On June 28, 2021 Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that it has been added to the Russell Microcap Index, following the annual Russell indexes reconstitution, effective after the US market opens today, June 28, 2021, according to a final list of additions posted on June 25, 2021 (Press release, Heat Biologics, JUN 28, 2021, View Source [SID1234584401]).

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Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in Russell’s appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings, and style attributes.

Jeff Wolf, Chief Executive Officer of Heat, commented, "We are extremely pleased to join the Russell Microcap Index and believe that our inclusion will increase our visibility and exposure to investors. Joining this index is a reflection of the progress we have made this year in our clinical programs, including both our oncology program and COVID-19 vaccine program, building a strong balance sheet with over $132 million of cash and short-term investments as of Q1 2021 and increasing shareholder value."

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell Microcap Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

On June 28, 2021 MaaT Pharma, a clinical-stage biotechnology company focused on developing Microbiome Ecosystem Therapies in oncology, reported that the Data Safety and Monitoring Board (DSMB) recommended to proceed to the fourth cohort of the dose-finding Phase 1b CIMON clinical trial, without modifications (Press release, MaaT Pharma, JUN 28, 2021, View Source [SID1234584417]). The DSMB is an independent committee monitoring the progress of the company’s clinical trial and is reviewing safety, tolerability and data quality while the trial is ongoing.

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"We are very pleased that the third of five cohorts in this important study with MaaT033 has successfully been completed without any safety signals reported. This is a very meaningful step towards determining the target dose of this oral capsule product candidate, and we expect to initiate a pivotal Phase 3 study next year," commented John Weinberg, MD, Chief Medical Officer at MaaT Pharma.

The CIMON trial (NCT04150393) is enrolling a total of 27 patients at 6 sites across France. It is an open-label Phase 1b study to investigate the maximum tolerated dose of MaaT033, over 7 or 14 days of therapy, that supports optimal gut microbiome colonization in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome who have undergone intensive chemotherapy.

The CIMON Phase 1b trial is expected to be completed at the end of 2021.

About MaaT033

MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness microbiome biotherapeutic. It is manufactured at MaaT Pharma’s centralized European cGMP production facility. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory "Butycore" species, which characterize MaaT Pharma’s Microbiome Ecosystem Therapies.

On June 28, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported the interim results of its second in-vivo POC study evaluating the efficacy of company’s proprietary drug candidate RCC-33 for the treatment of colorectal cancer on mice (Press release, Cannabics Pharmaceuticals, JUN 28, 2021, View Source [SID1234590050]). The study objective was to evaluate the potential efficacy of the RCC-33 drug candidate as a systemic treatment for colorectal cancer when administered orally. Interim study results confirmed the potential efficacy of RCC-33 as a systemic treatment for colorectal cancer when administered orally, showing a 30% reduction in tumor volume in comparison with sham control mice, after 24 days of treatment. The results indicated statistical significance with a p-value less than 0.05.

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The announcement comes following previously released in-vivo study results demonstrating a 33% reduction in tumor volume in mice treated with RCC-33 using intraperitoneal (IP) injection.

Inhibitory Effect of Cannabics RCC-33 (Oral Administration) on Tumor Growth in Mice Inoculated with Human Colorectal Cancer Cells
Gabriel Yariv, Cannabics Pharmaceuticals President & COO said: "Our first POC study in mice demonstrated that RCC-33 has potential anti-tumor effect on colorectal cancer. During the first POC study we used intraperitoneal (IP) administration, via injection to the abdomen, and while we were very pleased to see a 33% reduction in tumor volume, we did not know how RCC-33 would work when administered orally for systemic treatment. The leap between IP to oral administration is not a straightforward process, and it necessitated a great deal of attention. Today, after having seen the interim results, this second POC study is immensely important to us, as it reconfirms the potential of RCC-33 as a treatment candidate for colorectal cancer, as well as being efficacious via oral administration. This is another important step for us in the right direction".

Eyal Ballan Cannabics Pharmaceuticals CTO said "These positive results move us one step closer to in-human studies. After seeing the antitumor effect reconfirmed in this POC study, our next goal is to improve the bioavailability of the drug to be administered in our upcoming clinical studies".

On June 28, 2021 ImmunityBio, Inc., a publicly traded immunotherapy company, and privately-held NantOmics reported publication of a stepwise approach or "pipeline" for identification and validation of neoepitope and neoepitope-reactive T cells from individual patients (Press release, ImmunityBio, JUN 28, 2021, View Source [SID1234584402]). The identification of neoepitopes—short peptide sequences that are mutated in tumors and are capable of generating an immune response—provides critical support in the successful development of next-generation immunotherapies delivered by ImmunityBio’s Adeno- and yeast-based platforms. The pipeline is described in "Identification and validation of expressed HLA-binding breast cancer neoepitopes for potential use in individualized cancer therapy," which recently published in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

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The pipeline leverages the bioinformatics capabilities of NantOmics and ImmunityBio to predict neoepitopes based on genomic and expression analyses that have a high likelihood of generating a tumor-fighting immune response and the generation of neoepitope-specific CD4+ and CD8+ T cells when delivered using the Adeno and yeast vaccine platforms. These predicted neoepitopes once identified are synthesized as short peptides, and run through a series of studies to confirm their potential utility in the cancer vaccine platforms. The pipeline was developed in conjunction with physicians and scientists at Friedrich Alexander University in Germany and the National Cancer Institute (NCI) in the U.S.

In clinical use, this neoepitope discovery system supports the targeted delivery of antigens with ImmunityBio’s second-generation Adeno platform. This platform, which has shown promising results in Phase 1 and 2 trials, activates CD4+ and CD8+ T cells after delivery of tumor-associated antigens in patients with advanced solid tumors and colon cancer. In preclinical studies conducted in collaboration with the NCI, accurate prediction of neoepitopes, delivered via the adenovirus platform, resulted in complete response in colon cancer when combined with ImmunityBio’s IL-15 superagonist Anktiva and other immune-based therapies. That study highlights the potential for neoepitope identification to inform highly effective anti-tumor therapy.

"The future of immunotherapy is in a personalized approach," said Dr. Patrick Soon-Shiong, Founder and Executive Chairman of ImmunityBio. "By tailoring therapies to the individual biology of each patient’s cancer, we greatly increase the likelihood of successful treatment using our ever-increasing arsenal of immune-based therapies."

"Validation of the neoepitope identification pipeline in actual patients from the TILGen study was an important aspect of the proposed method," said Dr. Peter Fasching, who with Dr. Anita Kremer, was senior author on the manuscript. "We were able to isolate the specific immune cells that recognized the predicted neoepitopes. Those immune cells aimed at the cancer cells’ neoepitopes are very important because they could potentially kill a tumor. Clinically, the predicted and confirmed neoepitopes could be targeted by vaccines or adoptive cell transfer therapies and improve patient outcomes."

Neoepitopes can be unique for each patient and when the pipeline is applied, the analyses for identification of these neoepitopes would be performed using tumor and other tissues collected from individual patients.

This method for identifying tumor-specific immunogenic targets for individualized treatment can be used as part of a program including other immune and cell-based therapies available through ImmunityBio, including CAR T-cell therapies and vaccines. Efficacy of these therapies could be further enhanced by combination with an immune enhancer such as ImmunityBio’s Anktiva or Natural Killer (NK) cells.

About the Neoepitope Identification Pipeline

The bioinformatics methodology, well-established at NantOmics, readily and accurately predicts neoantigens;
Practical cell-based assays of synthesized neoepitope peptides refines candidates to those most likely to induce an immune response;
and Tissues and cells routinely collected from individual cancer patients can be used to confirm and further narrow neoepitope candidates.
The neoepitope identification and validation pipeline is feasible, practical and accurate, as this first report suggests. It is anticipated that it will be applied in future clinical studies of immunotherapies to determine the merits of this personalized approach to precision medicine for cancer.

On June 28, 2021 Kiromic reported as a pioneer of immuno oncology with a presentation at the 4th Annual Next-Gen Immuno Oncology Congress in June 2021 (Press release, Kiromic, JUN 28, 2021, View Source [SID1234584418]).

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At the conference, we will:

— Present our artificial intelligence (AI) predicted and selected targets, and

— Discuss how our AI targets will offer better safety and efficacy compared to immuno oncology peers with classic targets.

Our AI targets are predicted and selected based on the following characteristics:

High expression in cancer cells

Heat map of T-cell, B-cell epitopes

Low expression in normal cells

High affinity to TCR

Quantity surface antigen expression signature

We intend to use our AI target, Mesothelin isoform 2, in the upcoming first-in-human dosing for solid tumors in 3Q-2021. At the first-in-human dosing, Kiromic will also introduce a CAR-T with chPD1, our PD1 activator, which will we believe offer immuno oncology with new tools to address Tumor Micro Environment (TME).

Our topics for the session on June 29th are:

— Mesothelin isoform 2 is a novel target for allogenic CAR γδT cell therapy in solid tumors

— Diamond Artificial Intelligence /CancerSplice : ADVANCING CAR through A.I. for Target
Link to 4th Annual Next-Gen Immuno Oncology Congress (Virtual) June-28, 2021

Chief Executive Officer of Kiromic, Maurizio Chiriva-Internati, DBSc, PhDs, commented:

"We are honored to be invited to present at the 4th Annual Next-Gen Immuno Oncology Congress.

The challenges for immuno oncology and the employment of classic targets result from low specificity, which results in higher side effects and low affinity, which results in low efficacy.

We believe our AI selected iso-mesothelin will address both of these issues.

Our selection and prediction algorithm is robust and extensive, poring over billions of data points, to arrive at these targets in hours which otherwise would have required many man-years if done manually.

We believe that the first-in-human dosing will demonstrate the safety and efficacy of our product and will also demonstrate that AI targeting is superior compared with classic targeting with immuno chemistry."

Chief Medical Officer of Kiromic, Dr. Scott Dahlbeck, commented:

"As an oncologist treating these patients and reading the data, I know first-hand about the needs in immuno oncology to address the problems of specificity and affinity in targeting.

It’s very exciting for me to be part of our innovative team that is introducing AI algorithms into the search for better targets.

We are looking forward to the first in-human dosing with these AI targets in 3Q-2021."

Chief Strategy and Innovation of Kiromic, Gianluca Rotino, stated:

"The time has come for the world to see the power of AI algorithms unleashed on targets research and immuno oncology to finally get CAR-T which offers better safety and efficacy compared with classic small molecules."