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Linnaeus Therapeutics Granted U.S. FDA Fast Track Designation for LNS8801 for the Treatment of Patients with Metastatic or Unresectable Melanoma Who Have Progressed on Anti–PD-1/L1 Therapy

On June 18, 2020 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LNS8801 for the treatment of patients with metastatic or unresectable melanoma who have progressed on or after anti–programmed cell death receptor or ligand (anti–PD-1/L1) therapy (Press release, Linnaeus Therapeutics, JUN 18, 2020, View Source [SID1234561305]).

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Linnaeus is currently evaluating LNS8801 in a phase 1 clinical trial in patients with advanced cancer. The company expects to identify the recommended phase 2 dose this summer and to begin its phase 2 program evaluating LNS8801 as a monotherapy and in combination with targeted therapies in early fall.

LNS8801 is a first-in-class, orally bioavailable, small-molecule that is a highly specific and potent agonist of the G-protein estrogen receptor (GPER). GPER is widely expressed on cancers. Agonizing GPER both stops cancers from proliferating and makes them more visible to the immune system.

"Receiving Fast Track designation for LNS8801 is an important step in its clinical development as we near the end of our phase 1 dose-escalation study and advance LNS8801 into phase 2 clinical trials," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "We are pleased that the FDA recognizes the potential of LNS8801 to help patients with melanoma who have progressed after anti–PD-1/L1 therapy."

About Fast Track Designation

Fast Track designation is a process designed to facilitate the expedited development and review of new drugs that treat serious or life-threatening conditions and that have demonstrated the potential to fill an unmet medical need. The purpose is to advance new drugs earlier for patients who need them.

A company with a drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with the FDA to discuss the drug’s development and ensure collection of the appropriate data needed to support drug approval
More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
About LNS8801

LNS8801 is an orally bioavailable and highly specific agonist of GPER whose activity is dependent on the expression of GPER. GPER activation suppresses well-known tumor-associated genes, such as c-Myc and PD-L1. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. LNS8801 monotherapy has shown significant antitumor activity, including inducing complete responses that are immune to rechallenge. LNS8801 also has shown effects when combined with targeted therapies, chemotherapies, and immunotherapies. LNS8801 is currently in a phase 1/2 clinical trial in patients with advanced cancer at six comprehensive cancer centers in the United States.

$400,000 SBIR grant fast-tracks new approach to treating lung, thyroid cancers

On June 18, 2020 KinaRx reported that it novel approach to treating lung and thyroid cancers is moving closer to clinical trials.

$399,933 SBIR Phase I grant from the National Cancer Institute to KinaRx, a Purdue University-affiliated startup, will help to advance a novel platform aimed at producing more effective drugs to treat lung and thyroid cancers. The platform targets gene mutations that help cancers grow and expand within the body.

"Genetic and molecular characterization of cancer-driving kinase mutations has revolutionized the treatment of many types of cancer," said Herman O. Sintim, the Drug Discovery Professor of Chemistry in Purdue’s Department of Chemistry.

KinaRx was founded by Sintim, who is its chief scientific officer, along with M. Javad Aman, Rena Lapidus, Ashkan Emadi, Frederick Holtsberg and Joe O’Neill.

The compounds under development by KinaRx were developed using Sintim’s platform, which rapidly makes complex drug molecules using bioinformatics, multi-component compound synthesis and the understanding of disease biology.

The team has focused on developing novel RET inhibitors, which are compounds designed to target the various cancer cells at work in the body. First-generation RET inhibitors demonstrated about 30% overall response rate (ORR) and no complete regression of tumors. New-generation RET inhibitors in clinical development only showed complete regression of RET-driven tumors in a small subset of patients (2-14%). These poor complete regression rates call for more efficacious RET inhibitors, which are active against drug-resistant mutant RET kinases.

"This Phase I SBIR grant will facilitate several preclinical experiments that are required to advance the novel RET inhibitors into clinical trials," said Sintim, who is a member of the Purdue University Center for Cancer Research and the Purdue Institute for Drug Discovery.

KinaRx has licensed drug compounds through the Purdue Research Foundation Office of Technology Commercialization, which is now located in the Convergence Center for Innovation and Collaboration in Discovery Park District, adjacent to the Purdue campus.

The researchers are looking for partners to continue testing and developing their technology. For more information on licensing and other opportunities, contact Sintim at [email protected].

Ubiquigent DUB inhibitor pact survives Bristol-Celgene merger

On June 18, 2020 Bristol Myers Squibb reported a drug discovery collaboration with Ubiquigent that it inherited in its merger with Celgene (Press release, Bristol-Myers Squibb, JUN 18, 2020, View Source [SID1234561257]). The Big Pharma recently scrapped an alliance with Jounce Therapeutics that was formed by Celgene but is sticking with deubiquitinase (DUB) enzyme specialist Ubiquigent.

Celgene’s business was built around some of the areas in which Ubiquigent specializes. Thalidomide, Pomalyst and Revlimid—key drugs in Celgene’s product portfolio—all act on E3 ubiquitin ligases, a group of proteins involved in protein degradation. Celgene also struck protein degradation deals with Evotec, Nurix and Vividion Therapeutics in the years leading up to its merger with Bristol Myers.

In exploring the area, Celgene also entered into a drug discovery collaboration with Ubiquigent, a Scottish biotech that seeks to drive protein degradation through molecules that act on the ubiquitin system. Ubiquigent’s capabilities have landed it deals with companies including Forma Therapeutics.

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Bristol Myers has less of a legacy in the field than Celgene does, but it appears to have decided to build on the experience it acquired in the takeover. Ubiquigent’s statement about the continuation of the deal it signed with Celgene follows comments by Bristol Myers about the potential to get at undruggable targets via the ubiquitin-proteasome system.

"We’ve realized we can degrade hundreds of previously unrecognized proteins, and this number is the tip of the iceberg. There is potentially the ability to target perhaps thousands of protein targets. We’ve just scratched the surface when it comes to understanding how many proteins we can target, and our job now is to figure out which have therapeutic utility," Bristol Myers Senior Vice President Mark Rolfe said in a statement.

Bristol Myers published the comments made by Rolfe, who joined the company in the Celgene deal, weeks before releasing a Q&A with Josh Hansen about protein homeostasis. Hansen, who like Rolfe worked at a West Coast site Bristol Myers acquired from Celgene, cited solid tumors and immune diseases as conditions potentially amenable to treatment through protein degradation.

IVERIC bio, Inc. Announces Pricing of Upsized Public Offering of Common Stock and Pre-Funded Warrants

On June 18, 2020 IVERIC bio, Inc. (Nasdaq: ISEE) (the "Company"), reported the pricing of an upsized underwritten public offering of 24,535,720 shares of its common stock at a price to the public of $4.100 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,914,280 shares of its common stock at a price to the public of $4.099 per pre-funded warrant, in each case less underwriting discounts and commissions (Press release, Ophthotech, JUN 18, 2020, View Source [SID1234561248]). The purchase price of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.001 per share exercise price of such pre-funded warrant. In addition, in connection with the public offering, the Company has granted the underwriters an option for a period of 30 days to purchase up to an additional 3,967,500 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the securities are being offered by the Company.

Concurrent with the public offering, the Company has agreed to sell, subject to the consummation of the public offering and other customary conditions, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), 8,649,453 additional shares of its common stock to affiliates of Vivo Capital, LLC and Samsara BioCapital, LP, at a sale price equal to the price to the public in the public offering.

The aggregate gross proceeds from the public offering and the concurrent private placement are expected to be approximately $143.9 million, before underwriting discounts and commissions, placement agent fees and offering expenses payable by the Company, and without giving effect to any exercise by the underwriters of their option to purchase additional shares.

Cowen and Credit Suisse are acting as the book-running managers for the public offering and as placement agents for the concurrent private placement. Wedbush PacGrow is acting as lead manager for the public offering. The public offering and the concurrent private placement are expected to close on or about June 22, 2020, subject to customary closing conditions.

The public offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of an effective registration statement. A final prospectus supplement related to the public offering will be filed with the Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained, when available, by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by emailing [email protected], or by telephone: (833) 297-2926; or Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, or by telephone: (800) 221-1037, or by emailing [email protected].

The securities to be sold in the concurrent private placement have not been registered under the Securities Act, or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

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

PRESS RELEASE: EORTC and CDDF announce new collaboration

On June 18, 2020 CDDF reported that provides a neutral platform to stimulate interactions between all stakeholders involved in cancer drug development (Press release, EORTC, JUN 18, 2020, View Source [SID1234561242]). The aim of the organization is to accelerate the delivery of effective oncology agents to patients by encouraging multi-stakeholder discussions.

The collaboration will foster dialogue on common issues in clinical cancer research especially with other stakeholders. Both organisations intend to organise joint workshops and offer support and endorsement in each other’s events.

"Through the partnership with EORTC, one of the most important academic clinical research organizations worldwide, we believe we are offering unique value to stimulate advancement in oncology treatment and delivery" said Professor Jaap Verweij, CDDF Managing Director. "We believe collaboration is the key to improving outcomes for cancer patients and we look forward to a strong alliance with EORTC that will help identify and overcome challenges in the development and delivery of cancer drugs and deliver swift benefits to cancer patients."

"This is an important partnership for EORTC," said Dr Denis Lacombe, EORTC Director General. "CDDF has been instrumental in discussions with regulators and other stakeholders and with our combined efforts, we can bring challenging issues to the wider oncology community producing effective outcomes."