On March 13, 2019 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported that it will postpone its 2018 financial results corporate update from Thursday, March 14, 2019, to Monday, March 18, 2019 at 8:30 am ET (Press release, Protalix, MAR 13, 2019, View Source;p=RssLanding&cat=news&id=2391209 [SID1234534282]).

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To participate in the conference call, please dial the following numbers prior to the start of the call: United States: (844) 358-6760; International: (478) 219-0004. Conference ID number 9583103.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

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 13, 2019 Sanofi reported that it has successfully priced its offering of EUR 2 billion of notes (the "Notes") across 3 tranches (Press release, Sanofi, MAR 13, 2019, View Source [SID1234534266]):

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€850 million fixed rate notes, due March 2022, bearing interest at an annual rate of 0.0%
€650 million fixed rate notes, due March 2029, bearing interest at an annual rate of 0.875%
€500 million fixed rate notes, due March 2034, bearing interest at an annual rate of 1.25%

The Notes are being issued off the company’s Euro Medium Term Note Programme.

The transaction enables the company to lower its average cost of debt and extend the average maturity of its debt.

Sanofi intends to use the net proceeds of the offering for general corporate purposes.

BofA – Merrill Lynch and Natixis acted as Global Coordinators and Bookrunners, alongside ING and Santander which acted as Bookrunners for the offering.