On April 24, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported it will host its first quarter 2019 conference call and webcast at 4:30 PM ET on Wednesday, May 8, 2019, to discuss its first quarter financial results and provide an update of its clinical development activities (Press release, NewLink Genetics, APR 24, 2019, View Source [SID1234535378]). There will also be a question and answer session following the prepared remarks.

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Investors and the general public are invited to listen to a live audio webcast of the conference call, which can be accessed five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link can be accessed through the NewLink Genetics website at View Source A replay of the call will be available for two weeks from the date of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode: 8457627.

On April 24, 2019 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Masashi Miyamoto, "Kyowa Hakko Kirin") reported that it has submitted a supplemental application of KHK7580 (evocalcet)*1 for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy*2 to the Ministry of Health, Labor and Welfare (MHLW) in Japan (Press release, Kyowa Hakko Kirin, APR 24, 2019, View Source [SID1234535342]).

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This application is based on the interim result (24 weeks) of the phase 3 study that evaluates the efficacy of KHK7580 for hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy. The primary endpoint is the percentage of subjects whose corrected serum calcium level is maintain ≤ 10.3 mg/dL for 2 weeks in the evaluation period in a time frame up to 24 weeks. The primary endpoint was met with a 77.8% result, which exceeds the threshold set in the protocol.

KHK7580 was also granted Orphan Drug Designation for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy by the MHLW on March 4, 2019.

"We are delighted to submit the supplemental application for evocalcet," said Mitsuo Satoh, Ph.D., Head of Research and Development Division of Kyowa Hakko Kirin. "As it was granted Orphan Drug Designation by the MHLW, we believe that evocalcet has the potentials to provide more efficient treatment for hypercalcemia patients with parathyroid carcinoma and primary hyperparathyroidism."

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

*1 About KHK7580 (evocalcet)
KHK7580 is a small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation (President & Representative Director, CEO: Masayuki Mitsuka, "Mitsubishi Tanabe Pharma"). Kyowa Hakko Kirin signed a license agreement of KHK7580 with Mitsubishi Tanabe Pharma for the rights to cooperative research, develop, market and manufacture the product in Japan and some parts of Asia in March 2008. On March 2018, Kyowa Hakko Kirin received approval of KHK7580 for secondary hyperparathyroidism in maintenance dialysis patients and later on May 2018, the product was launched in Japan market, named Orkedia Tablets.

*2 About Hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism under inability parathyroidectomy or relapse after parathyroidectomy
Parathyroid carcinoma and primary hyperparathyroidism (PHPT) are diseases in which serum calcium levels elevates due to over autonomous secretion of parathyroid hormone (PTH) from tumors of the parathyroid gland. Parathyroidectomy (PTx) is the only reliable method to treat parathyroid carcinoma and PHPT. Control of hypercalcemia can prove challenging in cases of PHPT where PTx cannot be considered because of concomitant diseases or where PHPT recur after PTx and parathyroid carcinoma, although patients with such hypercalcemia are very rare. Hypercalcemia causes symptoms of fatigue, polyuria, thirst, and renal impairment and severe hypercalcemia can result in death due to a hypercalcemic crisis.

On April 24, 2019 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that Punit Upadhyaya, Ph.D., Senior Scientist at Bicycle, will present at the 6th Annual Peptides Congress in London (Press release, Bicycle Therapeutics, APR 24, 2019, View Source [SID1234535361]). The presentation, entitled "Bicycles as T-cell Modulators: Activation of CD137 Using Multivalent and Tumour-targeted Bicycle Peptides," will take place on Thursday, April 25, at 12:00 BST.

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"Our T-cell targeting Bicycles are set apart from other biological approaches because they are fully synthetic and modular, which is designed to enable the rapid creation of molecules with unique drug-like properties," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "We’re looking forward to sharing research showcasing that our multivalent and tumour-targeted bispecific Bicycles robustly activate CD137 positive T-cells in in vivo disease models as well as in patient-derived material."

On April 24, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (the "Company") reported that members of the management team will present a corporate overview at the 2019 Bloom Burton & Co. Healthcare Investor Conference on Tuesday, April 30, 2019 at 8:30am PT (11:30am ET) in Toronto, Ontario (Press release, Aurinia Pharmaceuticals, APR 24, 2019, View Source [SID1234535380]).

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The presentation will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of the presentation will also be archived on the Company website following the event

On April 24, 2020 Oncoceutics reported that Accelerate Brain Cancer Cure (ABC2) has awarded a $116,523 grant to a research team at University of California, Los Angeles to perform a natural disease history study of adult midline gliomas, a certain type of aggressive brain tumors (Press release, Oncoceutics, APR 24, 2019, View Source [SID1234558358]). The study will follow patients from first diagnosis through a series of therapeutic interventions that for a subset of patients will include ONC201, an investigational agent in clinical trials for H3 K27M-mutant gliomas that has induced radiographic regressions in some patients.

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"Novel therapies are desperately needed for treatment of H3 K27M-mutant gliomas," said Max Wallace, Chief Executive Officer of ABC2. "A dedicated natural history study will open up the path to accelerated approval based on radiographic responses to new treatments such as ONC201 in this rare and immediately life-threatening disease."

ONC201 is the first antagonist of D2-like dopamine receptors DRD2/3 to be developed for clinical neuro-oncology. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ONC201 for the treatment of adult recurrent H3 K27M-mutant high-grade glioma. Diffuse midline gliomas harboring the histone H3 K27M mutation have a dismal prognosis with a median survival from diagnosis consistently reported to be between 8 and 11 months. The mutation was chosen by the World Health Organization (WHO) as a criterion for WHO grade IV designation, the most severe grade that is associated with a diffuse and aggressive growth pattern. No drug has been approved for H3 K27M-mutant glioma and no investigational therapy has shown clinically meaningful efficacy in this indication. Radiation is typically used in newly diagnosed patients and associated with some benefit before the tumor progresses, leading to the dismal survival rates.

Despite the increased awareness for the prognostic importance of the H3 K27M mutation, dedicated studies of midline gliomas are sparse, particularly in adults. Response criteria that are often applied, e.g. RANO criteria, were developed for supratentorial glioblastoma that have different radiographic features than midline gliomas, including H3 K27M-mutant gliomas. Consequently, the utility of these criteria for many midline glioma patients are confounded by a number of features often found in this disease: minimal or no contrast enhancement, diffuse growth, multifocal dissemination, and sub-centimeter lesions (not measurable as per some criteria). With the disease classifications that consider phenotypic as well as genotypic disease characteristics (e.g. WHO 2016) and patient registries that collect historical data the disease can be studied in more detail. However, many features of midline gliomas are still poorly understood, including tumor growth rates, dissemination patterns, response to therapies, and the relationship of clinical outcomes to these features.

"The goal of the study is to quantify the dynamics of how midline gliomas change over time on clinical imaging to better understand the natural progression of this disease and if treatments can alter those dynamics," said Timothy F. Cloughesy, MD, Clinical Professor and Director of the Neuro-Oncology Program at the University of California, Los Angeles. "The natural disease history could serve as a benchmark for new therapies such as ONC201 and other agents targeting glioma. We are very thankful to ABC2 for their support that will allow us to research this important and unaddressed topic."