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.

On June 28, 2021 Lengo Therapeutics, a biopharmaceutical company developing novel precision medicines targeting driver mutations in oncology, reported the appointment of Enoch K. Kariuki, Pharm.D., as Chief Executive Officer (Press release, Lengo Therapeutics, JUN 28, 2021, View Source [SID1234584419]).

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Dr. Kariuki is an accomplished industry leader with broad experience in healthcare strategy, life sciences finance, operations and business development. Prior to joining Lengo, Dr. Kariuki was Chief Financial Officer at VelosBio, a clinical-stage biopharmaceutical company developing novel, first-in-class cancer therapies targeting ROR1, which was acquired by Merck in 2020 for $2.75 billion.

Prior to VelosBio, Dr. Kariuki served as Senior Vice President, Corporate Development at Synthorx, Inc., where he led the company’s initial public offering, managed relationships with bankers, sell-side equity analysts and investors, and led the business development process that concluded with the successful sale of Synthorx to Sanofi for $2.5 billion.

Dr. Kariuki was previously Vice President at H.I.G. Capital, where he led investments into, and served on boards of, several life sciences companies. His roles prior to H.I.G. include Senior Associate at Leerink Partners and Associate Director at UBS Investment Bank. At Leerink and UBS, Dr. Kariuki advised healthcare companies on equity capital financings, mergers and acquisitions, leveraged buyouts, and recapitalizations.

"Enoch brings to Lengo extensive experience leading high-performing teams in the private and public sectors. His background in global finance and operations, as well as his track record of financing and building biotech companies, is exactly the type of leader Lengo needs as we advance into our next phase of growth," said Dave Johnson, Chairman at Lengo Therapeutics. "Enoch will be an invaluable asset to Lengo, and I look forward to working with him again to build a best-in-class pipeline targeting driver mutations in oncology."

"I am excited to join Lengo at such an exciting time. I look forward to working with Dave, our Board members and the senior management and scientific teams to help advance our pipeline of differentiated, best-in-class targeted oncology therapeutics," said Enoch Kariuki, Pharm.D., Chief Executive Officer at Lengo Therapeutics.

Dr. Kariuki completed a Post-Doctoral Fellowship in R&D Strategy and Analytics at Bristol Myers Squibb and was a Pharmacist at CVS Caremark. He holds an MBA from the Tuck School of Business at Dartmouth College and a PharmD from Texas Southern University. He serves on the boards of Zentalis Pharmaceuticals (NASDAQ:ZNTL) and Imago Biosciences.

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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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.

On June 28, 2021 Agilent Technologies Inc. (NYSE: A) reported the publication of a study carried out in partnership with Resolution Bioscience (a part of Agilent) and Dana-Farber Cancer Institute (Press release, Agilent, JUN 28, 2021, View Source [SID1234584420]). The paper was published in the New England Journal of Medicine (NEJM) on June 24 and is titled "Acquired Resistance to KRAS G12C Inhibition in Cancer." It demonstrates the clinical utility of liquid biopsy techniques to detect resistance to targeted therapies, including inhibitors of KRAS, one of the most commonly mutated oncogenes in cancer.

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KRAS G12C inhibitors, such as adagrasib, have shown promising efficacy in clinical trials, however, mechanisms of acquired resistance are not yet fully understood. Leveraging cell-free DNA (cfDNA) analysis, this study was conducted to investigate mutations that arise that may confer resistance to patients treated with KRAS inhibitors, including adagrasib and to better understand the process of acquired resistance and to identify new strategies to combat acquired resistance.

The results of the study showed KRAS G12C cancers have diverse genomic and histologic mechanisms, including point mutations, copy number changes, and fusions, that appear to impart resistance to KRAS G12C inhibitors. Developing therapeutic strategies to delay and overcome drug resistance will be an essential component in improving therapeutic outcomes in cancer patients.

"While results from these early clinical trials are encouraging, the cancer usually becomes resistant to these drugs," said Dana-Farber’s Mark Awad, MD, Ph.D., the co-first author of the paper with Shengwu Liu, Ph.D., also of Dana-Farber. "The mechanisms of resistance – the genomic and other changes that occur that allow the cancer to begin growing again – are largely unknown. This study sought to identify them."

"Given the high prevalence of KRAS driven cancers and resulting unmet medical need, elucidating the genetic underpinnings of acquired resistance to KRAS inhibitors at the time of progression is critical," Mark Li, CEO of Resolution Bioscience, said. "Importantly, in this study, more than three times as many patients were able to be genotyped by cfDNA compared to tissue alone at the time of progression. Furthermore, this study highlights the importance for cfDNA assays to accurately detect all major types of genetic aberrations, including gene fusions and copy number variations."

Agilent’s Resolution Bioscience team has partnered with Mirati Therapeutics Inc. (NASDAQ: MRTX) to use the Resolution ctDx FIRST assay as a companion diagnostic (CDx) in support of adagrasib for identifying patients with non-small cell lung cancer patients that harbor a KRAS G12C mutation. Liquid biopsy biomarker testing of patients in the adagrasib registrational clinical trial is being performed in Resolution’s clinical lab based in Kirkland, Washington.