On May 24, 2021 Kiromic Biopharma, Inc. (Nasdaq: KRBP), an immuno-oncology target discovery and gene-editing company with a proprietary artificial intelligence neural network platform (Diamond AI) that is used to develop novel oncology therapeutics, reported the submission of a novel Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial that has the potential to be a universal CAR T-Cell therapy for any solid malignancy that expresses the biomarker Iso-mesothelin, with higher efficacy, higher safety, as well as lower manufacturing and distribution costs (Press release, Kiromic, MAY 24, 2021, View Source [SID1234580497]).

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The title of the clinical trial is: ALEXIS-ISO-1: A Phase 1, Open-label, Dose Escalation Study of KB-ISM, Allogeneic Gamma Delta T-cells Expressing a Chimeric Antigenic Receptor (CAR) Against the Isoform 2 of Mesothelin in Subjects with Metastatic or Progressive Locally Advanced Solid Malignancies.

The FDA feedback is expected within 30 days from IND submission.

Key features of the IND:

Product Name

KB-ISM

Product Type

CAR-T live cell therapy

Cancer Type

All solid tumors that express IsoMesothelin

Targeting

Isoform 2 of Mesothelin (AI algorithm predicted targets)

Patient Type

Patients with solid tumor positive for ISM

No. of Patients

30

Dosing

Dose escalation

Duration of Trial

18 months

First-in-human

3Q 2021 pending FDA authorization

First data from Trial

4Q 2021

How Our KB-ISM Live Cell Therapy CAR-T Improves CAR-T Market:

Marketed and traditional CAR-T

Kiromic KB-ISM

Malignancies
(Cancer Type)

Hematologic

Solid Tumors

Live Cell Origin

Autologous

Live Cells from pre-treatment patients

Allogenic

Live Cells from healthy donors

Live Cell Cloning
(Manufacturing)

Single batch
Single dose

Single batch
Multi dose

(aka. Off-The-Shelf)

Mass Manufacturing
on-demand
a single patient

— Will be manufactured like a traditional drug

— Kiromic proprietary manufacturing

— Kiromic proprietary cryopreservation processing techniques

This submission follows by one week the company’s prior submission of the IND for a phase 1 trial of the Gamma Delta chimeric PD1 Switch Receptor.

Both clinical trials support Kiromic’s clinical strategy of developing a "universal" off-the-shelf cell therapy against solid tumors.

This Submission was made 30 days ahead of the schedule previously announced on March 9, 2021.

This IND represents a Key Milestone of the program, which brings to the clinic the first target derived from the Kiromic’s AI and Bioinformatics target prediction platform.

Kiromic now expects that it will be able to deliver a first in human patient dosing by the end of the third quarter of 2021 Kiromic, an organization that is driven to achieve scientific breakthroughs, dedicated significant resources to the IND submission in an effort to achieve the optimal clinical trial design on the fastest possible timeline.

IQVIA (View Source) will be managing our clinical trial sites as the CRO (Clinical Research Organization). Leading global sites are lining up to be the first to dose our KB-ISM live cell therapies for solid tumors expressing IsoMesothelin.

IQVIA is an industry driver in data technology and advanced analytics, designed to produce and develop optimal clinical trial outcomes.

Site announcements are expected within the next few weeks.

Since Kiromic BioPharma’s Isoform 2 Mesothelin (KB-ISM) is off-the-shelf, it can be pre-manufactured like a typical drug, even though it is a living cellular therapy. This industry leading innovation is due to Kiromic’s proprietary manufacturing and cryopreservation processing techniques.

Kiromic is optimistic that any cancer cell that expresses the Isoform 2 Mesothelin marker will effectively activate and accelerate the ability of KB-ISM to traffic through the tumor microenvironment (TME), which thus far has proven to be an imposing barrier to effective T cell treatments in solid cancers.

————————————————

CEO of Kiromic, Dr. Maurizio Chiriva-Internati, DBSc, PhDs stated:

"Kiromic’s Off-The-Shelf (OTS) CAR Gamma Delta T-Cell (GDT) is a unique product, and I am very excited to present this IND to the FDA.

This technology is meant to potentially change the Cell and Gene Therapy landscape, helping to address the major issues on manufacturing, safety, cost and most importantly, time.

A Bioinformatics approach in the Cell Therapy & Gene Therapy field is disruptive and will help to screen and design specific binder (monoclonal Antibodies) with more specificity and avidity creating better and more robust therapy with less side effects.

Kiromic is in a unique position because its bioinformatic engine combines CancerDiff, a data-mining tool for the identification of tumor-preferred isoforms, with Diamond, an AI-driven immunogenic peptide identification system.

This combination allows Kiromic to identify targetable sections of a tumor isoform (peptides) that are a unique signature of cancer cells.

The advantage of Kiromic’s system is two-fold: 1) it saves time and money because it allows the prioritization of tumor-selective targets, and 2) it maximizes the likelihood of identifying targets that are safe by increasing the targeting specificity.

I am proud of our Translational and CMC teams that were capable of creating a feeder free expansion system with a purity of over 99% GDT, and it is very exciting that we can cryopreserve these cells in long term storage so that they are available on demand for shipment and ready to inject around the world.

I believe that our science will reshape and revolutionize the approach to Immune Oncology treatment in the years to come."

CFO of Kiromic, Mr. Tony Tontat stated:

"With this IsoMesothelin IND filing, Kiromic shows its commitment to invest in the latest AI technologies and then bring these AI predicted biomarkers into the clinic.

Going forth, we will look to announce our further investments in AI and how these investments in AI will keep the company in front of competitors in our space who are working without AI."

CSIO of Kiromic, Mr. Gianluca Rotino stated:

"This IND filing confirms the solidity of our IP portfolio, and highlights the results obtained by our Bioinformatics department and the application of our AI platform.

In combination with the ALEXIS-PRO-1 clinical trial, it represents the second element of the development of our clinical strategy, which will allow us at the end of the dose escalation phase of this trial, to select the best indication for the expansion phase that we project will ultimately lead to a BLA."

CMO of Kiromic, Dr. Scott Dahlbeck stated:

"I am looking forward to testing this novel AI discovered biomarker in metastatic cancer patients that desperately need safe and effective treatment options. This unique target was unearthed by our dedicated team of bioinformatic specialists, and if this clinical trial can validate the ability of Kiromic’s AI system to quickly discover dynamic targets, then it will meet one of the greatest needs in immunotherapy today, that of a lack of effective targets that can be used in immunotherapy treatments."

On May 21, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, reported that it has entered into a definitive agreement to acquire MagicMed Industries Inc. ("MagicMed"), a privately-held biotechnology company focused on creating a library of novel derivative psychedelic molecules such as psilocybin, N,N-dimethyltryptamine (DMT) and other molecular derivatives with applications across multiple indications, in an all-stock transaction (Press release, Enveric Biosciences, MAY 24, 2021, View Source [SID1234580514]).

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Through its extensive R&D capabilities at the state-of-the-art facility at the University of Calgary, MagicMed has focused on the discovery and early development of novel drug candidates, structurally related to psychedelics with vastly improved pharmaceutical characteristics and commercial potential for the treatment of neurological and psychological indications. The Psybrary is MagicMed’s library of novel psychedelic derivatives developed through the combination of synthetic biology and traditional chemistry techniques. MagicMed has 13 patent applications filed for derivatives of psilocybin and DMT, 2 patent applications filed for derivatives of mescaline and MDMA with further intellectual property protection for mescaline, MDMA, ibogaine and LSD in process.

The acquisition of MagicMed will expand and complement Enveric’s current pipeline of naturally occurring compounds, which is primarily focused on cannabinoids, to now include a robust portfolio of psychedelic-derived molecules. Enveric intends to continue to develop patient-centric support care therapies in oncology and central nervous system (CNS) indications. Upon closing, Enveric intends to commence drug discovery and development for treatment of cancer-related Post Traumatic Stress Disorder (PTSD) patients who are currently in treatment for cancer and those who are in remission. It is anticipated that the PTSD drug development program holds the potential to be expanded in the future beyond cancer-related applications to include other patient populations, such as military veterans.

"Our proposed acquisition of MagicMed underscores the core fundamental mission of Enveric to form a drug discovery and clinical stage biotechnology company with a focus on bringing forward nature-originated therapies to improve the standard of care and serve unmet needs in oncology and CNS indications," said David Johnson, Chairman and CEO of Enveric Biosciences. "Psychedelics and cannabinoids, in our opinion, have extensive patient benefits for the mind and body. We welcome MagicMed’s world class research and development team led by Dr. Joseph Tucker, who not only have experience in psychedelic drug discovery, but also research experience in cannabinoids, as well. Patients who are currently being treated for cancer or are in remission are forced to face debilitating physical and mental side effects with very few treatment options available to alleviate their pain. PTSD, for example, is a significant unmet need for this patient population. Together, with the MagicMed team, following the closing of the acquisition, we plan to commence the discovery and development of psychedelics-derived therapies."

Once closing is complete, Dr. Joseph Tucker will be appointed Chief Executive Officer of the Company and David Johnson, current Chief Executive Officer and Chairman, will be appointed Executive Chairman.

Dr. Joseph Tucker is a seasoned executive who has built several publicly traded biotechnology companies. Dr. Tucker was a founder and chief executive officer of Stem Cell Therapeutics, which was acquired by Trillium Therapeutics in 2013. Dr. Tucker has also held the position of co-founder and CEO of Epimeron Inc., a University of Calgary start-up acquired in the creation of Willow Biosciences Inc. At Willow, Dr. Tucker served as Executive Chairman and COO. Prior to founding these companies, Dr. Tucker was a healthcare analyst with two investment banks and has also worked in technology commercialization for a university technology transfer office. Dr. Tucker received his Ph.D. in Biochemistry and Molecular Biology from the University of Calgary.

"Our mission at MagicMed has always been focused on unlocking the full potential of psychedelic-derived medicines for the treatment of neurological and psychological indications," added Dr. Joseph Tucker, Chief Executive Officer of MagicMed. "Complementing our R&D capabilities, working together with Enveric will allow us to leverage the company’s clinical team, all of whom are focused on advancing our extensive pipeline of molecules through the clinic to help serve the millions of patients who are suffering with mental health issues around the globe. Through this acquisition – in the best interest of each of our respective teams – we have bolstered our pipeline, bringing together a seasoned team of experts with the leadership skills and knowledge that is crucial to creating a platform that aims to address large unmet total addressable markets (TAM)."

The transaction is structured as an amalgamation under the Business Corporations Act (British Columbia). At the closing, a recently formed subsidiary of Enveric will amalgamate with MagicMed, with the resulting corporation being an indirect wholly owned subsidiary of Enveric. Under the terms of the amalgamation agreement and other related agreements , Enveric will issue the shareholders of MagicMed an aggregate of 9,946,969 shares of common stock of Enveric, as well as warrants, options and restricted stock units to acquire an additional 9,039,882 shares of common stock of Enveric. The current Enveric shareholders will own approximately 63.4% of the combined company’s common stock, as calculated on a fully diluted basis, and current MagicMed shareholders will own approximately 36.6% of the combined company’s common stock, as calculated on a fully-diluted basis. The agreement is subject to customary closing conditions and the approval of Enveric’s and MagicMed’s shareholders and is expected to close during the second half of 2021. Additionally, as part of the closing of the transaction, Enveric will receive approximately $4 million (CAD) in cash from the MagicMed Treasury.

David Johnson and Dr. Joseph Tucker will host a conference call to discuss the transaction today, May 24th at 8:30 a.m. ET.

On May 24, 2021 1 Redx Pharma (AIM: REDX), the drug discovery and development company focused on cancer and
fibrosis, reported that it will be releasing its interim results for the six months ended 31 March 2021 on 7 June 2021 (Press release, Redx Pharma, MAY 24, 2021, View Source [SID1234580479]).

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A live webcast will be held at 12:00pm BST on 7 June 2021 for analysts. To join the webcast, please register in advance by sending an
e-mail to [email protected]
A recording of the webcast will be made available on Redx Pharma’s website following the webcast

On May 24, 2021 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "Aptorum"), a clinical-stage biopharmaceutical company, reported positive progress in respect of: (i) its ongoing Phase I clinical trial for ALS-4 (a first in-class anti-virulence approach based small molecule targeting Staphylococcus aureus, including, but not limited to Methicillin Resistant Staphylococcus Aureus ("MRSA")), under which two initial cohorts of the single dose ascending dose (SAD) portion of the trial in healthy male and female adult subjects have been completed with no serious adverse events observed (with in total 6 cohorts for SAD and 3 cohorts for multiple ascending dose (MAD) have been planned); and (ii) its ongoing Pre-IND preparation for SACT-1, a repurposed small molecule targeting neuroblastoma, under which the Pre-IND meeting with the US FDA has been completed (Press release, Aptorum, MAY 24, 2021, View Source [SID1234580498]).

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ALS-4’s first-in-human Phase I trial is a randomized, double-blinded, placebo-controlled, single and multiple ascending dose study designed to evaluate safety, tolerability, and pharmacokinetics of orally administered ALS-4 in healthy male and female adult volunteers. Dosing and safety reviews of Cohort A (25mg) and Cohort B (50mg) have been completed and eight subjects (6 received ALS-4 and 2 received placebo) were dosed in each cohort. We are pleased to announce that no human subjects were dropped out of the studies and there were no Serious Adverse Events (SAE) observed. In addition, no relevant clinical changes in respect of vital signs, ECG, clinical laboratory test results and physical examinations were observed compared to the relevant baseline. On this basis, the remaining ALS-4 Phase I study will continue to progress and as of this date, Cohort C (100mg) studies have been initiated.

SACT-1, a repurposed drug candidate for the treatment of neuroblastoma, has completed its Pre-IND meeting with the US FDA. With the guidance provided by the US FDA, SACT-1 is on track to open an IND to commence clinical studies in quarter 3 of 2021.

About ALS-4

As part of Aptorum Group’s Acticule infectious disease platform, ALS-4 is a novel first-in-class orally administered small molecule drug based on an anti-virulence approach targeting staphylococcus aureus including MRSA. ALS-4 targets the antimicrobial resistant properties of the bacteria and is believed to render the bacteria highly susceptible to the host’s immune clearance. ALS-4 is targeted for potential administration on a standalone or on a combination basis with other existing antibiotics such as vancomycin.

About SACT-1

As part of Aptorum Group’s SMART-ACT platform, SACT-1 was discovered from our SMART-ACT platform focused on orphan and unmet diseases. SACT-1 is a repurposed small molecule drug targeted for the treatment of neuroblastoma especially in combination with standard of care based chemotherapies. Our internal in vitro studies demonstrated that SACT-1’s mechanism has enhanced DNA damage and tumor cell death.

On May 24, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS") reported the approval of an investigational new drug application ("IND") by the United States Food and Drug Administration ("FDA") for CpG-STAT3siRNA, the company’s distinctive immuno-oncology RNA therapy for the treatment of multiple cancers (Press release, Scopus BioPharma, MAY 24, 2021, View Source [SID1234580515]).

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A Phase 1 clinical trial for B-cell non-Hodgkin lymphoma will be initiated at City of Hope.

Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases near Los Angeles, California.

CpG-STAT3siRNA encompasses both RNA therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. This highly-distinctive drug candidate was developed in the City of Hope laboratories of Hua Yu, Ph.D. and Marcin Kortylewski, Ph.D. Yu is co-leader of the Cancer Immunotherapeutics Program and Billy and Audrey L. Wilder Professor in Tumor Immunotherapy. Kortylewski is a professor in the Department of Immuno-Oncology.