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.

On January 6, 2023 AbbVie (NYSE: ABBV) and Immunome, Inc. (Nasdaq: IMNM), a clinical-stage biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported a worldwide collaboration and option agreement directed to the discovery of up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome’s Discovery Engine (Press release, AbbVie, JAN 6, 2023, View Source [SID1234625953]).

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"Partnering with Immunome represents AbbVie’s commitment to developing and commercializing novel treatment approaches for solid tumors," said Steve Davidsen, Ph.D., vice president, oncology discovery research, AbbVie. "Immunome’s approach has the potential to unlock novel cancer biology and yield multiple therapeutic candidates. We look forward to utilizing their Discovery Engine to enhance our existing oncology pipeline."

"This collaboration with AbbVie, a true leader in the development and commercialization of oncology therapeutics, demonstrates the strength of Immunome’s Discovery Engine," said Purnanand Sarma, Ph.D., president and CEO of Immunome. "AbbVie shares our vision of harnessing the power of the human immune response to yield novel and first-in-class therapeutics that represent a shift in the cancer discovery paradigm. We are delighted to be working with AbbVie and look forward to leveraging their vast development and commercialization expertise in bringing new therapies to patients suffering from life-threatening cancers. This collaboration fits well within Immunome’s strategy to maximize the new drug discovery potential of our Discovery Engine through partnerships across multiple therapeutic segments, in addition to advancing our own proprietary pipeline."

Under the terms of the agreement, Immunome will grant AbbVie the option to purchase worldwide rights for up to 10 novel target-antibody pairs arising from the selected tumors. Immunome will receive an upfront payment of $30M and will be eligible to receive additional platform access payments in the aggregate amount of up to $70M based on AbbVie’s election for Immunome to continue research using its Discovery Engine. Immunome is also eligible to receive development and first commercial sale milestones of up to $120M per target with respect to certain products derived from target-antibody pairs that AbbVie elects to purchase, with potential for further sales-based milestones as well as tiered royalties on global sales.

On January 6, 2023 2seventy bio, Inc. (Nasdaq: TSVT) reported an amendment to its collaboration with Regeneron that will facilitate an expanded and accelerated development plan for novel cell therapy-based combinations for solid tumors (Press release, 2seventy bio, JAN 6, 2023, View Source [SID1234625952]). The collaboration will leverage 2seventy bio’s unique cell therapy engineering and early-stage development capabilities, including the newly built in-house clinical cell therapy manufacturing facility, with Regeneron’s differentiated antibodies and bispecifics.

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"We’re excited to continue our collaboration with Regeneron which is now delivering several interesting CAR / TCR programs for potential clinical development. The deepened collaboration is a testament to the mutual desire to drive these programs and promising combinations forward faster and in more sophisticated ways," said Philip Gregory, D.Phil., chief scientific officer, 2seventy bio. "As an industry, we’ve experienced the challenges of developing transformative new therapies for solid tumors. Multi-layered approaches are needed to realize the potential of cell-based immunotherapy. The power of our renewed collaboration is the ability to leverage our end-to-end scientific and manufacturing cell therapy platform to test CAR-Ts, including enhanced CAR-Ts, in combination with innovative biologics in multi-arm proof of concept clinical studies. We believe this approach will be the most efficient way to accelerate the identification and development of the most transformative therapies possible."

"We look forward to building upon the strength of our existing collaboration to accelerate progress in the clinic," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "We have several exciting targets already identified and this opportunity to more rapidly explore 2seventy’s engineered T cell platform, in combination with our proprietary antibodies and bispecifics, will help us learn and move faster toward our goal of delivering the best possible therapeutic options for patients."

To support this expanded clinical development plan Regeneron will make a $20 million equity investment in 2seventy bio at a 50% premium and another approximately $20 million in near-term pre-clinical and clinical milestones. The parties will continue sharing costs for these activities in a manner largely consistent with the existing agreement, with Regeneron covering 75% of certain preclinical costs necessary to study combinations and 100% of the costs for the arms of clinical studies that include Regeneron agents through regulatory approval. For other programs, cost-sharing will follow the existing 50/50 cost sharing agreement.

On January 5, 2023 BroadenBio reported the first patient enrollment and dosed in the Phase 1 clinical trial of the independently developed, highly-selective small molecule inhibitor BB102 in Henan Cancer Hospital, marking the substantive progress of the clinical trial for this program (Press release, BroadenBio, JAN 5, 2023, View Source [SID1234640202]). The Phase 1 clinical trial of BB102 is led by renowned medical expert Professor Luo Suxia as the principal investigator.

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The Phase 1 clinical trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of the oral small molecule Fibroblast Growth Factor Receptor 4 (FGFR4) BB102 in adults with advanced solid tumors. Currently, no drug with the same target has been approved for marketing globally.

BB102 is an innovative, highly-selective, reversible covalent FGFR4 inhibitor, which has shown significant anti-tumor efficacy in a variety of mice tumor models in preclinical studies. Based on the novel mechanism and extensive translational medicine studies, BB102 will be investigated for the treatment of advanced solid tumors with FGFR4/FGF19 high expression or FGFR4 mutation. Besides, BB102 is expected to have lesser adverse effects in clinical trials, since no obvious off-target toxicity has been observed in animal studies.

"The successful administration of BB102 for the first patient is another milestone for BroadenBio. I would like to express my heartfelt thanks to the team of Professor Luo Suxia from Henan Cancer Hospital, the team of Professor Guo Yabing from Nanfang Hospital of Southern Medical University, The company’s shareholders and other people for their full support, and I am also grateful to the company’s team for their hard work," said Xingmin Zhang, M.D., Ph.D., founder and Chief Executive Officer of BroadenBio. "In the New Year, we look forward to proceeding the clinical research of BB102 efficiently with the joint efforts of everyone, accelerating the progress of the other two preclinical projects into the clinic, and benefiting more cancer patients."

On January 5, 2023 Frontier Medicines Corporation, a precision medicine company seeking to unlock the proteome to advance breakthroughs against otherwise undruggable disease-causing targets, reported the second and third programs under the company’s global partnership with AbbVie have advanced into lead generation (Press release, Frontier Medicines, JAN 5, 2023, View Source [SID1234630855]). These programs harness novel E3 Ligases for targeted protein degradation, through the discovery of small molecules from The FrontierTM Platform.

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"Our collaboration with Frontier is continuing to make progress against difficult-to-drug protein targets" said Jonathon Sedgwick, Ph.D., vice president and global head, Discovery Research, AbbVie. "Two years into our partnership, Frontier’s technology is showing important advances in the drugging of previously inaccessible biology, this time towards enabling binders for novel E3 ligases, with the potential to be applied to the discovery and development of new and better therapeutic options for patients."

Started in 2020, the objective of the global partnership is to discover, develop, and commercialize a pipeline of innovative small molecule therapeutics against certain high-interest, difficult-to-drug protein targets.

"We are excited that our team’s work, with support from AbbVie, has resulted in accessing two previously undruggable E3 Ligases for targeted protein degradation, and each program has the potential to drive new therapeutic opportunities for patients," said Chris Varma, Ph.D., Frontier’s co-founder, chairman, and CEO. "Our delivery of three programs into lead generation further validates The Frontier Platform’s ability to systematically discover and deliver small molecules to drug undruggable targets. We look forward to progressing these novel breakthrough discoveries to help advance transformative care for patients."

About Frontier and AbbVie Partnership

Under the partnership, the companies will collaborate on the research and pre-clinical development of programs directed to novel E3 ligases, and certain immunology and oncology targets. AbbVie will reimburse Frontier’s R&D costs through defined stages of pre-clinical development. Upon successful completion, AbbVie will assume full responsibility for global development and commercialization activities and costs for the programs. Frontier will retain an option to share development activities and expenses for certain oncology programs through the completion of Phase 2. Frontier will be eligible to receive success-based development and commercial milestone payments that could potentially exceed $1 billion, in addition to royalty payments on commercialized products. AbbVie retains the right to expand the collaboration in the future by exercising options to a defined number of additional targets. The collaboration excludes all of Frontier’s internal programs for which Frontier retains exclusive global rights.