Life Science News

Gilead to License Exclusive Worldwide Rights to the Investigational Candidate DF7001, a 5T4-Targeting NK Cell Engager for Solid Tumors –

Gilead to Have Options to License Several Additional NK Cell Engager Programs

Gilead Sciences, Inc. (Nasdaq: GILD) and Dragonfly Therapeutics today announced a collaboration designed to advance a number of Dragonfly's novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications. NK cell engagers represent a novel mechanism with the potential to address a broad range of cancers, including potential for activity in checkpoint resistant and refractory tumors, as well as other disease areas such as inflammation. Under the agreement, Gilead will receive an exclusive, worldwide license from Dragonfly for the 5T4-targeting investigational immunotherapy program, DF7001. The agreement also grants Gilead options, after the completion of certain preclinical activities, to license exclusive, worldwide rights to develop and commercialize additional NK cell engager programs using the Dragonfly Tri-specific NK Engager (TriNKET™) platform. TriNKETs are activators of the innate and adaptive immune systems, recruiting NK and cytotoxic T cells into the tumor microenvironment.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220429005730/en/

DF7001 is a TriNKET designed to activate and direct NK and cytotoxic T cell killing against cancer cells. The target of DF7001 is 5T4, a protein expressed on cancer cells and stromal cells that support tumor growth associated with poor prognosis in several cancers, including non-small cell lung cancer (NSCLC), pancreatic cancer, breast cancer, and head and neck squamous cell carcinomas (HNSCC). DF7001 has the potential to trigger the killing of 5T4+ expressing cells, including tumor cells, cancer-associated fibroblasts and cancer stem cells. The program is on track for filing an Investigational New Drug (IND) application in the first half of 2023.

"We are excited to partner with Dragonfly as we expand our pipeline with innovative NK cell engager programs. Using our scientific framework to focus our efforts, we are growing our portfolio with assets that have complementary MOAs and strong scientific rationale for combination opportunities," said Flavius Martin, MD, Executive Vice President, Research at Gilead. "We look forward to working with the Dragonfly team to explore novel NK engager treatments across diverse therapeutic areas to address some of the greatest gaps in care for cancer and inflammatory diseases."

"Gilead's investment in Dragonfly, and specifically in DF7001, reinforces the value of our TriNKET platform and the differentiated and sustainable approach focused on people with cancer and inflammatory diseases," said Bill Haney, Co-Founder and Chief Executive Officer of Dragonfly. "Gilead has a well-established track record in development and commercialization and is a well-matched partner for our scientific expertise and platform. We look forward to working with the Gilead team to advance new treatment options where there is a high unmet need."

Terms of the Agreement

Under the terms of the agreement, Gilead will make a $300 million upfront payment to Dragonfly. In addition, Dragonfly is eligible to receive potential opt-in payments and performance-based development, regulatory and commercial milestone payments. Dragonfly will also be eligible to receive royalties of up to 20% on worldwide net sales.

The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

DF7001 is an investigational product candidate; it is not approved by any regulatory agency for any use and has not been proven safe or efficacious.

About Dragonfly

Dragonfly Therapeutics, Inc. is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel TriNKET™ technology to harness the body's innate immune system to bring breakthrough treatments to patients.

For more information visit:
www.dragonflytx.com
https://www.linkedin.com/company/dragonfly-therapeutics-inc
https://twitter.com/dragonflytx

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of the parties to complete the transaction in a timely manner or at all; the possibility that various closing conditions for the transaction may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the risk that Gilead may not realize the potential benefits of this collaboration with Dragonfly or other investments in oncology; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead's revenues and earnings; the ability of the parties to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving DF7001 or any other NK cell engager program; the ability of the parties to file applications for regulatory approval or receive regulatory approvals in a timely manner or at all, including those involving DF7001 or any other NK cell engager program, and the risk that any such approvals may be subject to significant limitations on use; the possibility that the parties may make a strategic decision to terminate the collaborations, including the development of DF7001 or any other NK cell engager program, at any time; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Gilead Contacts:
Jacquie Ross, Investors
investor_relations@gilead.com

Jaisy Wagner Styles, Global Media
jaisy.styles@gilead.com

Dragonfly Contact:
Anne Deconinck, Media
anne@dragonflytx.com

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CORRECTION: Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

This document corrects and updates the final paragraph in the body of this news release. No other changes were required in this release.

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Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

  • Covid-19 has proven to be the "great revealer" of disparities in healthcare

  • Contakt World (CSE: HELP) and Satcher Health Leadership Institute, Morehouse School of Medicine executed a strategic collaboration in October 2020
  • Health Equity Tracker, supported by Google.org, Gilead Sciences (Nasdaq: GILD), Annie E. Casey Foundation, and CDC Foundation, is now operational
  • Contakt World's SaaS Platform, Smart Health RM, will help drive de-identified data to Health Equity Tracker to improve health equity and reduce disparities of care

Contakt World Technologies Corp. (CSE: HELP) (OTC: TLOOF) (FSE: B2I0) (the "Company" or "Contakt World") today announced its agreement in principle with Satcher Health Leadership Institute, Morehouse School of Medicine ("SHLI") to help collect de-identified demographic data for the Health Equity Tracker Project through Smart Health RM and other products and services provided by Contakt World like Engagency. This updates the previously announced collaboration between Contakt World and SHLI now that Health Equity Tracker is operational.

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HOOKIPA Advances HIV and HBV Vaccine Research with Gilead

HOOKIPA Pharma (NASDAQ:HOOK) announced that it has made progress in its collaboration with Gilead Sciences (NASDAQ:GILD) for arenavirus-based therapeutics intended to support cures for chronic Hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections.

As quoted in the press release:

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Kite Announces Initial Results From a Phase 1 Study of T Cell Receptor (TCR) Cell Therapy in HPV-16-Positive Solid Tumors

Kite, a Gilead Company (Nasdaq: GILD), today announced results from an ongoing Phase 1 study conducted by the National Cancer Institute (NCI) showing that clinical responses were observed with investigational T cell receptor (TCR) cell therapy targeting human papillomavirus type 16 (HPV-16) E7 in solid tumor cancers caused by HPV. These findings were presented today in a poster session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #3043).

As quoted in the press release:

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Gilead Sciences Announces Promotion in Oncology Division

Gilead Sciences (NASDAQ:GILD) shared the promotion of Dr. Alessandro Riva to executive vice president of Oncology Therapeutics, with responsibility for Gilead’s hematology and oncology programs.
As quoted in the press release:

Dr. Riva will become a member of Gilead’s senior leadership team.
Dr. Riva joined Gilead in January 2017 as Senior Vice President, Hematology and Oncology Therapeutic Area Head. He has been instrumental in expanding Gilead’s oncology program with the recent acquisition of Kite Pharma, establishing the company as a leader in the field of cellular therapy. He has also guided the strategy and development of Gilead’s broader oncology pipeline during his tenure.

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The Klein Law Firm Reminds Investors of Class Actions on Behalf of Shareholders of IBM, MYPS and AUPH

The Klein Law Firm announces that class action complaints have been filed on behalf of shareholders of the following companies. There is no cost to participate in the suit. If you suffered a loss, you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff

International Business Machines Corporation (NYSE:IBM)
Class Period: April 4, 2017 - October 20, 2021
Lead Plaintiff Deadline: June 6, 2022

Throughout the class period, International Business Machines Corporation allegedly made materially false and/or misleading statements and/or failed to disclose that: (i) Strategic Imperatives Revenue and growth, CAMSS and CAMSS Components' revenue and growth, and the Company's Segments' revenue and growth were artificially inflated as a result of the wrongful reclassification of revenues from non-strategic to strategic to make those revenues eligible for treatment as Strategic Imperatives Revenue; (ii) the Company's present success and positive future growth prospects concerning its Strategic Imperative business strategy were being fueled by the wrongful reclassification of revenues from non-strategic to strategic to make those revenues eligible for treatment as Strategic Imperative Revenue and, as a result (iii) the Company misled the market by portraying the Company's Strategic Imperative's financial performance and future prospects more favorable than they actually were as a result of the wrongful reclassification of revenues from non-strategic to strategic to make those revenues eligible for treatment as Strategic Imperatives.

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The Gummy Project

Potent Ventures Announces The Gummy Project Selected by Sweets & Snack Expo Committee to Participate in Power Pitch During Sweets & Snacks Expo

Potent Ventures Inc. (CSE: POT) (FSE: 0OS) (OTCQB: POTVF) ("Potent" or the "Company") is pleased to announce that The Gummy Project is one of two companies selected from the show's Startup Street to participate in Power Pitch at Sweets & Snacks Expo on May 24, 2022.

Power Pitch provides selected companies with an opportunity to showcase their products in a sales pitch-style presentation to a panel of leading US retailers, including the following:

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The Gross Law Firm Announces Class Actions on Behalf of Shareholders of ABBV, UPST and AXSM

The securities litigation law firm of The Gross Law Firm issues the following notice on behalf of shareholders in the following publicly traded companies. Shareholders who purchased shares in the following companies during the dates listed are encouraged to contact the firm regarding possible Lead Plaintiff appointment. Appointment as Lead Plaintiff is not required to partake in any recovery

ABBVie Inc. (NYSE:ABBV)

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Gilead and Kite Oncology to Highlight Advances Supporting New Innovations in Cancer Care at the ASCO Annual Meeting

Late-Breaking TROPiCS-02 Study Results in Heavily Pre-Treated HR+HER2- Metastatic Breast Cancer Patients to be Featured in ASCO Press Program –

New Sub-Analysis from Kite's ZUMA-7 CAR T-cell Therapy Study in Patients Aged 65+ and Data by Tumor Burden Characteristics in Second-Line Large B-cell Lymphoma to be Presented

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Investor Reminder: Kessler Topaz Meltzer & Check, LLP Reminds Investors of Deadline in Securities Fraud Class Action Lawsuit Filed Against AbbVie, Inc.

The law firm of Kessler Topaz Meltzer & Check, LLP(www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE:ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES. YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE

TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

LEAD PLAINTIFF DEADLINE: JUNE 6, 2022

CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS: James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

ABBVIE'S ALLEGED MISCONDUCT

AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

WHAT CAN I DO?

AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLPor other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087
(484) 270-1453
info@ktmc.com

SOURCE: Kessler Topaz Meltzer & Check, LLP



View source version on accesswire.com:
https://www.accesswire.com/701263/Investor-Reminder-Kessler-Topaz-Meltzer-Check-LLP-Reminds-Investors-of-Deadline-in-Securities-Fraud-Class-Action-Lawsuit-Filed-Against-AbbVie-Inc

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IBM, ABBV, & TWTR Class Actions: Bronstein, Gewirtz & Grossman, LLC, A Leading Class Action Firm Reminds Investors to Actively Participate

Bronstein, Gewirtz & Grossman, LLC reminds investors that a class action lawsuit has been filed against the following publicly-traded companies. You can review a copy of the Complaints by visiting the links below or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss, you can request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. A lead plaintiff acts on behalf of all other class members in directing the litigation. The lead plaintiff can select a law firm of its choice. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff

Bronstein, Gewirtz and Grossman, LLC, Tuesday, May 17, 2022, Press release picture

International Business Machines Corporation (NYSE:IBM)

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