1stOncology™: Cancer Intelligence Service – Page 5478 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Novocure Announces Review Article of Anti-Cancer Mechanisms of Action of Tumor Treating Fields Published in Journal of Molecular Cell Biology

On October 20, 2022 Novocure (NASDAQ: NVCR) reported a review article of anti-cancer mechanisms of action of Tumor Treating Fields (TTFields) has been published in the Journal of Molecular Cell Biology (JMCB) (Press release, NovoCure, OCT 20, 2022, View Source [SID1234622238]).

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!

"will guide strategies focused on the timing and combination of TTFields with other therapies, to further improve survival outcomes in patients with solid organ cancers."

The review article, written by Shadi Shams of Rowan University School of Osteopathic Medicine and Chirag B. Patel, MD, PhD, Assistant Professor and McNair Scholar, Department of Neuro-Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston, summarizes the known mechanisms of action of TTFields that have been reported by in vitro and in vivo studies of cancer. TTFields are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology and electrical properties) than cancer cells.

The review article cites that many studies to date have focused on TTFields’ effect on cancer cell division. More recently, research has demonstrated the effects of TTFields expand beyond preventing cancer cell division. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Along with disruption of mitosis, the review article states that preclinical research has also shown interference with cancer cell motility and migration, activation of downstream anti-tumor immunity, downregulation of genes important for DNA damage repair, and other potential mechanisms. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models.

"A fast-growing body of research, both in vitro and in vivo, is converging to demonstrate the multiple inhibitory effects of TTFields on cancer growth," the article states.

Shams and Patel state in the review article that further investigation and understanding of how TTFields work "will guide strategies focused on the timing and combination of TTFields with other therapies, to further improve survival outcomes in patients with solid organ cancers."

"This publication of peer-reviewed research on Tumor Treating Fields’ mechanisms of action encapsulates a thorough, scientific history of our therapy in the preclinical setting," said Novocure’s Chief Science Officer Uri Weinberg, MD, PhD. "We are very proud of the research that has been conducted to date and are energized by the interest in Tumor Treating Fields among our peers in the scientific community. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors."

About Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfieldstherapy.com.

Takeda Enters Collaboration and Licensing Agreement with Zedira and Dr. Falk Pharma to Develop First-in-Class Celiac Disease Therapy

On October 20, 2022 Takeda (TSE:4502/NYSE:TAK), Zedira and Dr. Falk Pharma GmbH reported a collaboration and licensing agreement to develop ZED1227/TAK-227, a Phase 2b investigational therapy for the treatment of celiac disease (Press release, Takeda, OCT 20, 2022, View Source [SID1234622237]). TAK-227 is a potential first-in-class therapy designed to prevent the immune response to gluten in celiac disease, a serious autoimmune disease where the ingestion of gluten leads to inflammation and damage to the small intestine. There are currently no approved therapies for the treatment of celiac disease.

"The continued development of TAK-227 in partnership with Zedira and Dr. Falk Pharma has the potential to offer a meaningful benefit to patients with celiac disease who suffer from symptoms and ongoing intestinal injury despite maintaining a gluten-free diet," said Chinwe Ukomadu, M.D., Ph.D., head, Gastroenterology Therapeutic Area Unit at Takeda. "With three novel programs now in the clinic, Takeda is at the forefront of developing transformative therapies for celiac disease and is advancing multiple therapies for patients living with this challenging lifelong autoimmune condition."

TAK-227 (ZED1227)1 is a selective, oral small molecule designed to inhibit tissue transglutaminase (TG2), an enzyme that generates immunogenic gluten peptide fragments upon the breakdown of gluten in the stomach and intestinal tissue. TAK-227 targets the dysregulated transglutaminase to prevent mucosal damage in the small intestine by preventing the body’s immune response to gluten, a disease process mediated by activation of gluten-specific T cells. A Phase 2a proof-of-concept study published in the New England Journal of Medicine previously demonstrated a protective effect of TAK-227 on the duodenal mucosa and symptoms during a six-week gluten challenge.2 The compound was also found to be safe and well tolerated.

"Patients with celiac disease urgently need appropriate therapeutic options to manage the significant negative impacts of the disease on health and daily quality of life," said Roland Greinwald, Ph.D., Managing Director Medicine & Pharmaceutics at Dr. Falk Pharma.

Martin Hils, Ph.D., CEO at Zedira, added "Takeda’s R&D expertise in gastroenterology, commercial footprint, and its strong commitment to develop therapies to treat celiac disease, make it an ideal partner to help us bring TAK-227 to patients."

Under the terms of the agreement, Takeda and Dr. Falk Pharma will conduct global clinical studies for TAK-227 in celiac disease. Takeda will receive an exclusive license to develop and commercialize TAK-227 in the United States and other territories outside of Europe, Canada, Australia and China. Zedira and Dr. Falk Pharma will receive an upfront payment and are eligible to receive potential development, regulatory and commercial milestones, as well as royalties on net sales. Originally discovered by Zedira, Dr. Falk Pharma licensed the European rights to ZED1227 from Zedira in 2011 and assumed responsibility for preclinical and clinical development of the program.

Takeda is advancing a portfolio of investigational therapies for the potential treatment of celiac disease. In addition to TAK-227, Takeda is developing two other investigational celiac disease therapies that recently entered Phase 2 clinical trials. TAK-062 is a potential best-in-class, highly potent glutenase – a protein that degrades ingested gluten – that was computationally engineered to treat celiac disease. TAK-101 is a potential first-in-class, immune-modifying nanoparticle containing gliadin proteins designed to promote immune tolerance to gluten in celiac disease by preventing gliadin-specific T-cell activation.

About Celiac Disease
Celiac disease is a systemic, immune-mediated disorder characterized by chronic enteropathic inflammation, and precipitated by exposure to dietary gluten in genetically predisposed individuals.3 Global prevalence of celiac disease is ~1%, with highest rates in women, in relatives of individuals with celiac disease, and in those with other immune-mediated disorders; prevalence of celiac disease is increasing worldwide, yet many cases remain undetected or not formally diagnosed.4,5,6 The amount of daily tolerable gluten varies widely among individuals with celiac disease. Although some can tolerate >50 mg/day, others develop mucosal abnormalities with gluten consumption of 10 mg/day, and mucosal damage has been associated with chronic exposures of as little as 1 mg/day.7,8,9 Celiac disease can cause symptoms, including abdominal pain, diarrhea, nausea, and vomiting. Long-term complications of celiac disease may include malnutrition, accelerated osteoporosis, nervous system problems and problems related to reproduction. There is no approved therapy for celiac disease. The only available management option for patients is maintaining a gluten-free diet, which involves strict, lifelong avoidance of exposure to gluten proteins from wheat, barley, and rye, which is not always effective.10

Biodesix to Report Third Quarter 2022 Financial Results on November 3, 2022

On October 20, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus on lung disease, reported that it will release financial results for the third quarter ended September 30, 2022 before the open of trading on Thursday, November 3 (Press release, Biodesix, OCT 20, 2022, View Source [SID1234622236]). Biodesix’s management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:00 a.m. Eastern Time on the same day.

Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

PACIRA TO REPORT THIRD QUARTER 2022 FINANCIAL RESULTS ON THURSDAY NOVEMBER 3, 2022

On October 20, 2022 Pacira BioSciences, Inc. (NASDAQ:PCRX) reported that it will report its third quarter financial results before the open of the U.S. markets on Thursday, November 3, 2022 (Press release, Pacira Pharmaceuticals, OCT 20, 2022, View Source [SID1234622235]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

For listeners who wish to participate in the question and answer session via telephone, please pre-register here. All registrants will receive dial-in information and a PIN allowing them to access the live call. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com. For those unable to participate in the live call, a replay of the webcast will be available on the Pacira website for approximately two weeks following the call.

Lantern Pharma Announces Issuance of New Patent that Strengthens Patent Portfolio for Cancer Drug Candidate LP-300

On October 20, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,471,431, for Lantern’s drug candidate LP-300, which is in a Phase 2 clinical trial, Harmonic, for never-smokers with relapsed non-small cell lung cancer (NSCLC) (Press release, Lantern Pharma, OCT 20, 2022, View Source [SID1234622234]).

The patent is directed to increasing the survival time of cancer patients receiving LP-300 for cancers that are marked by overexpression of the regulatory proteins thioredoxin (TRX) or glutaredoxin (GRX) and/or exhibition of TRX- or GRX-mediated resistance to one or more chemotherapeutic interventions. TRX and GRX are commonly overexpressed in adenocarcinomas, a cancer subtype of NSCLC, and can lead to increased tumor resistance to chemotherapy. LP-300 can inhibit activity of TRX and GRX, restoring the redox balance of cancer cells and improving their sensitivity to chemotherapy.

"Developing a strong and evolving patent estate around our drug candidates and technologies is an essential part of our business strategy. LP-300 has the potential to improve the lives of many cancer patient groups, including never-smokers with NSCLC," said Panna Sharma, Lantern President and CEO. "The issuance of this patent demonstrates our ability to create unique cancer insights that we can then translate into clinical practice. This has the potential to add significant value for patients and investors alike," continued Sharma.

U.S. Patent No. 11,471,431 is the latest U.S. patent added to LP-300’s patent portfolio. Lantern’s current patent estate for LP-300 includes 43 patents, covering 8 patent families. The strengthened patent estate relating to LP-300 will stimulate the opportunity for future partnering discussions with biopharma companies.

About LP-300:

LP-300 is a dithio-containing drug candidate that interferes with the activity of cancer promoting proteins by modifying cysteine residues and creating adducts. LP-300’s intended mechanism of action is to work together with chemotherapy to strongly interact with cancer-promoting proteins including TRX/GRX and tyrosine kinases. In a previous multi-center Phase 3 clinical trial, a subset of never smoker NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who received chemotherapy alone. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated.