On June 28, 2021 Sensei Biotherapeutics, an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported that it is reprioritizing its pipeline programs to focus on its product candidates, including its multi-antigenic next generation ImmunoPhage candidate, now referred to as SNS-401-NG, and its monoclonal antibody SNS-VISTA (V-set Immunoglobulin Domain Suppressor of T cell Activation) candidate (Press release, Sensei Biotherapeutics, JUN 28, 2021, View Source [SID1234584405]). With this reallocation of resources, Sensei expects its cash and cash equivalents will be sufficient to fund its operations into the first half of 2024.

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"Sensei’s approach to drug development is deeply rooted in targeting key mechanisms of checkpoint resistance to induce a robust, focused and coordinated immune response to cancer. We believe our next generation, multi-antigenic ImmunoPhage product candidates have the potential to drive robust antigen-specific T cell responses that will translate into clinical benefit," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "Given the totality of data generated to-date from the Phase 1/2 combination trial of first-generation SNS-301, we believe we have captured important insights into the power of our ImmunoPhage platform that will further advance development of our pipeline product candidates. Through SNS-301, we have gained important information on key product attributes that we believe contribute to the safety and immunogenicity of our ImmunoPhage platform as well as how to manufacture and scale our product candidates. Specifically, we have learned that the use of gpD fusion as an antigen display technology is suboptimal for use in an active cancer vaccine. We believe the incorporation of new antigen attachment technologies will ensure optimal immunogenicity. We are excited by our next generation programs, and we look forward to further advancing our two ongoing programs SNS-401-NG and SNS-VISTA into the clinic and completing discovery work for our VSIG4 antibody program."

"I would like to express my gratitude to all of the patients and their families, investigators and collaborators who participated in the SNS-301 study," said, Marie-Louise Fjaellskog, M.D., Ph.D. chief medical officer of Sensei Biotherapeutics. "Our data-driven decision-making process is at the forefront of our work, and we are well positioned and capitalized to further progress our next-generation pipeline programs, SNS-401-NG and SNS-VISTA, by utilizing our two unique drug discovery approaches – our ImmunoPhage platform and our monoclonal antibody and nanobody platform. We look forward to initiating IND-enabling studies for SNS-VISTA by the end of 2021 and for SNS-401-NG in second half of 2022."

SNS-301 was developed as a first-generation, bio-engineered, inactivated bacteriophage virus expressing a fragment of the tumor-associated antigen, human aspartate β-hydroxylase (ASPH), as a fusion protein to the bacteriophage lambda capsid decoration protein, gpD, for patients with locally advanced unresectable or metastatic squamous cell head and neck cancer (SCCHN). To date, 25 patients were enrolled in the Phase 1/2 clinical study and received at least one dose of SNS-301 in combination with pembrolizumab; one patient had a deep and durable partial response (PR) and 8 patients had stable diseases. While encouraged by the safety profile of the SNS-301 single antigen approach, based upon the recent analysis of antigen specific T-cell activation which did not show a significant increase in ASPH-specific T cells, including the one patient who experienced a long-standing and deep PR, and an updated analysis of clinical data, Sensei has decided to reprioritize its pipeline and refocus resources. Sensei anticipates sharing full SNS-301 clinical data and the results of specific B and T cell response data at a future scientific conference.

Next-Generation Pipeline Highlights and Upcoming Milestones

Sensei is focused on progressing novel product candidates generated from both its ImmunoPhage platform and Phortress Library, coupled with its human monoclonal antibody and nanobody platform. Sensei’s Phortress Library of immunophages, derived from antigens found across multiple patient populations and tumor types, enables a personalized, yet off-the-shelf therapeutic option to patients.

SNS-401-NG is a first-in-class, multi-antigenic personalized ImmunoPhage candidate being developed in collaboration with the University of Washington. Sensei has designed SNS-401-NG as a personalized product candidate composed of premanufactured Immunophage from Sensei’s Phortress library on an improved and proprietary bacteriophage construct. Sensei intends to initiate IND-enabling studies for this product candidate in the second half of 2022. The first clinical application is directed to the treatment of Merkel Cell Carcinoma (MCC), an aggressive form of skin cancer commonly driven by the Merkel Cell Polyoma Virus. If clinical proof of concept is achieved, Sensei plans to evaluate a broader basket study in patients with head and neck cancer, lung cancer, melanoma, and triple negative breast cancer based on the prevalence of Phortress antigens.
VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint that inhibits anti-tumor immune responses. VISTA is implicated in PD-1/PD-L1 resistance and therapeutic intervention. VISTA has the potential to be effective as a monotherapy and synergistic with PD-1/PD-L1 inhibition. Sensei has generated potent pH-dependent parental antibodies that block the interaction of VISTA with its receptor, PSGL1, expected to result in a favorable pharmacokinetic (PK) profile and selective activity in the acidic tumor microenvironment – a critical feature of this product candidate, and an important differentiator to other compounds in development targeting VISTA. Sensei plans to present preclinical data from the SNS-VISTA program at a scientific conference in 2021 and to initiate IND-enabling studies by the end of 2021.
VSIG4 (V-Set And Immunoglobulin Domain Containing 4) is a potent inhibitor of T cell activity, often overexpressed on macrophages within the tumor microenvironment. Sensei believes that a tumor-selective blocking monoclonal antibody will have potent anti-tumor immune effects. Sensei is extending its approach to developing antibodies with enhanced tumor selective activity to other candidate immune checkpoint targets, and anticipates selecting a product candidate from this program in 2023.
Conference Call and Webcast Information

Sensei will host a live conference and webcast today, June 28, 2021, at 4:30 p.m. ET, to discuss these company updates. To access the conference call, please dial 833-362-0204 (domestic) or 914-987-7673 (international) and refer to conference ID number 7464477. The live webcast can be accessed under the "Events & Presentations" section of Sensei’s website at www.senseibio.com. The webcast will be archived and made available for replay on Sensei’s website approximately two hours after the call and will be available for 30 days.

On June 28, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that the Company has been added to both the broad-market Russell 3000 Index as well as the Russell Microcap Index (Press release, Lineage Cell Therapeutics, JUN 28, 2021, View Source [SID1234584404])The 2021 Russell indexes annual reconstitution will be effective after the U.S. market opens today.

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"Lineage’s addition to both the Russell 3000 and the Russell Microcap Indexes reflects continued progress made in establishing the Company as a leader in cell therapy and regenerative medicine and should help us benefit from the tremendous growth that we foresee in the field of cell therapy," stated Brian M. Culley, Lineage’s CEO. "During the past year we have created considerable value for our shareholders by accomplishing significant clinical, manufacturing, and business milestones across our entire novel pipeline. We believe our addition to the Russell indexes can expand awareness of Lineage’s corporate mission and objectives among a broader audience of investors and help drive an increase in the liquidity of our stock."

Annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of May 7, 2021, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

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.

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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.

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 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.