On March 13, 2019 PsiOxus Therapeutics, Ltd. (PsiOxus), the gene therapy for cancer company, reported that it has started dosing NG-350A, an antibody based cancer gene therapy, to cancer patients (Press release, PsiOxus Therapeutics, MAR 13, 2019, View Source [SID1234534308]). The Phase 1 FORTITUDE study is being conducted at multiple cancer centers in the United States and will assess the safety, tolerability and preliminary antitumor activity of NG-350A in subjects with solid tumors.

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"Our approach is to systemically deliver a gene therapy vector to turn tumor cells into drug factories," stated Dr Brian Champion, the Chief Scientific Officer of PsiOxus. "The patient’s own tumor cells are used to produce the therapeutic antibody directly in the tumor micro-environment to treat their cancer." The monoclonal antibody delivered by NG-350A is a CD40 agonist, a potentially powerful activator of a patient’s immuno-inflammatory response. When delivered systemically, CD40 agonists have produced adverse events that may limit their use. NG-350A directs the production of the antibody locally within the tumor and PsiOxus is developing this agent to improve the potential for a tolerable and effective treatment. John Beadle, M.D., Chief Executive Officer of PsiOxus stated "PsiOxus is delighted to have our second cancer gene therapy in clinical development. We look forward to generating clinical data on this exciting new product to treat and benefit cancer patients."

FORTITUDE is an open-label, dose expansion, multicenter, Phase 1 study expected to enroll up to 125 patients across multiple clinical study sites in the United States. Phase 1a of the study will assess the safety, tolerability and dose of NG-350A and will enroll patients at study sites in the United States, led by Dr Aung Naing of the MD Anderson Cancer Center. Phase 1b of the study will evaluate NG-350A in expansion cohorts in subjects with specific metastatic or advanced tumors. The ClinicalTrials.gov identifier for the NG-350A study is: NCT03852511.

PsiOxus’ proprietary T-SIGn platform uses the enadenotucirev oncolytic virus as a vector to deliver combinations of therapeutic transgenes to carcinomas to fight cancer. All T-SIGn products are administered intravenously and are designed to selectively infect and replicate only in tumor cells. NG-348, the first T-SIGn virus to enter clinical trials, is licensed to Bristol-Myers Squibb.

On March 13, 2019 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that it has submitted a request for Fast Track Designation with the US Food and Drug Administration (FDA) for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia (AML) (Press release, Moleculin, MAR 13, 2019, View Source [SID1234534272]).

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"Now that we have some traction in our clinical trials of Annamycin for the treatment of relapsed or refractory AML," commented Walter Klemp, Moleculin’s Chairman and CEO, "we believe it is appropriate to request Fast Track designation for Annamycin. Importantly, this is a valuable first step in ultimately qualifying for Accelerated Approval and Priority Review."

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

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from 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 Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

On March 13, 2019 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) confirming composition of matter claims involving trypsinogen and chymotryosinogen have been allowed (Press release, Propanc, MAR 13, 2019, View Source [SID1234534283]). The additional composition claims are a continuation from the original foundation patent in the U.S. and as a result, both method of treatment and composition claims will protect the Company’s lead product candidate, PRP, a pharmaceutical composition for treating cancer.

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A Notice of Allowance is issued by the USPTO to indicate that it believes an invention qualifies for a patent. The reasons for allowance stipulated by the USPTO examiner stated that the scientific declarations presented establishes that compositions comprising trypsinogen and chymotrypsinogen exhibit a synergistic ability to inhibit the growth of various cancer cell lines, and that this effect would be unexpected to one of ordinary skill in the art, thus concluding the claims were patentable.

"We are delighted to receive allowance of additional claims from the USPTO, and composition of matter claims represent the strongest protection possible for PRP in our most important jurisdiction," said James Nathanielsz, Propanc’s Chief Executive Officer, "Presently, we have 65 patents either in force, or pending, in major global regions around the world, and our rapidly growing IP portfolio is becoming very significant as we advance PRP towards human trials."

On March 12, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported that management will participate in four investor conferences in March, including the 31st Annual ROTH Conference in Laguna Niguel, California, the Oppenheimer 29th Annual Healthcare Conference in New York City, the Oppenheimer’s Biotech Summit by the Lake at Northwestern University in Evanston, Illinois, and the ROTH Battle of NASH Thrones Spring Investor Conference in New York City (Press release, CymaBay Therapeutics, MAR 12, 2019, View Source [SID1234534243]).

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31st Annual ROTH Conference
Date: Monday, March 18
Time: 9:30am Pacific Time
Format: Panelist: Why Knowing NASH as a Generalist Can Make You Rich in 2019

Time: 12:00pm Pacific Time
Format: Fireside Chat
Webcast: View Source

Oppenheimer 29th Annual Healthcare Conference
Date: Tuesday, March 19
Time: 8:35am Eastern Time
Format: Fireside Chat
Webcast: View Source

Oppenheimer’s Biotech Summit by the Lake
Date: Wednesday, March 27
Time: 1:00pm Central Time
Format: Corporate Presentation

ROTH Battle of NASH Thrones Spring Investor Conference
Date: Thursday, March 28
Time: 8:00 am Eastern Time
Format: Panel: 12 Months of Data – 2019 Is the Year for FXR and PPAR Clinical Readouts

Time: 4:00pm Eastern Time
Format: Panel: Why MRI May Hold the Key to the Kingdom in Diagnosis and Drug Development

On March 12, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that it will be attending the 31st Annual ROTH Conference March 18-19, 2019, at The Ritz Carlton, Laguna Niguel in Dana Point, CA (Press release, DiaMedica, MAR 12, 2019, View Source [SID1234534285]). DiaMedica’s President and CEO, Rick Pauls, will be hosting one-on-one meetings with institutional investors at the conference and attendees can contact their Roth Capital Partners representative to arrange a meeting.

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