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CLSN Is Hot & Newsy, CTMX Soars On AMGN Deal, SUNFISH Fails To Help PTCT Shine


Today's Daily Dose brings you news about Celsion's encouraging data from OVATION Study; CytomX' collaboration with Amgen; FDA approval of Mylan's generic Copaxone; pricing of NewLink's stock offering and encouraging data from PTC Therapeutics' SUNFISH trial.

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Celsion Corp. (CLSN) surged over 300% on Tuesday, following encouraging clinical and translational research data from its OVATION Study.

The OVATION study is a phase Ib dose escalating clinical trial combining the Company's investigational drug GEN-1 with the standard of care for the treatment of newly-diagnosed patients with advanced Stage III/IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.

The translational research findings demonstrated that GEN-1 in ovarian cancer patients is biologically active and creates a shift in the primary tumor and in the surrounding tumor environment in the peritoneal cavity that promotes a pro-immune T-cell population dynamic and conversion of tumor naïve T-cell into cytotoxic effector T-cells in the tumor microenvironment, according to the Company.

The clinical data from the first fourteen patients who have completed treatment in the OVATION Study produced promising dose dependent efficacy signals.

Of the fourteen patients treated in the entire study, 2 patients demonstrated a complete response, 10 patients demonstrated a partial response and 2 patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate ("DCR") and an 86% objective response rate ("ORR"). Of the five patients treated in the highest dose cohort, there was a 100% objective response rate with 1 complete response and 4 partial responses, noted the Company.

CLSN closed Tuesday's trading at $6.06, up 301.32%. In after-hours, the stock rose another 12.54% to $6.82.

Shares of CytomX Therapeutics Inc. (CTMX) were up 35% in extended trading on Tuesday, following a strategic collaboration with Amgen (AMGN).

Under the terms of the agreement, Amgen and CytomX will co-develop a Probody T-cell engaging bispecific against EGFRxCD3 with CytomX leading early development and Amgen leading later development and commercialization. The global late-stage development costs will be shared between the two companies.

Amgen will make an upfront payment of $40 million and purchase $20 million of CytomX common stock. CytomX is entitled to receive up to $455 million in development, regulatory and commercial milestones for the EGFR program, and also tiered, double-digit royalties on net product sales outside of the U.S.

Amgen will also receive exclusive worldwide rights to develop and commercialize up to three additional, undisclosed targets. If Amgen opts to pursue all of these targets, CytomX will be eligible to receive up to $950 million in additional upfront and milestone payments and high single-digit to mid-double digit royalty payments on any resulting products.

CTMX closed Tuesday's trading at $19.00, down 1.30%. In after-hours, the stock was up 35% to $25.65.

Mylan N.V.'s (MYL) generic version of Teva's Copaxone 40 mg/mL, 3-times a week, and generic version of Copaxone 20 mg/mL once-daily, have been granted FDA approval.

Copaxone is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system.

Being the first applicant to submit a substantially complete Abbreviated New Drug Application for Copaxone 40 mg/mL, Mylan may be eligible for 180 days of generic drug exclusivity for Copaxone 40 mg/mL.

Copaxone is the most prescribed treatment for relapsing forms of multiple sclerosis in the United States with brand sales for the 20 mg/mL dose of approximately $700 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending July 31, 2017, according to QuintilesIMS.

MYL closed Tuesday's trading at $32.53, up 0.43%. In after-hours, the stock was up 4.92% to $34.13.

NewLink Genetics Corp. (NLNK) has offered to sell 5 million shares of its common stock to the public at a price of $10.25 each.

The underwriters have a 30-day option to purchase up to an additional 750,000 shares of its common stock sold in the public offering on the same terms and conditions.
The offering is expected to close on or about October 6, 2017.

NLNK closed Tuesday's trading at $10.91, up 5.00%. In after-hours, the stock was down 5.87% to $10.27.

PTC Therapeutics Inc.'s (PTCT) investigational drug for Spinal Muscular Atrophy RG7916 has demonstrated encouraging results in Part 1 of its SUNFISH trial.

The SUNFISH is a phase II trial evaluating RG7916 in individuals aged 2-25 with SMA type II or III.

According to the trial results, treatment with RG7916 has led up to a median 2.5-fold increase in SMN protein. Spinal Muscular Atrophy is caused by a deficiency of a protein called SMN, or "survival of motor neuron."

RG7916 is part of PTC's joint development program in SMA with Roche and the SMA Foundation (SMAF).

To date, RG7916 remains well-tolerated in patients at all doses and there have been no drug-related safety findings leading to withdrawal, noted the Company.

PTCT closed Tuesday's trading at $18.62, down 10.87%.

by RTTNews Staff Writer

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