On February 26, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA," the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the trial design for the expansion of its THIO-101 pivotal Phase 2 trial in non-small cell lung cancer (NSCLC) (Press release, MAIA Biotechnology, FEB 26, 2025, View Source [SID1234650657]). Following successful outcomes to date in THIO-101, the expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy.

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The THIO-101 study in 3L will enroll up to 48 patients with two arms: Arm 1, continuing the evaluation of THIO sequenced with Libtayo (cemiplimab); and Arm 2, evaluating THIO as a monotherapy, to further gain experience of THIO in the contribution of components. Treatment cycles for patients in both arms will administer THIO on 3 consecutive days, followed by immune activation on day 4. Arm 1 will administer Libtayo on day 5. The Company plans to enroll an additional 100 patients for the registration phase of the trial. MAIA expects to conduct the trials in the U.S. and select countries in Europe and Asia.

MAIA recently announced an amended clinical supply agreement with Regeneron to include the expansion portion of THIO-101. Under terms of the amended agreement, MAIA continues to sponsor THIO-101 and Regeneron will provide Libtayo for the treatment of all patients including the additional patients in the expansion and potentially, the registration studies.

"We are excited to start the expansion arm of our THIO-101 trial which is designed to determine overall response rates in third line NSCLC. We expect to have new patients enrolled in the coming weeks," said Vlad Vitoc, M.D., CEO of MAIA. "Through THIO-101 to date, THIO has delivered unprecedented disease control, response, and survival results. Continued efficacy and safety data generated by our study could support an FDA NDA submission directly, particularly as we plan to seek an accelerated approval of THIO in the U.S.

"We have multiple milestones that we believe are attainable for 2025 and we look forward to keeping our shareholders and investors well informed of our progress on value creation," Dr. Vitoc added.

As of January 15, 2025, data indicated that Median Overall Survival (OS) in third-line treatment was reached at 16.9 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months). The treatment has been generally well-tolerated to date in this heavily pre-treated population1.

Details on safety can be found on the previously announced SITC (Free SITC Whitepaper) 2024 presentation available on MAIA’s website.

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 second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by cemiplimab (Libtayo) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On February 26, 2025 FoRx Therapeutics AG, a Swiss-based company committed to discovering and developing innovative drugs targeting cancer-relevant DDR (DNA Damage Response) pathways, reported that it has appointed Jens Würthner, MD PhD, as Chief Medical Officer (Press release, FoRx Therapeutics, FEB 26, 2025, View Source [SID1234650656]). He is further strengthening FoRx Therapeutics’ existing management team with CEO Tarig Bashir, CSO Frank Zenke, and Head of Chemistry Ulrich Lücking.

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Jens Würthner has 20+ years of clinical development expertise and a track record that includes the successful progression of drug candidates from Phase I initiation to market approval. He has led clinical development programs at large pharmaceutical companies, namely Novartis, GlaxoSmithKline and AstraZeneca, as well as at biotech companies, such as ADC Therapeutics. At Swiss-based ADC Therapeutics, Jens oversaw all aspects of clinical development of several successful programs, including loncastuximab teserine (Zynlonta). Before that, he was Lead Clinical Program Leader at Novartis, where he was responsible for progressing small molecule compounds and a monoclonal antibody into the clinic and through multiple clinical trials. Jens joins FoRx Therapeutics from the Dutch company Scenic Biotech, where he has been building the translational and clinical teams for the oncology and rare disease franchise in preparation for first-in-human studies.

Jens Würthner holds an MD and a PhD from the University of Hamburg and completed a postdoctoral fellowship at the Laboratory of Cell Regulation & Carcinogenesis, National Cancer Institute, National Institutes of Health in Bethesda, Maryland (USA).

Tarig Bashir, PhD, CEO of FoRx Therapeutics, commented: "We are very happy that Jens is now part of our team. His long-standing expertise and track record in the clinical development of oncology therapeutics across all development stages is an outstanding asset for building FoRx Therapeutics’ clinical capabilities and will be key to successfully advancing our PARG inhibitor FORX-428 with its best-in-class profile through the clinic. We are excited to have Jens on board to work on our common and ambitious goal to improve patients’ lives and ultimately cure cancer."

Jens Würthner, MD PhD, CMO added: "I am looking forward to this new challenge at FoRx Therapeutics. Together with the team and all stakeholders, we will advance the Company’s lead development candidate FORX-428 with its convincing best-in-class profile into the clinic and through subsequent clinical studies. We are committed to bringing a novel therapeutic with transformative potential to cancer patients who have limited therapy options and require new targeted treatment approaches."

Pipeline update

Also today, the Company provided an update on its lead development candidate, FORX-428. The compound is an inhibitor of PARG (Poly(ADP-ribose) glycohydrolase) and is being developed for the treatment of solid tumors. FoRx Therapeutics reports significant progress towards IND (Investigational New Drug) submission for FORX-428 and anticipates clearance from the FDA by mid-2025. The Company has successfully finalized toxicological testing conducted according to GLP (Good Laboratory Practice) and also reports the identification and preclinical validation of predictive biomarkers which will be key in selecting patient populations most likely to benefit from treatment with FORX-428. Furthermore, recent data from animal studies with cell line-derived and patient-derived tumor models demonstrate outstanding anti-tumor efficacy and good tolerability, further corroborating the best-in-class proposition for FORX-428.

FoRx Therapeutics holds all development and commercial rights to FORX-428.

On February 26, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Vir Biotechnology, FEB 26, 2025, View Source [SID1234650655]).

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"2024 was a year of transformation for Vir Biotechnology as we successfully defined and executed on our renewed strategic direction, focusing our resources on our most promising programs in infectious diseases and oncology," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "As we enter 2025, we are poised for significant advancement with the initiation of our Phase 3 registrational program in chronic hepatitis delta and further clinical progression of our dual-masked T-cell engagers in solid tumors. Our disciplined capital deployment and strategic approach to partnerships enable us to maximize value creation from our pipeline and deliver transformative therapies to patients."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

ECLIPSE Phase 3 registrational clinical program in chronic hepatitis delta is advancing with the first patient in (FPI) expected during the first half of 2025.
Positive data from the SOLSTICE Phase 2 clinical trial were presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in November 2024. This data demonstrated the potential of the first-of-its-kind investigational combination to address a critical unmet need in CHD, showing rapid and sustained virologic suppression, using the most stringent measure of zero detectable hepatitis delta RNA in the blood or target not detected, (TND defined as HDV RNA < 0 IU/mL), and no treatment-related serious adverse events (SAEs).
Tobevibart and elebsiran combination therapy has received multiple regulatory designations potentially supporting an expedited development and review process and recognizing the significant unmet need in CHD: U.S. FDA Breakthrough Therapy designation, U.S. FDA Fast Track designation, European Priority Medicines (PRIME) designation and European Orphan Drug designation.
Solid Tumors

In January 2025, the Company presented encouraging preliminary safety and efficacy data in ongoing Phase 1 dose escalation trials for its dual-masked T-cell engager (TCE) programs.
VIR-5818, the only dual-masked HER2-targeting TCE in clinical trials, showed tumor shrinkage across various tumor types in 50% (10/20) of participants receiving doses ≥400 µg/kg, with confirmed partial responses in 33% (2/6) of participants with HER2-positive colorectal cancer (CRC).
VIR-5500, the only dual-masked PSMA-targeting TCE in clinical trials, showed PSA reductions in 100% (12/12) of metastatic castration resistant prostate cancer (mCRPC) patients after an initial dose ≥120 µg/kg. PSA50 response was confirmed in 58% (7/12) of participants.
Both clinical candidates have shown promising safety profiles, with maximum tolerated dose (MTD) not yet reached, no dose-limiting cytokine release syndrome (CRS) observed and no CRS greater than grade 2.
Initial clinical data demonstrate the PRO-XTEN masking technology’s potential to minimize systemic toxicity while enabling selective killing of cancer cells in the tumor microenvironment, minimizing CRS and expanding the therapeutic index compared to traditional therapeutic approaches.
The Company is advancing VIR-5818 and VIR-5500 through ongoing Phase 1 dose escalation studies, aiming to further optimize dosing and efficacy. Additionally, the Company plans to initiate a Phase 1 study of VIR-5525, its dual-masked EGFR-targeting TCE, in the first half of 2025, evaluating its potential across a number of solid tumor indications.
Chronic Hepatitis B (CHB)

The Company anticipates functional cure data from the 24-week follow-up of the MARCH Part B Phase 2 trial in the second quarter of 2025.
Positive end-of-treatment results of the MARCH Part B Phase 2 trial evaluating tobevibart and elebsiran in combination with PEG-IFNα or tobevibart and elebsiran alone were presented at AASLD The Liver Meeting in November 2024. The data demonstrated compelling hepatitis B surface antigen (HBsAg) loss and anti–hepatitis B surface antibody (anti-HBs) development at the end of treatment.
Future advancement in CHB by the Company will be contingent on securing a worldwide development and commercialization partner outside of China Territory (People’s Republic of China, Hong Kong, Taiwan and Macau) to best enable further development in this area of high unmet need.
Preclinical Pipeline Candidates

The Company is advancing multiple undisclosed dual-masked TCEs against clinically validated targets with potential applications across a variety of solid tumors. These preclinical candidates leverage the PRO-XTEN masking technology with novel TCEs discovered and engineered using Vir Biotechnology’s antibody discovery platform and the Company’s proprietary dAIsY (data AI structure and antibody) AI engine.
The Company continues to advance its HIV broadly neutralizing antibody program for HIV cure in collaboration with the Gates Foundation.
Corporate Update

In November 2024, the Company hosted an investor event highlighting positive data from its SOLSTICE Phase 2 trial in hepatitis delta and its MARCH Part B Phase 2 trial in hepatitis B presented at AASLD.
In January 2025, the Company announced positive initial Phase 1 dose escalation data for two of its PRO-XTEN masked TCEs through an investor event.
The Company announced Maninder Hora, Ph.D. will assume the role of Executive Vice President, Chief Technical Operations Officer in February 2025, following the departure of the current Chief Technology Officer, Aine Hanley, Ph.D.
Fourth Quarter and Full Year 2024 Financial Results

"Our focus on operational efficiency and program prioritization achieved a 28% year-over-year reduction in operating expense, excluding the upfront expense related to the Sanofi licensing agreement," said Jason O’Byrne, MBA, Executive Vice President and Chief Financial Officer, Vir Biotechnology. "We enter 2025 with a robust financial position to support our key strategic priorities, including $1.10 billion in cash, cash equivalents and investments and a cash runway into mid-2027."

Cash, Cash Equivalents and Investments: As of December 31, 2024, the Company had approximately $1.10 billion in cash, cash equivalents and investments, representing a decline of approximately $90.6 million during the fourth quarter of 2024. For the full year of 2024, cash, cash equivalents and investments declined approximately $532.3 million. The 2024 full year decrease includes a $103.7 million upfront payment made to Sanofi upon the closing of the Sanofi license agreement and $75.0 million that was reclassified to restricted cash in the third quarter of 2024 and subject to VIR-5525 achieving "first in human dosing" by 2026.

Revenue: Revenue for the quarter ended December 31, 2024 was $12.4 million compared to $16.8 million for the same period in 2023. Revenue for the full year of 2024 was $74.2 million compared to $86.2 million in 2023. The decreases in the fourth quarter and full year were primarily driven by grant revenue, where lower revenue was recognized in accordance with our agreement with BARDA and the Gates Foundation. In addition, the decrease in the full year 2024 was attributable to lower revenues from the release of profit-sharing amount previously constrained under the 2020 GSK Agreement, partially offset by the recognition of deferred revenue related to the expiry of GSK’s rights to select up to two additional non-influenza target pathogens during the first quarter of 2024.

Cost of Revenue: Cost of revenue for the fourth quarter of 2024 was $0.7 million compared to $0.8 million for the same period in 2023. Cost of revenue for the full year of 2024 was $0.8 million compared to $2.8 million in 2023. The decreases were due to lower third-party royalties owed based on the lower collaboration revenue under the 2020 GSK Agreement.

Research and Development Expenses (R&D): R&D expenses for the fourth quarter of 2024 were $106.1 million, which included $8.3 million of non-cash stock-based compensation expense, compared to $109.1 million for the same period in 2023, which included $16.5 million of non-cash stock-based compensation expense. R&D expenses for the full year of 2024 were $506.5 million, which included $43.9 million of non-cash stock-based compensation expense, compared to $579.7 million in 2023, which included $62.7 million of non-cash stock-based compensation expense. The decrease of the fourth quarter R&D expense was primarily due to lower expenses for personnel and de-prioritized programs, partially offset by non-cash in-process R&D assets impairment charges and contingent consideration liability revaluation. The decrease of the full year R&D expense was primarily due to lower clinical costs and contract manufacturing costs associated with the Company’s discontinued flu asset, VIR-2482, lower contract manufacturing costs associated with elebsiran used in the Company’s CHD and CHB clinical trials and lower personnel costs, partially offset by the $102.8 million of the Sanofi upfront payment being recognized as in-process R&D expense.

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the fourth quarter of 2024 were $26.7 million, which included $7.5 million of non-cash stock-based compensation expense, compared to $41.2 million for the same period in 2023, which included $11.8 million of non-cash stock-based compensation expense. SG&A expenses for the full year of 2024 were $119.0 million, which included $34.5 million of non-cash stock-based compensation expense, compared to $174.4 million in 2023, which included $48.6 million of non-cash stock-based compensation expense. The decrease in both the fourth quarter and the full year was primarily related to lower personnel and other expenses associated with previously announced cost-saving initiatives.

Restructuring, Long-Lived Assets Impairment and Related Charges: Restructuring, long-lived assets impairment and related charges for the fourth quarter of 2024 were $(3.9) million compared to $4.7 million for the same period in 2023. The $(3.9) million in the fourth quarter of 2024 was primarily related to a gain from terminating our lease in St. Louis, Missouri. The $4.7 million in the fourth quarter of 2023 was primarily related to the severance expenses.

Other Income: Other income for the fourth quarter of 2024 was $12.5 million compared to $18.3 million for the same period in 2023. The decrease was primarily due to lower interest income. Other income for the full year of 2024 was $64.1 million compared to $56.1 million in 2023. The increase was primarily due to lower unrealized loss from the Company’s equity investment and lower foreign exchange loss, partially offset by lower interest income.

Benefit from Income Taxes: Benefit from income taxes for the fourth quarter and the full year of 2024 was nominal. Benefit from income taxes for the fourth quarter and the full year of 2023 was $4.8 million and $13.1 million, respectively, primarily due to a pre-tax loss and the Company’s ability to carry back the research and development credit to 2022.

Net Loss: Net loss attributable to Vir Biotechnology for the fourth quarter of 2024 was $(104.6) million, or $(0.76) per share, basic and diluted, compared to a net loss of $(116.0) million, or $(0.86) per share, basic and diluted, for the same period in 2023. Net loss attributable to Vir Biotechnology for the year of 2024 was $(522.0) million, or $(3.83) per share, basic and diluted, compared to a net loss of $(615.1) million, or $(4.59) per share, basic and diluted, in 2023.

2025 Financial Guidance

Based on current operating plans, the Company expects its cash, cash equivalents and investments to fund its operations into mid-2027.

Conference Call

Vir Biotechnology will host a conference call to discuss the fourth quarter and full year 2024 results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on View Source and will be archived for 30 days.

About VIR-5818, VIR-5500, VIR-5525

VIR-5818, VIR-5500, VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the PRO-XTEN masking technology with three different T-cell engagers (TCEs) targeting HER2, PSMA, and EGFR, respectively.

TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.

About Tobevibart and Elebsiran

Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B.

On February 26, 2025 Eikon Therapeutics, Inc., a pivotal-stage biotechnology company that integrates advanced engineering with cutting-edge molecular and cell biology to accelerate drug discovery and development, reported the initial closing of a $350.7 million Series D financing. Since its founding in 2019, Eikon Therapeutics has privately raised in excess of $1.1 billion to support its mission of developing new medicines to address grievous illnesses (Press release, Eikon Therapeutics, FEB 26, 2025, View Source [SID1234650654]).

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The financing round was led by Eikon’s existing investors, with participation from new investors. The investment syndicate is composed of top mutual funds, sovereign wealth funds, and healthcare and technology-focused venture firms including Lux Capital, Alexandria Venture Investments, AME Cloud Ventures, The Column Group, E15 VC, Foresite Capital, General Catalyst, Soros Capital, StepStone Group, funds and accounts advised by T. Rowe Price Associates, Inc., and UC Investments (Office of the Chief Investment Officer of the Regents of the University of California), among others.

"Eikon has made remarkable progress in advancing a pivotal-stage clinical pipeline and early-stage development program powered by our single-molecule tracking technology and the deep expertise of our multidisciplinary team. With clinical studies now operating in 28 countries, across 5 continents, we are accelerating the development of much-needed therapies while continuing to expand our research and development capabilities," said Roger M. Perlmutter, M.D., Ph.D., CEO and Board Chair of Eikon Therapeutics. "This financing provides the resources necessary to build a fully-integrated, 21st-century biotechnology company that leverages advanced computing, data sciences, and decades of experience in bringing innovative medicines to patients. The continued support of our world-class syndicate of investors is a testament both to the progress we have already made, and to the confidence of investors in our ability to deliver important new medicines for the world."

Eikon’s clinical portfolio is anchored by its lead program, EIK1001, a systemically administered co-agonist of toll-like receptors 7 and 8 now in a Phase III trial for advanced melanoma. EIK1001 has demonstrated both single-agent efficacy and promising in-combination activity with anti-PD-(L)1 agents across multiple tumor types. In parallel, the company is advancing EIK1003, a highly selective PARP1 inhibitor currently undergoing Phase 1 evaluation in patients with breast, ovarian, prostate, or pancreatic cancers, and EIK1004, a central nervous system-penetrant PARP1-selective inhibitor poised to initiate Phase 1 studies targeting brain cancers.

Eikon’s early-stage pipeline features, among other undisclosed candidates, two androgen receptor antagonists and an internally derived WRN inhibitor (EIK1005) that is being studied for its potential as a therapy for patients with MSI-high and other DNA repair–deficient cancers.

"Eikon has engineered a next-generation drug discovery engine that seamlessly integrates automation, high-performance computing, and advanced data science to transform how new medicines are developed," said Lux Capital Co-founder and Managing Partner Josh Wolfe. "By harnessing its proprietary single molecule tracking technology, Eikon is uncovering biological processes in living cells with an unprecedented level of precision, generating insights at a pace that was previously out of reach. With a skilled leadership team that is deeply experienced in bringing groundbreaking therapies to patients, Eikon is setting a new standard for innovation in biotechnology."

Eikon Therapeutics will participate in the upcoming TD Cowen Healthcare Conference in Boston, March 3-5, 2025.

On February 26, 2025 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported that management will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Wednesday, March 5, at 1:10 p.m. ET (Press release, Arcellx, FEB 26, 2025, View Source [SID1234650653]).

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A live webcast of this discussion will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.