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21st July, 2020

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COVID-19 vaccine AZD1222 showed robust immune responses in all participants in Phase I/II trial
Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the trial, said: “The interim Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type. The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial programme to confirm this. We saw the strongest immune response in participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “We are encouraged by the Phase I/II interim data showing AZD1222 was capable of generating a rapid antibody and T-cell response against SARS-CoV-2. While there is more work to be done, today’s data increases our confidence that the vaccine will work and allows us to continue our plans to manufacture the vaccine at scale for broad and equitable access around the world.”
Collated by : Nisha Peter PhD
Regulatory News
EMA Validates Application for Lisocabtagene Maraleucel (liso-cel) for R/R DLBCL, PBMCL and Gr 3 FL patients based on positive results from TRANSCEND NHL 001 and TRANSCEND WORLD 001 studies
“With more than 30% of patients diagnosed with diffuse large B-cell lymphoma ultimately relapsing after initial therapy and an expected overall survival of about six months for patients who have had two or more prior therapies, there is a need for new treatments,” said Stanley Frankel, M.D., senior vice president, Cellular Therapy Development, Bristol Myers Squibb.1,2 “The EMA’s validation of our application is a critical step toward bringing liso-cel to patients in Europe.”
FDA advisory committee votes in favour of positive benefit/risk profile for belantamab mafodotin for RRMM patients
Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: “We are pleased the committee recognised the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options. We look forward to working with the FDA as they complete their review of our Biologics License Application.”
Click Here for more on Regulatory News
Trial/Program Status
Ph 2 Study of [Vic-]Trastuzumab Duocarmazine Initiated in Advanced Endometrial Cancer
“My team and I are excited to participate in the Phase II study of the investigational antibody-drug conjugate [vic-]trastuzumab duocarmazine in HER2-expressing advanced endometrial cancer,” said Professor Santin. “We had the opportunity to study the potential of SYD985 in our preclinical models for endometrial cancer and were impressed by its potential. This ADC combines the ‘double punch’ of anti-HER2 monoclonal antibody trastuzumab with a powerful duocarmycin-based cytotoxin – a combination that could prove beneficial for patients whose disease has progressed.”
Click Here for more on Trial/Program Status
Collated by : Richa Tewari, PhD
MedNess Reviews
FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing
Quest SARS-CoV-2 rRT-PCR test kit by Quest Diagnostics received a first of its kind reissue of the FDA’s emergency use authorization (EUA) for use with pooled samples containing up to four individual swab specimens collected under observation.
Sample pooling is an important tool to test larger pool of COVID patients using fewer number of testing resources,. This protocol not only significantly speeds up the process of testing in larger sample size, but it is a cost effective way of  testing as well. Samples of four or more individuals will be pooled together and screened, thus requiring fewer overall tests and faster screening times.
 “This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies,” said FDA Commissioner Stephen M. Hahn, M.D. “Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”
 Although effective in principal, this approach raises concerns of getting false negative results, as pooling of samples might lead to dilution of viral material present in the samples. Quest’s validation data however was able to detect any pooled sample with positive sample with a very high sensitivity. The test is also authorized for use with an authorized home-collection kit.
Collated by : Tanmoy Samaddar
Medness Business
Onco-News

Kronos Bio and Gilead Sciences Enter In to Asset Purchase Agreement for Gilead’s SYK Inhibitor Portfolio
“Despite recent advancements in AML, there remains a substantial need for targeted therapies that can extend life,” said John Byrd, M.D., D. Warren Brown Chair of Leukemia Research, and Distinguished University Professor of The Ohio State University Comprehensive Cancer Center and Chief Medical Officer of The Leukemia & Lymphoma Society Beat AML Trial. “SYK inhibition has demonstrated promising activity in clinical trials of AML patients who have high HOXA9/MEIS1 expression and is an optimal target for further clinical research to understand how HOXA9/MEIS1 dysregulation drives AML in these patients. The Beat AML Trial directed by The Leukemia & Lymphoma Society has partnered closely with Gilead and looks forward to continued close collaboration with Kronos Bio.”

Novocure and MSD collaborate to develop TTFs + KEYTRUDA® (pembrolizumab) for treatment of NSCLC
“We are very pleased to collaborate with MSD, a global leader in oncology, in this important combination study as we strive to extend survival in some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields,” said William Doyle, Novocure’s Executive Chairman. “Multiple preclinical studies suggest that the use of Tumor Treating Fields together with anti-PD-1 therapy can potentially augment the immune response resulting in improved tumor control. We look forward to generating clinical data demonstrating the effect of Tumor Treating Fields concurrent with KEYTRUDA in first-line NSCLC.”
Blueprint Medicines Announces Global Collaboration with Roche to Develop and Commercialize Pralsetinib for Patients with RET-Altered Cancers
"With Roche's global reach and unparalleled expertise in personalized healthcare, this collaboration will accelerate our ability to bring pralsetinib to patients with significant medical needs around the world and expand development of pralsetinib across multiple treatment settings where there is potential to benefit even broader patient populations," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "In addition, the collaboration is transformative for Blueprint Medicines and our efforts to build the leading precision medicine company, as it enables us to continue to build best-in-class commercial capabilities, further invest in our rapidly growing pipeline including our systemic mastocytosis programs and fortify our strong financial position to bridge the company to a self-sustaining future."
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech
GSK forges a $293 million deal with CureVac to collaborate over new mRNA vaccines and antibodies
On 20th July 2020, CureVac (Tubingen, Germany) announced a strategic partnership with GlaxoSmithKline (GSK, global HQ: Brentford, London) to co-develop CureVac’s self-amplifying mRNA vaccine platform and monoclonal antibody research programs against infectious diseases. GSK has purchased a 10% equity stake in CureVac with a payment of $163 million and has invested $130 million in cash towards research and development. GSK has further reserved manufacturing capacity at CureVac with an additional $32 million payment. Earlier in the year, CureVac received $337 million of German federal money, surrendering 23% equity stake to the Government of Germany.
Under the terms of the deal, CureVac is eligible to tiered royalties on sales, regulatory milestone payments ($349.75 million) and commercial milestone payments ($415.4 million). In return, CureVac is responsible for preclinical to Phase I clinical development of these projects, after which GSK takes over in terms of development and commercialization of lead molecules.
CureVac has developed a
proprietary platform that can return an mRNA sequence of 5’ and 3’ untranslated regions (UTRs) sandwiching an open reading frame (ORF) optimized for production of therapeutic proteins (antigens or antibodies) upon targeted delivery. The pipeline spans prophylactic vaccines, cancer immunotherapy and protein-based therapy for metabolic diseases.
Imvax raises $112 million in series C funding for its novel neoantigen-based therapeutic intervention in glioblastoma multiforme
Imvax Inc. (Imvax, Philadelphia) owns a proprietary therapeutic cocktail that delivers autologous tumor neoantigens and a generic anti-immunosuppressive antisense oligonucleotide through bio-diffusion chambers. Glioblastoma multiforme (GBM) patients receive the cocktail immediately after resection surgeries as opposed to standard-of-care chemotherapy that begins only 6 days after resection. This enables Imvax’s platform to make use of a penetrated blood-brain barrier for effective delivery of the neoantigens to elicit a robust immune response. The new intervention has performed well in Phase Ib clinical trials showing a 7-month improvement in median overall survival and an exceptional progression free survival of up to 30 months in a subset of patients. No side effects or cytokine storm issues were noted.
These results have led Imvax to raise $112 million in series C funding to support pivotal trials of its therapeutic cocktail, IGV-001, as announced on 16th July 2020. The
round was led by HP WILD Holding AG, Ziff Capital Partners, Magnetar Capital, TLP Investment Partners and Invus. Apart from Phase III trials the money will be used to further the platform into solid tumors by 2021.
Click Here for more news and details on mergers, acquisitions and business updates
Collated by : Divyaanka Iyer
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Tanmoy Samaddar
MedNess Reviews
Divyaanka Iyer
BioPharma News
Debarati Banik
HealthIT
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 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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