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Clarity Pharmaceuticals opens SARTATE™ neuroblastoma clinical trial

On July 23, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, reported that it has opened its trial of 67Cu-SARTATE for paediatric patients with neuroblastoma at Memorial Sloan Kettering Cancer Center (MSK) in New York City and recruitment has commenced (Press release, Clarity Pharmaceuticals, JUL 23, 2020, View Source [SID1234562244]).

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"We are very excited to commence recruitment for our trial in this very important patient population" commented Dr Alan Taylor, Clarity’s Executive Chairman. "The opening of the trial and commencement of recruitment comes shortly after the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation status for both the diagnostic and therapeutic applications of SARTATE in neuroblastoma. Achieving these milestones despite the challenging conditions presented by the coronavirus pandemic signifies strong support from the FDA, MSK and Clarity’s collaborators and importantly our team which relates to the importance of progressing the development of SARTATE in this vulnerable patient population."

67Cu-SARTATE trial is a Peptide Receptor Radionuclide Therapy (PRRT) administered to paediatric patients with high-risk neuroblastoma. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a theranostic clinical trial at MSK.1 MSK is the world’s oldest and largest private cancer centre. It has devoted more than 135 years to exceptional patient care, innovative research, and outstanding educational programs.

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

Dr Taylor said: "At this time, children with high-risk neuroblastoma have poor prognosis as current treatment strategies have limited effect in patients with late-stage disease where cancer has metastasised. It is evident that the development of new treatment approaches and strategies is crucial to improving treatment outcomes for this patient population. We are looking forward to progressing the development of SARTATE and getting closer to our ultimate goal of better treatment of children and adults with cancer."

G1 Therapeutics Announces License Agreement for Lerociclib

On July 22, 2020 G1 Therapeutics, a clinical-stage oncology company, reported a license agreement for lerociclib to EQRx, a biopharmaceutical company focused on making innovative medicines at dramatically lower prices for the benefit of people and society (Press release, G1 Therapeutics, JUL 22, 2020, View Source [SID1234634609]). Under the terms of the agreement, EQRx gains exclusive rights for lerociclib in the U.S., Europe, Japan and all other global markets, excluding the Asia-Pacific region (except Japan). G1 will receive an upfront cash payment of $20 million and will be eligible to receive development and commercial milestone payments of up to $290 million, plus tiered royalties ranging from mid-single digits to mid-teens based on annual net sales of lerociclib.

"We are excited to partner with EQRx to further development of lerociclib, a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies," said Mark Velleca, M.D., Ph.D., Chief Executive Officer of G1. "This is the third strategic collaboration we have executed this year. Collectively, these partnerships have advanced our goal to provide global access to our promising oncology therapies and extend our financial runway so that we can continue our efforts to bring novel treatments to patients with cancer."

Discovered and developed by G1, lerociclib has demonstrated clinical proof-of-concept and a differentiated profile in a Phase 1/2 trial in patients with ER+, HER2- breast cancer. Earlier this year, G1 licensed development and commercialization rights in the Asia-Pacific region (excluding Japan) to Genor Biopharma.

About Lerociclib
Lerociclib is a differentiated oral CDK4/6 inhibitor being developed for use in combination with other targeted therapies in certain types of breast and lung cancer. Preliminary clinical data in estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer have demonstrated proof-of-concept of the differentiated clinical profile of lerociclib versus currently marketed CDK4/6 inhibitors, with improved tolerability and less neutropenia. Neutropenia is one of the main toxicities associated with CDK4/6 inhibition. Current treatments require frequent blood testing for neutropenia. Less monitoring would mean fewer office visits and blood draws, improving the experience for patients and reducing the burden on physician offices and costs to the healthcare system.

TGEN, CITY OF HOPE LOOKING TO CREATE PERSONALIZED ROADMAPS FOR THE TREATMENT OF KIDNEY CANCER

On July 22, 2020 Experts at City of Hope and the Translational Genomics Research Institute (TGen) reported that they are using one of the world’s most comprehensive genomic analysis tools to map out personalized treatment plans for metastatic kidney cancer patients (Press release, TGen, JUL 22, 2020, View Source [SID1234562374]).

While the physician-scientists are at the beginning of this long journey, they believe they’re on the right path. They recently published a study in the Journal of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) that suggests mutations in the TERT gene predicts that a patient may not be receptive to immune checkpoint inhibitors such as nivolumab or pembrolizumab.

"The hope is to one day identify patients who will benefit from immunotherapy and those who will not. Eventually we may be able to distinguish which patient is better suited for other treatments, like targeted therapy," said Sumanta Pal, M.D., one of the study’s senior authors and co-director of the Kidney Cancer Program at City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases. Examples of targeted therapy include vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors like cabozantinib.

Nearly 74,000 new cases of kidney cancer will be diagnosed this year, and about 14,800 people will die from the disease, according to the American Cancer Society. Ironically, experts know patients who have certain genetic mutations are more susceptible to specific drugs, but most doctors are not genetically sequencing each kidney cancer patient’s tumors, Pal said.

"It’s a paradox: We don’t use targeted therapy in a targeted fashion," he added. "At City of Hope, we have begun to provide comprehensive genome and exome sequencing for all patients with Stage 4 cancer, regardless of their cancer site."

City of Hope is on pace to be the only major cancer center in the United States to genetically profile the tumors of every single patient, regardless of cancer type. The goal is to enable patients to receive effective targeted therapies or to enroll people in innovative clinical trials as early as possible so that they can fight their disease.

In the study, Pal and his colleagues sent samples of 91 patients’ tumors to TGen’s clinical laboratory, Ashion Analytics, so that the specimens could be sequenced by GEM ExTra a leading-edge tool that features tumor-normal whole exome sequencing and tumor whole transcriptome sequencing. These are molecular-level analyses of each patient’s entire protein-coding DNA and RNA.

"The goal was to identify genomic alterations that correlated with therapy response," said Sara Byron, Ph.D., assistant professor in TGen’s Integrated Cancer Genomics Division and co-senior author of the study. "We wanted to use this ‘real-world evidence’ to explore potential molecular and genomic features associated with response." (Ashion Analytics recently announced that Medicare has approved coverage of GEM ExTra, potentially providing 44 million more patients access to this test, which aims to match patients with the best available treatments for their disease.)

Kidney cancer treatment regimens involving either targeted therapy or immunotherapy have burgeoned since 2015. Because new treatments sprouted so rapidly, scientists have not yet discovered the ideal strategy to sequence regimens for optimal outcomes. Moreover, the current way treatment risk is assessed tends to be subjective with ingrained bias, the study reported. City of Hope and TGen are working to develop objective laboratory-based biomarkers for kidney cancer.

Only patients whose genomic profiling was performed prior to systemic treatment were included in the study. Patients received either targeted therapy known as VEGF tyrosine kinase inhibitors (sunitinib, cabozantib, lenvatinib/everolimus) or immunotherapy (nivolumab, ipilimumab, pembrolizumab). They were divided into those who received no clinical benefit, meaning their disease progressed, or those who received clinical benefit, meaning the disease shrunk or stabilized for more than six months. Some 19,396 genes and nucleic sequences were analyzed to tease out a therapeutic treatment plan that would have best suited each patient based on their specific tumor mutations. More research in larger sample sizes are needed, but the scientists are off to a good start.

"Stage 4 cancer is often considered incurable, but that doesn’t always have to be the case," Pal said. "By sequencing all protein-coding DNA, that is by sequencing the whole exome, we may be able to identify new therapeutic targets, and that’s a very exciting prospect."

Aurinia Announces Public Offering of Common Shares

On July 22, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported that it has commenced a registered underwritten public offering of its common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, JUL 22, 2020, View Source [SID1234562296]).

Jefferies and SVB Leerink are acting as joint book-running managers for the Offering.

The Company will grant the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase up to an additional 15% of common shares, for a period of up to 30 days. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.

The Offering is subject to customary closing conditions, including NASDAQ and TSX approvals. For the purposes of the TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on June 19, 2020 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated June 17, 2020. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request in the United States by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; and in Canada by contacting Jefferies Securities, Inc., attention: Steven Latimer, 161 Bay Street, Suite 2700 Toronto, Ontario M5J 2S1, by telephone at 416-572-2215.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Alkermes to Host Conference Call to Discuss Second Quarter 2020 Financial Results

On July 22, 2020 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 29, 2020 to discuss the company’s second quarter 2020 financial results (Press release, Alkermes, JUL 22, 2020, https://www.prnewswire.com/news-releases/alkermes-to-host-conference-call-to-discuss-second-quarter-2020-financial-results-301098230.html [SID1234562295]). Management will also provide an update on the company.

The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, July 29, 2020, through Wednesday, Aug. 5, 2020, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13707215.