On June 6, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported abstracts accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which convenes in Chicago from June 3-7, 2022 (Press release, Tempus, JUN 6, 2022, View Source [SID1234615661]). Tempus is presenting fourteen abstracts, including one oral presentation, two poster discussions, and eleven poster presentations.

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"The research we’re presenting at this year’s conference showcases the breadth and effectiveness of our offerings for oncologists, whether it is our RNA sequencing capabilities or our just-in-time clinical trial matching program," said Dr. James L. Chen, Senior Vice President of Cancer Informatics at Tempus. "We’ve been fortunate enough to work with physicians across the country to advance research that can have a real impact in improving patient outcomes."

The presented research showcases Tempus’ comprehensive collection of precision medicine solutions that are uniquely equipped to support physicians in optimizing each patient’s treatment. Tempus’ oral discussion and poster presentation highlights, include:

Oral Discussion: Operational Metrics for the ELAINE II study Combining a Traditional Approach with a Just-in-TIME Model
Session Date & Time: June 6, 2022, 3:00 – 6:00 PM CDT
Overview: This study demonstrates the success that Tempus’ TIME Trial Program had with Sermonix’s Elaine II trial for patients with ESR1-mutant, estrogen receptor (ER)–positive, HER2-negative metastatic breast cancer. It found that TIME trial sites enrolled their first patient nearly four months faster than traditional sites, and the same sites contributed 44.8% of the patients that were enrolled in the study. Ultimately, the Elaine II trial enrolled all patients in eight months, while the anticipated enrollment duration was twelve to eighteen months
Poster Title: #69 – Clinical whole transcriptome profiling improves the detection of clinically actionable fusions over DNA sequencing alone
Session Date & Time: June 5, 2022, 8:00 – 11:00 AM CDT
Overview: In the largest fusion analysis of its kind, Tempus reviewed a real-world dataset of 84,938 patient records for improvement in clinically actionable fusion detection due to the inclusion of RNA sequencing. The study found that RNA sequencing identified 29% more patients with clinically actionable fusions that were matched to biomarker linked therapies and that would have been missed by DNA sequencing alone.
Poster Title: #9 – Dual tissue and plasma testing improves detection of actionable variants in patients with solid cancers
Session Date & Time: June 5, 2022, 8:00 – 11:00 AM & 4:30 – 6:00 PM CDT
Overview: This study found that 4 out of 10 patients had unique actionable variants linked to targeted therapies from doing both solid tumor and liquid biopsy testing that would have been missed by single modality testing alone. In the study, 42% of an overall cohort of 3,153 patients had clinically actionable variants detected through tissue-based comprehensive genomic profiling and/or liquid biopsy. Of these patients with clinically actionable variants, all linked to targeted therapies, 37% were uniquely identified through tissue testing only or by liquid biopsy only.

On June 6, 2022 The Ottawa Hospital, The Ontario Institute of Cancer Research ("OICR") and Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that data from the INVINCIBLE study, a randomized, phase 2 presurgical Window-Of-Opportunity trial for Intratumoral INT230-6 comprising SHAO (dispersion enhancer), VINblastine (VIN) and Cisplatin (CIS) that is evaluating clinical and Biological Effects in patients with early-stage operable breast cancer (Press release, Intensity Therapeutics, JUN 6, 2022, View Source [SID1234615677]). The study, presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago and virtually from June 3-7, 2022, reported data demonstrating efficacy and tolerability of INT230-6.

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Abstract Title: Intratumoral (IT) INT230-6 can cause tumor necrosis In Vivo: Preliminary results of a phase II randomized presurgical window-of-opportunity study in early breast cancers (the INVINCIBLE study).
First Author: Angel Arnaout, MD, FACS
Session Type/Title: Poster Session/Breast Cancer—Local/Regional/Adjuvant
Session Date and Time: Monday, June 6, 2022, 9:00 AM – 12:00 PM EDT
Location: In-Person & On Demand
Abstract Number: 605
Poster: 376

Copies of the presentation materials will also be available on the Intensity Therapeutics website on the publications and posters page, following completion of the live presentation.

"For a breast cancer patient, the typical waiting period of 2-6 weeks from diagnosis to surgery is a very anxious time. Surgeons and patients feel helpless, as there are currently no therapeutic options for the patient during this time," said Angel Arnaout, M.D., Scientist and Surgical Oncologist at the Ottawa Hospital, and Professor of Surgery at the University of Ottawa. "The active drug agents comprising INT230-6 remain in the tumor following injection and can cause tumor cell death and high levels of necrosis in multiple breast cancer subtypes including triple negative breast cancer, as demonstrated by Part 1 of this study. Interestingly, we also saw immune activation with a relative increase in the abundance of CD4 T naïve, B and NK cells, post treatment, and within the tumor microenvironment, a relative increase in abundance of CD8 memory T, CD4 naïve and B cells, post treatment, when comparing drug treated with control samples. The ability to use just one or two doses of this agent to elicit a rapid and marked cytotoxic and immune induction response within the tumor during the surgical waiting period, all without an increase in postoperative complications, is very novel and highly attractive to patients. We are excited about how this may shift the paradigm on how we treat cancer patients awaiting surgery, in general. We look forward to future studies to demonstrate how this intra-tumoral agent can have systemic benefit and long term impact in patients with breast cancer."

"INT230-6 is our novel, proprietary, locally-delivered, tumor dispersive anti-cancer product that has shown favorable clinical results as monotherapy in a basket study of patients with advanced, relapsed and refractory disease," said Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "These first results reported from the INVINCIBLE breast cancer study provide evidence and support for the potential of our drug in treating local disease prior to surgery. The data from Part I of the INVINCIBLE study show that INT230-6 is well tolerated and, as we see in metastatic disease, elicits both rapid direct tumor killing and immune activating effects. We anticipate completing enrollment of Part II this summer and reporting the full patient study results at a future oncology conference."

About the INVINCIBLE Study
The INVINCIBLE study is a phase II, randomized, open label, multi-center study, expected to enroll up to 90 women with newly diagnosed operable early-stage intermediate or high-grade T1-T2 invasive breast cancers who are randomly allocated (2:1) prior to resection to IT injections of INT230-6, no treatment or saline sham injection. The study has two parts. Part I (N=29), now complete, randomized patients 2:1 to either 1-3 doses of INT230-6 injected weekly or no treatment, 2 to 5 weeks prior to surgery (lumpectomy or mastectomy). The purpose of this portion of the trial was to evaluate safety, feasibility, and optimal drug dosing. Part II is a double-blind, randomized arm of up to 60 patients, where patients will be randomized 2:1 to receive one or two IT doses of INT230-6 vs. saline injection. The objective of using saline will be to rule out the potential confounding effect of hydrostatic pressure on tumor necrosis. The results of Part II will further evaluate the potential cytotoxic, immunomodulatory and other biologic effects of INT230-6 and its role as a potential cancer therapy in breast cancer patients awaiting surgery. The INVINCIBLE Study is being conducted under a Health Canada (HC) approved Clinical Trial Application (CTA), under the direction and supervision of Principal Investigator, Dr. Angel Arnaout. OHRI will conduct subject enrollment and treatment, and evaluate clinical responses. OICR will analyze subject immune responses and conduct biomarker analyses.

About Potential INT230-6 Approval Pathways in the Presurgical Setting
The U.S Food and Drug Administration (FDA) instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. Pathological complete response (pCR) is an accepted FDA accelerated approval criterion for approval in high risk breast cancer, such as TNBC subtype. pCR is defined as the absence of residual invasive and in situ cancer after evaluation of the complete resected breast specimen and lymph nodes following completion of neoadjuvant systemic therapy.

Data from the INVINCIBLE study will provide an understanding of the effect of INT230-6 on cancer cell proliferation and tumor necrosis. If INT230-6 causes increased tumor necrosis with good safety, then the addition of INT230-6 to the existing or a modified neoadjuvant (presurgical) systemic standard-of-care treatment regimen may increase pCR rates in TNBC. In November of 2020, Intensity Therapeutics met with FDA and discussed the potential use of INT230-6 in the presurgical neoadjuvant breast cancer setting in an accelerated approval program.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile and the induction of an anti-cancer systemic immune response resulting in shrinkage of uninjected tumors.

On June 6, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported that, following consultation with the U.S. Food and Drug Administration (FDA), it will start a registrational Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, JUN 6, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-start-phase-3-trial-relacorilant-plus-nab [SID1234615612]). The company also announced that the positive results from its 178-patient, randomized, controlled, Phase 2 study will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting today.

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"We are excited to launch our pivotal Phase 3 trial, which we have named ROSELLA," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "Simply replicating the positive results of our Phase 2 study – improvements in progression free survival, duration of response and overall survival without increased side effect burden – will be of unprecedented benefit to women with advanced ovarian cancer, for whom relacorilant plus nab-paclitaxel has the potential to become a new standard of care."

"The ROSELLA trial design closely tracks the design of our successful Phase 2 study, with adjustments that emerged from constructive conversations with the FDA and leading clinicians from the Gynecological Oncology Group. Based on these conversations, we are confident that positive results in ROSELLA will support a new drug application."

ROSELLA has a planned enrollment of 360 women, randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy. The primary endpoint will be progression free survival, with overall survival as a key secondary endpoint.

All patients will have received prior bevacizumab therapy, which is the current standard of care in the United States for patients with platinum-resistant ovarian cancer. Almost two-thirds of the women enrolled in Corcept’s Phase 2 trial met this criterion. Women with a history of tumors that do not respond at all to initial platinum-based treatments (i.e., women with "primary platinum-refractory" disease) and those who have received more than three prior lines of therapy – both indicators of a very poor prognosis – will be excluded.

Corcept plans to start ROSELLA by the end of this month.

In Corcept’s Phase 2 trial, women who met the entry criteria for ROSELLA and received relacorilant exhibited substantial benefit, without increasing the frequency or severity of adverse events. Results for patients who received relacorilant at the time they received nab-paclitaxel – the "intermittent" dosing regimen that will be used in ROSELLA – are set forth in Table 1.

Phase 2 Trial Results (ROSELLA Patient Population)
Relacorilant +
Nab-paclitaxel
n=25 Comparator
n=31 Hazard Ratio
(95% CI)
Progression-Free Survival
(median) 7.3 months 3.7 months 0.40 (0.21, 0.77); p = 0.005
Duration of Response
(median) 5.6 months 3.1 months 0.29 (0.09, 0.99); p = 0.016
Overall Survival
(median) 17.9 months 12.6 months 0.38 (0.17, 0.82); p = 0.011
Table 1: Results for women in the intermittent and comparator arms of the Phase 2 trial who met the ROSELLA entry criteria.

The Kaplan-Meyer curve showing the survival benefit experienced by women in the Phase 2 trial’s intermittent arm and who met the ROSELLA entry criteria is set forth in Figure 1.

Figure 1

ASCO Oral Presentation

Results from the company’s Phase 2 study in patients with recurrent, platinum-resistant ovarian cancer will be featured in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting today. Presentation slides are available at www.corcept.com/research-pipeline/publications.

Presentation Title: "Overall survival data from a 3-arm, randomized, open-label, phase 2 study of relacorilant, a selective glucocorticoid receptor modulator, combined with nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer."

Speaker: Dr. Nicoletta Colombo; University of Milan-Bicocca and European Institute of Oncology, IRCCS

Presentation Time / Location: Monday, June 6, 2022, 9:00 AM – 9:12 AM CDT / E450

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women.1 Patients whose disease returns less than six months after receiving platinum-containing therapy are described as having "platinum-resistant" disease. In the United States, approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year.2 There are few treatment options and median overall survival following recurrence of disease is 12 months or less with single-agent chemotherapy.3 No approved therapy has been shown to significantly extend overall survival in patients with recurrent, platinum-resistant ovarian cancer compared to standard chemotherapy.4

About Corcept’s Oncology Programs

There is substantial evidence that cortisol activity at the glucocorticoid receptor ("GR") reduces the efficacy of certain anti-cancer therapies and that modulating cortisol’s activity may help anti-cancer treatments achieve their intended effect.

Many types of solid tumors express the GR and are potential targets for cortisol modulation therapy. In some cancers, cortisol inhibits cellular apoptosis – the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response; activating – not suppressing – the immune system is beneficial in fighting certain cancers.

Corcept is conducting clinical trials of its proprietary selective cortisol modulators in combination with three different anti-cancer treatments in patients with ovarian, adrenal and prostate cancers. Corcept’s first controlled study in oncology – relacorilant plus nab-paclitaxel for the treatment of patients with ovarian cancer – has demonstrated statistically significant and clinically meaningful results.

About Relacorilant

Relacorilant is a non-steroidal, selective glucocorticoid receptor modulator that does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian and adrenal cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents, as well as orphan drug designation in the United States for the treatment of pancreatic cancer and both the United States and the European Union for the treatment of Cushing’s syndrome.

On June 6, 2022 2seventy bio, Inc. (Nasdaq: TSVT) reported that it will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference in Rancho Palos Verdes, CA on Tuesday, June 14, 2022 at 3:20pm PT (Press release, 2seventy bio, JUN 6, 2022, View Source [SID1234615629]).

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A live webcast will be available via the Investors and Media section of 2seventy bio’s website at View Source A replay will be archived on 2seventy bio’s site for 30 days following the event.

On June 6, 2022 Vizgen, the life science company dedicated to improving human health by visualizing single-cell spatial genomics information, reported an expansion of its product roadmap and the availability of the Formalin-Fixed Paraffin-Embedded (FFPE) Human Immuno-oncology data release (Press release, Vizgen, JUN 6, 2022, View Source [SID1234615646]). Vizgen’s product updates will expand sample input flexibility, propel new applications, and empower greater data insights. These updates demonstrate the company’s continued commitment to exposing the research community to the power of spatial genomics. The updates will be presented as oral and poster presentations at the Advances in Genome Biology and Technology (AGBT) 2022 General Meeting, occurring June 6-9, 2022.

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Product roadmap updates for 2H 2022:

Formalin-Fixed Paraffin-Embedded Sample Preparation Solution enabling MERFISH measurements on FFPE tissue samples.
Protein Co-detection Kit for the simultaneous detection of RNA and proteins during a standard MERFISH experiment, enabling multi-omics measurements.
1,000 Plex Gene Panels for the detection of up to 1,000 gene targets within a single MERFISH experiment, resulting in higher gene target coverage which is crucial when performing initial discovery experiments.
The new publicly available FFPE Human Immuno-oncology dataset, generated with Vizgen’s MERSCOPE platform, represents the largest public data set for single-cell spatial genomics ever released. This data was generated using Vizgen’s forthcoming FFPE Sample Preparation Kit. The dataset contains 16 total datasets from 8 FFPE tumor tissue types including breast, colon, lung, liver, skin, prostate, uterine and ovarian, each measuring 500 genes totaling over 4 billion transcripts and 9 million cells cumulatively. The dataset is freely available to participants in the company’s Data Release Program to use in any way and can be downloaded at View Source

"We announced MERSCOPE, the industry’s first solution to combine single-cell and spatial transcriptomics in one turnkey system, and the only commercial platform solution for MERFISH technology, last year at AGBT. Customer adoption from academic research institutions and pharmaceutical companies has been tremendous and our platform continues to lead spatial genomics innovation in the industry," said Terry Lo, President and CEO of Vizgen. "With this first of its kind data release, the research community now has access to an unprecedented scale and quality of single-cell spatial genomics data from cancer samples. As we look to establish new standards in the field, we are excited about our upcoming roadmap of new capabilities that further our mission to improve human health."

For additional information about Vizgen’s Human FFPE Immuno-oncology Data Release, visit: View Source