On July 17, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of the company’s proprietary therapeutic agents, reported the publication in the journal OncoImmunology of results from nonclinical research conducted in partnership with the National Cancer Institute’s (NCI) Vaccine Branch under a Cooperative Research and Development Agreement (CRADA) (Press release, Intensity Therapeutics, JUL 17, 2019, View Source [SID1234537570]). All results and data reported in the paper were generated at the NCI.
"The results of this study are noteworthy because they demonstrate the anti-cancer benefits of INT230-6 extend beyond direct killing of the injected tumor to fighting tumors throughout the body by immune activation," said Anja C. Bloom, Ph.D., first author and former visiting postdoctoral researcher at the NCI Vaccine Branch, who conducted the majority of the work at the NCI. "We believe this is the first time that the well-known agents comprising INT230-6, cisplatin and vinblastine showed induction of a durable immune activation. We believe this result is due to the intratumoral delivery mechanisms of the compound, which appears to cause cell death that also releases antigens to initiate an adaptive immune response."

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The peer-reviewed paper entitled "Intratumorally delivered formulation, INT230-6, containing potent anticancer agents induces protective T cell immunity and memory," describes the immune response induced from direct injection of Intensity’s lead product candidate, INT230-6, into subcutaneously implanted murine colon and orthotopic breast tumors. Treatment resulted in regression from baseline in 100 percent of tumors and complete response in up to ninety percent of mice. Studies that knocked out the mouse immune cells prevented complete responses, indicating a critical role of immune cells in treatment benefit. Mice with complete responses were protected from subcutaneous and intravenous re-challenge of the cancer, revealing that long-term immunological memory was induced by INT230-6.

Complete remission of the primary tumors was accompanied by shrinking and disappearance of a number of untreated contralateral tumors when INT230-6 was combined with checkpoint inhibitors, demonstrating not only a local but also systemic immunological effect.

"Our work with Intensity Therapeutics was to evaluate the benefits of INT230-6 because of its delivery directly into solid tumors," said Jay A. Berzofsky, M.D., Ph.D., Chief of the Vaccine Branch at the National Cancer Institute. "The results show that not only was complete regression achieved in a majority of injected tumors, but T cell immunity and immunological memory to the cancer were induced, associated with regression observed also in non-injected tumors and synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. The treatment converts the tumor to an endogenous vaccine. Our results suggest that intratumoral approaches can be designed to provide a new strategy for effective immunotherapy of cancer."

"Intensity Therapeutics entered into the CRADA with the NCI in 2014, and this peer-reviewed publication is the culmination of that research. The positive results described in the paper demonstrate the unique potential of our novel cancer treatment approach," said Lewis H. Bender, Founder, President and Chief Executive Officer of Intensity Therapeutics. "We are currently evaluating INT230-6 in a Phase 1/2 clinical trial and have tested the drug in 15 different types of solid tumor cancers with promising results. The research with the NCI helped us design our clinical trial, and we recently presented clinical data at ASCO (Free ASCO Whitepaper) that indicate local treatment with INT230-6 alone in certain tumor types regresses injected tumors and initiates a systemic immune activation with results similar to the effects reported in our OncoImmunology paper. The nonclinical and clinical data generated to date increase our optimism about the potential of INT230-6 to kill tumors locally, activate the immune system, reduce the side effects associated with current systemic therapies and improve patient outcomes with achievement of a long-term, durable response for a number of cancers."

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

On July 17, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported the pricing of an underwritten public offering of 2,300,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase up to 2,300,000 shares of the Company’s common stock (Press release, Xenetic Biosciences, JUL 17, 2019, View Source [SID1234537586]). Each share of common stock is being sold together with one warrant to purchase one share of common stock at a combined price to the public of $6.50 per share and warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $15.0 million.

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The warrants will be immediately exercisable at a price of $13.00 per share of common stock and will expire five years from the date of issuance. The warrants are expected to begin trading on the Nasdaq Capital Market on July 19, 2019 or as soon thereafter as practicable, under the symbol "XBIOW." The warrants also provide that if the weighted-average price of common stock on any trading day on or after 30 days after issuance is lower than the then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis for one share of common stock. The shares of common stock and the accompanying warrants, can only be purchased together in the offering, but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about July 19, 2019, subject to customary closing conditions.

Maxim Group LLC is acting as sole book-running manager in connection with the offering.

Xenetic also has granted to the underwriter a 45-day option to purchase up to an additional 345,000 shares of common stock and/or warrants to purchase up to 345,000 shares of common stock, at the public offering price less discounts and commissions.

The offering is being conducted pursuant to the Company’s registration statement on Form S-1 (File No. 333-231508) previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). A prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.

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.

On July 17, 2019 NuCana plc (NASDAQ: NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, reported that the first patients have been dosed in the Phase I study of NUC-7738 (Press release, Nucana BioPharmaceuticals, JUL 17, 2019, View Source [SID1234537571]). This is the third ProTide NuCana has advanced to clinical studies and further broadens the therapeutic scope of the ProTide portfolio. NUC-7738 is NuCana’s ProTide transformation of 3’-deoxyadenosine (or cordycepin), a novel nucleoside analog with a unique mode of action, that has shown potent anti-cancer activity in preclinical studies.

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Hugh Griffith, NuCana’s Chief Executive Officer, stated: "The dosing of the first patients in this Phase I study of NUC-7738 is another major step in the expansion of NuCana’s product pipeline. NUC-7738 is our third ProTide to advance to the clinic and the first that is based on a novel nucleoside analog. We are grateful to the patients and clinicians who are making this study possible."

More information about this study may be found here.

NUC-7738 is a ProTide transformation of cordycepin, a nucleoside analog that was isolated from the fungus Cordyceps sinensis in 1950. Cordycepin has demonstrated potent anti-cancer activity in multiple preclinical studies, but has not been successfully developed primarily due to its degradation by the enzyme adenosine deaminase (or ADA). Unlike the parent nucleoside analogue, NUC-7738 is not a substrate for this enzyme and is therefore resistant to degradation by ADA. Similar to NuCana’s other ProTides, NUC-7738 is designed to generate significantly higher levels of the active anti-cancer metabolite of cordycepin, 3’-deoxyadenosine triphosphate (or 3’-dATP), directly inside cells, bypassing the resistance mechanisms of transport, activation and breakdown.

Sarah Blagden, Associate Professor of Experimental Cancer Therapeutics at The University of Oxford and Principal Investigator of the study stated: "Oxford Early Phase Trials unit has enrolled the global first cancer patient to receive NUC-7738, the latest ProTide anti-cancer agent from NuCana’s pipeline. This is an exciting study to participate in and we look forward to seeing the clinical results."

On July 17, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will reported its second quarter 2019 financial results on Wednesday, July 31, 2019 after the financial markets close (Press release, Vertex Pharmaceuticals, JUL 17, 2019, View Source [SID1234537573]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

On July 16, 2019 Cyclica, a Toronto-based biotechnology company leveraging AI and computational biophysics for drug discovery, and Professor Igor Stagljar from the Donnelly Centre for Cellular and Biomolecular Research, Department of Biochemistry & Department of Molecular Genetics at the University of Toronto, reported a collaboration to optimize lead compounds and de novo design of novel compounds in an effort to advance precision medicine with the next-generation EGFR-inhibitors in non-small cell lung cancer (NSCLC) (Press release, Cyclica, JUL 16, 2019, View Source [SID1234537555]). The Stagljar Lab is located in the Donnelly Centre, a cutting-edge, interdisciplinary research institute in the heart of Toronto’s research district.

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NSCLC makes up approximately 85% of lung cancers. Evolved drug resistance has been a key challenge for treating NSCLC due to EGFR mutations, which are present in roughly 17% of people with lung cancer in the United States. The prevalence of these mutations increase to 50% in people of Eastern Asian descent, and are more common in women than men. Additional research in treating NSCLC is critical to developing effective precision medicines that can target the evolving nature of this disease.

MatchMaker, Cyclica’s proprietary deep learning protein-ligand binding technology, will be used to batch deconvolute a shortlist of shared targets among a group of promising lead compounds identified at the Stagljar Lab using their proprietary MaMTH-Drug Screening (MaMTH-DS) assay to drive new mechanistic insights of such a disease. Ligand Design, Cyclica’s multi-targeted and multi-objective drug design platform, will then create structural variants of the existing lead compounds, and computationally design novel compounds that have the preferred polypharmacological, pharmacokinetic, and physicochemical properties. Recently, Nature Medicine online published an article featuring Cyclica’s drug discovery platforms, and highlighted the value of designing multi-targeted drugs for oncology. The Stagljar Lab will synthesize selected the novel compounds, and conduct downstream validation through its proprietary set of assays for further research and commercialization opportunities. All IP generated from this project related to the compounds will be shared equally by Cyclica and the University of Toronto.

"We are thrilled to be working with the world class Stagljar Lab to leverage our drug discovery platform to progress our shared interests in creating novel advanced lead compounds for non-small cell lung cancer," says Naheed Kurji, President & CEO, Cyclica. "This project is an example of the growing integration between science and industry focused on commercialization, and a testament to the hyper innovative work being done in our own backyard at the University of Toronto."

"We are extremely pleased to be working with Cyclica since our collaboration represents a unique approach that unites two completely novel and complementary approaches, Cyclica’s artificial intelligence MatchMaker and our MaMTH-DS live-cell drug discovery assay, for the rapid identification and validation of novel EGFR inhibitors in NSCLC. I’m positive that our joint efforts will accelerate our ability to build novel EGFR inhibitors with these cutting-edge technologies and will thus speed up their implementation in the clinics," says Dr. Igor Stagljar, University of Toronto.

Cyclica is a Toronto-based, globally recognized biotechnology company that leverages AI and computational biophysics to reshape drug discovery. Cyclica provides the pharmaceutical industry with Ligand Express and Ligand Design, an integrated, holistic, and end-to-end enabling platform focused on polypharmacology. Ligand Design and Ligand Express augment how scientists design advanced lead like molecules that minimize off-target effects, and gain insights into structural pharmacogenomics. By doing more with artificial intelligence, Cyclica aims to revolutionize a system troubled with attrition and costly failures, accelerate the drug discovery process, and develop medicines with greater precision.

The Stagljar Lab at the University of Toronto is focused on protein-protein interactions (PPIs), with a particular interest in disease progression due to altered signalling pathways. They examine how proteins involved in these signalling pathways interact with each other, and try to understand how impaired PPIs lead to numerous human diseases such as lung cancer, pancreatic cancer, breast cancer, brain cancer and aging. In close collaboration with medicinal chemists and clinical investigators, the Stagljar lab investigates the molecular mechanisms behind challenging, unexplained observations on drugs and on pathological events.

The Donnelly Centre for Cellular and Biomolecular Research is an interdisciplinary research institute at the University of Toronto in which scientists make fundamental discoveries in biology to improve health. Founded in 2005, the Centre is globally recognized as a leading biomedical research hub thanks to our researchers’ landmark discoveries in genetics, stem cell biology and the molecular basis of disease, as well as state-of-the-art tools in large-scale data analysis. As well as making discoveries, our researchers also strive to translate their findings into tangible advances in medicine to help patients.