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Xilio Therapeutics Announces Initiation of Enrollment for Phase 1 Combination Trial of XTX101, a Tumor-Activated, Fc-Enhanced Anti-CTLA-4, and Updated Phase 1 Monotherapy Data

On December 7, 2023 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported the initiation of enrollment for its Phase 1 clinical trial of XTX101, an investigational tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab and reported updated monotherapy data from its ongoing Phase 1 clinical trial evaluating XTX101 in late-line patients with advanced and immuno-oncology (IO) refractory solid tumors (Press release, Xilio Therapeutics, DEC 7, 2023, View Source [SID1234638260]). The data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress on December 7, 2023.

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"With the recent initiation of Phase 1 dose escalation for XTX101 in combination with atezolizumab, we look forward to establishing a recommended Phase 2 dose in support of our plans to evaluate the combination in a Phase 2 trial in patients with microsatellite stable colorectal cancer (MSS CRC), including patients with liver metastases where there is an especially significant unmet need," said Katarina Luptakova, M.D., chief medical officer of Xilio. "The new Phase 1 data we reported for XTX101, which include 18 patients treated at the recommended Phase 2 dose of 150 mg Q6W, continue to demonstrate XTX101’s promising safety profile with primarily Grade 1 or 2 treatment-related adverse events. In addition to the previously reported confirmed partial response in a non-small cell lung cancer patient through 36 weeks, these new data also suggest further evidence of monotherapy anti-tumor activity in late-line and IO refractory patients at the recommended Phase 2 dose."

Updated Data from the Ongoing Phase 1 Clinical Trial for XTX101

As of the data cutoff date of November 13, 2023, 36 patients with advanced solid tumors had been administered XTX101 monotherapy, including 18 patients at the recommended Phase 2 dose and schedule (RP2D) of 150 mg once every six weeks (Q6W).

Patients treated at the RP2D of 150 mg Q6W were heavily pre-treated, with 83% of patients receiving three or more lines of anti-cancer therapy and 56% previously treated with an immunotherapy.

Preliminary Safety Data

At the RP2D of 150 mg Q6W, 18 patients (including 9 patients previously reported) were evaluable for safety as of the data cutoff date:

● Safety data were consistent with previously reported results. XTX101 monotherapy was generally well-tolerated with treatment-related adverse events (TRAE) primarily Grade 1 or 2, and no patients discontinued treatment due to a TRAE. In addition, as previously reported, only one patient had a dose reduction due to an adverse event.
● The most common TRAE of any grade (≥10% incidence) reported by investigators was fatigue (11%).
● As previously reported, investigators reported only two Grade 3 TRAEs: Grade 3 TRAE of diarrhea, which occurred after two doses and resolved after five days without steroid use, and one Grade 3 TRAE of dermatitis.

In addition, as previously reported, no Grade 4 or 5 TRAEs were reported by investigators across all dosing levels and dosing intervals.

Preliminary Anti-Tumor Activity Data

At the RP2D of 150 mg Q6W, 12 patients were evaluable for anti-tumor activity as of the data cutoff date:

● As previously reported, a confirmed partial response (PR) was observed in a patient with Stage 4 PD-L1 negative non-small cell lung cancer (NSCLC), including complete resolution of liver metastases. The confirmed PR continued through 36 weeks of treatment with XTX101, with the patient discontinuing treatment after week 36 due to an unrelated adverse event.
● Additional data reported today demonstrated a disease control rate (DCR) of 33% in late-line and IO refractory patients administered XTX101 monotherapy at the RP2D of 150 mg Q6W, consisting of the confirmed PR in the NSCLC patient and stable disease in three patients (triple-negative breast cancer, melanoma and microsatellite stable colorectal cancer (n=1 each)).

Preliminary Pharmacokinetic Data

As previously reported, consistent with the tumor-selective design for XTX101, preliminary pharmacokinetic analyses demonstrated 96% activation of XTX101 in a melanoma tumor and 73% activation in a metastatic liver lesion in a colorectal cancer patient, compared to minimal peripheral activation of XTX101 of 13% in both patients.

Poster Presentation

A copy of Xilio’s data presentation from the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress for XTX101 is available in the "Our Approach—Publications and Presentations" section of the company’s website at www.xiliotx.com.

Clinical Development Plans for XTX101

Xilio recently completed enrolling patients at the RP2D of 150 mg Q6W in monotherapy dose expansion and initiated enrollment in Phase 1 combination dose escalation to evaluate the safety, tolerability and efficacy of XTX101 in combination with atezolizumab.

As previously reported, subject to obtaining sufficient additional capital, Xilio plans to:

● Complete Phase 1 combination dose escalation and select a RP2D for XTX101 in combination with atezolizumab in the second quarter of 2024
● Subject to the results of Phase 1 combination dose escalation, initiate a Phase 2 trial to evaluate the safety and efficacy of XTX101 in combination with atezolizumab in patients with MSS CRC in the third quarter of 2024

About XTX101 (anti-CTLA-4) and the Phase 1 Monotherapy and Phase 1/2 Combination Clinical Trials

XTX101 is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). The Phase 1 clinical trial is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX101 for the treatment of adult patients with advanced solid tumors. Xilio has completed enrollment in monotherapy dose escalation (Part 1A) and monotherapy dose expansion (Part 1B). Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

Xilio is currently evaluating the safety and tolerability of XTX101 in combination with atezolizumab (Tecentriq) in Phase 1 dose escalation in patients with advanced solid tumors, and subject to obtaining additional capital and the results of Phase 1 combination dose escalation, Xilio plans to evaluate the safety and efficacy of the combination in a Phase 2 trial in patients with microsatellite stable colorectal cancer (MSS CRC).

Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant

On December 7, 2023 Sanofi reported that the Phase 3 IMROZ trial evaluating the investigational use of Sarclisa (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival (PFS) compared with VRd alone in transplant-ineligible patients with newly diagnosed multiple myeloma (MM) (Press release, Sanofi, DEC 7, 2023, View Source [SID1234638259]). This is also the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care.

Thierry Facon, MD
Professor of Haematology in the Department of Haematology, Lille University Hospital, Lille, France, member of French Academy of Medecine and IMROZ Principal Investigator

"The IMROZ trial outcome is promising for patients with newly diagnosed multiple myeloma who are transplant-ineligible, as there remains a significant unmet need for potential new therapies. First line therapeutic options are critical for all patients, but especially for those who are transplant-ineligible, given attrition rates in subsequent lines of therapy."

The safety and tolerability of Sarclisa observed in this trial was consistent with the established safety profile of Sarclisa and VRd.

Dietmar Berger, MD, PhD
Global Head of Development, Sanofi

"This is the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care, reinforcing our belief in Sarclisa as a best-in-class medicine. These data underscore our commitment to advancing scientific innovation for people living with multiple myeloma, and we look forward to sharing more detail on Sarclisa’s potential to improve outcomes for patients receiving earlier lines of therapy."

Study results will be submitted for presentation at an upcoming medical meeting and form the basis of a future regulatory submission.

About the IMROZ trial

The randomized, multi-center, open label Phase 3 IMROZ clinical trial enrolled 484 patients with newly diagnosed transplant-ineligible MM across 104 centers spanning 21 countries. During the trial, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for five weeks during first 42-day cycle and once every two weeks in cycles 2 to 4 in combination with subcutaneous bortezomib, oral lenalidomide and intravenous or oral dexamethasone. Then Sarclisa was administered every 2 weeks from cycle 5 to 17 and every 4 weeks in cycles 18+ during 28-day cycles in combination with lenalidomide and dexamethasone at the standard dose, until disease progression, unacceptable safety profile or patient’s decision to stop the study treatment. The primary endpoint of IMROZ is progression-free survival. Key secondary endpoints include complete response rate, minimal residual disease negativity rate for patients with a complete response, very good partial response or better rate, overall survival. Other secondary endpoints are: overall response rate, time to progression, duration of response, time to first response, time to best response, progression-free survival on next line of therapy, progression-free survival by MRD status, sustained MRD negativity greater than or equal to 12 months rate, safety, pharmacokinetic profile, immunogenicity, disease-specific and generic health-related quality of life, disease and treatment-related symptoms, health state utility, and health status.1

The use of Sarclisa in combination with VRd in transplant-ineligible newly diagnosed MM is investigational and has not been fully evaluated by any regulatory authority.

About Sarclisa

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Based on the Phase 3 ICARIA-MM study, Sarclisa is approved in >50 countries, including the U.S. and EU, in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed refractory MM (RRMM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor and who progressed on last therapy. Based on the Phase 3 IKEMA study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the U.S. for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA).

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies, and its safety and efficacy have not been evaluated by any regulatory authority outside of its approved indication.

For more information on Sarclisa clinical trials, please visit www.clinicaltrials.gov.

About multiple myeloma

MM is the second most common hematologic malignancy.2 Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.

Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma

On December 7, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the primary endpoint analysis from the pivotal trial (LINKER-MM1) investigating linvoseltamab demonstrated high rates of deep and durable responses in patients with relapsed/refractory (R/R) multiple myeloma (MM) (Press release, Regeneron, DEC 7, 2023, View Source [SID1234638257]). These Phase 1/2 results are planned to be submitted to regulatory authorities, including to the U.S. Food and Drug Administration (FDA) this year. Linvoseltamab is an investigational BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

"Multiple myeloma remains an incurable disease, in which patients endure cycles of relapse and remission, resulting in a critical need for innovative medicines," said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Hematology at Regeneron. "With longer follow-up data on linvoseltamab, we’re seeing deep and durable responses with a complete response rate nearing 50% in a difficult-to-treat patient population who had received a median of 5 prior lines of therapy. Furthermore, in our trial, the regimen had a short monitoring time and a convenient, response-adapted administration schedule that enabled deep responders to go from every two-week to every four-week dosing. This regimen saved time for clinicians and patients, underscoring the potential for linvoseltamab as a patient-centric option in relapsed/refractory multiple myeloma."

At a median duration of follow-up of 11 months, an objective response rate of 71% as assessed by an independent review committee, with 46% achieving a complete response or better, was observed in patients treated with linvoseltamab 200 mg in the Phase 1/2 trial (n=117). After a minimum of 24 weeks of therapy, patients who achieved a very good partial response (VGPR) or better shifted from every two-week to every four-week dosing. These results build on an earlier data cut, with 8 months of median follow-up, that will be presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition from December 9 to 12 in San Diego, CA.

Among this group of patients, 27% of patients were over 75 years old, 16% had extramedullary plasmacytomas, 23% had bone marrow plasma cells ≥50%, and 39% had high-risk cytogenetics – representing a patient population with a high disease burden and typically poor prognosis. Additionally, 17% were Black or African American, mirroring rates that are representative of MM in the U.S.

Based on the latest data cut, all patients treated with 200 mg experienced an adverse event (AE), including 85% who experienced Grade ≥3 adverse events (AE). The most commonly occurring AE was cytokine release syndrome (CRS; 46%). Of the CRS cases, the majority (35%) were Grade 1, 10% were Grade 2 and there was one case (1%) of Grade 3 CRS. Adjudicated immune effector cell-associated neurotoxicity syndrome (ICANS) events occurred in 9 patients (8% all Grades); Grade 3 ICANS occurred in 3 patients, and no cases of ≥Grade 4 cases. All grade infections were observed in 73% of patients; 34% were Grade 3 or 4. Deaths due to treatment-emergent AEs on-treatment or within 30 days post last dose occurred in 14 patients (12%), of which 11 (9%) were due to infections.

The development program investigating linvoseltamab, including in earlier stages of the disease is underway. In the U.S., linvoseltamab has been granted Fast Track Designation for multiple myeloma by the FDA. Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Investor Webcast Information
Regeneron will host a conference call and simultaneous webcast to share updates on the company’s hematology portfolio on Thursday, December 14 at 8:30 AM ET. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

About the Phase 1/2 Trial
The ongoing, open-label, multicenter Phase 1/2 dose-escalation and dose-expansion trial is investigating linvoseltamab in patients with R/R MM. Among the 282 patients enrolled, all have received at least three prior lines of therapy or are triple refractory. Patients were administered linvoseltamab utilizing a step-up dosing regimen that was designed to help mitigate CRS.

The Phase 1 intravenous dose-escalation portion of the trial, which is now complete, primarily assessed safety, tolerability and dose-limiting toxicities across nine dose levels of linvoseltamab exploring different administration regimens. The Phase 2 dose expansion portion of the trial (LINKER-MM1) is further assessing the safety and anti-tumor activity of linvoseltamab, with a primary objective of ORR. Key secondary objectives include duration of response, PFS, rate of minimal residual disease negative status and overall survival.

About Multiple Myeloma
Multiple myeloma is the second most common blood cancer. Globally, there are over 176,000 new cases diagnosed annually and an estimated 35,000 people were diagnosed in the U.S. It is characterized by the proliferation of cancerous plasma cells (multiple myeloma cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Multiple myeloma is not curable despite treatment advances, and while current treatments are able to slow the progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.

Regeneron to Share Progress of Novel Combination Therapies in Oncology at ESMO IO

On December 7, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the presentation of new and updated data on multiple combination therapies from its oncology pipeline at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2023 from December 6 to 8 in Geneva, Switzerland (Press release, Regeneron, DEC 7, 2023, View Source [SID1234638255]). Highlights include first Phase 1 dose-escalation data for the investigational costimulatory bispecific antibody REGN5668 (MUC16xCD28) in combination with PD-1 inhibitor Libtayo (cemiplimab) showing encouraging initial activity in patients with recurrent ovarian cancer. Additionally, a late-breaking oral presentation will detail the first results from a Phase 2 trial investigating neoadjuvant Libtayo in combination with low-dose stereotactic body radiotherapy (SBRT) in patients with early-stage hepatocellular carcinoma (HCC).

"Our ESMO (Free ESMO Whitepaper) IO presentations highlight the continued progress of Regeneron’s oncology pipeline, which was strategically curated to have the potential to offer novel and differentiated combinations targeting several types of difficult-to-treat cancers. We look forward to sharing first clinical data from our costimulatory bispecific program in patients with recurrent ovarian cancer, which is investigating a MUC16xCD28 bispecific antibody in combination with our PD-1 inhibitor Libtayo," said Israel Lowy, Senior Vice President, Translational and Clinical Oncology at Regeneron. "This is our second costimulatory bispecific program to report clinical data, with a total of four such agents currently in the clinic, and adds to the evidence showing that our novel CD28 costimulatory bispecifics can potentially enhance the anti-tumor activity of anti-PD-1 therapies in a synergistic fashion. Studies are also underway exploring the combination of CD28 costimulatory bispecifics with CD3 bispecifics, including REGN5668 with ubamatamab, our MUC16xCD3 bispecific."

Per initial results to be shared at ESMO (Free ESMO Whitepaper) IO, a combination of REGN5668 with Libtayo showed early clinical activity in patients with recurrent ovarian cancer. The trial enrolled 28 platinum-experienced patients with recurrent ovarian cancer, who received infusions of REGN5668 once-weekly at a dose range of 0.3-300 mg, with the addition of Libtayo infusions every three weeks beginning between day 21 and 28. At the time of initial data cut off (July 14, 2023), 6 patients (21%) had stable disease, while 1 patient (in the 300 mg REGN5668 cohort) had an ongoing confirmed partial response with a 59% target lesion reduction from baseline. Dose escalation is ongoing and has included administration of REGN5668 doses beyond 300 mg in combination with Libtayo.

The combination of REGN5668 and Libtayo demonstrated an acceptable safety profile in 28 patients with fatigue (32%), nausea (29%) and pain (18%) as the most common treatment-related adverse events (TRAEs). Infusion-related reactions occurred in 7% of patients and cytokine release syndrome occurred in 11% of patients and were all grade 1 or 2. There was one instance of a TRAE that was grade 3, which was fatigue. As of data cut off, there were no dose-limiting toxicities or adverse events resulting in death or treatment discontinuation. Dose escalation is continuing in order to define an optimal dose for expansion cohorts.

Regeneron presentations at ESMO (Free ESMO Whitepaper) IO:

Medicine(s) Abstract Title Abstract Lead Author Presentation date/time (all CET)

Libtayo, REGN5668 REGN5668 (MUC16xCD28 bispecific antibody) with cemiplimab (anti-PD-1 antibody) in recurrent ovarian cancer: Phase 1 dose-escalation study #127P John L. Hayes, M.D., Ph.D. Thursday, December 7, 2023; 12PM–1PM CET

Libtayo, chemotherapy Patient-reported outcomes (PROs) of cemiplimab + chemotherapy in advanced non-small cell lung cancer (NSCLC): EMPOWER-lung 3 liver metastases subpopulation #783P Ana Baramidze, M.D., Ph.D. Thursday, December 7, 2023; 12PM–1PM CET

Libtayo, SBRT Low-dose stereotactic body radiotherapy prior to pre-operative cemiplimab for patients with resectable hepatocellular carcinoma #LBA4 Thomas Marron, M.D., Ph.D. Thursday, December 7, 9:25AM–9:30AM CET
The potential uses of Libtayo and REGN5668 described above are investigational, and their safety and efficacy in these uses have not been fully evaluated by any regulatory authority. REGN5668 is not currently approved for use in any indication.

PureTech Presents Data from Phase 1 Trial of LYT-200 Targeting Galectin-9 in Solid Tumors at the ESMO Immuno-Oncology Congress 2023

On December 7, 2023 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, reported a poster presentation with results from the Phase 1 portion of the Phase 1/2 dose escalation and expansion clinical trial of LYT-200 at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2023 (Press release, PureTech Health, DEC 7, 2023, View Source [SID1234638254]). LYT-200 is an anti-galectin-9 antibody being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene, in metastatic solid tumors, including urothelial and head and neck cancers. LYT-200 is also in development for the treatment of hematological malignancies, such as acute myeloid leukemia.

The data being presented from an ongoing study including all evaluable patients demonstrate that LYT-200 has a favorable safety profile in all cohorts, including the monotherapy and combination arms, and shows disease control and initial anti-tumor activity in combination with tislelizumab. In the combination cohort, anti-tumor activity was observed in patients with relapsed or refractory head and neck squamous cell carcinoma, a patient population that has historically demonstrated a low response rate to anti-PD-1 agents of around 20 percent and 10 percent with chemotherapy.

"Galectin-9 is thought to play a foundational role in suppressing immune-mediated activity against tumor cells, and increases in galectin-9 expression have been shown to correlate with aggressive disease and higher mortality, as is seen in patients with head and neck and urothelial cancers," said Julie Krop, M.D., Chief Medical Officer at PureTech Health. "LYT-200 is the most advanced clinical program against this target, and we are very encouraged by the initial results and look forward to completing this study and advancing this program into late-stage development."

The Phase 1/2 clinical trial includes a dose finding/dose escalation phase (part 1) and an expansion cohort phase (part 2) in patients with relapsed and refractory, locally advanced/metastatic solid tumors. In the monotherapy cohort, 20 patients received LYT-200 across seven escalation doses, with dose levels of 0.2 mg/kg to 16 mg/kg once every two weeks or 10 mg/kg once a week. LYT-200 was well-tolerated with no observed dose-limiting toxicities and only low-grade adverse events, as well as long-term disease stabilization exceeding one year in patients with heavily pre-treated pancreatic cancer and in one patient with colorectal cancer. The monotherapy arm of the trial has been completed, and the clinically relevant dose was selected for the Phase 2 portion of the trial.

In the combination arm, 11 patients have been dosed, and the initial subset of all evaluable patients treated so far includes four patients with head and neck cancers and two patients with urothelial cancer. In the evaluable patients with head and neck cancers, disease control was observed in three of the four patients, with one patient experiencing a complete response for nine months, one patient with a deepening partial response for eight months, and one patient with disease stabilization for four months, and treatment in these patients remains ongoing. The two evaluable patients with urothelial cancer experienced disease stabilization for seven months and three months, and both remain on treatment. The combination arm continues to enroll patients with urothelial and head and neck cancers.

"Galectin-9 is a promising target for the treatment of solid tumors, and the initial results from the LYT-200 Phase 1 trial support its clinical potential," said Zev Wainberg, M.D., Professor of Medicine at UCLA and Co-director of the UCLA GI Oncology Program, and the lead primary investigator of the study.

The poster titled "Phase 1/2 Trial of Galectin-9 Antibody LYT-200 +/- Tislelizumab" will be presented today at The ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2023, which is taking place in Geneva, Switzerland.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational immunosuppressive protein, galectin-9, for the potential treatment of metastatic/locally advanced solid tumors, including urothelial and head and neck cancers, with otherwise poor survival rates. A wide variety of preclinical data supports the potential clinical efficacy of LYT-200 and the importance of galectin-9 as a target and suggests a potential opportunity for biomarker development. PureTech has presented data demonstrating high expression of galectin-9 across various solid tumor types and blood cancers and has found that in several cancers that galectin-9 levels correlate with shorter time to disease relapse and poor survival. Preclinical work also demonstrates single mechanistic and anti-tumor efficacy of LYT-200 in multiple animal and patient-derived tumor cell models. For example, LYT-200 outperforms anti-PD-1 in preclinical models as a single agent. LYT-200 also synergizes with anti-PD-1 in activating CD4 and CD8 T cells in cancer in vivo models. LYT-200 is currently being evaluated in a Phase 1/2 adaptive design trial for the potential treatment of advanced solid tumors and in a Phase 1b clinical trial for the potential treatment of acute myeloid leukemia (AML).