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MedNess: bite-size biopharma and medtech news

26th May, 2020

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COVID Special
FDA approves at-home sample collection kit for Covid-19, that can be used with certain authorized tests
FDA recently authorized the use of an at-home sample collection kit for collecting samples to be sent to specified laboratories for the diagnosis of Covid-19.
“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”
An experimental coronavirus vaccine under development at Oxford University shows promise and reaches advanced clinical trial stages
Preprints of a recent study from Oxford University has shown a vaccine under development to be effective in preventing Covid-19 in Rhesus macaques. Preprints suggest that the studies have not yet undergone rigorous peer review process which is intrinsic to scientific article publishing. These preprints are used to provide information and generate interest in areas like vaccine development especially under the present situation where the pandemic of coronavirus is a global concern.
Professor Andrew Pollard, head of the Oxford Vaccine Group, said: “The clinical studies are progressing very well and we are now initiating studies to evaluate how well the vaccine induces immune responses in older adults, and to test whether it can provide protection in the wider population. We are very grateful to the huge support of the trial volunteers in helping test whether this new vaccine could protect humans against the pandemic coronavirus.”
Click Here for more details and updates on COVID19
Collated by : Esha Sehanobish, PhD
Drug Approvals
FDA approves Tecentriq® in 1L EGFR/ALK WT mNSCLC patients with high PD-L1 expression
“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease.”
Lynparza approved in the US for HRR gene-mutated mCRPC patients
Maha Hussain, one of the principal investigators of the PROfound trial and deputy director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, said: “Prostate cancer has lagged behind other solid tumours in the era of precision medicine. I am thrilled by the approval of Lynparza which now brings a molecularly targeted treatment to men with HRR gene-mutated metastatic castration-resistant prostate cancer in the US. The PROfound trial was an international effort and I want to thank the patients, their families, the investigators and their teams involved in making it possible.”
Regulatory News
Enhertu granted Breakthrough Therapy Designation in the US for HER2-mutant mNSCLC
José Baselga, Executive Vice President, R&D Oncology, said: “Today’s news is very welcome as we continue to evaluate the potential of Enhertu to help patients with this devastating type of lung cancer. Targeted treatments and immunotherapies are demonstrating tremendous advancements, but there remains an unmet medical need for patients with HER2 mutations who are not benefiting from such therapies or for those whose cancer continues to progress.”
EMA validates MAAs for Idecabtagene Vicleucel (Ide-cel, bb2121) and CC-486 in RRMM and AML, respectively
“Europe has one of the highest incidence rates of multiple myeloma, and patients who have relapsed and are refractory to standard treatment regimens are in need of treatment options to improve outcomes,1” said Stanley Frankel, M.D., senior vice president, Cellular Therapy Development, Bristol Myers Squibb. “We will continue to work with the EMA to bring ide-cel to patients in the European Union who are battling this aggressive blood cancer.”
Click Here for more Regulatory News
Trial/Program Status
First patient dosed in Ph 1 trial of P-PSMA-101 in mCRPC patients
“Extending our gene engineering technology to solid tumors represents the next opportunity in oncology where we believe our proprietary platforms and approach have advantages over others in the space,” said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida. “Our platform technologies, which include the piggyBac DNA Modification System and Cas-CLOVER site-specific gene editing system, are driving our diverse pipeline of next-generation CAR-T treatments for hematologic and solid tumors, as well as gene therapies addressing rare diseases.”
Ph 1 Trial initiated with DS-6157 in GIST patients
“We are proud to build upon our relationship with Sarah Cannon to initiate this trial evaluating the potential of DS-6157 as a new type of targeted therapy for patients with advanced GIST,” said Arnaud Lesegretain, Vice President Oncology R&D and Head, Alpha Portfolio, Daiichi Sankyo. “Based on preclinical assessments, biomarker research and the demonstrated portability of our DXd ADC technology, we believe that DS-6157 could potentially play a major role in the treatment of patients with GIST that is resistant to TKIs.”
Conference Coverage - ASCO 2020
  1. GSK to present 26 abstracts across 8 tumour types
  2. Oncternal Therapeutics to present Update on Ph 1/2 Trial of Cirmtuzumab + Ibrutinib
  3. G1 Therapeutics, Inc. to present data across three randomized, double-blind, placebo-controlled Phase 2 trials of trilaciclib in SCLC
  4. MacroGenics Announces Preliminary Clinical Results from MGD013 and MGC018 to be Presented 
  5. BeiGene Announces Clinical Data of BTK inhibitor BRUKINSA™ (zanubrutinib) and anti-PD-1 antibody tislelizumab to Be Presented
  6. Janssen Presents First Data from Phase 1 Study of BCMAxCD3 Bispecific Teclistamab in Patients with Heavily Pretreated RRMM patients
  7. First data from Allogene’s Phase 1 dose escalation ALPHA study of ALLO-501 in R/R NHL to be presented
  8. BMS and bluebird bio to Present Updated Positive Results from Pivotal KarMMa Study of Ide-cel in RRMM Patients
  9. BMS to present 3-yr follow-up OS results from Part 1 of the Ph 3 CheckMate -227 trial of Opdivo (nivolumab) + Yervoy (ipilimumab) in mNSCLC presented
  10. BMS announces the presentation of First results from CheckMate -9LA
  11. Merck to present PFS result from KEYTRUDA® (pembrolizumab) + Chemotherapy in Certain Patients with mTNBC
  12. Merck to present results from KEYTRUDA’s Ph 3 KEYNOTE-204 in R/R cHL patients
  13. Merck to present new combination data for KEYTRUDA® (pembrolizumab) in Stage III NSCLC and Reinforce Long-Term Survival in mNSCLC
  14. Merck to present ORR data from HIF-2α Inhibitor in Patients with von Hippel-Lindau (VHL) Disease-Associated ccRCC
  15. Janssen to present Final analysis of the Phase 3 SPARTAN study
  16. Janssen to present Longer-term follow-up data from Phase 1b/2 CARTITUDE-1 study
  17. Bayer to present data from the pre-specified final OS analysis of the Phase III ARAMIS trial
  18. Data from 23 studies across Eli Lilly and Company's (NYSE: LLY) oncology product portfolio will be presented
  19. AstraZeneca to present 98 abstracts, including 19 oral presentations with one plenary and 10 late-breakers
  20. Novartis to present Data from more than 110 abstracts, including Novartis-sponsored and investigator-initiated trials in ASCO and EHA conferences
  21. Regeneron Pharmaceuticals, Inc. to share updates from its diverse clinical oncology portfolio
  22. Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program
  23. Eisai to Present Latest Data from Oncology Pipeline including KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Investigational Combination Therapy and HALAVEN® (eribulin mesylate)
  24. Gilead and Kite Continue to Advance Next Generation Cancer Therapies 
  25. ImmunoGen Announces Initial Data from FORWARD II Study of Mirvetuximab Soravtansine + Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status
  26. Exelixis Announces Results From COSMIC-021 Trial of Cabozantinib + Atezolizumab in Multiple Advanced Solid Tumor Types
  27. Arvinas Announces Updated Ph 1 Data Demonstrating Clinical Activity of PROTAC® Protein Degrader ARV-110 in Patients with Refractory Prostate Cancer
  28. INOVIO's to present OS12 data from Ph 1/2 trial of INO-5401 + Libtayo® (cemiplimab) in 1L Glioblastoma Patients
  29. MorphoSys to Present Data from Tafasitamab program
  30. MEI Pharma and Kyowa Kirin Announce to announce Data from Ph 1b Study of ME-401 on an Intermittent Schedule in FL and Other B-cell Malignancies patients
  31. Helsinn and MEI Pharma to present Updated Clinical Data from Ph 2 Study of Pracinostat + Azacitidine in Patients with High/Very-high Risk Myelodysplastic Syndromes
  32. Janssen Announces Ph 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced NSCLC Harboring Exon 20 Insertion Mutations
  33. Progenics to Present Results from the Ph 3 CONDOR Trial of PyL™ (18F-DCFPyL) in Prostate Cancer
  34. Innovent Announces Key Results from a Number of Clinical Studies to Be Presented
  35. Pfizer to present new data from clinical trials of 18 approved and investigational medicines
  36. Roche to present first clinical data on novel anti-TIGIT cancer immunotherapy tiragolumab
  37. Karyopharm to present Data from Ph 3 BOSTON Study
  38. BeiGene to present data from Tislelizumab and Zanubrutinib trials
  39. AVEO Oncology to Present Final OS Analysis from Ph 3 TIVO-3 Trial of Tivozanib in RCC
  40. Genmab to present Epcoritamab, Tisotumab Vedotin and Daratumumab results
  41. Calithera Biosciences to present Telaglenastat Ph 2 KEAPSAKE Trial data
  42. Celyad to Present Update from CYAD-101 for Advanced CRC and Next-Gen shRNA Platform
  43. Iovance Biotherapeutics to Present Updated melanoma Data from C-144-01 trial
  44. Allogene Therapeutics & Servier to present data from dose escalation Phase 1 ALPHA study of ALLO-501 in R/R NHL patients
  45. Merck to present 25 abstracts to Showcase Significant Clinical Advances in Cancer Care
  46. Roche to present new data from clinical trials of 19 approved and investigational medicines across 21 cancer types
  47. bluebird bio to Present Updated Results From Pivotal Phase 2 KarMMa Study of Ide-cel in RRMM patients
Collated by : Richa Tewari, PhD
Medness Plus
FDA announces Fast Track Designation for Omecamtiv Mecarbil in heart failure
FDA recently announces a Fast Track Designation for omecamtiv mecarbil, a selective cardiac myosin activator (also known as a cardiac myotrope) for the potential treatment of chronic heart failure with reduced ejection fractions (HFrEF).
"This Fast Track designation represents an important milestone in the development of omecamtiv mecarbil," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Today, half of heart failure patients will die within five years of diagnosis, underscoring the urgent need for new therapies for this grievous condition." "We are pleased that the FDA has granted Fast Track designation for omecamtiv mecarbil for the potential treatment of heart failure," said Robert I. Blum, president and chief executive officer of Cytokinetics. "The prevalence of heart failure is growing with our aging demographics, and GALACTIC-HF is designed to assess the clinical effects of our novel myosin activator in patients meaningfully at risk."
Click Here for more on MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness Business
Onco-News

MD Anderson and Innovent Biologics to develop anti-PD-1 therapy TYVYT® (sintilimab injection) in rare cancers
“TYVYT® (sintilimab injection) was approved in 2018 by the National Medical Products Association (NMPA) in China for the treatment of relapsed or refractory classic Hodgkin's lymphoma after second-line or later systemic chemotherapy, where it is currently being evaluated in additional clinical trials for solid tumors” said Dr. Michael Yu, Founder, Chairman and CEO of Innovent. “We believe TYVYT® has great potential in various tumor types, both as a single agent and in combination with other inhibiting agents, and currently we are conducting more than 20 related clinical trials including over 10 registration clinical trials. Through this new co-development collaboration, we will work to advance TYVYT® into rare tumors, where we hope it will continue to demonstrate its efficacy across multiple tumor types.”

Surface Oncology and Merck to develop SRF617 + KEYTRUDA® (pembrolizumab) in Solid Tumor Patients
“Surface is committed to delivering truly breakthrough therapies that can transform treatment for people with cancer. This collaboration with Merck will add an important dimension to our clinical program for SRF617, and allow us to more rapidly assess its potential,” said Robert Ross, M.D., chief medical officer at Surface Oncology. “We have demonstrated in preclinical studies that the inhibition of CD39 results in substantial activation of both the innate and adaptive arms of the immune system. Encouragingly, we also found that activation is heightened in combination with anti-PD-1 treatment and that this combinatory approach has the potential to overcome anti-PD-1 resistance.”
BeiGene and Medison Pharma Announce Exclusive Distribution Agreement and Acceptance of New Drug Application for BTK Inhibitor BRUKINSA™ (zanubrutinib) in Israel
“Our first distribution agreement for BRUKINSA and the acceptance of our first NDA outside of the United States and China marks a significant step in realizing our global commercialization plans. We are excited to work with Medison, a leader in drug commercialization with extensive experience, to bring our potentially best-in-class BTK inhibitor to patients in Israel,” commented Howard Liang, Ph.D., CFO and Chief Strategy Officer of BeiGene. “In addition, our planned expansion into new markets illustrates BeiGene’s patient-first principle and commitment to bringing meaningful treatments to patients worldwide.”
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech

Nautilus Biotechnology bags $100 million to fund the first ever high throughput proteomics platform
Nautilus Biotechnology (Nautilus; San Carlos CA, Seattle, WA) announced raising a $100 million in series B funding on 21st May 2020. The funding round was led by Vulcan Capital followed by Perceptive Advisors, Bezos Expeditions and Defy Partners- as new investors, along with previous investors AME Cloud Ventures, Andreessen Horowitz, Bolt and Madrona Venture Group.
“We’re focused on building a platform where everyone can access proteomics in an expansive way. Ultimately the platform will be an instrument.” - Nautilus CEO and co-founder Sujal Patel, to
Endpoint News.

Atea Pharmaceuticals bags $215 million in series D funding to pit its nucleotide IND against COVID-19
Atea Pharmaceuticals Inc. (Atea, Boston, MA) is clinical stage biopharmaceutical company that develops orally administered direct acting antivirals (DAAs). Its DAA candidate AT-527 is a purine nucleotide prodrug that acts as a nucleotide analogue to viral RNA dependent RNA polymerases, inhibiting viral replication with high selectivity.
“Atea’s portfolio is focused on developing novel, best-in-class, potent DAA’s and we have shifted all of our immediate resources and our team’s deep expertise in virology and pharmacology to help address the unmet needs in the fight against the COVID-19 pandemic. An oral treatment for COVID-19 patients should prevent progression of the disease and may help lessen the burden on critical inpatient resources. Atea is moving rapidly, in concert with regulatory authorities, to determine if our oral DAA is a safe and effective therapeutic against COVID-19.”- Jean-Pierre Sommadossi, Atea Chairman and CEO.
BARDA awards $1 billion to Astrazeneca to hasten Phase III trials of Oxford university’s coronavirus vaccine
On 21st May 2020, AstraZeneca announced a $1 billion backing from the US Biomedical Advanced Research and Development Authority (BARDA) for the rapid development and Phase III clinical trial advancement of the Oxford university developed coronavirus vaccine AZD1222.
To meet the demands of the pandemic AstraZeneca has put its manufacturing strength behind AZD1222, producing over 1 billion doses of the vaccine to be deployed by September 2020. It will support supplies to a US based phase III clinical trial with 30000 participants as well as the UK based Phase I/II vaccine trial involving over 1000 volunteers (aged 18 to 55) to be conducted in September 2020.
To its credit, the company has partnered with global organizations such as the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organisation (WHO) for global allocation and distribution of the vaccines to reach it in fair proportions to developing countries. AstraZeneca is also involved in talks with the Serum Institute of India (Pune, Maharashtra) to increase the vaccine’s production and distribution.
 
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
Debarati Banik
HealthIT
Divyaanka Iyer
MedNess Reviews
Nisha Peter, PhD
Managing Editor
Mayur Vadhvani, PhD
Consulting Editor
Abhi Dey
Consulting 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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Content Editors: Richa Tewari , Esha SehanobishDivyaanka Iyer, Arundithi AnanthanarayananDebarati BanikMayur Vadhvani and Abhinav Dey 
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