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Onco-this-Week
6th August, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals
FDA approved Pembrolizumab monotherapy in 2L patients with PD-L1+ve locally advanced or metastatic squamous cell carcinoma of the esophagus
  • Approval based on results from KEYNOTE-181 and Ph II KEYNOTE-180 trials 
  • OS HR in ESCC patients: 0.77 (95% CI: 0.63, 0.96) 
  • OS HR in patients with tumors expressing PD-L1 CPS ≥10: 0.70 (95% CI: 0.52, 0.94) 
  • OS HR in all randomized patients: 0.89 (95% CI: 0.75, 1.05) 
  • mOS in ESCC patients with PD-L1 expression (CPS ≥10): 10.3 months vs 6.7 months in the chemo 
  • mPFS: 3.2 months vs 2.3 month 
  • ORR: 22% (CR 5%, PR 18%) vs 7% (CR 1%, PR 6%) 
  • mDOR: 9.3 months vs 7.7 months
FDA approves darolutamide plus androgen deprivation therapy (ADT) in nmCRPC patients based on the Ph III ARAMIS trial
“Patients at this stage of prostate cancer typically don’t have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy,” said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. “This approval marks an important new option for the prostate cancer community.”
 
Regulatory News
FDA granted Breakthrough Therapy Designation to CD122-preferential IL-2 agonist bempegaldesleukin (NKTR-21) + nivolumab combination for 1L unresectable or metastatic melanoma, based on data from Ph I/II PIVOT-02 trial
ASCO 2019 data (n=38, mFUP: 12.7 months):
  • ORR: 53% (CR: 34%); PD-L1neg patients:43%; PD-L1+ patients: 62%  
  • Patients with maximum reduction of 100% in target lesions: 42%
  • DCR: 74%.
  • mDOR: NR
  • mPFS: NE
  • Grade 3 (G3) or higher TRAE: 14.6%
  • Tx discontinuation: 9.8%
Positive CHMP opinion for Pembrolizumab + Axitinib in 1L RCC patients based on Ph III KEYNOTE-426 trial results
“For patients with advanced renal cell carcinoma, the prognosis is poor, with a five-year survival rate of less than 10%,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “The positive opinion adopted by the EMA, which is based on data showing KEYTRUDA in combination with axitinib significantly improved overall survival regardless of PD-L1 expression, is an important step toward a new first-line treatment option for these patients.”
 
Onco-Trial Results
Abemaciclib significantly improves OS in HR+, HER2- advanced breast cancer patients in Ph III MONARCH 2 trial
"I believe we must continue to fight this devastating disease because the women who are living with metastatic breast cancer want to do everything they can to lead more fulfilling lives and be there for those who need them most," said Anne White, president, Lilly Oncology. "While Verzenio had already shown an impressive benefit for progression-free survival, we are delighted that Verzenio is the first and only CDK4 & 6 inhibitor in combination with fulvestrant that has significantly extended life for both pre/peri- and postmenopausal women."
 
Onco-Trial Status/Progress
TRIAL DISCONTINUATION: IDMC recommends stopping enrollment in Ph III PHOCUS trial of Pexa-Vec (followed by Sorafenib vs Sorafenib alone) in 1L HCC patients
  • Trial unlikely to meet primary endpoint 
  • This data readout was make-or-break moment for the trial, and unfortunately the study failed to survive it 
  • Ph II trial of the drug had shown statistically significant OS improvement (14.1 mos with high dose and 6.7 mos with low dose group) - this, when compared to 10.7 mos with Sorafenib, was definitely impressive and led to initiation of Ph III PHOCUS study
Medicenna selects lead immuno-oncology clinical candidate, MDNA19, from its IL-2 Superkine platform
"We are excited to announce MDNA19 as our lead clinical candidate for the treatment of solid tumors which marks a major milestone for Medicenna and our Superkine platform," said Dr. Fahar Merchant, President and CEO of Medicenna. "Unlike competing IL-2 programs which are unable to meaningfully stimulate cancer killing immune cells, MDNA19 is designed to dramatically boost the population of immune cells to attack cancer instead of immune cells that protect cancer while maintaining a superior safety profile. We strongly believe that MDNA19 could deliver increased benefits to the patient, expand partnering opportunities and become a core driver of the Company's short and long term success."
 
Click Here for more Progress/status of ongoing trials
DIAGNOSTIC ASSAYS
Agilent Companion Diagnostic Gains Expanded FDA Approval in Esophageal Squamous Cell Carcinoma (ESCC)
"PD-L1 has been established as an essential biomarker for PD-1/PD-L1 checkpoint inhibitors,” said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "As a growing number of patients are becoming eligible for treatment with these inhibitors, pathologists’ confidence in their PD-L1 test is critical. With the approval of expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent is able to aid in the identification of patients with ESCC for treatment with KEYTRUDA, while providing pathologists the quality, reliability, and accuracy they need to ensure diagnostic confidence.”
 
MedNess Business
Onco-News
Alligator Bioscience regains global rights to CD40-agonistic antibody, ADC-1013 (JNJ-64457107) from Janssen
Alligator Biosciences has regained the exclusive rights with Janssen to develop and commercialize CD40 agonistic antibody, ADC-1013, for the treatment of metastatic cancer. The deal was terminated in 2015 as a result of strategic decisions by Janssen to prioritize other programs. In 2015, Janssen made an upfront payment of $35M and milestone payment of $11M during the partnership with a potential of up to $695M in milestone-based payments upon commercialization. The first part of the Phase 1 trial was conducted by Alligator where results showed that ADC-1013 is well tolerated at clinically relevant doses. The second part of Phase 1 is currently being run by Janssen to identify safe, tolerable and biologically effective dose for ADC-1013.
Jobs at Alligator
Jobs at Janssen
 
Chimerix licenses CX-01 from Cantex Pharmaceuticals to expedite its Ph III development in 1L AML
Chimerix announced an exclusive worldwide license of CX-01 from Cantex Pharma for Phase 3 development of the molecule for Acute Myeloid Leukemia (AML). CX-01 is derived from unfractionated heparin that targets key protein pathways essential for cancer cell migration to bone marrow besides binding with proteins involved in chemotherapy resistance. CX-01 has received fast track and orphan drug designation from the FDA for treatment of AML. Under the agreement, Chimerix will make an upfront payment of $30M to Cantex besides issuing 10 million shares to Cantex. Additionally, the deal involves regulatory and commercial milestone payment of up to $587.5M and tiered royalties to Cantex.
Jobs at Cantex
BioPharma and MedTech

Vida Ventures to support life science innovation through its $600M Vida-II Fund
Boston-based life science venture firm Vida Ventures raised $600M for its Vida Ventures II (Vida II). With Vida II, Vida has raised approximately $1 billion since its inceptions in 2017. Vida II will be used on furthering life science ventures that focus on changing the paradigm of patient care. The previous investment round of $255M was used to build a portfolio of 14 companies of which there completed IPO and one was acquired by Merck for $2.2B in 2019.

 

Wellington Partners raises €210M for life science ventures 
The leading European venture Capital firm, Wellington Partners, closed its fifth-generation fund Wellington Partners Life Science Fund V (WPLS-V) with a total of €210M for investments into early- and growth-stage life science companies. The fund will focus on building a portfolio of 15-20 companies in novel biotechnology platforms, new therapeutics and medical devices primarily in German-speaking countries in Europe but will also consider opportunities in North America and Asia. Investors for WPLS-V include KfW Capital, Talanx, UTIMCO, University of Texas/Texas A&M Investment Company as well as existing investors European Investment Fund and European Investment Bank. With a total fund of €1 billion with over €400M invested in life science, Wellington Partners has invested in 46 innovative life science companies.

 
Click Here for more collaborations, acquisitions, mergers and licensing...
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 sponsors do not have any influence on the nature or kind of the news/analysis reported in Onco-this-Week. 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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