Kiromic Announces the Completion of its GMP Manufacturing Facility in Houston, Texas, to Support the Manufacturing of the First In-Human Allogenic CAR-T Trial

 

Kiromic BioPharma, Inc. (Nasdaq: KRBP), an immuno-oncology target discovery and gene-editing company, with a proprietary artificial intelligence neural network platform (Diamond AI) to develop novel oncology therapeutics, has announced the completion and certification of its GMP facility in Houston, Texas:

• GMP facility construction is complete and certified to meet all FDA required regulatory guidelines.
• GMP facility is ready to support our upcoming first in-human, off-the-shelf, allogenic CAR-T trial. The CAR-T ovarian cancer trials will have these targets: chPD1 Gamma-Delta and anti-ISOMSLN.
• Gamma-Delta-T cell (GDT cell) GMP manufacturing test batch optimization and qualification studies are proceeding as scheduled.

“The in-house capability to manufacture allogenic, off-the-shelf CAR products removes a layer of complexity in the workflow, which we believe will greatly enhance our ability to move swiftly through our CAR-T trials,” says Dr. Maurizio Chiriva-Internati, PhD, CEO of Kiromic BioPharma.

“The key features of the facility have been completed, clearing the path for the production of our off-the-shelf Gamma-Delta-T cells, a novel approach to CAR-T cell therapy, which will be evaluated in the upcoming clinical trials,” says David Aguilar, PhD, Head of CMC Manufacturing of Kiromic BioPharma.

“Thanks to the hard work of our scientists, contractor engineers, suppliers, and the third party certifiers, our Houston Facility is completing the final steps needed for launching the next-generation of allogenic, off-the-shelf CAR-T,” says Mr. Tony Tontat, CFO, COO of Kiromic BioPharma.

(chPD1: Chimeric PD1; ISOMSLN: Iso-mesothelin; CAR: Chimeric Antigen Receptors)

About Allogenic Gamma-Delta-T cells

GDT cells are a small fraction of blood lymphocytes, but they are the predominant T cell type in epithelia, where they patrol the barrier between the body and the outside world, with their potent multi-anti-pathogen abilities. Compared with alpha-beta-T cells (ABT), currently used in CAR therapies, GDT cells are more efficient in killing tumor cells and more resistant to mechanisms by which solid tumors escape from the immune system.

Furthermore, unlike ABT cells, GDT cells manufacturing does not require the patient’s blood, but can be produced using the blood of healthy donors, a process called allogenic cell transfer. This is possible because, while ABT cells from another individual will attack a patient’s normal organs, GDT cells will only target the tumor target for which they were engineered, leaving non-tumoral cells untouched.

The workflow of CAR-T therapy is as follows:

1. The GDT cells are grown and purified from the blood of healthy individuals.
2. The GDT cells are expanded with a proprietary process.
3. The GDT cells are then genetically modified to target tumor antigens discovered by Kiromic’s Diamond AI technology, resulting in the next generation of CAR-T cell therapy for solid malignancies.

About Kiromic

Kiromic BioPharma, Inc. is an immuno-oncology biopharmaceutical company focused on discovering, developing, and commercializing novel immuno-oncology applications through its robust product pipeline. The pipeline development is leveraged through the Company’s proprietary target discovery engine called “DIAMOND.” Kiromic’s DIAMOND is essentially big data science meeting target identification, dramatically compressing the man-years and the millions of drug development dollars needed to develop a live drug. The Company’s headquarters are located in Houston, TX adjacent to the world’s largest medical center and the MD Anderson Cancer Center.

For more information, please visit Kiromic’s website at:

www.kiromic.com

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about our intentions, projections, assessments, or expectations regarding items such as the following:

• our goals and strategies
• research, development, and regulatory activities
• FDA authorization timeline for clinical trial initiation
• clinical trial enrollment or participation by clinical sites
• facility manufacturing capabilities for clinical trial support
• expectations related to gamma delta CAR therapy
• performance and success of clinical trials
• our future business development, financial condition, and results of operations
• expected changes in our revenue, costs, or expenditures
• growth of and competition trends in our industry
• our expectations regarding demand for, and market acceptance of, our products
• our expectations regarding our relationships with investors, institutional funding partners and other parties we collaborate with
• fluctuations in general economic and business conditions in the markets in which we operate; including those fluctuations caused by COVID-19
• relevant government policies and regulations relating to our industry.

In some cases, you can identify forward-looking statements by terms such as “may,” “could,” “will,” “should,” “would,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “project” or “continue” or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the heading “Risk Factors” included in our Registration Statement on Form S-1 (file no. 333-238153), originally filed with the Securities and Exchange Commission (SEC) on May 11, 2020, as amended, and elsewhere in this press release. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.

The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this press release. Except as expressly required by the federal securities laws, there is no undertaking to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason. You are advised, however, to review any further disclosures we make on related subjects in our Forms 10-Q, 8-K and other reports filed with the SEC.

Tony Tontat
Chief Financial Officer
(844) 539 – 2873
ttontat@kiromic.com

SOURCE: Kiromic

Helius Medical Technologies, Inc. Submits Response to U.S. FDA in Pursuit of De Novo Classification and Clearance of the PoNS™ Device for the Treatment of Gait Deficit Due to Symptoms of Multiple Sclerosis

 

Submits formal response to the U.S. Food and Drug Administration’s request for additional information

 

NEWTOWN, Pa., Jan. 11, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has submitted its formal response to the U.S. Food and Drug Administration’s (the “FDA” or “Agency”) request for additional information.

The FDA’s request for additional information was related to the Company’s request for de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNS™) device as a potential treatment for gait deficit due to symptoms of Multiple Sclerosis (“MS”), to be used as an adjunct to a supervised therapeutic exercise program in patients over 18 years of age.

“The Helius team is very excited to announce the timely submission of our response to the FDA’s request for additional information,” said Dane Andreeff, Interim President and Chief Executive Officer of Helius. “The achievement of this important milestone was made possible by the diligent efforts of our regulatory and clinical affairs team, and I would like to thank them for their hard work and dedication in recent months.”

Mr. Andreeff continued: “Looking ahead, we expect that the FDA’s receipt of our response will enable the FDA to resume its review of our request for de novo classification and clearance. We remain committed to our goal of bringing our PoNS technology to the aid of U.S. patients suffering with gait deficit due to MS-related symptoms as expeditiously as possible, and hope to receive the FDA’s decision on our request for de novo classification and clearance during the first half of this year.”

Additional Background Information:

Helius submitted its request for de novo classification and clearance of the PoNS device for the treatment of gait deficit due to symptoms from MS on August 4, 2020, following the receipt of Breakthrough Designation by FDA in early May. On October 19, 2020, the Company announced the receipt of the FDA’s request for additional information, which was received approximately 75 days following the submission date and placed the FDA’s review on hold until receipt by the FDA of the requested information.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for de novo classification and clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Jack Powell
investorrelations@heliusmedical.com

Cautionary Disclaimer Statement:

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future growth and operational progress, clinical and regulatory development plans for the PoNS device, and potential regulatory clearance of the PoNS device, including expected timing for the FDA to resume its review of our request for de novo classification and clearance and expected timing for receipt of the FDA’s decision on such request.

These statements involve substantial known and unknown risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the clinical development process and FDA regulatory submission and approval process, including that the Company’s request for de novo classification and clearance may be declined by the FDA, that the FDA is not required to and may not respond to the Company’s request in the timeframe indicated by its de novo review goals or in the time the Company expects, whether the Company’s response will be satisfactory to the FDA, whether the FDA will require additional information, whether the Company will be able to provide it in a timely manner and whether such additional information will be satisfactory to the FDA, uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, uncertainties associated with future clinical trials and other development activities, and other risks detailed from time to time in the filings made by the Company with securities regulators, including the risks and uncertainties described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

SOURCE: Helius Medical Technologies