On February 27, 2025 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, reported that the first patient has been dosed with IO-108 in a global clinical collaboration with Roche (Press release, Immune-Onc Therapeutics, FEB 27, 2025, View Source [SID1234650732]). The Phase 1b/2 trial is designed to evaluate IO-108, a first-in-class antibody targeting LILRB2 (also known as ILT4), in combination with Roche’s atezolizumab and bevacizumab as a potential first-line treatment for patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC).

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"IO-108 has demonstrated promising clinical efficacy as a single agent and has a well-established safety profile to combine with different standard of care regimens. Dosing the first patient in this trial represents a significant advancement for Immune-Onc and, more importantly, for people battling advanced liver cancer," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "We are excited to work with Roche to investigate how this combination therapy with IO-108 could enhance the current standard of care and offer improved outcomes for those who urgently need new therapeutic options."

The atezolizumab and bevacizumab combination is the first cancer immunotherapy regimen approved by the U.S. Food and Drug Administration for HCC and is the standard of care recommended by the National Comprehensive Cancer Network. By modulating myeloid cells in the tumor environment, IO-108 may reduce immune suppression, thereby enhancing the overall anti-tumor response and the potential to improve patients’ clinical outcomes.

The trial, sponsored by Roche, is expected to enroll 40 patients across 25 sites worldwide in the IO-108-containing arm. This arm will be compared to an active control arm of the atezolizumab and bevacizumab combination.

ABOUT THE RANDOMIZED CLINICAL TRIAL

The Phase 1b/2 global, randomized HCC study is part of Roche’s Morpheus-Liver program. It will evaluate IO-108 in combination with atezolizumab and bevacizumab versus atezolizumab and bevacizumab, the standard of care in patients with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment.

Initially, 40 patients will be enrolled across 25 sites worldwide in the IO-108 triplet combination, which will be compared to an active control arm of the atezolizumab and bevacizumab doublet combination. The study’s primary endpoint is objective response rate, and key secondary endpoints include progression-free survival and overall survival.

Under the terms of the clinical collaboration agreement, Roche will manage the study operations, and Immune-Onc will supply IO-108 to support the trial while retaining global rights to IO-108.

Tecentriq (atezolizumab) and Avastin (bevacizumab) are registered trademarks of Genentech, a member of the Roche Group.

Learn more about the trial here.

ABOUT HEPATOCELLULAR CARCINOMA

According to the American Cancer Society1, more than 800,000 people are diagnosed with liver cancer each year worldwide. It is also one of the leading causes of cancer deaths worldwide, accounting for more than 700,000 deaths each year. The number of people diagnosed is predicted to rise, with the incidence of liver cancer increasing by 55.0% and the number of deaths increasing by 56.4% between 2020 and 20402. Hepatocellular carcinoma is the most common form of liver cancer in the United States, making up almost 90% of cases3. Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD), and cirrhosis resulting from these conditions4.

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards the myeloid checkpoint, LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A, and CD1d. Clinical data from the U.S. Phase 1 dose escalation study of IO-108 (NCT05054348) was selected as an oral presentation at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and published in the Journal for ImmunoTherapy of Cancer in 2024, which demonstrated a favorable safety profile and encouraging clinical benefit utilizing IO-108 as a monotherapy and in combination with anti-PD-1 across multiple tumor types. A global, randomized Phase 1b/2 study is underway to evaluate IO-108 in combination with atezolizumab and bevacizumab as a potential first-line therapy for hepatocellular carcinoma (HCC).

On February 27, 2025 Novocure (NASDAQ: NVCR) reported financial results for the quarter and full year ended December 31, 2024 (Press release, NovoCure, FEB 27, 2025, View Source [SID1234650731]). 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).

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"Entering 2024, our team was focused on three objectives – grow our core business treating glioblastoma, launch in non-small cell lung cancer, and deliver on the promise of our clinical pipeline. I am proud to say we have successfully achieved all three goals," said Ashley Cordova, CEO Novocure. "2025 is a defining year for Novocure as we enter a new era with a multi-indication platform propelled by positive Phase 3 data in three indications – one FDA-approved and two advancing toward regulatory submission. We believe we are positioned to transform patient outcomes across multiple high-need oncology indications."

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

Total net revenues for the year were $605.2 million, an increase of 19% year-over-year, primarily driven by continued launch success in France for Optune Gio for glioblastoma (GBM) and improved approval rates in the U.S., which are now reflected in our revenue baseline. 2025 net revenue growth is expected to reflect growth in Optune Gio active patients. As the GBM business reaches maturity we expect to continue to grow at a low mid-single digit rate this year.
Total net revenues for the quarter were $161.3 million, an increase of 21% year-over-year.
The U.S., Germany, France and Japan contributed $107.2 million, $17.4 million, $15.7 million and $8.5 million in quarterly net revenues, respectively, with our other active markets contributing $10.4 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.
Gross margin for the quarter was 79%. In 2025, we expect our gross margins will be impacted by current and future product enhancements, such as the U.S. launch of our Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio, and the launch of Optune Lua in metastatic non-small cell lung cancer (NSCLC). Our current analysis of the global tariff environment leads us to believe there should not be a material impact to margins in the short term and we are actively working to mitigate any potential impacts in the medium-to-long term.
Research, development and clinical studies expenses for the quarter were $51.2 million, a decrease of 6% from the same period in 2023. Clinical trial expenses can fluctuate quarter-to-quarter depending on the number of clinical trials actively underway, amount of clinical research organization services delivered and clinical materials procured.
Sales and marketing expenses for the quarter were $67.4 million, an increase of 14% from the same period in 2023. This primarily reflects the expansion of our NSCLC sales force as we launch in this new indication.
General and administrative expenses for the quarter were $72.5 million, an increase of 84% from the same period in 2023. This was primarily driven by $36.1 million in one-time stock-based compensation expenses related to U.S. Food and Drug Administration (FDA) approval of our metastatic NSCLC indication.
Net loss for the quarter was $65.9 million with loss per share of $0.61.
Adjusted EBITDA* for the quarter was $2.6 million, an increase of $34.1 million from the same period in 2023. This increase was primarily driven by revenue growth and operational efficiencies.
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 for the treatment of GBM were received in the quarter, consistent with the same period in 2023. The U.S., Germany, France and Japan contributed 897; 190; 194 and 109 prescriptions, respectively, with the remaining 130 prescriptions contributed by other active markets.
As of December 31, 2024, there were 4,077 active Optune Gio patients on therapy. The U.S., Germany, France and Japan contributed 2,161; 564; 426 and 420 Optune Gio 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. FDA for the treatment of metastatic NSCLC concurrently with PD-1/PD-L1 inhibitors or docetaxel, in adults who have progressed on or after a platinum-based regimen. Between approval and year end, 52 Optune Lua prescriptions were received for metastatic NSCLC.
As of December 31, 2024, there were 20 active metastatic NSCLC patients on Optune Lua and 29 active malignant pleural mesothelioma (MPM) patients on Optune Lua.
Beginning in Q1 2026, Novocure intends to stop reporting new prescriptions received in period and will provide active patients on TTFields therapy by indication and by material market as the key operating statistics.
Fourth quarter and recent updates and achievements:

In October 2024, the FDA granted Breakthrough Device designation for the use of TTFields therapy for the treatment of brain metastases from NSCLC. 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 2024, the FDA approved Novocure’s new HFE transducer arrays for use with Optune Gio for the treatment of adult patients with GBM.
In December 2024, 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 2024, 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 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 fourth quarter and full year 2024 financial results at 8:00 a.m. EST today, 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 and 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.

On February 27, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant to checkpoint inhibitors and chemotherapy (Press release, MAIA Biotechnology, FEB 27, 2025, View Source [SID1234650730]). The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients.

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"THIO has consistently and substantially outperformed standard treatment options in our THIO-101 Phase 2 trial to date. THIO-104 will give us direct comparative data from a randomized study in patients in third line of treatment," said Vlad Vitoc, M.D., CEO of MAIA. "We expect that the results from this study will further illuminate THIO’s unmatched benefits for advanced stage NSCLC patients.

"Our initiation of THIO-104 will mark an important milestone along our goal for THIO’s FDA commercial approval," Dr. Vitoc added.

MAIA expects to begin enrolling patients in THIO-104 in the second half of 2025 in select countries in Asia, Europe and in the U.S.

The primary endpoint of the clinical trial is overall survival for THIO sequenced with a CPI compared to investigator’s choice of chemotherapy in a third line setting. The secondary endpoints include disease control rate, overall response rate, duration of response, progression-free survival and safety.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a third line of treatment for NSCLC for patients that are resistant to checkpoint inhibitors and chemotherapy.

On February 27, 2025 Akeso, Inc. (9926.HK) reported the first patient has been enrolled in the Phase I clinical trial of AK138 D1 for the treatment of advanced malignancies in Australia (Press release, Akeso Biopharma, FEB 27, 2025, View Source;adc-strategy-302387166.html [SID1234650729]). AK138D1, a self-developed and differentiated HER3-targeting ADC (antibody-drug conjugate), is Akeso’s first ADC drug to enter clinical studies.

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Akeso is dedicated to transforming the global oncology treatment landscape by establishing new standards of care for cancer patients worldwide. A key element of this mission is the company’s "IO 2.0 + ADC" strategy. Akeso’s self-developed, first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), have both received regulatory approval and are now available to patients in China. Akeso is the only global biopharmaceutical company with two approved bispecific checkpoint antibodies for cancer immunotherapy.

The continued development of differentiated ADC therapies, such as AK138D1, further extend Akeso’s ability to explore the full clinical potential of its innovative in-house pipeline and to create synergistic new combination treatment options includes that multiple checkpoints and tumor targets.

Dr. Xia Yu, Founder, Chairwoman, President and CEO of Akeso said,

"The initiation of the clinical study for AK138D1 in Australia marks a pivotal moment in Akeso’s strategic advancement into next-generation ADC therapies. Building on our global prominence in bispecific antibodies and a robust pipeline of high-potential drug candidates, the development of AK138D1 and subsequent ADCs/bispecific ADCs will significantly bolster our product offering. This is part of Akeso’s continued effort to redefine standard of care in cancer treatment.

Following our achievements in bispecific antibody development, ADC therapies have emerged as a strategic priority for Akeso. Based on our extensive experience in bispecific antibody development, we are excited by the potential of our proprietary ADCs and bispecific ADCs. Our goal is to enhance drug efficacy while minimizing ADC toxicity, offering transformative treatment alternatives for patients worldwide.

Moreover, Akeso has established cutting-edge ADC research, pilot production, and manufacturing facilities. These investments position us for high-quality clinical development and for global market expansion of our ADC portfolio."

HER3 has emerged as an active target in cancer drug development and is the focus of ongoing research. Although experimental drugs targeting HER3 have not shown satisfactory antitumor effects over the past 30 years, studies indicate that HER3 is expressed or overexpressed in various malignancies, including breast cancer, ovarian cancer, lung cancer, colorectal cancer, melanoma, head and neck cancers, cervical cancer, and prostate cancer. Additionally, upregulation of HER3 and its synergistic interactions with other receptors contribute to tumor initiation, metastasis, and resistance to certain anticancer treatments, such as resistance to EGFR-targeted therapies, endocrine therapy in breast cancer, HER2-targeted therapies, and chemotherapy.

About AK138D1

Injectable AK138D1 is a HER3-targeted antibody-drug conjugate (ADC), with a fully humanized anti-HER3 IgG1 antibody, patritumab. It is conjugated to the topoisomerase I inhibitor DXd through a cleavable linker, MC-AAA (maleimide-alanine-alanine-alanine). After binding to HER3 on tumor cells, the ADC is internalized into the tumor cells, where the linker is cleaved, releasing the membrane-permeable DXd. This leads to DNA damage and subsequent cell apoptosis. Currently, Akeso has initiated patient enrollment for a Phase I dose-escalation and expansion clinical study in Australia. This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AK138D1 for the treatment of advanced malignancies.

On February 27, 2025 RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported the presentation of a business update by Guy Goldberg, RedHill’s Chief Business Officer, highlighting recent significant corporate activity, R&D advances and commercial progress with Talicia, at the Sachs Associates’ 18th Annual European Life Sciences CEO Forum in Zurich (Press release, RedHill Biopharma, FEB 27, 2025, View Source [SID1234650728]).

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"We have had a very positive start to 2025, making significant progress on multiple fronts. We have just announced the out-licensing of RHB-102 to Hyloris, in a deal worth up to $60 million in potential milestone payments plus additional royalties on revenues. We also recently announced the initiation of a Bayer-funded Phase 2 clinical study of opaganib in combination with Bayer’s darolutamide for advanced prostate cancer, for which there are very limited options. This is in addition to the multiple U.S. government- and academia-supported R&D programs with key 2025 potential catalysts, including for radiation injury protection, oncology, and various pandemic preparedness indications," said Guy Goldberg, RedHill’s Chief Business Officer. "The commercial team are working equally hard on cementing, and building on, Talicia’s position as the number one branded H. pylori therapy. Subject to the successful completion of our ongoing discussions, we expect to substantially reduce Talicia’s COGS, directly boosting the bottom line. Other recent achievements include the Humana Part D win, adding another eight million Medicare lives; inclusion as first line option in the new ACG guideline; and the FDA sNDA approval to switch to a more convenient TID dosing. There are also opportunities for Talicia opening up in new markets outside of the U.S. and the recent commercial launch in the UAE, and we are evaluating additional marketing authorization applications in other countries. Talicia has now surpassed the 100,000 prescriptions milestone, our ground-breaking warranty program, with minimal claimed refunds, reflects a positive experience, and now, with new potential markets on the horizon, we are optimistic about the future for Talicia and the value it can deliver."

The presentation was available for registered attendees only.