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Lineage Cell Therapeutics Joins Russell 3000® and Russell Microcap® Indexes

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.

About FTSE Russell

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.com.

Intellia Therapeutics Announces Proposed Public Offering of Common Stock

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.

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.

ImmunityBio and NantOmics Announce Clinical Validation of a Proprietary Method to Identify Unique Targets for Immunotherapy in Individual Breast Cancer Patients

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).

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.

Heat Biologics Joins Russell Microcap® Index

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]).

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.

Moffitt Receives $10.2 Million Grant to Develop New Lung Cancer Therapies

On June 28, 2021 The National Cancer Institute reported that it has awarded the Lung Cancer Metabolism Working Group at Moffitt Cancer Center with a Research Program Project Grant (P01CA250984) (Press release, Moffitt Cancer Ctr, JUN 28, 2021, View Source [SID1234584400]). The grant, which will provide more than $10.2 million over five years, will support team research across several Moffitt programs, including Cancer Biology and Evolution, Molecular Medicine and Immuno-Oncology. All projects will focus on investigating lung cancer metabolism.

Moffitt’s program project consists of four projects and four shared cores. The goal is to unveil common metabolic mechanisms regulated by common genetic drivers across non-small cell lung cancer, specifically lung adenocarcinoma and squamous cell carcinoma, and small cell lung cancer. Researchers will then use that information to utilize standard of care therapeutics or develop new therapies that can target the common molecular signatures.

"Many of the driver genes mutated in lung cancer, like p53, Nrf2 and myc, are transcription factors, which are difficult to target therapeutically and have been deemed ‘undruggable.’ But by learning more about the cancer metabolism and how malignant cells are rewiring their metabolic network to survive, we can develop novel therapies to target those rewired cells while preserving the integrity of normal surrounding tissues," said Elsa Flores, Ph.D., principal investigator for this grant, chair of the Department of Molecular Oncology and leader of the Cancer Biology and Evolution Program.

Lung cancer is the leading cause of cancer deaths worldwide. There are two types of lung cancer: non-small cell lung cancer, which accounts for roughly 80% to 85% of cases, and small cell lung cancer, which has been classified by the NCI as a recalcitrant tumor – a type of cancer with a five-year relative survival rate of less than 50%.

Common therapy for both lung cancer types includes surgery, radiation, chemotherapy and immunotherapy. These treatments can be debilitating for patients, and for those treated with chemotherapy and/or radiation, healthy surrounding tissue can be harmed. Although immunotherapy has improved lung cancer outcomes, it only works for a small subset of patients.

"We see about 1,800 new lung cancer patients each year in our thoracic clinic. We are seeing what works and what doesn’t. We know improvements can be made to appropriately apply standard of care treatments and even develop new, more targeted therapies, but first we need to further our understanding of the basic biology of lung cancer disease progression. These four projects will help our team do just that," said Eric Haura, M.D., co-principal investigator of the grant, associate center director of Clinical Science and director of the Lung Cancer Center of Excellence.

Preliminary data for this project was supported by Moffitt’s Lung Cancer Center of Excellence and Miles for Moffitt.