On September 14, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that the Company will host a virtual Key Opinion Leader event on radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer on Thursday, September 23 at 11:00 a.m. ET (Press release, Galera Therapeutics, SEP 14, 2021, View Source [SID1234587659]).

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Dr. Carryn Anderson, Clinical Associate Professor of Radiation Oncology at the University of Iowa, will provide a review of the current clinical treatment paradigm for patients with locally advanced head and neck cancer, including the use of intensity-modulated radiation therapy.

Dr. Anderson’s presentation will be followed by a video from a head and neck cancer survivor on his experience with SOM and a presentation from Galera’s President and CEO, Mel Sorensen, M.D., with an overview of the SOM market in patients with head and neck cancer.

The live audio webcast of the event will be accessible from the News & Events section of the Investors page of Galera’s website at investors.galeratx.com. Individuals can participate in an interactive Q&A session by submitting questions via the webcast platform.

An archived version of the webcast will be available for 30 days following the event.

On September 14, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that its Decipher Prostate RP genomic classifier is uniquely recommended in the 2022 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Oncology to guide treatment decisions for men with prostate cancer (Press release, Veracyte, SEP 14, 2021, View Source [SID1234587678]). The new guidelines specifically recommend Decipher Prostate RP after radical prostatectomy and that men with high-risk scores (>0.6) should be strongly considered for salvage radiotherapy with the addition of concurrent hormone therapy, when early radiation therapy is missed.

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"We are thrilled that Decipher Prostate RP is now recommended by the NCCN to guide specific treatment decisions," said Elai Davicioni, Ph.D., Veracyte’s senior vice president, scientific and clinical operations, urologic cancers. "The NCCN’s designation is unique to Decipher Prostate RP and underscores the extensive clinical validation and clinical utility data behind the test. We believe this recommendation will ultimately enable more men to receive the treatment they need, while reducing unnecessary therapy."

The new NCCN recommendations are based on results of the NRG Oncology Phase 3 randomized controlled trial, RTOG 96-01. This study, which followed patients for a median of 12 years, demonstrated that Decipher risk results were associated with hormone therapy benefit, with Decipher high-risk men receiving greater absolute benefit from hormone therapy compared to Decipher low-risk men. In the subset of patients who received hormone therapy in addition to early salvage radiotherapy, Decipher high-risk men experienced improvements in distant metastasis, prostate cancer-specific mortality and overall survival, while Decipher low-risk men had good oncologic outcomes without hormone therapy.

The Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, Phase 3, prospective, randomized controlled clinical trials; 13 Phase 2/3 prospective trials; and more than 20 retrospective studies of Phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

On September 14, 2021 DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, reported the appointment of David Liebowitz, M.D., Ph.D., an industry veteran with over 20 years of experience in oncology drug and viral vaccine development, as chief medical officer (Press release, DNAtrix, SEP 14, 2021, View Source [SID1234587694]).

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"We are thrilled to welcome Dave to the executive leadership team at DNAtrix," said Jeffrey Knapp, chief executive officer of DNAtrix. "Dave has expertise in developing products that elicit immune responses against targets of interest through various therapeutic modalities, including viral-based vaccines. His deep experience leading oncology drug development programs for innovative, young, as well as established biopharmaceutical companies ­­– such as Amgen — will prove invaluable as we advance our pipeline with multiple product candidates being studied in several tumor types and two programs in pivotal stage development."

Prior to joining DNAtrix, Dr. Liebowitz was most recently vice president of Clinical Oncology at Xencor, Inc. From 2012 to 2018, he served as the chief medical officer for Vaxart, Inc., a novel vaccine development company. He was previously the Chief Scientific and Medical Officer for Vivaldi Biosciences, an influenza vaccine and therapeutics biotechnology company. Prior to that, he was the executive vice president of Research and Development at Galileo Pharmaceuticals, and he also served as co-CEO of Galileo for a period of time. Prior to joining Galileo, Dr. Liebowitz was at Amgen, where he was the director of research responsible for all oncology and vascular biology drug discovery and development programs at their Washington research site. He also managed external development collaborations and licensing activities. Dr. Liebowitz joined Amgen through their acquisition of Immunex, where he held several senior positions in clinical and preclinical development. Prior to joining Immunex, he was an associate investigator in the Abramson Cancer Institute at the University of Pennsylvania, where he was director of their immunotherapy and cellular therapy programs targeting cancer and chronic viral diseases. Dr. Liebowitz was an early recipient of a grant from the Bill and Melinda Gates foundation. He began his academic career as an assistant professor of Medicine and Virology at the University of Chicago, and was the director of the Bone Marrow Transplantation Program. Dr. Liebowitz has B.S. and M.S. degrees in Biology from Emory University, an M.D. with honors and a Ph.D. in Molecular Genetics and Cell Biology, both from the University of Chicago.

Dr. Liebowitz added, "I am impressed by the compelling clinical data for the company’s lead drug candidate, DNX-2401, in diffuse intrinsic pontine glioma (DIPG) and recurrent glioblastoma (rGBM), two tumor types that have been notoriously difficult to treat and where therapeutic advances are desperately needed. Given the promise demonstrated with these programs, I also believe there is tremendous potential to leverage DNAtrix’s oncolytic adenoviral platform further for the treatment of other tumor types, and the company has studies underway evaluating therapeutic activity in additional cancers, such as colorectal cancer."

On September 13, 2021 Redx Pharma plc (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported that data from the Company’s RXC004 Phase 1 monotherapy study will be presented at the forthcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, 16-21 September 2021 (Press release, Redx Pharma, SEP 13, 2021, View Source [SID1234587580]).

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RXC004 is the Company’s lead drug candidate and is a potent, orally active porcupine inhibitor being developed as a targeted therapy for Wnt-ligand driven cancer. Based on the safety profile observed in the Phase 1 study, Redx has selected the 2mg dose of RXC004 for its planned Phase 2 monotherapy, proof of concept clinical trials which are expected to start during the second half of 2021.

The presentation at the ESMO (Free ESMO Whitepaper) Congress 2021 will be made by the Study Principal Investigator, Dr Natalie Cook, Consultant Medical Oncologist at the Christie Hospital NHS Trust, Manchester, UK.

Presentation No: 517MO
Authors: N Cook, S Blagden, J Lopez, D Sarker, A Greystoke, N Harris, F Kasmi, A Naderi, G Nintos, A Ortego Franco, R Pihlak, R Shinde, L Goodwin, C Phillips, J Robertson, A Saunders, C Tilston, S Woodcock, R Plummer
Title: Phase 1 study of the Porcupine (PORCN) inhibitor RXC004 in patients with advanced solid tumours
Day/Date: Monday 20 September 2021
Presentation Time: 17:50pm to 17:55pm (CET)
Session Channel: Channel 3
Session Title: Developmental therapeutics
Session Type: Mini oral session
Session Time: 17:30pm to 18:30pm (CET)

Redx to host R&D Event
Presented data will be discussed by Medical Experts during Redx’s online R&D Event to be held on Monday 11 October 2021 at 1:00pm BST / 8.00am EDT. The event will also cover the Company’s pipeline beyond RXC004.

On September 13, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that recapped the schedule of upcoming data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL), being held virtually September 17 – 20, 2021 (Press release, TG Therapeutics, SEP 13, 2021, View Source [SID1234587595]). Full text abstracts are now available through the iwCLL virtual platform, and details of the upcoming data presentations are below.

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The Company will also host a virtual investor and analyst event on Monday, September 20, 2021 at 8:30 AM ET, to review the updated Phase 1 data evaluating the investigational combination of UKONIQ (umbralisib) and ublituximab (U2) plus venetoclax presented at iwCLL, as well as provide an overview of the ULTRA-V Phase 2/3 trial.

Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "We are pleased to see the iwCLL full text abstracts are now available, highlighting updated data from four combination trials including our proprietary U2 doublet regimen. Of particular note, is the updated U2 plus venetoclax Phase 1 data showing among 46 relapsed or refractory CLL patients, an overall response rate of 100% including 35% complete response rate. Additionally, at cycle 12, the data show 88% of evaluable patients achieved undetectable minimal residual disease (uMRD) in the peripheral blood, and 72% uMRD in the bone marrow. These data are encouraging, and we look forward to additional updates at the iwCLL conference as well as reviewing these data and an overview of the ULTRA-V program evaluating the U2 plus venetoclax combination during the virtual event we have planned for Monday, September 20, 2021."

IwCLL 2021 PRESENTATION INFORMATION

Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment-Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study

Abstract Number: 1083667
Presentation Date/Time: Saturday, September 18, 2021 at 1:30 PM EDT/ 19:30 CEST
Session: Session 6: Front-Line Therapy of CLL
Lead Author: Wojciech Jurczak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland
Oral Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Abstract Number: 1083987
Presentation Date/Time: Sunday, September 19, 2021 at 10:50 AM EDT/ 16:50 CEST
Session: Session 8: New Agents in CLL Clinical Trials
Lead Author: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY
Oral Poster Presentation Title: TG-1701, a Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia

Abstract Number: 1083634
Presentation Date/Time: Sunday, September 19, 2021 at 2:00 PM EDT/ 20:00 CEST
Session: Poster Session
Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, and Medical School, University of Western Australia, Crawley, Western Australia
Poster Presentation Title: Phase I/II Study of Umbralisib (TGR-1202), Ublituximab (TG-1101), and Pembrolizumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Transformation: 5-Year Follow-up

Abstract Number: 1083523
Presentation Date/Time: Available on demand
Session: Virtual Poster Gallery
Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY
The above full text abstracts are now available via the iwCLL virtual platform at View Source

At the time of each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

INVESTOR & ANALYST VIRTUAL EVENT INFORMATION
The Company will host a virtual event on Monday, September 20, 2021 at 8:30 AM ET, to discuss the updated Phase 1 data evaluating UKONIQ (umbralisib) and ublituximab (U2) in combination with venetoclax in patients with CLL as well as provide an overview of the Phase 2/3 ULTRA-V program.

To attend the live event, please visit the Events page, located within the Investors & Media section, of the Company’s website at View Source Following the live event, an archive file will be available for replay, for a period of 30 days after the call.

ABOUT U2 PLUS VENETOCLAX PHASE 1 TRIAL
The Phase 1/2 trial, (NCT03379051), is a multi-center, dose-escalation trial designed to assess the safety and efficacy of UKONIQ and ublituximab (U2) plus venetoclax in patients with relapsed or refractory CLL. The primary objective of the trial is to evaluate the safety of venetoclax after U2 induction. The secondary objectives are clinical efficacy as defined by overall response rate (ORR), including complete response (CR) rate, progression-free survival (PFS), and undetectable minimal residual disease (uMRD) rate after 12 cycles of therapy. The trial enrolled approximately 50 CLL patients and is being led by Dr. Paul Barr of the Wilmot Cancer Institute, University of Rochester Medical Center.

ABOUT ULTRA-V PHASE 2 TRIAL
The ULTRA-V Phase 2 trial, (NCT03801525), is an open-label, multicenter, trial designed to investigate the efficacy and safety of UKONIQ and ublituximab (U2) combined with venetoclax in subjects with CLL. The primary endpoint of the trial is overall response rate (ORR) and complete response (CR) rate. The trial enrolled approximately 165 patients with front-line and previously treated CLL at 26 sites throughout the United States.

ABOUT ULTRA-V PHASE 3 TRIAL
The ULTRA-V Phase 3 trial is an open-label, multicenter, randomized controlled clinical trial comparing the time-limited triple combination of UKONIQ and ublituximab (U2) plus venetoclax, to an active control arm of continuous U2. The Phase 3 trial includes two independent randomized cohorts of CLL subjects: a treatment-naïve cohort and a previously treated cohort, with each cohort being enrolled and evaluated independently of each other. The primary endpoint for the trial is progression-free survival (PFS). This trial is being led by Richard R. Furman, MD, Director of CLL Research Center at Weill Cornell Medicine and targeting over 60 U.S. trial sites.