On October 22, 2021 Egle Therapeutics SAS (Egle), an emerging biotechnology company focused on developing First-In-Class immunotherapies targeting immune suppressor regulatory T-cells (Tregs) for oncology and autoimmune diseases, reported that it has completed a €40M ($46.4M) Series A financing (Press release, Egle Therapeutics, OCT 22, 2021, View Source [SID1234591777]). The Series A was co-led by LSP and Bpifrance through their InnoBio 2 fund. Fund+, Bioqube Ventures and Takeda Ventures, Inc. also participated in this round.

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Egle Therapeutics was founded in early 2020 with a vision to become a game changer in the field of Tregs immunomodulation through the unique concept of Tregs starving and specifically targeting the most immunosuppressive ones. Spun out of Institut Curie, Egle’s scientific foundation leverages unprecedented, computational-based, IL-2 modified variants and newly tumor-associated Treg targets to build a furnished pipeline of First-In-Class immunocytokines against Tregs. The new capital will be used primarily to advance 2 leads assets into the clinic and further strengthen its internal drug pipeline.

"Closing a substantial Series A of €40M from a high-quality syndicate of renowned investors, as well as a partnership with a top big pharma like the one we have announced with Takeda in June 2020, all in less than 18 months, puts Egle on a trajectory to execute its vision of tackling regulatory T cells to restore immunity in patients suffering from cancer and autoimmune diseases" commented Luc Boblet, co-founder and CEO of Egle. "The funding will give us appropriate resources to push the first Treg starvers into the clinic and we feel very privileged to undertake such responsibility for the benefit of the whole patient community".

The investor syndicate will join the Egle Therapeutics Board which will consist of Felice Verduyn-van Weegen (LSP), Vincent Brichard (LSP), Jean-Francois Morin (Bpifrance – InnoBio 2) and Sacha Mann (Takeda Ventures). Philippe Monteyne (Fund+), Jacques Mizrahi (Bioqube Ventures) and Elisa El Nouchi (Bpifrance InnoBio 2) will join as observers.

"Egle represents a strategic investment in a First-In-Class technology platform based on innovative research with novel T regulatory modulations and potential in the oncology and auto-immunity fields", commented Vincent Brichard, Venture Partner at LSP. "We feel privileged to be part of such an exciting company, with world class science and look forward to build it out together with the team" adds Felice Verduyn-van Weegen, partner at LSP.

"InnoBio 2 strives to invest in breakthrough ideas and to promote First-In-Class drugs candidates. We are delighted to have co-led a financing round that will enable Egle Therapeutics to broadly invest in its platform technologies, development programs, people and ultimately, towards delivering a pioneering new generation of immunotherapies to patients in need," said Jean-François Morin, Investment Director at Bpifrance.

On October 22, 2021 Chugai Pharmaceutical Co., Ltd. reported that the Company resolved at the meeting of its Board of Directors held on October 22, 2021 to revise the dividend forecast per share as described below (Press release, Chugai, OCT 22, 2021, View Source [SID1234591775]).

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1. Reasons for the revision
Reflecting the significant changes in the business environment, year-end dividend forecast has been revised to undecided. The year-end dividends will be decided after the fiscal year end based on basic profit distribution principles*.

*Regarding income distribution, taking into account the strategic funding needs and earning prospects, Chugai aims for a consolidated dividend payout ratio of 45% on average in comparison with Core EPS to provide a stable allocation of profit to all shareholders.

2. Contents of the revision

**Effective July 1, 2020, Chugai implemented a three-for-one stock split of its common stock. The dividends are calculated based on the assumption that the stock split was implemented at the beginning of the fiscal year 2020.

On October 22, 2021 Athenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company will provide a corporate and financial update for the third quarter 2021, on Thursday, November 4, 2021 (Press release, Athenex, OCT 22, 2021, View Source [SID1234591773]). Athenex’s management team will host a conference call and live audio webcast at 10:00 a.m. Eastern Time.

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To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

Domestic: (855) 227-0567

International: (612) 979-9912

Passcode: 7292300

The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website under "Events and Presentations", located at View Source

On October 22, 2021 Applied DNA Sciences, Inc. (Applied DNA or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported signing a mutual collaboration agreement (the "Agreement") with Ganesha Ecosphere Ltd. (Ganesha), the largest recycled polyester (rPET) fiber producer in India with over 300-plus customers, 250-plus suppliers, and 500-plus product variants (Press release, Applied DNA Sciences, OCT 22, 2021, View Source [SID1234591772]). Under the terms of the Agreement, Ganesha will deploy the CertainT platform, Applied DNA’s traceability system, to tag an initial pilot production of recycled polyester (rPET) at Ganesha’s facilities in India and conduct confirmatory samples testing at Applied DNA’s laboratories in India and the U.S. The collaboration between the two companies will provide brands and textile manufacturers with a trusted solution to support their sustainability goals for rPET and confirm raw material authenticity at all stages of the textile value chain.

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The Agreement enables Ganesha to introduce and apply CertainT-verified rPET to provide assurance for the raw material with textile and apparel customers. Ganesha will also employ Applied DNA’s recently introduced SigNature T-100 tracer system that enables rPET source material to be quantified in polyester blends by the CertainT platform. SigNature T-100 is a proprietary molecular-based tracer system used to identify, analyze, and verify rPET, polypropylene, acrylic, and potentially other man-made materials for claims of both identification and quantification of the raw material tagged and subsequently spun into yarn for various textile products.

On October 22, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported a strategic decision to withdraw its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor (Press release, Agenus, OCT 22, 2021, View Source [SID1234591771]). The decision to withdraw the BLA does not change the development plans for balstilimab combinations.

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Following the full approval of pembrolizumab, announced four months earlier than the FDA goal date, the U.S. Food and Drug Administration (FDA) no longer considered it appropriate to review the BLA for accelerated approval and recommended Agenus withdraw. The BLA submission for balstilimab received Fast Track and Priority Review designation from the FDA, with a target action date of December 16, 2021. As part of the BLA review process, Agenus successfully completed 3 FDA inspections with no cited issues, concerns, or Form-483s.

As previously reported, in the largest single-arm trial to date in this population (140 evaluable patients), balstilimab demonstrated objective responses in both PD-L1 positive and negative patients, with an objective response rate (ORR) of 20% and 8% respectively1. Pembrolizumab has demonstrated an ORR of 14% and 0% in PD-L1 positive and negative patients respectively, which led to its accelerated approval in 2018. Balstilimab has shown superior killing of PD-L1 negative tumors compared to other anti PD-1 therapies, including pembrolizumab, suggesting a broader mechanism consistent with balstilimab’s clinical activity in both PD-L1 positive and negative cervical cancer2.

Concurrent with the withdrawal, Agenus will discontinue its ongoing confirmatory trial (BRAVA) in this population, which is expected to reduce R&D expenses by over $100M. However, given the clinical benefit demonstrated by balstilimab, Agenus plans to launch expanded access programs to give patients and doctors access to balstilimab in several countries, including the US, pending regulatory processes.

"While the commercial market for balstilimab monotherapy in second line cervical cancer was always anticipated to be small, Agenus’ priority remains developing balstilimab as a necessary component of highly effective and affordable combination therapies, both with its own portfolio and with partners, including in combination with Agenus’ next-generation CTLA-4, AGEN1181," said Garo Armen, CEO and Chairman of Agenus.

"Balstilimab has demonstrated meaningful clinical activity and an excellent safety profile in second-line cervical cancer, including in PD-L1 negative patients, who are ineligible to receive standard of care anti-PD-1 therapy, which makes the decision to withdraw so difficult for us," said Steven O’Day, MD, Chief Medical Officer of Agenus. "Balstilimab remains a critical component of our combination regimens, including with our next-generation CTLA-4 agent, AGEN1181. Concomitant with presentation of new data at SITC (Free SITC Whitepaper) next month, we continue to accelerate development of AGEN1181 in combination with balstilimab in trials designed to rapidly support full or accelerated approval in multiple tumor types."

Agenus executives will host a conference call to discuss this update at 8:30AM ET today.

Conference Call

Dial-in numbers: (833) 614-1394 (US) or (914) 987-7115 (International); Conference ID: 5399638.

Webcast

A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

References

1. D.M. O’Malley, A. Oaknin, B.J. Monk, et al., Phase II study of the safety and efficacy of the anti-PD-1 antibody balstilimab inpatients with rec…, Gynecologic Oncology, View Source

2. C. Joyce, D. Chand et al., Differentiated activity profile for the PD-1 inhibitor balstilimab. Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021) 5529-5529.

About Balstilimab

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market.