On June 8, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported that Alpine is set to join the broad-market Russell 3000 Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the US market opens on June 28, 2021, according to a preliminary list of additions posted by FTSE Russell on June 4, 2021 (Press release, Alpine Immune Sciences, JUN 8, 2021, View Source [SID1234583700]).

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

For more information on the Russell 3000 Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

On June 8, 2021 AIVITA Biomedical, Inc., a private biotechnology company specializing in innovative stem cell applications, reported data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1, in patients with newly diagnosed glioblastoma (GBM) (Press release, AIVITA Biomedical, JUN 8, 2021, View Source [SID1234583699]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The analysis focused on the 57 Phase 2 patients who received eight doses of AV-GBM-1 over approximately six months. At the time of the analysis, surviving patients had completed therapy and had been followed between 10.1 and 27.6 months from enrollment. The median length of PFS was 10.4 months (95% confidence interval; 8.6 to 11.7 months), an improvement of approximately 50% compared to a median PFS of 6.9 months (95% confidence interval; 5.8 to 8.2 months) in the landmark STUPP study1 that established the standard of care for patients with newly diagnosed GBM. This represents a 42% reduction in the risk of progression or death at 6.9 months. Median survival has not been reached and will be assessed after the final patient has a minimum follow up of 15 months. Overall, the treatment was well tolerated. There were 54 serious adverse events among 28 of 57 patients but none were attributed to the vaccine.

"The potential for AV-GBM-1 to significantly improve PFS in newly diagnosed GBM patients over and above current standard of care is very encouraging," said Robert O. Dillman, M.D., chief medical officer of AIVITA. "We look forward to confirming this benefit in a randomized Phase 3 multi-center trial."

AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor neoantigens derived from self-renewing tumor-initiating cells isolated from tumors after routine surgical debulking. The treatment is administered to patients via subcutaneous injection. The treatment is uniquely pan-antigenic, targeting multiple antigens, including all neoantigens, from autologous tumor-initiating cells that are responsible for the tumor growth.

"This milestone is an encouraging first step in the fight against GBM, a disease that has a devastating impact on patients and their families," said study principal investigator Daniela Bota, M.D., Ph.D., director, University of California, Irvine (UCI) Alpha Stem Cell Clinical and medical director, UCI Health Comprehensive Brain Tumor Program.

AIVITA is currently conducting two clinical studies in the United States investigating its platform immunotherapy in patients with GBM and melanoma.

1. Stupp R et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 2005;352:987-996.

On June 8, 2021 Aclaris Therapeutics, Inc. (Nasdaq: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that it intends to offer and sell, subject to market conditions, $75 million in shares of its common stock in an underwritten public offering (Press release, Aclaris Therapeutics, JUN 8, 2021, View Source [SID1234583698]). All of the shares of common stock to be sold in the offering will be offered by Aclaris. Aclaris also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering on the same terms and conditions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Jefferies LLC, SVB Leerink LLC, and Piper Sandler & Co. are acting as joint book-running managers for the offering.

A shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) and was effective on May 20, 2021. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; Email: [email protected]; Telephone: (877) 821-7388; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110; Email: [email protected]; Telephone: 1-800-808-7525, ext. 6105; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402; Email [email protected]; Telephone: (800) 747-3924.

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

On June 8, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that it is set to join the Russell 2000 and Russell 3000 Indexes at the conclusion of the Russell indexes annual reconstitution, effective after the US markets open on June 28, 2021 (Press release, Greenwich LifeSciences, JUN 8, 2021, View Source [SID1234583697]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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CEO Snehal Patel commented, "The addition of our company to the Russell 2000 Index is an important opportunity to increase our institutional ownership and reflects the progress we have made this past year. We welcome the enhanced visibility as we continue to develop our GP2 immunotherapy to prevent metastatic breast cancer. We look forward to sharing our future progress, including our planned Phase III clinical trial, with our expanding shareholder base."

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.

FTSE Russell primarily uses objective, market-capitalization rankings, and style attributes to determine membership for its Russell indexes. Membership in the small-cap Russell 2000 Index, which remains in place for one year, is based on membership in the broad-market Russell 3000 Index. For more information on the Russell 2000 Index and the Russell indexes reconstitution, visit the FTSE Russell website at: View Source

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. FTSE Russell is wholly owned by London Stock Exchange Group.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On June 8, 2021 Bioneer reported that The presentation if part of the Focus Sessions of the ISSCR Annual Meeting, where Dr. Benjamin Schmid and Dr. Mikkel Rasmussen from Bioneer will be presenting (Press release, Bioneer, JUN 8, 2021, View Source [SID1234583696]).

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Focus Sessions provide in-depth coverage of specific topics of interest and are presented by interested academic and industry groups. These educational opportunities in science, society, and education are organized by members and open to all meeting attendees. Sessions are held live, with Q&A and chat, and will be available as on-demand programming for 30 days after the meeting.

The Focus Session on developments to simplify and accelerate iPSC research is organized by The European Bank for induced Pluripotent Stem Cells (EBiSC).

The European Bank for iPSCs (EBiSC) is a centralized repository, currently in a second project phase including both non-profit and commercial iPSC researchers (EBiSC2), working to make iPSC tools available and developing protocols which improve and simplify their use. This focus session will share how EBiSC2 partners are adapting and consolidating iPSC expansion, differentiation and cryopreservation approaches to help ease transition into high volume applications whilst also ensuring accessibility for non-expert users. We will discuss how the inclusion of iPSC tool lines in these protocol developments enables rapid generation of functionally mature derived cell types and how the associated iPSC datasets can be broadly shared in an ethically compliant manner. Lastly, common stumbling blocks will be discussed to raise awareness across the community.

See below the full program of the session:

The European Bank for iPSCs Program

Julia Neubauer, PhD, Fraunhofer-IBMT, Germany
Alfredo Cabrera-Socorro, PhD, Janssen Pharmaceutica NV, Belgium
Welcome and Overview

Julia Neubauer, PhD, Fraunhofer-IBMT, Germany
Approaches Towards Expansion, Differentiation and Banking Of iPSCs At High Volume

Mikkel Rasmussen, PhD, Bioneer, Denmark
Emilie Lemesre, PhD, Servier, France
iPSC-Derived Hepatocytes in Drug Screening and Toxicology

Alfredo Cabrera-Socorro, PhD, Janssen Pharmaceutica NV, Belgium
Development of A Fully Human Neuronal and Astrocyte Co-Culture Assay Amenable For Electrophysiological Studies In Functionally Mature Neurons

Benjamin Schmid, PhD, Bioneer, Denmark
Gene-Editing in iPSCs – Unexpected Pitfalls: On-Target Effects

Andreas Kurtz, PhD, Fraunhofer-IBMT, Germany
Collection, Standardisation and Sharing Of iPSC Associated Datasets Using Open Tools

Eugenia Jones, PhD, Fujifilm Cellular Dynamics, USA
Common Non-Scientific Challenges in The Generation, Use and Sharing Of iPSC Lines.

Panel Discussion: Upcoming Challenges In iPSC Research from An Academic and Industry Perspective.