On March 30, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial stage company engaged in the discovery, development and sale of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the hormone cortisol, reported overall survival ("OS") data from its 178-patient, randomized, controlled, Phase 2 study of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, MAR 30, 2022, https://ir.corcept.com/news-releases/news-release-details/relacorilant-plus-nab-paclitaxel-extends-survival-women [SID1234611193]).

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Women treated with relacorilant the day before, the day of and the day after their regular nab-paclitaxel infusions (the trial’s "intermittent" arm) experienced a 33% reduction in risk of death compared to women treated with nab-paclitaxel alone (hazard ratio: 0.67; p-value: 0.066). Their median OS was 13.9 months, compared to 12.2 months for women receiving nab-paclitaxel monotherapy. (See Figure 1)

Corcept Therapeutics Incorporated

The women who enrolled in this trial were very sick and had experienced disease progression following prior therapy (median number of prior therapies: three). By chance, more women with either primary platinum-refractory disease or who had already received four or more prior lines of therapy, both indicators of a very poor prognosis, were assigned to the intermittent arm. As is typical of late-stage clinical trials, such women will not be enrolled in Corcept’s upcoming Phase 3 trial.

Excluding primary platinum-refractory patients and women who had already received four or more prior lines of therapy, women treated with relacorilant intermittently experienced a 48% reduced risk of death compared to women treated with nab-paclitaxel alone (hazard ratio: 0.52; p-value: 0.010). Their median OS was 13.9 months, compared to 12.2 months for women receiving nab-paclitaxel monotherapy. (See Figure 2)

Corcept Therapeutics Incorporated

"Corcept has introduced a novel oncologic therapeutic platform, cortisol modulation. These results constitute a potentially important medical advance," said Thomas Herzog, MD, Deputy Director at the University of Cincinnati Cancer Center, member of the Board of Directors of the Gynecologic Oncology Group (GOG) Foundation and Associate Director of GOG Partners. "In this large, randomized study, women with recurrent, platinum-resistant ovarian cancer who were administered relacorilant at the time they received nab-paclitaxel exhibited meaningful improvements in progression free survival, duration of response and overall survival – without increased side effects – compared to women who received nab-paclitaxel alone. For this patient population, relacorilant plus nab-paclitaxel has the potential to become a new standard of care."

"We are excited to receive these survival data, which have continued to improve as the trial has progressed," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "If our Phase 3 trial replicates the results in progression free survival, duration of response and overall survival that we’ve seen in Phase 2, it will be an unprecedented success for patients with ovarian cancer. No approved therapy has been shown to significantly extend survival compared to standard chemotherapy in women with platinum-resistant ovarian cancer. We plan to meet with the FDA as soon as possible to define the best path forward and to open our Phase 3 trial in the second quarter of 2022."

On March 31, 2022, Corcept will host an event for investors and analysts regarding its ovarian cancer program. Click here to register. In addition, the company plans to present these results at a major oncology conference in 2022.

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 Ovarian Cancer Program

The data in this release come from Corcept’s 178-patient, randomized, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer.5 The women who entered the trial had experienced disease progression on prior lines of therapy. The median number of prior treatments was three.

Study participants were randomized 1:1:1 to receive either (i) nab-paclitaxel plus 150 mg of relacorilant given the day before, the day of, and the day after each weekly nab-paclitaxel infusion ("intermittent" arm), (ii) nab-paclitaxel plus 100 mg relacorilant given daily ("continuous" arm) or (iii) nab-paclitaxel alone ("comparator" arm).

OS was assessed after a pre-determined number of patient deaths had occurred. At the time of database cutoff, 128 of the 178 women who enrolled in the study had died. Fourteen additional women in the intermittent arm and nine additional women in the comparator arm are expected to contribute to the final overall survival results. One woman in the intermittent arm and one in the continuous arm have yet to experience tumor progression – for both patients it has been over twenty months since they initiated therapy with relacorilant.

Relative to women in the comparator arm, women in the intermittent arm experienced significantly improved progression free survival (PFS) (median PFS: 5.6 months versus 3.8 months; hazard ratio: 0.66; p-value: 0.038) and duration of response (DoR) (median DoR: 5.6 months versus 3.7 months, hazard ratio: 0.36; p-value: 0.006). They also lived longer (median OS: 13.9 months versus 12.2 months, hazard ratio: 0.67; p-value: 0.066). Safety and tolerability of relacorilant plus nab-paclitaxel was comparable to nab-paclitaxel monotherapy. (See Table 1)

Phase 2 Trial Results – Intermittent and Comparator Arms (All Patients)
Intermittent Comparator Intermittent vs Comparator
Median PFS* (95% CI) 5.6 months 3.8 months Hazard Ratio: 0.66 (0.44, 0.98)
p-value: 0.038
Median DoR* (95% CI) 5.6 months 3.7 months Hazard Ratio: 0.36 (0.16, 0.77)
p-value: 0.006
Median OS* (95% CI) 13.9 months 12.2 months Hazard Ratio: 0.67 (0.43, 1.03)
p-value: 0.066
Table 1: Summary of results of intermittent and comparator arms – all patients.
*PFS: progression free survival; OS: overall survival; DoR: duration of response.

Excluding women with primary platinum-refractory disease and patients who had received four or more prior lines of treatment, women in the intermittent arm experienced significantly improved PFS (median PFS: 5.6 months versus 3.8 months, hazard ratio: 0.58; p-value: 0.016) and OS relative to women in the comparator arm (median OS: 13.9 months versus 12.2 months, hazard ratio: 0.52; p-value: 0.010). The women in the intermittent arm also experienced a significant improvement in DoR relative to those in the comparator arm (median DoR: 5.6 months versus 3.6 months, hazard ratio: 0.26; p-value: 0.001). Safety and tolerability of relacorilant plus nab-paclitaxel was comparable to nab-paclitaxel monotherapy. (See Table 2)

Phase 2 Trial Results – Intermittent and Comparator Arms (Planned Phase 3 Patient Population)
Intermittent Comparator Intermittent vs Comparator
Median PFS* (95% CI) 5.6 months 3.8 months Hazard Ratio: 0.58 (0.37, 0.91)
p-value: 0.016
Median DoR* (95% CI) 5.6 months 3.6 months Hazard Ratio: 0.26 (0.11, 0.62)
p-value: 0.001
Median OS* (95% CI) 13.9 months 12.2 months Hazard Ratio: 0.52 (0.31, 0.86)
p-value: 0.010
Table 2: Summary of results of intermittent and comparator arms – excluding patients with primary platinum-refractory disease and patients who had received four or more prior lines of treatment.
*PFS: progression free survival; OS: overall survival; DoR: duration of response.

About Corcept’s Oncology Programs

There is substantial evidence that cortisol activity at the glucocorticoid receptor ("GR") allows certain solid tumors to resist treatment 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 March 30, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that financial results for the fourth quarter and year ended December 31, 2021 (Press release, Crinetics Pharmaceuticals, MAR 30, 2022, View Source [SID1234611191]).

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"We are excited to have started 2022 with the momentum that we generated in 2021 across all facets of the company," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "Last year was transformative for Crinetics as the company achieved multiple key milestones in our discovery and clinical programs, raised significant additional capital, and continued to add world-class talent to the company from the bench to the board. Since inception, we have had a strategy of investing in innovative drug discovery programs to build a diverse endocrine pipeline. We advance this pipeline by following a uniquely efficient development paradigm that leverages endocrine biomarkers from preclinical experiments through patient studies. I am proud of how this strategy came together over the past year to move us significantly closer to our vision of building the world’s leading endocrine company."

FULL YEAR 2021 AND RECENT HIGHLIGHTS
Reported positive proof-of-concept data from two Phase 1 programs of CRN04777 and CRN04894. In September 2021 and via a separate press release issued today, Crinetics announced positive data from a Phase 1 single- and multiple-ascending dose (MAD) study of CRN04777, a somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital and syndromic hyperinsulinisms. The results supported clinical proof-of-concept, showing strong dose-dependent suppression of fasting insulin as well as dose-dependent suppression of glucose- and sulfonylurea-induced insulin secretion. In August 2021, Crinetics announced positive preliminary data from the single ascending dose (SAD) cohorts of an ongoing Phase 1 study of CRN04894, its adrenocorticotropic hormone (ACTH) antagonist being developed for the treatment of conditions of ACTH excess, including Cushing’s disease and congenital adrenal hyperplasia. The data supported clinical proof-of-concept by providing evidence of clinically relevant cortisol suppression as well as showing dose-dependent reductions in basal cortisol levels and suppression of cortisol following ACTH challenge. The data from the Phase 1 studies for CRN04777 and CRN04894 suggested that the molecules are both orally bioavailable and support once daily dosing schedules. Preliminary data from the MAD cohorts of the CRN04894 Phase 1 study
Initiated Phase 3 PATHFNDR program evaluating paltusotine in acromegaly. In the second quarter of 2021, Crinetics initiated its Phase 3 PATHFNDR program, which consists of two Phase 3 trials assessing the safety and efficacy of once-daily oral paltusotine. Together these trials are designed to evaluate paltusotine in a wide cross section of acromegaly patients. If successful, Crinetics believes these trials could support registration of paltusotine for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from standard of care. Topline data from both of these trials (PATHFNDR-1 and PATHFNDR-2) are expected to be available in 2023.
Entered into strategic licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. ("Sanwa") for the development and commercialization of paltusotine in Japan. Per the agreement, Crinetics received $13 million upfront and is eligible to receive development, regulatory, and commercial milestones. In addition, Crinetics will be eligible to receive tiered royalties on net product sales should paltusotine receive marketing approval in Japan. In exchange, Sanwa was granted an exclusive right to develop and commercialize paltusotine in Japan and will assume all costs associated with clinical trials and regulatory applications in the territory. Crinetics retains all rights to develop and commercialize paltusotine outside of Japan.
Co-founded Radionetics Oncology. In October 2021, Crinetics, together with 5AM Ventures and Frazier Healthcare Partners, founded Radionetics Oncology, Inc., an independently operated company that aims to develop a deep pipeline of novel, targeted, nonpeptide radiopharmaceuticals for the treatment of a broad range of oncology indications. In conjunction with formation of the company, Radionetics received an exclusive world-wide license to Crinetics’ radiotherapeutics technology platform and associated intellectual property in exchange for equity, milestones in excess of $1 billion, and single-digit royalties on net sales. Radionetics launched with $30 million from a private financing with 5AM Ventures and Frazier Healthcare Partners as the sole investors.
Announced data from an open-label extension trial of paltusotine in acromegaly. Results showed that oral paltusotine maintained serum IGF-1 at levels previously achieved with injected somatostatin receptor ligands for up to 51 weeks. The results were featured in a poster presentation at the Society for Endocrinology BES congress, which can be found here.
Unveiled a parathyroid hormone receptor antagonist program. In September 2021, Crinetics announced its intent to develop a nonpeptide oral parathyroid hormone (PTH) receptor antagonist for the treatment of hypercalcemia associated with hyperparathyroidism (HPT) and other diseases of PTH receptor type 1 (PTHR1) over-activation. Crinetics is in the late stages of selecting a lead candidate from this family of compounds and anticipates initiation of IND-enabling studies in 2022. If successful, PTHR1 antagonists could represent a viable treatment option to improve the outcomes and experience of patients with primary hyperparathyroidism. Details on the preclinical efforts supporting the program were presented in a late-breaking poster at the annual meeting of the American Society for Bone and Mineral Research (ASBMR). More information on the program and a copy of the poster can be found here.
Strengthened balance sheet with successful common stock offerings. In April 2021, Crinetics completed an underwritten follow-on offering of 4,562,044 shares of its common stock at a price to the public of $16.44 per share, raising gross proceeds of approximately $75.0 million. In July 2021, Crinetics entered into a securities purchase agreement with Frazier Healthcare Partners for the private placement of 851,306 shares at $17.62 per share, raising gross proceeds of $15.0 million. In October 2021, Crinetics completed an underwritten public offering of 8,712,400 shares of its common stock at a price to the public of $19.80 per share, raising gross proceeds of approximately $172.5 million.
Strengthened company leadership with appointments to management team and Board of Directors. Throughout 2021 and in early 2022, Crinetics built upon its strong leadership and scientific expertise by appointing Garlan Adams to the role of general counsel, Jeff Knight to the role of chief operating officer, James Hassard to the role of chief commercial officer, Christopher Robillard to the role of chief business officer, and Dr. Rogério Vivaldi Coelho and Caren Deardorf to the Board of Directors.

FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS
Research and development expenses were $24.6 million and $84.3 million for the three months and full year ended December 31, 2021, respectively, compared to $16.8 million and $57.0 million for the same periods in 2020. The increases were primarily attributable to increased spending on manufacturing and development activities associated with our clinical and nonclinical activities for paltusotine, CRN04777, CRN04894, and our other preclinical research programs.
General and administrative expenses were $7.4 million and $24.5 million for the three months and full year ended December 31, 2021, respectively, compared to $5.0 million and $18.0 million for the same periods in 2020. The increases were primarily due to personnel-related costs.
Net loss for the three months ended December 31, 2021, was $30.8 million, compared to a net loss of $21.6 million for the same period in 2020. For the year ended December 31, 2021, the company’s net loss was $107.6 million compared to a net loss of $73.8 million for the year ended December 31, 2020.
Unrestricted cash, cash equivalents and investments totaled $333.7 million as of December 31, 2021, compared to $193.3 million as of September 30, 2021, and $170.9 million as of December 31, 2020.
Revenues were $1.1 million for the three months and full year ended December 31, 2021, consisting of non-cash upfront consideration recognized upon the transfer of intellectual property from Crinetics to Radionetics Oncology.
The company had 47,784,611 common shares outstanding as of March 25, 2022.

WEBCAST AND CONFERENCE CALL ON CRN04777 MULTIPLE-ASCENDING DOSE DATA
Crinetics will hold a conference call and live audio webcast today, March 30, 2022, at 4:30 p.m. Eastern Time to discuss results from the multiple-ascending dose cohorts of the Phase 1 trial of CRN04777. These results were announced in a separate press release issued earlier today, which is available on the company’s website. To participate, please dial 1-877-407-0789 (domestic) or 1-201-689-8562 (international) and refer to conference ID 13727857. To access the webcast, click here. Following the live event, a replay will be available on the Events page of the Company’s website.

On March 30, 2022 Acacia Pharma Group plc ("Acacia Pharma" or the "Company") (EURONEXT: ACPH), reported that it will not publish its results for the full year to end December 2021 on 31 March 2022 as originally scheduled (Press release, Acacia Pharma, MAR 30, 2022, View Source [SID1234611190]).

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This comes as a result of the changes in regulatory requirements following Brexit. The Company is required under Belgian law to have its accounts audited by either an EU audit firm or a third country audit firm registered in Belgium. Following Brexit, the Company’s statutory auditor PwC UK ceased to be an EU audit firm on 30 June 2021.

The Company has been informed that there is currently no legal mechanism for PwC UK to register as a third country audit firm in Belgium; the Company is therefore required to also have its accounts audited by PwC Belgium. A new date for the publication of its results will be set and these will be released before the end of April 2022 as required under the applicable rules.

On March 30, 2022 BioVaxys Technology Corp. (CSE:BIOV, FRA:5LB, OTCQB:BVAXF) ("BioVaxys" or "Company"), reported the expansion of its cancer vaccine platform with BVX-0922, its autologous haptenized tumor vaccine for colorectal cancer ("CRC") (Press release, BioVaxys Technology, MAR 30, 2022, View Source [SID1234611189]). BioVaxys plans to advance an Investigator-Sponsored Clinical Trial Application ("CTA") in the EU with the European Medicines Agency ("EMEA") this year for BVX-0922. An Investigator Sponsored CTA is submitted to regulatory authorities by a clinical investigator who both initiates and conducts an initial clinical study of a new drug or procedure, and under whose immediate direction the investigational drug is administered.

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CRC is the third most common malignancy and the second most deadly cancer world-wide, with an estimated 1.9 million new CRC cases diagnosed and 0.9 million deaths globally in 2020. The incidence of CRC is higher in highly developed countries, with global new CRC cases predicted to reach 3.2 million in 2040. When diagnosed early, the five-year relative survival rate for stage I and stage II colon cancer is 90%; however, CRC patients often experience no signs or symptoms associated with the disease. The 5-year survival rate for patients diagnosed at Stage IV is only 14% (Journal of Translational Oncology, Global Colorectal Cancer Burden in 2020 And Projections to 2040, Vol 14, Issue 10, October 2021).

A major benefit of the Company’s autologous haptenized tumor vaccine technology platform is the rapid scalability into a range of tumor types, especially those where the standard of care for these cancer patients typically involves surgical excision of tumor tissue. Access to these tumor cells is necessary for BioVaxys to manufacture autologous haptenized tumor cell vaccines, such as BVX-0918 for late-stage ovarian cancer or BVX-0922 for CRC.

The BioVaxys vaccine platform is based on the established immunological concept that modifying surface proteins—whether they are viral or tumor—with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys’ cancer vaccines are created by extracting a patient’s own (i.e., autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic.

Haptenization is a well-known and well-studied immunotherapeutic approach in cancer treatment, and has been evaluated in both regional and disseminated metastatic tumors. BioVaxys has a significant advantage over many other companies looking at cancer therapies in that it already has extensive promising clinical data for its cancer vaccines.

First-generation single-hapten vaccines invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in his previous FDA-approved Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study.

For example, two studies of patients with metastatic melanoma were completed and published. The first trial tested the activity of the autologous, DNP-modified vaccine in 83 evaluable patients with incurable, metastatic melanoma (Berd et al, Int J Cancer 2001; 94: 531-539). Following vaccine administration there were 11 responses—2 complete, 4 partial, and 5 mixed; 2 patients were judged to have stable disease. Both complete responses and two of the four partial responses occurred in patients with lung metastases. Response durations were as follows: partial responses— 5, 6, 8, and 47+ months; complete responses—12, 29 months. In a second trial 214 patients with advanced stage III melanoma (lymph node metastases) underwent excision of large lymph node masses and then were administered the haptenized vaccine. With a median follow-up time of 5.1 years the 5-year overall survival rate was 46%, which is considerably higher than survival times reported with surgery alone (Berd et al, J. Clin. Oncology, 1997, 15:2359)

A first generation autologous, haptenized vaccine was also tested in two clinical trials conducted by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. In the first trial 13 evaluable patients with bulky, chemotherapy-refractory disease were treated. The patients exhibited complete regression of a residual peritoneal mass by computed tomography (CT) and a concomitant fall in serum CA-125 (an ovarian cancer serum marker) from 65 to 6. Both the CT and CA-125 responses were maintained for 6 months.

In a second study (Taha et al, Gynecol Oncol 2014; 134, Abstract 25: 428-437), 26 subjects with recurrent platinum resistant ovarian cancer were enrolled. Vaccine was prepared for, but not administered to, 25 additional subjects. In six vaccinated subjects, CA125 levels became normal following surgery plus vaccine and remained normal throughout the 9-month duration of the protocol. Median overall survival by Kaplan–Meier method after surgery in the vaccinated group was 25.4 months compared to 6.5 months in the vaccine prepared but not administered group.

Finally, preliminary studies of a first generation, autologous, single-hapten vaccine have been performed in kidney cancer, non-small cell lung cancer, breast cancer, and acute myelogenous leukemia. The results indicated that preparation and administration of vaccine was feasible.

BioVaxys has enhanced the first-generation approach in these previous studies of using a single-hapten to now utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results. The global colorectal cancer therapeutics market is projected to reach $16.5 billion by 2026 (fortunebusinessinsights.com).

On March 30, 2022 Nextera AS, a drug and target discovery company built on the unique and novel NextCore protein engineering and discovery platform, reported a strategic collaboration with Zelluna Immunotherapy AS on optimizing T cell receptors (TCRs) for subsequent implementation into the "off-the-shelf" TCR based Natural Killer (TCR-NK) cell approach of Zelluna Immunotherapy AS for the treatment of cancer (Press release, Nextera, MAR 30, 2022, View Source [SID1234611188]).

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Nextera’s aim is to engage into strategic commercial partnerships focused on the huge unmet medical demand in autoimmunity and immuno-oncology by leveraging its NextCore platform. This partnership represents the first collaboration on engineering TCRs, which will complement the company’s focus on TCR-Like antibodies and HLA peptidome target deconvolution.

TCR-NK products are a novel and proprietary class of allogeneic cellular therapies that combine the inherent pan cancer killing mechanism, efficiency, and the allogeneic nature of NK cells with the targeting capabilities of TCRs. Arming NK cells with TCRs may unlock the potential to treat a wide range of currently untreatable cancers.

"We are delighted to engage into this collaboration with Zelluna, which is pioneering the TCR-NK field with its innovative and proprietary allogenic "off-the-shelf" approach. Engineered TCR therapy has very recently entered the mature clinical pipeline and further expansion of this field has the outlook to make a transformational difference for patients across multiple cancer indications. Our differentiated NextCore platform is uniquely well situated to harness the new generation of TCR targeting modules in these approaches to maximize efficacy and safety" said Dr. Geir Åge Løset, co-founder and CEO/CSO of Nextera.