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
[email protected]

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
[email protected]

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

 

Sigyn Therapeutics™ Reports Results of Pilot Study to Address Inflammatory CytoVesicles

 

Sigyn Therapy™ is a Candidate to Treat Life-Threatening Inflammatory Conditions That Are Not Addressed with Drug Therapies

SAN DIEGO, Jan. 06, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Sigyn Therapeutics, Inc. (OTCMarkets: SIGY), a medical technology company whose focus is the treatment of life-threatening inflammatory conditions precipitated by Cytokine Storm Syndrome (the Cytokine Storm), today announced the results of an in vitro pilot study that successfully modeled the ability of Sigyn Therapy™ to address CytoVesicles that transport inflammatory cytokine cargos in the bloodstream.

Cytokine Storm Syndrome is an excessive response of the immune system that is induced by infectious and non-infectious conditions. A hallmark indicator of Cytokine Storm Syndrome is the excessive or uncontrolled release of pro-inflammatory cytokines, which can lead to multiple organ failure and cause death. The annual market opportunity to address Cytokine Storm related indications exceeds $20 billion and includes sepsis, the most common cause of hospital deaths worldwide. Virus-induced Cytokine Storm Syndrome is a leading cause of death resulting from severe SARS-CoV-2 (COVID-19) infections.

Sigyn Therapy is a proprietary blood purification technology designed to overcome the limitations of previous drug and device candidates to treat acute inflammatory conditions. Incorporated within Sigyn Therapy is a cocktail of adsorbent components with unique binding and capture characteristics to optimize the broad-spectrum depletion of inflammatory targets from the bloodstream. These targets include pro-inflammatory cytokines, endotoxin and CytoVesicles (extracellular vesicles that transport inflammatory cytokine cargos) that participate in concert with freely circulating cytokines to further escalate the Cytokine Storm. CytoVesicles are an important yet previously elusive target as they can be 20-60 times larger than cytokines themselves.

In the in vitro pilot study, 104nm liposomes were utilized as a model system to assess the ability of Sigyn Therapy’s adsorbent components to deplete CytoVesicles from human blood plasma. After a two-hour interaction with Sigyn’s adsorbent components, liposome concentrations in human blood plasma were reduced ~90%. Previously published studies have validated liposomes as a model for the isolation of extracellular vesicles from blood based on the similarity of their size and structural characteristics.

“When we designed Sigyn Therapy, we envisioned a device that could be broadly deployed by the medical community, yet also have expansive first-in-industry capabilities that offer to improve patient outcomes,” stated Jim Joyce, Chairman and CEO of Sigyn Therapeutics. “When considering our previous report that Sigyn Therapy™ clears both endotoxin and inflammatory cytokines from human blood plasma, the observation from our CytoVesicle pilot study further reinforces the potential for our vision to become a therapeutic reality.”

Sigyn Therapy is a single-use device designed for use on the established infrastructure of dialysis and CRRT machines already located in hospitals and clinics worldwide. On December 1, 2020, the Company reported the results of an in vitro study that validated the ability of Sigyn Therapy to simultaneously reduce the presence of endotoxin and relevant pro-inflammatory cytokines, which included Interleukin-1 Beta (IL-1B), Interleukin-6 (IL-6) and Tumor Necrosis Factor alpha (TNF-a). Endotoxin (lipopolysaccharide or LPS) is a potent mediator implicated in the pathogenesis of sepsis and septic shock. The dysregulated over-production of IL-1B, IL-6 and TNF-a can lead to organ failure and cause death.

An objective of the study was to rebalance elevated cytokine levels and optimize the elimination of endotoxin from human blood plasma. The study was conducted in triplicate over four-hour time periods with a pediatric version of Sigyn Therapy. Average reduction of endotoxin load peaked at 83% during the studies. The average reduction of IL-1B was 69%, IL-6 reduction was 59% and TNF-a reduction was 57% during the four-hour studies.

The resulting data from each of these studies will be incorporated into an Investigational Device Exemption (IDE) that Sigyn Therapeutics plans to submit to the United States Food and Drug Administration (FDA) in 2021.

About Sigyn Therapeutics

Sigyn Therapeutics™ is a development-stage therapeutic technology company headquartered in San Diego, California USA. Our focus is directed toward a significant unmet need in global health; the treatment of life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome and not addressed with an approved therapy. Our mission is to save lives.

Sigyn Therapy™ is a novel blood purification technology designed to mitigate cytokine storm syndrome through the broad-spectrum depletion of inflammatory targets from the bloodstream. Cytokine storm syndrome is the hallmark of sepsis, which is the most common cause of in-hospital deaths and claims more lives each year than all forms of cancer combined. Virus induced cytokine storm (VICS) is associated with high mortality and is a leading cause of SARS-CoV-2 (COVID-19) deaths. Other therapeutic opportunities include, but are not limited to bacteria induced cytokine storm (BICS), acute respiratory distress syndrome (ARDS) and acute forms of liver failure, such as hepatic encephalopathy.

To learn more, visit www.SigynTherapeutics.com or www.SigynTherapy.com

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “could,” “will,” “plan,” “intend,” “anticipate,” “approximate,” “expect,” “potential,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about Sigyn’s future financial performance, the impact of management changes, any proposed organizational restructuring, results of operations, capital resources to fund operations; statements about Sigyn’s expectations regarding the capitalization, resources and ownership structure of the combined company; statements about the potential benefits of the transaction; the expected completion and timing of the transaction and other information relating to the transaction; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that Sigyn makes due to a number of important factors, including (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect Sigyn’s business and the price of the common stock of Sigyn, (ii) the failure to satisfy of the conditions to the consummation of the transaction, (iii) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement, (iv) risks related to the ability to realize the anticipated benefits of the transaction, including the risk that the businesses will not be integrated successfully, (v) the effect of the announcement or pendency of the transaction on Sigyn’s business relationships, operating results and business generally, (vi) risks that the proposed transaction disrupts current plans and operations, (vii) risks related to the combined entity’s ability to up-list to a national securities exchange, (viii) risks related to the combined entity’s access to existing capital and fundraising prospects to fund its ongoing operations, (ix) risks related to diverting management’s attention from Sigyn’s ongoing business operations, (x) other business effects, including the effects of industry, market, economic, political or regulatory conditions, future exchange and interest rates, and changes in tax and other laws, regulations, rates and policies, and (xi) risks related to an inability to manufacture Sigyn Therapy, risks related to the clinical advancement of Sigyn Therapy with regulatory agencies, and no assurance that Sigyn Therapy will be proven to be a safe and efficacious treatment for any condition. The forward-looking statements in this press release represent Sigyn’s views as of the date of this press release. Sigyn anticipates that subsequent events and developments may cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing Sigyn’s views as of any date subsequent to the date of this press release.

Contact Sigyn Therapeutics, Inc.

Jim Joyce
Chairman, CEO
(619) 368-2000
[email protected]

Source: Sigyn Therapeutics, Inc.