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MedNess: bite-size biopharma and medtech news

12th November, 2019
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HIGHLIGHTS
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Regulatory News
TT-00420 granted Orphan Drug Designation from FDA to treat cholangiocarcinoma
Dr. Frank Wu, Founder and CEO of TransThera, commented: “Cholangiocarcinoma lacks effective therapies and remains a huge unmet medical need around the world. TT-00420 has demonstrated great potential in multiple experiments. We believe that today’s orphan drug designation will help accelerate the development of this potential product in the clinical trials and bring meaningful benefit to cholangiocarcinoma patients. We are very excited about this news, which expands the horizon of our lead product in development. In addition to triple negative breast cancer, cholangiocarcinoma is identified by our scientists to be second indication for TT-00420.”
Trial Results
Phase III JAVELIN Gastric 100 study of avelumab as 1L maintenance therapy in unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) patients failed to meet the primary endpoint of OS improvement
“Advanced gastric cancer is a hard-to-treat tumor, and there is a key unmet need for additional treatments. Additionally, it is rarely immunogenic, and to date no immune checkpoint inhibitor has demonstrated superiority to the current standard of care with chemotherapy,” said Prof. Dr. Markus Möhler, Head of GI Oncology, Senior Physician Gastroenterology & Endosonography, Johannes-Gutenberg University, Mainz, Germany and coordinating investigator. “As we have yet to define the ideal strategy for incorporating immunotherapy in the continuum of care, the results of JAVELIN Gastric 100 will provide essential information in advancing our understanding and potential treatment options of this challenging disease.”
Ph III TOURMALINE-MM4 trial of NINLAROTM (ixazomib) as 1L maintenance therapy met primary endpoint in multiple myeloma patients not treated with stem cell transplantation
“We are very encouraged by the results of the TOURMALINE-MM4 trial and continue our forward momentum in developing maintenance options for multiple myeloma patients. Importantly, this is the third positive Phase 3 readout from the TOURMALINE clinical trial program,” said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. “We remain committed to bringing this convenient and well-tolerated treatment option to patients.”
80% PFS6 announced in Ph II GBM trial of INO-5401 + Libtayo® (cemiplimab)
Dr. David Reardon, M.D., Coordinating Principal Investigator of the study and the Clinical Director for Neuro-Oncology at the Dana-Farber Cancer Institute, said, "This innovative trial provides promising information that the combination of INO-5401 plus INO-9012, a T cell-promoting therapy, combined with Libtayo, a checkpoint inhibitor, may provide clinically meaningful benefit in this very difficult to treat disease."
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Trial Status/Progress
Ph II CyFi-2 trial of Ficlatuzumab + high-dose cytarabine initiated in R/R AML patients
“Supported by promising Phase 1b/2 results from the CyFi-1 study, which showed a 50% complete response rate in primary refractory AML patients (n=18) and an acceptable tolerability profile, the ficlatuzumab-cytarabine combination has the potential to improve outcomes in this historically difficult to treat population,” said Michael Bailey, president and chief executive officer of AVEO. “The CyFi-2 study, along with our ongoing randomized Phase 2 study in head and neck cancer, provide two opportunities to potentially pursue registration strategies for ficlatuzumab, assuming favorable study outcomes.”
Dosing Initiated in Ph III trial of RRx-001 in 3L SCCLC patients
"The need for progress in third-line or beyond SCLC is clear, as the outcomes for these patients are uniformly fatal," said Corey A. Carter, M.D., President & CEO of EpicentRx and former head of thoracic oncology at Walter Reed Military Medical Center. "SCLC, especially SCLC in third-line or beyond, is dramatically underserved with ineffective options for patients.”
Click Here for more Trial Status/Progress
Conference Coverage
Society for Immunotherapy of Cancer (SITC) Annual Meeting 2019
  1. Data from Ph I/II trial of INT230-6 highlights prolonged disease control, abscopal effects and immune response activity in patients with advanced solid tumors
  2. Data from Ph I dose-escalation trial of AVID200 presented
  3. New data from ARTISTRY-1 and ARTISTRY-2 trials of ALKS 4230 program presented
  4. Updated data from Ph I/Ib trial of CPI-006 presented
  5. Toca 6 Ph Ib data from non-CNS tumor patients presented
  6. Positive Ph II data of Natural Killer Cell Therapy aNK + N-803 presented in metastatic merkel cell carcinoma
  7. Updated Ph II clinical data from the Lifileucel metastatic melanoma trial presented
  8. Immune Pharmacodynamic Data (IPD) from Ph II Melanoma and Triple Negative Breast Cancer trial of Imprime PGG and KEYTRUDA® (pembrolizumab) presented
  9. Data from the AWARE-1 trial of pelareorep in early breast cancer patients presented
  10. Positive interim data from Ph II TACTI-002 trial of eftilagimod alpha + KEYTRUDA® presented
  11. ORR data from Cohort A of Ph II BGBC008 trial of bemcentinib + KEYTRUDA® in 2L+ NSCLC patients presented
  12. Updated data from Ph I/II NC318 trial of NC318 in solid tumor patients presented
  13. Interim Data from Ph I/IIb CLASSICAL-Lung trial of Pepinemab (VX15/2503) + Avelumab (BAVENCIO®) in NSCLC patients presented
  14. Results from first-in-human Ph I trial of anti-CD27 agonist as monotherapy and in combination with Pembrolizumab in patients with advanced Solid Tumors presented
  15. Results of Ph IIb trial of BL-8040 + KEYTRUDA® (pembrolizumab) in metastatic pancreatic cancer patients announced
  16. Positive clinical data with CMP-001 + Pembrolizumab in refractory melanoma patients presented
MedNess Plus
FDA approves the marketing of a next generation sequencing technology-based test to detect HIV-1 drug resistant mutation
“The ability to rationally select treatments for patients about to start or already taking antiviral therapy provides another tool in our ongoing fight against HIV” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s authorization offers health care providers a new tool in helping to select treatment options for their patients. The right combination of antivirals can lower viral loads, or the amount of virus in the blood stream, and help keep patients with HIV healthy for many years. However, according to a recent report from the Centers for Disease Control and Prevention and the World Health Organization, the percentage of people living with HIV around the world that have resistance to some HIV drugs has increased from 11% to 29% since 2001. Today’s authorization can help health care providers better tailor drug treatment for patients who are beginning antiviral therapy and also for those who have developed resistance to HIV drugs by helping to identify mutations in the HIV-1 virus that can impact the effectiveness of certain drugs.”
FDA announces the approval of a treatment for anemia in beta thalassemia patients
“When patients receive multiple blood transfusions, there is a risk for iron overload, which can affect many organs,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides patients with a therapy that, for the first time, will help decrease the number of blood transfusions. This approval is an example of our continued progress for rare diseases and providing important new drugs to patients earlier.”
Novartis announces encouraging results from the first-of-its-kind head-to-head trial of Cosentyx® versus Humira® for the treatment of psoriatic arthritis
“EXCEED is the first ever monotherapy head-to-head trial with a primary endpoint in psoriatic arthritis specific to joints.” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology & Dermatology. “Novartis continues to reimagine care for patients and advance science in rheumatology. We will assess the EXCEED data in their totality and we view the results as confirming our vision of Cosentyx becoming standard of care in psoriatic arthritis.” “These data will be welcomed by patients and clinicians to guide clinical decision making and highlight secukinumab as a viable option as a first-line biologic for the treatment of psoriatic arthritis,” said Iain McInnes, Professor of Rheumatology, University of Glasgow and an investigator in the secukinumab clinical trial program.
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MedNess Business
Onco-News

Takeda and MD Anderson Cancer Center collaborate to develop off-the-shelf CAR NK-Cell Therapy platform
Takeda has announced an exclusive license and research agreement with MD Anderson Cancer Center to target B-cell malignancies and other cancers using cord blood-derived chimeric antigen receptor-directed natural killer (CAR NK) cell therapies with IL-15. According to the agreement, Takeda will receive exclusive rights to develop and commercialize up to four programs including CD-19 and BCMA-targeted CAR NK cell therapy. The ongoing phase 1/2a clinical study is expected to enroll patients in 2021 and could have the potential to become the first CAR cell therapy approved for outpatient administration.

Promega and Merck collaborate to develop genome instability diagnostic for use with KEYTRUDA®
Promega announced a global collaboration with Merck (MSD) to develop its Microsatellite Instability (MSI) technology for use with Merck’s anti-PD1 therapy, KEYTRUDA®, as a companion diagnostic. MSI technology measures the insertion and deletion errors in the DNA microsatellites of genome that are hallmark of certain solid tumors. This technology has been marketed for use only for research purposes since 2004. The collaboration with seek initial regulatory approval in the USA and China before adding additional territories.
Bio-Pharma and MedTech

eGenesis raises $100 million in series B financing round to generate human-compatible organs using gene editing
eGenesis announced successful completion of $100 million financing in series B to solve global organ shortage by utilizing alternative sources of human-compatible organ generation for xenotransplantation. eGenesis uses gene editing techniques such as CRISPR to overcome immune-based and virus-based concerns during transplantation. The funds will be used for accelerating the kidney xenotransplantation program into the clinic. Fresenius Medical Care Ventures led the round with participation from Leaps by Bayer and Wellington Partners.

Arkuda Therapeutics raises $44 million in series A to combat neurodegenerative diseases
Arkuda Therapeutics announced $44 million in series A financing to develop medicines targeting neurodegeneratives diseases. Established in 2018, Arkuda approach focuses on improving lysosomal function and neuronal health by increasing levels of progranulins and granulins in the central nervous system. Arkuda will initially focus on the Granulin-related frontotemporal dementia (FTD-GRN) which is observed in patients between 45-65 years of age and is marked by progressive and rapid nerve cell loss in frontal and temporal lobes of the brain resulting in impaired memory, behavior and movement. This Atlas Venture co-funded and seeded company is led by Pfizer Ventures for series A with participation of Tekla Capital Management LLC and Bioinnovation Capital.
Click Here for more mergers, acquisitions and job opportunities in the featured companies
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Mayur Vadhvani, PhD
Business News
Abhi Dey
Consulting Editor
Arundithi Ananthanarayanan
I-cube
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
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The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. 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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