A Multi-center, Single-group, Open Phase Ib/2 Study of Nelmastobart in Combination with Trifluridine/Tipiracil and Bevacizumab in Metastatic Colorectal Cancer Patients with Resistance or Intolerance to Oxaliplatin and Irinotecan-based Chemotherapy

The objective of this multi-center, single-group, open-label Phase Ib/II study is to evaluate the safety, pharmacokinetics, and efficacy of nelmastobart in combination with trifluridine/tipiracil and bevacizumab in metastatic or recurrent colorectal cancer patients with resistance or intolerance to oxaliplatin- and irinotecan-based chemotherapy, and to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and the efficacy and safety of the combination therapy in BTN1A1-positive patients.

Start Date01 May 2025

Sponsor / Collaborator

STCube, Inc.

NCT06882915

/ Not yet recruitingPhase 1IIT

Efficacy and Safety of Trifluridine/tipiracil (TAS-102) Combined with Bevacizumab and Putalimab in the Treatment of Patients with MCRC After Cytoreductive Surgery: a Single-arm, Single-center Clinical Study

Colorectal cancer (CRC) is one of the most common malignant tumors. With the rapid development of China's economy, people's living standards have been significantly improved, and lifestyles and dietary structures have changed. Smoking, drinking, high-fat, high-energy diets, etc. have led to an increase in the incidence of colorectal cancer year by year. Data show that in 2022, there will be 510,000 new cases of colorectal cancer in China, and about 240,000 deaths related to colorectal cancer. Radical surgery is the main initial treatment for early and middle-stage colorectal cancer and some metastatic colorectal cancer. Although the level of surgical treatment of colorectal cancer has been greatly improved and can achieve cure for some patients, its 5-year overall survival rate is only about 60%, and the main cause of death is distant metastasis and recurrence. In recent years, with the in-depth understanding of the treatment mechanism of metastatic colorectal cancer (mCRC), a variety of new treatment options have been proposed and applied in clinical practice in order to improve the quality of life of patients and prolong their survival.
Trifluridine/tipivirine (TAS-102) is a new type of cytotoxic drug that exerts anti-tumor effects by directly incorporating into DNA chains to destroy DNA function. Its mechanism of action is different from that of fluorouracil drugs, and it can resist 5-fluorouracil (5-FU) resistance, providing a new treatment option for mCRC patients. TAS-102 has been approved in China for mCRC patients who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, as well as those who have previously received or are not suitable for anti-vascular endothelial growth factor (VEGF) therapy and anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type). Bevacizumab, as a monoclonal antibody targeting VEGF, exerts its anti-tumor effect by inhibiting tumor angiogenesis. Putlimumab, as an immune checkpoint inhibitor, enhances the body's immune response to tumors by blocking the PD-1/PD-L1 signaling pathway.
Combination therapy has attracted much attention due to its possible synergistic effect. Studies have shown that TAS-102 combined with bevacizumab can achieve longer overall survival (OS) than TAS-102 monotherapy. In addition, TAS-102 combined with bevacizumab for refractory mCRC has also been approved by the FDA, showing its potential and importance in the treatment of mCRC. Therefore, this study aims to explore the efficacy and safety of TAS-102 combined with bevacizumab and putelimab in patients with mCRC after cytoreductive surgery, in order to provide a more effective treatment for mCRC patients. Through the design of a single-arm, single-center clinical study, we can have a deeper understanding of the efficacy and safety of this combined treatment in a specific patient population, providing a scientific basis for future clinical applications.

Start Date01 May 2025

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

NCT06607458

/ Not yet recruitingPhase 2

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment with Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients with Refractory Metastatic Colorectal Cancer with Liver Dominant Disease

The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with colorectal cancer that has spread to the liver is safe and tolerable. The clinical trial will also learn if the liver-directed therapy with high dose chemotherapy works on the disease in the liver. Investigators will compare the use of the liver-directed therapy with high dose chemotherapy followed by approved cancer treatment or approved cancer treatment alone.
Participants will:
* Undergo up to two liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone
* Visit clinic at least every two weeks for checkups and tests
* Complete scans approximately every two months

Start Date01 May 2025

Sponsor / Collaborator

Delcath Systems, Inc.

100 Clinical Results associated with Tipiracil Hydrochloride/Trifluridine

100 Translational Medicine associated with Tipiracil Hydrochloride/Trifluridine

100 Patents (Medical) associated with Tipiracil Hydrochloride/Trifluridine

448

Literatures (Medical) associated with Tipiracil Hydrochloride/Trifluridine

01 Feb 2025·EClinicalMedicine

Trifluridine-tipiracil in previously treated patients with oestrogen receptor-positive, HER2-negative metastatic breast cancer (BOOG 2019-01 TIBET trial): a single-arm, multicentre, phase 2 trial

Article

Author: Nieboer, Peter ; Guchelaar, Niels A D ; Bijlsma, Rhodé M ; Heijns, Joan B ; Hamming, Lisanne ; de Boer, Maaike ; van Bekkum, Marlies L ; Bos, Monique E M M ; van den Berg, Susan M ; Mathijssen, Ron H J ; Beelen, Karin J ; Kessels, Lonneke W ; van Rosmalen, Mandy M ; Vriens, Birgit E P J ; Hoop, Esther Oomen-de

Background:

Effective later-line chemotherapy treatment options are scarce for patients with metastatic breast cancer (MBC). Trifluridine-tipiracil has shown survival benefit in heavily pre-treated patients with metastatic colorectal and in gastric cancer refractory to a fluoropyrimidine. This study aimed to investigate the efficacy of trifluridine-tipiracil in a Western population of previously treated patients with oestrogen receptor (ER+), HER2- MBC to facilitate further optimization of this treatment strategy.

Methods:

Adult patients at least 18 years old diagnosed with hormone receptor positive, HER2- receptor negative MBC with a performance status of 0 or 1 who have been treated with capecitabine in the metastatic setting and up to two other lines of chemotherapy, including a taxane, were enrolled in this single-arm, multicentre, phase 2 study in the Netherlands. The participants received trifluridine-tipiracil 35 mg/m² orally twice a day on days 1-5 and days 8-12 during a 28-day cycle until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the disease control rate (DCR) at 8 weeks, defined as the percentage of patients that had stable disease, partial response or complete response according to RECIST 1.1, in all patients that received at least one dose of trifluridine-tipiracil and met the key eligibility criteria defined a priori. Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and quality of life and were performed in all patients that received at least one dose of trifluridine-tipiracil. The primary endpoint was considered met, justifying further research of this treatment regimen, if the lower boundary of the 80% confidence interval (CI) exceeded 30%. The study was registered within ClinicalTrials.gov (NCT04489173) and is closed for inclusion.

Findings:

Fifty female patients were enrolled from September 2020 to July 2023, with a median of 3 (IQR, 2-3) previous endocrine therapy lines and 2 (IQR, 2-3) chemotherapy lines for MBC. The DCR rate at 8 weeks was 64.0% (n = 32, 95% CI: 50.1-75.9%; 80% CI: 55.0-72.1%), thereby meeting the primary endpoint of this study. At data cutoff (January 8, 2024), the median follow-up time was 18.2 months (IQR, 13.1-25.1 months). The median PFS was 5.4 months (95% CI: 2.0-7.2 months) and the median OS 14.0 months (95% CI: 8.8-17.8 months). The safety profile of trifluridine-tipiracil aligned with expected toxicities and included leukopenia (n = 36, 69%), neutropenia (n = 43, 83%), and fatigue (n = 43, 83%). The most common grade 3-4 AEs were primarily haematological disorders and included neutropenia (n = 38, 73%), leukopenia (n = 15, 29%) and anaemia (n = 6, 12%). The most common SAEs (any grade) with a possible relationship with trifluridine-tipiracil included anaemia (n = 2) and vomiting (n = 2). No treatment-related deaths occurred. Quality of life scores remained stable throughout the treatment.

Interpretation:

Trifluridine-tipiracil demonstrated promising efficacy in heavily pre-treated patients with MBC, despite prior exposure to a fluoropyrimidine. Clinically, this suggests that trifluridine-tipiracil holds potential as a viable oral later-line treatment option with a manageable toxicity profile while maintaining quality of life. Preparations for a phase 3 trial are underway.

Funding:

Servier, France.

14 Dec 2024·BRITISH JOURNAL OF CANCER

Phase II Study of Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab as a Later-line Therapy for Patients with Metastatic Colorectal Cancer (mCRC): a prospective single-center explorative study

Article

Author: Bi, Deying ; Yang, Wenwei ; Yang, Tingting ; Liu, Na ; Wu, Guifu ; Sun, Yongkun ; Li, Baoqi

Abstract:

Purpose:

To explore the efficacy and safety of the combination of irinotecan, trifluridine/tipiracil (TAS-102), and bevacizumab in a later‐line setting for metastatic colorectal cancer (mCRC) patients.

Patients and methods:

This was a single-center, phase II trial. The mCRC patients who are refractory to standard first-line and second-line treatment are eligible. Patients who previously received irinotecan while progressing during maintenance therapy are also eligible. The primary endpoint was the objective response rate (ORR).

Results:

Between August 1, 2022, and September 30, 2023, 35 patients were enrolled, and 31 of them were evaluable for efficacy. The ORR was 25.8% (8/31), and the disease control rate (DCR) was 93.5% (29/31). As of April 30, 2024, the median progression-free survival (PFS) was 9.2 months (95% CI 6.285-12.115), whereas the median overall survival (OS) was not reached with the 1-year OS rate of 73.5%. The most common grade 3/4 treatment-related adverse events were neutropenia (34.3%), anemia (17.1%), and thrombocytopenia (8.6%).

Conclusion:

Irinotecan, TAS-102 plus bevacizumab regimen preliminarily demonstrated promising efficacy with tolerable toxicity for mCRC patients as later‐line treatment. This regimen warrants further exploration in refractory mCRC patients.

06 Dec 2024·ONCOLOGIST

Association between sidedness and survival among chemotherapy refractory metastatic colorectal cancer patients treated with trifluridine/tipiracil or regorafenib

Article

Author: Hsieh, Meng-Che ; Liu, Kuang-Wen ; Rau, Kun-Ming ; Hsiao, Kai-Yuan ; Chang, Wei-Shan ; Liang, Hao-Yun ; Chen, Hsin-Pao ; Shia, Ben-Chang

Abstract:

Background:

The impact of sidedness on survival of later-line treatment in patients with metastatic colorectal cancer (mCRC) is undetermined. This study aimed to investigate the association between sidedness and survival among chemotherapy refractory patients with mCRC treated with trifluridine/tipiracil (TAS-102) or regorafenib or both.

Patients and Methods:

Patients with mCRC treated with TAS-102 or regorafenib between 2015 and 2020 was retrospectively collected. Patients were stratified into TAS-102 first and regorafenib first, then subdivided into TAS-102 followed by regorafenib (T-R) and regorafenib followed by TAS-102 (R-T) groups. The oncologic outcomes were presented with time-to-treatment failure (TTF) and overall survival (OS).

Results:

After matching, 376 TAS-102 patients and 376 regorafenib patients were included for outcomes comparison. TTF had insignificant differences while OS was significantly different between TAS-102 and regorafenib groups. Median TTF and OS were 1.9 months versus 2.0 months (P = .701) and 9.1 months versus 7.0 months (P = .008) in TAS-102 and regorafenib, respectively. The OS benefits were consistent regardless primary tumor location. Subgroup analysis with 174 T-R patients and 174 R-T patients was investigated for treatment sequences. TTF and OS had significant differences in both groups. Median TTF and OS were 8.5 months versus 6.3 months (P = .001) and 14.4 months versus 12.6 months (P = .035) in T-R and R-T groups, respectively. The TTF and OS benefits were persisted regardless primary tumor location.

Conclusion:

TAS-102 first provided a better survival benefit in chemotherapy refractory patients with mCRC across all sidedness. Further prospective studies are warranted to validate our conclusions.

113

News (Medical) associated with Tipiracil Hydrochloride/Trifluridine

18 Mar 2025

·www.globenewswire.com

March 2025 Letter to Shareholders

VANCOUVER, Washington, March 18, 2025 (GLOBE NEWSWIRE) -- Dear Shareholders, As envisioned, 2025 is unfolding to be an exciting year for CytoDyn Inc. (“CytoDyn” or the “Company”). On February 24, 2025, the Company announced increased survival rates in patients with metastatic Triple-Negative Breast Cancer (“mTNBC”) who were treated with leronlimab in prior CytoDyn-sponsored studies. The impressive survival observations at 12, 24, and 36 months in patients who previously failed treatment in the metastatic or locally advanced setting indicate leronlimab could play a significant role as a paradigm-shifting therapeutic in oncology. Of particular interest, we identified a subgroup of these patients who remain alive and well today and currently identify as cancer-free. This is only the beginning of the Company’s 2025 oncology story. We are eager to provide updates in the coming months as they are available to share. There is still much work to be done, but I am encouraged by what is on the near horizon. I’d like to offer a word of deep gratitude to the CytoDyn team and the key opinion leaders (“KOLs”) who worked so diligently these last months to bring these data together. I would also like to reiterate my appreciation for you – the shareholders. Our business priorities are (i) getting leronlimab to patients in need; and (ii) generating value for our dedicated shareholders. As a long-time supporter of the company and now CEO, I believe investors deserve clear and direct updates as it relates to milestones, regulatory process, and finances. We will continue to incorporate this principle into our messaging as we move forward, presenting a clear picture of where we stand in the development pipeline and celebrating major milestones together. Looking ahead, we are excited to share more about the clarity forming around the putative mechanism of action of leronlimab in solid tumors, as well continued updates relating to the Colorectal Cancer (“CRC”) trial, as further described below. In terms of the regulatory process, I am confident that our collaborative relationship with the FDA has placed us on a positive trajectory. To accelerate progress in oncology where feasible, we’re establishing an oncology advisory board to ensure we are exploring the fastest and most responsible pathway(s) forward. We will continue to look for opportunities to solicit feedback regarding our development process from both KOLs and the FDA. Maintaining strong relationships and credibility with the FDA and industry partners remains a top priority as we chart our future course. The Company continues to be on track financially and we forecast sufficient cash and drug supply on hand to advance our clinical priorities in 2025. As we approach key milestones and announcements in the coming months, we’ll evaluate opportunities to raise additional funds at optimal times and through methods that best serve the Company and its shareholders. We believe leronlimab has already established the potential for tremendous value in the clinic, and in the coming months we look forward to sharing the basis for that conclusion. In sum, the developments in oncology have set the stage for 2025 to be a benchmark year for CytoDyn. This is no longer a platform drug in search of an indication; we now have compelling data to support a role for leronlimab in solid-tumor oncology and are executing on that vision. With Gratitude, Jacob Lalezari, MDCEO Oncology – March 2025 Update The Company continues to prioritize oncology in 2025, as we believe this indication holds the highest potential and shortest timeline for return on investment in the form of a partnership or drug approval. The exciting survival outcomes announced in February 2025 provide early clinical evidence of leronlimab’s potential impact across the field of solid-tumor oncology. As previously announced, we’ve submitted our findings as an abstract to the European Society for Medical Oncology meeting in Munich, Germany in May 2025. We are eager to share additional insights into the apparent mechanism behind the survival outcomes and will do so once appropriate and in compliance with pre-conference publication and announcement allowances. In the meantime, CytoDyn has initiated a follow-up protocol so we can continue to monitor the surviving patients into the future. The CytoDyn/Syneos study teams have now approved eight clinical sites and counting to participate in CytoDyn’s Phase II study of patients with CRC and refractory disease. These clinical sites will include a mix of both large community practices as well as academic centers which all have well-established track records of superior work and high enrollment. With our clinical trial agreements in place and study initiation visits about to start, we expect screening of patients into the CRC study to commence shortly. As previously mentioned, Dr. Ben Weinberg from Georgetown University and the MedStar Health Alliance will be the lead Principal Investigator for the CRC study. Per the FDA’s request, the first five patients enrolled will receive 350 mg of leronlimab SQ once/week in combination with TAS-102 and bevacizumab. After a preliminary safety review by the Data and Safety Monitoring Board (“DSMB”), subsequent patients will be randomized to 350 or 700 mg of weekly leronlimab along with the same background regimen. The DSMB will perform a second safety review after the first 20 patients have completed at least 1 cycle of therapy and can then recommend restricting further enrollment to a single dose level, if deemed appropriate. For additional information, the CRC study protocol is posted on the NCI Clinical Trials website, and can be viewed here. In concert with the observation of prolonged survival in patients with mTNBC described above, CytoDyn remains focused on expeditiously resuming our clinical development in this indication. Two previously announced preclinical studies in TNBC that will identify treatment strategies to optimize the design of future studies are now underway. A third study has begun to further examine the apparent mechanism behind the observed increase in survival as compared to existing treatment paths. In the meantime, we will continue discussions with KOLs about the possibility of initiating a follow-up study in patients with mTNBC on an abbreviated timeline, based on currently available data. The Company also continues to explore the possible use of leronlimab in the treatment of glioblastoma multiforme (“GBM”). A preclinical study at the Albert Einstein College of Medicine sequencing temozolomide and leronlimab is now underway. CytoDyn is also in discussions with several KOLs in neuro-oncology about the possibility of initiating a pilot study in patients with GBM, also based on currently available data. Inflammation – March 2025 Update As previously announced, CytoDyn applied to the NIH/RECOVER-TLC group for the inclusion of leronlimab in their next round of Long Covid treatment studies. The shifting policy landscape in the United States has created some uncertainty around government-sponsored funding of research, but we have been informed by a member of the RECOVER team that their review process has resumed, and we expect a decision soon. In addition, the protocol for a pilot study of leronlimab in the treatment of patients with mild to moderate Alzheimer’s Disease (“AD”) is now finalized. The study will take place at Cornell Medical Center in New York and will evaluate a neuroradiology endpoint that should provide a clear signal of leronlimab’s potential role in treating AD. The study is fully funded, and our colleagues at Cornell are engaged to move the project forward through Cornell’s institutional review process and FDA submission. A new collaborator, Dr. Tom Carmichael, Professor and Chair of Neurology at the University of California, Los Angeles, has published important preclinical observations demonstrating how a small molecule CCR5 inhibitor can expedite recovery following a cerebrovascular accident (“CVA” or “stroke”). CytoDyn is working with Dr. Carmichael and Dr. Kate Schunke at the University of Hawaii to conduct a preclinical study of stroke in transgenic mice that express human CCR5. We are excited by this initiative, given our view that there is an unmet need for innovative and effective treatment paths for patients in this category, and our belief that the market for therapies to treat stroke and/or traumatic brain injury could grow significantly over the next several decades. Dr. Carmichael will also be advising on the pilot study of AD to be initiated at Cornell Medical Center in New York. As announced via press release on February 6, 2025, the final results from SMC Laboratories (“SMC”) indicated statistically significant reversal of liver fibrosis (p< 0.01) in all 3 studies conducted at SMC. Importantly, the reversal of fibrosis appears to be independent of the mechanism of liver insult, as the effect was seen in both metabolic-dysfunction associated steatohepatitis (“MASH”) and CCL4 models of liver injury. To call attention to a key point of clarification, the final results at SMC did not confirm a significant effect of leronlimab on fat accumulation in the liver in the MASH model. Given this observation, we will pause development efforts related to MASH in the near term. Instead, we are continuing discussions with potential partners who have expressed interest in funding studies of leronlimab in the treatment of patients with organ fibrosis to build on the promising findings listed above. Other – March 2025 Update As previously announced, CytoDyn is partnering with the American Foundation for AIDS Research (“amfAR”) to sponsor an HIV cure study called LATCH (Leronlimab in Allogenic stem cell Transplant to Cure HIV). The clinical teams at Oregon Health and Sciences University and the University of Washington remain confident in the chances of success of their LATCH protocol and we look forward to the launch of this program in 2025. CytoDyn continues to prioritize the publication of our clinical data. The exciting observation of improved survival in patients with mTNBC treated with leronlimab has naturally prompted us to reframe the focus of our oncology manuscripts. Submission of these oncology manuscripts for peer review is a top publication priority. Additional ongoing publication efforts include: The manuscript for our CD02 Phase 3 study in patients with multi-drug-resistant HIV was recently published by the Journal of Acquired Immune Deficiency Syndromes and has been posted to our website.The manuscripts for the CD12 Acute Covid and MASH clinical studies are in final preparation for submission.A manuscript summarizing the results of treatment with leronlimab on liver fibrosis from SMC is in preparation.As previously announced, CytoDyn is preparing a manuscript summarizing the integrated safety data from the almost 1,600 patients who have already received leronlimab. The final draft of that safety summary will be completed shortly. Note Regarding Forward-Looking Statements This letter contains forward-looking statements relating to, among other things, clinical drug development and research strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements,” and in Part I, Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statements as a result of new information or future events or developments other than as required by law. Media Contacts CytoDynRiyaz LalaniGagnier CommunicationsCytoDyn@gagnierfc.com

Phase 2Phase 3

17 Mar 2025

·www.fiercebiotech.com

Otsuka\'s Taiho pays $400M for Swiss partner to \'turbocharge\' 3 ADCs to clinic

Taiho Pharmaceutical\'s \"significant cancer expertise will support us in turbocharging the clinical development of our potent ADC candidates in hematological and solid tumors,” Araris Biotech\'s CEO said.\n Otsuka’s Taiho Pharmaceutical is paying $400 million upfront to acquire Switzerland’s Araris Biotech and its antibody-drug conjugate (ADC) linker platform.The two companies have been working together since November 2023, when Araris agreed to use its AraLinQ platform to develop ADCs aimed at Taiho’s targets of choice. Taiho presumably liked what it saw, as the biotech has now decided to go all-in and buy Araris.The deal will see Taiho hand over $400 million, with Araris’ shareholders potentially in line for a further $740 million in milestone payments, according to a March 17 release.Araris has its origins in Switzerland’s Paul-Scherrer-Institute, before spinning off in 2019. The biotech is focused on designing ADCs that have greater linker solubility, with three preclinical therapies aimed at hematological and solid tumors expected to enter human trials over the course of 2025 and 2026.Araris touts its linker tech as having three benefits over its competitors. Firstly, the attachment site on a specific amino acid within the antibody IgG-Fc framework means the antibody maintains almost the same performance when part of the ADC. Meanwhile, the strong peptide bond connecting the linker antibody to the therapy’s payload results in “exceptional stability in the blood stream and therefore, avoidance of healthy tissue damage,” according to the release. This bond then breaks easily inside a cancer cell.“Araris’ unique ADC technology represents a quantum leap for the ADC field, potentially offering precise payload delivery of multiple mechanisms of action simultaneously to the tumor, with less toxicity,” CEO and co-founder Dragan Grabulovski said. “We are proud to combine with Taiho, our partner since November 2023, whose significant cancer expertise will support us in turbo-charging the clinical development of our potent ADC candidates in hematological and solid tumors.”Taiho is a subsidiary of Japan’s Otsuka and markets a wide range of anticancer drugs in the country. In the U.S., the subsidiary has three FDA-approved products: the colorectal treatment Lonsurf, the bile duct cancer med Lytgobi and the myelodysplastic syndromes treatment Inqovi.Using Araris’ ADC drug tech alongside Taiho’s own small-molecule drug discovery platform Cysteinomix will allow Taiho to “further expand its ongoing development portfolio in the field of oncology,” according to this morning’s release.ADCs have been one of the hottest spaces for dealmaking in recent years, with the likes of AstraZeneca, Roche, Merck & Co. and Ipsen all posting billion-dollar-plus biobucks pacts.

$Otsuka\'s Taiho pays $400M for Swiss partner to \'turbocharge\' 3 ADCs to clinic$

ADCDrug ApprovalAcquisition

17 Mar 2025

·www.biopharmadive.com

Taiho buys Swiss biotech and its ADC tech for $400M

Japan-based Taiho Pharmaceuticals on Monday said it will acquire Switzerlands Araris Biotech and its antibody-drug conjugate technology for $400 million upfront.The two companies have worked together since 2023, when they agreed to use Araris technology to explore and develop new drug candidates aimed at targets chosen by Taiho. The deal announced Monday, which they expect to close in the first half of this year, could hand Araris up to $740 million more if certain milestones are met.Antibody-drug conjugates, or ADCs, pair tumor-killing toxins with a targeting molecule via a linker. Improvements in this linking technology have helped buoy the field, yielding new treatments and sparking greater investment. Many large pharmaceutical companies, among them AstraZeneca, Pfizer and Merck & Co, have inked multibillion-dollar deals to pad their pipelines with ADC prospects. AstraZeneca, together with its partner Daiichi Sankyo, have arguably had the most success recently with their ADC drugs Enhertu and Datroway.Spun off from the Paul Scherrer Institute six years ago, Araris was funded by 4BIO Capital in 2020 and again in 2022. The biotech touts its AraLinQ technology, which it claims can provide more stable and more potent ADCs. It is developing three candidates for blood and solid tumors, and expects to advance these prospects into clinical testing this year and next.Araris unique ADC technology represents a quantum leap for the ADC field, potentially offering precise payload delivery of multiple mechanisms of action simultaneously to the tumor, with less toxicity, Dragan Grabulovski, CEO and co-founder of Araris, said in a statement.Taiho, a subsidiary of Japans Otsuka, sells several cancer drugs in the U.S: Lytgobi for bile duct cancer, Lonsurf for colorectal cancer and the myelodysplastic syndromes treatment Inqovi. It also markets other anticancer medicines in Japan. '

ADC

100 Deals associated with Tipiracil Hydrochloride/Trifluridine

External Link

KEGG	Wiki	ATC	Drug Bank
-	Tipiracil Hydrochloride/Trifluridine	L01BC	DB08937

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HER2-positive gastric cancer	South Korea	Jeil Pharmaceutical Co., Ltd.	17 Oct 2019
Metastatic Gastric Carcinoma	Australia	SERVIER LABORATORIES (AUST.) PTY. LTD.	23 May 2017
Metastatic Gastroesophageal Junction Adenocarcinoma	Australia	SERVIER LABORATORIES (AUST.) PTY. LTD.	23 May 2017
Gastroesophageal junction adenocarcinoma	European Union	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	Iceland	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	Liechtenstein	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	Norway	Les Laboratoires Servier SAS	25 Apr 2016
Metastatic Colorectal Carcinoma	United States	Taiho Oncology, Inc.	22 Sep 2015
Colorectal Cancer	Japan	Taiho Pharmaceutical Co., Ltd.	24 Mar 2014
Stomach Cancer	Japan	Taiho Pharmaceutical Co., Ltd.	24 Mar 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	United States	Adir SRL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Japan	Adir SRL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Belgium	Adir SRL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Denmark	Adir SRL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Finland	Adir SRL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Hungary	Adir SRL	21 Apr 2022
Solid tumor	Phase 3	France	Servier Group	30 Jan 2022
Adenocarcinoma of large intestine	Phase 2	France	Les Laboratoires Servier SAS	01 Apr 2025
Dihydropyrimidine Dehydrogenase Deficiency	Phase 2	France	Les Laboratoires Servier SAS	01 Apr 2025
Gastrooesophageal junction cancer	Phase 2	France	Les Laboratoires Servier SAS	01 Apr 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04489173 (BOOG 2019-01 TIBET trial, Pubmed \| EClinicalMedicine)	Phase 2	Metastatic HER2-Negative Breast Carcinoma oestrogen receptor-positive \| HER2-negative	50	Trifluridine-tipiracil 35 mg/m2	yyzqownvad(nobkebiqau) = odcgstcvkx hzlkxkhroh (apodtdqtia, 50.1 - 75.9) View more	Positive	01 Feb 2025
ASCO_GI2025 Manual	Not Applicable	Metastatic Colorectal Carcinoma	639	trifluridine-tipiracil	lyzqjttfos(owishicqrp) = nxpdhzbwuj djjdqtdmdb (hqltspgnqc, 5.7 - 6.9) View more	Positive	23 Jan 2025
				trifluridine-tipiracil+bevacizumab	lyzqjttfos(owishicqrp) = dxvkpxycme djjdqtdmdb (hqltspgnqc, 7.8 - 16.0) View more
NCT04457297 (ALTAIR, ASCO_GI2025) Manual	Phase 3	Colorectal Cancer	243	Trifluridine/Tipiracil (FTD/TPI)	fahipvbdth(hbnwhvxgtn) = ccrsxnvqbk erwhizucst (ajegyqoxyu ) Not Met View more	Negative	23 Jan 2025
				Placebo	fahipvbdth(hbnwhvxgtn) = erpiicepog erwhizucst (ajegyqoxyu ) Not Met View more
ASCO_GI2025 Manual	Not Applicable	Metastatic Colorectal Carcinoma	3,680	trifluridine-tipiracil	uigfcvjupt(bxbxzwcdbx) = usoghyibnv svzzyejrli (zddoedpjnc, 6.1 - 6.6) View more	Positive	23 Jan 2025
				trifluridine-tipiracil+bevacizumab	uigfcvjupt(bxbxzwcdbx) = pvkchwkkff svzzyejrli (zddoedpjnc, 8.0 - 10.1) View more
BeTAS trial (ASCO_GI2025)	Not Applicable	Metastatic Colorectal Carcinoma Third line RAS mutations	208	Trifluridine/tipiracil and bevacizumab (FTD/TPI+BEV)	brtucqdozq(yrzcrmcxwr) = vpuenmvcyx brhyeermqd (bzwnqgwhfd ) View more	Positive	23 Jan 2025
NCT06202001 (ASCO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma Second line	60	Trifluridine/tipiracil (TAS-102) + Irinotecan + Bevacizumab	xbdgmgyqjs(bbzknnbzyu) = yuvonngztd culcujvraf (cczceinzgi ) View more	Positive	23 Jan 2025
ASCO_GI2025	Not Applicable	Colorectal Cancer Third line	75	TAS-102	zxbmmeijod(qrbpqapcqy) = tutybypyyv ojzrdicfej (gybasvtuoo )	Negative	23 Jan 2025
				Chemotherapy rechallenge	zxbmmeijod(qrbpqapcqy) = aexenpglcl ojzrdicfej (gybasvtuoo )
HGCSG2302 (ASCO_GI2025)	Not Applicable	Advanced gastric carcinoma	164	FTD/TPI plus Ramucirumab	asinuoeifu(bzywtwarqn) = 48.6% vs 52.4% (p=0.707) bidnytvdov (imifqzfynv ) View more	Positive	23 Jan 2025
				FTD/TPI
ASCO_GI2025	Not Applicable	MSI-high \| deficient MMR	18	trifluridine/tipiracil (FTD/TPI + BEV)	bnmzmwgbhv(cspkuszots) = udkidcrdbu ixoqdjulbz (aqrzhhdlwz, 3.6 - 41.4) View more	Positive	23 Jan 2025
				trifluridine/tipiracil (FTD/TPI)	eyuxdzewep(silyhdtiva) = xjwluulljk hggeatsedt (ccvliizrej )
NCT02848079 (ASCO_GI2025)	Phase 1/2	Colorectal Cancer RAS mutated	54	TAS102 with oxaliplatin (TASOX)	xezvymxeqt(cdunrjpaph) = kbznlfmtte vdlpvicyxg (nrfcobqrdy ) View more	Positive	23 Jan 2025

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