KDST Kadimahstem Ltd

DGAP-News: Kadimastem Announces the Approval of a 4M NIS ($1.29M) Budget from the Israel Innovation Authority

DGAP-News: Kadimastem
Kadimastem Announces the Approval of a 4M NIS ($1.29M) Budget from the Israel Innovation Authority

13.12.2021 / 13:00
The issuer is solely responsible for the content of this announcement.


(TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS and a potential cure for diabetes, has received a grant of NIS 1.6 million ($500K), 40% of the approved budget of NIS 4 million ($1.29M) from the . This brings the total amount of financing raised by Kadimastem in 2021 to NIS 51.6 million ($16 M).

MaWMjKPK.jpg

As Kadimastem intends to submit the IND for the Phase IIa clinical study before the end of 2022, the IIA funding will be used to scale up the production of a frozen, off-the-shelf product of in preparation for the trial. Using large reactors and special tools, hundreds of millions of high-quality astrocyte cells, the brain supporting cells that comprise AstroRx(R), will be produced for the clinical trial, as well as for future commercialization purposes for the benefit of the hundreds of thousands of ALS patients worldwide.

Kadimastem has already completed a Phase I/IIa clinical trial (). This trial was the first of its kind in the world, whereby the supporting cells of the central nervous system (AstroRx(R)), produced by the company, were injected into the spinal fluid of patients, in a standard lumbar puncture procedure.

Five ALS patients were injected with 100 million cells and five patients were injected with 250 million cells. The results of both doses demonstrated a high safety profile. No serious treatment-related side effects were reported and no side effects limiting the treatment dose were found.

In order to determine initial efficacy, an analysis was performed comparing the rate of disease progression according to the ALSFRS-R index in the pre-treatment follow-up period and the post-treatment follow-up period. It was found that with both doses the rate of disease progression slowed significantly during the three months following injection.

In light of these clinical trial results, in the next study, the company intends to examine if dosing every three months with the cellular off-the-shelf AstroRx(R) product prolongs the therapeutic effect.

Kadimastem CEO Asaf Shiloni said, "In the past year, Kadimastem has experienced an unprecedented show of support from both existing and new investors. Today's grant by the Israeli Innovation Authority is another strong endorsement of the company's important work in developing an improved therapeutic treatment for the millions suffering from debilitating neurological diseases. Kadimastem is at an exciting turning point and this grant supports us with the necessary resources to advance the plans for the quantitative production of the company's flagship product - AstroRx(R). In other words, after this past year's fund raising, we now have the capital to create increased quantities of brain supporting cells, enough to truly make a big difference in helping the hundreds of thousands of ALS patients worldwide."

Chief Scientist of Kadimastem Professor Michel Revel said, "We thank the Israel Innovation Authority for its continued support and for further helping Kadimastem to proceed on this very worthwhile journey."

About Kadimastem:

Kadimastem is a clinical stage cell therapy company, developing and manufacturing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx(R), the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS. IsletRx is the company's second product in development. IsletRx is comprised of functional, insulin producing, pancreatic islet cells intended to treat and cure patients with insulin-dependent diabetes. IsletRx demonstrated safety and efficacy in a proof-of-concept preclinical study. An INTERACT meeting took place with the FDA on October 7, 2021, where the diabetes treatment program was discussed, and the company received directions how to prepare its Pre-IND submission. In November 2021, the company announced its intention to list on NASDAQ. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif(R), a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).

Forward Looking Statement:

This document may include forward-looking information as defined in the Securities Law, 5728 - 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future.

Contact Details

Asaf Shiloni

3

Company Website


News Source: News Direct


13.12.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at


Language: English
Company: Kadimastem
United States
ISIN: IL0011284614
EQS News ID: 1257205

 
End of News DGAP News Service

1257205  13.12.2021 

fncls.ssp?fn=show_t_gif&application_id=1257205&application_name=news&site_id=research_pool
EN
13/12/2021

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Kadimahstem Ltd

Kadimastem Ltd: 1 director

A director at Kadimastem Ltd sold 2,230,144 shares at 1.072ILS and the significance rating of the trade was 72/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearl...

 PRESS RELEASE

DGAP-News: Kadimastem Receives US Patent For Amyotrophic Lateral Scler...

DGAP-News: Kadimastem Kadimastem Receives US Patent For Amyotrophic Lateral Sclerosis (ALS) Treatment 09.08.2022 / 13:00 CET/CEST The issuer is solely responsible for the content of this announcement. (TASE: KDST), a clinical stage cell therapy company developing treatments for ALS and diabetes, has been granted a patent from the United States Patent and Trademark Office for its cell therapy technology for treating ALS and other neurodegenerative diseases. This US patent joins additional patents granted to Kadimastem in the US, Israel and Europe for the treatment of ALS an...

 PRESS RELEASE

DGAP-News: Kadimastem and Implant Therapeutics, Inc. Sign an Evaluatio...

DGAP-News: Kadimastem Kadimastem and Implant Therapeutics, Inc. Sign an Evaluation Agreement Towards the Potential Licensing of “Immune Evasive” Cells 08.06.2022 / 13:00 The issuer is solely responsible for the content of this announcement. If the feasibility study is successful, it would be a significant step forward towards pancreatic tissue engineering that could be used to develop Kadimastem’s IsletRx for diabetes in a way where transplantation would be possible without concern of immune rejection (TASE: KDST), a clinical stage cell therapy company developing a treatme...

 PRESS RELEASE

DGAP-News: Kadimastem Awarded Patent in Japan for AstroRx® For ALS and...

DGAP-News: Kadimastem Kadimastem Awarded Patent in Japan for AstroRx® For ALS and Drug Screening 30.05.2022 / 15:10 The issuer is solely responsible for the content of this announcement. (TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS, exploring one for multiple sclerosis and developing a potential cure for diabetes, has received a patent from the Japan Patent Office for ® for the treatment of ALS and drug screening. The patent also protects AstroRx® for the treatment of multiple sclerosis. AstroRx® is comprised of a differentiated cell...

 PRESS RELEASE

DGAP-News: Kadimastem Expands R&D Program to Include Multiple Sclerosi...

DGAP-News: Kadimastem Kadimastem Expands R&D Program to Include Multiple Sclerosis 18.05.2022 / 13:00 The issuer is solely responsible for the content of this announcement. (TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS and a potential cure for diabetes, is expanding its R&D activity with the exploration of developing a treatment for Multiple Sclerosis (MS). Kadimastem remains on track to submit IND to the FDA before the end of 2022 to begin a multicenter clinical trial of for ALS in 2023 in the U.S.As part of this initiative, the comp...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch