Softbank-backed cancer diagnostics firm Guardant Health set for $200M IPO

Guardant Health, which makes non-invasive blood-based cancer diagnostics tests, announced terms for its IPO last Friday.

The Redwood City, CA-based company plans to raise $200 million by offering 12.5 million shares at a price range of $15 to $17. At the midpoint of the proposed range, Guardant Health would command a fully diluted market value of $1.4 billion and an enterprise value of $944 million.

Guardant Health was founded in 2013 and booked $67 million in sales for the 12 months ended June 30, 2018. It plans to list on the Nasdaq under the symbol GH. J.P. Morgan and BofA Merrill Lynch are the joint bookrunners on the deal. It is expected to price during the week of October 1, 2018.

Relevant Profile: GH

https://www.renaissancecapital.com/IPO-Center/News/59931/Softbank-backed-cancer-diagnostics-company-Guardant-Health-sets-terms-for-$

ObsEva Phase 2b trial shows sustained efficacy, safety, for endometriosis pain

– Linzagolix overall efficacy and safety maintained or improved at week 24

– Linzagolix 75mg once daily showed no clinically significant impact on Bone Mineral Density (BMD), supporting further development with no need for add back therapy (ABT)

– Linzagolix 200mg once daily results support further development with low dose add back therapy (ABT)

– Initiation of Phase 3 endometriosis trials expected in early 2019

ObsEva SA , a Swiss clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced additional positive results from the EDELWEISS clinical trial of its oral GnRH receptor antagonist, linzagolix, for the treatment of endometriosis-associated pain.

In the EDELWEISS trial, hallmark pain symptoms of endometriosis, dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP), showed sustained reduction or further improvement after 24 weeks of treatment, as compared to the positive 12-week results that were announced in June 2018. Sustained efficacy was also seen in additional endpoints such as dyspareunia and dyschezia, as well as in the assessments of patient well-being, most notably the Patient Global Impression of Change (PGIC) and Endometriosis Health Profile-30 (EHP-30) questionnaire.

The main pain efficacy endpoints of the EDELWEISS clinical trial were reported as a responder analysis, with responses defined as a reduction of at least 30% in pain, recorded daily via electronic diary using a verbal rating scale (VRS) of 0 (no pain) through 3 (severe pain).

“We are very pleased with these favorable results that further demonstrate the differentiated therapeutic potential of linzagolix for alleviating the severe, painful and chronic symptoms of endometriosis. These data strongly validate ObsEva’s development strategy for linzagolix as a potential best in class oral GnRH antagonist,” said Dr. Loumaye, co-founder and Chief Executive Officer of ObsEva.

https://www.marketwatch.com/press-release/final-results-of-obseva-sa-phase-2b-edelweiss-trial-of-linzagolix-show-sustained-efficacy-and-bone-mineral-density-safety-for-the-treatment-of-endometriosis-associated-pain-2018-09-28

Roche jumps on Tregs trend with a potential $750M deal

• Roche will pay more than $80 million upfront to snag a preclinical candidate focused on regulatory T cells, a trending research area in immuno-oncology that the Swiss pharmaceutical giant hopes will complement its blockbuster drug Tecentriq in treating cancer.
• Tusk Therapeutics announced Friday it had inked the takeover deal on Sept. 27, handing over its experimental antibody to Roche for 70 million euros with potential milestone payments worth up to an additional 585 million euros ($677 million). The private Stevenage, U.K.-based firm will spinout into a new, independent company called Black Belt Therapeutics to develop its other preclinical asset.
• Roche called its newly acquired candidate “the most advanced asset” to test whether an antibody can deplete harmful regulatory T cells that normally suppress immune reactions against cancer cells, as a company spokesperson described in an email to BioPharma Dive.

Tusk had two preclinical regulatory T cell, or Tregs, treatments in development, respectively targeting two specific proteins: CD25 and CD38. Roche will take CD25 in this deal, while Tusk spins out into Black Belt with CD38.

Tusk stated it expects clinical trials with cancer patients to start by the end of 2019.

“Tusk’s antibody has been designed to deplete these harmful Tregs, while not interfering with other immune cells acting against the tumor,” a Roche spokesperson stated in an email to BioPharma Dive. “The importance has not been evaluated in humans yet. However, we believe that this is the most advanced asset to test this hypothesis.”

Roche highlighted Tecentriq (atezolizumab) as a potential combination partner, but its spokesperson also noted “other combinations may be evaluated in the future.”

Tusk CEO Luc Dochez highlighted the anti-CD25 antibody earlier this year in an April presentation at the American Association for Cancer Research.

“Unlike existing CD25 antibodies, our antibody has the ability to deplete Tregs without inhibiting effector cell responses,” he said at the time. “Based on the promising pre-clinical data, we believe that our anti-CD25 candidates will be an ideal combination partner for existing standard of care and immuno-oncology treatments.”

Roche is far from the first pharma to buy into the space, as it’s been a trendy area in immuno-oncology over the past year. Celgene, Novartis and Eli Lilly all reached licensing deals in 2017 for various Tregs-related assets.

In July 2018, the gene therapy biotech Sangamo bought TxCell for $84 million in a deal expected to close by the end of this year.

Tusk was founded in 2014 and based at the Stevenage Bioscience Catalyst in the U.K, a geographic biotech hotspot that also features the Cell and Gene Therapy Catapult, an accelerator that gained several new manufacturing licenses earlier this month.

https://www.biopharmadive.com/news/roche-jumps-on-tregs-trend-with-a-potential-750m-deal/533498/

Taro Pharmaceutical terminates license agreement with NovaBiotics

Taro Pharmaceutical Industries announced that it has terminated the license agreement with NovaBiotics for the onychomycosis drug, Novexatin. As previously disclosed in May 2018, the Novexatin clinical study did not meet the main goal of a Phase IIb study under current guidelines of the FDA and did not show superiority over the placebo. Upon further analysis and evaluation, the Company has decided to terminate its agreement with NovaBiotics.
https://thefly.com/landingPageNews.php?id=2797335

Insmed wins FDA approval for lung disease treatment

Insmed’s (NASDAQ:INSM) Arikayce — amikacin liposome inhalation suspension — has won FDA approval for treating a lung disease caused by mycobacterium avium complex, in a limited population of patients not responding to conventional treatment.

The advisory panel in August failed to broadly back the drug for that application, but it did get an OK as part of a combination for patients with few or no treatment options.

The label has a boxed warning about an increased risk of respiratory conditions.

Bloomberg estimates the drug can bring in 2019 sales of $82.8M, rising to more than $500M by 2022.

Shares were halted at 4:35 p.m. for the pending news and haven’t gotten a reopening time yet.

Updated 6:04 p.m.: Insmed issues a press release about the approval and sets a conference call at 6:15 p.m. (in a few minutes) to discuss it. Insmed says it’s collaborating with the FDA on the design of an additional clinical study to support full approval.

https://seekingalpha.com/news/3393875-insmed-wins-fda-approval-lung-disease-treatment-updated

Novavax Nanoparticle Flu Vaccine for Older Adults Begins Phase 2 Trial

A new phase 2 trial is underway for an investigative nanoparticle seasonal influenza vaccine in older adults. Novavax, creators of the NanoFlu, will undergo a randomized, observer-blind trial prior to a meeting with the US Food and Drug Administration (FDA) to discuss appropriate phase 3 trial design accommodated by accelerated approval designation.

In the new clinical trial, investigators will assess the efficacy, safety, and tolerability of NanoFlu doses and formulationsboth adjuvanted and unadjuvantedin comparison to a pair of US marketed vaccines. Approximately 1375 healthy older adults across the country will be enrolled, with Novavaxs intent to select a dose and formulation of the vaccine that can be brought forward into its phase 3 immunogenicity trial.

NanoFlu trivalent formulation first reported topline phase 1 and 2 clinical trial results in older adults in Feburary of this year. When compared to Fluzone HD, the investigative vaccine demonstrated acceptable safety and a short-term reactogenicity. Investigators also reported patient hemagglutination inhibition (HAI) immune responses were 28% to 64% greater in those treated with NanoFlu versus those treated with homologous and 4 generations of drifted wild-type A(H3N2) influenza strain. The vaccine also reported higher HAI responses than the homologous A(H1N1) strain, and comparable responses against the homologous B/Brisbane strain.

Influenza is a particular concern among adults aged 65 years or older, advised the US Centers for Disease Control and Prevention (CDC), due to the populations increased risk of infection and comorbidities. Vaccination has also been pointed to the greatest resolvea 2017 study run by the CDC showed that rates of death, intensive care unit admissions and length of stay, and overall hospitalization duration were most significantly improved by vaccine in people aged 65 years and older.

As a recombinant hemagglutinin (HA) protein nanoparticle vaccine, the NanoFlu contains Novavaxs Matrix-M adjuvant. The adjuvant stimulates entry of antigen-presenting cells into the injection site and enhances antigen presentation in local lymph nodes, result in potent and well-tolerated effects in older adult populations.

Gregory Glenn, MD, president of Research and Development at Novavax, suggested the characteristics and makeup of the investigative vaccine make it a sorely missing option in the influenza market.

The dual problems of antigenic drift and antigenic changes resulting from egg-based vaccine production have, in recent years, resulted in generally poor influenza vaccine effectiveness with potentially severe medical consequences, particularly in older adults, Glenn said in a statement. A substantially improved seasonal influenza vaccine is a widely recognized, high-priority unmet medical need.

Stanley C. Erck, president and chief executive officer of Novavax, is anticipating topline results from the phase 2 trial in the Q1 of 2019. He called the initiation of this phase an important milestone for the company.

https://www.marketscreener.com/NOVAVAX-INC-10281/news/Novavax-Nanoparticle-Flu-Vaccine-for-Older-Adults-Begins-Phase-2-Trial-27340006/

Kalytera Sees Progress with Cannabinoid-Based Pain Treatment

Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced a major step forward in its program to develop the first cannabinoid-derived pain treatment targeting activation of alpha3 glycine receptors.

When activated, the alpha3 glycine receptor strongly blocks pain signals from being sent to the brain. Kalytera, and its research partner, Beetlebung Pharma Ltd. (BPL), have carried out a medicinal chemistry program to identify a novel analogue of cannabidiol (CBD) that will block such pain signals via the activation of the alpha3 glycine receptor channel in the spinal cord. To date, no company has introduced into the market an agent specifically targeting this receptor.

Through a series of manipulations of the structure of CBD, a new compound has been invented. This new compound is 40-fold more potent than desoxy-CBD, which is the prototypic alpha3 glycine receptor agonist. The new compound activates only the alpha3 glycine receptor and has no effect on a closely related protein, known as the alpha1 glycine receptor, which may produce unwanted symptoms of muscle weakness.

Based on these findings, Kalytera believes that this novel molecule constitutes the first completelyselective alpha3 glycine receptor agonist that can potently activate this critical analgesic pathway without producing complications via the alpha1 glycine receptor pathway.

The high potency of the compound and its total selectivity justify its advancement to human clinical testing as a potential substitute for opioids in the treatment of severe pain. Kalytera is now preparing to evaluate the compound in various animal models in order to select the optimal pain setting in which to conduct human clinical testing.

Patents for this compound have been filed in the U.S. and other jurisdictions, and Kalytera has obtained an exclusive, worldwide license for this compound from BPL. BPL is an Israeli-based pharmaceutical discovery company focused on cannabinoid-based therapeutics for the treatment of human disease.

The objective of our program is to develop a potent, non-psychotropic, oral analgesic for intractable pain that will be safe and well tolerated. The cannabinoid compound that has been invented has the potential to achieve these goals, and become a next generation pain medication, stated Robert Farrell, President and CEO of Kalytera. “This novel compound may provide effective pain reduction, without the risks of addiction or respiratory suppression that exist with opioid analgesics. We have also found a way to make this compound water soluble, which will allow for treatment of acute pain in in-patient settings, such as childbirth, short surgical procedures, and post-operative pain care.

https://www.marketscreener.com/SANTA-MARIA-PETROLEUM-INC-10879045/news/Kalytera-Therapeutics-Announces-Progress-with-Cannabinoid-Based-Compound-for-Treatment-of-Acute-an-27338389/