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

On June 6, 2022 The US Oncology Network (The Network), US Oncology Research and Ontada reported that Results from the second phase of the broad, collaborative MYLUNG ConsortiumTM research study in non-small cell lung cancer (NSCLC) were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, US Oncology, JUN 6, 2022, View Source [SID1234615662]). The findings show that the incorporation of a remote oncology pharmacist in clinical research teams significantly enhanced patient enrollment for Protocol 2 of the MYLUNG Consortium.

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"Advances in science are quickly enabling new treatment opportunities, but timely enrollment into clinical trials continues to be a challenge," said Elizabeth Koselke, PharmD, senior clinical pharmacist for The Network. "Our study showed that by incorporating an oncology-trained clinical pharmacist to remotely review chemotherapy regimens and a customized recruitment report, we were able to more efficiently screen patients and significantly enhance Protocol 2 enrollment."

Koselke presented the findings during an oral presentation at ASCO (Free ASCO Whitepaper) titled, "Impact of oncology clinical pharmacist intervention on clinical trial enrollment in The US Oncology Network ’s MYLUNG Consortium."

In the study, oncology-trained clinical pharmacists reviewed over an eight-month period 506 newly diagnosed and untreated NSCLC patients from six practices in The Network. Working remotely, the pharmacist reviewed chemotherapy regimen orders and identified, screened and assisted with recruitment of eligible patients for enrollment in MYLUNG Consortium Protocol 2. Working remotely enabled the pharmacists to identify patients quickly across the country who were potential candidates for the study. Enrollments and intervention data were then tracked to monitor the impact of the pharmacist intervention. The study showed that average monthly enrollment was significantly greater after pharmacist intervention (6.6 patients a month per practice) when compared to monthly enrollment before pharmacist intervention (3.4 patients a month per practice).

"These data show that using an interdisciplinary approach to trial enrollment can be an effective method to increase speed and efficiency in real-world clinical research," noted Robert L. Coleman, MD, FACOG, FACS, chief scientific officer of US Oncology Research and the MYLUNG Consortium Principal Investigator. "As we move into Protocol 3 of the MYLUNG Consortium study, we look forward to continuing to validate pharmacist intervention across a wider spectrum of practices across The Network."

An additional study at ASCO (Free ASCO Whitepaper) 2022 took a further look at the MYLUNG Consortium Protocol 1 results that were first presented at ASCO (Free ASCO Whitepaper) 2021. These initial findings reported that fewer than 50 percent of metastatic non-small cell lung cancer patients had the recommended biomarker tests.

In a poster presentation titled, "Predictors of biomarker testing among patients (pts) with metastatic non-small cell lung cancer (mNSCLC)," MYLUNG Consortium researchers examined the social and economic factors associated with biomarker undertesting. The research found that lower comprehensive biomarker testing rates were associated with patients who were of the African American race, seen in a smaller practice size or in a practice in the southern part of the United States, or had squamous cell histology.

"This retrospective analysis took the previously reported research from Protocol 1 and further examined the patient factors that are associated with a lack of biomarker testing," said Dr. Nicholas Robert, chief medical officer of Ontada. "Understanding these clinical and social determinants of health will be important interventions to improve testing rates as we enter into the prospective phases of the MYLUNG Consortium study."

The MYLUNG Consortium is a collaborative and innovative research study comprised of three protocols over a five-year period, enabled through a unique collaboration of various organizations and stakeholders working together across the spectrum of NSCLC drug development, therapy and care. The number of consortium participants continues to grow, all bringing unique perspectives to this innovative study. The MYLUNG Consortium brings together providers and researchers in The Network, US Oncology Research and Ontada with life sciences companies Amgen, AstraZeneca, Eli Lilly and Company, Genentech (a member of the Roche Group), and Mirati Therapeutics, Inc. Patient advocacy groups LUNGevity and GO2 Foundation for Lung Cancer are also participating, playing a key role in the study by keeping the focus on patients. Participating practices in The Network include Illinois Cancer Specialists, Maryland Oncology Hematology, Minnesota Oncology, New York Oncology Hematology, Oncology Hematology Care, Rocky Mountain Cancer Centers, Texas Oncology, Southern Cancer Center, Virginia Cancer Specialists, Virginia Oncology Associates, Willamette Valley Cancer Institute and Research Center and Woodlands Medical Specialists.

Read more about the MYLUNG Consortium here. To schedule a media interview with one of the study investigators, contact Claire Crye at [email protected].

On June 6, 2022 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vectored immunotherapies, reported first data from the completed Phase 1 trial evaluating NOUS-209 in combination with anti-PD-1 checkpoint inhibitor (pembrolizumab) (Press release, NousCom, JUN 6, 2022, View Source [SID1234615678]). The data, presented yesterday in a poster discussion session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrated NOUS-209 to be safe, highly immunogenic and with promising signs of clinical efficacy.

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NOUS-209, Nouscom’s lead product, is an off-the-shelf cancer vaccine targeting 209 shared neoantigens. It has been investigated in a Phase 1 clinical trial, administered in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, for the treatment of deficiency in Mismatch Repair/Microsatellite Instable High (dMMR/MSI-H) unresectable or metastatic gastric, colorectal and gastro-esophageal junction tumors.

The key findings from the study are as follows:

NOUS-209 continues to be safe and well tolerated
NOUS-209 immunogenicity was demonstrated by ex-vivo IFN-ɣ ELISpot assay in 83% of evaluable patients; vaccine induced immune responses were potent and broad
Early signs of clinical efficacy with 10 durable confirmed partial responses (PR), 4 durable stable disease (SD) and 6 progressive disease (PD)
Previously presented interim clinical and translational data of the combination indicated that neoantigen-specific CD8+ T cells expand and diversify only upon treatment with NOUS-209, and successfully infiltrate the tumor microenvironment to exert anti-tumor activity (presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)1 in April 2022).

Professor Marwan G. Fakih, M.D., Medical Oncology Specialist at City of Hope’s Duarte California, and Study investigator said: "With clinical and translational data now available from all patients enrolled in this trial, it is encouraging to see NOUS-209 continuing to be safe, highly immunogenic and have signs of clinical efficacy. Durability of response in all PR and SD patients is particularly encouraging and provides hope for this patient group where there is still a significant unmet need. I look forward to seeing further clinical development of this compound in MSI-H patients."

Dr. Marina Udier, Chief Executive Officer of Nouscom, said: "These new data with all patients enrolled continues to reinforce our compelling and differentiating data for NOUS-209. This is a significant step for the company, validating the potency of our platform in inducing neoantigen specific CD8+ T cells, which are also able to successfully infiltrate tumors of metastatic cancer patients, exerting anti-tumor efficacy. We are actively working on the next stages of NOUS-209’s clinical development plan and look forward to announcing the start of the Phase 2 study in the second half of 2022."

Poster Presentation Details:

Title: First clinical and immunogenicity results including all subjects enrolled in a phase I study of NOUS-209, an off-the-shelf immunotherapy, with pembrolizumab, for the treatment of tumors with a deficiency in mismatch repair/microsatellite instability (dMMR)
The abstract is available here

References

AACR Presentation: Characterization of immune correlates of clinical activity for NOUS-209, an Off-the-Shelf immunotherapy, with Pembrolizumab for treatment of tumors characterized by Microsatellite Instability (MSI), Professor Marwan G. Fakih, M.D.
About NOUS-209

NOUS-209 is an off-the-shelf immunotherapy for Microsatellite Instable High (MSI-H) tumors. MSI-H tumors are characterized by a defective DNA mismatch repair system, which generates highly immunogenic frame shift peptides (frameshift mutations, FSPs) that are not found on healthy tissue.

NOUS-209 is designed to comprise 209 shared FSP neoantigens, selected by Nouscom’s proprietary GENESIS (GE(netic)NE(oantigen)S(election)I(n)S(ilico)) algorithm, on the basis that an average of 50 neoantigens on any patient’s tumor will be shared with those in NOUS-209. Nouscom’s heterologous prime/boost platform clones these FSPs into Great Ape Adenoviral (GAd) and Modified Vaccinia Ankara (MVA) vectors, to generate the viral-vectored vaccine, combined with other immunomodulators to harness the full power of the immune response by generating neoantigen specific CD8+ T cells, which successfully infiltrate tumor to exert anti-tumor activity.

NOUS-209 is in Phase 1 clinical trial (NCT04041310), a multicenter, open label, multiple cohorts, first-in-human clinical study of NOUS-209 in combination with pembrolizumab, designed to evaluate safety, tolerability and immunogenicity and to detect preliminary evidence of anti-tumor activity.