory agencies around the world to bring Rozlytrek to more patients with NTRK fusion-positive cancer, as well as to those with ROS1 fusion-positive NSCLC, as soon as possible.”
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Regulatory News
Priority Review granted to niraparib in late stage BRCA-mutated or HRD+ partial platinum-sensitive ovarian cancer patients based on Ph III QUADRA trial data; PDUFA: 24 Oct 2019
Mary Lynne Hedley, Ph.D., President and Chief Operating Officer of TESARO, said, “The results of the QUADRA study demonstrate that ZEJULA is active as a late-line treatment for patients beyond those with BRCA mutations. With this study, we continue to advance our mission to provide more patients with ovarian cancer an opportunity to benefit from treatment with ZEJULA.”
FDA accepted IND application for ETB targeting CD38 TAK-169; Ph I dose escalation and expansion trial planned in RRMM patients
“We are excited to continue our collaboration with Takeda advancing the development of TAK-169 for the treatment of multiple myeloma patients,” said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. “It represents a novel CD38 targeted therapy which could provide benefit in patients with multiple myeloma and overcome mechanisms of resistance to existing CD38 targeted therapies.”
Fast Track designation granted to Deep-Primed™ T cell immunotherapy program, TRQ-1501 (Deep IL-15 Primed T cells) in R/R solid tumors and lymphomas expressing any of five TAAs (PRAME, WT-1, SSX2, Survivin, and NY-ESO-1)
“Patients with relapsed or refractory solid tumors and lymphomas have a poor prognosis and limited treatment options. We are delighted to receive this Fast Track designation of TRQ-1501 for a broad, tumor-agnostic indication, which provides significant flexibility for our clinical trial program,” said Becker Hewes, MD, Chief Medical Officer of Torque. “Working in close collaboration with the FDA supports our goal of improving patient outcomes in multiple difficult-to-treat solid and hematologic cancers.”
Onco-Trial Results
Ph III CheckMate-459 trial of Nivolumab in 1L unresectable HCC patients fails to meet primary endpoint of OS improvement vs Sorafenib
“We are encouraged by the promising efficacy and safety trends seen with Opdivo in CheckMate -459, especially as HCC is a devastating and difficult-to-treat cancer, for which there have been no significant advances over sorafenib, a standard treatment, in more than a decade,” said Bruno Sangro, M.D., head of the Liver Unit, Clínica Universidad de Navarra, Pamplona, Spain.
Preliminary top-line results from Ph IIb trial of IL4-guided toxin MDNA55 in rGBM patients announced
"The preliminary top-line clinical results of the Phase 2b trial of MDNA55 are very promising when compared to approved therapies for rGBM especially in patients exhibiting high levels of IL4R expression, a biomarker for more aggressive forms of brain cancer," said Dr. Fahar Merchant. "While treatment options for patients with rGBM are very limited, MDNA55 has shown early evidence of substantial clinical benefit as well as improved survival for patients. We believe these results are evidence of the opportunity for MDNA55 to become a leading treatment option for a sizeable patient population with this devastating disease."
Click Here for more Onco-Trial Results 
Onco-Trial Status/Progress
FDA lifts partial clinical hold on Ph III CANOVA trial of Venetoclax in RRMM patients positive for the t(11;14) genetic abnormality
"We are pleased to move forward with the CANOVA study which, with the t(11;14) biomarker test, can help identify patients who may respond better to treatment and add clarity for physicians when choosing a therapy, if approved," said Mohamed Zaki, M.D., Ph.D., global head of hematology development, AbbVie. "We are working closely with regulatory authorities worldwide to continue our efforts to understand the potential of venetoclax for patients with multiple myeloma while continuing to advance research in patients with the t(11;14) genetic abnormality."
Ph II EMERGE trial of Vopratelimab + Ipilimumab initiated in NSCLC or urothelial cancer patients
“The Phase 2 EMERGE clinical trial of vopratelimab and ipilimumab builds upon the original science from our founders as well as the reverse translational subset analysis from patients who benefitted in our ICONIC trial versus those who did not. Vopratelimab treatment resulted in the emergence of ICOS hi CD4 T effector cells in the peripheral blood and emergence of these cells was associated with response and improvements in progression free survival and overall survival, as presented at the 2019 American Association for Cancer Research Annual Meeting,” said Beth Trehu, M.D., chief medical officer of Jounce Therapeutics. “Ipilimumab is known to induce a population of ICOS hi CD4 T cells, making it a scientifically logical combination partner for vopratelimab in the EMERGE study, as we have shown vopratelimab stimulates, expands and sustains ICOS hi CD4 T cells. We are pleased to have begun enrollment in the EMERGE clinical trial and expect to report preliminary efficacy data in 2020.”
Click Here for more Progress/status of ongoing trials
MedNess Plus
 
“The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy,” said Lisa Yanoff, M.D, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.”
FDA announces the extension of indication for Symdeko for the treatment of cystic fibrosis in patients ages 6 and older
“Decades ago, patients with cystic fibrosis were generally expected to live until 10 years of age, with few surviving into their teenage years. Since then, wide-ranging research on the disease resulted in more treatments for this debilitating disease that have extended life expectancy and improved quality of life for patients, but there is still no cure,” said Banu Karimi-Shah, M.D., acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Based on their individual genetic makeup, individuals may respond differently to certain drugs, so it is important to provide a variety of options. Today’s approval of Symdeko for children as young as 6 years old provides an important treatment option for younger patients, and also provides more context on the safety and dosing specific to this population. The FDA remains committed to advancing novel treatment options for areas of unmet patient need, particularly in diseases impacting children.”
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MedNess Business
Onco-News
Gilead and Nurix collaborate to develop therapies for cancer using protein degradation technology
Nurix Therapeutics, a company with pipeline of innovative targeted protein degradation drugs for patients with cancer and other diseases, has established a strategic partnership with Gilead for development of novel therapies. According to the agreement, Nurix will receive an upfront payment of $45M and is eligible to receive up to $2.3B additionally upon completion of research, preclinical, clinical, regulatory and commercialization milestones.
BeiGene and SpringWorks form MapKure to initiate Ph 1 trial of BGB-3245 in B-RAF driver mutations and RAF fusions positive solid tumor patients, and in first-gen BRAF inhibitors-refractory patients
“Preclinical data demonstrate that BGB-3245 could potentially address a significant unmet medical need for patients with non-V600 B-RAF mutations or RAF fusions that are presently unaddressed with approved B-RAF-directed therapies. In addition, BGB-3245’s preclinical activity in cancer models driven by V600 B-RAF mutations demonstrate that it could provide an additional therapeutic option for these patients with the potential to reduce dimer-driven resistances,” said Dr. Rosen. “I look forward to being part of this endeavor to evaluate the therapeutic potential of BGB-3245.”
BioPharma and MedTech

Acutus Medical raises $170M in series D for arrhythmia detection and treatment
Acutus Medical specializing in innovative technology to transform arrhythmia care has raised $170M financing with $100M in equity financing and $70M in credit facility. FDA approved and CE marked Acutus technology platform, AcQMap, is the cardiac imaging and mapping system incorporating precision ultrasound atrial anatomy reconstruction and high-definition charge density mapping thereby increasing the clarity of arrhythmia patterns. With an estimated expenditure of $26B on atrial fibrillation alone in USA, Acutus focuses on cardiac access, diagnostic, mapping and visualization technology to reduce the burden of atrial arrhythmia. The funds raised will be used to accelerate commercialization and for global business development. 
Tangen Biosciences gets $9M series A financing for development of DNA diagnostic platform
Tangen Biosciences has closed a $9M series A financing round to accelerate its diagnostic platform TangenDxTM to clinic for two infectious disease test. TangenDxTM uses novel isothermal acid detection platform to amplify DNA at a constant temperature that enables fast and accurate detection of DNA and RNA directly from specimens. Based on this technology, TangenDx will launch two 510(k) clinical studies this year, utilizing product produced in its cGMP-complaint facility.
Click Here to know more about  M&A – Fund raising – Investments and more..
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Mayur Vadhvani, PhD
Business News
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
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The sponsors do not have any influence on the nature or kind of the news/analysis reported in Onco-this-Week. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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