On September 14, 2020 At the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which will be held virtually from 17th to 19th of September, PharmaMar (MSE:PHM) reported that it will present data on lurbinectedin in second-line SCLC patients who had received previous platinum-based chemotherapy and relapsed 90 and 180 days after its completion and therefore, being candidates for platinum re-challenge (Press release, PharmaMar, SEP 14, 2020, View Source [SID1234565098]). Phase I results for lurbinectedin in Japanese patients with previously treated advanced Solid Tumours, will also be presented.

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Results of trabectedin in combination with immunotherapy (durvalumab) in pre-treated patients with advanced Soft-Tissue Sarcomas, will be presented at an oral session.

In addition, results of Yondelis (trabectedin) in combination with immunotherapy (nivolumab) for the treatment of Soft-Tissue Sarcoma, as well as results of trabectedin in combination with doxorubicin (PLD) for the treatment of Recurrent Ovarian Cancer, will be presented.

ZepzelcaTM (lurbinectedin)
The poster, titled "Activity of Lurbinectedin in Second-line SCLC Patients Candidates for Platinum Re-challenge" will present the evaluation of a subset of patients from the Phase II basket trial, conducted both in the United States and in Europe, in which 105 patients with SCLC who had progressed after previous platinum-based chemotherapy, participated.

In the 20 patients who were platinum-sensitive and had a CTFI (Chemotherapy-Free Interval) of more than 180 days and were, therefore, candidates for platinum re-challenge according to National Comprehensive Cancer Network guidelines (NCCN), an overall survival of 16.2 months and an Overall Response Rate (ORR) of 60% were achieved.

A poster on a Phase I trial of lurbinectedin in Japanese patients with advanced solid tumours will also be presented.

Yondelis (trabectedin)
During this ESMO (Free ESMO Whitepaper) Congress, different studies carried out with Yondelis (trabectedin) will be presented, including an oral presentation by the French Sarcoma Group on late breaking results of trabectedin in combination with durvalumab in pre-treated patients with advanced Soft-Tissue Sarcomas.

Data from a non-randomised, open-label, phase II trial, assessing the efficacy and feasibility of the treatment with trabectedin in combination with nivolumab, in patients with metastatic or inoperable Soft-Tissue Sarcomas after anthracycline treatment, will be presented as a poster.

Moreover, a sub-analysis of a randomised, phase III study, comparing trabectedin in combination with pegylated liposomal doxorubicin (PLD) versus PLD monotherapy, in patients with recurrent Ovarian Cancer, will also be presented as a poster.

Finally, as an oral presentation, results of the InovatYon study -an international, randomised, phase III study comparing PLD with either trabectedin or carboplatinum in patients with recurrent Ovarian Cancer, progressing 6-12 months after the last platinum line– will be presented.

The studies presented at the ESMO (Free ESMO Whitepaper) 2020 congress are available at:
View Source

Outstanding studies in ESMO (Free ESMO Whitepaper) 2020
ZepzelcaTM (lurbinectedin)
Activity of Lurbinectedin in Second-line SCLC Patients Candidates for Platinum Re-challenge
E-Poster Display session. 17.09.2020. 09:00 – 23:59, Channel: On-Demand
Main author: Subbiah V et al.

Phase I study of lurbinectedin in Japanese patients with pretreated advanced tumors: Final results
E-Poster Display session. 17.09.2020. 09:00 – 23:59, Channel: On-Demand
Main author: Takahashi et al.

Yondelis (trabectedin)
Randomized, phase III international study to evaluate whether the administration of trabectedin/PLD followed by platinum at progression could improve overall survival in comparison with a platinum-based regimen in patients with recurrent ovarian cancer and a platinum-free interval between 6-12 months
Oral session. 19.09.2020. 13:26 – 13:38.
Presentation number: LBA30
Main author: Nicoletta Colombo (Milan, Italy)

TRAMUNE, a phase Ib study combining Trabectedin and Durvalumab: Results of the expansion cohort in patients with advanced pretreated Soft Tissue Sarcomas
Oral session. 20.09.2020, 16:32 – 16:44.
Presentation number: LBA67
Main author: Maud Toulmonde (Bordeaux, CEDEX, France)
Treatment: trabectedin in inmunotherapy + durvalumab

Subanalysis of a randomized phase 3 study comparing trabectedin and PLD vs PLD alone in patients with recurrent ovarian cancer (ROC)
E-Poster Display session. 17.09.2020. 09:00 – 23:59, Channel: On-Demand
Main author: Monk, Herzog, Coleman

A non-randomized, open-label phase II trial evaluating efficacy and feasibility of combined treatment with trabectedin and nivolumab in patients with metastatic or inoperable soft tissue sarcomas after failure of an anthracycline-containing regimen.
E-Poster Display session. 17.09.2020. 09:00 – 23:59, Channel: On-Demand
Main author: Pink et al.
Treatment: trabectedin in inmunotherapy + nivolumab

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

About Yondelis
Yondelis (trabectedin) is a novel, synthetically produced antitumor agent originally isolated from Ecteinascidia turbinata, a type of sea squirt. Yondelis exerts its anticancer effects primarily by inhibiting active transcription, a type of gene expression on which proliferating cancer cells are particularly dependent.

About lurbinectedin
Lurbinectedin (ZepzelcaTM), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.

On September 14, 2020 Varian (NYSE: VAR) reported the following leadership appointments, effective October 5, 2020 (Press release, Varian Medical Systems, SEP 14, 2020, View Source [SID1234565096]):

Chris Toth, Varian Oncology Systems President, has been appointed to the newly created role of President and Chief Operating Officer;

Kevin O’Reilly, Senior Vice President of Global Operations, will succeed Toth as Senior Vice President and President of Varian Oncology Systems; and

Stephanie Foster, Vice President of Revenue Operations, has been named Senior Vice President of Global Supply Chain Operations.

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As President and COO, Toth will oversee Varian’s business operations, including execution of the Company’s fiscal 2021 goals and strategic initiatives. Toth will continue to report to Chief Executive Officer Dow Wilson. In addition, O’Reilly will be focused on executing Varian’s proven strategy in Oncology Systems, and Foster will lead all aspects of the Company’s integrated supply chain for Oncology Systems.

"This announcement is a testament to the deep and diverse bench of talented leaders we have at Varian, as well as a reflection of our commitment to realizing our vision and strengthening our support for Varian’s customers and their patients," said Wilson. "I’m thrilled to congratulate Chris, Kevin and Stephanie on their expanded leadership roles, and I’m confident that they will ensure our entire team is well positioned to build on Varian’s success and accomplish our goals for 2021 and beyond."

Wilson continued, "Chris is an ideal fit for Varian’s President and COO, as he is a proven leader whose contributions over the past two decades have been invaluable to the growth of our company – from both a business perspective and a cultural one. In addition to an impressive track record of strategic planning and execution, Chris brings a passion to his work that inspires and motivates our team to advance the fight against cancer. I’m excited to see all that Varian will accomplish under his leadership."

"This is an important moment in Varian’s history, and I am honored to work with our talented and agile team to build on our strong momentum," said Toth. "Varian is moving at full speed to achieve our goal of a world without fear of cancer. While we work toward completing a transformational combination with Siemens Healthineers, we’re continuing to make impressive progress on our efforts to provide more intelligent solutions, data and insights to deliver world-class cancer care globally. Looking ahead, we don’t intend to slow down. Our unwavering focus on helping our customers care for their patients will continue to propel us forward."

About Chris Toth

Chris Toth is an established leader with nearly 20 years of industry experience. Since joining Varian in 2001, he has held multiple executive positions. Most recently, Toth has served as President of Varian Oncology Systems, managing more than $3 billion in revenue and over 7,000 employees worldwide. In this role, he helped return Varian to double-digit growth. Prior to his role as President of Varian Oncology Systems, Toth served as President of Global Commercial and Field Operations, where he was responsible for a global sales strategy and execution across Varian’s Oncology and Proton Therapy businesses. Under his leadership, Varian grew its global market share and the Company’s Net Promoter Score reached all-time highs.

About Kevin O’Reilly

Kevin O’Reilly is a global executive with over 30 years of experience across multiple industries and geographies. He currently serves as Varian’s SVP of Global Operations, overseeing Varian Oncology Systems’ global supply chain, revenue and customer support, and managing $3 billion in revenue and over 2,000 employees worldwide. Previously, O’Reilly was President of Asia Pacific, where he tripled Varian’s Net Promoter Score and increased revenues and orders faster than the market. Prior to joining Varian in 2009, he held executive positions at RPO, Inc. and Photon Dynamics.

About Stephanie Foster

Stephanie Foster has over 30 years of experience in supply chain, operations and manufacturing in highly complex, regulated industries. In her current role as Vice President of Revenue Operations, Foster oversees contracts, sales and operation planning, logistics, installation services and environmental health and safety. Prior to joining Varian in 2019, she served as Vice President of Supply Chain at Honeywell, where she managed operations for a $4 billion division that manufactured products for the Defense, Space and Aviation industries. Before joining Honeywell, Foster held executive roles at Orbital ATK and Raytheon.

On September 14, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported a presentation of the results for Cohort 2 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, SEP 14, 2020, View Source [SID1234565094]). In addition, a poster presentation of results from a single site expanded access program will also be presented for poziotinib in the treatment of patients with advanced NSCLC with EGFR or HER2 exon 20 insertion mutations. These presentations will take place as part of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 Science Weekend to be held September 19 – 21, 2020. Details of the presentations are as follows:

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Title: ZENITH20, a multinational, multi-cohort Phase 2 study of poziotinib in NSCLC patients with EGFR or HER2 Exon 20 insertion mutations
Speaker: Mark A. Socinski, M.D.
Session: On-Demand Mini Oral Session
Date and Time: September 18, 2020, 09:00 hours CEST, pre-release of mini oral sessions
Presentation Number: LBA60

Abstract Title: Poziotinib in advanced NSCLC with EGFR or HER2 exon 20 mutations; initial results from a single site expanded assess program
Speaker: Arsela Prelaj, M.D.
Session: On-Demand E-Poster Display
Date and Time: September 17, 2020, 09:00 hours CEST, pre-release of e-posters on demand
Presentation Number: 1388P

Access to the presentations is available to members of ESMO (Free ESMO Whitepaper) and can be found here: esmo.org/meetings/esmo-virtual-congress-2020/registration.

On September 14, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor for the treatment of myelofibrosis, reported that Dr. Stephen Dilly, President and CEO, will present an overview of the company at two investor conferences in September: the H.C. Wainwright 22nd Annual Global Investment Conference and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (Press release, Sierra Oncology, SEP 14, 2020, View Source [SID1234565093]).

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H.C. Wainwright Annual Global Investment Conference

Date:

Wednesday, Sept 16

Time:

11:00 am ET

Webcast link:

View Source

Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

Date:

Monday, September 21

Time:

11:40 am ET

Webcast Link:

View Source

Replays of these presentations will be available on the Investors section of Sierra’s corporate website in the Events & Webcast tab.

On September 14, 2020 Pascal Biosciences Inc. (TSX.V:PAS) ("Pascal") and SōRSE Technology Corporation ("SōRSE") reported that they have entered into a Collaborative Research Agreement (the "Agreement") to advance Pascal’s PAS-393 into clinical testing (Press release, Pascal Biosciences, SEP 14, 2020, View Source [SID1234565089]). Pascal and SōRSE will share their respective technologies to test the cannabinoid PAS-393 in human volunteers, enabling testing of cancer patients treated with checkpoint inhibitors.

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As initially announced last March, this partnership leverages SōRSE’s industry-leading formulation technology with Pascal’s proprietary cannabinoid programs for clinical trials. This will be the first pharmaceutical use of the novel formulation technology developed by SōRSE. The Agreement will include Pascal’s intellectual property, which covers the use of cannabinoids in cancer patients treated with checkpoint inhibitors.

SōRSE currently sells and licenses a proprietary water-soluble cannabinoid emulsion technology (patent-pending) that enables increased bioavailability, accurate dosing, and more than 12 months’ shelf stability. Pascal and SōRSE scientists will optimize a cannabinoid formulation for human subjects and will then test the formulated PAS-393 in volunteers. SōRSE will provide US$750,000 in research funding to Pascal throughout the 15-month collaboration and will pay for related research expenditures.

Following characterization of safety and pharmacology in a Phase 1a clinical trial, Pascal and SōRSE may elect to continue clinical development as equal partners in a Phase 1b cancer trial in combination with a checkpoint inhibitor. Dr. Gray will present scientific data this September 16th at the 3rd Annual International Cannabinoid-Derived Pharmaceutical Conference occurring in Boston, MA; the topic of his presentation is "Identifying and Validating Mechanism of Action In vivo/vitro."

"This is an impressive step forward for both Pascal and SōRSE, and hopefully our product will be a significant help to patients," commented Dr. Patrick Gray, CEO of Pascal. "This will be the first clinical trial for each company, and we look forward to a long, fruitful relationship."

"At SōRSE, we’re driven by our mission to help people better their lives through superior cannabinoid ingredients and delivery methods," said SōRSE CEO Howard Lee. "We were thrilled when Pascal reached out to us in the summer of 2019 asking to use our emulsion in their research study on immune recognition markers on cancer cells. Today, we are excited to continue to support pharmaceutical studies of cannabinoids with Pascal and other world-class researchers."

SōRSE intends to collaborate with other researchers and product developers to study cannabinoids in other medical applications. Pascal will continue to pursue other non-cancer indications for PAS-393.