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Servier Announces Positive Topline Data from the Global Phase 3 Study of TIBSOVO® (ivosidenib tablets) in Combination with Azacitidine in Patients with Previously Untreated IDH1-mutated Acute Myeloid Leukemia

On August 2, 2021 Servier, a global pharmaceutical company, reported the global Phase 3 double blinded placebo controlled AGILE study of TIBSOVO (ivosidenib tablets) in combination with the chemotherapy azacitidine in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) met its primary endpoint of event-free survival (EFS)1,2 (Press release, Servier, AUG 2, 2021, View Source [SID1234585561]). Treatment with TIBSOVO in combination with azacitidine compared to azacitidine in combination with placebo demonstrated a statistically significant improvement in EFS. Additionally, the trial met all of its key secondary endpoints, including complete remission rate (CR rate), overall survival (OS), CR and complete remission with partial hematologic recovery rate (CRh rate) and objective response rate (ORR). The safety profile of TIBSOVO in combination with azacitidine was consistent with previously published data. The study recently halted further enrollment based on the recommendation of the Independent Data Monitoring Committee (IDMC), as a difference of clinical importance was noted between the treatment groups.

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"The results of AGILE represent a major breakthrough and will be welcome news for patients dealing with previously untreated IDH1-mutated acute myeloid leukemia," said Claude Bertrand, Executive Vice President, R&D, Servier Group. "We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world."

A full analysis of the AGILE trial will be submitted for a presentation at a future medical congress.

"Acute myeloid leukemia has a poor prognosis, especially for newly diagnosed patients who are not eligible for intensive chemotherapy," said Susan Pandya, M.D., Vice President Clinical Development, Servier Pharmaceuticals. "TIBSOVO monotherapy has been instrumental in transforming outcomes for adult patients with newly diagnosed or relapsed refractory AML harboring an IDH1 mutation. These promising results from the AGILE study support the added benefit of inhibiting the mutant IDH1 enzyme in combination with standard chemotherapy in the newly diagnosed intensive chemotherapy ineligible setting. We look forward to presenting the full results of the AGILE trial to show how TIBSOVO in combination with azacitidine may improve outcomes in previously untreated patients with IDH1-mutated acute myeloid leukemia."

TIBSOVO* is currently approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML), and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. Recently, the U.S. Food and Drug Administration (FDA) accepted Servier’s supplemental New Drug Application (sNDA) for TIBSOVO as a potential treatment for patients with previously treated IDH1-mutated cholangiocarcinoma. The sNDA was granted Priority Review by the FDA.

About AGILE Phase 3 Trial
The AGILE trial is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy and safety of TIBSOVO in combination with azacitidine compared to placebo in combination with azacitidine, in newly diagnosed AML patients non eligible for intensive chemotherapy. The study’s primary endpoint is event-free survival (EFS), defined as the time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurs first. Treatment failure is defined as failure to achieve complete remission (CR) by Week 24.

Other key secondary endpoints included complete remission rate (CR rate), defined as the proportion of participants who achieve a CR; overall survival (OS), defined as the time from date of randomization to the date of death due to any cause; CR and complete remission with partial hematologic recovery (CRh) rate, defined as the proportion of participants who achieve a CR or CRh; and objective response rate (ORR), defined as the rate of CR, CR with incomplete hematologic recovery (CRi) (including CR with incomplete platelet recovery [CRp]), partial remission (PR), and morphologic leukemia-free state (MLFS).

About Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow marked by rapid disease progression and is the most common acute leukemia affecting adults with approximately 20,000 new cases in the U.S., and 43,000 cases in Europe each year3,4. The majority of patients with AML eventually relapse. Relapsed or refractory AML has a poor prognosis5. The five-year survival rate is approximately 27%3. For 6 to 10 percent of AML patients, the mutated IDH1 enzyme blocks normal blood stem cell differentiation, contributing to the genesis of acute leukemia6.

Hummingbird Bioscience Announces UK MHRA Approval for First-in-Human Phase 1 Trial of HMBD-001 in Advanced Cancers

On August 2, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, reported that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the clinical trial application (CTA) to initiate first-in-human phase 1 trial of HMBD-001 in patients with advanced cancers (Press release, Hummingbird Bioscience, AUG 2, 2021, View Source [SID1234585560]).

HMBD-001 is a novel antibody with a unique, differentiated mechanism of action that fully inhibits HER3 activation of the MAPK/PI3K tumor growth signaling pathway. By binding to the HER3 dimerization interface, HMBD-001 blocks the formation of all HER3 dimers, regardless of NRG1 ligand-binding or HER2/EGFR overexpression. Pre-clinical studies in multiple HER3 cancer models, including those with NRG1-fusions, have shown that these differentiated properties of HMBD-001 result in robust and sustained tumor growth inhibition.

The phase 1 trial will be a multi-center, open-label, dose-escalation and -expansion study, to be conducted in two parts. First, the safety and tolerability profile and recommended phase 2 dose of HMBD-001 will be determined in patients with advanced tumors known to overexpress HER3. This will be followed by further evaluation of safety and preliminary anti-tumor activity of HMBD-001 as a monotherapy in biomarker-selected patients, including those with NRG1 fusions, as well as in combination with other selected targeted therapies. Under a clinical development partnership agreement, Cancer Research UK will be funding and conducting the phase 1 trial in the UK.

"This marks an exciting next step in our journey to deliver a potentially transformative therapy for hard-to-treat cancers that express HER3 and are resistant to standard of care treatments," said Jerome Boyd-Kirkup, Chief Scientific Officer and co-founder of Hummingbird Bioscience. "Our platform technology was developed specifically to tackle biologically relevant yet extremely challenging targets for which research efforts to-date have yet to generate effective treatments. HMBD-001 is the first of our growing pipeline of rationally designed antibodies to obtain clinical trial approval, demonstrating the power of the platform to develop highly differentiated, precision therapies."

About HMBD-001
HMBD-001 is a anti-HER3 neutralizing antibody, with a novel mechanism of action that offers significant potential for clinical benefit. Previous attempts to block the HER3 receptor, a key player in the PI3K/MAPK signaling pathways that promotes cell division and tumor growth in cancer, have not proven to be effective. HER3 is activated by the binding of NRG1, which stabilizes a transient open conformation to allow it to form heterodimers with HER2/EGFR. In the presence of abundant HER2/EGFR, heterodimers can form without NRG1.

Pre-clinical studies have shown that HMBD-001 potently inhibits the formation of these heterodimers, blocking activation of the signalling pathway – and consequently, prevents tumor growth. Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel drug candidate into clinical trials for the treatment of HER3-driven cancers.

Bionomics Announces Plans to Conduct U.S. Initial Public Offering

On August 2, 2021 Bionomics Limited (ASX: BNO,OTCQB: BNOEF), (Bionomics) a global, clinical stage biopharmaceutical company, reported that it plans to conduct a registered initial public offering of American Depositary Shares (ADSs) in the United States and a concurrent listing of ADSs on Nasdaq (Press release, Bionomics, AUG 2, 2021, View Source [SID1234585559]). The number of ADSs and price of the proposed offering have not yet been determined. The proposed offering is expected to commence after the U.S. Securities and Exchange Commission completes its review process of a registration statement relating to the proposed offering (the Registration Statement) that the company intends to file, and subject to market and other conditions, including the effectiveness of the Registration Statement and shareholder approval under Australian Securities Exchange (ASX) Listing Rule 7.1. Each ADS would represent a certain number of fully paid ordinary shares in Bionomics.

No final decision has been made in respect of the Nasdaq listing and there can be no assurance as to the occurrence, timing or completion of such a listing. Following any Nasdaq listing Bionomics shares would continue to trade on ASX.

This press release is being made pursuant to and in accordance with Rule 135 under the U.S. Securities Act of 1933, as amended. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

IDEAYA Biosciences to Participate in Panel Discussion at 2021 Wedbush PacGrow Healthcare Virtual Conference on August 10, 2021

On August 2, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in a panel discussion at the 2021 Wedbush PacGrow Healthcare Virtual Conference on August 10, 2021 (Press release, Ideaya Biosciences, AUG 2, 2021, View Source [SID1234585558]).

2021 Wedbush PacGrow Healthcare Virtual Conference
"Synthetic Lethal (Weapon)" panel discussion Tuesday, August 10, 2021 at 11:30 am ET
Panelists include:

Michael Dillon, Senior Vice President and Chief Scientific Officer, Head of Research, IDEAYA Biosciences
Markus Renschler, President and CEO, Cyteir Therapeutics
Vatnak Vat-Ho, CBO, Ryvu Therapeutics
Barbara Weber, Chief Executive Officer, Tango Therapeutics
A live audio webcast of the event will be available by visiting the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of the webcast will be available for 30 days following the live event.

Avidity Biosciences, Inc. Announces Proposed Public Offering of Common Stock

On August 2, 2021 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported that it intends to offer and sell, subject to market and other conditions, $100 million of shares of its common stock in an underwritten public offering (Press release, Avidity Biosciences, AUG 2, 2021, View Source [SID1234585557]). In addition, Avidity intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares to be sold in the offering are to be sold by Avidity. 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.

Avidity intends to use the net proceeds from this offering, together with its existing cash, cash equivalents and marketable securities: to complete its Phase 1/2 MARINA trial for AOC 1001; to advance AOC 1044 and its AOC FSHD program into clinical development; to further advance its AOC platform in and beyond its muscle franchise; and towards working capital and other general corporate purposes.

Cowen, SVB Leerink, Evercore ISI and Wells Fargo Securities are acting as joint bookrunning managers for the offering.

The securities described above are being offered by Avidity pursuant to a shelf registration statement that became automatically effective upon filing with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; from SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, or by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

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