On May 14, 2018 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported that the U.S. Food and Drug Administration (FDA) has accepted and acknowledged for review the re-submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate (Press release, Coherus Biosciences, MAY 14, 2018, View Source;p=RssLanding&cat=news&id=2348926 [SID1234526578]). In the communication, FDA indicated that they consider the resubmission a complete response to their June 9, 2017 action letter. FDA provided a biosimilar user fee act (BSUFA) action date of November 3, 2018. The letter did not indicate the need to prepare for an advisory committee meeting.

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"We appreciate FDA’s prompt action on our file and look forward to working with them on the review," said Denny Lanfear, President and CEO of Coherus BioSciences. "We believe that CHS-1701 is well-positioned to deliver greater access to oncology patients and savings to the healthcare system. We are continuing to make good progress in building inventory of CHS-1701 and in preparing for commercial launch in the U.S."

On May 14, 2018 CStone Pharmaceuticals (CStone) reported dosing of the first patient in a Phase I clinical trial in Australia for CS1003, an investigational anti-programmed death-1 (PD-1) monoclonal antibody (mAb) (Press release, CStone Pharmaceauticals, MAY 14, 2018, View Source [SID1234526640]). The open-label, first-in-human (FIH) study is initiated at Scientia Clinical Research Ltd in Australia and will investigate the safety, tolerability, and preliminary efficacy of CS1003 in patients with advanced solid tumors.

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"We are excited to announce initiation of clinical development for PD-1 inhibitor CS1003, our second pipeline candidate to enter Phase I studies in Australia after the CTLA-4 mAb CS1002 within one month," said Dr. Frank Jiang, Chief Executive Officer at CStone. "CS1003 is cross-reactive with human and mouse PD-1 which enables quick pre-clinical proof of concept experiments in combination with novel targets, leading to global first-in-combination potential. Because of this unique feature, CS1003 is critical to CStone’s combination strategy in cancer immunotherapy."

The launch of clinical studies for CS1003 is a key milestone for CStone, which now has three important checkpoint inhibitors for cancer therapy under clinical development. Alongside CS1001 (PD-L1) and CS1002 (CTLA-4), CS1003 will provide the backbone for CStone’s pipeline development of oncology combination therapies.

As noted by Dr. Jason Yang, Chief Medical Officer of CStone, "In preclinical studies, CS1003 demonstrated high affinity and selectivity for PD-1, as well as synergistic anti-tumor effects with multiple small-molecule drugs in animal models. The launch of this clinical program will allow us to gather important safety and efficacy data on CS1003. This will lay the foundation for future development of this molecule, in particular as the basis of combination therapies."

"We are excited to be enrolling our first patient treated with CS1003 and are hopeful that this novel immunotherapy drug will add to the available therapeutic options for advanced-stage tumors, either by itself or in combination with other drugs," said Dr. Charlotte Lemech, MBBS, BSc, FRACP, MD, lead investigator for this trial at Scientia Clinical Research Ltd.

The Phase Ia/Ib study includes a dose-escalation stage followed by a dose-expansion stage. Additional information on the trial can be found here.

About CS1003 and the PD-1/PD-L1 pathway

CS1003 is a humanized anti-PD-1 IgG4 monoclonal antibody developed by CStone using an internationally leading hybridoma platform. CS1003 has shown good tolerability and efficacy profile in preclinical in vivo studies.

PD-1, or programmed death-1, is an inhibitory checkpoint receptor expressed on T cells. Under normal circumstances, it binds with its ligands, programmed death ligand-1 or ligand 2 (PD-L1/PD-L2), inhibiting T cell and cytokine activation, serving to dampen the immune response in order to prevent damage to healthy tissues. However, studies have shown that PD-L1 can be abundantly expressed on the surface of many solid tumors as well as hematological malignancies. Cancer cells can therefore make use of the PD-1/PD-L1 pathway to successfully avoid immune system recognition and attack. Targeting of the PD-1/PD-L1 checkpoint by anti-tumor drugs can block the "tumor immune evasion mechanism" and restore anti-cancer immune ability in patients.

Currently, there are two anti-PD-1 antibodies approved globally: Opdivo (nivolumab) from Bristol-Myers Squibb and Keytruda (pembrolizumab) from Merck, Sharp & Dohme. Unlike other anti-PD-1 mAbs, CS1003 recognizes both human and murine PD-1, providing a unique competitive advantage during efficacy testing in syngeneic mouse tumor models particularly for development of effective combination therapies.

On May 14, 2018 Aradigm Corporation (NASDAQ: ARDM) (the "Company") reported financial results for the first quarter and three months ended March 31, 2018 (Press release, Aradigm, MAY 14, 2018, View Source [SID1234526609]).

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First Quarter 2018 Financial Results

The Company recorded $1.5 million in revenue in the first quarter of 2018 compared with $1.7 million in revenue in the first quarter of 2017. The Company recognized $1.3 million in contract revenue – related party, $29,000 in government contract revenue and $129,000 in government grant revenue for the first quarter of 2018, as compared to $1.6 million in contract revenue – related party, $39,000 in government contract revenue and $31,000 in government grant revenue for the first quarter of 2017.

Total operating expenses for the first quarter of 2018 were $5.3 million, compared with total operating expenses of $4.5 million for the first quarter of 2017. The increase in expenses was related to the FDA Advisory Committee Meeting. General and administrative costs were unchanged. Research and development expenses increased $800,000. In the first quarter of 2018, our research and development expenses were higher due to higher consulting costs related to the FDA meeting and the submission fees for our MAA application as well as severance expenses. This increase in expenses was offset by lower costs for clinical expense and lower employee related expenses due to a reduction in headcount. The receipt of a tax incentive in Australia offset a portion of the research and development expenses in the first quarter of 2017.

Net loss for the first quarter of 2018 was $4.8 million or $0.32 per share, compared with a net loss of $3.7 million or $0.25 per share in the first quarter of 2017. The increase in net loss resulted primarily from an increase in operating expenses of $800,000 related to the FDA meeting in January and the submission of the MAA to EMA in March for approval of Linhaliq. A decrease in revenue of $200,000 and an increase in interest expense of $100,000 related to the convertible notes was recorded.

Liquidity and Capital Resources and Related Matters

As of March 31, 2018, the Company’s cash and cash equivalents totaled $1.4 million.

In January, Aradigm received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).

The CRL states that the FDA has determined that it cannot approve the NDA in its present form and provides specific reasons for this action along with recommendations needed for resubmission; the areas of concern include clinical data, human factor validation study and product quality.

The Aradigm Board of Directors approved temporary measures on February 9, 2018 intended to preserve the Company’s cash resources.

In April Aradigm raised $2.0 million through the issuance of bridge notes and obtained commitments for additional monthly funding through September of 2018 totaling $5 million. This $7.0 million along with the cash balance of $1.4 million will be sufficient to fund operations through the third quarter of 2018.

Aradigm is pursuing potential alternatives to resolve our cash position in the short term as well as developing strategic options that would provide for our long term viability. We feel it is very important to bring Linhaliq to commercialization in as many geographies as possible to allow patients suffering from non-cystic fibrosis bronchiectasis (NCFBE) to receive the benefits of Linhaliq. Patients, patient advocacy groups and key opinion leaders have expressed support as we work towards this goal. The MAA was filed in early March and validated for review in late March and that is the first step in achieving regulatory approval in Europe.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition

On May 14, 2018 Augmenix, Inc. reported that they will be exhibiting at this year’s American Urological Association meeting in San Francisco, California (Press release, Augmenix, MAY 14, 2018, View Source [SID1234526598]). Located at Booth 6251 Hall D, the company will be featuring their leading product, SpaceOAR hydrogel, which is used in patients receiving radiation therapy for prostate cancer. Attendees of the AUA meeting are invited to visit the exhibit to learn about the latest developments that make SpaceOAR hydrogel the #1 rectal spacer for prostate cancer radiotherapy worldwide.

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Highlights Include:

In booth presentations from Urology experts including Dr. Katsuto Shinohara, from University of California, San Francisco who will speak about the clinical benefits and procedural overview of SpaceOAR hydrogel. Dr. Evan Goldfischer from the Premier Medical Group and Clinical Assistant Professor of Urology at the New York Medical College will speak about integrating SpaceOAR hydrogel into office-based Urology practices. Mark Painter, CEO of PRS, LLC will present the recent positive developments in national reimbursement for the SpaceOAR hydrogel procedure.

Augmenix will also unveil its new customized hands-on simulators at the exhibit, designed to provide Urologists with the ability to perform the SpaceOAR procedure before using it with patients.

The company will also formally launch the Augmenix Spacing Academy, designed to provide the information, tools and on-site support to enable Urologists to experience consistent and optimal patient outcomes.

About SpaceOAR Hydrogel

In April 2015, the Food and Drug Administration (FDA) cleared SpaceOAR hydrogel. In a prospective, randomized, multi-center clinical trial in the United States, patients treated with SpaceOAR hydrogel prior to prostate cancer radiation treatment demonstrated bowel, urinary, and sexual benefits through three years median of follow-up. The study found that the patients who did not receive SpaceOAR hydrogel experienced a clinically significant decline in bowel, urinary, and sexual quality of life eight times more often than patients who received SpaceOAR hydrogel. (1,2)

Most recently, Augmenix announced that a Category 1 CPT code (55874) was issued for SpaceOAR hydrogel, which became effective on January 1, 2018. SpaceOAR hydrogel is covered by six out of seven Medicare Administrative Contractors (MACs), Geisinger Health Plan, Aetna, Inc., and military payer TRICARE.

On May 14, 2018 Precision BioSciences, the ARCUS genome editing company with novel product development programs in gene therapy, cancer immunotherapy and non-GMO food, reported that it will give three presentations at the upcoming ASGCT (Free ASGCT Whitepaper) 21st Annual Meeting held in Chicago, Illinois, May 16-19, 2018 (Press release, Precision Biosciences, MAY 14, 2018, View Source [SID1234526597]).

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Precision’s co-founder and CSO, Derek Jantz, will attend the conference along with a group of Precision scientists. He notes,

"The Precision team is looking forward to participating in the research dialogue at ASGCT (Free ASGCT Whitepaper) this year. We are particularly eager to share our experiences towards developing an in vivo gene editing solution, including results of extensive NHP testing. We will also present new data from our gene-edited allogeneic T cell platform, including manufacturing results for our lead CAR T program."

Precision BioSciences presentations at ASGCT (Free ASGCT Whitepaper) include:

1. Development and Optimization of a PCSK9-Specific Meganuclease That Mediates Long-Term LDL Reduction in Non-Human Primates (#658; follows content of #657).
Oral Session Title: Cardiovascular and Pulmonary Diseases
Date and Time: Friday, May 18, 2018, 4:00 p.m. – 5:45 p.m. CDT
Location: International Ballroom South

2. Development of a Clinical-Grade Meganuclease for Allogeneic CAR T Cell Production (#784).
Poster Session Title: Cell Therapies III
Session Date and Time: Friday, May 18, 2018, 5:45 p.m. – 7:45 p.m. CDT
Location: Stevens Salon C & D

3. A P23H RHO-Specific Meganuclease Rescues Photoreceptor Morphology and Function in Mouse Models of Retinitis Pigmentosa (#565).
Poster Session Title: Neurologic Diseases II
Session Date and Time: Thursday, May 17, 2018, 5:15 p.m. – 7:15 p.m. CDT
Location: Stevens Salon C & D