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First Ascent Biomedical Secures $6 Million Investment from Vidal Duart Enterprises, Inc. to Revolutionize Cancer Treatment

On January 13, 2025 First Ascent Biomedical, a pioneer in personalized cancer treatment, reported a $6 million investment from Vidal Duart Enterprises, Inc., with an additional co-investment from Techstars (Press release, First Ascent Biomedical, JAN 13, 2025, View Source [SID1234649694]). The funding will accelerate First Ascent Biomedical’s mission to transform medical oncology with highly individualized, prospective treatment planning technologies that improve patient survival.

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First Ascent Biomedical’s technology represents a shift from a one-size-fits-all approach to a tailored strategy, offering hope to cancer patients who have exhausted traditional options. The company’s functional precision medicine platform integrates drug testing, DNA/RNA sequencing and AI-guided tumor weakness mapping to test hundreds of FDA-approved drugs against a patient’s unique cancer profile. The platform delivers a highly personalized, actionable plan to a patient’s physician in an average of 10 days. Results show that First Ascent Biomedical’s technology has significantly improved patient outcomes. Patients treated with decisions guided by the platform demonstrated an 83% greater benefit than those treated with the standard of care of a doctor’s choice.

The platform’s technology was developed by Dr. Noah Berlow, co-founder and CTO, and Dr. Diana Azzam, First Ascent Biomedical’s co-founder and scientific advisor. Dr. Berlow designed the company’s AI framework. Dr. Azzan brings years of cancer research and a wealth of functional precision medicine expertise to First Ascent Biomedical, currently serving as an assistant professor of environmental health sciences at the Florida International University Robert Stempel College of Public Health and Social Work.

The capital raised will support the expansion of First Ascent Biomedical’s operations, including the establishment of a state-of-the-art lab in Florida, where the company will continue its mission to transform cancer care for all patients, especially those in underserved communities.

"The funding we have raised is a defining moment for First Ascent Biomedical and for cancer care," said Jim Foote, Co-founder and CEO of First Ascent Biomedical. "As someone who tragically lost my son to cancer, I know the devastating toll this disease takes on families. With this fresh capital, we are not just advancing technology—we are giving patients and their families hope. Florida is where our technology was invented, so we are excited to open our first commercial lab here as we charge forward in making personalized cancer care widely accessible."

"First Ascent Biomedical is at the forefront of a new era in cancer treatment. Their groundbreaking technology has already proven its potential to save lives and change the trajectory of this disease," said Carlos Duart, Owner of Vidal Duart Enterprises. "This investment is not just a business decision—it’s a commitment to improving outcomes for cancer patients everywhere."

Tina Vidal Duart, Co-owner of Vidal Duart Enterprises, added: "We are proud to support a company that combines innovation with compassion. The work First Ascent Biomedical is doing will have a ripple effect far beyond Florida, giving patients personalized care that improves their chances of survival. We are honored to help bring this vision to life."

"First Ascent Biomedical represents the future of cancer care, where innovation and personalization come together to save lives," said Andrew Cleland, Chief Investment Officer at Techstars. "The opportunity to transform medical oncology through precision medicine is immense, and First Ascent Biomedical is paving the way to make customized cancer treatment a reality with its drug prediction technologies."

Immunome Provides Pipeline Update in Advance of Presentation at the 43rd Annual J.P. Morgan Healthcare Conference

On January 13, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that Clay Siegall, Ph.D., President and CEO of Immunome, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 9:45 a.m. PT (Press release, Immunome, JAN 13, 2025, View Source [SID1234649693]).

Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

The presentation will cover Immunome’s pipeline of targeted therapeutics, including varegacestat (formerly known as AL102), a once-daily oral gamma secretase inhibitor in the Phase 3 RINGSIDE clinical trial for the treatment of desmoid tumors. Immunome expects to report topline data in the second half of 2025.

Immunome also announced the FDA clearance of its IND submission for IM-1021, a ROR1-targeted ADC. Immunome anticipates submitting an IND for IM-3050, its FAP-targeted radioligand therapy, by the end of the first quarter of 2025.

Immunome additionally disclosed three novel ADCs for solid tumor indications that are in preclinical development: IM-1617, IM-1340 and IM-1335.

Incyte Highlights Commercial Growth, Clinical Progress and 2025 Milestones at the 43rd Annual J.P. Morgan Healthcare Conference

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]).

"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.

Daiichi Sankyo Acquires Intellectual Property Rights for Anti-TA-MUC1 Antibody in DS-3939 from Glycotope GmbH

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.

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.

Novocure Announces Preliminary Full Year and Fourth Quarter 2024 Performance and Provides Company Update

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).

"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.