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MedNess: bite-size biopharma and medtech news

5th November, 2019
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HIGHLIGHTS
Our Sponsors
Regulatory News
CAR-T Therapy CT053 Granted RMAT Designation by the U.S. FDA for R/R Multiple Myeloma
“RMAT eligibility is an important regulatory milestone for CARsgen in the continued development and commercialization of CT053 anti-BCMA CAR T cell therapy,” said Zonghai Li, M.D., Ph.D., the chief executive officer of CARsgen. “The RMAT designation indicates that CT053 has demonstrated potential to address unmet medical needs for patients with rrMM. The designation is a remarkable achievement towards expediting the product development and review of our planned biologics license application (BLA) and will be invaluable to bringing this cutting-edge advance to patients as quickly as possible. RMAT as well as the PRIority MEdicines (PRIME) eligibility received from the European Medicines Agency (EMA) empower us to collaborate closely with the U.S. FDA and EMA to rapidly advance the CT053 development program toward global regulatory approvals.” The CT053 anti-BCMA CAR-T program has also received Investigational New Drug (IND) clearance and Orphan Drug designation from the U.S. FDA and authorization of its Clinical Trial Application (CTA) from Health Canada.
U.S. FDA agrees with proposed pivotal Ph III trial design to support an NDA submission and approval of Namodenoson in the treatment of liver cancer
“Namodenoson is a novel approach to treating advanced liver cancer with an orally bioavailable drug specifically targeting the tumor cells, a unique mechanism that contributes to the favorable safety profile. We are very pleased with this outcome from our meeting with the FDA. With the FDA’s guidance, we plan to now finalize our Phase III study protocol for this unmet advanced liver cancer indication,” stated Dr. Michael Silverman, Can-Fite’s Medical Director.
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Trial Results
Halozyme Announces HALO-301 Phase 3 Study Fails To Meet Primary Endpoint
"Patients in both treatment arms of the HALO-301 trial surpassed the published median overall survival rates from the pivotal registration study of ABRAXANE® plus gemcitabine as first-line therapy for metastatic pancreas cancer, published in 2013. Based on the lack of benefit over standard-of-care in this study, which performed well versus published data, we will be discontinuing PEGPH20 clinical development," said Dr. Helen Torley, president and CEO of Halozyme. "This well-designed and well-executed study did not have the outcome that we or the study participants wanted or expected. I would like to extend a heartfelt thank you to all those who supported and who made this study possible, including the patients who were enrolled, their families, our investigators, their staff, our investors and all of the dedicated Halozyme employees."
Ph III POSEIDON trial meets primary endpoint of PFS improvement in 1L squamous and non-squamous NSCLC patients
José Baselga, Executive Vice President, Oncology R&D, said: “The POSEIDON trial provides evidence of the efficacy of Imfinzi in patients with Stage IV non-small cell lung cancer. Clinical benefit was observed in a trial population that included a high proportion of patients with squamous disease and multiple choices of chemotherapy regimens. Additionally, the potential to add tremelimumab to Imfinzi and chemotherapy may present an important treatment approach in this challenging setting, especially taking into consideration the favourable safety profile.”
Updated data from Ph II trial of tipifarnib showed durable anti-tumor activity in heavily pretreated HRAS-mutated SCCHN patients
“Tipifarnib is a targeted therapy that has demonstrated rapid and durable anti-tumor activity as a single agent in patients with head and neck squamous cell carcinomas that carry HRAS mutations, a disease that can be resistant to current standards of care, including immunotherapy,” said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the study.
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Trial Status/Progress
First patient dosed with off-the-shelf UCARTCS1 for relapsed/refractory multiple myeloma
"This first patient dosing for our MELANI-01 clinical trial is an important advancement, as our team has worked tirelessly to develop and take the CS1 target from the lab to the clinic,” said Dr. André Choulika, Chairman and CEO, Cellectis. "In taking this next clinical step, we look forward to deepening our understanding of UCARTCS1 as a potential new treatment option for relapsed/refractory multiple myeloma patients in the future.”
Ph II trial of anti-PD-L1 probody CX-072 + YERVOY® initiated in patients with relapsed or refractory melanoma
“The initiation of this first Phase 2 study for CX-072 marks the ongoing advancement of our innovative pipeline of Probody therapeutics and reflects our vision for this novel checkpoint inhibitor to become a differentiated centerpiece of combination therapies in multiple cancer types,” said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics.
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MedNess Business
Onco-News

Amgen and BeiGene collaborate to tap Chinese oncology market

Amgen is set to acquire a 20.5% stake in BeiGene for $2.7 billion in cash to tap into the oncology market in China. The collaboration is set to advance 20 medicines from Amgen’s oncology pipeline in China with BeiGene gaining commercial rights for seven years after their launch in China, beyond which BeiGene will retain the rights of up to six products in China. The transaction is expected to be completed in early 2020.

Ziopharm and MD Anderson Cancer Center announce R&D agreement to advance T-cell therapy

Ziopharm and The University of Texas MD Anderson Cancer Center have announced a R&D agreement to develop and clinically evaluate Ziopharm’s Sleeping Beauty T-cell immunotherapy program for solid tumors. According to the agreement, Ziopharm will infuse $20 million for the program until 2023 besides adding milestone based payment depending on clinical development and regulatory approval. Additionally, Ziopharm will lease lab and office space with the institution’s campus to facilitate the R&D activities.
Bio-Pharma and MedTech

T3D Therapeutics raises $15 million series B to advance Alzheimer’s disease treatment
T3D Therapeutics has raised $15 million in series B financing to advance the phase 2 development of oral-administered lead candidate T3D-959. T3D-959 is a brain-penetrating small molecule agonist intended for improving glucose and lipid metabolism that goes awry in Alzheimer’s disease. With support from National Institute of Aging, part of the National Institute of Health (NIH), the PIONEER study is designed to evaluate the safety and efficacy starting early 2020.

Google acquires Fitbit for $2.1 billion

Google has entered in a definitive agreement to acquire the 12-year-old popular wearable brand Fitbit for $2.1 billion. With over 28 million active users and over 100 million devices sold, Google will shell out $7.35 per share. The acquisition comes soon after Fitbit’s alliance with pharma majors Pfizer and Bristol Meyer Squibbs to detect atrial fibrillations on its wearable devices. This is the second wearable acquisition by Google this year after Fossil’s undisclosed technology for $40 million.
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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