On January 30, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the stress hormone cortisol, reported preliminary fourth quarter revenue of $87.9 million, compared to $66.8 million in the fourth quarter of 2018 (Press release, Corcept Therapeutics, JAN 30, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2019 [SID1234553696]). Preliminary 2019 revenue was $306.5 million, an increase of 22 percent from 2018.

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Cash and investments increased by $48.4 million in the fourth quarter, to $315.3 million.

These results are prior to completion of the company’s annual independent audit and are subject to adjustment.

Corcept projects 2020 revenue of $355 – 375 million.

"Our Cushing’s syndrome business had an excellent year," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "As awareness of the poor health outcomes associated with hypercortisolism increased and physicians screened more patients for Cushing’s syndrome, the number of patients receiving Korlym grew. We expect that growth to continue."

"Korlym’s commercial success has given us the resources to develop our proprietary selective cortisol modulators in a wide range of serious disorders," added Dr. Belanoff. "These compounds represent Corcept’s future. We look forward to an important year."

"Our program in Cushing’s syndrome is the most advanced," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "The pivotal trial of Korlym’s planned successor, relacorilant, is actively enrolling patients at sites in the United States, Europe and Israel. We are also launching a Phase 3 trial in patients whose Cushing’s syndrome is caused by adrenal adenomas.

"Our programs in metabolic and oncologic disorders are poised to advance significantly. In the second quarter, we will have results from the second part of our Phase 1b trial of miricorilant for the prevention of antipsychotic-induced weight gain (APIWG). Miricorilant’s Phase 2 trial for the reversal of recent APIWG continues to accrue patients. We plan to start two additional Phase 2 trials – one for the reversal of long-standing APIWG and another for the treatment of patients with non-alcoholic steatohepatitus (NASH) – by year-end.

"Our Phase 2 trial of relacorilant to treat advanced ovarian cancer continues to enroll patients at sites in the United States and Europe," added Dr. Grauer. "In the second quarter, we anticipate starting a Phase 3 trial of relacorilant in metastatic pancreatic cancer and a Phase 1b trial of relacorilant combined with an immunotherapeutic agent in adrenal cancer. By year-end, we expect to conclude the dose-finding trial of our proprietary cortisol modulator exicorilant in combination with enzalutamide in castration-resistant prostate cancer."

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.

On January 30, 2020 F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific (mAb2) antibodies, reported that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for FS120, F-star’s proprietary tetravalent bispecific antibody targeting CD137 and OX40 (Press release, f-star, JAN 30, 2020, View Source [SID1234553713]).

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FS120 is a first-in-class dual agonist bispecific antibody that has the potential to overcome cancer resistance by simultaneously targeting CD137 (4-1BB) and OX40 (CD134, TNFRSF4), two receptors present on the surface of tumor-infiltrating lymphocytes. Unlike checkpoint inhibitors, the mechanism of action of FS120 triggers a positive signal that enhances several cellular functions essential for killing tumor cells. FS120 has a natural antibody format with silenced Fc effector functions, providing increased specificity and superior performance while reducing toxicity through conditional, crosslink-dependent activation upon binding to both CD137 and OX40, when compared to traditional monoclonal antibodies.

F-star expects to enroll 70 patients in a Phase 1 dose escalation clinical trial to assess the safety, tolerability and efficacy of FS120 in patients with advanced malignancies.

Dr Louis Kayitalire, CMO of F-star, said: "The FDA acceptance of our IND application is a crucial milestone for this first-in-class dual agonist, as well as significant validation for the program. Advancing our pipeline and moving our second asset into the clinic brings us another step closer to providing more effective therapies for patients with otherwise difficult-to-treat cancers. Preclinically FS120 has demonstrated an effective tumor-killing response and, importantly, a good tolerability profile."

Preclinical data recently presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting demonstrated that FS120’s conditional, unique crosslink-dependent activation approach has the potential to provide therapeutic benefit, for example in combination with checkpoint inhibitors, and reverse T cell exhaustion in immunosuppressive tumor environments.

On January 30, 2020 Isofol Medical AB (publ) (Nasdaq First North Premier: ISOFOL), reported that the recruitment and treatment of patients in the company’s Phase 1/2a study with arfolitixorin has been completed (Press release, Isofol Medical, JAN 30, 2020, View Source [SID1234553729]). Totally 101 patients have been treated at 10 hospitals in the Nordic countries and Europe. The final analysis has started and study data is expected to be presented at ESMO (Free ESMO Whitepaper) 2020.

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Ulf Jungnelius, M.D., Chief Executive Officer of Isofol, comments: "ISO-CC-005 has fulfilled its purpose by determining the dose we have chosen for further development in our Global Phase 3 AGENT study. Our focus now is taking the AGENT study in goal and submitting the results for a market approval. "

Isofol’s target with the ISO-CC-005 study was to develop an effective and safe dose of arfolitixorin for continued clinical development. An expanded patient group to determine the safety profile of arfolitixorin in combination with the today’s standard of care in first-line metastatic colorectal cancer, has now been conducted in accordance with protocol and the study has fulfilled its purpose and concluded.

The information was submitted for publication, through the agency of the contact person set out above, at 08:15 CET on January 30, 2020.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On January 30, 2020 Bayer reported results from the preplanned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC) show a statistically significant improvement in overall survival (OS) in patients receiving darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT (Press release, Bayer, JAN 30, 2020, View Source [SID1234553678]).

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Results of ARAMIS previously published show a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT compared to placebo plus ADT. Detailed data on the updated OS and other additional endpoints as well as an update on longer term safety will be presented at an upcoming scientific meeting.

Darolutamide, an oral androgen receptor inhibitor (ARi), has been approved in the U.S., Brazil and Japan, and filings in the European Union and other regions are underway or planned by Bayer. The compound is developed jointly by Orion Corporation and Bayer.

On January 30, 2020 Genetron Health, a China-based precision oncology company that provides full cycle cancer management solutions, reported it was selected to participate in 2019 China National Key Research and Development Project led by the China National Center for Biotechnology Development, to support research on development and evaluation of liquid biopsy technology for early screening of cancer (Press release, Genetron Health Technologies, JAN 30, 2020, View Source [SID1234553714]).

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Led by the Cancer Hospital Chinese Academy of Medical Sciences, this research, which is part of the 2019 China National Key Research and Development Project, aims for a technology breakthrough in liquid biopsy technology of early screening and treatment of malignancy by December 2021, which would establish a high-sensitivity, high-specificity, high-efficiency, and cost-effective diagnosis technology system.

As a pioneer in the innovation of cancer early screening technology, Genetron Health will leverage its independently developed Mutation Capsule technology to detect tumor-specific mutations and methylation in cell free DNA (cfDNA) , and establish models for cancer early diagnosis.

In addition, Genetron Health plans to commercialize the early screening product by conducting prospective cohort studies on a large sample size regarding lung cancer and digestive system cancers in selected areas. Study results will be compared and examined against widely applied screening technologies and will apply for IVD registration as testing assays.

In 2019, Proceedings of the National Academy of Sciences of the USA (PNAS) published promising results of a pilot study on a liver cancer early screening study using cfDNA and protein markers, a collaborative effort between Genetron Health and the National Cancer Center/ Cancer Hospital Chinese Academy of Medical Sciences.

"Genetron Health is working diligently to develop technologies and products for early screening of malignancy," said Mr. Sizhen Wang, co-founder and CEO of Genetron Health, "The company is expanding the early screening technology platform to cover multiple cancers, accelerating the design of new assays and starting the commercialization to benefit the public."