On December 12, 2019 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported that the primary endpoint (overall response rate) of the Phase 2 trial evaluating TG4010 in combination with chemotherapy and Opdivo (nivolumab) was not reached (Press release, Transgene, DEC 12, 2019, View Source [SID1234552318]). This combination regimen was assessed as a first-line treatment for patients with advanced non-squamous non-small cell lung cancer (NSCLC) with low-to-no expression of PD-L1 by the tumor cells (PD-L1<50%). Transgene has taken the decision to stop further development of TG4010.
This multi-center single-arm Phase 2 trial enrolled 40 evaluable patients in the USA and Europe. It was conducted under a clinical collaboration agreement with Bristol-Myers Squibb, which is supplying nivolumab.

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Philippe Archinard, PhD, Chairman and CEO of Transgene, added:
"We are obviously very disappointed with the outcome of this Phase 2 trial which showed that the triple combination regimen of TG4010, chemotherapy and nivolumab did not sufficiently increase the response rate in this patient population with advanced NSCLC whose tumor express low or undetectable levels of PD-L1. Additional data analyses are still ongoing and the complete study results will be presented at an upcoming scientific conference.
With funding until 2022 and a diversified portfolio of novel immunotherapies targeting solid tumors, our strategy remains clear and unchanged. The Phase 2 combination trial of TG4001 in HPV-positive cancers is recruiting well and we expect to report the next clinical readout as planned in H1 2020. We are also advancing our two novel technology platforms myvac and Invir.IO. Clinical sites have been initiated and the first two trials evaluating TG4050, the first myvac candidate, will soon be enrolling patients. These trials will be jointly funded with NEC. A trial with TG6002 administered via the intrahepatic artery is also about to enroll its first patient. In addition, we expect to submit a clinical trial application in the first half of 2020 for BT-001, the first Invir.IO oncolytic virus encoding for an anti-CTLA4 antibody. Finally, our collaboration with AstraZeneca focused on generating novel multi-armed Invir.IO oncolytic viruses is making excellent progress.
These multiple advances give me great confidence that Transgene is well placed to demonstrate and deliver the potential of its novel therapeutic vaccines and oncolytic viruses designed to improve the treatment of solid tumors."

A conference call in English is scheduled on December 12, 2019, at 6:30 p.m. CET.

Webcast link to conference call: https://channel.royalcast.com/webcast/transgene/20191212_1/

Participant telephone numbers:

France: +33 (0) 1 7037 7166

United Kingdom: +44 (0) 20 3003 2666

United States: +1 212 999 6659

Confirmation code: Transgene

A replay of the call will be available on the Transgene website (www.transgene.fr) following the live event.

About TG4010
TG4010 is an immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2 (IL2). It is based on a modified Vaccinia virus (MVA) and has been shown to induce an immune response against MUC1 expressing tumors, such as non-small cell lung cancer (NSCLC). Its mechanism of action and safety profile make TG4010 a very suitable candidate for combinations with other therapies. The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of progression-free survival and overall survival in patients with advanced stage NSCLC in a Phase 2b trial (Quoix et al. Lancet Oncol. 2015).

On December 12, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that its collaborators at The Institute of Cancer Research, London, presented results from the cohort of patients in the plasmaMATCH trial treated with Puma’s drug neratinib at the 2019 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas (Press release, Puma Biotechnology, DEC 12, 2019, View Source [SID1234552317]). The oral presentation entitled, "Results from the plasmaMATCH trial: A multiple parallel cohort, multi-centre clinical trial of circulating tumour DNA testing to direct targeted therapies in patients with advanced breast cancer (CRUK/15/010)," and the poster presentation entitled, "Results from plasmaMATCH trial treatment Cohort B: A phase II trial of neratinib plus fulvestrant in ER positive breast cancer or neratinib alone in ER negative breast cancer in patients with a ERBB2 (HER2) mutation identified via ctDNA screening (CRUK/15/010)" were presented by Professor Nicholas Turner, M.D., Ph.D., Professor of Molecular Oncology at The Institute of Cancer Research (ICR) and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, who is the principal investigator of the plasmaMATCH trial, and Andrew M. Wardley, M.D., consultant medical oncologist at The Christie NHS Foundation Trust in Manchester, England and Medical Director of the National Institute for Health Research (NIHR) Manchester Clinical Research Facility at The Christie, respectively. The plasmaMATCH trial was funded by Cancer Research UK.

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The plasma-based Molecular profiling of Advanced breast cancer to inform Therapeutic Choices (plasmaMATCH) trial is a phase IIa, multiple parallel cohort, open-label, multicentre trial in patients with advanced breast cancer, which aims to assess whether analyzing a blood sample for circulating tumor DNA (ctDNA) could provide an alternative to biopsies for identifying the genetic mutations present in advanced breast cancer and whether subgroups of patients with advanced breast cancer, identified through ctDNA screening, may benefit from a treatment targeting their type of cancer.

Approximately 1,044 patients with advanced breast cancer from approximately 20 sites in the United Kingdom registered for the trial and ctDNA results were available for 1,033 (98.9%) of the patients. Depending on the results of the ctDNA screening, patients were enrolled in one of five treatment cohorts and received therapy to target their type of breast cancer. Patients with HER2 mutations were enrolled in the cohort of patients who received either neratinib monotherapy (for patients with hormone receptor negative disease) or neratinib in combination with fulvestrant (for patients with hormone receptor positive disease). Twenty-one patients with HER2 mutations were enrolled in the cohort and 20 patients were evaluable for the primary endpoint of the trial, which was confirmed objective response rate as determined by RECIST 1.1 assessed by the investigator.

In the HER2-mutant cohort, 18 (86%) of the 21 patients had hormone receptor positive breast cancer, 18 patients (86%) had visceral disease, 18 patients (86%) had received prior chemotherapy for metastatic disease, and 11 patients (52%) had received two or more prior lines of chemotherapy for metastatic disease.

The efficacy results from the trial showed that for the 20 efficacy evaluable patients, 5 patients (25%) experienced a confirmed objective response, and three further patients had unconfirmed responses. The median duration of response was 5.7 months, and the median progression free survival in this cohort of patients was 5.4 months.

Prof. Nicholas Turner, Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said, "Somatic HER2 mutations can be readily and accurately identified from ctDNA blood samples and are clinically actionable for targeted therapy in metastatic breast cancers. The combination of neratinib plus fulvestrant therapy demonstrates encouraging clinical activity with durable responses in this heavily pretreated metastatic breast cancer patient population with HER2-mutated disease."

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, added, "We are very pleased with the activity seen in this cohort of patients with HER2-mutated breast cancer with neratinib in plasmaMATCH. This data correlates with the data observed in the neratinib plus fulvestrant arm of the SUMMIT trial, and we look forward to the further development of the combination of neratinib plus trastuzumab plus fulvestrant in this patient population."

On December 12, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the acceptance of an abstract highlighting new biomarker data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer (Press release, Oncolytics Biotech, DEC 12, 2019, View Source [SID1234552316]). The data will be part of a poster presentation at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper), January 23 – 25, 2020, in San Francisco.

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The abstract, CEACAM6 is a candidate biomarker for REOLYSIN (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), was co-authored by Dr. Anne Noonan, Department of Medical Oncology, Ohio State University Wexner Medical Center, Richard Solove Research Institute and James Cancer Hospital, and Dr. Tanios Bekaii-Saab Senior Associate Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona.

Abstracts will be published at 5:00 pm ET on Tuesday, January 21, 2020 on the ASCO (Free ASCO Whitepaper) meeting library website at View Source

Abstract ID: 285103
Abstract Number: 746
Poster Board: M13
Abstract Title: CEACAM6 as a candidate biomarker for pelareorep sensitivity in pancreatic adenocarcinoma (PDAC)
Session Information: Poster Session B: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer
Session Date & Time: January 24, 2020 from 12:00 PM-1:30 PM & 4:30 PM-5:30 PM

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On December 12, 2019 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported the start of enrollment and screening in the Company’s Phase lb/ll clinical development program for previously treated patients with advanced pancreatic cancer (Press release, Helix BioPharma, DEC 12, 2019, View Source [SID1234552315]).

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The study is entitled "A Phase Ib/II Study of the Microenvironment Modifier L-DOS47 plus Doxorubicin for the Treatment of Patients with Previously Treated Advanced Pancreatic Cancer". The Phase Ib portion of the study involves three dose escalating cohorts enrolling a total of nine (9) patients. The Phase II portion of the study will enroll an additional eleven (11) patients depending on meeting safety and efficacy criteria. The principal investigator of the study is Dr. Erkut Borazanci. The study center is located in Scottsdale, Arizona at the Scottsdale Hospital dba HonorHealth.

Pancreatic cancer is the third leading cause of cancer death in the United States for which there are few treatment options. L-DOS47 with its novel mechanism of action aims to transform the treatment landscape by combatting the acidic tumor microenvironment, which is hostile to the body’s immune system.

"I would like to personally thank Dr. Daniel Von Hoff in helping us develop this clinical study," said Dr. Heman Chao, Helix’s Chief Executive Officer. "We are very excited to expand our clinical drug development program to include this new indication. With excellent safety and tolerability data already obtained from a monotherapy study in late stage non-small cell lung cancer and ongoing combination studies in similar patient groups, this new clinical study will add to the expanding utility of L-DOS47 in multiple cancer indications."

On December 12, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biotechnology company targeting the epigenetic causes of cancer, reported the acceptance of an abstract at the "Epigenetics Symposium: 15 Years of Lysine Demethylases: From Discovery to the Clinic" taking place Monday, December 16, 2019 at the Franklin Institute in Philadelphia, PA (Press release, Flex Pharma, DEC 12, 2019, View Source [SID1234552314]). The trial-in-progress poster presentation will include an overview of the ongoing Phase 1/2 clinical trial for Salarius’ lead drug candidate, Seclidemstat, a potent reversible LSD1 inhibitor being developed as a treatment for Ewing sarcoma, a rare pediatric bone cancer.

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Details of the symposium and poster presentation are as follows:

Abstract Title: Trials in progress: A phase I/II clinical trial of the reversible LSD1 inhibitor, seclidemstat, in patients with relapsed/refractory Ewing sarcoma
Where: The Franklin Institute, 222 North 20th Street, Philadelphia
When: Monday, December 16, 2019 at 8:30 a.m. EST to 7 p.m. EST
Symposium Website: Epigenetics Symposium: 15 Years of Lysine Demethylases: From Discovery to the Clinic

"The Epigenetics Symposium is an ideal event to showcase our progress bringing our lead drug candidate, Seclidemstat, into the clinic and the impact it could have on Ewing sarcoma, a rare and deadly bone cancer that most often strikes children and young adults and for which there are no targeted therapies approved," stated David Arthur, Chief Executive Officer of Salarius Pharmaceuticals. "Lysine demethylase enzymes are a well-known target for epigenetic-based drug development. We have developed Seclidemstat to be a differentiated LSD1 inhibitor, and we are excited that it has reached the clinical trial setting where its safety and therapeutic activity can be assessed. Research shows that LSD1 expression is elevated in 60% of Ewing sarcoma patients and correlates with poor patient prognosis and decreased overall survival. Given the potential of Seclidemstat to address this great unmet need, we look forward to releasing early cohort data next year from our Ewing sarcoma study and a Phase 1 study in advanced solid tumors."