ANAB, GSK Amend Agreement, BSGM Plunges As COVID-19 Trial Flops, CATB Craters, MRTX Abuzz

biotech oct27

Today's Daily Dose brings you news about the amended immuno-oncology collaboration agreement between AnaptysBio and GlaxoSmithKline, BioSig discontinuing its phase II trial of investigational antiviral Merimepodib in COVID-19, the failure of Catabasis' phase III trial of Edasalonexent in Duchenne muscular dystrophy, and Mirati's promising early data of Adagrasib in lung cancer.

Read on…

1. All ends well for AnaptysBio, GlaxoSmithKline

AnaptysBio Inc. (ANAB) and GlaxoSmithKline (GSK) have amended their immuno-oncology collaboration agreement.

The immuno-oncology collaboration agreement was originally signed between AnaptysBio and Tesaro in 2014.

When GlaxoSmithKline acquired Tesaro in 2018, it inherited the collaboration agreement, approved ovarian cancer drug Zejula, and investigational drug Dostarlimab, which was developed as part of a collaboration between Tesaro and AnaptysBio.

Under the terms of the amended agreement, GlaxoSmithKline has agreed to increase the Dostarlimab royalties to AnaptysBio from 4-8% to 8-25% of global net sales.

Dostarlimab is under FDA review for its first indication endometrial cancer, with a decision expected this quarter. If the global net sales of Dostarlimab are below $1 billion, AnaptysBio will receive 8% royalty and if the global net sales are above $1 billion, AnaptysBio will receive royalty in the range of 12-25%.

GlaxoSmithKline has also agreed, starting January 1, 2021, to pay AnaptysBio a 1% royalty on all global net sales of Zejula. In addition, GlaxoSmithKline has agreed to pay AnaptysBio a one-time cash payment of $60 million within 30 days.

In August of this year, AnaptysBio had expressed its displeasure over GlaxoSmithKline's plan to begin a phase III clinical trial of Zejula, involving a third-party anti-PD-1 antibody, i.e., Merck's Keytruda, in non-small cell lung cancer without AnaptysBio's consent.

AnaptysBio had notified GlaxoSmithKline that it is in breach of its obligations under the 2014 immuno-oncology collaboration agreement. A suit was also filed by AnaptysBio in Delaware Chancery Court seeking GlaxoSmithKline to return all PD-1 antagonist related rights under the 2014 agreement, including the Dostarlimab program, across all clinical indications.

Now that the collaboration agreement has been amended, AnaptysBio has provided GlaxoSmithKline with freedom to conduct development and commercialization of Zejula in combination with any third-party molecules.

ANAB closed Monday's trading at $27.73, up 7.77%.

2. BioSig Discontinues phase II Trial of Merimepodib in COVID-19

Shares of BioSig Technologies Inc. (BSGM) plunged more than 39% on Monday, following disappointing news related to its investigational antiviral Merimepodib.

The company's majority owned subsidiary, ViralClear Pharmaceuticals, Inc. has decided to discontinue its phase II study of oral Merimepodib in combination with Gilead's intravenous Remdesivir in adult patients with advanced COVID-19 as the trial was unlikely to meet its primary safety endpoints.

The company noted that it does not intend to further develop Merimepodib but will see if other parties are interested in acquiring or licensing Merimepodib.

BSGM closed Monday's trading at $3.03, down 39.64%.

3. Catabasis Throws in the Towel on DMD drug Candidate Edasalonexent

Catabasis Pharmaceuticals Inc.'s (CATB) phase III trial of Edasalonexent in Duchenne muscular dystrophy, dubbed PolarisDMD, has not met the primary and secondary endpoints.

The primary endpoint was a change from baseline in the North Star Ambulatory Assessment (NSAA) over one year of Edasalonexent compared to placebo. The secondary endpoint was the timed function tests such as time to stand, 10-meter walk/run and 4-stair climb.

In view of the disappointing results, Catabasis is stopping activities related to the development of Edasalonexent, including the ongoing GalaxyDMD open-label extension trial.

The company plans to work with external advisors to explore and evaluate strategic options going forward.

CATB closed Monday's trading at $5.36, down 7.90%. In after-hours, the stock was down over 62% at $2.00

4. Mirati Therapeutics Hits New High on promising early data of Adagrasib

Shares of Mirati Therapeutics Inc. (MRTX) briefly crossed the $200 mark in intraday trading Monday, following promising data from the company's phase I/Ib and phase II monotherapy cohorts of Adagrasib in patients with advanced Non-Small Cell Lung Cancer.

According to the company, Adagrasib demonstrated a 45% confirmed *objective response rate and 96% disease control rate across the phase 1/1b and phase II monotherapy cohorts. (Objective response rate is the percentage of patients whose disease decreased following treatment. Disease control rate is the percentage of patients whose disease shrinks or remains stable over a certain time period). (Source: Evidence based Medicine and Practice Journal).

Enrollment is complete in the phase II cohort of Adagrasib as a monotherapy treatment for patients in 2nd/3rd line NSCLC, and a New Drug Application seeking accelerated approval for Adagrasib is expected to be submitted in the second half of 2021.

The company also reported initial preclinical data for MRTX1133, which demonstrated significant tumor regression in mutant animal models. The company plans to make IND filing for advancing the compound into clinical trials in the first half of next year.

Adagrasib is a selective KRAS G12C inhibitor while MRTX1133 is a selective KRAS G12D inhibitor. The KRAS G12D mutation drives tumor growth and poor outcomes in an even greater number of cancer patients than the KRAS G12C mutation, noted the company.

In other news, the company announced that it intends to sell in an underwritten public offering $700.0 million of shares of its common stock and that a selling stockholder intends to offer 375,000 shares in the offering. Mirati will not receive any proceeds from the sale of shares in the offering by the selling stockholder.

MRTX touched an all-time high of $211.50 in intraday trading Monday, before closing at $196.68, up 9.15%.

5. Stocks That Hit New Highs/Lows

Shattuck Labs Inc. (STTK) closed at a new high of $23.78, up 9.28%.

Spruce Biosciences Inc. (SPRB) closed at a new high of $19.25, up 6.06%.

Amicus Therapeutics Inc. (FOLD) closed at a new high of $18.75, up 1.46%.

EyePoint Pharmaceuticals Inc. (EYPT) closed at a new low of $0.41, down 10.47%.

Baudax Bio Inc. (BXRX) closed at a new low of $1.29, down 11.64%.

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