On September 20, 2021 Mauna Kea Technologies (the "Company"), inventor of Cellvizio, the multidisciplinary probe and needle-based confocal laser endomicroscopy ("pCLE" and "nCLE") platform, reported that it has entered into a new research collaboration agreement with the Lung Cancer Initiative ("LCI") at Johnson & Johnson1 to advance the validation of Cellvizio as a real-time biopsy guidance tool during robotic-assisted bronchoscopy to potentially reduce the near-miss rate of peripheral lung cancer (Press release, Mauna Kea Technologies, SEP 20, 2021, View Source [SID1234587983]).

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Under the terms of the agreement, Mauna Kea Technologies will participate in a prospective, multi-center, open-label, single-arm clinical feasibility study (the "Study") led by LCI. The Study will combine nCLE and robotic-assisted bronchoscopy, using both Cellvizio and the Monarch Platform from Auris Health, Inc., part of the Johnson & Johnson Medical Devices Companies, to assess the capability of nCLE to accurately confirm needle position for the diagnosis of peripheral lung nodules. LCI will sponsor and fund the Study. In consideration of the Company’s resources and support to the Study, pursuant to the terms of the Agreement, LCI will provide total funding to the Company of 978,375 euros, a portion of which is contingent upon the successful completion of certain Study activities under the Agreement.

In addition, pursuant to the Agreement, the Company granted a right of first refusal ("ROFR") to LCI (through JJEI) with respect to any transaction relating to Mauna Kea Technologies’ nCLE variant (i) for use in endoluminal robotic procedures for any lung applications, (ii) for the application of machine learning, artificial intelligence solutions and learning models for diagnosis, risk stratification, and treatment associated with lung disease and (iii) for use for endoluminal or transthoracic intra-tumoral drug delivery procedures for lung. The ROFR is effective for the term of the Study plus an additional four months thereafter.

"We are pleased to announce this important clinical study and expanded agreement as part of our collaboration with the Lung Cancer Initiative at Johnson & Johnson," said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. "We are also pleased with the progress we have made in our strategic collaboration with LCI and the potential impact of real-time in vivo cellular imaging with Cellvizio, combined with the Monarch Platform, particularly as it relates to using Cellvizio for real-time tool-in-lesion confirmation during robotic-assisted bronchoscopy procedures."

On September 20, 2021 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, reported that new data in an oral presentation at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2021 evaluating DetermaIO as a biomarker for immune therapy response (Press release, Oncocyte, SEP 20, 2021, View Source [SID1234587980]). The results demonstrated in a randomized clinical trial setting that DetermaIO, a 27-gene precision diagnostic, is predictive of response to neoadjuvant immune checkpoint inhibitor treatment of triple negative breast cancer (TNBC), and support the potential of DetermaIO to serve as a precision diagnostic for this important class of novel therapies with expanding indications across tumor types.

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Commenting on the trial results, Ron Andrews, Chief Executive Officer of Oncocyte, stated, "Demonstrating the utility of DetermaIO in the rigorous setting of a randomized, therapeutic clinical trial is a landmark accomplishment for Oncocyte, and simply put, we are very enthusiastic about the results. These data from a prestigious international clinical trial provide important confirmation of DetermaIO’s capacity to work as a precision diagnostic across the checkpoint inhibitor class of therapies which we believe can benefit both drug development and add precision to patient treatment decisions. We are thrilled to add this new data to the compelling collection of studies that validate the assay’s utility in Lung, TNBC, and Bladder cancers, and across four approved immunotherapies – Keytruda, Opdivo, Tecentriq and Imfinzi – suggesting a potential pan-cancer and pan-immunotherapy utility in both primary and metastatic settings. We look forward to advancing DetermaIO toward clinical launch in Q4, allowing us access to a US market estimated at three billion dollars."

Key results and conclusions from the late breaking oral presentation titled, "Predictive value of gene-expression profiles (GEPs) in the Neo TRIPaPDL1 trial", include:

The utility of DetermaIO (IO Score) was evaluated as part of the NeoTRIPaPDL1 (NCT02620280) study, an international clinical trial that enrolled 241 Stage I-III TNBC patients from seven countries across Europe and Asia, and randomized them into two study arms: neoadjuvant treatment with chemotherapy or with chemotherapy in combination with an immunotherapy
A key goal for DetermaIO was to assess its utility as a predictive diagnostic for immune therapy, a successful result for a precision diagnostic shows that patients benefit only in the combination of a positive test and receiving the specific immunotherapy (IO score and atezolizumab in this study)
In the group of IO score positive patients who received both immunotherapy and chemotherapy, response rates were substantially higher compared to those who received chemotherapy alone (71% versus 51%)
Conversely, in the IO score negative population, no significant difference in response rates was seen (40% versus 44%)
The IO score positive patients who received atezolizumab demonstrated a predictive response at least 20% higher than the other three groups and was statistically significant as measured by an interaction test (p = 0.029)
42.7% of the patients were IO score positive demonstrating that the test is identifying a substantial subset of TNBC patients who may benefit from immune checkpoint therapy
Taken together, these data demonstrate the potential of DetermaIO to be a precision diagnostic to identify both responders and non-responders to immunotherapy. This shows its potential to inform the selection of patients who will benefit from treatment while also helping to avoid treatment associated toxicities for those who will not benefit.
Giampaolo Bianchini, M.D., Head of the Breast Cancer Group at the San Raffaele Scientific Institute, and trial investigator said, "Looking at pathologic complete response in this prospectively, randomized Phase III trial, IO score demonstrated the ability to identify those TNBC patients who benefitted the most from the addition of atezolizumab, and this was supported statistically by a significant test of interaction. Notably, we assessed more than 80 immune-related signatures and none of them showed similar significant tests of interaction. In addition, IO score was significantly more associated with pCR in atezolizumab arm than any other immune-related signatures. This observation underscores the capability of the test to measure features across the tumor microenvironment, including those intrinsic to the tumor (mesenchymal features) and extrinsic to the tumor such as immune infiltration."

Rob Seitz, Head of Immune Oncology at Oncocyte, said, "One of the most common questions we get from experts in the immune oncology field is how does DetermaIO compare to other immune related signatures. The additional research of Dr. Bianchini’s group showed that the IO score clearly distinguished itself from the numerous immune related signatures that were tested, a result that demonstrates DetermaIO has a unique and pivotal role versus other tests in selecting patients for immunotherapy. This is an extremely important milestone, where for the first time, by evaluating the tumor micro environment or TME, we have a precision diagnostic for immunotherapy that can find the right treatment for the right patient with specificity for response."

On Tuesday, September 28th, 2021 from 1-2PM EST, the Company will be hosting a Key Opinion Leader event with Dr. Bianchini and Priyanka Sharma, M.D., Professor of Medicine at the University of Kansas Medical Center to discuss the unmet need for identifying patients with triple-negative breast cancer (TNBC) who will respond to immunotherapy, with Dr. Bianchini highlighting the NeoTRIPaPDL1 randomized clinical trial ESMO (Free ESMO Whitepaper) data.

Abstract and Presentation Details:

Title: Predictive value of gene-expression profiles (GEPs) in the Neo TRIPaPDL1 trial
Abstract #: LBA12
Session type: Late-breaking abstract and oral presentation
Presenter: Bianchini, G.
Authors: Bianchini, G., et al.
Date and time: September 20, 2021, 17:30 CET
About The NeoTRIPaPDL1 Study

The NeoTRIPaPDL1 (NCT02620280) study is an international clinical trial comprising patients from seven countries across Europe and Asia which randomized TNBC patients into two treatment arms: treatment with chemotherapy or treatment with chemotherapy in combination with an immunotherapy. 241 patients with Stage I-III triple negative breast cancer were randomized to either receive immunotherapy plus chemotherapy, or standard of care chemotherapy, prior to their surgery (the neoadjuvant setting). The trial investigators have previously reported initial response data describing how the patient responded with the strongest response being no evidence of the tumor at the time of surgery (pathologic complete response or pCR).

On September 20, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported preclinical data demonstrating the synergistic immunotherapeutic effects of pelareorep combined with radiotherapy in a murine cancer model (Press release, Oncolytics Biotech, SEP 20, 2021, View Source [SID1234587974]). The data were featured in a poster presentation at The International Conference on Immunotherapy Radiotherapy Combinations, which took place in Paris, France from September 14 – 17, 2021.

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Preclinical studies presented in the poster evaluated various treatment combinations of pelareorep, ionizing radiation (radiotherapy), and anti-PD-1 therapy in mice with two bilateral tumors, each located subcutaneously (under the skin) on a different side of the body. Radiotherapy and/or pelareorep treatment was delivered locally to one tumor (denoted the primary tumor), while the second tumor (denoted the abscopal tumor) was not directly exposed to either therapy. Anti-PD-1 therapy was delivered systemically.

Results showed that in primary tumors, pelareorep monotherapy led to a numerical increase in the number of infiltrating anti-cancer CD8+ T cells, which reached statistical significance when combined with radiotherapy (a 15-fold increase compared to control). In abscopal tumors, both pelareorep monotherapy and pelareorep-radiation combination therapy led to a statistically significant increase in infiltrating anti-cancer CD8+ T cells. This effect was not seen with single-agent radiotherapy in either the primary or the abscopal tumors.

Local delivery of radiotherapy alone and the pelareorep-radiotherapy combination into primary tumors significantly improved survival compared to untreated controls. Compared to single-agent radiotherapy, the pelareorep-radiotherapy combination led to a numerical increase in survival, which reached statistical significance when anti-PD-1 therapy was added to the treatment regimen.

"The observed increases in survival and in the number of anti-cancer immune cells within both primary and abscopal tumors following treatment is indicative of the synergistic immunotherapeutic effects of the pelareorep-radiotherapy combination," said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "This is a compelling finding that has the potential to be broadly applicable across multiple cancer indications and warrants further study. Together with prior clinical and preclinical data, these results also highlight pelareorep’s potential as an enabling technology to enhance the efficacy of a wide range of therapies."

A copy of the poster titled, "Combination treatment with radiotherapy and oncolytic reovirus generates CD8+ T cell infiltration in primary and abscopal tumours in an organoid model of basal-like breast cancer," can be found on the Posters & Publications page of Oncolytics’ website (LINK).

On September 20, 2021 Triumvira Immunologics ("Triumvira") reported that the first patient has been dosed as part of the TACTIC-2 trial evaluating the company’s lead candidate, TAC01-HER2, an autologous T cell therapy for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors (Press release, Triumvira Immunologics, SEP 20, 2021, View Source [SID1234587969]). Triumvira, a clinical-stage company, is developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid and liquid tumors. The company’s proprietary T cell Antigen Coupler (TAC) platform technology activates natural T cell functions differently from other cell therapies such as Chimeric Antigen Receptor T cell (CAR-T) and engineered T cell receptor therapies.

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"Despite advances with CAR-T cell therapies in hematological malignancies, there remains a substantial patient population within solid tumors in need of treatments that can demonstrate prolonged safety and efficacy," said Paul Lammers, M.D., M.Sc., President and CEO of Triumvira. "The initiation of our TACTIC-2 trial represents a significant milestone for Triumvira and an opportunity to establish clinical proof of concept for our TAC technology. We look forward to sharing our progress with this program as we build out a pipeline of candidates targeting solid tumors."

Triumvira’s TAC technology has the potential to empower T cells to locate and destroy tumor cells by activating the natural T cell receptor for maximal and controlled anti-tumor responses. Triumvira’s HER2-TAC engineered T cells have demonstrated superior anti-cancer properties and more favorable safety profiles in preclinical studies when compared to both CAR-T cell and standard-of-care therapies.

Triumvira’s TAC01-HER2 was manufactured using Lonza’s Cocoon Platform, a state-of-the-art, automated and self-contained manufacturing system that offers an elegant solution to address many of the challenges of manufacturing autologous cell therapies. With this trial, Triumvira is the first company in the U.S. to dose a patient with a therapy manufactured with Lonza’s Cocoon Platform. As previously announced, Triumvira and Lonza have established a collaboration to expand the use of the Cocoon as an elegant manufacturing solution for TAC-T cell therapeutics.

TACTIC-2 is a Phase 1/2 multicenter, open-label trial designed to evaluate the safety, tolerability and efficacy of TAC01-HER2 in people with HER2-positive metastatic, advanced, unresectable solid tumors such as breast, gastric and many other cancers. The clinical trial is actively enrolling participants at MD Anderson Cancer Center in Houston, Texas, and Dana Farber Cancer Institute in Boston, Mass., and University of Chicago, Ill. and plans to enroll approximately 70 participants.

In addition to TAC01-HER2, Triumvira intends to bring multiple TAC programs directed at other promising targets in solid and liquid cancers into clinical development in the coming years. More information on Triumvira’s pipeline and programs can be found at www.triumvira.com and details on the this clinical trial can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04727151.

on September 20, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data from the Phase III IMpower010 study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS) benefit offered by Tecentriq (atezolizumab) for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%. Data from the IMpower010 trial were published simultaneously in The Lancet (Press release, Hoffmann-La Roche, SEP 20, 2021, View Source [SID1234587967]). In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the risk of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1≥1%, compared with best supportive care (BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.

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"Today, more than half of all people with early-stage NSCLC experience recurrence following surgery," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "IMpower010 shows how, for the first time, a cancer immunotherapy may help many of these patients live longer without their disease returning. The data presented at ESMO (Free ESMO Whitepaper) and WCLC further contribute to our understanding of Tecentriq in this treatment setting."

At the 2021 ESMO (Free ESMO Whitepaper) Virtual Congress, new real-world data show that almost three-quarters of patients with early-stage NSCLC in the US did not receive adjuvant treatment, despite guideline recommendations.1 Data presented from IMpower010 show that adjuvant Tecentriq offers a DFS benefit in the Stage II-IIIA patient population, irrespective of the stage of disease and across the main prior therapies.2,3 Specifically, time to relapse appeared to be improved with Tecentriq, compared with BSC, among people with Stage II-IIIA NSCLC whose tumours express PD-L1 TC ≥1%, for both locoregional and distant sites. There was no clear difference in patterns of relapse. An extended analysis of PD-L1 subgroups in the Stage II-IIIA population shows there is a higher magnitude of benefit from adjuvant Tecentriq in people with PD-L1 expression ≥50%, compared with those with 1-49% PD-L1 expression.2 The exploratory nature of the analysis in patients with 1-49% PD-L1 expression prevents any firm conclusions, and these data will be further analysed and shared at a future medical congress.

Additional IMpower010 data, recently presented at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer (WCLC) Presidential Symposium, showed that treatment with Tecentriq improved DFS in the PD-L1≥1% Stage II-IIIA NSCLC population, compared with BSC, regardless of most surgery types and adjuvant chemotherapy regimens.3

Based on the IMpower010 data, the US Food and Drug Administration (FDA) recently granted Priority Review to Tecentriq as an adjuvant treatment for certain people with early NSCLC and is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The FDA is expected to make a decision on approval by 1 December 2021.

Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets around the world. It was the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types.

About the IMpower010 study
IMpower010 is a Phase III, global, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomised 1,005 people with a ratio of 1:1 to receive either Tecentriq (up to 16 cycles) or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomised Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.

About NSCLC
Lung cancer is one of the leading causes of cancer death globally.4 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.4 Lung cancer can be broadly divided into two major types: NSCLC and SCLC. NSCLC is the most prevalent type, accounting for around 85% of all cases.5 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.5

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies.

To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: