On December 5, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO (Free ESMO Whitepaper) Asia Congress 2025. Data in treatment-naïve and in previously treated NSCLC patients with EGFR exon 20 mutations were presented at an oral session, and the presentation can be found in the publication section of ORIC’s website here.

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"Enozertinib was purposefully designed to be highly brain-penetrant and exquisitely selective in order to address the limitations of available therapies and potentially drive differentiated durability. These data provide clinical support for this design approach, demonstrating strong systemic and CNS activity in NSCLC patients with EGFR exon 20 mutations," said Pratik S. Multani, M.D., chief medical officer. "The profile we have seen with enozertinib compares favorably to other approved and investigational therapies and continues to support enozertinib’s best-in-class potential."

Enozertinib Phase 1b Trial Design
Enozertinib is being evaluated in a Phase 1b trial in patients with locally advanced or metastatic NSCLC with EGFR exon 20 mutations. Notably, enrollment allows patients with active untreated brain metastases. Prior therapy in 2L patients consisted of platinum-based chemotherapy. The primary endpoint of the trial is to determine the recommended Phase 2 dose (RP2D), and secondary endpoints include investigator-assessed objective response rate (ORR), CNS response rate by blinded independent central review (BICR) using response assessment in neuro-oncology (RANO) criteria in treatment-naïve patients, disease control rate (DCR), and safety.

2L NSCLC Patients with EGFR Exon 20 Mutations
As of the August 29, 2025 cutoff date, 45 2L patients were dosed — 24 patients received 80 mg QD oral enozertinib and 21 patients received 120 mg QD. Brain metastases were present in 38% of patients at baseline, including those with active brain metastases.

Preliminary Safety Analysis
Enozertinib was well tolerated with mostly Grade 1 or 2 treatment-related adverse events (TRAEs) and no significant off-target toxicities. Most frequent TRAEs included diarrhea, paronychia, and stomatitis. Only 3 patients discontinued treatment due to TRAEs and higher rates of dose reductions occurred in the 120 mg cohort compared to the 80 mg cohort.

Preliminary Activity Analysis
In the 20 efficacy evaluable patients in the 80 mg cohort, enozertinib demonstrated strong systemic and CNS antitumor activity.

45% confirmed ORR and 100% DCR, with comparable rates in patients with brain metastases at baseline
As of the data cutoff (at a median follow-up of over 30 weeks), 67% of responders remained on treatment
1L NSCLC Patients with EGFR Exon 20 Mutations
As of the August 29, 2025 cutoff date, 33 1L patients were dosed — an initial cohort of 15 patients received 120 mg QD oral enozertinib and a subsequent cohort of 18 patients received 80 mg QD. Brain metastases were present in 39% of patients at baseline, including those with active brain metastases.

Preliminary Safety Analysis
Enozertinib was well tolerated with mostly Grade 1 or 2 TRAEs and no significant off-target toxicities. Most frequent TRAEs included diarrhea, paronychia, and stomatitis. Only 2 patients discontinued treatment due to TRAEs.

The initial cohort of efficacy-evaluable patients was treated at 120 mg QD and 80% of these patients underwent early dose reductions due to TRAEs, such that most of these patients received an effective dose of 80 mg QD. The subsequent cohort of patients was treated at 80 mg QD, for which follow-up is still in progress.

Preliminary Activity Analysis
In the 15 efficacy-evaluable patients in the 120 mg cohort, the majority of which received an effective dose of 80 mg QD, enozertinib demonstrated strong systemic and CNS antitumor activity.

67% best ORR (60% confirmed ORR) and 93% DCR
100% confirmed intracranial ORR (by BICR-RANO) in patients with measurable CNS disease
In 4 patients with non-measurable CNS disease, 2 achieved confirmed intracranial complete responses, both with active untreated brain metastases
As of the data cutoff (at a median follow-up of 33 weeks), 80% of responders remained on treatment
Next Steps
Based on these data, 80 mg QD oral enozertinib has been selected as the dose for potential Phase 3 development. Enrollment and follow-up continues in 1L EGFR exon 20 patients with the next update expected in mid-2026, ahead of initiation of a potential Phase 3 trial.

Conference Call and Webcast Details
In conjunction with the ESMO (Free ESMO Whitepaper) Asia Congress, ORIC will host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of ORIC’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

(Press release, ORIC Pharmaceuticals, DEC 5, 2025, View Source [SID1234661170])

On December 5, 2025 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, notes that its Founded Entity, Gallop Oncology, reported initial topline results from the Phase 1b clinical trial evaluating LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, in patients with relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The data demonstrated a favorable tolerability profile and strong efficacy, supporting the advancement of LYT-200 into a potentially registrational Phase 2 trial in AML. Additional details will be shared at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 6th, 2025.

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"Patients with relapsed/refractory AML or high-risk MDS face extremely limited treatment options, and overall survival at this stage is typically less than 2.5 months. With LYT-200, we have demonstrated durable responses, enabled a substantially meaningful proportion of patients to proceed to transplant, and shown initial median overall survival data of 13.2 months at the proposed Phase 2 dose – all alongside a very favorable safety profile. Together, these findings represent a potential step change in the treatment of AML," said Luba Greenwood, JD, Chief Executive Officer of Gallop Oncology. "Importantly, these compelling results were observed in patients across several high-risk mutations, underscoring the central role of galectin-9 in driving this disease as well as the potential broad applicability of LYT-200 in AML and beyond. The strength of the data gives us confidence as we advance toward a potentially registrational Phase 2 study in AML and supports future evaluation of LYT-200 in earlier lines of treatment. We look forward to engaging with regulatory authorities once the maturing overall survival data are finalized."

The Phase 1b, open-label, dose-escalation and dose-expansion trial evaluated LYT-200 both in combination with the standard-of-care (SOC) regimen of venetoclax (VEN) and a hypomethylating agent (HMA) and as a monotherapy in a heavily pretreated patient population (median prior lines of treatment: 3; range: 1-7).

TOPLINE SAFETY

LYT-200 demonstrated a favorable safety profile, with no LYT-200-related serious adverse events or dose-limiting toxicities observed in the trial (n=101). Importantly, no overlapping or additive toxicities were seen when LYT-200 was combined with VEN/HMA.

INITIAL TOPLINE EFFICACY

Combination Cohorts

The majority of participants (87.5%) in the combination cohort had previously been treated with VEN/HMA, and their disease had either returned or failed to respond. Across all evaluable patients[1] treated with LYT-200 in combination with VEN/HMA (n=43), robust antileukemic activity was demonstrated, with a combined complete response (complete response + complete response with incomplete hematological recovery) rate of 33%. Among those who achieved a complete response, 50% proceeded to stem cell transplant. Responses were observed in patients with diverse, high-risk mutations, including KRAS, NRAS, JAK2, and KIT, underscoring LYT-200’s mutation-agnostic mechanism of action and potential for broad use.

At the proposed Phase 2 dose of 12 mg/kg (n=32 evaluable), treatment with LYT-200 in combination with VEN/HMA demonstrated:

38% combined complete response rate
97% disease control rate
Initial median overall survival of 13.2 months, with data continuing to mature into the first half of 2026

Monotherapy Cohorts

As a monotherapy (n=26 evaluable), LYT-200 demonstrated clinical activity and disease stabilization in patients whose disease had progressed following multiple prior lines of treatment, supporting the independent mechanism of galectin-9 blockade as a single agent. Median overall survival in this cohort was 6.5 months, and one partial response has been maintained for 27 months in a patient whose disease previously progressed following five prior rounds of treatment.

"For patients whose AML has progressed, survival is often measured in months, and the toxicities of additional treatments frequently limit what we can realistically offer. What stands out with the LYT-200 data is not only the durable responses we have seen and the ability for some patients to proceed to transplant, but that these outcomes were achieved with a highly favorable tolerability profile," said Amir T. Fathi, MD, Program Director of the Center for Leukemia at the Massachusetts General Hospital Cancer Center and Associate Professor of Medicine at Harvard Medical School. "LYT-200 is not a targeted therapy in the traditional sense; it targets galectin-9, a foundational driver of leukemia biology. The significance of this approach is evidenced by the activity observed across multiple high-risk mutations, suggesting LYT-200 may be uniquely applicable across a broad patient population. Coupled with the emerging overall survival signal at the proposed Phase 2 dose, these data provide strong clinical rationale to advance LYT-200 into late-stage development for the treatment of AML."

LYT-200 has been granted Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of AML. Gallop intends to engage with regulatory authorities to discuss the proposed Phase 2 dose and potentially registrational path after the overall survival data have fully matured. Final overall survival results are expected in the first half of 2026.

The poster shared at ASH (Free ASH Whitepaper) 2025 will be made available on Gallop’s website.

About AML

Acute myeloid leukemia (AML) is an aggressive blood cancer characterized by the rapid growth of abnormal myeloid cells in the bone marrow and blood. It is the most common form of acute leukemia in adults, with a five-year survival rate of less than 30%. Despite available therapies, many patients relapse or fail to respond, and outcomes are especially poor in the relapsed/refractory setting. Around 450,000 people globally are living with AML.

AML is an area of urgent medical need where new therapies with improved efficacy and durability are critical. Importantly, the incidence of AML is increasing, and the market is expected to grow to $6 billion by 2030, underscoring the scale of the opportunity to bring forward therapies that are not only more effective but also applicable across a broader segment of patients.[2]

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody in development for the treatment of hematological malignancies and solid tumors with otherwise poor survival rates.

LYT-200’s target, galectin-9, is a key oncogenic driver and potent immunosuppressor in cancer. Blocking galectin-9 is believed to have a dual mode of action, both killing tumor cells directly while also stimulating anti-tumor immunity. Galectin-9 is the fundamental driver of the AML disease process. AML stem cells have higher expression of galectin-9 than their healthy counterparts, and higher expression is associated with treatment failure.

LYT-200 has been granted Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia, underscoring the high unmet need in this disease and the potential for LYT-200 to serve as a meaningful therapeutic option.

(Press release, PureTech Health, DEC 5, 2025, View Source [SID1234661171])

On December 5, 2025 Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, reported an upcoming scientific presentation of the company’s Phase 1/2 study of WU-CART-007 (Soficabtagene Geleucel "Sofi-cel"). Researchers will present Phase 1/2 correlative data and long-term follow-up update for its investigational cell therapy this week at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, Dec. 6-9 in Orlando.

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Sofi-cel is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy currently under evaluation in a pivotal trial (T-RRex) for patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL).

In the Phase 1/2 Study, Sofi-cel exhibited over one-hundred-fold expansion following infusion and persisted in circulation for up to three months. The serum cytokine profile was consistent with the mechanism of action. In the Long-Term Follow-Up study, there were no reported late adverse-events of special interest or drug-related serious adverse effects. Three patients who received a successful allogeneic stem cell transplant in the Phase 1/2 study remain alive approximately two years after Sofi-cel infusion, highlighting the promise of this investigational therapy in a challenging patient population.

"The robust cellular pharmacokinetics and long-term survival observed in heavily pretreated patients with R/R T-ALL/LBL in the Phase 1/2 study give confidence in the therapeutic potential of Soficabtagene Geleucel," said Wugen Chief Medical Officer, Cherry Thomas, M.D. "The T-RRex investigators bring extensive experience in this challenging disease and are committed to delivering meaningful clinical benefit for patients with limited treatment options."

The pivotal Phase 2 T-RRex study (NCT06514794) is a single-arm trial evaluating the safety and efficacy of Sofi-cel in patients with R/R T-ALL/LBL. The study is currently enrolling patients aged ≥ 1 year with R/R T-ALL/LBL and will include an exploratory cohort assessing patients with minimal residual disease (MRD)-positive status.

Wugen Presentation at ASH (Free ASH Whitepaper)

4163 WU-CART-007, a CD7-directed allogeneic CAR-T cell therapy for R/R T-cell acute lymphoblastic leukemia/lymphoma: Phase 1/2 correlative data and long-term follow-up update

Presenter: Alexander S. Hamil, Ph.D., Wugen Inc., St. Louis

Presentation type: Poster

Time/location: Sunday, Dec. 7, 6:00-8:00 p.m. ET; OCCC – West Halls B3-B4
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II

About Soficabtagene Geleucel (Sofi-cel)

Sofi-cel is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat T-cell cancers. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC) genes, thereby preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host disease (GvHD). Sofi-cel is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-ALL/T-LBL. More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT04984356 and on the pivotal trial on clinicaltrials.gov, identifier NCT06514794.

Sofi-cel has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed or refractory T-ALL/T-LBL. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.

(Press release, Wugen, DEC 5, 2025, https://wugen.com/wugen-to-present-correlative-data-and-long-term-follow-up-updates-for-off-the-shelf-allogeneic-cd7-targeted-car-t-cell-therapy-at-the-2025-ash-annual-meeting/ [SID1234661172])

On December 5, 2025 XOMA Royalty Corporation ("XOMA Royalty") (Nasdaq: XOMA), the biotech royalty aggregator, reported it has successfully completed its previously announced acquisition of the entire issued and to be issued share capital of Mural Oncology plc ("Mural") (Nasdaq: MURA) (the "Acquisition") pursuant to an Irish High Court sanctioned scheme of arrangement under Chapter 1 of Part 9 of the Companies Act 2014 of Ireland (the "Scheme"). Mural shareholders received $2.035 in cash per share (the "Consideration").

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The Acquisition was approved by Mural shareholders at a special meeting of shareholders convened pursuant to section 450(1) of the Irish Companies Act 2014 and an extraordinary general meeting of shareholders held on October 24, 2025.

The Irish High Court sanctioned the Scheme on December 3, 2025. On December 5, 2025, the Scheme and the Acquisition became effective upon delivery of the court order to the Irish Companies Registration Office.

Prior to the opening of trading on December 5, 2025, all of Mural’s shares will cease trading on Nasdaq, and Mural intends promptly to cause such shares to be delisted from Nasdaq and deregistered under the Securities Exchange Act of 1934, as amended.

Advisors
XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP and Mason Hayes & Curran LLP, who acted as U.S. and Irish legal advisors, respectively. Davy Corporate Finance UC acted as financial advisor to XOMA Royalty. Lucid Capital Markets, LLC acted as exclusive financial advisor to Mural, and Wilmer Cutler Pickering Hale and Dorr LLP and Arthur Cox LLP served as U.S. and Irish legal advisor, respectively, to Mural.

(Press release, Xoma, DEC 5, 2025, View Source [SID1234661173])

On December 5, 2025 ImCheck Therapeutics reported an oral presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2025, taking place from December 6 to December 9, in Orlando, FL, USA. The presentation will highlight the high remission rates and overall survival observed in EVICTION, ImCheck’s open-label, randomized Phase I/II study evaluating ICT01, a first-in-class γ9δ2 T-cell activator, in combination with azacitidine and venetoclax in older or unfit patients with newly diagnosed acute myeloid leukemia (AML).

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Details of the oral presentation at ASH (Free ASH Whitepaper) 2025 are:

Abstract Title: "γ9δ2 T-cell (γ9δ2TC) activation with ICT01 and azacitidine-venetoclax (Aza-Ven) induces high rates of remission and overall survival in patients with newly diagnosed (ND) acute myeloid leukemia (AML): Results from the phase 1/2 study eviction"

Presenter: Sylvain GARCIAZ, MD, PhD, Institut Paoli-Calmettes, Marseille, France

Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Immunotherapy and chemotherapy combinations in AML

Room: OCCC – Chapin Theater (320)

Date: Sunday, December 7, 2025

Time: 5:15 p.m.- 5:30 p.m. ET

The ASH (Free ASH Whitepaper) presentation will be available on ImCheck’s corporate website after the presentation has been held.

(Press release, ImCheck Therapeutics, DEC 5, 2025, View Source [SID1234661174])