On December 8, 2022 Oncolytics Biotech Inc.’s (NASDAQ: ONCY) (TSX: ONC) Chinese partner Adlai Nortye reported interim results from a multicenter, single-arm bridging clinical trial to evaluate the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced/metastatic HR+/HER2- breast cancer (Press release, Oncolytics Biotech, DEC 8, 2022, View Source [SID1234624957]). The data were featured in a poster presented yesterday at the San Antonio Breast Cancer Symposium (SABCS), which is being held at the Henry B. González Convention Center in San Antonio, Texas through December 10, 2022.

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Fifteen patients were treated in the trial as of the data cut-off date (September 26, 2022), with fourteen having had at least one post-baseline tumor assessment (i.e., evaluable for efficacy). All patients enrolled into the trial were previously treated with at least one endocrine therapy and no more than one line of chemotherapy for recurrent/metastatic disease. Data and conclusions presented in the poster are summarized below.

•Disease control, partial response (PR) or stable disease (SD), was achieved in thirteen of fourteen evaluable patients (93%), with twelve (86%) showing tumor shrinkage from baseline.
•Seven of fourteen evaluable patients achieved a PR (50%). Three of these patients achieved a confirmed PR (20%), while two patients are awaiting potential confirmatory scans.
•One patient achieving a PR at week 8 has maintained the PR through week 48 and remains on study.
•Evolving median progression-free survival (PFS) for trial participants as of the data cut-off date was 9.1 months (95% confidence interval: 3.8 – NA).
•The studied combination has been well tolerated, with no dose-limiting toxicities or serious adverse events (SAEs) reported to date.

"These impressive results have us well-positioned to leverage Oncolytics’ prior positive data and join pelareorep’s global development program," said Lars Birgerson, M.D., Ph.D., Adlai Nortye President and Chief Medical Officer. "With no SAEs reported, the data suggests the favorable safety and potent anti-cancer activity displayed by the studied combination in North American HR+/HER2- breast cancer patients extends to the Chinese population. There are also promising signs of pelareorep-paclitaxel combination therapy driving durable clinical benefit, with one patient notably still on study for nearly a year while maintaining a PR. We look forward to further characterizing the efficacy and durability of the studied combination as data from the trial mature and to continuing our collaboration with Oncolytics."

Data from the bridging trial are expected to accelerate Adlai Nortye’s development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics’ North American metastatic breast cancer trials, IND-213 and BRACELET-1. IND-213 is a previously completed randomized phase 2 trial that showed a statistically significant near doubling of median overall survival when HR+/HER2- metastatic breast cancer patients were treated with paclitaxel plus pelareorep vs. paclitaxel alone. BRACELET-1 is an ongoing randomized phase 2 trial in HR+/HER2- metastatic breast cancer patients with cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel plus pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 inhibitor avelumab. Oncolytics expects to report overall response rate, PFS, and evolving overall survival data from BRACELET-1 at a major medical meeting in the first half of 2023.

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "BRACELET-1’s upcoming readout represents a crucial catalyst for Oncolytics, as data from the trial are expected to pave the way for pelareorep’s advancement to a registrational breast cancer study. We believe Adlai Nortye’s latest data significantly de-risk this upcoming readout as they validate IND-213’s positive results by confirming the ability of pelareorep plus paclitaxel to drive durable clinical responses in HR+/HER2- breast cancer patients. I’d like to thank Adlai Nortye for the productive partnership that led to these results, providing us with added enthusiasm for the outlook of our breast cancer program."

A copy of the SABCS poster (P3-07-04), entitled, A Multicenter, Single-Arm, Open-Label Phase I Study of AN1004 (Pelareorep) Oncolytic Virus Plus Paclitaxel in Chinese Patients with Hormone Receptor-Positive and HER2-Negative Advanced/Metastatic Breast Cancer (REO 026-1), will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the symposium.

On December 8, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the CONTACT-01 study did not meet its primary endpoint of overall survival (OS) at the final analysis (Press release, Ipsen, DEC 8, 2022, View Source [SID1234624955]). CONTACT-01 is a phase III clinical trial evaluating Cabometyx (cabozantinib) in combination with atezolizumab (Tecentriq) versus docetaxel in patients with unmutated metastatic non-small cell lung cancer (NSCLC) who experienced disease progression on or after treatment with an immune checkpoint inhibitor and platinum-containing chemotherapy.

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Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen, said: "The results from the CONTACT-01 clinical trial have shown the challenge of treating NSCLC patients after prior lines of treatment have failed. While the findings of the study have not met the primary endpoint in this setting, we remain confident in the clinical efficacy of cabozantinib alone and in combination with another treatment in existing indications in difficult-to-treat tumor types. We wish to thank the patients, their families and healthcare teams for their participation in this clinical trial."

The safety profile of the combination of cabozantinib and atezolizumab observed in the trial was consistent with the known safety profiles for each single agent, and no new safety signals were identified. Detailed findings from CONTACT-01 will be submitted for presentation at a future medical meeting.

About CONTACT-01
CONTACT-01 is a global, multicenter, randomized, phase 3, open-label study that enrolled 366 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of docetaxel. The study enrolled patients with both squamous and non-squamous NSCLC who progressed during or following anti-PD-1/PD-L1 therapy administered either concurrently or sequentially with chemotherapy. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, objective response rate and duration of response. Results from cohort 7 of the phase 1b COSMIC-021 trial informed the CONTACT-01 trial design. CONTACT-01 was sponsored by Roche and co-funded by Exelixis. Both Ipsen and Takeda Pharmaceutical Company Limited (Takeda) opted in to participate in the trial and are contributing to the funding for this study under the terms of the companies’ respective collaboration agreements with Exelixis. More information about the trial is available at ClinicalTrials.gov.

About CABOMETYX (cabozantinib)

Cabometyx is a multi-targeted tyrosine kinase inhibitor (TKI) with targets including vascular endothelial growth factor receptor (VEGFR), c-MET and the TAM receptor family, which block the growth of cancer.

Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of Cabometyx outside of the U.S. and Japan. Exelixis granted exclusive rights to Takeda for the commercialization and further clinical development of Cabometyx for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize Cabometyx in the U.S.

In over 60 countries outside of the United States and Japan, including in the European Union (E.U.), Cabometyx is currently indicated as:

Monotherapy for advanced renal cell carcinoma:
as first-line treatment of adult patients with intermediate or poor risk
in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy
In combination with nivolumab for the first-line treatment of advanced renal cell carcinoma in adults
Monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy
Monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.

On December 8, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial of a genetically modified autologous gamma-delta T cell therapy (INB-400) targeting newly diagnosed glioblastoma (GBM) (Press release, In8bio, DEC 8, 2022, View Source [SID1234624954]). The study will assess the safety, efficacy and tolerability of genetically modified DeltEx drug-resistant immunotherapy (DRI) cells at leading medical centers across the United States.

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"Obtaining clearance to begin the INB-400 Phase 2 clinical trial is an important milestone for IN8bio as it is our first company-sponsored IND. This milestone demonstrates the clinical, regulatory and CMC capabilities of the IN8bio team in continuing to advance novel gamma-delta T cell therapies to cancer patients," said William Ho, Chief Executive Officer and co-founder of IN8bio. "The clinical program is designed to eventually assess DeltEx DRI with both autologous and allogeneic approaches in both the front-line and relapsed setting. We believe the insights we unlock in GBM will be essential as we apply our DeltEx platform across multiple solid tumor cancers."

The Phase 2 clinical trial will commence with the enrollment of newly diagnosed GBM patients, with the initial arm assessing autologously derived MGMT-modified gamma-delta T cells. In line with recent FDA guidance, the Company is planning to expand the trial to include an allogeneic DeltEx DRI drug product in relapsed refractory GBM and potentially the frontline setting. The primary endpoint of the study is overall survival (OS); secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP).

Conference Call Details

IN8bio will host a conference call and webcast on Monday, December 12th at 8:30 a.m. ET to review recent clinical updates, including updated data from the Phase 1 clinical trial of INB-100 being presented at ASH (Free ASH Whitepaper). The webcast can be accessed by clicking the link: View Source and can also be accessed on the Events & Presentations page of the Company’s website.

About INB-400

INB-400 is IN8bio’s DeltEx chemotherapy resistant autologous and allogeneic DRI technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or "off-the-shelf" DeltEx DRI technology.

On December 8, 2022 Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, reported data for IMC-C103C, a bispecific T cell engager targeting MAGE-A4, in patients with ovarian cancer (Press release, Immunocore, DEC 8, 2022, View Source [SID1234624953]).

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The Phase 1 data, presented in a poster at the ESMO (Free ESMO Whitepaper) Immuno-Oncology 2022 Congress, include 33 heavily pre-treated patients with ovarian cancer, who received doses of ≥ 90 mcg intravenously. This includes 16 new patients, and 17 patients previously reported at the ESMO (Free ESMO Whitepaper) Immuno-Oncology 2021 Congress, now with longer follow-up. All patients had platinum relapsed/refractory ovarian cancer (70% PARP inhibitors experienced) and were enrolled regardless of MAGE-A4 protein expression, which was analyzed retrospectively.

Of the 33 patients, 39% (13/33) were MAGE-A4 negative as measured by immunohistochemistry (IHC), and 2 patients had an unknown H score. Of the 55% (18/33) MAGE-A4 positive patients, the majority had low expression (median score = 29 of 300), and only 2 had an H score > 150.

The safety profile was consistent with that reported previously and the mechanism of action, i.e., T cell activation. No related AE led to treatment discontinuation or death.

At the time of data cut-off, 32 patients were evaluable for response, with one additional patient (H score 21) still on treatment and not having had first tumor assessment​. Of the 17 evaluable MAGE-A4 positive patients, one had a durable Partial Response (PR), with a duration of 12.7 months, one patient who had a Stable Disease (SD) converted to an unconfirmed PR after the poster data cutoff date and is still ongoing, and 5 had SD. Reductions in ctDNA were observed in over half of ctDNA evaluable patients (12/22), including 7 with ≥ 50% reductions, and even in those with low or zero MAGE-A4 expression.

"Immunocore has learned from tebentafusp that OS benefit and ctDNA reduction are observed in patients with both high and low total protein expression, while RECIST responses are enriched at higher protein expression," said David Berman, Head of Research and Development of Immunocore. "The emerging IMC-C103C results, where most patients had either no or very low MAGE-A4 expression, are consistent with the RECIST and ctDNA reduction results reported for tebentafusp."

IMC-C103C is part of a co-development / co-promotion collaboration with Genentech, a member of the Roche Group under which Immunocore shares program costs and profits equally. Both companies are evaluating next steps for the IMC-C103C program.

On December 8, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it has entered into a collaboration with AstraZeneca to pursue the development, regulatory approval and commercialization of the Guardant360 CDx blood test as a companion diagnostic to identify patients with ESR1-mutated metastatic breast cancer (Press release, Guardant Health, DEC 8, 2022, View Source [SID1234624952]). The initiative is part of a larger strategic collaboration investigating the use of liquid biopsy as a tool to inform early therapy intervention.

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The collaboration is one of the first to explore the potential of a comprehensive genomic profiling ctDNA (circulating tumor DNA) assay to identify mutation-driven resistance to a prior line of therapy in metastatic breast cancer. The Guardant360 CDx liquid biopsy test is being used to identify patients with detectable ESR1mutations in the SERENA-6 phase III clinical trial, which is evaluating camizestrant, a next-generation oral selective estrogen receptor degrader (ngSERD) being developed by AstraZeneca, in combination with CDK4/6 inhibitors versus aromatase inhibitors in combination with CDK4/6 inhibitors in patients with HR-positive, HER2-negative metastatic breast cancer.

"We’re pleased to collaborate with AstraZeneca on this important study for breast cancer patients," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "We look forward to exploring the potential benefit of early comprehensive genomic profiling using a simple blood draw, which can provide faster results than a tissue biopsy and enable clinicians to consider earlier intervention with the goal of achieving improved patient outcomes."

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360, Guardant360 CDx, Guardant360 TissueNext, Guardant360 Response, and GuardantOMNI tests for advanced stage cancer patients, and Guardant Reveal for early-stage cancer patients. The Guardant Health screening portfolio, including the ShieldTM test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter.