On June 11, 2020 City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, reported that it has signed an exclusive, worldwide licensing agreement with Scopus BioPharma Inc., a biopharmaceutical company focused on novel therapeutics for serious diseases with significant unmet medical needs (Press release, City of Hope, JUN 11, 2020, View Source [SID1234561015]). Scopus will further develop and plans to commercialize a City of Hope first-in-class, targeted immuno-oncology gene therapy.

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A first in-human phase 1 clinical trial for B cell lymphoma patients that uses the licensed gene therapy drug, CpG-STAT3siRNA, a STAT3 inhibitor, is expected to commence at City of Hope in the second half of this year.

Growing evidence links B cell non-Hodgkin lymphomas to persistent activation of STAT3, a gene that drives tumor cell growth and anti-tumor immune suppression. The STAT3 inhibitor is a highly selective and targeted therapy that silences the activity of the STAT3 gene by way of RNA interference. It also stimulates the TLR9 receptors to activate the body’s immune defense to recognize and kill cancer cells.

In preclinical testing at City of Hope, the STAT3 inhibitor has successfully reduced growth and metastasis of various preclinical tumor models, including melanoma, and colon and bladder cancers, as well as leukemia and lymphoma.

City of Hope’s Hua Yu, Ph.D., Billy and Audrey L. Wilder Professor in Tumor Immunotherapy, associate chair/professor in the Department of Immuno-Oncology, and co-leader of the Cancer Immunotherapeutics Program, and Marcin Kortylewski, Ph.D., associate professor in the Department of Immuno-Oncology, who are both leading experts in the role of STAT3 in tumor angiogenesis and tumor immune evasion and in oligonucleotide-based cancer immunotherapies, developed the STAT3 inhibitor. The strategy was developed based on seminal discoveries by Yu’s team defining the key role of STAT3 in cancer cell survival and immune tolerance, combined with pioneering work by Kortylewski’s team on STAT3 targeting using TLR9-targeted delivery of siRNA oligonucleotide therapeutics into immune cells.

"City of Hope is proud to work with Scopus to bring this long-anticipated STAT3 drug to our clinical trial patients," Yu said. "STAT3 is critical for the survival and metastasis of cancer cells, and for suppressing anti-tumor immune responses. If City of Hope and Scopus can develop the first therapy against STAT3, many cancer patients will benefit from this lifesaving drug."

"Our laboratories were the first to demonstrate that successful cancer immunotherapy needs to be two-step since TLR9 immunostimulation is only effective when STAT3 in the tumor microenvironment is no longer active," Kortylewski added. "It is exciting to see this technology approaching clinical application with a strong ally in biopharma."

Both an academic medical center and a drug development powerhouse, City of Hope is known for creating the technology used in the development of human synthetic insulin and numerous breakthrough cancer drugs. Its unique research and development hybrid of the academic and commercial creates an infrastructure that enables City of Hope researchers to submit an average of 50 investigational new drug applications to the U.S. Food and Drug Administration each year. The institution currently holds more than 450 patent families.

"Scopus is extremely excited about licensing such a promising gene therapy drug with a robust intellectual property portfolio, compelling preclinical efficacy and safety profile, and a plan to enter phase 1 this year," said Joshua R. Lamstein, Scopus co-chairman. "We are privileged to have the opportunity to work with City of Hope, a globally recognized research institution and cancer center. We are looking forward to working with Drs. Yu and Kortylewski, who are among the preeminent researchers in immuno-oncology."

On June 11, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for DKN-01 for the treatment of gastric and gastroesophageal junction cancer (Press release, Leap Therapeutics, JUN 11, 2020, View Source [SID1234561000]). DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling.

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"Orphan Drug Designation for DKN-01 in gastric and gastroesophageal junction cancer is another significant milestone in our DKN-01 development program and underscores the need for new treatment options for these indications," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We believe DKN-01 has the potential to be an important new therapy for this patient population that remains an area of high unmet medical need."

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan drug designation provides to Leap certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.

DKN-01 is currently being evaluated in Phase 1/2 and Phase 2 clinical trials for gastroesophageal, gynecologic, hepatobiliary, and prostate cancers. Site initiation activities are now underway for the Company’s combination study of DKN-01 plus tislelizumab, BeiGene, Ltd.’s anti-PD-1 antibody, in patients with gastric or gastroesophageal junction cancer with dosing of the first patients expected in the third quarter of 2020.

About DKN-01

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling, a signaling pathway frequently implicated in tumorigenesis and suppressing the immune system. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK ligands on tumor cells.

On June 11, 2020 Accellix, the Cell Therapy QC company, reported a Series D financing round of $9.5 million led by bioMérieux, a world leader in the field of in vitro diagnostics for over 55 years (Press release, Accellix, JUN 11, 2020, View Source [SID1234561016]). All existing major investors participated in this raise and have also agreed to convert their pre-existing convertible note in the amount of $8.5 million, bringing the company’s total funding in this round to $18 million. This latest round of funding will be used to further expand the market reach of the Accellix system for Cell Therapy QC, enabling its customers greater access to the expertise, scale, resources, and technology needed to effectively assess the quality of life saving immunotherapies.

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"Companies developing cellular therapies in the area of immuno-oncology and other therapeutic areas understand the need to replace costly and complicated flow cytometry based procedures with an easy to use sample-to-answer system. Being recognized by bioMérieux for our achievements to-date and having access to their vast array of resources and expertise, will help us serve our existing customers while attracting new ones," said Nir Nimrodi, Accellix Chairman and CEO.

"The Accellix platform eliminates extensive training and complex operational procedures by automating inherent manual complex flow cytometry processes. It provides accurate and immediate flow cytometry results at the point of need, removing the requirement of sending samples out to a central lab. We have been searching for such a platform that will complement our Industry-leading Microbial Quality Control offering and it is our intention to work with Accellix on enabling them to advance their market reach and service and support capabilities," stated Michael Reynier, bioMérieux Vice President, Healthcare Industries Business Area. "Testing a precious cell therapy product for sterility and for quality, swiftly, accurately and reproducibly, will improve patients’ access to the lifesaving cellular therapies that are currently being developed."

On June 11, 2020 Travecta Therapeutics reported it has raised an additional $12 million in financing, closing its Series A round at a total of $27 million (Press release, Travecta Therapeutics, JUN 11, 2020, View Source [SID1234605570]). The fund-raise was led by TKS1, a life science focused venture capital fund formed by the partnership between SPRIM and Tikehau Capital.

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"The positive traction we are having with our data along with the strength of interest from development and licensing partners has motivated our current investors to contribute an additional $12 million," said Michael Shleifer, CEO of Travecta Therapeutics. "This financing will accelerate our trajectory into the next phase of development, and we’re thankful to our partners for the support."

This funding comes on the heels of Travecta Therapeutics’ mVECTATM platform achieved targeting of a broad range of product candidates across the blood-brain-barrier with proven efficacy against pharmacological targets. "Our mVECTATM platform technology is unlocking key biological targets in neurological diseases that were previously difficult to engage because of the blood-brain barrier," said Dr. Mahmood Ahmed, Chief Scientific Officer.

The proceeds from the Series A financing will be used to support Travecta’s growth and advance the development of TVT-004, Travecta’s lead non-opioid product targeting pain. The company plans to enter clinical trials in 2021. The funding will also support the progression of the company’s earlier stage research programs in neuro-oncology and neuro-inflammation.

Bruno de Pampelonne, Chairman of Tikehau IM said, "Travecta Therapeutics’ mVECTATM platform could revolutionize treatments in a broad range of neurological indications often very difficult to treat. We are thrilled to partner with Travecta’s team in this endeavor"

On June 11, 2020 ChemoCentryx, Inc. (Nasdaq:CCXI) reported that it has commenced an underwritten public offering of its common stock (Press release, ChemoCentryx, JUN 11, 2020, View Source [SID1234561001]). In connection with this offering, ChemoCentryx plans to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of shares sold. SVB Leerink and Piper Sandler are acting as joint bookrunning managers for the offering. All shares of the common stock to be sold in the offering will be offered by ChemoCentryx. 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.

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The offering will be made by ChemoCentryx pursuant to a registration statement on Form S-3 previously filed with the U.S. Securities and Exchange Commission (SEC), which became effective upon filing on June 10, 2020. A preliminary prospectus supplement related to the offering and the accompanying prospectus have been filed with the SEC and are available on the SEC’s website located at View Source These documents may also be obtained from: SVB Leerink LLC, Attn: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by email at [email protected]; or Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, 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 such state or other jurisdiction.