On August 19, 2019 Lumicell, Inc., an innovation leader in image guided cancer surgery, reported that it has completed enrollment in its Phase C feasibility clinical trial of the Lumicell Imaging System for breast cancer (Press release, Lumicell Diagnostics, AUG 19, 2019, View Source [SID1234538862]). With results from the Phase C feasibility trial expected in late 2019, Lumicell expects to begin the pivotal trial by the end of 2019 before applying for FDA approval.

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Breast-conserving surgery is a critical first step of treatment for many women with breast cancer. The goal is to remove all the cancer cells, leaving behind only healthy tissue. However, today, surgeons do not have adequate tools to determine if all cancer has been removed during the initial surgery; instead, patients must wait until days after surgery to find out if all the cancer has been removed. Unfortunately, in as many as 20-40% of cases, cancer cells are found at the margins of the removed tissue, typically requiring patients to undergo a second surgery to remove the remaining cancer.

Lumicell has developed a novel system intended to enable surgeons to see and remove residual cancer cells in real-time during the initial surgery, with the ultimate goal of reducing the risk of second surgeries and cancer recurrence, while also minimizing healthy tissue removal and improving efficiency in the operating room.

"My goal is to provide the best outcomes for patients under our care at Novant Health. One of the most important ways we do that is through innovative technology. The Lumicell System gives me increased confidence during my lumpectomy procedures; for numerous patients enrolled in the Phase C trial, my team was able to avoid a second surgery by identifying and removing tissue highlighted by the Lumicell System. I’m encouraged by our experiences with the system thus far, and I’m eager to have this as an option available for all of our breast cancer patients," said Dr. David Carr, MD, General Surgeon at Novant Health Salem Surgical Associates and principal investigator for the Lumicell breast cancer trial at Novant Health.

The Lumicell Phase C trial is a multi-center, prospective clinical study of 234 patients across 16 sites, comprised of both academic medical centers and community hospitals. Dr. Barbara Smith, MD, PhD, Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School, is the lead investigator of the Lumicell breast cancer trials. Findings from this trial — the third feasibility study of the Lumicell System for Breast Cancer — will be published at the end of 2019. Lumicell is also expecting to initiate the pivotal trial stage later this year to support an FDA submission for approval of the Lumicell System for the treatment of breast cancer.

"With the Lumicell Phase C trial now fully enrolled, we are quickly moving forward with the data review, and finalizing the design and plans for the pivotal study to begin later this year," said Andrey Zarur, PhD, Executive Chairman at Lumicell. "We’re confident that we have developed a pivotal trial design that is compelling to patients and surgeons. And we’re optimistic that the pivotal trial will deliver results clearly demonstrating the clinical value of the Lumicell System in the treatment of breast cancer and benefits to the patients."

The Lumicell System is also in early feasibility trials for treatment of prostate, brain, colorectal, esophageal and pancreatic cancers, as well as peritoneal metastases from primary ovarian and colon cancers.

On August 19, 2019 Mateon Therapeutics, Inc. (OTCQB:MATN) ("Mateon") and PointR Data Inc. (PointR), a privately-held, developer of high performance cluster computer and artificial intelligence company, reported that they have entered into a definitive agreement with respect to a merger, creating a publicly traded artificial intelligence ("AI") driven immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma (Press release, Mateon Therapeutics, AUG 19, 2019, View Source [SID1234538861]).

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"We believe that the merger of Mateon and PointR will create a combined company that can generate shareholder value through a promising pipeline of next generation immunotherapies leveraging high performance, personalized and secure cluster computer for AI driven drug development and personalized healthcare deliveries," said Vuong Trieu, Ph.D., Chairman and Chief Executive Officer of Mateon. "This is culmination of over a year of working together on disruptive technologies for drug development and healthcare."

"We are thrilled at the opportunity of vertically integrating AI and drug development capabilities under one roof. We expect to quickly identify promising new therapeutic opportunities for various diseases delivering compelling business value," said Saran Saund, PointR’s Chief Executive Officer. "The prospect of interdisciplinary teams from biotech and technology sectors can significantly accelerate drug candidates towards the clinic while expanding our proprietary datasets."

"The integration of AI and machine learning algorithms in new drug discovery and lead optimization, design of biomarker-driven clinical studies as well as identification of biomarker-enriched patient populations most likely to respond to new anti-cancer drug candidates are potentially paradigm-shifting initiatives with a very high scientific merit. AI-based cognitive technologies have the potential to streamline our clinical development strategy for the portfolio drug candidates, including our lead compound OT101, by amplifying our knowledge and understanding of the target cancers, their biology as well as structural and pharmacologic characteristics of the lead compounds," said Dr. Fatih Uckun, MD, PhD, the Chief Medical Officer of Mateon. "Furthermore, the combined use of AI and the Blockchain technology supported by the PointR AI computing platform has a very high impact potential for better cancer care and especially patient-tailored cancer treatments," he added. Dr. Uckun explained: "Blockchain technology-powered clinical development platforms for the anti-cancer drug candidates in our pipeline, including our lead compound OT101 could (i) expedite multi-stakeholder collaboration via optimized peer-to-peer data sharing for success of R&D efforts aimed at a cure for difficult-to-treat forms of cancer, (ii) amplify data management capabilities that are critical for the clinical development of the most promising drug candidates, and (iii) enable rapid identification of best clinical study sites and investigators as well as optimized clinical protocol designs to ensure high quality clinical trials with streamlined feasibility checks and very short study start-up and rapid completion times.

Merger Terms

Under the terms of the merger agreement, PointR will be merged into and become a wholly owned subsidiary of Mateon. Holders of PointR common stock prior to the merger will be entitled to $15,000,000 payable in shares of Mateon common stock, calculated at of $0.18 per share. The merger agreement also provides for two additional tranches of merger consideration based on: (1) PointR’s achievement of proof of concept and (2) licensing deal for AI based asset for minimum of $100 million in life-time license fees of which at least $10 million has been received. Each tranche is for $7,500,000 in value of additional Mateon common stock, based on the market price at the time of payment, subject to a minimum value of $0.18 per share.

The merger is subject to customary conditions to closing. In addition, Mateon’s obligation to close is conditioned on PointR providing audited financial statements that would be required for Mateon to comply with the SEC’s filing requirements. PointR’s obligation to close is conditioned on Mateon raising a minimum of $10 million in an equity financing transaction or $5 million in a commercial agreement. In addition, PointR’s obligation is conditioned upon Mateon to grant a license to allow the former shareholders of PointR to use elements of the technology in fields outside of pharmaceutical development. Mateon and PointR intend to actively seek additional capital to support the combined business, no additional equity financing or commercial agreement is in place at this time. The merger is not expected to close until such financing is secured.

On August 19, 2019 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the company will participate in the following conference in September (Press release, Horizon Therapeutics, AUG 19, 2019, View Source [SID1234538860]):

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Morgan Stanley 17th Annual Global Healthcare Conference

Date: Sept. 10, 2019
Presentation Time: 10 a.m. ET
Location: New York
The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for the event.

On August 19, 2019 PharmaMar (MSE: PHM) reported that the FDA (Food and Drug Administration) agreed with PharmaMar’s proposal to file for accelerated approval its New Drug Application (NDA) for lurbinectedin monotherapy for the treatment of second-line SCLC (Press release, PharmaMar, AUG 19, 2019, View Source [SID1234538859]).

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The FDA’s accelerated approval program allows the submission of the registration dossier for evaluation based on investigational drug results of a Phase II study for serious conditions that satisfy an unmet medical need.

The application will be based on data from the SCLC cohort of the lurbinectedin Phase II monotherapy basket trial that enrolled a total of 105 patients at 39 centers in more than 9 countries in Western Europe and the United States. The primary endpoint of Overall Response Rate (ORR), was achieved by both the investigator and the Independent Review Committee (IRC) assessment. Secondary endpoints included Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS), and safety.

PharmaMar anticipates that the NDA filing will take place in the fourth quarter of 2019.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On August 19, 2019 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the closing of its previously announced registered underwritten public offering (Press release, Deciphera Pharmaceuticals, AUG 19, 2019, View Source [SID1234538857]). 10,810,810 shares of the Company’s common stock at a price to the public of $37.00 per share were issued and sold in the offering. The gross proceeds to Deciphera from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $400.0 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to 1,621,621 additional shares of its common stock.

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J.P. Morgan, Piper Jaffray and Jefferies acted as joint book-running managers for the offering. Guggenheim Securities acted as lead manager for the offering. SunTrust Robinson Humphrey acted as co-manager for the offering.

Deciphera intends to use the net proceeds of the offering to fund: clinical trials for ripretinib, including the expansion stage of its current Phase 1 clinical trial, its ongoing pivotal Phase 3 clinical trials, and additional clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material, and pre-commercialization manufacturing process development and validation; clinical trials for DCC-3014, including the expansion stage of its current Phase 1 clinical trial, as well as clinical research outsourcing and manufacturing of clinical trial material; clinical trials for rebastinib, including its current Phase 1b/2 clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material; Investigational New Drug-enabling studies and the potential development of DCC-3116; new and ongoing research activities for future drug candidates using its proprietary kinase switch control inhibitor platform; continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company; and working capital purposes, including general operating expenses.

The offering was made only by means of a prospectus supplement and accompanying prospectus forming part of a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on October 12, 2018. The final prospectus supplement and the accompanying prospectus was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

This press release does 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 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.