Apexian Chief Scientific Officer Awarded $2.3 Million National Cancer Institute Grant

On September 26, 2018 Apexian Pharmaceuticals’ Chief Scientific Officer, Dr. Mark Kelley, reported that it has been awarded $2.3 million by the National Cancer Institute (NCI) to research the effects of APX3330 on chemotherapy-induced peripheral neuropathy (CIPN) (Press release, Apexian Pharmaceuticals, SEP 26, 2018, View Source [SID1234529731]). CIPN affects many cancer patients and can cause severe pain, loss of feeling, balance problems, muscle weakness, and even paralysis or organ failure. The symptoms may continue years after treatment ends. Currently, there is no effective treatment for CIPN.

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Kelley’s research will focus on augmenting a DNA repair mechanism called APE1 to prevent or reverse CIPN using APX3330, a key molecule being used to treat solid tumors as part of a phase 1 clinical trial by Apexian Pharmaceuticals.

"Previous research has demonstrated APX3330’s effectiveness in protecting neurons and enhancing tumor-killing effects by itself or in combination with anticancer therapeutics, this could offer a win-win for preventing or treating CIPN," said Dr. Kelley, Apexian’s Chief Scientific Officer and the Betty and Earl Herr Professor of Pediatric Oncology Research at the Indiana University Simon Cancer Center.

"We appreciate the National Cancer Institute’s support of Dr. Kelley’s research," said Steve Carchedi, CEO of Apexian Pharmaceuticals. "In addition to acting on deadly forms of cancer involving the colon, pancreas, bladder, and brain, APX3330’s promise as a treatment for CIPN, for which there is currently no treatment, is very exciting."

The grant Dr. Kelley received is part of the NCI’s "Provocative Questions Initiative," which supports research designed to solve specific problems and paradoxes in cancer care that have not received sufficient attention. The funding will be awarded over five years.

CTI BioPharma to Present at the Cantor Fitzgerald Global Healthcare Conference Wednesday, Oct. 3

On September 26, 2018 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management will provide a corporate overview at the Cantor Fitzgerald Global Healthcare Conference at the InterContinental New York Barclay Hotel (Press release, CTI BioPharma, SEP 26, 2018, View Source;p=RssLanding&cat=news&id=2368987 [SID1234529703]).

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Presentation details:

Event:

Cantor Fitzgerald Global Healthcare Conference

Date:

Wednesday, Oct. 3, 2018

Time:

4:35 p.m. EDT

The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma’s website at www.ctibiopharma.com.

Kitov to Present Data on NT219 in Combination with Keytruda® and Erbitux® at AACR International Cancer Immunotherapy Conference

On September 26, 2018 Kitov Pharma (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company, reported that Hadas Reuveni, Ph.D., Chief Technology Officer at Kitov’s subsidiary, TyrNovo Ltd., will present pre-clinical data on NT219, an anti-tumor resistance drug candidate, in a poster session at the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival, to be held September 30 – October 3, 2018, in New York (Press release, Kitov Pharmaceuticals , SEP 26, 2018, View Source [SID1234529701]).

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"We are pleased to have been chosen to present an abstract at the upcoming AACR (Free AACR Whitepaper) meeting. These very exciting data, which we had also presented at a cancer conference earlier this year, hold great promise for mobilizing the patient’s immune system against tumors," Dr. Reuveni commented. "In the future, tumors in patients who have functional immune systems may respond to NT219 both by blocking feedback pathways, overcoming drug resistance, and by removing the ‘protective shield’ from the tumor, allowing anti-tumor immune attack."

The poster demonstrates NT219’s efficacy in synergy with immuno-oncology therapies, which are widely used today, but to which unfortunately most patients still do not respond. In double autologous PDX models, dosing with NT219 converted tumors that were resistant to pembrolizumab (Keytruda) into responsive tumors. The models also demonstrated the efficacy of NT219 in enhancing the immunotherapeutic potential of cetuximab (Erbitux).

Abstract: B127
Abstract Title: NT219, A Novel Dual Inhibitor of STAT3 and IRS1/2, Converts Immuno-Oncology Resistant Tumors to Responders
Session Date: Tuesday, October 2, 2018
Session Time: 12.45 p.m. – 3.15 p.m. EDT
Session Location: Poster Session B, New York Marriott Marquis, Westside Ballroom

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation and inhibiting the phosphorylation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1/2 and signal transducer and activator of transcription 3 (STAT3), respectively. While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers, including sarcoma, melanoma, pancreatic, lung, head & neck, prostate and colon cancers, by preventing the tumors from developing drug resistance and reversing resistance after it had been acquired. NT219 is developed by TyrNovo Ltd., a Kitov Pharma company. For more information on TyrNovo please visit View Source

NANOBIOTIX TO PRESENT POSITIVE RESULTS FROM ITS PHASE II/III CLINICAL TRIAL OF NBTXR3 IN PATIENTS WITH SOFT TISSUE SARCOMA (STS) AND OTHER ONGOING PHASE I/II TRIALS AT UPCOMING ESMO AND ASTRO ANNUAL
CONFERENCES

On september 26, 2018 NANOBIOTIX (Euronext: NANO – ISIN:FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches in the treatment of cancer, reported that detailed results of its phase II/III clinical trial of NBTXR3 in patients with soft tissue sarcoma (STS) will be presented by Dr. Sylvie Bonvalot, MD, PhD at the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich (Germany) on the 19th of October 2018 during the Proffered Paper (Oral) presentation – Sarcoma and at the ASTRO 60th Annual Meeting in San Antonio (USA) on the 21st of October 2018 during the late-breaking abstract session (Press release, Nanobiotix, SEP 26, 2018, View Source [SID1234529667]).

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European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress
October 19 – 23, 2018 – Munich, Germany
• A phase II/III trial of hafnium oxide nanoparticles activated by radiotherapy in the treatment of locally
advance soft tissue sarcoma of the extremity and trunk wall (LBA66)
Oral communication presented by Dr. Sylvie Bonvalot, MD, PhD (Paris, France) during the Proffered Paper
presentation – Sarcoma
Date: 10.19.2018
• Elderly patients with locally advanced head and neck squamous cell carcinoma treated with NBTXR3
nanoparticles activated by radiotherapy: a phase I trial (1058P)
Poster presented by Prof. Christophe Le Tourneau (Paris, France)
Date: 10.21.2018
• Hepatocellular carcinoma and liver metastasis treated by hafnium oxide nanoparticles activated by
stereotactic body radiation therapy (711P)
Poster presented by Dr. Marc Pracht (Rennes, France)
Date: 10.21.2018
American Society for Radiation Oncology (ASTRO) 60th Annual Meeting
October 21 – 24, 2018 – San Antonio, Texas, United States
• Act.in.Sarc: An International Randomized Phase III Trial Evaluating Efficacy and Safety of First-in-Class
NBTXR3 Hafnium Oxide Nanoparticles Activated by Preoperative Radiotherapy in Locally Advanced
Soft Tissue Sarcoma (LBA7)
Oral communication presented by Dr. Sylvie Bonvalot, MD, PhD (Paris, France) during the late-breaking abstract
session
Date: 10.23.2018
• Hafnium Oxide Nanoparticles Activated by Radiation Therapy for the Treatment of Solid Tumors
(SU_44_2434)
Poster presented by Prof. Juliette Thariat, MD, PhD (Caen, France)
Date: 10.21.2018
• Hafnium Oxide Nanoparticles Activated by Radiation Therapy: An Innovative Approach for the
Treatment of Liver Cancers (SU_13_2124)
Poster presented by Dr. Enrique Chajon Rodriguez, MD, PhD (Rennes, France)
Date: 10.21.2018
• Elderly patients: NBTXR3 as a novel treatment option in locally advanced HNSCC (MO_10_2547)
Poster presented by Dr. Valentin Calugaru, MD (Paris, France)
Date: 10.22.2018
• Exploratory Dosimetric Study of the Impact of the Pre-Radiation Therapy Intra Tumoral Injection of
Hafnium Oxide Nanoparticles Along the Radiation Treatment of Extremity and Trunk Wall Soft Tissue
Sarcomas (MO_15_2596)
Poster presented by Eliane Graulieres, PhD (Toulouse, France)
Date: 10.22.2018
• Hafnium Oxide Nanoparticle Activated by Radiation Therapy Generates an Anti-Tumor Immune
Response (1096)
Poster presented by Prof. Juliette Thariat, MD, PhD (Caen, France)
Date: 10.23 2018

About NBTXR3
NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy:
• tumors through physical cell death
• metastasis due to immunogenic cell death leading to activation of the immune system
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and Nanobiotix believes has the ability to fit into current worldwide standards of radiation care.
Nanobiotix’s broad clinical program includes 10 patient population evaluated in 7 clinical trials.
In June 2018, Nanobiotix established human proof of concept for this first-in-class product in its Soft Tissue Sarcoma (STS) Phase III clinical trial.

NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients that are unable to receive chemotherapy or cetuximab and have very limited therapeutic options. Promising results have been observed from the ongoing Phase I/II trial regarding the local control of the tumors.

Nanobiotix is running an Immuno-Oncology development program. In the United States, Nanobiotix has received approval from the U.S. Food and Drug Administration (FDA) to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).

The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma.

The first market authorization process (CE Marking) is ongoing in Europe in the STS indication.

Kitov to Present Data on NT219 in Combination with Keytruda® and Erbitux® at AACR International Cancer Immunotherapy Conference

On September 26, 2018 Kitov Pharma (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company, reported that Hadas Reuveni, Ph.D., Chief Technology Officer at Kitov’s subsidiary, TyrNovo Ltd., will present pre-clinical data on NT219, an anti-tumor resistance drug candidate, in a poster session at the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (Press release, Kitov Pharmaceuticals , SEP 26, 2018, View Source [SID1234529665]): Translating Science into Survival, to be held September 30 – October 3, 2018, in New York.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to have been chosen to present an abstract at the upcoming AACR (Free AACR Whitepaper) meeting. These very exciting data, which we had also presented at a cancer conference earlier this year, hold great promise for mobilizing the patient’s immune system against tumors," Dr. Reuveni commented. "In the future, tumors in patients who have functional immune systems may respond to NT219 both by blocking feedback pathways, overcoming drug resistance, and by removing the ‘protective shield’ from the tumor, allowing anti-tumor immune attack."

The poster demonstrates NT219’s efficacy in synergy with immuno-oncology therapies, which are widely used today, but to which unfortunately most patients still do not respond. In double autologous PDX models, dosing with NT219 converted tumors that were resistant to pembrolizumab (Keytruda) into responsive tumors. The models also demonstrated the efficacy of NT219 in enhancing the immunotherapeutic potential of cetuximab (Erbitux).

Abstract: B127
Abstract Title: NT219, A Novel Dual Inhibitor of STAT3 and IRS1/2, Converts Immuno-Oncology Resistant Tumors to Responders
Session Date: Tuesday, October 2, 2018
Session Time: 12.45 p.m. – 3.15 p.m. EDT
Session Location: Poster Session B, New York Marriott Marquis, Westside Ballroom

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation and inhibiting the phosphorylation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1/2 and signal transducer and activator of transcription 3 (STAT3), respectively. While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers, including sarcoma, melanoma, pancreatic, lung, head & neck, prostate and colon cancers, by preventing the tumors from developing drug resistance and reversing resistance after it had been acquired. NT219 is developed by TyrNovo Ltd., a Kitov Pharma company. For more information on TyrNovo please visit View Source