On January 13, 2025 Incyte (Nasdaq:INCY) reported it will provide an update on commercial growth, clinical progress and significant 2025 catalysts during a presentation today at 10:30 a.m. PT at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Incyte, JAN 13, 2025, View Source [SID1234649692]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With significant advancements being made across our portfolio, 2025 will be a transformational year not only for Incyte, but also for the patients we serve," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We have several novel medicines in development that can potentially address significant patient needs, and we remain on track to deliver numerous first- or best-in-class high impact launches from our pipeline by 2030."

Today’s presentation will highlight:

The launch of Niktimvo (axatilimab-csfr) for patients living with chronic graft-versus-host disease (GVHD) and ongoing studies of axatilimab in additional indications.
Near-term opportunities for tafasitamab (Monjuvi) following positive results from the Phase 3 inMIND trial in patients with relapsed/refractory follicular lymphoma (FL), as well as the anticipated data evaluating tafasitamab in first line diffuse large B-cell lymphoma (DLBCL).
The potential of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, to establish best-in-class efficacy across numerous indications with high unmet needs, including hidradenitis suppurativa (HS).
Incyte’s mCALR-targeting molecule (INCA33989) and its potential to be a first-in-class targeted therapy for mCALR positive myelofibrosis (MF) and essential thrombocythemia (ET) patients.
The development path for Incyte’s CDK2 inhibitor (INCB123667) and its potential to become a foundational treatment for patients with ovarian cancer.
The J.P. Morgan Healthcare Conference presentation and Q&A session can be accessed at investor.incyte.com. A replay will be archived on the Company’s website for 30 days following the presentation.

About Niktimvo (axatilimab-csfr)

Niktimvo (axatilimab-csfr) is a first-in-class anti-CSF-1R antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in cGVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids are expected to initiate by year end. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

Niktimvo is a trademark of Incyte.

About Tafasitamab (Monjuvi)

Tafasitamab (Monjuvi) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally.

In the United States, Monjuvi (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

XmAb is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

About Povorcitinib (INCB54707)

Povorcitinib (INCB54707) is an oral small-molecule JAK1 inhibitor currently in Phase 3 clinical trials for hidradenitis suppurativa (HS) and vitiligo. A Phase 3 trial is being planned for prurigo nodularis (PN). Phase 2 studies of povorcitinib in PN, asthma and chronic spontaneous urticaria are also ongoing.

On January 13, 2025 Daiichi Sankyo Company, Ltd (TSE: 4568) reported that it will pay Glycotope $132.5 million to acquire intellectual property rights of the anti-tumor-associated mucin-1 (TA-MUC1) antibody, gatipotuzumab (Press release, Daiichi Sankyo, JAN 13, 2025, https://www.businesswire.com/news/home/20250113621008/en/Daiichi-Sankyo-Acquires-Intellectual-Property-Rights-for-Anti-TA-MUC1-Antibody-in-DS-3939-from-Glycotope-GmbH [SID1234649691]). Such payment by Daiichi Sankyo satisfies all potential clinical, regulatory and sales milestone payments, as well as royalties of products that include gatipotuzumab as part of a 2018 licensing agreement between the parties. In 2018, Daiichi Sankyo in-licensed exclusive rights to develop and commercialize gatipotuzumab worldwide as an antibody drug conjugate (ADC) from Glycotope.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The anti-TA-MUC1 is the antibody contained in DS-3939, an ADC being developed by Daiichi Sankyo. DS-3939 is a specifically engineered potential first-in-class TA-MUC1 directed medicine designed using Daiichi Sankyo’s proprietary DXd ADC technology. DS-3939 is currently being evaluated in a phase 1/2 clinical trial in patients with several types of advanced solid tumors including non-small cell lung, breast, urothelial, ovarian, biliary tract and pancreatic cancer.

About TA-MUC1
TA-MUC1 is a tumor-specific transmembrane glycoprotein with aberrant glycosylation due to changes of the expression patterns of some sialyltransferases.1 Based on the overexpression of TA-MUC1 in most human epithelial cancers, it is an attractive target for cancer therapy.2 Currently, there are no TA-MUC1 directed therapies approved for any type of cancer.

About DS-3939
DS-3939 is an investigational potential first-in-class TA-MUC1 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, DS-3939 is comprised of a humanized anti-TA-MUC1 antibody, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

On January 13, 2025 Novocure (NASDAQ: NVCR) reported preliminary unaudited financial and operational results for the quarter and full year ended December 31, 2024 (Press release, NovoCure, JAN 13, 2025, View Source [SID1234649690]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Novocure is at an exciting inflection point as we continue to expand our multi-indication TTFields treatment platform. In 2024, we brought Optune Gio to more than 4,000 glioblastoma patients across the globe, earned FDA approval and launched Optune Lua in non-small cell lung cancer in the U.S., announced two additional successful Phase 3 trial readouts and released our next generation arrays," said Ashley Cordova, Chief Executive Officer. "With two additional indication launches on the horizon, we are well positioned for 2025 and beyond. This progress demonstrates our steadfast commitment to our patient-forward mission: together with our patients, we strive to extend survival in some of the most aggressive forms of cancer."

Financial updates for the year and fourth quarter ended December 31, 2024*:

Total preliminary net revenues for the year were $605.2 million, an increase of 19% compared to the prior year.
2024 growth was primarily driven by our successful launch in France and significantly improved approval rates in the U.S., which are now reflected in our revenue baseline. 2025 net revenue growth is expected to closely reflect growth in Optune Gio active patients.
Total preliminary net revenues for the fourth quarter were $161.3 million, an increase of 21% compared to the same period in 2023.
The U.S., Germany, France and Japan contributed $107.2 million, $17.7 million, $16.0 million and $8.5 million, respectively, with other active markets contributing $9.9 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $2.0 million.
Improved approval rates in the U.S. resulted in $8.3 million of increased net revenue from prior period claims during the quarter, which we believe should not be considered in our 2025 baseline. This is in addition to the $14.0 million of increased revenue from prior period claims disclosed through the third quarter.
Cash, cash equivalents and short-term investments were $959.9 million as of December 31, 2024.
Operational updates for the fourth quarter ended December 31, 2024:

As of December 31, 2024, there were 4,126 total active patients on TTFields therapy globally.
1,520 Optune Gio prescriptions were received in the quarter, consistent with the same period in 2023. Optune Gio prescriptions from the U.S., Germany, France and Japan contributed 897; 190; 194 and 109 prescriptions, respectively, with the remaining 130 prescriptions received from other active markets.
As of December 31, 2024, there were 4,077 active Optune Gio patients on therapy. Active Optune Gio patients from the U.S., Germany, France and Japan contributed 2,161; 564; 426 and 420 active patients, respectively, with the remaining 506 active patients contributed by other active markets.
On October 15, 2024, Optune Lua was approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic non-small cell lung cancer (NSCLC) concurrently with PD-1/PD-L1 inhibitors or docetaxel, in adults who have progressed on or after a platinum-based regimen. As of December 31, 2024, 52 Optune Lua prescriptions were received for NSCLC.
As of December 31, 2024, there were 20 active NSCLC patients on Optune Lua. Additionally, there were 29 active mesothelioma patients on Optune Lua around the globe.
In Q1 2026, Novocure intends to stop reporting new prescriptions and focus on active patients by indication and material market as the key operating statistic.
Fourth quarter and recent updates and achievements:

In October, the FDA granted Breakthrough Device designation for the use of TTFields therapy for brain metastases from non-small cell lung cancer. Breakthrough Device designation provides more frequent, faster and interactive access to the FDA review team and senior management during the review process, priority review of marketing applications upon filing, and expedited review of pre-Premarket Approval Application (PMA) manufacturing and quality systems compliance inspections.
In October, the FDA approved Novocure’s new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio for the treatment of adult patients with glioblastoma (GBM).
In December, the company announced the Phase 3 PANOVA-3 clinical trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer. Novocure plans to submit the full data for presentation at an upcoming medical congress.
In December, the FDA granted Breakthrough Device designation for the use of TTFields therapy for the treatment of unresectable, locally advanced pancreatic cancer.
In January 2025, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved Novocure’s new HFE transducer arrays for use with Optune Gio for the treatment of adult patients with GBM.
Anticipated clinical milestones:

Data from Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (2026)
Data from Phase 3 TRIDENT clinical trial in newly diagnosed GBM (2026)
Fourth quarter and full year 2024 financial results conference call:

Novocure will host a conference call and webcast to discuss full year and fourth quarter 2024 financial results at 8:00 a.m. EST on Thursday, February 27, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

*The unaudited results in this press release are preliminary and subject to the completion of the Company’s annual independent audit and, therefore, are subject to adjustment.

On January 13, 2025 AbCellera (Nasdaq: ABCL) reported that it has expanded its existing collaboration with AbbVie Inc. (NYSE: ABBV) to include the discovery of T-cell engagers (TCE) in oncology (Press release, AbCellera, JAN 13, 2025, View Source [SID1234649689]). The expansion builds upon the successful partnership established in December 2022 and includes access to AbCellera’s TCE platform to develop therapeutic antibodies for tumor targets.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to broaden our AbbVie collaboration and look forward to using AbCellera’s TCE platform to bring novel cancer immunotherapies to patients in need," said Carl Hansen, Ph.D., founder and CEO of AbCellera.

Under the terms of the agreement, AbCellera will lead discovery activities and AbbVie has the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera will receive upfront and research payments and is eligible to receive downstream milestone payments as well as tiered royalty payments on net sales.

On January 13, 2025 Scribe Therapeutics Inc., a genetic medicines company unlocking the potential of CRISPR to transform human health, reported the achievement of a success milestone for one of the targets in its research collaboration with Sanofi to develop in vivo CRISPR-based therapeutics (Press release, Scribe Therapeutics, JAN 13, 2025, View Source [SID1234649688]). Scribe is eligible to receive over $1.2 billion across all programs in milestone payments for the achievement of certain research, development, regulatory and commercial milestones, as well as high-single-digit to mid-teen royalties.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited about the progress we have made towards creating potentially curative in vivo genetic medicines with a partner like Sanofi," said Benjamin Oakes, Ph.D., co-founder and Chief Executive Officer of Scribe. "The complementary expertise of our teams has enabled the program to move quickly and attain early validation of our CRISPR genome editing technologies. We look forward to further advancement of this program with a direct line of sight towards bringing breakthrough CRISPR-based therapeutics to patients with significant unmet need."

CRISPR by Design is Scribe’s data-driven design and engineering approach for optimizing its CRISPR-based platforms and assets, including X-Editing (XE) technologies, to drive forward a new era of transformative genetic medicines.

"Advancing our in vivo program with Sanofi speaks to the versatility and strength of Scribe’s CRISPR-based platforms," said Svetlana Lucas, Ph.D., Chief Business Officer at Scribe. "We are pleased to reach this important milestone and continue progressing our collaboration to accelerate and expand our patient impact globally."

Scribe announced its initial research collaboration with Sanofi for CRISPR-based cell therapies to address oncology indications in 2022, followed by an expansion in 2023 to advance in vivo medicines for genomic diseases.