On October 29, 2024 Incyte reported 2024 third quarter financial results, and provides a status update on the Company’s clinical development portfolio (Press release, Incyte, OCT 29, 2024, View Source [SID1234647507]).

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"We are on track to achieve over ten impactful launches by 2030."

"In the third quarter of 2024, we delivered significant achievements, including strong revenue growth for both Jakafi (ruxolitinib) and Opzelura (ruxolitinib) cream, and the advancement of our clinical pipeline highlighted by the submission to the FDA of the supplemental New Drug Application (sNDA) for ruxolitinib cream in pediatric atopic dermatitis and several key data readouts including CDK2i, retifanlimab, tafasitamab, povorcitinib and ruxolitinib cream, which all hold near to mid-term launch potential. Additionally, in August, the FDA approved Niktimvo (axatilimab-csfr) for patients with chronic graft-versus-host disease, after failure of two prior lines of therapy, making it the first anti-CSF-1R antibody approved to target the inflammation and fibrosis associated with chronic GVHD," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We are on track to achieve over ten impactful launches by 2030."

Key Recent Company Updates

In October, the sNDA submission for ruxolitinib cream in pediatric atopic dermatitis was filed with the FDA with approval anticipated in the second half of 2025.
In October, Opzelura was granted a Notice of Compliance by Health Canada for the topical treatment of both mild to moderate atopic dermatitis and nonsegmental vitiligo in patients 12 years of age and older.
In September, Incyte presented late-breaking Phase 3 results for retifanlimab (Zynyz) and initial data from the Phase 1 CDK2 inhibitor program at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.
Featured during the Presidential Symposium, the Phase 3 POD1UM-303/InterAACT2 trial for retifanlimab met the primary endpoint of progression free survival (PFS) and demonstrated improvement across secondary endpoints in patients with squamous cell anal carcinoma (SCAC) receiving retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel). Incyte plans to file a supplemental Biologics License Application (sBLA) for retifanlimab in SCAC by the end of 2024. A potential approval in 2025 could represent the first PD-(L)1 antibody for patients with SCAC.
Phase 1 data of INCB123667, a highly selective and potentially first-in-class CDK2 inhibitor, were presented demonstrating single-agent antitumor activity across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1. The Phase 1 trial of INCB123667 in combination with other agents is ongoing. Incyte plans to initiate a pivotal trial in ovarian cancer in 2025.
In August, Incyte and its partner Syndax announced the U.S. Food and Drug Administration (FDA) approval of Niktimvo, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients. Niktimvo is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD. In September, Incyte and Syndax announced the New England Journal of Medicine publication of data from the pivotal AGAVE-201 trial of Niktimvo in chronic GVHD and the addition of Niktimvo to the NCCN Clinical Practice Guidelines in Oncology for the treatment of chronic GVHD.
In August, Incyte announced positive topline results from the Phase 3 clinical study evaluating tafasitamab (Monjuvi) in relapsed or refractory follicular lymphoma (FL). The pivotal Phase 3 inMIND trial met the primary endpoint of PFS by investigator assessment in FL. The trial also met key secondary endpoints. No new safety signals with tafasitamab were observed. The full dataset is anticipated to be presented at an upcoming medical meeting in 2024 and Incyte expects to file an sBLA for tafasitamab in combination with lenalidomide and rituximab in FL by the end of 2024.
Jakafi:

Net product revenues for the third quarter 2024 of $741 million (+16% Y/Y):

Net product revenues were primarily driven by patient demand, which increased 10% in the third quarter of 2024 versus the same quarter in the prior year, with growth across all indications.
Opzelura:

Net product revenues for the third quarter 2024 of $139 million (+52% Y/Y):

Net product revenues of $119 million in the third quarter of 2024 in the U.S. were primarily driven by patient demand and refills in both atopic dermatitis (AD) and vitiligo.
Net product revenues of $20 million in the third quarter of 2024 ex-U.S. were primarily driven by sales in Germany and France.
Additional Pipeline Updates

Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights

A bioequivalence study of ruxolitinib extended-release (XR) is enrolling. The data are anticipated in the first half of 2025.
A Phase 2 trial evaluating the safety and efficacy of axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD is enrolling.
Trials of ruxolitinib twice daily (BID) with BETi and zilurgisertib are ongoing. Additional data for BETi and zilurgisertib are anticipated in the fourth quarter of 2024.
The Phase 1 studies evaluating mCALR and JAK2V617Fi are ongoing and enrolling patients. Initial data for both studies are anticipated in 2025.

MPN and GVHD Programs

Indication and status

Ruxolitinib XR (QD)

(JAK1/JAK2)

Myelofibrosis, polycythemia vera and GVHD

Ruxolitinib + zilurgisertib

(JAK1/JAK2 + ALK2i)

Myelofibrosis: Phase 2

Ruxolitinib + INCB57643

(JAK1/JAK2 + BETi)

Myelofibrosis: Phase 2

Ruxolitinib + axatilimab1

(JAK1/JAK2 + anti-CSF-1R)

Chronic GVHD: Phase 2

Steroids + axatilimab1

(Steroids + anti-CSF-1R)

Chronic GVHD: Phase 3 in preparation

INCA33989

(mCALR)

Myelofibrosis, essential thrombocythemia: Phase 1

INCB160058

(JAK2V617Fi)

Myelofibrosis: Phase 1

1 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.

Other Hematology/Oncology – key highlights

Following the announcement of the positive topline results from the Phase 3 study evaluating retifanlimab, a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in non-small cell lung cancer (NSCLC), Incyte anticipates sharing the full dataset at an upcoming medical meeting in the fourth quarter of 2024.
The Phase 3 study evaluating tafasitamab in first-line diffuse large B-cell lymphoma (DLBCL) is ongoing. The Phase 3 data are anticipated in the first half of 2025.
The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 are ongoing and enrolling patients. Initial data for both studies are anticipated in 2025.

On October 29, 2024 Immunome, Inc., a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported the company recently presented promising preclinical data for IM-1021 and the associated proprietary ADC payload HC74 (Press release, Immunome, OCT 29, 2024, View Source [SID1234647506]). The results were presented in a poster entitled "Preclinical evaluation of IM-1021, a ROR1-targeted antibody-drug conjugate with a novel topoisomerase I linker payload" at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona on October 24, 2024.

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The poster included preclinical results for IM-1021 in both liquid and solid tumors while also highlighting the enhanced ADME properties of HC74:

IM-1021 showed superior efficacy compared to zilovertamab vedotin in both the Jeko-1 mantle cell lymphoma model and the MDA-MB-468 triple negative breast cancer model. In the MDA-MB-468 study, 5 out of 8 animals achieved complete responses after three 5 mg/kg doses.
HC74 demonstrated superior potency (IC50=5nM) compared to deruxtecan (IC50=20nM) in a panel of 89 cancer cell lines.
HC74 showed faster hepatocyte clearance, higher permeability, and lower efflux than deruxtecan.
When evaluated in doxorubicin-resistant and vincristine-resistant cell lines, HC74 showed no reduction in potency compared to the parental NCI-H69 cell line.
Immunome expects to submit an IND for the IM-1021 program to the FDA in the first quarter of 2025.

"We believe that transformative ADCs require matching the target with the right combination of antibody, linker, and payload. Based on this data, we continue to believe that IM-1021 is a promising preclinical candidate," said Immunome’s Chief Scientific Officer Jack Higgins, Ph.D. "HC74’s differentiated profile, including substantial potency in chemo-resistant cell lines, provides intriguing opportunities for clinical development. We look forward to submitting the IM-1021 IND and starting clinical trials upon IND clearance to further validate these findings."

A copy of the poster is available in the "Events & Presentations" portion of Immunome’s website.

On October 29, 2024 Owkin , the first end-to-end AI biotech company using cutting-edge causal AI to drive precision drug discovery, development and diagnostics, reported MSIntuit CRC v2 1 , a next-generation AI solution (Press release, Owkin, OCT 29, 2024, View Source [SID1234647505]). Designed to transform the detection and treatment of colorectal cancer (CRC), MSIntuit CRC v2 will initially launch as an RUO version in the United States on Roche’s navify Digital Pathology enterprise software.

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MSIntuit CRC v2 builds on the success of CE-IVD certified MSIntuit CRC by integrating Owkin’s industry-leading machine learning models with Roche’s unmatched expertise in oncology diagnostics. MSIntuit CRC v2 will now integrate resection and biopsy analysis, addressing a critical need in pathologists’ workflows.

This latest release features a new architecture with advanced machine learning models that significantly improve model performance. It also features enhanced staining techniques, including H&E (hematoxylin and eosin) and HES (hematoxylin, eosin, and saffron), further refining the product’s accuracy and reliability and expanding the solution’s accessibility to more labs.

Meriem Sefta, Owkin’s Chief Diagnostics Officer, said: "We are excited to bring the next innovations of MSIntuit CRC to pathology laboratories, marking a significant advancement in medical diagnostics. This innovation represents our commitment to pushing the boundaries of artificial intelligence in healthcare. By leveraging cutting-edge AI technology, we aim to provide more accurate diagnostic tools that will enable pathologists and oncologists to make more informed decisions. Our goal is to help deliver highly personalized treatment plans, improving patient outcomes and ensuring that each individual receives the most accurate care, tailored to their unique medical needs. This is just the first step in transforming the future of patient care through technology solutions and we look forward to expanding our collaboration with Roche Diagnostics as we pursue this critical mission."

These tools are designed to improve pathology knowledge, enabling cancer patients to benefit from precision medicine and targeted treatments. The RUO version of MSIntuit CRC v2 will soon be available in the United States on Roche’s navify Digital Pathology enterprise software, with additional platforms to come.

On October 29, 2024 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the third quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical and pipeline development milestones (Press release, Exelixis, OCT 29, 2024, View Source [SID1234647504]).

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"The favorable ruling on our cabozantinib intellectual property estate and recently announced zanzalintinib development collaboration with Merck have generated important momentum to drive future growth across all components of our business"

"The favorable ruling on our cabozantinib intellectual property estate and recently announced zanzalintinib development collaboration with Merck have generated important momentum to drive future growth across all components of our business," said Michael M. Morrissey, Ph.D., President and CEO, Exelixis. "We are increasing 2024 full year guidance for total and net product U.S. revenues based on the strong commercial performance of the cabozantinib franchise in the third quarter. We continue to execute on our plans for potential cabozantinib label expansions in neuroendocrine tumors and prostate cancer, with the final results from CABINET published in The New England Journal of Medicine in September and our partner Ipsen’s regulatory submission in Europe."

Dr. Morrissey continued: "Importantly, the zanzalintinib development program, which is now the subject of six ongoing or planned phase 3 pivotal trials, including two new renal cell carcinoma studies as part of our collaboration with Merck, headlines our emerging pipeline of novel agents with the potential to improve standards of care for patients with cancer. At the same time, we are accelerating our early-stage clinical pipeline with XL309, XB010 and XL495 in phase 1 development. I want to thank everyone at Exelixis for their hard work and dedication as we continue driving value for shareholders and innovating on behalf of the patients we serve."

Third Quarter 2024 Financial Results

Total revenues for the quarter ended September 30, 2024 were $539.5 million, as compared to $471.9 million for the comparable period in 2023.

Total revenues for the quarter ended September 30, 2024 included net product revenues of $478.1 million, as compared to $426.5 million for the comparable period in 2023. The increase in net product revenues was primarily due to an increase in sales volume and average net selling price.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $61.5 million for the quarter ended September 30, 2024, as compared to $45.4 million for the comparable period in 2023. The increase in collaboration revenues was primarily related to an increase in milestone-related revenues recognized in the quarter and higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partners, Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited, partially offset by a decrease in development cost reimbursements earned.

Research and development expenses for the quarter ended September 30, 2024 were $222.6 million, as compared to $332.6 million for the comparable period in 2023. The decrease in research and development expenses was primarily related to decreases in license and other collaboration costs.

Selling, general and administrative expenses for the quarter ended September 30, 2024 were $111.8 million, as compared to $138.1 million for the comparable period in 2023. The decrease in selling, general and administrative expenses was primarily related to decreases in corporate giving, stock-based compensation expenses and legal and advisory fees.

Impairment of long-lived assets for the quarter ended September 30, 2024 of $51.7 million was related to the non-cash asset impairment charge to certain of Exelixis’ leased facilities which are currently not in use and may be subleased.

Provision for income taxes for the quarter ended September 30, 2024 was $36.8 million, as compared to $4.8 million for the comparable period in 2023.

GAAP net income for the quarter ended September 30, 2024 was $118.0 million, or $0.41 per share, basic and $0.40 per share, diluted, as compared to GAAP net income of $1.0 million, or $0.00 per share, basic and diluted, for the comparable period in 2023. GAAP net income per share for the quarter ended September 30, 2024 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended September 30, 2024, as compared to the comparable period in 2023, as a result of the stock repurchase programs.

Non-GAAP net income for the quarter ended September 30, 2024 was $135.7 million, or $0.47 per share, basic and diluted, as compared to non-GAAP net income of $32.1 million, or $0.10 per share, basic and diluted, for the comparable period in 2023.

On October 29, 2024 Foresee Pharmaceuticals Co., Ltd. (TPEx: 6576), ("Foresee") reported that it has submitted a 505(b)(2) New Drug Application for the 3-month version of CAMCEVI, a ready-to-use 3-month depot formulation of leuprolide mesylate, to the U.S. Food and Drug Administration (FDA) (Press release, Foresee Pharmaceuticals, OCT 29, 2024, View Source [SID1234647503]). The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer.

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This NDA submission is supported by a previously successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with leuprolide mesylate injection every 3 months was demonstrated to be effective, safe and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint.

"Following the successful launch of CAMCEVI 6-month depot formulation in 2022, we are excited to announce the submission of the 3-month version of CAMCEVI NDA to the U.S. FDA. This marks a significant milestone in our efforts to expand treatment options for patients with advanced prostate cancer. We look forward to the regulatory approval from the FDA in 2025, and commercial launch in 2026, providing patients with its differentiated ready-to-use profile," said Dr. Ben Chien, Founder and Chairman of Foresee.