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Wave of FDA Fast Track Designations Highlight Biotech Momentum Carrying into 2023

FN Media Group Presents USA News Group News Commentary

 

Vancouver, BC – September 13, 2023 – USA News Group  –  Sufferers of many different ailments saw reason to grow their hope in 2022 when the US Food and Drug Administration (FDA) granted several approvals and new Fast Track designations towards the end of 2022 and into January of 2023. In particular, the FDA’s Fast Track Designation (FTD) is designed to facilitate the development and to expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need. It’s these drugs that receive Fast Track designation that become eligible for more frequent communications and meetings with the FDA for the purpose of discussing the drug’s development plan. Drugs with FTD may also qualify for accelerated approval and priority review if relevant criteria are met. Some recent examples with FTDs include Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Avidity Biosciences, Inc. (NASDAQ:RNA), Fulcrum Therapeutics, Inc. (NASDAQ:FULC), BriaCell Therapeutics Corp. (NASDAQ:BCTX) (TSX:BCT), and a once-Fast Track designated and now approved drug from Gilead Sciences, Inc. (NASDAQ:GILD).

 

Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) closed out 2022 on a high note, having received notice of FTD for its flagship asset, pelareorep, a first-in-class intravenously delivered immunotherapeutic agent for the treatment of solid tumors and hematological malignancies.

 

“Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication,” stated Dr. Matt Coffey, President and CEO of Oncolytics Biotech. “We expect the opportunity for more frequent communication about our data with FDA provided by this designation will be invaluable as we work to align with the Agency on the best design for a registrational PDAC study.”

 

Coming swiftly on the heels of the release of interim clinical data in a cohort of first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) patients from the company’s phase 1/2 GOBLET study treated with the combination of pelareorep, the chemotherapies gemcitabine and nab-paclitaxel, and Roche Holdings AG’s (RHHBY) anti-PD-L1 checkpoint inhibitor, atezolizumab, Oncolytics announced that pelareorep received FTD for the treatment of advanced/metastatic PDAC.

 

The GOBLET study’s pancreatic cohort delivered an impressive 69% objective response rate (ORR), including a complete response, which the National Cancer Institute defines as “the disappearance of all signs of cancer in response to treatment” (aka “remission”).

 

For contextual reference, these ORR results were nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer.

 

“We were particularly excited to see a partial response deepen into a confirmed complete response as of the latest data cut, since this further indicates potentially durable anti-cancer effects from the combination therapy,” said Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech.

 

Also in December, the FDA gave another FTD to Fulcrum Therapeutics, Inc. (NASDAQ:FULC) for FTX-6058, which is the company’s candidate for the genetic blood disorder sickle cell disease (SCD). After the drug moved into a Phase Ib trial and reported improved biomarkers of hemolysis on 6 mg doses, Fulcrum began enrolling patients in a study using a 12 mg dose, with a new release of data planned for the fourth quarter of 2023.

 

“We are entering 2023 with a tremendous amount of momentum and expect it to be a productive year for our two clinical programs: FTX-6058 for SCD, and losmapimod for FSHD,” said Robert J. Gould, Ph.D., Fulcrum’s interim President and CEO. “FTX-6058 is a potential best-in-class oral HbF inducer candidate that could address critical gaps in the SCD treatment landscape.”

 

Avidity Biosciences, Inc. (NASDAQ:RNA) just received its own FTD for AOC 1020 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). FSHD is a serious, rare, hereditary muscle-weakening condition marked by life-long, progressive loss of muscle function that causes significant pain, fatigue, and disability.

 

“The FDA Fast Track designation for AOC 1020 reinforces the importance of finding an effective treatment to help people living with FSHD, a devastating and debilitating muscular dystrophy disorder with no treatment options,” said Steve Hughes, M.D., Chief Medical Officer at Avidity. “AOC 1020 is designed to directly target the disease-causing gene, DUX4, to address the underlying cause of FSHD. We look forward to working collaboratively with the FDA to bring the first RNA therapy directly targeting DUX4 to patients as quickly as possible.”

 

AOC 1020 is being studied in the Phase 1/2 FORTITUDE™ clinical trial in adults with FSHD and is the company’s second muscle-targeting small interfering RNA (siRNA) AOC in clinical development. The FORTITUDE™ trial is a randomized, placebo-controlled, double-blind, Phase 1/2 clinical trial designed to evaluate AOC 1020 in approximately 70 adult participants with FSHD. Avidity plans to share data from a preliminary assessment of AOC 1020 in approximately half of study participants from the FORTITUDE trial in the first half of 2024.

 

After a positive End of Phase II meeting with the FDA, BriaCell Therapeutics Corp. (NASDAQ:BCTX) (TSX:BCT) announced it had come to an agreement and positive feedback from the FDA regarding the company’s lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor (under Fast Track designation), in advanced metastatic breast cancer.

 

As per the announcement, BriaCell and the FDA have agreed on the primary end point, the essential elements of the study design, and the type of patients to be enrolled in BriaCell’s upcoming pivotal clinical study. This pivotal registration study will be enrolling advanced metastatic breast cancer patients for whom no approved treatment options exist.

 

“The importance of this milestone speaks for itself and is yet another major step towards our goal to become one of the leading immuno-oncology companies,” said Dr. William V. Williams, BriaCell’s President and CEO. “Jumping directly into a pivotal study shortly after receiving Fast Track status has greatly advanced our lead clinical program timetable with the ultimate goal of commercializing our novel immunotherapy approach for women with no approved treatment options.”

 

For an example of what can happen next after the FDA has already given a FTD and lived up to the “fast track” moniker, look no further to the FDA’s late-December approval of Sunlenca (lenacapavir) from Gilead Sciences, Inc. (NASDAQ:GILD) for adult patients living with HIV, whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations.

 

Sunlenca is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1. Sunlenca works by blocking the HIV-1 virus’ protein shell (the capsid), thereby interfering with multiple essential steps of the viral lifecycle. Sunlenca’s starting dose is given as oral tablets and subcutaneous injections, followed by maintenance injections every six months; Sunlenca is given in combination with other antiretroviral(s).

 

For more information please visit: https://usanewsgroup.com/2023/05/31/could-this-company-be-on-track-to-cure-pancreatic-and-breast-cancer-2/

  

Article Source: 

USA News Group
http://USAnewsgroup.com
info@usanewsgroup.com

  

DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. (“MIQ”). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.

 

While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

 

USA News Group is Source of all content listed above.  FN Media Group, LLC (FNM), is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with USA News Group or any company mentioned herein.  The commentary, views and opinions expressed in this release by USA News Group are solely those of USA News Group and are not shared by and do not reflect in any manner the views or opinions of FNM.  FNM is not liable for any investment decisions by its readers or subscribers.  FNM and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security.  FNM was not compensated by any public company mentioned herein to disseminate this press release.

 

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SOURCE USA News Group

The post Wave of FDA Fast Track Designations Highlight Biotech Momentum Carrying into 2023 appeared first on Financial News Media.

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