Mirati Therapeutics Announces Proposed Public Offering of Common Stock

On October 26, 2020 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported that it intends to offer and sell in an underwritten public offering $700.0 million of shares of its common stock and a selling stockholder intends to offer 375,000 shares in the offering (Press release, Mirati, OCT 26, 2020, View Source [SID1234569075]). In addition, Mirati and the selling stockholder expect to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the total shares offered in the public offering at the public offering price, less the underwriting discounts and commissions. Mirati will not receive any proceeds from the sale of shares in the offering by the selling stockholder. The offering is subject to market and other 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.

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Goldman Sachs & Co. LLC, SVB Leerink LLC, Cowen and Company, LLC and Evercore Group, L.L.C. are acting as joint book-running managers in the offering.

The securities described above are being offered pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected]; or from Evercore Group, L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

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

CStone and EQRx Enter Global Strategic Partnership for Two Immune Checkpoint Inhibitors: sugemalimab (anti-PD-L1) and CS1003 (anti-PD-1)

On October 26, 2020 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported an agreement to out-license ex-Greater China rights for two key late-stage immuno-oncology assets, sugemalimab (anti-PD-L1) and CS1003 (anti-PD-1), to EQRx, a biopharmaceutical company with an innovative business model that will allow these drugs to be competitively positioned in global markets against established treatments for the target indications (Press release, CStone Pharmaceauticals, OCT 26, 2020, View Source [SID1234569073]).

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Under the terms of the agreement, CStone will receive an upfront payment of US$150 million and up to US$1.15 billion in milestone payments for both drugs as well as separate tiered royalties. EQRx will obtain exclusive rights to lead global development and commercialization worldwide, excluding Mainland China, Taiwan, Hong Kong and Macau. CStone retains rights to CS1003 in Greater China, where it can continue to pursue development as a monotherapy or as part of its combination strategy for this drug.

Frank Jiang, M.D., Ph.D., Chairman and Chief Executive Officer of CStone, said: "We are pleased to be partnering with EQRx, an outstanding company led by an exceptional management team with a track record of building and investing in biotech companies as well as leadership roles at commanding heights of the industry. They have a unique blend of expertise to execute on this agreement and maximize the global potential of our two lead immuno-oncology assets. "

"This partnership demonstrates the clinical as well as the commercial potential of sugemalimab and CS1003. Both are well suited to serve as backbone molecules for various combination therapies, an approach that is part of EQRx’s vision for these drugs. The broad potential to develop combination therapies further strengthens our ability to pursue our combo strategy for CS1003 in China. In addition, the capital proceeds that we generate through this transaction will enhance our ability to invest in strategic development initiatives and advance our transition into a fully integrated biopharma company."

Alexis Borisy, Chairman, Founder and Chief Executive Officer of EQRx, said: "CStone is recognized globally for excellence in drug development and we look forward to advancing their foundational work to expand access to these two late-stage, innovative immunotherapies. We believe the addition of PD-L1 and PD-1 drug candidates to our expanding clinical pipeline provides EQRx and our strategic partners with optionality to deliver high-quality, lower cost treatment regimens across a broad range of cancers. Ultimately, adding this unique combination of potentially best-in-class immunotherapeutic agents advances our mission to deliver equal access to innovative medicines while lowering costs for patients, payers and healthcare systems around the world."

Sugemalimab is a potential best-in-class PD-L1 antibody that is being developed for high-incidence cancer indications in China, including frontline non-small cell lung, gastric and esophageal cancers, among others. The U.S. Food and Drug Administration ("FDA") has recently granted Breakthrough Therapy Designation ("BTD") to this drug for adult relapsed or refractory extranodal natural killer/T-cell lymphoma ("R/R ENKTL"), and orphan drug designation ("ODD") for T-cell lymphoma. CS1003 is currently being studied for the treatment of advanced solid tumors, including a global registration trial in first-line hepatocellular carcinoma. The FDA has granted ODD for this indication.

Closing of the agreement is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Act.

Investor Presentation Information
CStone will host a live webcast at 11:00am (Hong Kong time) October 27th, 2020. Please find the access information as below.

All other regions: View Source;tp_key=e37a82bd34
Mainland China: View Source;tp_key=e37a82bd34
Password (case sensitive): CStone

About Sugemalimab (PD-L1)

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by a company based in the U.S., Ligand Pharmaceuticals Inc. (NASDAQ: LGND), sugemalimab is developed using the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 ("IgG4") human antibody, which may reduce the risk of immunogenicity and toxicities in patients, a potentially unique advantage over similar drugs.

Sugemalimab has completed a Phase I dose-escalation study in China. During Phase 1a and 1b stages of the study, sugemalimab showed antitumor activity in multiple tumor types and was well-tolerated.

Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase I bridging study in the U.S., the clinical programs in China include one multi-arm Phase Ib study for several tumor types, one Phase II registrational study for lymphoma, and four Phase III registrational studies, respectively, for stage III/IV non-small cell lung cancer, gastric cancer, and esophageal cancer. The phase III clinical trial of sugemalimab in patients with stage IV non-small cell lung cancer has reached its primary endpoint. CStone plans to submit a new drug application to the National Medical Products Administration of China soon.

About CS1003 (PD-1)

CS1003 is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1) being developed for immunotherapy of various tumors. Compared to most of the monoclonal antibodies that bind human and monkey PD-1 (either already approved or in clinical stage), CS1003 demonstrates comparable high binding affinities across species against human, cynomolgus monkey and mouse PD-1, and is developed to disrupt the interaction of PD-1 with its ligands PD-L1 and PD-L2.

Ascentage Pharma Announces Approval for the Phase Ib/II Clinical Study of MDM2-p53 Inhibitor APG-115 in Combination with Immunotherapy for the Treatment of Patients with Advanced Liposarcoma or other Advanced Solid Tumors in China

On October 26, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved a Phase Ib/II study of Ascentage Pharma’s novel MDM2-p53 inhibitor APG-115 in combination with PD-1/PD-L1 inhibitors for the treatment of patients with advanced liposarcoma (LPS) or other advanced solid tumors (Press release, Ascentage Pharma, OCT 26, 2020, View Source [SID1234569072]).

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This multicenter, open-label Phase Ib/II study of the combination therapy in patients with advanced LPS or other advanced solid tumors in China comprises two stages – a Phase Ib dose-escalation study designed to evaluate the safety and tolerability of APG-115 in combination with a PD-1 inhibitor (toripalimab); and a Phase II dose-expansion study which will also assess the efficacy in the treatment of patients with TP53 wild-type MDM2-amplified LPS.

LPS is a common histologic subtype of soft issue sarcomas, accounting for around 20% of all soft tissue sarcoma incidences. MDM2 amplification is common in LPS, while TP53 wild-type LPS accounts for approximately half of all LPS cases[1]. Surgical resection is the current primary standard of care treatment for LPS, and pre/post-surgical chemotherapy, with or without radiation, are also recommended. Patients with advanced relapsed or metastatic LPS also receive systemic chemotherapy. However, according to the existing data, chemotherapy only offers limited benefits to patients with advanced LPS, with 80% LPS cases eventually relapsing[2]. Furthermore, current targeted therapies and immunotherapies for the treatment of LPS remain very limited in options and efficacy[3]. Therefore, a comprehensive understanding of the pathological characteristics of LPS and the development of novel and effective combination therapies for LPS are urgently needed.

APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2 protein. APG-115 has strong binding affinity to MDM2 and is designed to activate tumor suppression activity of p53 by blocking the MDM2-p53 protein-protein interaction. APG-115 is the first MDM2-p53 inhibitor entering clinical development in China, with multiple ongoing clinical studies in solid tumors and hematologic malignancies in China and the US.

Thus far, APG-115 as a single agent in advanced LPS has already shown promising antitumor activities. The Phase I study of APG-115 single agent demonstrated clinical activities in LPS and other tumors of the TP53 wild-type, implicating that TP53 wild-type is a potential biomarker for predicting the efficacy of APG-115 in the treatment of LPS and other tumor types. The study has observed over 10 months of sustained post-treatment response in a patient who had achieved partial response (PR), indicating the potential host immune-modulating effect of APG-115. These results paved the way for the further investigation of APG-115 as a single agent or in combinations with immunotherapies[4]. Preclinical studies have shown that APG-115 could stimulate the release of proinflammatory cytokines in T-cells, enhance the activation of CD4+ T-cells, and elevate the PD-L1 expression in various tumor cells. Also observed was that the APG-115 plus PD-1 inhibitor combination significantly bolstered the antitumor activities in multiple tumor models.

"At present, there is urgent unmet medical need in the treatment of LPS and other solid tumors globally," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "As the first MDM2-p53 inhibitor entering clinical development in China, APG-115 single agent has demonstrated promising clinical utility in the treatment of advanced LPS. Meanwhile, preclinical studies of the APG-115 plus PD-1 inhibitor combination has also shown encouraging results. We will press ahead with this Phase Ib/II study of APG-115 plus immunotherapy combination in China, which hopefully will offer a new option to the treatment of LPS and other solid tumors."

Scorpion Therapeutics Launches with $108 Million to Advance Precision Oncology 2.0

On October 26, 2020 Scorpion Therapeutics, Inc., a next-generation precision oncology company, reported the closing of a $108 million Series A financing, led by Atlas Venture, Omega Funds, and Vida Ventures, with participation from Abingworth and Partners HealthCare Innovation (Press release, Scorpion Therapeutics, OCT 26, 2020, View Source [SID1234569070]). The financing will be used to advance Precision Oncology 2.0., the next wave in precision medicine, with the goal of delivering best- and first-in-class small molecule drugs that are safe and well-tolerated and that can provide deeper, more durable responses to many more people with cancer. The company was founded by a team of world-renowned drug developers and researchers in cancer biology and targeted oncology, including Gary D. Glick, Ph.D., Keith Flaherty, M.D., Gaddy Getz, Ph.D., and Liron Bar-Peled, Ph.D.

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Scorpion’s drug discovery and development engine builds on two decades of innovation in cancer genomics and integrates cutting-edge technologies across target discovery, medicinal chemistry, and translational medicine to deliver the next generation of precision oncology medicines. By developing medicines that are better able to spare healthy tissue and minimize side effects, the company aims to address cancers that are untreatable or treatment-resistant today so that precision oncology can become the norm – rather than the exception.

"Cancer is a complicated and devastating disease that continues to evade our best efforts to conquer it. Precision medicine represents a tremendous advance, with the potential to offer increased efficacy and decreased toxicity, but its promise remains unfulfilled for far too many patients," said Dr. Glick, the company’s founding president and CEO. "At Scorpion, we have assembled a world-class team to push the limits of biology, bioinformatics, and medicinal chemistry to identify and drug the most promising therapeutic targets for cancer patients. Our deep capabilities in next-generation chemistry enable us to design precision therapeutics for both new targets and those previously dismissed as undruggable. Moreover, we have assembled leaders in clinical development, with the expertise to efficiently advance our product candidates to patients. With these tools, we are building an unparalleled pipeline of small-molecule drugs to address untapped vulnerabilities in cancer and provide fresh hope to people in need."

Comprehensive tumor molecular profiling has uncovered thousands of recurrent genetic mutations now known to be important drivers of cancer. This has led to some notable therapeutic breakthroughs; however, the promise of precision oncology has not been fully exploited. First, many existing therapies have suboptimal therapeutic profiles, failing to provide maximum benefit to patients; second, many targets that are now known to be important for cancer proliferation and survival are still considered to be "undruggable" and therefore have yet to be targeted for therapy; and third, multi-omic data that may hold the key to transformative novel cancer targets has historically been too difficult to mine.

Scorpion has assembled the talent and technology to address these current limitations and developed a strategy to deliver on the full promise of precision oncology. Scorpion will focus initially on three key efforts: designing best or first-in-class drugs against known oncogenes; drugging known – but classically undruggable – cancer targets; and discovering and rapidly drugging novel targets with the potential to transform cancer treatment paradigms.

Scorpion’s lead investors noted that they were drawn to the company’s founding team, cutting-edge science, and bold vision of making precision oncology the norm rather than the exception.

"Scorpion’s delivery of Precision Oncology 2.0 is smart and systematic. Even in the midst of the COVID-19 pandemic, the company has assembled a renowned team, built a cutting edge discovery engine, and established a robust preclinical pipeline," said Paulina Hill at Omega Funds.

"Their investments in data sciences and next-generation chemistry power a discovery engine that is purpose-built to find the best drugs for proven targets, as well as exploit novel ones. We look forward to supporting the Scorpion team in their mission to change the landscape of cancer treatment," said Arjun Goyal, Co-founder and Managing Director at Vida Ventures.

"I am delighted to partner again with Gary, and like we did at IFM, help build another world-class biopharmaceutical company," said Jean-François Formela, Partner at Atlas Venture.

Pioneering founders

Scorpion’s founders and scientific advisors are pioneers in the field of cancer genomics and in the development of targeted cancer therapies.

Dr. Glick is a biotech entrepreneur, academic chemist, and immunology researcher. He previously founded Lycera, FirstWave Bio, and IFM Therapeutics. During Dr. Glick’s tenure as CEO of IFM, the company progressed three programs from ideation to clinical development and executed several major transactions. In 2017, IFM sold two cancer assets to Bristol-Myers Squibb in a deal valued over $2.3 billion and, in 2019, IFM sold its NLRP3 inhibitor program to Novartis for $1.6 billion. Dr. Glick also led the structuring and negotiation of a collaboration and option agreement with Novartis valued at over $840 million to develop inhibitors of the cGAS/STING pathway to treat inflammatory and autoimmune diseases. He currently serves as Executive Chairman of IFM.

Dr. Flaherty is director of clinical research at the Massachusetts General Hospital Cancer Center and professor of medicine at Harvard Medical School. A co-author of more than 300 papers, he led teams that made seminal discoveries about the genetics and treatment of melanoma. In 2013, Dr. Flaherty co-founded Loxo Oncology, where he served on the Board of Directors and chaired the Scientific Advisory board until its acquisition by Eli Lilly for $8 billion. He is also a co-founder of Strata Oncology, X4 Pharmaceuticals, and Apricity.

Dr. Getz is an internationally acclaimed and widely published leader in cancer genomics and directs the Cancer Genome Computational Analysis Group at the Broad Institute of MIT and Harvard, among other affiliations. He directs bioinformatics research and holds an endowed chair at the Massachusetts General Hospital Cancer Center. His lab focuses on characterizing cancer genetics and identifying key drivers of disease.

Dr. Bar-Peled is an assistant professor of medicine at Harvard Medical School and the Cancer Center at Massachusetts General Hospital. His lab has made key contributions to understanding how cells sense and respond to oxidative stress and developing small molecule inhibitors against difficult-to-drug cancer drivers.

An experienced scientific leadership team

Scorpion is led by an experienced group of drug hunters who have led the discovery, development, and commercialization of multiple oncology drugs. Joining Dr. Glick is Darrin Stuart, Ph.D. as chief scientific officer, Angel Guzman Perez, Ph.D. as head of discovery, and Erica Jackson as EVP of target biology.

Dr. Stuart previously served as executive director of cancer biology and drug discovery at Novartis, where he led or oversaw ten small-molecule oncology programs from ideation into first-in-human trials. Notably, Dr. Stuart was the project leader for the BRAFTOVI (encorafenib) program, which is now approved to treat patients with BRAFV600mut melanoma and colorectal cancer. Dr. Stuart also led an active basic research lab, which published multiple high-impact manuscripts on MAPK pathway biology and therapeutics.

Dr. Guzman-Perez joins Scorpion from Amgen’s research organization, where he served as executive director, head of medicinal chemistry, and was responsible for the small-molecule portfolio across therapeutic areas. Previously, Dr. Guzman-Perez spent 14 years at Pfizer. He has co-authored more than 50 peer-reviewed publications, been a co-inventor on more than 20 patents, and contributed to the advancement of more than 20 compounds to preclinical development.

Dr. Jackson has spent the past 20 years leading teams and mentoring scientists in oncology target validation and large and small molecule drug discovery. Prior to joining Scorpion, Erica was Senior Director of Oncology Discovery at AbbVie, where she led a cross-site team responsible for all biology aspects of drug discovery from target ID through candidate nomination. Before AbbVie, she spent two years at ORIC Pharmaceuticals, helping to move ORIC-101, a glucocorticoid receptor inhibitor, into the clinic. Erica began her industry career at Genentech, where she spent 10 years across roles of increasing responsibility in oncology discovery.

Eagle Pharmaceuticals to Discuss Third Quarter 2020 Financial Results on November 2, 2020

On October 26, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that the Company will release its 2020 third quarter financial results on Monday, November 2, 2020, before the market opens (Press release, Eagle Pharmaceuticals, OCT 26, 2020, View Source [SID1234569068]).

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Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date

Monday, November 2, 2020

Time

8:30 a.m. ET

Toll free (U.S.)

866-342-8591

International

203-518-9713

Webcast (live and replay)

www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-934-3336 (US) or 402-220-1148 (International) and entering conference call ID EGRXQ320. The webcast will be archived for 30 days at the aforementioned URL.