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Cardax Reports Q2 2019 Results

On August 14, 2019 Cardax, Inc. (OTCQB:CDXI) reported filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 (Press release, Cardax Pharmaceuticals, AUG 14, 2019, View Source [SID1234538743]).

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Recent developments include:

CHASE Clinical Trial Update

Cardax plans a pre-specified interim review in September 2019 of the aggregate data by treatment group from its CHASE human clinical trial. The CHASE trial is evaluating the effect of ZanthoSyn on cardiovascular inflammatory health, as measured by C-Reactive Protein or "CRP," as a primary endpoint. Other data collected includes secondary inflammatory health markers as well as safety parameters. Positive results could not only support ZanthoSyn marketing but serve as an important proof-of-concept for the Company’s pharmaceutical program and provide additional intellectual property protection.

Interim Financing Update

Cardax also announced today that it raised $1,675,000 in additional capital since the beginning of Q2 2019 ($750,000 in Q2 2019 and $925,000 in Q3 2019 to date), using a combination of convertible notes, equity units (stock and warrants), and loans, the proceeds of which are being used for general corporate purposes.

ZanthoSyn Update

As reported previously, in Q1 2019 retail "sell-through," defined as retail sales of ZanthoSyn to customers at General Nutrition Corporation ("GNC") stores, surpassed all previous periods and Q2 2019 continued at strong levels as the third best performing quarter since launch. In addition, ZanthoSyn is the top-selling product nationwide in GNC’s antioxidant category for 2019 year-to-date as well as the top-selling overall product in GNC’s Hawaii stores. Notwithstanding, GNC continued to trim the inventory sell-in substantially in Q2 2019. "Sell-in" is defined as wholesale orders of ZanthoSyn by GNC less sales incentives, promotions, discounts, and refunds. As a result, Cardax net revenues were $45,391 and $210,363 for the 3 and 6 months ended June 30, 2019 compared to $272,049 and $585,359 for the 3 and 6 months ended June 30, 2018.

While ZanthoSyn sell-in to GNC in Q3 2019 to date has already exceeded the total Q2 2019 sell-in, Cardax provided notice to GNC that its "U.S. brick-and-mortar retail store" exclusivity contract with GNC for ZanthoSyn would not automatically renew in October 2019. Cardax may expand ZanthoSyn distribution to mass market retailers, other specialty nutrition stores, pharmacies, and other retailers.

Cardax plans to expand its direct-to-consumer e-commerce efforts by capitalizing on one of the most important lessons learned from its sales and marketing program: "Conversations Create Customers." Whether at GNC stores, directly with Cardax personnel, or at conferences for healthcare professionals, thousands of ZanthoSyn customers have been created by understanding and experiencing the benefits of ZanthoSyn firsthand. Cardax plans to implement strategies that it believes may create a similar customer experience more broadly, with fulfillment online, where margins are greater than retail stores.

"As inflammatory health becomes ever more important to the scientific, medical, and financial communities, we look forward to the interim review of our CHASE clinical trial," said David G. Watumull, Cardax President and CEO. "We are also pleased to see ZanthoSyn’s strong retail sales at GNC drive an increase in wholesale orders in Q3 and look forward to expanding our ZanthoSyn marketing and distribution more broadly."

CEL-SCI Corporation Reports Third Quarter Fiscal 2019 Financial Results

On August 14, 2019 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2019 (Press release, Cel-Sci, AUG 14, 2019, View Source [SID1234538742]). The Company also reported key clinical and corporate developments achieved during the quarter.

Clinical and Corporate Developments included:

CEL-SCI’s Phase 3 head and neck cancer study continued to follow all 928 patients who were enrolled. The Company is now awaiting final study results. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if the primary endpoint of the study, a 10% improvement in overall survival of the Multikine* treatment regimen plus Standard of Care (SOC) vs. SOC alone will be met. The primary endpoint will be determined after a total of 298 events (deaths) have occurred in the two main comparator arms of the study and have been recorded in the study database. These final results could be available soon since the last cancer patients were treated in September 2016, and the first cancer patients in the study were treated in early 2011.
On May 11, 2019 and July 3, 2019, new data was presented on CEL-SCI’s experimental LEAPS therapeutic antigen-specific treatment for rheumatoid arthritis. The work was performed in conjunction with researchers at Rush University Medical Center, Chicago, Illinois.
On June 3-6, 2019, CEL-SCI was an exhibitor and showcased its presentation at the BIO International Convention. CEL-SCI was selected to be part of the Innovation Zone sponsored by the U.S. National Institutes of Health (NIH). The focus was the Company’s experimental LEAPS platform technology and CEL-SCI’s ongoing development of a LEAPS based therapeutic antigen-specific treatment for rheumatoid arthritis. The NIH has funded research studies for CEL-SCI’s LEAPS technology in the treatment of rheumatoid arthritis through a $1.5 million grant. There was a lot of corporate interest in the LEAPS technology for rheumatoid arthritis.
On June 28, 2019, CEL-SCI joined the broad-market Russell 3000 Index that was effective after the US market opened on July 1, 2019.
Following this quarter, between July 1, 2019 and August 13, 2019, the Company received over $2.5 million through the exercise of warrants to purchase shares of the Company’s common stock.
"We look forward to the readout of our Phase 3 data, as we believe Multikine immunotherapy may increase the success rate of the first ‘intent to cure’ cancer treatment regimen by adding the tumor cell killing ability of the still healthy immune system to the known anti-tumor effects of surgery, radiation and chemotherapy. Multikine is unique in cancer immunotherapy because it can potentially be effective when administered for just three weeks, right after diagnosis and prior to surgery, as compared to other immuno-oncology drugs on the market today that are used to treat people with recurrent cancer, or end stage disease," stated CEL-SCI CEO, Geert Kersten. "Our experimental LEAPS vaccine platform continues to show promise as we continue IND-enabling studies in conjunction with the NIH."

CEL-SCI reported a net loss of $17.3 million for the nine months ended June 30, 2019 versus a net loss of $16.9 million for the nine months ended June 30, 2018. The net loss increase was in large part due to the change in value of the non-cash derivative instruments that were caused mainly by fluctuation in the share price of the Company’s common stock.

During the three months ended June 30, 2019, the Company’s cash increased by approximately $4.0 million, as compared to the second quarter of fiscal 2019, to $9.5 million. Significant components of this increase included net proceeds from the exercise of warrant and stock options of approximately $8.4 million and the purchase of common stock by officers and directors of approximately $0.2 million. The increase was offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $4.6 million.

Deciphera Pharmaceuticals Announces Pricing of Public Offering of Common Stock

On August 14, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the pricing of its previously announced registered underwritten public offering of 10,810,810 shares of its common stock at a price to the public of $37.00 per share (Press release, Deciphera Pharmaceuticals, AUG 14, 2019, View Source [SID1234538741]). The gross proceeds to Deciphera from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be $400.0 million. The offering is expected to close on or about August 19, 2019, subject to customary closing conditions. In addition, Deciphera has granted the underwriters a 30-day option to purchase up to 1,621,621 additional shares of its common stock.

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 trial, 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.

A shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) and was declared effective by the SEC on October 12, 2018. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, 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.

M2Gen® Appoints Dr. Helge Bastian President and Chief Executive Officer

On August 14, 2019 M2Gen, a health informatics solutions company focused on accelerating the discovery, development and delivery of precision medicine, reported the appointment of Helge Bastian, Ph.D., as president and chief executive officer (CEO) (Press release, M2Gen, AUG 14, 2019, View Source [SID1234538740]). Bastian succeeds M2Gen Executive Chair William S. Dalton, M.D., Ph.D., who has served as interim CEO since September 2018.

"Dr. Bastian has a proven track record of building profitable and sustainable businesses in the life sciences and healthcare sectors including many years of experience in leading clinical research and biobanking organizations supporting precision medicine approaches. We are excited to have Dr. Bastian join M2Gen and lead our company to the next level as we deliver health information solutions that link patient-specific clinical and molecular data with the objective of developing and delivering personalized medicine for patients. With Dr. Bastian at the helm, M2Gen will continue to grow and advance the company’s mission to learn from each patient and proactively develop therapeutic options to meet patient needs," said Dalton.

Dr. Bastian is an experienced executive and scientific leader with more than 27 years of international experience while contributing to the growth of leading life science and healthcare companies in Germany, Switzerland and the USA. His expertise spans, molecular and synthetic biology including game-changing technologies such as genome editing, gene synthesis and re-programming, molecular and companion diagnostics, clinical research, drug development, pharmaceutical manufacturing and biobanking. As M2Gen’s new CEO, he will focus on expanding the company’s business portfolio and growing the Oncology Research Information Exchange Network (ORIEN), an alliance of biopharmaceutical companies and leading cancer centers, powered by M2Gen’s data and informatics platforms that work in collaboration to address the greatest challenges in oncology drug development. He will also join M2Gen’s Board of Directors.

"I am very excited about M2Gen’s revolutionizing data-driven approach to precision medicine in such an important area as oncology that affects so many people’s lives. I look forward to bringing my leadership experiences from the life science and healthcare industry to M2Gen and taking the company to the next level of its exciting growth strategy," said Bastian. "Understanding a patient’s genetic predisposition and the real-time molecular patterns in a patient’s tumor in combination with his / her clinical data is paramount to unravel the molecular mechanisms responsible for cancer development, and for developing new drugs and therapies as well as for accurate patient enrolling to clinical trials and even for developing strategies for cancer prevention. M2Gen’s initiative to build this unique and growing healthcare ecosystem of cancer centers to support clinical and molecular data sharing from a large number of cancer patients via M2Gen’s platforms is designed to fundamentally change the way cancer is being studied and treated, and will accelerate the discovery and development of precision treatment options for patients."

Dr. Bastian joins M2Gen from Thermo Fisher Scientific, Inc., where he led the Sample Preparation and Synthetic Biology businesses as Vice President and General Manager since 2014. Before Thermo Fisher Scientific, Dr. Bastian held a number of senior leadership positions and served as a member of several executive leadership teams, including Managing Director and Chief Commercial Officer at Indivumed, an integrated oncology company; Vice President Global Marketing, Business Development and Strategy at Sigma-Aldrich (now Merck KGaA); Executive Vice President Life Science Services for SGS, the world’s leading inspection, verification, testing and certification company. Prior to SGS, he held various management positions during his 11-plus years at Qiagen including Vice President Molecular Diagnostics, Vice President Global Strategic Marketing, and Vice President PreAnalytiX, a QIAGEN / Becton Dickinson joint venture. Dr. Bastian earned his diploma in biology / biochemistry from Georg-August University and holds a Ph.D. in molecular and cell biology performed at the Max-Planck Institute for Biophysical Chemistry. From 2014-2018, Dr. Bastian served as a board member to the International Gene Synthesis Consortium (IGSC). Dr. Bastian has recently been appointed to the board of directors at enzymatic gene synthesis pioneer Molecular Assemblies, Inc., San Diego, and is an alumnus from the Max-Planck-Network and the Columbia Business School.

Fate Therapeutics Announces Issuance of Foundational U.S. Patent Covering iPSC-derived CAR T Cells

On August 14, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the U.S. Patent and Trademark Office has issued U.S. Patent No. 10,370,452 covering compositions and uses of effector T cells expressing a chimeric antigen receptor (CAR), where such T cells are derived from a pluripotent stem cell including an induced pluripotent stem cell (iPSC) (Press release, Fate Therapeutics, AUG 14, 2019, View Source [SID1234538739]). The foundational patent, which expires in 2034, is owned by Memorial Sloan Kettering Cancer Center (MSK) and is licensed exclusively to Fate Therapeutics for all human therapeutic uses.

"The breadth of this newly-issued patent, which is not restricted by the signaling domain of the CAR construct nor by the antigen to which the CAR targets and binds, covers off-the-shelf, iPSC-derived CAR T cell therapy for the treatment of cancer, infectious disease and immune disorders," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "This patent is a testament to the prescient work of MSK’s Dr. Michel Sadelain in combining CAR and iPSC technologies in an effort to overcome the significant challenges that limit the widespread adoption of patient- and donor-sourced engineered T-cell immunotherapy."

Fate Therapeutics and MSK are conducting research and development of T-cell product candidates derived from iPSCs. These activities include the conduct of IND-enabling studies for FT819, an off-the-shelf CAR T-cell product candidate derived from a clonal master engineered iPSC line with complete elimination of T-cell receptor (TCR) expression and a novel 1XX CAR targeting CD19 inserted into the T-cell receptor alpha constant (TRAC) locus. Fate Therapeutics recently expanded its laboratory operations to New York City to support its research and development of off-the-shelf, iPSC-derived T cells.

Fate Therapeutics has built a dominant intellectual property position broadly covering iPSC technology and iPSC-derived cell products. Its proprietary portfolio includes compositions and methods for generating iPSCs, including engineering their biological properties using CRISPR and other nucleases, and for producing genetically edited cells of the hematopoietic lineage, including NK cells and T cells, from iPSCs. Fate Therapeutics’ iPSC product platform is supported by over 250 issued patents and 150 pending patent applications.

About FT819
FT819 is an off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell product candidate manufactured from a clonal master iPSC line that is undergoing IND-enabling activities in collaboration with Memorial Sloan Kettering Cancer Center (MSK). FT819 is manufactured from a clonal master engineered iPSC line with complete elimination of TCR expression and a novel 1XX CD19-specific CAR inserted into the T-cell receptor alpha constant (TRAC) locus. These synthetic features are intended to mitigate the risk of graft-versus-host disease, a severe life-threatening condition that occurs when donor T cells attack a patient’s healthy tissue, and to regulate CAR expression to enhance the therapeutic potency and durability of CAR T cells. Scientists from the Company and MSK have presented preclinical data demonstrating that FT819 lacks TCR expression, is highly cytotoxic and specific to CD19 antigen and controls tumor progression comparable to peripheral blood CAR19 T cells in a mouse model of acute lymphoblastic leukemia.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is fraught with batch-to-batch and cell-to-cell variability that can affect safety and efficacy.