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.

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"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.

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]).

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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."

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]).

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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.

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.

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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.

On July 22, 2020 Ashion Analytics LLC reported a partnership with Elevation Oncology, a clinical stage biopharmaceutical company, focused on the matching of patients with tumors harboring an NRG1 gene fusion identified using Ashion’s proprietary GEM ExTra test with CRESTONE, a registration-directed Phase 2 study sponsored by Elevation Oncology (Press release, Ashion Analytics, JUL 22, 2020, View Source [SID1234562266]).

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NRG1 gene fusions are a rare genomic alteration implicated as a driver of tumorigenesis and growth across many types of solid tumors, including lung, breast, pancreatic, ovarian, and colorectal cancers. CRESTONE — or Clinical study of REsponse to Seribantumab in TumOrs with NEuregulin 1 (NRG1) fusions — provides an investigational treatment opportunity for patients with any advanced solid tumor who have not responded or are no longer responding to standard cancer treatment, and whose tumor has tested positive for an NRG1 fusion.

This partnership creates a new dynamic in the way cancer patients can be matched to precision medicine therapeutics. By first identifying a genetic driver that has an available targeted therapy option, in this case an NRG1 fusion and the investigational therapy seribantumab, the diagnostic technology, data insights, and network reach at Ashion Analytics can be leveraged to efficiently identify and directly match eligible patients to the CRESTONE trial using test results that are already available today, while also maximizing the value of every additional test.

"The comprehensive nature of the GEM ExTra test means that its value grows directly with each new genomic driver that is identified and each new precision therapy under development," said Laurie Goodman, Ph.D., Ashion Analytics Director of Business Development and Medical Affairs. "Partnerships like this enable us to continuously facilitate the ability for our patients to receive the most up-to-date information about the emerging treatment opportunities available to them today."

Ashion Analytics recently announced that Medicare has approved coverage of its proprietary cancer profiling test, GEM ExTra, one of the nation’s most comprehensive genomic cancer analysis tests. Medicare coverage enables potentially 44 million more patients to afford this test, which aims to match patients with best available treatments for their disease.

GEM ExTra detects tumor-specific mutations in both DNA and RNA, allowing physicians to make the best-available treatment recommendations for patients with advanced solid tumors. An Ashion study poster presented at the 2020 annual meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) details the importance of using RNA as part of the analysis to give cancer physicians the best possible options for treating their patients: Employing RNA Sequencing to Enhance Treatment Options for Cancer Patients.

This leading-edge test provides treating physicians with vital interpreted information needed to understand changes to a patient’s genomic profile. It outlines a therapeutic treatment plan best suited for each patient. Conditions that may benefit from this approach include treatment of refractory, rare or aggressive cancers.

"We are partnering with Ashion Analytics because we recognize the sensitivity and continuing potential of their GEM ExTra cancer profiling test," said Shawn Leland, PharmD, RPh, Founder and Chief Business Officer of Elevation Oncology. "Elevation Oncology is committed to expanding the benefit of precision medicine to all patients with cancer by developing therapies that make results from tests like GEM ExTra clinically actionable, no matter how rare the finding. Close collaboration between diagnostic and therapeutic developers is critical to re-thinking our approach to clinical trial enrollment as an industry and finding more efficient ways to bring the right treatment opportunities to the patients that need them."