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Clarity Pharmaceuticals Announces Submission of Orphan Drug Designation Application for 64Cu-SARTATE™

On September 11, 2019 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, reported that it has submitted an Orphan Drug Designation (ODD) request with the U.S. Food and Drug Administration (FDA) for 64Cu-SARTATE, a diagnostic for the clinical management of neuroendocrine tumours (NETs) (Press release, Clarity Pharmaceuticals, SEP 11, 2019, View Source [SID1234539431]).

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NETs are a group of cancers that originates in the diffuse neuroendocrine system. They most commonly occur in the gastrointestinal tract (48%), lung (25%), and pancreas (9%), but may also occur in other areas including the breast, prostate, thymus and skin. NET patients commonly present at an advanced (metastatic) disease stage. Due to the rarity of NETs and nonspecific presentation of symptoms, a delay in diagnosis or misdiagnosis is common. Mean patient-reported time from first symptom onset to diagnosis was 52 months; 29% of patients required ≥ 5 years for a NET diagnosis, and 58% of patients had metastases at the time of diagnosis. As a result, the median survival for patients can be as short as 10 months.

FDA grants ODDs to facilitate the development of investigational therapies intended to treat, diagnose or prevent rare diseases affecting fewer than 200,000 people in the United States. An ODD provides a number of benefits to pharmaceutical development companies, including potential tax credits for clinical costs, exemptions from certain administrative FDA fees, eligibility for grants to fund future clinical work and seven years of marketing exclusivity if a marketing application is approved.

Dr Alan Taylor, Clarity’s Executive Chairman, said "At Clarity, we are continuing to progress our products to market and this is an important regulatory step for the development of 64Cu-SARTATE in NETs.

"Despite the recent advances in diagnostic methods with gallium-68 (68Ga) labelled somatostatin analogs becoming a preferred diagnostic imaging agent for well-differentiated NETs, most NETs are still diagnosed at an advanced stage and can rarely be cured in these cases.

The issues relating to 68Ga mean that many patients are not getting access to the latest diagnostic tools. 68Ga is normally eluted from expensive and inefficient generators on site which require highly trained personnel to prepare the products and maintain the generators at each treatment centre. The short half life and limited supply of 68Ga also present challenges in scheduling and scanning of patients leading to significant patient backlogs.

"64Cu-SARTATE utilises copper-64, which has a half life that allows finished product to be centrally manufactured in large volumes to meet fluctuating end-user demands without the logistical and financial challenges associated with 68Ga. 64Cu-SARTATE therefore has the potential to improve early-stage diagnosis to prolong survival. Given the superior affinity of our products to copper, 64Cu-SARTATE also has the benefit of measuring later time points compared to 68Ga-based products, which may have the added benefit of better diagnostic and therapeutic outcomes.

"The receipt of the ODD status from the US FDA would enable us to advance the development of this product more quickly and efficiently, getting Clarity closer to our ultimate goal of better treatment of children and adults with cancer."

References
Cheung, Vincent T F, and Mohid S Khan. 2015. "A Guide to Midgut Neuroendocrine Tumours (NETs) and Carcinoid Syndrome." Frontline Gastroenterology 6 (4): 264–69. View Source

Hallet, Julie, Calvin How Lim Law, Moises Cukier, Refik Saskin, Ning Liu, and Simron Singh. 2015. "Exploring the Rising Incidence of Neuroendocrine Tumors: A Population-Based Analysis of Epidemiology, Metastatic Presentation, and Outcomes." Cancer 121 (4): 589–97. View Source

2018 Raphael, Michael J., David L. Chan, Calvin Law, and Simron Singh. 2017. "Principles of Diagnosis and Management of Neuroendocrine Tumours." CMAJ : Canadian Medical Association Journal 189 (10): E398–404. View Source

Bristol-Myers Squibb Announces Dividend

On September 11, 2019 The Board of Directors of Bristol-Myers Squibb Company (NYSE:BMY) reported a quarterly dividend of forty one cents ($0.41) per share on the $.10 par value Common Stock of the corporation (Press release, Bristol-Myers Squibb, SEP 11, 2019, View Source [SID1234539430]). The next quarterly dividend will be payable on November 1, 2019, to stockholders of record at the close of business on October 4, 2019.

The directors also declared a quarterly dividend of fifty cents ($0.50) per share on the $2.00 Convertible Preferred Stock of the corporation, payable December 2, 2019 to stockholders of record at the close of business on November 5, 2019.

Atomwise and Atropos Launch Joint Venture to Discover Senescence Modulating Small Molecules for Cancer Patients

On September 11, 2019 Atomwise Inc., a leader in artificial intelligence (AI) for drug discovery, and Atropos Therapeutics, Inc., a senescence platform discovery company, reported that they will launch a joint venture company to discover and advance a pipeline of compounds for promising discovery targets for the treatment of cancer (Press release, Atomwise, SEP 11, 2019, View Source [SID1234539429]).

Cellular senescence is a regulated biological process by which cells stop dividing irreversibly and is a normal part of aging. However, the failure and induction of senescence also have an important role in the development and treatment of cancers, respectively. Compounds that modulate senescence have enormous potential as novel anticancer agents. Atropos and Atomwise will use their platform technologies and complementary capabilities to perform screens to identify and develop novel compounds for undisclosed targets that modulate cellular senescence and evaluate their potential for development as safe and effective drugs for the treatment of cancer.

"We are excited to be embarking on this joint enterprise with Atomwise. We value the innovation that the two respective teams bring and look forward to working together toward new and better therapies for cancer patients," said Tommy Nguyen, M.D., Ph.D. CEO and Co-Founder of Atropos.

"This partnership with Atropos is an opportunity to ultimately provide patients with a fundamentally different class of drugs," said Abraham Heifets, Ph.D. CEO and Co-Founder of Atomwise. "We are excited to apply our technology to targets that are considered to be intractable and advance the discovery and development of drugs that modulate cellular senescence to treat cancer."

Under the terms of the agreement, the joint venture company will have access to Atropos’ and Atomwise’s cutting-edge technology and expertise in aging, cancer biology, computational and medicinal chemistry, and artificial intelligence for drug discovery.

Publication Reports Clinical Efficacy of ONC201 in Expanded Access H3 K27M-mutant Glioma Patients

On September 10, 2019 Oncoceutics, Inc. reported a scientific publication in the Journal of Neuro-Oncology describing a complete response and other forms of clinical benefit in pediatric and adult H3 K27M-mutant glioma patients treated with ONC201 on expanded access protocols (Press release, Oncoceutics, SEP 10, 2019, View Source [SID1234558332]).

This manuscript details radiographic findings and other clinical outcomes in eighteen H3 K27M-mutant glioma patients who were enrolled on expanded access protocols. These patients initiated ONC201 after prior radiation, and in many cases after also failing additional chemotherapy, a disease setting in neuro-oncology where no available therapies have been proven effective.

Overall findings include disease stabilization and radiographic regressions after initiation of ONC201 that are atypical for the disease course. Two adult and two pediatric cases are highlighted due to improvements in radiographic imaging of their disease, as well as disease-associated neurological symptoms. The most dramatic response was observed in an adult who initiated ONC201 at second recurrence following prior radiation and chemotherapy. After initiating ONC201, the patient’s tumor located in the thalamus and other sites in the brain completely regressed. These imaging findings were accompanied by improvements in headaches, nausea, and right-sided numbness caused by the disease.

Among the 14 patients with recurrent disease prior to initiation of ONC201, median progression-free survival was 14 weeks and median overall survival was 17 weeks. Three adults among the 14 recurrent patients remain on treatment progression-free with a median follow up of 41, 49.6, and 76.1 weeks. Among the 4 pediatric patients who initiated adjuvant ONC201 following radiation, two DIPG patients remain progression-free for at least 53 and 81 weeks and the other two progressed at 28.4 and 41.9 weeks.

"Expanded access to ONC201 was critical in allowing our H3 K27M-mutant patients to access the therapy while clinical trials were being initiated for this form of glioma that previously had no effective therapy," said Nicole Shonka, MD, Associate Professor of Internal Medicine at Nebraska Medical Center. "The complete response in the patient I treated is very striking, given the dismal prognosis of this type of grade IV glioma that is typically unresponsive to anything after initial radiation. We are eager to continue the evaluation of ONC201 in clinical trials to further establish the exciting results we saw in expanded access."

I-Mab Biopharma and Junshi Biosciences Announce Collaboration to Evaluate TJD5 in Combination with Toripalimab for the Treatment of Patients with Cancers in China

On September 10, 2019 I-Mab Biopharma (I-Mab), a China and U.S.-based clinical stage biopharmaceutical company exclusively focused on the discovery and development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases reported the signing of a collaboration agreement with Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences), an innovation-driven biopharmaceutical company to evaluate the combination therapy of I-Mab’s TJD5, a proprietary innovative CD73 antibody with Junshi Biosciences’ Toripalimab (Trade name: Tuoyi), a recombinant humanized anti-PD-1 monoclonal antibody in patients with cancers in China (Press release, I-Mab Biopharma, SEP 10, 2019, View Source [SID1234539422]).

Dr. Jingwu Zang, Founder and Chairman of I-Mab, commented, "TJD5 is an innovative CD73 antibody with best-in-class potential that has entered into Phase I trial in the US. We are very pleased to collaborate with Junshi to explore the clinical synergies with Toripalimab which is an innovative drug with distinctive treatment advantages. We are looking forward to bringing more clinical benefits to patients across various cancer types."

Dr. Ning Li, CEO of Junshi Biosciences, commented, "As an anti multi-tumor drug, toripalimab has shown good safety and efficacy in clinical trials with mono and combination therapy. We believe, through the cooperation with I-Mab, we could continue to explore the combination potential of toripalimab and innovative drugs to improve the outcomes of immune-oncology therapy, lightening hope for more patients.

About TJD5:

TJD5 is a novel and differentiated blocking antibody against CD73, a surface enzyme on stromal cells and cancer cells responsible for the production of adenosine, which is highly immunosuppressive. It is expected to stimulate the immunosuppressive tumor micro-environment and to work in concert with other cancer therapies such as PD-1 and PD-L1 antibodies. TJD5 is in a Phase 1 clinical trial in the US, it is a proprietary innovative CD73 monoclonal antibody from I-Mab’s discovery pipeline with best-in-class potential.

About Toripalimab (JS001, Trade name: Tuoyi)

Toripalimab. a recombinant humanized anti-PD-1 monoclonal antibody for injection is the first domestic-developed anti-PD-1 mAb granted marketing approval in China, supported by National Science and Technology Major Project. In March 2018, its New Drug Application ("NDA") was accepted by the NMPA and put into prioritized evaluation and approval process. On Dec 2018, Toripalimab was conditionally granted marketing approval for use in the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy by the NMPA, which is the first commercialized product of Junshi Biosciences. In the pivotal clinical trial, patients were observed with the ORR of 17.3% and the DCR of 57.5%, and the one-year overall survival rate is 69.3%. The NDA approval of toripalimab witnessed the pivotal step from pre-revenue biotech start-up to a commercial-stage biopharmaceutical company.

Since Toripalimab started its clinical trials at the beginning of 2016, over 30 trials have been conducted in China, the US and other countries, covering 14 kinds of tumors, i.e. NPC, UC, lung cancer, EC, HCC, TNBC, etc. Cooperations with domestic and overseas innovation pharma companies on combination therapy are also under exploration.