Frequency Therapeutics launches mid-stage study of hearing loss candidate

Dosing is underway in a Phase 2a clinical trial evaluating Frequency Therapeutics’ (FREQ +1.5%) lead candidate FX-322 in patients with stable sensorineural hearing loss (SNHL) (the most common type).

The primary efficacy endpoints are three measures of hearing ability at day 210 compared to placebo. The estimated completion date is September 2020.

The company says FX-322 is a small molecule designed to treat the underlying cause of SNHL by regenerating hair cells via the activation of progenitor cells in the cochlea (spiral cavity in the inner ear).

https://seekingalpha.com/news/3505021-frequency-therapeutics-launches-mid-stage-study-hearing-loss-candidate-fxminus-322

J&J offloads midphase pain program to Neumentum

Neumentum has licensed a midphase oral analgesic from Johnson & Johnson. The agreement covers an asset that came through a phase 2 pain trial in 2015 only to stall following the completion of the study.
J&J tested two doses of the drug, JNJ-10450232, in a trial of 269 subjects with dental pain after the surgical removal of teeth. The study compared the analgesic efficacy of capsules of JNJ-10450232 to that of placebo and acetaminophen over the six hours after treatment. Secondary endpoints looked at the change in pain intensity at multiple time points from 15 minutes to 24 hours after treatment.
The higher dose of JNJ-10450232—1000 mg—performed comparably to acetaminophen against the primary endpoint, although patients on the comparator reported numerically bigger improvements in pain in the first two hours of the trial.

Public references to JNJ-10450232, which were scant prior to the start of the phase 2 trial, dried up completely after J&J reported the data on ClinicalTrials.gov. Now, Neumentum wants to give the drug a second life and, in doing so, further its bid to become a leading non-opioid analgesic company.
“By strategically expanding our pipeline, Neumentum will be well positioned to address patients’ and providers’ needs for acute pain relief in both hospital and community settings, with both IV and oral non-opioid products,” Neumentum CEO Scott Shively said in a statement. “There is a real lack of innovation in the pain management space, despite a growing need for new options that are safe and effective.”
Neumentum wants to take JNJ-10450232, which it describes as neither an opioid nor a nonsteroidal anti-inflammatory drug, forward in the treatment of moderate to moderately severe acute pain. The deal, financial details of which were not disclosed, also gives Neumentum control of a portfolio of backup compounds.
JNJ-10450232 will slot into a pipeline spearheaded by NTM-001, a ketorolac formulation designed for the short-term management of moderately severe acute pain that requires opioid-level painkilling.
https://www.fiercebiotech.com/biotech/j-j-offloads-midphase-pain-program-to-neumentum

Seattle Genetics Starts Phase 3 for Breast Cancer Combo

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced dosing of the first patient in HER2CLIMB-02, a randomized phase 3 clinical trial evaluating investigational agent tucatinib versus placebo, in combination with standard-of-care ado-trastuzumab emtansine (T-DM1, Kadcyla^®), for patients with locally advanced or metastatic HER2-positive (HER2+) breast cancer. This trial is intended to support registration in the U.S. Tucatinib is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2.

“We are building a comprehensive strategy for tucatinib in combination with other medicines across a range of HER2-positive cancers,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “We are pleased to advance this tucatinib clinical trial with the vision of improving combination outcomes for patients with HER2-positive metastatic breast cancer who receive T-DM1. This trial has the potential to support tucatinib use in earlier lines of therapy.”
HER2CLIMB-02 is a multi-center, randomized, double-blind, placebo-controlled phase 3 trial designed to evaluate tucatinib versus placebo, in combination with T-DM1, in patients with unresectable locally-advanced or metastatic HER2+ breast cancer, including those with brain metastases, who have had prior treatment with a taxane and trastuzumab in any setting. The primary endpoint is progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints include overall survival, objective response rate and duration of response. The trial is expected to enroll approximately 460 patients. More information about this phase 3 trial, including enrolling centers, is available at www.clinicaltrials.gov.
https://www.biospace.com/article/releases/seattle-genetics-announces-initiation-of-phase-3-clinical-trial-of-tucatinib-in-combination-with-ado-trastuzumab-emtansine-t-dm1-kadcyla-for-patients-with-advanced-or-metastatic-her2-positive-breast-cancer/

Amicus up on preliminary Q3 results

Amicus Therapeutics (NASDAQ:FOLD) expects Galafold sales in Q3 to be ~$48M, up 133% from a year ago and above consensus of ~$45M.

It is raising the lower end of its full-year range for Galafold sales to $170M – 180M from $160M – 180M. It expects to end the year with more than $420M in cash which should extend its runway into H1 2022.

The webcast of its Analyst Day is currently underway.

Shares up 6% premarket on light volume.

https://seekingalpha.com/news/3504981-amicus-6-percent-premarket-preliminary-q3-results

OncoSec up after strategic deal for TAVO and VLA

OncoSec Medical (NASDAQ:ONCS) is up 34% premarket on entering into a strategic transaction with Grand Decade Developments Limited, a direct, wholly-owned subsidiary of China Grand Pharmaceutical and Healthcare Holdings, and its affiliate, Sirtex Medical US Holdings.

OncoSec will receive a $30M investment from CGP and Sirtex at $2.50/share.

Upon the closing of this transaction, CGP and Sirtex together will hold 53% of OncoSec common shares and will be entitled to three of nine seats on the OncoSec Board of Directors.

OncoSec will grant Grand Decade and its affiliates an exclusive license to develop, manufacture, commercialize, or otherwise exploit OncoSec’s current and future products, including TAVO and OncoSec’s new Visceral Lesion Applicator (VLA), in Greater China and 35 other Asian countries (the “Territory”).

Grand Decade will pay up to 20% royalties on the net sales of such products in the Territory.

Sirtex will support and assist OncoSec with pre-marketing activities for TAVO and VLA in exchange for low single-digit royalties.

https://seekingalpha.com/news/3504997-oncosec-plus-34-percent-premarket-strategic-deal-tavo-vla

BioNTech prices initial public offering

BioNTech SE (BNTX) has priced its initial public offering of 10M American Depositary Shares, each representing one ordinary share at $15.00 per ADS, for gross proceeds of $150M.

Underwriters over-allotment is an additional 1.5M ADSs.

The ADSs are expected to begin trading today on the Nasdaq Global Select Market.

The offering is expected to close on October 15.

Previously: BioNTech readies IPO (Oct. 9)

https://seekingalpha.com/news/3504901-biontech-prices-initial-public-offering

UCB agrees to buy Ra Pharma for $2.5B

UCB SA (OTCPK:UCBJF) has agreed to acquire Ra Pharmaceuticals (NASDAQ:RARX) for $48 per share in cash or $2.5B (€2.2B)($2.1B net of RARX cash).

UCB says the deal is consistent with its “Accelerate and Expand” strategy. In this case, it gains access to RA’s zilucoplan, in Phase 3 development for myasthenia gravis (MG), complementing its own rozanolixizumab, also in late-stage development for MG.

Zilucoplan is also being evaluated in other complement-mediated disorders like ALS and immune-mediated necrotizing myopathy.

The transaction will not affect UCB’s 2019 financial guidance. It will be dilutive to its mid-term earnings and will extend its mid-term goal of EBITDA/revenue of 31% out one year to 2022.

The deal should close by the end of Q1 2020.

RARX is up 106% premarket on light volume.

https://seekingalpha.com/news/3504914-ucb-agrees-buy-ra-pharma-2_5b