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Monday, July 27, 2020

NGM Biopharma launches mid-stage study for NGM621 in eye disorder

NGM Biopharmaceuticals (NASDAQ:NGM) has initiated the Phase 2 CATALINA study, to evaluate the safety and efficacy of NGM621 intravitreal injections in geographic atrophy (GA), secondary to age-related macular degeneration.
The 240-subject study’s primary efficacy endpoint is change from baseline in the square root of GA lesion area at 48 weeks, as measured by fundus autofluorescence imaging, compared to sham control.
Safety endpoints will evaluate the incidence and severity of ocular and systemic adverse events.
Preclinical and Phase 1 study showed positive safety and tolerability data for NGM621. NGM recently presented preclinical findings at The Association for Research in Vision and Ophthalmology Annual Meeting.
NGM621 is a humanized IgG1 monoclonal antibody designed to inhibit complement C3, key component, which helps orchestrate the body’s response to infection and maintains tissue homeostasis.

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TCR2 Therapeutics’ TC-210 successful in mid-stage cancer study

TCR2 Therapeutics (NASDAQ:TCRR) announces positive interim data from the first five patients treated in the Phase 1 portion of the TC-210 Phase 1/2 trial for mesothelin-expressing solid tumors.
All five patients showed tumor regression including two RECIST unconfirmed partial responses and two patients with stable disease through six months.
Translational data further demonstrated TRuC-T cell expansion and activation. A manageable toxicity profile was observed with only one patient exhibiting TC-210-related non-hematologic grade >2 toxicity and no evidence of neurotoxicity or on-target, off-tumor toxicity.
The primary objectives of the Phase 1 portion are to define the safety profile of TC-210 in patients whose tumors overexpress mesothelin and to determine the recommended Phase 2 dose (RP2D).
Secondary objectives include overall response rate (ORR) and disease control rate (DCR). Exploratory objectives include the assessment of expansion, tumor infiltration, and persistence of TC-210 T cells.
In the Phase 2 portion of the trial, approx. 50 patients are planned to receive TC-210 at the RP2D in four distinct cohorts according to their cancer diagnosis: NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma.
The company hosted a conference call and webcast today at 8:00 am E.T.

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Eton Pharma files U.S. drug for methanol poisoning

Eton Pharmaceuticals (NASDAQ:ETON) has submitted a new drug application (NDA) for dehydrated alcohol injection, previously known as DS-100, to the FDA for the treatment of methanol poisoning.
The filing is the company’s second for an orphan drug candidate and fifth total candidate under FDA review.

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Large-scale study of Moderna COVID-19 vax to be fully enrolled in 4-6 weeks – CEO

In an interview on CNBC this morning, Moderna (NASDAQ:MRNA) CEO Stephane Bancel said that he expects the 30K-subject study assessing mRNA-1273 should be fully enrolled in 4-6 weeks.
Preliminary efficacy data may be available as early as September/October/November depending on the event rate.
Safety is top concern. On the efficacy front, he is confident that mRNA-1273 can meet the FDA threshold of 50% effectiveness compared to control.
Data from non-human primate study will provide additional color on potential efficacy.

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MediciNova inks deal to jointly develop SARS-CoV-2 Vaccine in Japan

MediciNova (NASDAQ:MNOV) announces an agreement to jointly develop a SARS-CoV-2 vaccine with BC-PIV, a human parainfluenza virus type 2 vector being developed by BioComo and Mie University.
The company has been granted exclusive worldwide development rights to use BC-PIV for COVID-19 vaccine development.
To date, BioComo has succeeded in producing a recombinant Ebola virus vaccine and a Respiratory Syncytial virus prefusion F vaccine using this BC-PIV platform technology.
Financial terms are not disclosed.

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Aerie Pharma steroid implant shows benefit in macular edema study

Aerie Pharmaceuticals (NASDAQ:AERI) announces positive results from a 49-subject Phase 2 clinical trial evaluating two formulations of AR-1105 (dexamethasone intravitreal implant) in patients with macular edema associated with retinal vein occlusion.
The data showed sustained treatment effects with both formulations as measured by best corrected visual acuity and reductions in macular edema. Peak efficacy was observed with formulation #1 (340µg dose of dexamethasone in a single intravitreal injection), while a longer duration of effect was observed with formulation #2 (different release profile).
No new safety signals were observed.
Additional details will be presented at an upcoming ophthalmology conference.
The company does not plan to initiate any new clinical trials of AR-1105 until H2 2021 after it receives results from other studies on AR-13503 in wet AMD and AR-15512 in dry eye.

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FDA maintains clinical hold on Solid Bio’s Ignite DMD trial

The FDA notifies Solid Biosciences (NASDAQ:SLDB) that its IGNITE DMD Phase I/II clinical trial remains on clinical hold.
In November 2019, the Agency placed IGNITE DMD on clinical hold as the result of a serious adverse event related to the study drug. The study evaluated gene therapy candidate SGT-001 in Duchenne muscular dystrophy.
Thereafter, the company provided measures taken to improve patient safety, as well as information related to improvements to its manufacturing process.
On Friday, July 24, the FDA responded by maintaining the clinical hold and requesting further manufacturing information, updated safety and efficacy data for all patients dosed, and providing direction on total viral load to be administered per patient.

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