On July 25, 2024 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug (ODD) and Rare Pediatric Disease Designation (RPDD) Status to UCART22 product candidate for the treatment of Acute Lymphoblastic Leukemia (ALL) (Press release, Cellectis, JUL 25, 2024, View Source [SID1234645085]).

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ALL represents about 10% of all leukemia cases in the United States, progresses rapidly, and is typically fatal within weeks or months if left untreated. It is estimated that 6,660 new cases of ALL and 1,560 deaths related to the disease occurred in the US in 2022[2].

Mark Frattini, M.D., Ph.D., Chief Medical Officer at Cellectis said: "We are excited that the FDA granted UCART22 both ODD and RPDD Status in the treatment of acute lymphoblastic leukemia. This decision represents additional evidence of the potential of UCART22 to bring a much-needed therapeutic option to these patients with ALL. There is an urgent need to develop new therapies for ALL for patients who are not candidates for HSCT or relapse after CD19 directed CAR T-cell therapies and/or HSCT."

UCART22 is an allogeneic CAR T-cell product candidate targeting CD22 and evaluated in BALLI-01, a Phase 1/2 open-label dose-escalation and dose-expansion study, designed to evaluate the safety, expansion, persistence and clinical activity of UCART22 in patients with relapse/refractory ALL.

The last clinical data presented by Cellectis at the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2023 were encouraging and suggested that UCART22-P2 (fully manufactured at Cellectis) is more potent with a preliminary response rate of 67% at Dose Level 2, compared to a 50% response rate at Dose Level 3 with UCART22-P1 (manufactured by an external CDMO). Cellectis expects to provide updates on the progress of BALLI-01 by year-end 2024.

The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US, an RPDD is granted for serious or life-threatening disease in which the serious or life-threatening manifestations, such as mortality with relapsed and/or refractory disease, primarily affect individuals aged from birth to 18 years. Receiving ODD may help to expedite and reduce the cost of development, approval, and commercialization of a therapeutic agent. Receiving RPDD may lead to receiving a rare pediatric disease priority review voucher at the time of marketing approval.

On July 25, 2024 Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, reported that it has commenced a Phase 1 first-in-human clinical trial (CITADEL-123) of 123I-ATT001, its Iodine-123 labelled PARP inhibitor, in patients with recurrent glioblastoma (Press release, Ariceum Therapeutics, JUL 25, 2024, View Source [SID1234645083]).

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The trial opened at University College London Hospitals (UCLH) and will assess the safety and early efficacy of Ariceum’s radiotherapeutic candidate, ATT001. UCLH consultant medical oncologist, Dr Paul Mulholland, designed the trial and is also chief investigator of the study. Ariceum is the first company to sponsor a clinical trial of Auger therapy for recurrent glioblastoma, an aggressive form of brain cancer with a high unmet medical need.

The initiation of the Phase 1 clinical trial follows Ariceum’s submission of a Clinical Trial Authorisation (CTA) application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in December 2023 and subsequent approval received from the MHRA in February 2024. The trial has commenced at UCLH, with other sites due to open in the UK and EU later this year. The dose escalation study will be followed by expansion cohorts at a recommended dose in monotherapy and in combination with other therapies in recurrent glioblastoma, with the potential to move into primary glioblastoma.

Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: "The start of this clinical trial marks a significant clinical milestone for Ariceum’s targeted radionuclide therapy, ATT001, especially so soon after receiving approval from the MHRA. We are very pleased to have begun the trial and hope it will bring a much-needed therapy to patients affected by glioblastoma, an aggressive and devastating form of brain cancer."

Germo Gericke, Chief Medical Officer at Ariceum Therapeutics, commented: "Recurrent glioblastoma is a very challenging brain cancer with currently no cure and limited treatment options. Ariceum’s radiotherapeutic, ATT001, has demonstrated promising pre-clinical results as a potential treatment for patients. We hope to achieve further favourable results in the clinic from our continued collaboration with the team at UCLH, led by Dr Paul Mulholland."

Dr Paul Mulholland, who leads the Glioblastoma Research Group at the UCL Cancer Institute, added: "We have been working with Ariceum Therapeutics for some years to develop this study. It will allow us to deliver a low level of radioactivity directly into the tumour of patients with recurrent glioblastoma. I’m very pleased that this clinical trial is now opening."

ATT001 delivers its radioisotope payload, Iodine-123, in a highly targeted way to cancer cells expressing PARP, an enzyme they use to repair their DNA. This radioisotope emits low energy Auger electrons, which deposit their energy over short distances, making them particularly useful for causing lethal damage to cancer cells while sparing healthy tissue. An additional benefit of using Iodine-123 is that this isotope is more widely available than others, being produced in a cyclotron. Ariceum in parallel is also exploring 123I-ATT001 in other solid tumour indications, as PARP is a validated target, highly expressed in several other cancers.

On July 25, 2024 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, reported financial results for the six months ended June 30, 2024 and provided corporate updates (Press release, Adagene, JUL 25, 2024, View Source [SID1234645082]).

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"With the potential best-in-class product profile of ADG126 and its outstanding safety data in combination with the widely used anti-PD-1 therapy, pembrolizumab, we are well positioned to develop a new cornerstone immunotherapy doublet that can be broadly combined, addressing indications and patient populations beyond the available IO agents today," said Peter Luo, Ph.D., Chairman, CEO and President of R&D at Adagene. "Our deep commitment to develop a safe and effective anti-CTLA-4 therapy is coming to fruition. We are confident that higher, more frequent and repeat dosing of anti-CTLA-4 in combination will translate into improved patient outcomes, including clinical response and survival."

ADG126 HIGHLIGHTS

ADG126 is a masked anti-CTLA-4 SAFEbody targeting a unique epitope of CTLA-4 on regulatory T cells (Tregs) in tumor tissue which shows a potential best-in-class profile in combination with pembrolizumab.

ESMO Poster Presentation in September

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Longer-term data from a phase 1b/2 trial in MSS CRC will be presented at the ESMO (Free ESMO Whitepaper) Congress 2024 taking place in Barcelona, September 13–17, including additional patients from expansion cohorts of ADG126 10 mg/kg in combination with pembrolizumab. The update will include:

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Additional follow up in evaluable patients at doses of ADG126 10 mg/kg Q3W (n=12; Part 1) and 10 mg/kg Q6W (n=10) without liver metastases, including durability of partial responses and stable disease, as well as progression-free survival (PFS) and initial overall survival (OS) data

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Data on 12 more patients at ADG126 10 mg/kg Q3W (Part 2) without liver metastases

Highlights of Prior Data Reported at ASCO (Free ASCO Whitepaper) GI 2024

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Data from Part 1 of an ongoing phase 1b/2 single arm trial evaluating ADG126 in combination with pembrolizumab showed a differentiated safety profile for ADG126 at doses from 6 mg/kg to 10 mg/kg administered every 3 or 6 weeks in heavily pre-treated advanced/metastatic patients with solid tumors (N=46):

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Grade 3 TRAEs occurred in 5/46 patients (10.8%), with no Grade 3 colitis, no Grade 4 or 5 TRAEs, and a discontinuation rate of 6.5% (3/46)

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Grade 3 TRAEs occurred in 13% of patients treated with ADG126 10 mg/kg Q3W in combination with pembrolizumab

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The safety profile of ADG126 in combination with pembrolizumab was comparable to that of pembrolizumab monotherapy

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This has been achieved with limited safety management for immune-mediated diarrhea/colitis, such as infliximab infusion in no more than 10% of patients

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A strong efficacy signal was observed in dose expansion in MSS CRC with an overall response rate of 22% [2 confirmed Partial Response (PRs)] in patients treated with ADG126 10 mg/kg Q3W in combination with pembrolizumab (200 mg/Q3W) without peritoneal and liver metastases (n=9):

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Seven patients in this subset experienced stable disease (SD) for an overall disease control rate of 100% (2 PRs and 7 SD)

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One confirmed PR was observed in a patient with lung and lymph node metastases who initially presented without detectable liver lesions. The patient, who had previously failed two lines of therapy, later experienced shrinkage of sizable new liver lesions while on treatment

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In a preliminary progression-free survival (PFS) analysis of those MSS CRC patients free of liver and peritoneal metastasis, a median progression-free survival (PFS) of seven months was observed in those treated with ADG126 10 mg/kg at two dosing frequencies pooled together [every three weeks (n=9) and every six weeks (n=6)].

Additional MSS CRC Patient Cohorts Enrolled

● Adagene has enrolled five additional patients prospectively without peritoneal and liver metastases treated with ADG126 10 mg/kg Q3W in combination with pembrolizumab (Part 3) to further expand the patient sample with this dosing regimen.

● Adagene is also evaluating patients treated with a 20 mg/kg loading dose followed by ADG126 10 mg/kg Q3W in combination with pembrolizumab at sites in the US and Asia Pacific. Ten patients have been enrolled in a dose expansion cohort for this dosing regimen with initial results planned for later this year.
Greater China Expansion

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Adagene recently initiated evaluation of ADG126 in combination with pembrolizumab in Greater China. Following a safety evaluation, this study enables the company to broaden its dose expansion cohorts for MSS CRC at selected dosing regimens, and potentially in other tumor types.

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Additionally, a small cohort of patients (~5) with advanced/metastatic cancers is ongoing to evaluate 30 mg/kg ADG126 monotherapy Q3W in Greater China and define the potential maximum tolerated dose of ADG126 monotherapy.

Clinical Activity Suggested in PD-1 Experienced and PD-L1 Low Patients

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In a dose escalation cohort across three dosing regimens (n=11) presented at ASCO (Free ASCO Whitepaper)-GI 2024, two confirmed PRs were observed among the three patients treated with ADG126 10 mg/kg Q3W in combination with pembrolizumab. One of the patients had PD-1 refractory cervical cancer and the other had endometrial cancer. The cervical cancer patient had progressed after two lines of prior therapy, including nine cycles of pembrolizumab monotherapy, meeting criteria for PD-1 resistance. Both confirmed PRs are sustained after more than 18 months with repeat dosing while maintaining robust safety profiles.

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Data at ASCO (Free ASCO Whitepaper)-GI 2024 also showed a confirmed PR in a patient with head and neck squamous cell carcinoma who was treated with ADG126 10 mg/kg Q6W in combination with pembrolizumab (n=17). The patient was IO-naïve with a low CPS score and experienced a complete reduction in target lesions.

Clinical Activity Suggested in MSS CRC Patients with Liver Metastases

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In a cohort evaluating ADG126 plus the approved anti-PD-1 therapy, toripalimab (240 mg Q3W), two cases of significant tumor shrinkage were observed in MSS CRC patients with liver metastasis. Both patients were heavily pre-treated with three lines of prior therapy:

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One patient with lung, lymph node and liver metastases experienced more than a 30% reduction in target lesions (ADG126 10 mg/kg Q3W). Due to the presence of new lesions, the mixed response was not considered an objective response following RECIST criteria.

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The second patient (ADG126 6 mg/kg Q3W) experienced a 21% reduction in two target lesions on the liver (55 and 48 mm, respectively).

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Further, in a dose escalation cohort (n=6) evaluating the unmasked/parental antibody to ADG126, ADG116 (3 mg/kg Q3W), in combination with pembrolizumab, a patient with liver metastases who failed five previous lines of therapy experienced significant reduction in carcinoembryonic antigen (CEA) levels. The data were presented in a poster at SITC (Free SITC Whitepaper) 2022.

ADDITIONAL SAFEBODY PIPELINE

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Phase 1 evaluation is ongoing for ADG206, a masked, IgG1 FC-enhanced anti-CD137 POWERbody in patients with advanced/metastatic tumors:

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Adagene has now enrolled 13 patients in an ongoing phase 1 trial of ADG206 to evaluate safety, efficacy and tolerability profiles for this next generation anti-CD137 candidate. Dose escalation continues with a cohort ongoing at 6 mg/kg Q3W. No maximum tolerated dose (MTD) has yet been reached.

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Preclinical data demonstrated that ADG206 was well tolerated and had robust anti-tumor activity as a single agent in multiple tumor models, with 4-fold stronger anti-CD137 agonistic activity of its activated form than a benchmark antibody (urelumab analog) that displayed dose-dependent liver toxicity with an MTD of 0.1 mg/kg Q3W.

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ADG206 is the company’s first SAFEbody with Fc enhancement, called a POWERbody, to advance into clinic. ADG206 combines SAFEbody precision masking, Fc enhancement and targeting of a unique epitope to solve the safety and efficacy challenges of anti-CD137 therapies, reflecting versatility of Adagene’s dynamic antibody discovery and masking platform.

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Preclinical candidates in IND-enabling studies demonstrate the versatility and potential best-in-class safety profiles of candidates developed using SAFEbody precision masking technology in IgG format. Candidates include two masked CD3 T Cell Engagers (TCEs) in IND-enabling phase with a prolonged half-life and robust preclinical safety profiles, demonstrating well-controlled cytokine release syndrome (CRS) in non-human primate studies, as well as others applying the SAFEbody platform:

o

ADG138 is a double masked CD3xHER2 with a high therapeutic index relative to its parental non-masked TCE in both HER2 high and low expressing solid tumors, supporting its development for HER2-expressing solid tumors as a single agent and in combination with other immune modulating agents.

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ADG152 is a masked bispecific CD3xCD20 that integrates SAFEbody precision masking technology to minimize CRS and on-target/off-tumor toxicities for an increased therapeutic index. The anti-CD20 arm of ADG152 has enhanced binding to CD20, while its anti-CD3 arm has tailor-made affinity for CD3 using SAFEbody technology. Preclinical data show ADG152 induced strong and sustained B-cell depletion across different dose levels.

o

ADG153 is a masked anti-CD47 in IgG1 format that is differentiated by its strong antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity. ADG153 is designed with SAFEbody masking technology with active Fc to realize the full potential of anti-CD47 therapy for both hematologic and solid tumor indications.

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CD28 bispecific TCEs exhibit enormous potential to fulfill the promises of safe and durable T cell-mediated synergistic immunotherapies when combined with CD3 bispecific TCEs and/or checkpoint inhibitors. Preclinical data demonstrated the potential to mitigate the serious safety concerns of CD28 activation and make custom designed antibodies targeting a highly conserved epitope with broad species reactivity.

COLLABORATIONS

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Exelixis: Adagene and Exelixis are collaborating under a collaboration and licensing agreement to develop novel masked antibody-drug conjugate candidates using Adagene’s SAFEbody precision masking technology. Terms of the agreement, which was executed in February 2021, include an upfront payment from Exelixis of US$11 million to Adagene, allowing Exelixis the ability to nominate two targets during the collaboration term. Adagene will be eligible for development and commercialization milestones, as well as royalties on net sales of products developed around each of these targets. To date, Adagene has received US$6 million for successful nomination of lead SAFEbody candidates in the collaboration.

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Sanofi: Under a collaboration announced in March 2022, Adagene will develop masked versions of Sanofi bispecific and monoclonal antibody candidates, using Adagene’s SAFEbody technology, for potential future development and commercialization by Sanofi.

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Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC). To date the combination has been well tolerated. Adagene retains global development and commercialization rights to ADG126.

2024 MILESTONES & CASH RUNWAY INTO 2026

Adagene expects its current cash balance to fund activities into 2026, with multiple readouts anticipated from the ongoing program evaluating ADG126 in combination with pembrolizumab in MSS CRC at major medical conference(s).

FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents

Cash and cash equivalents were US$95.7 million as of June 30, 2024, compared to US$109.9 million as of December 31, 2023. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$20.5 million as of June 30, 2024 from US$21.9 million as of December 31, 2023. The associated loan proceeds were primarily used to support the company’s R&D activities in China.

Net Revenue:

Net revenue was nil for the six months ended June 30, 2024, compared to US$17.3 million for the same period in 2023. The company did not enter into any new contracts with customers and did not complete any performance obligations in relation to existing contracts with customers during the six months ended June 30, 2024.

Research and Development (R&D) Expenses:

R&D expenses were US$14.7 million for the six months ended June 30, 2024, compared to US$21.3 million for the same period in 2023. The 31% decrease in R&D expenses reflects clinical focus on and prioritization of the company’s masked, anti-CTLA-4 SAFEbody ADG126.

Administrative Expenses:

Administrative expenses were US$3.6 million for the six months ended June 30, 2024, compared to US$4.5 million for the same period in 2023. The decrease was driven by reduction in personnel and cost-control measures.

Other Operating Income, Net:

Other operating income, net was nil for the six months ended June 30, 2024, compared to US$3.4 million for the same period in 2023. The amount of US$3.4 million included a one-time compensation payment from a contract manufacturer for a preclinical-related outsourcing arrangement.

Net Loss:

Net loss attributable to Adagene Inc.’s shareholders was US$17.0 million for the six months ended June 30, 2024, compared to US$4.1 million for the same period in 2023.

Ordinary Shares Outstanding:

As of June 30, 2024, there were 55,338,480 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.

On July 25, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported that the Company will participate in the 3rd Annual Targeted Radiopharmaceuticals Summit US, being held in San Diego, CA, from July 30 – August 1, 2024 (Press release, Actinium Pharmaceuticals, JUL 25, 2024, View Source [SID1234645081]). Actinium’s presentation titled, "Overcoming Adverse Cytogenetics, TP53, Other Mutations & Treatment Resistant Disease in Relapsed/Refractory AML Using Antibody Radiation Conjugates," will take place on Wednesday, July 31, 2024th. The presentation will highlight the following:

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Exploring Iomab-B, a CD45 I-131 ARC, to enable bone marrow transplant (BMT) in otherwise ineligible patients, while Actimab-A, a CD33 Ac-225 ARC, demonstrates strong anti-leukemic activity

Outlining responses in heavily pretreated patients for both Iomab-B and Actimab-A, including prior venetoclax treatment or TP53-mutated disease, to demonstrate how targeted radiotherapies offer broad therapeutic potential as backbone regimens

Revealing preclinical data to further show the benefits of combining Actimab-A with targeted therapies, such as FLT3 inhibitors, to enhance anti-tumor response
For more information about the Targeted Radiopharmaceutical Summit and the conference agenda, please visit View Source

On July 25, 2024 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2024 (Press release, AbbVie, JUL 25, 2024, View Source [SID1234645080]).

"Our business continues to perform exceptionally well, with second quarter results meaningfully ahead of our expectations," said Robert A. Michael, chief executive officer, AbbVie. "Based upon the significant momentum of our ex-Humira growth platform, our continued investments in the business and our pipeline progress, we are very well positioned to deliver our top-tier long-term outlook."

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Second-Quarter Results

•Worldwide net revenues were $14.462 billion, an increase of 4.3 percent on a reported basis, or 5.6 percent on an operational basis.

•Global net revenues from the immunology portfolio were $6.971 billion, an increase of 2.3 percent on a reported basis, or 3.5 percent on an operational basis.
◦Global Humira net revenues of $2.814 billion decreased 29.8 percent on a reported basis, or 28.9 percent on an operational basis. U.S. Humira net revenues were $2.360 billion, a decrease of 31.6 percent. Internationally, Humira net revenues were $454 million, a decrease of 18.9 percent on a reported basis, or 12.5 percent on an operational basis.
◦Global Skyrizi net revenues were $2.727 billion, an increase of 44.8 percent on a reported basis, or 45.6 percent on an operational basis.
◦Global Rinvoq net revenues were $1.430 billion, an increase of 55.8 percent on a reported basis, or 59.2 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.634 billion, an increase of 10.5 percent on a reported basis, or 12.2 percent on an operational basis.
◦Global Imbruvica net revenues were $833 million, a decrease of 8.2 percent, with U.S. net revenues of $595 million and international profit sharing of $238 million.
◦Global Venclexta net revenues were $637 million, an increase of 11.5 percent on a reported basis, or 15.8 percent on an operational basis.
◦Global Elahere net revenues were $128 million.

•Global net revenues from the neuroscience portfolio were $2.162 billion, an increase of 14.7 percent on a reported basis, or 15.2 percent on an operational basis.
◦Global Botox Therapeutic net revenues were $814 million, an increase of 8.7 percent on a reported basis, or 9.6 percent on an operational basis.
◦Global Vraylar net revenues were $774 million, an increase of 17.6 percent.
◦Global Ubrelvy net revenues were $231 million, an increase of 17.5 percent.
◦Global Qulipta net revenues were $150 million, an increase of 56.3 percent.

•Global net revenues from the aesthetics portfolio were $1.390 billion, an increase of 0.5 percent on a reported basis, or 2.8 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $729 million, an increase of 6.4 percent on a reported basis, or 8.6 percent on an operational basis.
◦Global Juvederm net revenues were $343 million, a decrease of 6.8 percent on a reported basis, or 3.1 percent on an operational basis.

•On a GAAP basis, the gross margin ratio in the second quarter was 70.9 percent. The adjusted gross margin ratio was 85.2 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 23.3 percent of net revenues. The adjusted SG&A expense was 22.9 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 13.5 percent of net revenues. The adjusted R&D expense was 13.3 percent of net revenues.

•Acquired IPR&D and milestones expense was 6.5 percent of net revenues.

•On a GAAP basis, the operating margin in the second quarter was 27.6 percent. The adjusted operating margin was 42.6 percent.

•Net interest expense was $506 million.

•On a GAAP basis, the tax rate in the quarter was 36.0 percent. The adjusted tax rate was 18.8 percent.

•Diluted EPS in the second quarter was $0.77 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.65. These results include an unfavorable impact of $0.52 per share related to acquired IPR&D and milestones expense.

Recent Events

•As previously announced, Robert A. Michael assumed the role of chief executive officer (CEO) and has joined AbbVie’s Board of Directors, effective July 1, 2024. Mr. Michael succeeds Richard A. Gonzalez, who served as CEO since the company’s inception in 2013. Mr. Gonzalez has become executive chairman of the board of directors.

•AbbVie announced the U.S. Food and Drug Administration (FDA) approved Skyrizi (risankizumab) for adults with moderately to severely active ulcerative colitis (UC). AbbVie also announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Skyrizi for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. The FDA approval and positive CHMP opinion are based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that evaluated the efficacy and safety of Skyrizi in adults with moderately to severely active UC. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

•AbbVie announced that it submitted applications for a new indication to the FDA and EMA for Rinvoq (upadacitinib) for the treatment of adult patients with giant cell arteritis (GCA). The regulatory submissions are supported by results from the SELECT-GCA Phase 3 study evaluating the safety and efficacy of Rinvoq in patients with GCA.

•At the 2024 Digestive Disease Week (DDW) Annual Meeting, AbbVie presented 15 abstracts, including three oral presentations, reinforcing AbbVie’s commitment to advancing the standards of care in inflammatory bowel diseases (IBD). Highlights included data from the SEQUENCE head-to-head trial comparing Skyrizi versus Stelara (ustekinumab) in Crohn’s disease (CD), as well as presentations that included efficacy and safety data evaluating clinical, endoscopic, and histologic outcomes from both the INSPIRE Phase 3 induction study and the COMMAND Phase 3 maintenance study of Skyrizi as a therapy for adults with moderately to severely active UC.

•AbbVie announced that it completed its acquisition of Landos Biopharma. The transaction adds the first-in-class investigational asset, ABBV-113 (NX-13), to AbbVie’s pipeline, which has the potential to offer a novel approach to the treatment of UC and CD.

•AbbVie and FutureGen Biopharmaceutical announced a license agreement to develop FG-M701, a next generation anti-TL1A antibody for the treatment of IBD, currently in preclinical development. FG-M701 is uniquely engineered with potential best-in-class functional characteristics compared to first-generation anti-TL1A antibodies, with the goal to drive greater efficacy and less frequent dosing as a therapy for IBD.

•AbbVie announced the acquisition of Celsius Therapeutics, a privately held biotechnology company pioneering new therapies for patients with inflammatory disease. Celsius’ lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody for the treatment of IBD that has completed a Phase 1 clinical study.

•AbbVie announced the FDA approved Epkinly (epcoritamab) to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of prior therapy. AbbVie also announced that the EMA’s CHMP adopted a positive opinion for Tepkinly (epcoritamab) for the treatment of adults with r/r FL. The FDA approval and positive CHMP opinion are based on results from the Phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of Epkinly/Tepkinly in adult patients with r/r FL. Epkinly/Tepkinly is being co-developed by AbbVie and Genmab.

•AbbVie announced positive topline results from the Phase 2 PICCOLO trial evaluating Elahere (mirvetuximab soravtansine) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The trial met its primary endpoint with an objective response rate (ORR) of 51.9% and demonstrated a median duration of response (DOR), a key secondary endpoint, of 8.25 months. The safety profile of Elahere was consistent with findings from previous studies, and no new safety concerns were identified. Full data from the PICCOLO study will be presented at a future medical meeting.

•AbbVie announced the start of the Phase 3 CERVINO clinical trial which will evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with standard available therapies (SATs) in patients with r/r multiple myeloma (MM) who have received at least two lines of prior therapy. The start of the CERVINO trial marks an important step forward in AbbVie’s continued commitment to advance new oncology treatments and elevate the standard of care for blood cancer patients.

•At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, AbbVie showcased its solid tumor pipeline with new data from its innovative antibody-drug conjugate (ADC) platform. Highlights included new safety and efficacy data from a Phase 1 study of ABBV-400, a next-generation, potential best-in-class c-Met directed ADC, in patients with metastatic colorectal cancer (CRC); data from a first-in-human study of ABBV-706, a potential best-in-class SEZ6 directed ADC, in small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine neoplasms (NENs); data from the primary analysis of the Phase 2 LUMINOSITY trial evaluating Telisotuzumab vedotin (Teliso-V), a potential first-in-class c-Met directed ADC, in advanced non-small cell lung cancer (NSCLC); and data from the Phase 3 MIRASOL trial of Elahere in patients with platinum-resistant ovarian cancer (PROC) and high FRα expression.

•AbbVie announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). In its letter, the FDA cited observations that were identified during inspection of a third-party manufacturer listed in the NDA. The CRL did not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device, and does not request that AbbVie conduct additional efficacy or safety trials related to the drug or device-related testing. AbbVie continues to work with the FDA to bring ABBV-951 to patients in the U.S. as quickly as possible.

•AbbVie and Gilgamesh Pharmaceuticals announced a collaboration and option-to-license agreement to develop next-generation therapies for psychiatric disorders. These next-generation therapies known as neuroplastogens target mechanisms that have shown potential to provide significant clinical benefits and are designed to minimize the challenging effects seen with first-generation compounds. This collaboration will leverage AbbVie’s expertise in psychiatry and Gilgamesh’s innovative research platform to discover novel neuroplastogens.

Full-Year 2024 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2024 from $10.61 – $10.81 to $10.71 – $10.91, which includes an unfavorable impact of $0.60 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2024. The company’s 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2024, as both cannot be reliably forecasted.