On June 21, 2022 Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for immune health based on the EpiSwitch 3D genomics platform, reported that its flagship Checkpoint inhibitor Response Test (CiRT) clinical blood test is now available to private physicians considering ICI therapy for their patients in the UK (Press release, Oxford Biodynamics, JUN 21, 2022, View Source [SID1234616148]).

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The first-of-its-kind EpiSwitch CiRT blood test predicts the likelihood of a cancer patient’s response to the widely used class of therapeutics – ICIs – including anti-PD-L1 and anti-PD-1 immunotherapies. Using a routine blood test, rather than an invasive biopsy, CiRT provides fast, personalized guidance for a physician on expected efficacy, enabling a more considered decision whether to begin or continue treatment.

The robust EpiSwitch qPCR blood test has demonstrated best-in-class performance, with high sensitivity (93%), specificity (82%), accuracy (85%), and a significant negative predictive value (NPV) of 93% [1], across several ICIs from multiple pharmaceutical companies and more than 15 key oncological indications, including melanoma and lung cancer.

This expansion to the UK follows encouraging early uptake by early adopters of EpiSwitch CiRT in the US where it was first launched in February 2022 as a Laboratory Developed Test (LDT). The CiRT will initially be available as an LDT to private healthcare providers in the UK. It is only available to registered physicians.

An estimated 2.9 million people were living with cancer in the UK in 2020, a prevalence rate expected to rise to 4 million by 2030 (Macmillan Cancer Support). It is estimated that around 350,000 people are diagnosed each year, amounting to over 1,000 new cases per day (Cancer Research UK).

Despite the potential powerful efficacy of ICIs [2], it has been estimated that they are ineffective for up to 70% of patients treated. The situation is exacerbated by ICIs being some of the most highly priced medicines in the world. The bestselling ICI in the UK has a list price of £84,000 per patient course for the drug alone.

The UK’s NHS and private healthcare systems could save significant amounts, estimated to be close to £1bn, by avoiding or reducing the administration rate of ineffective treatments, through straightforward personalised testing. Savings for the US healthcare system could amount to more than $10bn.

Dr Geoff Higgins, Honorary Consultant Clinical Oncologist, Oxford University Hospitals NHS Foundation Trust, said: "Immune checkpoint inhibitors are a great advancement in cancer therapy but since many patients do not respond, and as treatment can frequently cause significant side effects, there is a pressing need for robust biomarkers of response. The current standard of PD-L1 IHC lacks the accuracy that many oncologists desire. There is a significant unmet clinical need to better predict response to ICIs for which EpiSwitch CiRT promises to be a valuable addition."

Dr Simon Lord, Consultant Medical Oncologist, Oxford University Hospitals NHS Foundation Trust, commented: "There are significant limitations with current routine PDL-1 IHC testing processes not being highly discriminatory in terms of benefits for certain patients for which immunotherapy is indicated. EpiSwitch CiRT has the potential to address this testing issue with the introduction of a specific and accurate IO [immuno-oncology] response test. There is a great advantage in having a liquid biopsy tool which is less invasive than tumour sampling and can be reassessed in a longitudinal fashion, whilst on treatment at multiple timepoints."

CEO of OBD, Jon Burrows, added: "We understand that in order to provide the best-quality care for cancer patients, clinicians should be able to base their decision of therapy choice on meaningful and accurate data. We have already seen in the US that a simple blood test, such as the CiRT, that can predict the patient response to ICIs, could quickly become an essential tool for clinicians. We are proud to make this now available to UK patients, as well. While initially this is only available to private healthcare providers, we aim to widen availability through the NHS as well."

OBD recently presented important clinical utility data at on the EpiSwitch CiRT clinical assay’s prediction of patient response to ICI therapies, at the American Society of Clinical Oncologists Annual Meeting (ASCO 2022) in Chicago, IL. The test was very well received by oncologists and health care providers from around the world [3]. OBD will be attending and continue to present new data at the ESMO (Free ESMO Whitepaper) Congress 2022 (Paris) from September 9 to 13, 2022.

For more about EpiSwitch CiRT, and to order the test, please visit www.myCiRT.com.

Read more about the importance of the recently launched CiRT test here.

On June 21, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported progress on its parallel lead clinical programs NVL-520, a novel ROS1-selective inhibitor, and NVL-655, a novel ALK-selective inhibitor (Press release, Nuvalent, JUN 21, 2022, View Source [SID1234616147]). Nuvalent announced that it plans to share preliminary data from the dose-escalation portion of its ongoing ARROS-1 Phase 1/2 clinical trial for NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors in the second half of 2022. In addition, Nuvalent announced that the first patient has been dosed in ALKOVE-1, its Phase 1/2 clinical trial evaluating NVL-655 in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. NVL-520 and NVL-655 have been designed to address the clinical challenges of emergent treatment resistance, off-target CNS adverse events, and brain metastases that may limit the use of currently available ROS1 and ALK kinase inhibitors.

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"Advancing two novel candidates into clinical development in a little over six months is a significant achievement that we believe demonstrates our ability to scale as a clinical stage company with our growing portfolio, and the value of continued collaboration with leading physician-scientists in the advancement of investigational opportunities for patients in need of new therapies," said Christopher Turner, M.D., Chief Medical Officer of Nuvalent. "We remain committed to the efficient and data-driven development of NVL-520 and NVL-655 through our ARROS-1 and ALKOVE-1 studies and look forward to the opportunity to share preliminary data from the dose-escalation portion of the ARROS-1 trial later this year."

ARROS-1 is a Phase 1/2, multicenter, open-label, dose-escalation and expansion trial evaluating NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors. ARROS-1 is actively enrolling patients with previously treated ROS1-positive solid tumors in the Phase 1 portion of the study. Additional information on the ARROS-1 trial is available on www.ClinicalTrials.gov (NCT05118789).

ALKOVE-1 is a Phase 1/2, multicenter, open-label, dose-escalation and expansion trial evaluating NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors. The Phase 1 dose-escalation portion of the study is open and enrolling patients with previously treated ALK-positive solid tumors and will evaluate the overall safety and tolerability of NVL-655. Additional objectives include determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity.

Once a safe and tolerable dose is determined as the RP2D, the ALKOVE-1 trial is designed to transition directly into the Phase 2 multiple cohort expansion portion, which will evaluate the overall activity of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors. The Phase 2 portion will examine several cohorts of patients based on the number and type of prior anti-cancer therapies they have received. The Phase 2 cohorts are designed with the intent to expand in size, as data emerge and in collaboration with the U.S. Food and Drug Administration (FDA), into potential registrational cohorts for the treatment of previously treated patients with ALK-positive NSCLC. Additional information on the ALKOVE-1 trial is available on www.ClinicalTrials.gov (NCT05384626).

"The ALKOVE-1 study has been designed with the goal of seamlessly accelerating from first-in-human dose-exploration of NVL-655 into Phase 2 cohorts evaluating a range of ALK-positive patient populations," said Darlene Noci, A.L.M., Senior Vice President of Product Development & Regulatory Affairs for Nuvalent. "We believe the growing body of preclinical data generated to date for NVL-655 continue to demonstrate its promise as a differentiated ALK-selective inhibitor with the potential to overcome the limitations of currently available therapies, and are supportive of its development throughout the treatment paradigm for patients with ALK-positive cancers."

In addition to NVL-520 and NVL-655, Nuvalent continues to advance its pipeline expansion efforts with multiple discovery-stage research programs.

About NVL-520
NVL-520 is a brain-penetrant ROS1-selective inhibitor designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with the prevalent G2032R resistance mutation and those with the S1986Y/F, L2026M, or D2033N resistance mutations. NVL-520 has been optimized for brain penetrance to potentially improve treatment options for patients with brain metastases. NVL-520 has been observed in preclinical studies to selectively inhibit wild-type ROS1 and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and drive more durable responses for patients. NVL-520 is currently being investigated in the ARROS-1 study (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors.

About NVL-655
NVL-655 is a novel brain-penetrant ALK-selective inhibitor created to overcome limitations observed with currently available ALK inhibitors. NVL-655 is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R / L1196M ("GRLM"), G1202R / G1269A ("GRGA"), or G1202R/L1198F ("GRLF"). NVL-655 has been optimized for CNS penetrance to improve treatment options for patients with brain metastases. NVL-655 has been observed in preclinical studies to selectively inhibit wild-type ALK and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and drive more durable responses for patients. NVL-655 is currently being investigated in the ALKOVE-1 study (NCT05384626), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors.

On June 21, 2022 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PT217 for the treatment of small cell lung cancer (SCLC) (Press release, Phanes Therapeutics, JUN 21, 2022, View Source [SID1234616146]).

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PT217 is a first-in-class bispecific antibody targeting Delta-like ligand 3 (DLL3) and cluster of differentiation 47 (CD47) being developed for patients with SCLC and other neuroendocrine cancers. SCLC is an aggressive pulmonary carcinoma hallmarked by high early mortality rates and significant morbidities throughout the disease’s progression. The 1-year survival of patients with SCLC is only 32.9%, with only 10.7% of patients surviving 3 years.

"PT217 has the potential to be a transformative treatment option for SCLC patients whose initial response to chemotherapy is short-lived and inevitably becomes resistant to chemotherapeutic agents" said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics. "We have built a strong pipeline in immuno-oncology by leveraging our proprietary technology platforms and expect to file an IND for PT217 by the third quarter of this year. This orphan drug designation follows two recent IND clearances for our PT199, an anti-CD73 monoclonal antibody and PT886, an anti-Claudin 18.2/anti-CD47 bispecific antibody, programs which we are progressing into the clinic."

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended to treat, diagnose, or prevent rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.

On June 21, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious disease, reported that it will issue financial results for its fiscal year ended March 31, 2022, at 4:15 p.m. EST on Tuesday, June 28, 2022 (Press release, Aethlon Medical, JUN 21, 2022, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-fiscal-year-end-financial-results-and-host-conference-call-on-june-28-2022-301571954.html [SID1234616145]).

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Management will host a conference call on Tuesday, June 28, 2022 at 4:30 p.m. EST to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

A replay of the call will be available approximately one hour after the end of the call through July 28, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 4234353.

On June 21, 2022 OncoHost, a global leader in next-generation precision oncology for improved personalized cancer therapy, reported a peer-reviewed article published in Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC), a BMJ oncology journal (Press release, OncoHost, JUN 21, 2022, View Source [SID1234616144]). The study highlights the role of blood plasma proteomic profiling for assessing resistance in non-small cell lung cancer (NSCLC) patients being treated with immune checkpoint inhibitors (ICIs).

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Over the last decade, ICIs targeting the PD-1/PD-L1 axis have emerged as standard-of-care treatments for NSCLC. Although ICI therapy achieves impressive long-term survival in some, the overall response rate is modest, ranging from 20-30 percent in NSCLC patients. A significant proportion of patients display innate resistance to ICIs, and many of those who derive initial clinical benefit experience disease progression at a later stage. The mechanisms underlying innate and acquired resistance to ICIs are not yet fully understood.

The study, Longitudinal plasma proteomic profiling of non-small cell lung cancer patients undergoing immune checkpoint blockade, focuses on how ICI resistance can be predicted in NSCLC patients through proteomic profiling. The analysis was done using PROphet, OncoHost’s first-of-its-kind diagnostic platform that combines proteomic analysis with AI to predict patient response to immunotherapy and identify resistance associated processes.

"While ICIs have played a major role in revolutionizing cancer therapy, we are still lacking clear biomarkers to predict resistance in patients being treated with these modalities," said Dr. Michal Harel, Director of Science and Innovation at OncoHost. "In this study, we have analyzed the largest and deepest plasma proteome dataset for NSCLC patients receiving ICI-based treatment published so far, revealing a predictive signature for response to treatment comprised of two proteins and two clinical parameters using our AI-powered PROphet platform. In addition, using bioinformatic tools, we have identified 3 subtypes of patients based on their plasma proteome, each subtype with distinct clinical and functional characteristics. Altogether, these results have the power to create a paradigm shift in truly understanding and overcoming resistance to cancer by characterizing systemic proteomic changes along ICI-based therapy."

The paper was authored by a team of Israeli and international scientists and oncologists, including Dr. Michal Harel, Prof. Yuval Shaked, co-founder and Chief Scientific Advisor at OncoHost, and professor of cell biology and cancer science at the Technion – Israel Institute of Technology, and Prof. Adam Dicker, a leading radiation oncologist at Thomas Jefferson University and Chief Medical Officer at OncoHost. Additional key investigators included Dr. David Carbone, professor of internal medicine and director of the James Thoracic Center, Prof. Jair Bar, Deputy Director, Institute of Oncology at Sheba Medical Center, and Dr. Alona Zer, Head, Department of Medical Oncology at Rambam Health Care Campus.

"This paper highlights continued success in our clinical trial initiatives as we prepare for the upcoming U.S. launch of PROphet," said Dr. Ofer Sharon, CEO of OncoHost. "We are finally making significant headway in overcoming the long-standing issue in clinical oncology of patient resistance to treatment. The knowledge that PROphet can provide clinicians with is an industry game-changer, and we are excited to be playing a part in transforming cancer patient care. I am proud of our team and look forward to what lies ahead."