Caris Life Sciences and Hummingbird Bioscience Enter Into Collaboration to Advance Clinical Development of Anti-HER3 Therapy

On December 6, 2022 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, and Hummingbird Bioscience, a data-driven precision biotherapeutics company discovering and developing transformative biologic medicines for hard-to-treat diseases, reported a strategic collaboration to advance clinical development of Hummingbird Bioscience’s anti-HER3 therapy, HMBD-001 (Press release, Hummingbird Bioscience, DEC 6, 2022, View Source [SID1234624841]).

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Hummingbird Bioscience, a clinical-stage biotechnology company, uses their proprietary and differentiated technologies to drug clinically-validated targets which have previously been elusive. Their most advanced program, HMBD-001, is a HER3 antibody that uniquely targets an epitope on the critical dimerization interface. HER3 is a member of the epidermal growth factor receptor (EGFR) family, known to be important in tumor progression and metastasis. Unlike earlier generations of HER3 antibodies, HMBD-001 blocks both ligand-dependent and ligand-independent signaling, eliciting potent anti-tumor effects. Leveraging Caris’ extensive real-world clinico-genomic database to support clinical trial design, Hummingbird Bioscience will be better able to prospectively identify patients with molecular biomarkers that are potentially associated with response to HMBD-001.

"Caris’ partnership with Hummingbird Bioscience aligns with our goal of leveraging molecular and clinical data to power and accelerate the development of precision therapies," said Brian Lamon, Ph.D., Chief Business Officer at Caris Life Sciences. "Our partnership will help evaluate biomarkers to better understand the clinical utility for this novel therapy, drive patient recruitment and clinical trial access, and may ultimately provide new treatment alternatives and options to patients who are not responding to current therapies."

"With our proprietary technologies, Hummingbird Bioscience discovers and develops unique biotherapeutics against challenging oncology and autoimmune targets. To ensure that these novel therapies succeed, we must conduct intelligent and focused clinical trials on patients who are likely to benefit the most," said Jerome Boyd-Kirkup, Ph.D., Chief Scientific Officer and co-founder at Hummingbird Bioscience. "As a data-driven company, we understand the value of using large cohorts of molecular and clinical information to gain a deeper understanding of the patients who may respond to this exciting new therapy and track their response. We are excited by the potential of this partnership, and we look forward to better, more efficient clinical development with access to Caris’ vast amount of real-world data and state-of-the-art comprehensive profiling technologies."

Since the launch of its molecular profiling service in 2009, Caris has amassed molecular data on more than 400,000 patients and real-world clinical outcomes on more than 275,000 patients. Caris’ state-of-the-art sequencing laboratories are among the most advanced in the world, which allows the company to perform whole exome DNA sequencing and whole transcriptome RNA sequencing on every patient. Caris’ data-driven, molecular insights are changing the landscape of precision medicine with actionable insights from retrospective, epidemiologic and real-time molecular data to enhance research and commercial activities.

Genomic Testing Cooperative to Present Data at the American Society of Hematology Meeting on New Applications of its Proprietary Tests that Combine Transcriptome Data Obtained from Tissue or Liquid biopsies with Machine Learning

On December 6, 2022 Genomic Testing Cooperative, LCA (GTC) announced the presentation of four innovative studies at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting that will be held from December 10 to 13, 2022 in New Orleans, Louisiana (Press release, Genomic Testing Cooperative, DEC 6, 2022, View Source [SID1234624840]). The studies highlight and validate the value of the extended molecular profiling testing currently offered by GTC in evaluating hematologic neoplasms using DNA and RNA next generation sequencing (NGS).

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GTC reports that by combining targeted transcriptome with a proprietary machine learning algorithm, they can predict which patients with advanced myelodysplastic syndrome/acute myeloid leukemia will respond to treatment with Venetoclax-based therapy. In another study, GTC demonstrates that combining targeted transcriptome with machine learning can predict which patients will develop acute graft-versus-host disease (aGVHD) not only post-transplant, but also using pre-transplant sample, which suggests that the patient’s own bone marrow microenvironment may contribute to the development of aGVHD.

GTC continues to demonstrate the superior capabilities of their new cell-free (cfDNA) and cell-free RNA (cfRNA) liquid biopsy test called Liquid Trace. Using cfRNA, GTC studies show that the cfRNA levels can be used in "liquid immunoprofiling" of hematologic neoplasms. Combining this liquid immunophenotyping with machine learning algorithms report high reliability in the differential diagnosis between various types of lymphoid neoplasms/lymphoma.

A fourth study explored the disparity in somatic mutations and outcome in primary central nervous system lymphoma between Hispanic and non-Hispanic patients.

"The work presented at ASH (Free ASH Whitepaper) reflects the commitment of GTC to be the leading diagnostic company in innovation and in advancing the science of diagnostics and biomarkers discovery, especially in hematologic neoplasms," said Dr. Maher Albitar, founder, chief executive officer and chief medical officer of GTC. "The use of RNA profiling in tissue and liquid biopsies is opening new horizons in diagnostics, especially when combined with artificial intelligence. Because of the collaborative business model adapted by GTC as a cooperative (Co-Op) company, we are able to lead in this field. The commitment of all members of the Co-Op to work closely with GTC to improve patient care and advance precision medicine made this work possible" added Dr. Albitar.

Following is a list of GTC presentations:

1) DNA and RNA Profiles in Machine Learning Algorithm to Predict Which Patients with AML/MDS Will Respond to Venetoclax-Based Therapy. December 11, 2022: 6:00 PM-8:00 PM

2) Liquid Immunophenotyping and the Diagnosis of Lymphoid Neoplasms Using Cell-Free RNA. Sunday, December 11, 2022: 6:00 PM-8:00 PM

3) Using Targeted Transcriptome and Machine Learning of Pre- and Post-Transplant Bone Marrow Samples to Predict Acute GVHD (aGVHD) and Overall Survival after Allogeneic HSC Transplantation. Saturday, December 10, 2022: 5:30 PM-7:30 PM

4) Disparities in Somatic Mutations and Outcomes in Primary Central Nervous System Lymphoma Comparing Patients of Hispanic and Non-Hispanic Ethnicity. Saturday, December 10, 2022: 5:30 PM-7:30 PM

Please visit GTC booth #205 at the ASH (Free ASH Whitepaper) exhibit hall for more information.

Exact Sciences Highlights the Impact of Precision Oncology Portfolio on Breast Cancer Treatment with 10 New Data Presentations at SABCS® 2022

On December 6. 2022 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported that new data presentations supporting the clinical value of its Precision Oncology portfolio will be shared in ten abstracts and three presentations at the 2022 San Antonio Breast Cancer Symposium (SABCS) (Press release, Exact Sciences, DEC 6, 2022, View Source [SID1234624839]). The data presented highlight the Oncotype DX Breast Recurrence Score test, Oncomap ExTra test, a new investigational test to predict radiation therapy benefit, and an initial look at Exact Sciences’ tumor-naive minimal residual disease (MRD) approach.

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Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

"The breadth of evidence presented at SABCS 2022 showcases Exact Sciences’ growing Precision Oncology portfolio and commitment to personalizing cancer care and potentially enabling better outcomes at every step," said Rick Baehner, M.D., chief medical officer of Precision Oncology. "We’re developing new tests to support cancer patients and strengthening the evidence of our current tests, including updated results from the landmark TAILORx and RxPONDER trials for the Oncotype DX test."

12-year results from TAILORx trial confirm findings from previous analysis
An independently led analysis by ECOG-ACRIN Cancer Research Group with sponsorship from the National Cancer Institute (NCI) will highlight 12-year results from the Trial Assigning IndividuaLized Options for Treatment (Rx) (TAILORx). The largest randomized adjuvant breast cancer trial ever conducted, TAILORx showed that the Oncotype DX test identifies the vast majority of women with node-negative disease who receive no substantial benefit from chemotherapy (approximately 80%), as well as the important minority (with a Recurrence Score result of 26-100) for whom chemotherapy can be lifesaving.2,5,6

The new 12-year analysis confirms findings from the original primary analysis that endocrine therapy (ET) is non-inferior to chemotherapy plus ET in patients with hormone receptor (HR)-positive, HER2-negative, node-negative early breast cancer and Recurrence Score results of 11 to 25.7 As in the original exploratory analysis2, the subgroup of women aged 50 and younger with Recurrence Score results of 16 to 25 derive some chemotherapy benefit that persists out to 12 years. For those with Recurrence Score results of 0 to 25, late recurrence events beyond five years exceeded earlier recurrence; however, risk of distant recurrence at 12 years remains below 10%, still indicating low risk.

"The immediate clinical impact is that with longer follow-up, the main TAILORx study findings remain unchanged. Physicians can continue to use the 21-gene Recurrence Score results to guide decisions about the use of chemotherapy," said Joseph A. Sparano, MD, deputy director of The Tisch Cancer Center at Mount Sinai Health System. Dr. Sparano leads the TAILORx trial on behalf of the ECOG-ACRIN Cancer Research Group.

Two RxPONDER analyses provide a new perspective for breast cancer treatment
The Rx for Positive Node, Endocrine Responsive Breast Cancer (RxPONDER) trial demonstrated that the Oncotype DX test identifies the majority of early-stage breast cancer patients with one to three positive lymph nodes who may omit chemotherapy.8 An additional exploratory analysis of race and clinical outcomes data in the RxPONDER trial was selected for the SABCS press program. The analysis suggests that Black patients had worse outcomes compared to White patients that were independent of Recurrence Score result, treatment arm and grade.9 The underlying causes of the established racial differences in breast cancer risk and outcomes are complex and likely multifactorial, and the effects of socioeconomic factors and other social determinants of health on breast cancer research need to be further explored.

Another analysis of a questionnaire completed by a subset of patients in the RxPONDER trial demonstrated that cancer-related cognitive impairment is greater with chemotherapy plus endocrine therapy than with endocrine therapy alone, and this impairment lasts past three years of follow-up.10 This analysis reinforces the importance of using the Oncotype DX test to ensure chemotherapy is only used for patients who will benefit. The RxPONDER trial was led by the independent SWOG Cancer Research Network and sponsored by NCI, and its original findings were published in The New England Journal of Medicine in 2021.

An independent UK study evaluates the use of the Oncotype DX test to guide chemotherapy decisions in node-positive breast cancer
A prospective multicenter decision impact study of 680 patients (664 evaluable) with early-stage breast cancer and 1-3 positive nodes demonstrated the clinical and economic value11 of the Oncotype DX test. Specifically, use of the test led to more than half of women being spared chemotherapy (51.7%), a significant improvement in physicians’ confidence in their treatment recommendations (55% improvement), and significant cost savings to the healthcare system (£1,7 million).

Data presentations including Exact Sciences Precision Oncology Portfolio at SABCS 2022
Oral Presentation: Validation of Profile for the Omission of Local Adjuvant Radiotherapy (POLAR) in a meta-analysis of three randomized controlled trials of breast conserving surgery +/- radiotherapy
Data embargoed until 9 a.m. CT on Friday, December 9
Authors: Karlsson P, et al.
Date/Time: Friday, December 9, 9:30-9:45 a.m. CT
Location: Hall 3

Poster #P3-05-59: ER+ HER2-negative BRCA1/2 carriers breast cancer (BC) patients (n=81): Clinical outcomes and molecular characterization via the 21-gene Recurrence Score (RS) test vs. the general RS-tested population (799,986 samples)
Summary: This is a database cohort comparison of Oncotype DX Recurrence Score results, between patients with germline BRCA1/2 mutations and breast population undergoing Oncotype DX testing. BRCA1/2 carriers are characterized by higher Recurrence Score results and distinct gene expression profiles.12
Authors: Yerushalmi R, et al.
Date/Time: Tuesday, December 7, 7:00 a.m. CT

Poster #P2-23-11: Quantitative gene expression by RT-PCR in histologic subtypes of invasive breast carcinoma: an update in nearly one million cases
Summary: This Oncotype DX quantitative gene expression study highlights unique patterns of the Recurrence Score test and single genes across the various histologic subtypes of invasive ductal carcinoma (IDC), suggesting that the Oncotype DX test may be used to further stratify patients with IDC and its histological subtypes.13
Authors: Can NT, et al.
Date/Time: Wednesday, December 7, 7:00 a.m. CT

Poster #P2-23-14: Molecular characterization of HER2-low invasive breast carcinoma by quantitative RT-PCR using Oncotype DX
Summary: This is a multicenter report comparing Oncotype DX RT-PCR and immunohistochemical molecular characterization of HER2-low in HR+ invasive breast carcinomas.14
Authors: Rozenblit M, et al.
Date/Time: Wednesday, December 7, 7:00 a.m. CT

Poster #P2-11-06: Plasma assay of methylated DNA markers (MDM) detects patients with metastatic breast cancer (MBC) compared to healthy controls and treated breast cancer patients with no evidence of disease
Summary: This is a marker discovery study to support a tumor-naive minimal residual disease (MRD) approach. The MDM assay successfully distinguished between patients with metastatic breast cancer and normal healthy control subjects.15
Authors: Giridhar KV, et al.
Date/Time: Wednesday, December 7, 7:00 a.m. CT

Poster #P4-02-12: Validation of a radiation omission signature in early-stage breast cancer patients of the Scottish Conservation Trial
Summary: A study of the 16-gene POLAR signature that successfully identified early-stage breast cancer patients who are at low risk of local regional recurrence from the Scottish Conservation Trial.16
Authors: Taylor KJ, et al.
Date/Time: Thursday, December 8, 7:00 a.m. CT

Poster #P5-03-15: Application of 21-gene Breast Recurrence Score assay to evaluate prognosis and benefit of adjuvant chemotherapy in BRCA1 and BRCA2 pathogenic variant carriers with early stage, estrogen receptor positive breast cancer
Summary: This study shows that women with an inherited BRCA1/2 mutation are more likely to have a higher Oncotype DX Recurrence Score result than their matched controls for age, grade, and stage. These findings suggest that ER+ breast cancers with a germline BRCA1/2 mutation are biologically more aggressive.17
Authors: Saha P, et al.
Date/Time: Thursday, December 8, 5:00 p.m. CT

Poster #P5-14-12: ESR1-alterations in HR+HER2- breast cancer patients
Summary: An evaluation of ESR1 alterations in HR+ HER2- breast cancer samples sequenced by the Oncomap ExTra assay demonstrated that through comprehensive RNA sequencing, the test was uniquely able to identify both common and rare ESR1 fusions, which occurred most frequently in metastatic samples. This is important to potentially help guide treatment for patients who become refractory to endocrine therapy.18
Authors: Basu G, et al.
Date/Time: Thursday, December 8, 5:00 p.m. CT

Poster #P6-01-39: The impact of the 21-gene Recurrence Score assay upon physician treatment recommendations in the neoadjuvant setting in lymph node-negative breast cancer patients in Quebec
Summary: A multicenter, prospective Oncotype DX neoadjuvant decision impact study in HR+ lymph-node negative breast cancer patients in Quebec, Canada demonstrated the clinical utility of the test in decreasing the use of chemotherapy in the neoadjuvant setting.19
Authors: Yordanova M, et al.
Date/Time: Friday, December 9, 7:00 a.m. CT

Equillium and Ono Pharmaceutical Announce Exclusive Option and Asset Purchase Agreement for the Development and Commercialization of Itolizumab

On December 6, 2022 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, and Ono Pharmaceutical Co., Ltd. ("Ono"), reported an option and asset purchase agreement through which Ono gains the exclusive option to purchase Equillium’s rights to itolizumab, a first-in-class monoclonal antibody targeting CD6 (Press release, Equillium, DEC 6, 2022, View Source [SID1234624838]). These rights include all therapeutic indications and the rights to commercialize itolizumab in the United States, Canada, Australia, and New Zealand.

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"We are very pleased to partner itolizumab with Ono, a leading Japanese pharmaceutical company dedicated to fighting disease and pain," said Bruce Steel, Chief Executive Officer at Equillium. "This strategic partnership validates the potential of itolizumab to address autoimmune and immuno-inflammatory disorders for patients in significant need of new therapies. Through this partnership we have secured the resources necessary to continue advancing our Phase 3 EQUATOR study of itolizumab in the treatment of first-line acute graft-versus-host disease, a severe life-threatening disease, and our ongoing EQUALISE study in lupus nephritis. Based on our current operating plan we expect this strategic partnership will enable us to fund operations into 2025, enabling us to advance our wholly-owned pipeline of multi-cytokine inhibitors through multiple key milestones, including our ongoing Phase 2 study of EQ101 in alopecia areata and Phase 1 study of EQ102 in celiac disease."

"We believe this collaboration with Equillium reinforces our commitment to research and development and creating innovative therapeutics in immunology," said Gyo Sagara, President and Chief Executive Officer of Ono. "We are very pleased to be partnering with Equillium to develop a novel medicine for patients with difficult-to-treat immuno-inflammatory disorders. We hope that itolizumab will serve as our foundation for expanding our business in the United States and pave the way for becoming a global specialty pharmaceutical company."

Under the terms of the agreement, Equillium will receive a non-refundable upfront payment of approximately $26.0 million (¥3.5 billion) and will also be eligible to receive up to an aggregate of approximately $138.5 million (¥18.7 billion) for exercise of the option and milestone payments from development through first commercial sale. Equillium will be responsible for the conduct of all research and development of itolizumab, which will be fully funded by Ono on a quarterly basis commencing July 1, 2022 through the option period.1 The option period will expire three months following delivery of topline data from the EQUALISE study in lupus nephritis and interim data from the EQUATOR Phase 3 study in acute GVHD.

Upfront and option exercise payments are based in Japanese yen and subject to currency exchange rates at the time of payment (U.S. dollar amounts are estimates based on the average exchange rate on December 2, 2022). R&D funding and milestone payments are to be paid in U.S. dollars.

Conference Call

Management will host a conference call to discuss the option and asset purchase agreement with Ono Pharmaceutical Co., Ltd. for analysts and institutional investors, at 8:30 a.m. ET today, December 6, 2022. To access the call, please dial (888) 350-3846 or (646) 960-0251 and, if needed, provide confirmation number 8770084. A live webcast of the call will also be available on the company’s Investor Relations page at www.equilliumbio.com/investors/events-and-presentations/default.aspx. The webcast will be archived for 180 days.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

About Multi-Cytokine Platform: EQ101 & EQ102

Our proprietary Multi-Cytokine Platform (MCP) generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach provides multi-cytokine inhibition at the receptor level and is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as JAK inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.

Current MCP assets include EQ101, a first-in-class, selective, tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21.. These rights include all therapeutic indications and the rights to commercialize itolizumab in the United States, Canada, Australia, and New Zealand.

"We are very pleased to partner itolizumab with Ono, a leading Japanese pharmaceutical company dedicated to fighting disease and pain," said Bruce Steel, Chief Executive Officer at Equillium. "This strategic partnership validates the potential of itolizumab to address autoimmune and immuno-inflammatory disorders for patients in significant need of new therapies. Through this partnership we have secured the resources necessary to continue advancing our Phase 3 EQUATOR study of itolizumab in the treatment of first-line acute graft-versus-host disease, a severe life-threatening disease, and our ongoing EQUALISE study in lupus nephritis. Based on our current operating plan we expect this strategic partnership will enable us to fund operations into 2025, enabling us to advance our wholly-owned pipeline of multi-cytokine inhibitors through multiple key milestones, including our ongoing Phase 2 study of EQ101 in alopecia areata and Phase 1 study of EQ102 in celiac disease."

"We believe this collaboration with Equillium reinforces our commitment to research and development and creating innovative therapeutics in immunology," said Gyo Sagara, President and Chief Executive Officer of Ono. "We are very pleased to be partnering with Equillium to develop a novel medicine for patients with difficult-to-treat immuno-inflammatory disorders. We hope that itolizumab will serve as our foundation for expanding our business in the United States and pave the way for becoming a global specialty pharmaceutical company."

Under the terms of the agreement, Equillium will receive a non-refundable upfront payment of approximately $26.0 million (¥3.5 billion) and will also be eligible to receive up to an aggregate of approximately $138.5 million (¥18.7 billion) for exercise of the option and milestone payments from development through first commercial sale. Equillium will be responsible for the conduct of all research and development of itolizumab, which will be fully funded by Ono on a quarterly basis commencing July 1, 2022 through the option period.1 The option period will expire three months following delivery of topline data from the EQUALISE study in lupus nephritis and interim data from the EQUATOR Phase 3 study in acute GVHD.


Upfront and option exercise payments are based in Japanese yen and subject to currency exchange rates at the time of payment (U.S. dollar amounts are estimates based on the average exchange rate on December 2, 2022). R&D funding and milestone payments are to be paid in U.S. dollars.

Conference Call

Management will host a conference call to discuss the option and asset purchase agreement with Ono Pharmaceutical Co., Ltd. for analysts and institutional investors, at 8:30 a.m. ET today, December 6, 2022. To access the call, please dial (888) 350-3846 or (646) 960-0251 and, if needed, provide confirmation number 8770084. A live webcast of the call will also be available on the company’s Investor Relations page at www.equilliumbio.com/investors/events-and-presentations/default.aspx. The webcast will be archived for 180 days.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

About Multi-Cytokine Platform: EQ101 & EQ102

Our proprietary Multi-Cytokine Platform (MCP) generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach provides multi-cytokine inhibition at the receptor level and is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as JAK inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.

Current MCP assets include EQ101, a first-in-class, selective, tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21.

EpicentRx Announces Patent Issued for Radiation Protection with RRx-001 in Combination Regimens

On December 6, 2022 EpicentRx Inc. ("EpicentRx"), a leading-edge, clinical stage biopharmaceutical company that uses groundbreaking science to treat cancer and inflammatory-driven diseases, reported that the U.S. Patent and Trademark Office has issued Patent No. 11,510,901 with claims covering its dual anticancer and radio/chemoprotective investigational agent, RRx-001, for the reduction of toxicity prior to, during, or after exposure to radiation from anticancer therapy or nuclear incidents (Press release, EpicentRx, DEC 6, 2022, View Source [SID1234624837]). EpicentRx has also filed additional patent applications for the use of RRx-001 as a radioprotector and a chemoprotector.

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The potential of RRx-001 as a radiation protection agent is related to evidence of NLRP3 inflammasome inhibition and Nrf2 activation, reducing the toxicity of radiation through the suppression of inflammation, free radical and oxidative stress. These protective effects of RRx-001 have also been seen in combination with chemotherapy such as alkylating and platinum compound agents.

EpicentRx recently completed a Phase 2 pilot study named PREVLAR (NCT03515538) which evaluated RRx-001 in head and neck cancer for protection against radiation-induced oral mucositis. Final analysis has been completed showing favorable results and a study manuscript is pending peer-reviewed publication. A larger Phase 2b randomized study named KEVLAR is being planned for further clinical evaluation of oral mucositis prevention.

In addition, studies are underway to develop RRx-001 as a so-called countermeasure under the U.S. Food and Drug Administration’s Animal Efficacy Rule for Acute Radiation Syndrome (ARS) or radiation poisoning from any exposure resulting from a nuclear or radiological weapon, or from a nuclear accident. The Animal Rule approval pathway requires demonstration of efficacy in representative animal models. RRx-001 was granted orphan drug designation by FDA for ARS in 2020.

"This issued patent and other filed patent applications demonstrate our commitment to develop RRx-001, currently in a Phase 3 trial for the treatment of cancer, as a radioprotector, which is important not only to reduce side effects from radiation therapy in many different types of cancer but also in the case of a nuclear war or another Chernobyl accident," said Tony R. Reid, M.D., Ph.D., Chief Executive Officer of EpicentRx.

About RRx-001
RRx-001 is a first-in-class investigational agent with potential to reduce the harmful and debilitating side effects of effective yet toxic treatments like radiotherapy and chemotherapy. The two-stage mechanism of action has also shown anticancer benefit when combined with other treatments and is currently being evaluated with platinum-based chemotherapy in a Phase 3 study for small cell lung cancer.