AGTC Sheds Light On Achromatopsia Trials, LLY, VIR And GSK Team Up, CVM Turns Head As It Awaits Data

biotech jan28 lt

Today's Daily Dose brings you news about Applied Genetic's Achromatopsia trial results; the deadlock in AstraZeneca vaccine supply in EU; partnership of Lilly, Vir Biotech and GlaxoSmithKline in fighting COVID-19; and ZymeWork's progress with ZW49 study.

Read on…

1. Applied Genetic Throws Light on Achromatopsia Trials

Applied Genetic Technologies Corp.'s (AGTC) phase I/II clinical trials evaluating AAV gene therapy product candidates in patients with achromatopsia caused by CNGB3 or CNGA3 mutations, dubbed ACHMB3 and ACHMA3 trials, have provided for the first time quantitative evidence of improvements in visual sensitivity.

Achromatopsia (ACHM) is an inherited condition caused by mutations in one of several genes, with the two most common being mutations in either the CNGB3 or CNGA3 genes.
ACHM is associated with extremely poor visual acuity (most affected individuals are legally blind), extreme light sensitivity resulting in daytime blindness, and complete loss of color discrimination. There is no specific treatment for ACHM, although deep red tinted glasses or contact lenses can reduce symptoms of light sensitivity and daytime blindness.

The preliminary results of the ACHMB3 trial include 12-month data from 15 patients, 9month data from five patients, 6-month data from three patients and 3-month data from three patients, for a total of 26 patients across all dose groups. For ACHMA3, the new data analysis consists of 12-month data from 10 patients, 9-month data from four patients, 6-month data from one patient and 2 or 3-month data from three patients, for a total of 18 patients across all dose groups.

In the ACHMB3 trial, 7 of the 16 patients in the three highest dose groups showed improvements in visual sensitivity, in the treated area, as measured by static perimetry while in the ACHMA3 trial, 3 of the 16 patients in the four highest dose groups showed improvements in visual sensitivity.

The company expects to report 12-month data from the adult patients in the ACHMB3 and ACHMA3 trials in second quarter of calendar year 2021, and preliminary 3-month data from the pediatric patients in both trials is anticipated in the fourth quarter of calendar year 2021.

AGTC closed Wednesday's trading at $4.45, down 5.72%. In after-hours, the stock was up 5.62% at $4.70.

2. Deadlock on AstraZeneca Vaccine Supply Continues

Stella Kyriakides, the European Commissioner for Health and Food Safety, on Wednesday, has urged AstraZeneca plc (AZN) to deliver on its commitments in the COVID-19 vaccine supply contract it had signed last August.

AstraZeneca's COVID-19 vaccine was approved for emergency supply in the UK on Dec.30, 2020. In the EU, the drug regulator is scheduled to decide on the vaccine's approval tomorrow.

The company had initially pledged to deliver 80 million doses of the vaccine to the 27 EU countries for February and March and more than 80 million doses in the second quarter. However, last week, AstraZeneca said that the initial supply of vaccine will be cut by 60% due to production issues.

In a PR issued January 27, Kyriakides noted, "Not being able to ensure manufacturing capacity is against the letter and the spirit of our agreement. I call on AstraZeneca to engage fully, to rebuild trust, to provide complete information and to live up to its contractual, societal and moral obligations".

As per the deal signed last August, the European Commission agreed to purchase 300 million doses of the AstraZeneca vaccine, with an option to purchase 100 million more, on behalf of EU Member States.

3. CEL-SCI Catches Eye As it awaits head & neck cancer Trial Data

Shares of CEL-SCI Corporation (CVM) closed at a five-year high of $25 on Wednesday, as the company continues to await the final results of its phase III study of Multikine in head and neck cancer.

The phase III trial was started in late 2010 and the last patient was enrolled in the study in September 2016. With 928 patients having been enrolled, this study is said to be the largest ever in head and neck cancer.

In a letter to shareholders early this month, Geert Kersten, the company's CEO, said that the database for the study was locked late last year (meaning it was ready to be analyzed) and experts are now analyzing the data according to a statistical analysis plan that was agreed to and finalized before database lock.

CVM touched an intraday high of $40.91 Wednesday, before closing at $25, up 72.53%.

4. Vir Biotech Continues To Rally

Eli Lilly and Co. (LLY), Vir Biotechnology Inc. (VIR) and GlaxoSmithKline plc (GSK) have teamed up to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19.

As part of the collaboration, Lilly has expanded its ongoing phase II trial, dubbed BLAZE-4, to evaluate the administration of Bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as GSK4182136) 500mg for COVID-19. The first patient has been dosed in the expanded BLAZE-4 trial as well.

This unique collaboration marks the first time that monoclonal antibodies from separate companies will be brought together to explore potential outcomes.

The ongoing BLAZE 4 trial is evaluating the efficacy and safety of Bamlanivimab alone, and Bamlanivimab with other neutralizing antibodies including VIR-7831 (GSK4182136) versus placebo for the treatment of symptomatic COVID-19 in the outpatient setting.

Bamlanivimab, a neutralizing antibody borne out of the collaboration between Lilly and AbCellera, is authorized for emergency use for the treatment of mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization. VIR-7831 is a dual-action monoclonal antibody that was selected for clinical development based on its potential to both block viral entry into healthy cells and clear infected cells.

On Tuesday, Vir announced encouraging initial topline data from its ongoing phase I trial of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection, sending the stock up over 70% to $77.

VIR closed Wednesday's trading at $83.07, up 7.35%.

5. Zymeworks Progresses with ZW49 Study

Zymeworks Inc. (ZYME), on Wednesday, announced that it has begun enrolling patients into the expansion cohort portion of its ongoing phase I clinical trial for ZW49.

ZW49, a HER2-targeted antibody drug conjugate (ADC), is being developed as a treatment for patients with locally advanced or metastatic HER2-expressing cancers that have progressed following treatment with existing approved therapies, including HER2-targeted agents.

The expansion cohorts include HER2-positive breast cancer, HER2-positive gastroesophageal adenocarcinoma, and a basket cohort of other HER2-positive cancers and are actively enrolling at sites in U.S. and Canada, and are expected to open soon at additional sites in South Korea and Australia in collaboration with the company's partner, BeiGene.

ZYME closed Wednesday's trading at $44.06, down 4.78%. In after-hours, the stock fell another 24% and was at $33.40.

6. Stocks That Gained/Lost The Most

Sorrento Therapeutics Inc. (SRNE) closed Wednesday's trading at $15.23, up 46.16%.

Rubius Therapeutics Inc. (RUBY) closed at $14.69, up 43.88%.

PetMed Express Inc. (PETS) closed at $51.80, up 33.64%.

ENDRA Life Sciences Inc. (NDRA) closed at $2.20, down 22.81%.

AIkido Pharma Inc. (AIKI) closed at $1.41, down 21.23%.

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