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."

On June 28, 2021 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported that it has now finalised and executed a Collaboration Agreement and a Research & Licence Agreement with the Garvan Institute of Medical Research ("Garvan") in Sydney, Australia that was announced in March 2021 (Press release, Amplia Therapeutics, JUN 28, 2021, View Source;[email protected] [SID1234584386]). These Agreements define the structure of an ongoing collaborative research and clinical development program to be undertaken with Garvan which initially focuses on the use of Amplia’s FAK inhibitor, AMP945, to treat patients with pancreatic cancer.

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The collaboration, which was forecast with the signing of a non-binding Term Sheet in March 2021, provides Amplia with access to Garvan’s research strength in FAK biology and its extensive clinical research network. Already, non-clinical studies conducted in the laboratory of Professor Paul Timpson, Cancer Research Theme Leader at Garvan, a world-renowned expert in FAK biology, have provided Amplia with valuable insights into the ability of AMP945 to inhibit fibrosis and significantly improve survival in an animal model of aggressive pancreatic cancer. The Company is incorporating these insights and using its access to Garvan’s clinical research network to assist with the design and planning of a Phase 2 clinical trial of AMP945 in patients with pancreatic cancer that is scheduled to commence later this year. The terms of the final Collaboration Agreement also provide for expansion into other therapeutic areas.

Amplia’s CEO and Managing Director, Dr John Lambert, commented that "It is very exciting for Amplia to be able to tap into the extensive experience in FAK biology, cancer biology, and clinical networks that are available at a globally-recognised research institute such as Garvan. We have already seen the benefits of this collaboration through the results of the non-clinical studies which we announced earlier this year. These studies have provided important insights into the biology of AMP945 and have further validated our decision to progress this promising drug into a Phase 2 clinical trial in pancreatic cancer patients."

Professor Chris Goodnow, Garvan’s Executive Director noted that "At Garvan, we aim to translate our cancer research findings into better treatment options and improved clinical outcomes for patients. We are delighted to be working with Amplia in the development of its unique FAK inhibitors as potential new anti-fibrotic treatments for patients with pancreatic cancer or other fibrotic diseases."

Under the terms of the Collaboration Agreement, which has an initial term of 2 years, Amplia will receive first rights to participate in research projects relating to the use of FAK inhibitors in combination with other therapeutic products for the treatment of cancer. Under the terms of the Research and Licence Agreement, Amplia agrees to fund studies of the use of AMP945 in combination with gemcitabine / Abraxane for the treatment of cancer, with an initial focus on pancreatic cancer, and Amplia will receive first rights to new intellectual property arising from the collaboration.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics

On June 28, 2021 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it has commenced an underwritten public offering of $400 million of shares of its common stock (Press release, Intellia Therapeutics, JUN 28, 2021, View Source [SID1234584403]). Intellia also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering. All of the shares in the proposed offering are to be sold by Intellia.

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Goldman Sachs & Co. LLC, Jefferies, SVB Leerink and Barclays are acting as joint book-running managers for the proposed offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares of common stock are being offered by Intellia pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and may be obtained, when available, from: Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at [email protected]; SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Barclays Capital Inc., by mail at c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.