TEST:

DetermaIO™

"Oncocyte Corp...announced that Chief Executive Officer Josh Riggs and Chief Financial Officer Andrea James will attend “J.P. Morgan Week,” coinciding with the 43ʳᵈ Annual J.P. Morgan Healthcare Conference in San Francisco, from January 13-16, 2025."

We performed a comprehensive evaluation of liver-metastatic (LM) disease among mCRC patients enrolled in the phase II randomized AtezoTRIBE trial, that showed a modest benefit from the addition of atezolizumab (atezo) to 1st line FOLFOXIRI/bevacizumab (bev) and identified Immunoscore IC as a predictor of ICI efficacy in the proficient mismatch repair (pMMR) population... In our cohort of pMMR mCRC patients, the immune microenvironment of tumors with LM spread does not differ from that of tumors with no liver involvement. The presence or not of LM disease does not affect the efficacy of adding atezo to first-line FOLFOXIRI/bev, differently than Immunoscore IC.

This dataset reaffirms excellent outcomes for T1c, chemo-treated TNBC, and highlights a potential role for chemo-deescalated, ICI-based therapy for patients with IO+ and sTIL-lo/int tumors who are predicted to benefit from ICI but who still are at high risk of recurrence without systemic therapy. A clinical trial is warranted to evaluate efficacy of ICI in T1c TNBC, and to test the utility of IO score for determining ICI benefit in this setting.

"Oncocyte Corp...announced the peer-reviewed publication of positive data related to its proprietary gene expression test, DetermaIO™."

P3 | N=278 | NeoTRIPaPDL1 (NCT02620280) | "Oncocyte Corp...announced the peer-reviewed publication of positive data related to its proprietary gene expression test, DetermaIO....As noted above, patients receiving a DetermaIO-positive (IO+) result had a significantly higher pathologic complete response (pCR) rate when treated with atezolizumab plus chemotherapy (69.8%) compared to chemotherapy alone (46.9%). DetermaIO-negative (IO-) result patients did not show improved pCR rates with the addition of atezolizumab compared to chemotherapy alone (44.6% vs 49.2%). The interaction test between DetermaIO and the treatment arm was statistically significant (P-value = 0.043). In an unselected patient population, the addition of atezolizumab achieved a numerically higher pCR rate (48.6%) but did not show a significant improvement over the chemotherapy-only arm (44.4%) in patients with TNBC."

We assessed the 27-gene RT-qPCR-based DetermaIO assay and the same score calculated from RNA sequencing (RNA-seq) data as predictors of sensitivity to immune checkpoint therapy in the neoTRIPaPDL1 randomized trial that compared neoadjuvant carboplatin/nab-paclitaxel chemotherapy (CT) plus atezolizumab with CT alone in stage II/III triple-negative breast cancer. We also assessed the predictive function of the immuno-oncology (IO) score in expression data of patients treated with pembrolizumab plus paclitaxel (N = 29) or CT alone (N = 56) in the I-SPY2 trial...In IO-negative cancers, pCR rates were 46.7% versus 16.1%. DetermaIO identified patients who benefited from neoadjuvant immunotherapy resulting in improved pCR rate, independently of PDL1.

We performed a comprehensive evaluation of LM among mCRC patients enrolled in the phase II randomized AtezoTRIBE trial, that showed a modest benefit from the addition of atezolizumab (atezo) to 1-line FOLFOXIRI/bevacizumab (bev) and identified Immunoscore IC as a predictor of ICI efficacy in the proficient mismatch repair (pMMR) population. We investigated the association of LM disease with tumor immune-related biomarkers – including MMR, TMB, Immunoscore IC, Immunoscore, Tumor-Infiltrating lymphocytes (TILs) assessed by optical microscope, PD-L1 expression by Tumor Proportion Score (TPS), and the immune 27-gene signature DetermaIO – and treatment outcome, in the cohort of patients with pMMR tumor enrolled in the AtezoTRIBE study. 151 (75%) out of 202 enrolled patients with pMMR tumor had LM... In our cohort of pMMR mCRC patients, the immune microenvironment of tumors with LM spread does not differ from that of tumors with no liver involvement. The presence or not of LM does not affect the efficacy of adding atezo to first-line FOLFOXIRI/bev, differently than Immunoscore IC.

Investor Presentation

P2; These results provide data on an alternative anthracycline-free chemoimmunotherapy regimen for patients who are not eligible for anthracycline-based regimens and support further evaluation of this regimen as a chemotherapy de-escalation strategy in randomized studies for TNBC. ClinicalTrials.gov Identifier: NCT03639948.

Subjects with stage II-III TNBC were randomized 1:1 (n=12) to receive induction pembrolizumab (200mg IV) +/- peri-areolar IRX-2 (IRX-2 arm: 1 ml SQ x2 daily for 10 days + cyclophosphamide 300 mg/m2 IV x 1) preceding initiation of pembrolizumab + NAC... A subset of TNBCs experience brisk IO response following single-cycle IO (IOpath response), which is associated with 100% pCR in this preliminary dataset, highlighting IOpath as a potential surrogate biomarker to guide NAC de-escalation or omission in early-stage TNBC. Baseline 27-gene IO score predicts pCR and week 3 IOpath response. A future study is planned (neoINBRX) to evaluate the feasibility of combining baseline IO score with week 3 IOpath response to identify and treat IO-sensitive tumors with chemotherapy-sparing IO combination therapy.

Further exploration of the IO score and spatial TIL biomarkers is warranted. The clinical trial registration is NCT02734290.

Investor Presentation

Investor Presentation

"Oncocyte Corporation...announced that five posters of original research are being presented at the Annual Meeting of the American Association for Cancer Research. Four abstracts explore the tumor microenvironment and its potential implications for therapeutic response, leveraging expertise and technology behind DetermaIO. A fifth poster highlights exciting study results applying DetermaCNI, Oncocyte’s proprietary therapeutic monitoring blood test, to metastatic pancreatic cancer."

"DetermaIO may be useful to predict benefit of adding atezolizumab to first-line FOLFOXIRI plus bevacizumab in mCRC. The exploratory IOOPT cut-point should be validated in independent mCRC cohorts."

P2 | N=201 | AtezoTRIBE (NCT03721653) | "Oncocyte Corporation...announces the peer-reviewed publication of the results of a study applying DetermaIO™ to samples collected from the randomized Phase II AtezoTRIBE clinical trial in metastatic colorectal cancer (mCRC)....In the overall population (n=122), DetermaIO positive patients achieved better outcomes in terms of progression-free survival from the addition of atezolizumab among mCRC patients than DetermaIO negative patients, regardless of MMR status. A similar trend was observed in the pMMR population (n=110) that does not currently qualify for ICI therapy in mCRC."

The association of DTIO with efficacy to ICI therapy has previously been validated in TNBC, NSCLC, bladder, colon, renal cell, and gastric cancers using an established threshold. These results support the previously selected uniform threshold for these cancers and suggest that it is appropriate for esophageal cancer. H&N, ovarian, pancreatic and prostate cancers have lower ICI efficacy rates and with the exception of H&N cancer, have struggled in unstratified studies to achieve adequate efficacy for drug approval.

These cell-type signatures may be identifying novel immune infiltrate populations that co-exist within the tumor immune microenvironment and are potentially predictive of ICI response. The two signatures were not independent of DTIO in either cohort, suggesting that the 27-gene algorithm DTIO largely incorporates this information. This analysis begins to dissect the complex physiology of the tumor immune microenvironment that mediates response to immune therapy.

Interestingly, the IO score predicted benefit in patients with high FGFR expression, despite conflicting data regarding response rates among the FGFR aberrant population. Taken together, these results demonstrate that the IO score assessment of the TIME is associated with a clinical benefit from ICI therapy and that this novel biomarker may inform therapeutic sequencing decisions in mUC, potentially improving outcomes for this notoriously difficult-to-treat disease.

These data confirm the association of DetermaIO with ICI clinical benefit in NSCLC, and expand on previous studies by demonstrating that first line treated PD-L1≥50% patients can further be stratified by IO score to identify efficacy. Exploratory analysis suggested that the IO score identifies benefit in patients with poor PS.

IO score with the predefined cut-point may help to predict benefit from the addition of atezo to firstline FOLFOXIRI/bev in mCRC, even within pMMR tumours. Exploratory IOOPT cut-points should be validated in independent mCRC cohorts.

Considering the 64 HR+/HER- patients in the paclitaxel arm, 10 achieved pCR (15.6%) and 21 were IO+ (32.8%). These data extend on previous findings in neoadjuvant treatment of TNBC and advanced colon cancer that IO score is associated with response only in the presence of ICI therapy, not in the presence of chemotherapy alone. This is the first study to demonstrate the association of IO score with pathologic complete response to immune therapy in hormone receptor positive BC.

"Oncocyte Corporation...announced that DetermaIO has been selected by the SWOG Cancer Research Network, an independent global cancer research community that designs and conducts publicly funded clinical trials, to be used in a prospectively designed biomarker study of breast cancer tissues. These tissues were collected during the S1418 Phase III randomized clinical trial of Keytruda^® (pembrolizumab) in primary triple negative breast cancer (TNBC)."

"Individual consent for this retrospective analysis and the use of tumor samples for the IO score assay was required for live patients. Consent was waived by the REB for deceased patients."

Individual consent for this retrospective analysis and the use of tumor samples for the IO score assay was required for live patients. Consent was waived by the REB for deceased patients.

P2 | N=119 | IMvigor210 (NCT02951767) | Sponsor: Hoffmann-La Roche | P2 | N=310 | IMvigor210 (NCT02108652) | Sponsor: Hoffmann-La Roche | "Oncocyte Corporation...announces the peer-reviewed publication evaluating the performance of DetermaIO™ in metastatic urothelial (bladder) cancer treated with the immune checkpoint inhibitor (ICI), Tencentriq^® (atezolizumab)....The results of the newly published biomarker study showed that DetermaIO identified 40% of the 348 patients available for DetermaIO biomarker analysis as likely responders, and that they had a median survival of 15.6 months compared to 8.8 months without biomarker stratification. At two years, 41.5% of DetermaIO-positive patients were alive versus 28.6% in the population as a whole....Highlights of the peer-reviewed publication include...DetermaIO outperformed nineteen other genomic signatures and additional existing biomarkers originally selected for testing."

The IMvigor210 results demonstrate the potential for the IO Score as a clinically useful biomarker in mUC. As this is the third tumor type assessed using the same algorithm and threshold, the IO Score may be a promising candidate as a tissue agnostic marker of ICI clinical benefit. The concordance between IO Score and inflammatory gene expression suggests that the classifier is capturing common features of the TIME across cancer types.

Investor Presentation

P2 | N=201 | AtezoTRIBE (NCT03721653) | "The ESMO GI oral presentation, titled An immune-related gene expression profile predicts the efficacy of adding atezolizumab to first-line FOLFOXIRI/bevacizumab in metastatic colorectal cancer: a translational analysis of the phase II randomized AtezoTRIBE study, highlights how researchers found that within the unstratified cohort of patients from AtezoTRIBE, IOOPT+ tumors more frequently had a high amount of tumor mutational burden and longer PFS. When stratifying by treatment arm, IOOPT+ tumors saw significantly higher PFS for patients who received chemotherapy plus immunotherapy versus those who received chemotherapy alone."

"Oncocyte Corporation...announced that it will host a key opinion leader (KOL) webinar on the role of DetermalO™ and the tumor microenvironment in clinical practice..."

"Oncocyte Corporation...announced today new data from ongoing clinical research evaluating the utility of DetermaIO™, the Company’s proprietary test designed to determine the likelihood of benefit of immune checkpoint inhibitors (ICIs), at the upcoming American Society of Clinical Oncology Annual Meeting (ASCO), taking place June 3-7, 2022 virtually and in-person in Chicago."

Conclusions The investigated IO score signature using the predefined cut-point may help to predict benefit from the addition of atezolizumab to first-line FOLFOXIRI/bevacizumab in mCRC, even within pMMR tumours. The exploratory IO OPT cut-points should further be validated in independent mCRC cohorts.

"Oncocyte Corporation...announced today that it plans to present new data from ongoing clinical research evaluating the utility of DetermaIO™ at the upcoming American Society of Clinical Oncology Annual Meeting (ASCO), taking place June 3-7, 2022 virtually and in-person in Chicago."

"The investigated immunomodulatory signature (IO score) may be helpful to predict benefit from the addition of atezolizumab to first-line FOLFOXIRI/bev in metastatic colorectal cancer, also in the cohort of pMMR tumours. Our results support the hypothesis that a deeper characterization of tumour immune microenvironment may help identifying mCRC patients more likely to benefit from ICI-based therapeutic strategies. These findings are worthy of further investigation in independent cohorts."

Neoadjuvant pembrolizumab plus Cb+D regimen yields pCR of 60% and 2-year EFS of 88% in the absence of adjuvant pembrolizumab. The regimen was well tolerated, and no new toxicity signals were noted. Immune enrichment identified by sTILs or DetermaIO signature was associated with high pCR rates approaching or exceeding 80%.

PD-L1 and TMB have shown marked levels of both spatial and temporal heterogeneity in GCs, thus there exists a need for a more comprehensive biomarker that can fully assess the TIME. The 27 gene IO score is associated with many existing biomarkers in GC and has now been shown to also be associated with response to ICIs. As such, further studies are warranted to demonstrate that the 27 gene IO score may be a more comprehensive biomarker for assessing the TIME and provide complementary data to tumor-specific biomarkers, which together could aid in clinical decision making for ICI treatment of GCs.

The IO score predicts clinical outcome following immune checkpoint inhibitor therapy in NSCLC and bladder cancer, and recently was shown to predict benefit by pCR of atezolizumab plus CT over neoadjuvant CT alone in early stage TNBC (NeoTRIPaPDL1 trial)...mTNBC subjects received 1st/2nd line pembro (200mg IV q3wk) plus investigator’s choice paclitaxel (80mg/m2 IV q1wk, n = 15) or capecitabine (2000mg PO BID x 7d, q2wk, n = 14)... IO score is associated with favorable outcome following pembro + CT, and may identify PD-L1-negative cases that respond to pembro + CT. Further investigation in larger datasets is warranted to ascertain the clinical utility of IO score in this setting. Funding: Drug support and funding provided by Merck Sharpe & Dohme as part of the Merck Investigator Studies Program.

This study is the first application of this 27-gene IO RT-qPCR assay in a clinical cohort with outcome data. IO scores were significantly associated with response to ICI therapy and prolonged progression-free survival. Together, these data suggest the IO score should be further studied to define its role in informing clinical decision-making for ICI treatment in NSCLC.

"Oncocyte Corporation...will present data at the American Association for Cancer Research (AACR) Annual Meeting 2022. The data is from a real-world cohort of patients with bladder cancer or metastatic urothelial cancer (mUC) and confirms the association of results from the Company’s DetermaIO™ test with response to treatment with immune checkpoint inhibitors (ICI). Notably, this is the second independent mUC cohort to show the capability of DetermaIO to identify ICI responders using the same algorithm and threshold previously established and validated in bladder and other tumor types."

"Oncocyte Corporation...announced that it will present new confirmatory data on DetermaIO™, its 27-gene expression test used to identify responders to immune checkpoint inhibitor (ICI) therapies, at the American Association for Cancer Research (AACR) Annual Meeting 2022, taking place April 8-13, 2022 in New Orleans."

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"Oncocyte Corporation...announced a development and co-marketing agreement for two distributed in vitro diagnostic (IVD) assays on Thermo Fisher Scientific’s Ion Torrent™ Genexus™ System...Under the terms of the collaboration, Oncocyte will clinically validate Thermo Fisher’s existing Oncomine Comprehensive Assay Plus* on the Genexus System, paving the way toward IVD clearance for use in tumor profiling and future submissions as a companion diagnostic...Oncocyte will also develop its 27-gene expression DetermaIO™ test as a distributed kit on the Genexus."