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MedNess: bite-size biopharma and medtech news

22nd October, 2019
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MedNess This Week

HIGHLIGHTS
Regulatory News
FDA grants Priority Review to Trastuzumab deruxtecan for treatment of patients with HER2-positive metastatic breast cancer; PDUFA: Q2 2020
José Baselga, Executive Vice President, Oncology R&D, said: “Trastuzumab deruxtecan has the potential to transform the treatment landscape for patients with HER2-positive metastatic breast cancer who have limited treatment options today. This Priority Review draws on the strength and the consistency of results seen in the Phase I and Phase II trials and is a critical step on the journey to deliver this potential new medicine to patients.”
Positive EU CHMP opinion for KEYTRUDA® (pembrolizumab) as 1L monotherapy or with platinum and 5-FU chemotherapy in all comers or PD-L1+ve metastatic or unresectable recurrent SCCHN patients
“Head and neck cancer remains a devastating disease with poor long-term outcomes and advances in survival have been difficult to achieve for more than 10 years” said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. “The positive EU CHMP opinion further validates the potential of KEYTRUDA, as monotherapy and in combination with chemotherapy, to help patients and address the high unmet need in this aggressive form of head and neck cancer.”
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Trial Results
FAILED TRIAL: Ph III SEQUOIA trial of pegilodecakin + FOLFOX did not meet primary endpoint of overall survival in 2L metastatic pancreatic cancer patients
"Pancreatic cancer has proven to be one of the most difficult tumor types to treat and there have been very few recent treatment advancements in the later-line metastatic setting. We are grateful to the patients, investigators and researchers who participated in the study," said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. "While we are disappointed by the outcome of the SEQUOIA study, we look forward to the upcoming results in lung cancer, learning from those results and increasing our understanding of pegilodecakin's novel mechanism of action in cancer immunotherapy."
FAILED TRIAL: Stage 1 of Ph II trial of CV301 + atezolizumab (TECENTRIQ®) in 1L-2L locally advanced or metastatic urothelial bladder cancer patients did not meet efficacy threshold to progress into stage 2 with expanded enrollment
“We have diversified our immuno-oncology strategy over the past years, which is reflected in smaller studies seeking to evaluate different aspects of our technology. While the results of this study are disappointing, they contribute to our overall understanding of our platform and provide important learnings to refine our approach to equip the body’s immune system with more weapons to fight cancer from within,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.
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Trial Status/Progress
First patient enrolled in Ph II trial of RP1 + Libtayo® (cemiplimab-rwlc) in CSCC patients
“We are pleased to announce the initiation of our first registration-directed clinical trial for which we believe the data generated to date for RP1 in CSCC is strongly supportive," said Robert Coffin, Ph.D., President and CEO of Replimune. “Having reviewed the initial data in CSCC, we also intend to initiate a new clinical trial of single agent RP1 in organ transplant recipients with CSCC, which we expect to begin enrolling early next year.”
First-in-human Ph I trial of IL-15 Agonist NKTR-255 initiated in R/R NHL or multiple myeloma patients
"We are excited to launch the first-in-human clinical study of NKTR-255, which has shown promising and substantial anti-tumor activity in our preclinical studies," said Wei Lin, M.D., Senior Vice President and Head of Development at Nektar Therapeutics. "By increasing the number and activity of NK cells, NKTR-255 has the potential to enhance the host's tumor-fighting response, both as a single agent and in combination with tumor-targeting antibodies, including daratumumab and rituximab."
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MedNess Business
Onco-News

Rafael Pharmaceuticals and NIH enter into a collaboration to test CPI-613® (devimistat) for T-cell leukemia/lymphoma

Rafael Pharmaceuticals will test its first-in-class lead compound CPI-613® (devimistat) for Cytokine Independent (Acute) HTLV-1 Associated Adult T-cell Leukemia/Lymphoma in collaboration with National Cancer Institute (part of NIH). Devimistat targets the enzyme involved in cell energy metabolism to regulate tumor cell survival and proliferation. Rafael will provide the compound for the study and NCI will conduct pre-clinical studies of devimistat alone or in combination with other compounds to test their efficacy.

Verseau Therapeutics raise $50 million to develop macrophages-targeted immunotherapies against cancer

Verseau Therapeutics has raised $50 million to develop antibodies that will target macrophages, defense cells of the immune system.  Verseau has licensed lipid nanoparticle siRNA delivery  technology from MIT labs to discover and validate novel targets. Veraeau has discovered that modulation of a cell adhesion molecule, PSGL-1, reprograms macrophages to pro-inflammatory cells generating an effective anti-tumor response. 3SBio comes as a strategic collaborator of Verseau and will receive exclusive license to develop and commercialize selected antibodies for cancer in Greater China area. The financing is backed by 20/20 HealthCare Partners, 3SBio, Alexandria Venture Investments, Highlight Capital, InHarv Partners Ltd., The Mark Foundation for Cancer Research and Yonghua Capital.

CRISPR Therapeutics and KSQ Therapeutics enter into an agreement for the development of cancer cell therapy platforms

CRISPR Therapeutics and KSQ Therapeutics announced a license agreement of undisclosed amount where each company gains access to others' intellectual property (IP). KSQ will provide IP access to CRISPR for editing selected gene targets for its allogenic oncology cell therapy program while CRISPR will provide IP access to KSQ for editing gene targets identified by KSQ as a part of its eTIL® (engineered tumor infiltrating lymphocyte) cell programs.
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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