AVEO Oncology Stockholders Approve Acquisition by LG Chem

On January 6, 2023 AVEO Oncology ("AVEO") (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, reported that at a special meeting of stockholders (the "Special Meeting") held today, AVEO stockholders approved the adoption of the Agreement and Plan of Merger among LG Chem, Ltd. ("LG Chem"), a subsidiary of LG Chem and AVEO (the "merger agreement") (Press release, AVEO, JAN 6, 2023, View Source [SID1234625959]). As previously announced, under the terms of the merger agreement, AVEO stockholders will receive $15.00 per share in cash upon the closing of the transaction.

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"Today’s approval is a significant step toward the completion of AVEO’s transaction with LG Chem, and I thank our stockholders for their strong support," said Michael Bailey, President and Chief Executive Officer of AVEO. "As the U.S. late stage development and commercial foundation for LG Chem Life Sciences’ oncology segment, we believe AVEO will be well positioned to advance its mission of passionately pursuing a better life for patients with cancer."

The final voting results will be reported in a Current Report on Form 8-K to be filed by AVEO with the Securities and Exchange Commission after certification by AVEO’s inspector of elections. The stockholders also approved a non-binding, advisory proposal relating to certain compensation that may be paid or become payable to certain of AVEO’s executive officers that is based on or otherwise relates to the merger between AVEO and LG Chem.

Completion of the transaction remains subject to certain customary closing conditions, including clearance of the transaction by the Committee on Foreign Investment in the United States, and the transaction is expected to close in early 2023.

Advisors

BofA Securities is serving as exclusive financial advisor to LG Chem, and Latham & Watkins LLP is serving as LG Chem’s legal counsel. Moelis & Company LLC is serving as exclusive financial advisor to AVEO, and WilmerHale LLP is serving as AVEO’s legal counsel.

Corporate presentation

On January 6, 2023 Aura Biosciences presented its corporate presentation (Presentation, Aura Biosciences, JAN 6, 2023, View Source [SID1234625958]).

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Aptose Corporate presentation

On January 6, 2023 Aptose Biosciences presented its corporate presentation (Presentation, Aptose Biosciences, JAN 6, 2023, View Source [SID1234625957]).

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Agilent and Akoya Biosciences Announce Partnership to Drive Multiplex Tissue Assay Development for Biopharma Applications

On January 6, 2023 Agilent Technologies, Inc. (NYSE: A) reported a partnership with Akoya Biosciences, Inc. (Nasdaq: AKYA), The Spatial Biology Company, to develop multiplex-immunohistochemistry diagnostic solutions for tissue analysis and to commercialize workflow solutions for multiplex assays in the clinical research market (Press release, Akoya Biosciences, JAN 6, 2023, View Source [SID1234625955]). Integrating Agilent’s Dako Omnis (autostaining instrument) and Akoya’s PhenoImager HT (imaging platform) for multiplex chromogenic immunohistochemistry (mIHC) and immunofluorescent (mIF) assays will create a singular end-to-end commercial workflow, including reagents, staining, imaging, and analysis.

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Agilent and Akoya will partner to develop chromogenic and immunofluorescent multiplex assays that include spatial analysis for biopharma companies developing precision cancer therapeutics. These assay solutions will enable researchers and medical professionals to address patient selection needs of novel therapeutics and rapidly translate their discoveries into clinical testing. Spatial phenotyping using multiplex imaging provides the advantages of single-cell analysis while preserving spatial relationships between the cells. This offers an invaluable tool for uncovering novel insights into cellular organization in the tumor microenvironment and therapeutic response.

This agreement will deliver an end-to-end multiplex solution for biomarker clinical research enabled by digital pathology, providing capabilities across the pharma value chain. Combining Agilent’s companion diagnostic and IHC workflow expertise, the large install base of Dako Omnis instruments, and a strong network of pharma partners; with Akoya’s install base of imagers, spatial analysis expertise, and CLIA lab capabilities will further empower biopharma partners to leverage this integrated workflow solution for their biomarker discovery and validation needs, helping drive better patient stratification. Under a separate Value-Added Reseller agreement, Akoya Biosciences will distribute and resell Dako Omnis as a part of the end-to-end multiplex solution.

"We are delighted to be partnering with Akoya to create industry-leading products and services for multiplex chromogenic and immunofluorescence tissue assays," said Sam Raha, president of Agilent’s Diagnostic and Genomics Group. "This partnership enables an ecosystem that assists the development of novel precision cancer therapeutics and offers a streamlined workflow to our joint customers in the clinical research market to meet the needs of future clinical diagnostics," Raha added.

"Multiplex tissue analysis has the potential to transform the field of cancer therapeutics and usher in a new era of precision pathology," said Brian McKelligon, CEO of Akoya Biosciences. "This partnership and the combined strength of both organizations will catalyze the development and deployment of multiplex tissue-based biomarkers for the benefit of our biopharma and CRO partners and, ultimately, patients."

Aclaris Therapeutics Provides 2023 Outlook

On January 6, 2023 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported a corporate outlook for 2023 (Press release, Aclaris Therapeutics, JAN 6, 2023, View Source [SID1234625954]).

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"2023 is setting up to be an incredibly exciting year for Aclaris with several important expected data read-outs for our two lead clinical programs, zunsemetinib (ATI-450) and ATI-1777," stated Douglas Manion, M.D., Aclaris’ Chief Executive Officer and President. "In addition to these highly anticipated clinical milestones, we also are eager to progress the development of our earlier stage assets such as ATI-2138 for T cell mediated diseases and ATI-2231 for certain oncology indications," continued Dr. Manion. "Our research and development team also continues to identify and develop novel kinase drug candidates targeting areas of significant unmet need further bolstering our rich clinical development pipeline."

Clinical Development Programs:

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:
Currently being developed as a potential treatment for immuno-inflammatory diseases
Rheumatoid Arthritis (ATI-450-RA-202): This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis (RA) is ongoing. Aclaris expects topline data in the second half of 2023.

Hidradenitis Suppurativa (ATI-450-HS-201): This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib (50 mg twice daily) over 12 weeks in subjects with moderate to severe hidradenitis suppurativa (HS) has completed enrollment with 95 patients randomized and is ongoing. Aclaris expects topline data in mid-first half of 2023.

Psoriatic Arthritis (ATI-450-PsA-201): This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib (50 mg twice daily) in subjects with moderate to severe psoriatic arthritis (PsA) is ongoing. Aclaris expects topline data by year end 2023.
ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor:
Currently being developing as a potential treatment for moderate to severe atopic dermatitis (AD)

Atopic Dermatitis (ATI-1777-AD-202): This Phase 2b trial to determine the efficacy, safety, tolerability, and PK of multiple doses and application regimens of ATI-1777 in subjects with moderate to severe AD is ongoing. Aclaris expects topline data mid-year 2023.
ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor:
Currently being developed as a potential treatment for T cell-mediated autoimmune diseases
Aclaris has selected ulcerative colitis as the intended first clinical development target for ATI-2138. Aclaris is also exploring additional indications that are relevant to the mechanism of action.
Aclaris initiated a Phase 1 MAD trial of ATI-2138 in healthy volunteers in December of 2022. Aclaris expects topline data from the MAD trial in the second half of 2023.
Preclinical Development Program:

ATI-2231, an investigational oral MK2 inhibitor compound:
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer

Second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and designed to have a long plasma half-life.
Aclaris expects an IND to be submitted in 2023.

Upcoming Corporate Presentation

Dr. Manion will provide a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023 at 2:15 PM PT/5:15 PM ET. The conference is being held in San Francisco, CA. A copy of Aclaris’ corporate presentation will be posted to the Investor’s page of the Aclaris corporate website prior to the event.

A webcast of the presentation may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.