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Artera Launches with $90 Million in Funding to Personalize Cancer Therapy With Multimodal AI

On March 21, 2023 Artera, the developer of multimodal artificial intelligence-based predictive and prognostic cancer tests, reported that it launches publicly today with $90M in funding (Press release, Artera, MAR 21, 2023, View Source [SID1234629131]). The investment comes from a syndicate of prominent tech and healthcare investors, comprised of seven institutions (Coatue, Johnson & Johnson Innovation – JJDC, Inc., Koch Disruptive Technologies, Walden Catalyst Ventures, TIME Ventures, Breyer Capital, The Factory) and 11 angel investors (Marc Benioff, Jim Breyer, Lip-Bu Tan, Chris Re, Andy Jacques, Amarjit Gill, Jeff Dean, Steve Blank, Dennis Wong, Clarence So, Michael Driscoll).

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Artera’s flagship test is the ArteraAI Prostate Test, the first test to predict therapy benefit in localized prostate cancer. The investment will help distribute this test in the U.S. and internationally. The company also plans to use the funding to invest in the development of tests to support therapy personalization in other cancers.

"The American Cancer Society estimates that more than 288,000 new cases of prostate cancer will arise in 2023, with more than 34,000 deaths. AI has given clinicians and patients a powerful weapon in the fight against this disease," said Andre Esteva, co-founder and CEO of Artera. "Clinicians can now leverage Artera’s unique test to prognosticate patient outcomes and personalize treatment decisions."

"We are honored to be part of what we believe to be one of the greatest advances in prostate oncology in the last 20 years," said Marc Benioff, CEO of Salesforce.

"In the last 18 months, Artera’s AI-informed approach to personalized cancer treatment has unlocked commercial and regulatory traction well ahead of genomic competitors," said Stephen Cho, Partner at Coatue. "We are thrilled to support Artera as a pioneer in computational diagnostics for an important therapeutic area."

This announcement comes on the heels of Artera’s recently released, positive data at ASCO (Free ASCO Whitepaper) GU 2023, highlighting that the prognostic biomarker was validated across six phase III randomized trials. The study further demonstrated the ability of Artera’s multimodal artificial intelligence prognostic biomarker to help enable personalized, shared decision-making for patients and clinicians.

The ArteraAI Prostate Test is a clinically available, laboratory-developed test. For more information or to order the test please visit artera.ai.

Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

On March 21, 2023 Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, reported a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA) (Press release, Lumicell Diagnostics, MAR 21, 2023, View Source [SID1234629130]).

LUMISIGHT is intended for use with the Lumicell Direct Visualization System (DVS), an investigational system designed to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery.

"Lumicell is committed to revolutionizing the way breast cancer surgery is performed and bringing the benefits of the Lumicell Direct Visualization System to breast cancer patients," said Kevin Hershberger, president and chief executive officer of Lumicell. "Submission of the LUMISIGHT NDA is a significant step toward achieving this goal. We look forward to working with the FDA on acceptance of our LUMISIGHT application for review and submitting the PMA for the Lumicell DVS in the second quarter."

The LUMISIGHT NDA submission is supported by data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers. Results from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial (NCT03686215) of 406 patients at 14 sites will be presented at the upcoming American Society of Breast Surgeons (ASBrS) annual meeting. The FDA granted LUMISIGHT Fast Track designation and the Lumicell DVS Breakthrough Device designation in recognition of its potential benefit of identifying residual cancer after the initial lumpectomy.

"Data has shown that the risk of local recurrence is directly related to incomplete tumor removal. Currently, at least 20% of women having breast conserving surgery require a second surgery because of positive margins and 6-10% of women with breast cancer experience a local recurrence," said Barbara Smith, MD, PhD, director of the Breast Program at Massachusetts General Hospital, professor of surgery at Harvard Medical School and lead investigator of the INSITE clinical trial. "As surgeons, technology that helps ensure we are doing everything in our power to remove cancer during the initial lumpectomy gives us and patients greater piece of mind and has the potential to support improved outcomes."

About the Lumicell Direct Visualization System

The investigational Lumicell Direct Visualization System (DVS) is intended for use with the LUMISIGHT Optical Imaging Agent and features a hand-held imaging probe that is designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer, thereby enabling a more complete resection. The safety and efficacy of the Lumicell DVS in detecting residual cancer left behind by standard of care surgical procedures has been evaluated in two studies: INSITE and a feasibility study of 234 patients at 16 sites, results of which were published in JAMA Surgery.

The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only. The Lumicell DVS is not commercially available.

Guardant Health collaborates with The Ohio State University Comprehensive Cancer Center to study colorectal cancer screening adherence

On March 21, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, has reported support for an investigator initiated study led and conducted by The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) to evaluate patient compliance with a blood-based test for colorectal cancer (CRC) screening (Press release, Guardant Health, MAR 21, 2023, View Source [SID1234629129]). In this study, The Ohio State University Guardant Shield Colorectal Cancer Screening Project, individuals from minority and underserved populations aged 45 and older who are in need of CRC screening will have the option to receive the Shield blood test, administered by a mobile phlebotomist, as part of their engagement with a community health van. Integrating Shield into mobile health services will allow health care providers to bring blood-based screening directly to communities making it accessible for eligible individuals who are not compliant with CRC screening.

Colorectal cancer is the second leading cause of cancer related death in the United States.1 Although CRC screening has been shown to improve survival rates, one in three adults have not completed the recommended CRC screening.2,3 The Appalachian region’s cancer mortality rate is 10% higher than the national average, and the region has higher than average incidence and mortality rates for colorectal cancer specifically.4,5 Over 40% of the Appalachian population is rural, compared with 20% of the national population, and residents are more likely to have lower incomes, lower levels of education, higher poverty and unemployment rates, and poorer health than their non-Appalachian counterparts.6

With a simple blood draw, the Shield test can assist in removing barriers associated with established CRC screening methods because it requires no special preparation, no sedation, no dietary changes, and no extra time away from family or work, and it can be completed as part of any patient office visit.7 Shield test performance was recently clinically validated by the ECLIPSE Study – one of the largest cancer screening studies of its kind – and achieved 83% sensitivity for the detection of CRC. Since the launch of Shield, it has shown approximately 90% adherence demonstrating the value of blood-based screening in a real-world clinical setting.8

"We learned early on in the COVID-19 pandemic that we need to be innovative in how we deliver care to our communities. By deploying a mobile phlebotomist as part of a mobile health clinic, we are further able to understand the potential and ease of a blood test to reach rural and underserved communities," said AmirAli Talasaz, Guardant Health co-CEO. "The Ohio State University Comprehensive Cancer Center research team has a long legacy of community leadership in Ohio and Appalachia, so we know we are meeting patients where they are, helping to further reduce barriers to access, and improve CRC screening rates to pre-pandemic levels."

About The Ohio State University Guardant Shield Colorectal Cancer Screening Project (NCT05716477)

This study will enroll individuals aged 45 years and older from minority and underserved populations who are in need of colorectal cancer screening via mobile health clinics. Approximately 300 patients will be enrolled during the study period. Researchers will evaluate attitudes and beliefs about colorectal cancer screening as part of the study, which is funded by Guardant Health, the manufacturer of the Shield test.

About the Shield Test

The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA). Specifically, the test identifies specific characteristics of the DNA that may indicate the presence of cancer.

The clinical performance of the Shield assay was validated using an analyzed set of over ten thousand patient samples in a screening study. The test demonstrated 83% sensitivity in detecting individuals with CRC. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. This test also demonstrated 13% sensitivity in detecting advanced adenomas.

Since the launch of the laboratory developed version of the Shield test in May 2022, it has shown approximately 90% adherence in the real-world clinical setting, demonstrating the value of blood-based screening to increase adherence to recommended screening protocols.8 In fact, the effective sensitivity of the test, which measures the true impact of a screening test by evaluating adherence and test performance, shows that Shield has the potential to detect more CRCs than traditional modalities.8,9,10,11

Shield is commercially available for eligible individuals by prescription only through healthcare professionals. This LDT (Laboratory Developed Test) is intended to be complementary to, and not a replacement for, current recommended CRC screening methods. A negative result does not rule out the presence of cancer. Patients with an abnormal blood-based screening result should be referred for a diagnostic colonoscopic evaluation.

More information about the Shield test is available at bloodbasedscreening.com.

280Bio Provides Update on the KRAS Inhibitor TEB-17231 at the 2023 AACR Annual Meeting

On March 21, 2023 280Bio, Inc. a clinical stage biotechnology company, focused on the development of precision oncology medicines, reported a presentation featuring the Company’s lead development candidate TEB-17231 at the AACR (Free AACR Whitepaper) Annual Meeting in Orlando, Florida to be held April 14-19, 2023 (Press release, 280Bio, MAR 21, 2023, View Source [SID1234629128]). The 280Bio pipeline is focused on novel oral oncology drug candidates directed at frequently mutated genetic changes in signaling pathways and the known genetic instability features of many cancers.

The presentation describes preclinical findings on a lead series of small molecule inhibitors directed against multiple KRAS-mutation-altered tumor cell lines. The lead candidate TEB-17231 showed robust tumor growth inhibition, against KRASG12V, KRASG12C, KRASG12D and other RAS mutant tumor cell lines. TEB-17231 was also shown to be active in blocking tumor growth in KRASG12C-resistant cell lines bearing different secondary mutations in KRAS. With its excellent pharmacologic properties, TEB-17231 oral dosing demonstrates strong inhibition of in vivo KRAS mutant xenograft tumor growth.

The presentation details at 2023 AACR (Free AACR Whitepaper) are as follows:

The small molecule KRAS inhibitor, TEB-17231, blocks tumor progression and overcome KRASG12C inhibitor mediated resistance
Session Category: Molecular/Cellular Biology and Genetic; Session Title: Ras-related Signaling; Monday April 17, 2023 1.30PM to 5.00PM EST
Location Section 11, Poster Board 11 abstract # 2627
280Bio is advancingTEB-17231 through IND enabling studies in preparation for Phase1 studies for the treatment of KRAS-mutated cancer patients.

Reflecting on the importance of the discovery and early research being presented at AACR (Free AACR Whitepaper) 2023, Michael Hui, MBA, CEO & President of 280Bio, stated, "We are actively developing TEB-17231 given its demonstrated abilities to effectively inhibit different KRAS mutant tumor cells through its actions in KRAS signaling. We are excited that TEB-17231 is emerging from the company’s KRAS target hub discovery platform, exemplifying the utility of our strong medicinal chemistry capabilities at 280Bio. The strategic collaboration with the MD Anderson Cancer Center (MDACC), Houston, TX, further contributes to our understanding of this interesting drug class and KRAS signaling mechanisms, and will accelerate development of TEB-17231 and other KRAS target hub agents toward the clinic."

"The scientific presentation at the AACR (Free AACR Whitepaper) meeting of our KRAS lead candidate TEB-17231 highlights the progress we made to move the drug candidate this year into the clinic", said Dr. Xu Zusheng, General Manager and Head of Research and Development of Yingli Pharma, "Novel agents that interfere with KRAS signaling are highly desirable, particularly in cancers where KRAS is dysregulated. Precision oncology approaches offer the advantage of identifying the KRAS mutated cancers that may be most susceptible to these novel targeted agents. The TEB-17231 drug candidate potentially brings an additional treatment option to address a high unmet need for many patients with cancer."

Atossa Therapeutics and Quantum Leap Healthcare Announce New Study Arm to Evaluate (Z)-Endoxifen in the Ongoing I-SPY 2 Clinical Trial

On March 21, 2023 Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology, and Quantum Leap Healthcare Collaborative reported that Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, will be evaluated in a new study arm of the ongoing I-SPY 2 clinical trial (Press release, Atossa Therapeutics, MAR 21, 2023, View Source [SID1234629127]). The I-SPY 2 TRIAL evaluates neoadjuvant treatments for locally advanced breast cancer and is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. Approximately 20 patients will be treated with (Z)-endoxifen for up to 24 weeks prior to surgery.

The new study arm evaluating (Z)-endoxifen is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), which targets patients with newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. These patients have substantial risk for recurrence, often after five years, and need novel agents that are more tolerable and effective than the current standard of care and address the risk of recurrence.

"Atossa is proud to partner with Quantum Leap Healthcare Collaborative and excited that (Z)-endoxifen has been added to their unprecedented I-SPY clinical trial, which is designed to quickly and efficiently bring new drug therapies to breast cancer patients who need them urgently," said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. "Data from this trial will supplement data generated through our ongoing Phase 2 EVANGELINE trial, which is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+ / HER2- breast cancer. There remains a critical need for more effective and tolerable treatment options for this patient population."

"(Z)-endoxifen is one of the most active metabolites of tamoxifen. Tamoxifen is known to be effective in treating and preventing ER+ breast cancer, but may be most effective in those patients who can adequately metabolize it, " said Dr. Laura Esserman of the University of California San Francisco, founder and leader of the I-SPY TRIAL. "(Z)-endoxifen may overcome some of the shortcomings of tamoxifen, as it is already the active metabolite. Perhaps most exciting is that it may be effective in premenopausal women without the need for ovarian suppression. Ovarian suppression in premenopausal women and aromatase inhibitors in postmenopausal women are associated with both short-term and potential long-term side effects that diminish adherence. (Z)-endoxifen holds promise of being a more effective and tolerable alternative to targeting the estrogen receptor in women with early-stage breast cancer."

Atossa is currently evaluating (Z)-endoxifen in two ongoing Phase 2 studies:

The EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) trial is a randomized non-inferiority study of (Z)-endoxifen compared to exemestane plus goserelin as a neoadjuvant treatment for premenopausal women with Grade 1 or 2 ER+ / HER2- breast cancer. Participants receive neoadjuvant treatment for up to six months, followed by surgery. The primary objective of the EVANGELINE study is to determine whether the endocrine sensitive disease (ESD) rate, measured by Ki-67 (a proliferation marker prognostic for disease free survival), after four weeks of treatment with (Z)-endoxifen is non-inferior to the ESD rate following treatment with current standard of care, exemestane plus goserelin. Exemestane is an aromatase inhibitor designed to block the synthesis of estrogen and slow the growth of ER+ cancers. Goserelin is a medication given to block the ovaries from making estrogen, which in premenopausal women is associated with significant morbidity and inadequate compliance, which compromises efficacy and increases the risk of mortality.

The Karisma-Endoxifen trial is a randomized, double-blind, placebo-controlled efficacy study of oral (Z)–endoxifen in premenopausal women with measurable breast density. Participants receive daily doses of (Z)-endoxifen for six months, over the course of which mammograms are conducted to measure reduction in mammographic breast density (MBD). Participants also have a mammogram at 24 months to assess the durability of the MBD changes. MBD affects more than 10 million women in the United States and many millions more worldwide. Increased MBD reduces the ability of mammograms to detect cancer. Studies have also shown that women with MBD have an increased risk of developing breast cancer and that the higher the MBD, the higher the incidence of breast cancer.

Atossa will supply (Z)-endoxifen and provide financial support to Quantum Leap for this study. Quantum Leap, as sponsor, will provide the clinical sites and clinical expertise. Currently, there are 41 open sites, all of which have the EOP program open.

About Premenopausal Patients with ER+ / HER2- Breast Cancer
Breast cancer is the most frequently diagnosed cancer in premenopausal women worldwide and accounts for almost half of the cancers that occur in women aged 15-49. An overwhelming majority (75%) of premenopausal breast cancer falls under luminal A (ER+/HER2-) or B (ER+/HER2+) subtypes. Ovarian function suppression, when combined with either tamoxifen or an aromatase inhibitor, is the standard of care for the endocrine management of stage 2 and 3 premenopausal ER+/HER2- breast cancer. The I SPY Endocrine Optimization Pilot (EOP) specifically targets women of all ages with molecularly low risk stage 2 and 3 breast cancer.

About (Z)-Endoxifen
(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the anti-estrogenic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein.

Atossa has developed a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions converts a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. We are currently studying our (Z)-endoxifen in healthy women with measurable breast density and premenopausal women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by two issued U.S. patents and numerous pending patent applications.