Immunovant Up On Data, And Other News: The Good, Bad And Ugly Of Biopharma

Immunovant stock shoots up on positive trial data news

Immunovant Inc. (IMVT) stock reacted positively to its top-line data from Phase IIA study ASCEND MG. The trial seeks to evaluate the potential of its lead drug candidate IMVT-1401, administered subcutaneously, for treating myasthenia gravis. The data demonstrated that the trial met its primary endpoint. The company is looking to start a pivotal phase III study on IMVT-1401 in the first half of 2021.

Phase IIA study is a multi-center, randomized, placebo-controlled trial. The study was designed to test the safety, tolerability, pharmacodynamics, and efficacy of IMVT-1401 in patients with moderate-to-severe generalized MG. The study consisted of three groups including 340mg dosage, 680mg dosage, and placebo administered over the course of the six-week treatment period.

The pooled analysis of 15 patients who completed Day 42 showed that patients given the drug candidate had a mean 3.8-point improvement on the MG-ADL scale vs. a mean decline of +0.6 for placebo. Pete Salzmann, M.D., CEO of Immunovant said:

The clinical benefits we observed in this trial provide strong support that IMVT-1401 might ultimately become a best-in-class anti-FcRn agent for MG patients. Importantly, IMVT-1401 was delivered by subcutaneous injection, opening the future possibility of at-home, self-administered treatment rather than infusion center-based treatment.”

IMVT-1401-treated patients also demonstrated a highly statistically significant improvement on the MGC scale, showing an average improvement of 8.0 points vs. a mean decline of +1.4 for placebo. MG-ADL responder rates were 60 percent for IMVT-1401-treated patients vs. 20 percent for placebo. MG-ADL responder rates have been defined as the percentage of patients showing a > 2-point improvement.

IMVT-1401 was also found to be generally well-tolerated and safe, in line with previously reported data from Phase I. The trial also did not show any serious adverse events or withdrawals due to adverse events. 340 mg and 680 mg cohorts showed mean reductions in total serum IgG from baseline at 59% and 76%, respectively.

The data further showed that MG-ADL deep responder rates were 40% for IMVT-1401-treated patients vs. 0% for placebo. MG-ADL deep responder rates have been defined as the percentage of patients showing a > 6-point improvement. MGC deep responder rates were 40% for IMVT-1401-treated patients vs. 0% for placebo. This metric was defined as the percentage of patients showing a > 10-point improvement.

Owing to a change in circumstances due to a virus outbreak, the company decided to unblind the study, 5 of an anticipated 21 patients had completed the six-week treatment course. Immunovant plans to use the data for designing a pivotal Phase 3 study.

INVT-1401 is a fully human monoclonal antibody. It works by focusing the neonatal Fc receptor, which aids IgG recycling. It quickens the process of degradation of IgG by targeting FcRn and stopping endogenous IgG from binding. The elevated catabolism of IgG is believed to curb the detrimental immune response shown by auto-antibodies. The company submitted an IND for WAIHA in November 2019.

Immunovant, Inc. is a clinical-stage biopharmaceutical company. It mainly focuses on developing treatments for autoimmune diseases.

REGENXBIO received FDA approval for Phase II trial of RGX-314

REGENXBIO Inc. (RGNX) announced that the FDA has given the clearance to its Investigational New Drug Application for the Phase II trial of RGX-314. The trial seeks to assess the suprachoroidal delivery of RGX-314 in patients with diabetic retinopathy. The company plans to initiate the dosing of patients in the second half of 2020.

ALTITUDE is a multi-center, open-label, randomized, controlled dose-escalation study. The main aim of the study is to assess the efficacy, safety, and tolerability of suprachoroidal delivery of RGX-314. Steve Pakola, M.D., Chief Medical Officer of REGENXBIO said:

We believe one-time treatment with RGX-314 can provide sustainable, long-term anti-VEGF delivery to the eye, potentially reducing the severity of DR and preventing vision threatening complications.”

The trial will likely enroll 40 patients with DR across two cohorts. These participants will be randomized and will be administered RGX-314 versus observational control at a 3:1 ratio. The trial will test dose levels of the drug candidate at 2.5×1011 GC/eye and 5.0×1011 GC/eye. No prophylactic immune-suppressive corticosteroid therapy before or after administration of RGX-314 will be given to the participants.

The primary endpoint of the trial pertains to the proportion of patients that improve in DR severity as shown by the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at 48 weeks. Secondary endpoints for the trial include the safety and development of DR-related ocular complications. REGENXBIO expects the interim data from the trial to be out in 2021.

RGX-314 has the potential to become a one-time treatment for diabetic retinopathy, wet AMD, and other chronic retinal conditions treated with anti-VEGF. The drug candidate works by encoding an antibody fragment and inhibiting VEGF. It alters the pathway for the formation of new leaky blood vessels, causing retinal fluid accumulation, and vision loss.

REGENXBIO uses its NAV Technology Platform for developing various therapies. The platform comprises exclusive rights to more than 100 novel AAV vectors.

Cardinal Health allegedly gamed small business government plan

Cardinal Health Inc. (CAH) received a setback as the company has been sued by a whistleblower for cheating a government program aiming to aid small businesses. A False Claims Act lawsuit has been filed against Cardinal and two of its front companies in the United States District Court for the Eastern District of Washington.

The case has been filed by UPPI, a group of small business nuclear pharmacies that specialize in radiopharmaceutical products. It claims that the company used its SDVOSB front companies to unlawfully avoid competitive bidding for Government radiopharmaceutical supply contracts. It further states that such front companies generally do not have the expertise to perform specialized tasks required by the contracts, but they use their preferred SDVOSB status for winning the awards.

The government is now cracking down on companies using such tactics including “rent-a-vet” arrangements. Apart from harming the integrity of the program, these tactics also make small businesses suffer, who are supposed to be the original beneficiary of the scheme.

UPPI is a membership organization and aims to promote the business interests of its members. The members of these organizations are individual, small business, and university-based nuclear pharmacies. These pharmacies are mainly engaged in manufacturing, producing, marketing, selling, and distributing nuclear pharmaceuticals.

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p class=”p p4″>Cardinal Health, Inc. is one of the biggest medical supplies and pharmaceutical distributors in the United States. The company is also embroiled in opioid litigation. The company, along with other major distributors such as McKesson (NYSE:MCK) and AmerisourceBergen (NYSE:ABC), is involved in talks pertaining to the payment of damages. The distributors are mainly held responsible for failing to notify the suspicious diversion of the supplies.

That means that when the catalyst comes that will make or break a stock, we’ve positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Credit: SeekingAlpha

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