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 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 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 previously treated NSCLC patients with HER2 exon 20 mutations were presented at a poster session, and the poster can be found in the publication section of ORIC’s website here.

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Enozertinib Phase 1b Trial Design
Enozertinib is being evaluated in a Phase 1b trial in patients with locally advanced or metastatic NSCLC with HER2 exon 20 mutations. Notably, enrollment allows patients with active untreated brain metastases. Prior therapies include chemotherapy and HER2 targeted therapies. 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), disease control rate (DCR), and safety.

Previously Treated NSCLC Patients with HER2 Exon 20 Mutations
As of the August 29, 2025 cutoff date, 49 patients were dosed — 26 patients received 80 mg QD oral enozertinib and 23 patients received 120 mg QD. Patients were treated with up to 4 prior therapies, with 80% of patients having received prior chemotherapy and 35% having received a prior HER2 targeted therapy. Brain metastases were present in 47% 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 paronychia, diarrhea, and dermatitis acneiform. Only 2 patients discontinued treatment due to TRAEs. Higher rates of dose reductions occurred in the 120 mg cohort compared to the 80 mg cohort.

Preliminary Activity Analysis
Tumor responses were observed in both the 80 mg and 120 mg cohorts, including in patients with baseline brain metastases. Patients in the 80 mg cohort experienced deeper tumor regressions potentially due to the lower rate of dose reductions.

35% ORR (26% confirmed ORR) and 100% DCR in the 80 mg cohort
As of the data cutoff (at a median follow-up of 50 weeks), 32% of patients remained on treatment in both the 80 mg and 120 mg cohorts
Next Steps
Based on data generated in patients with EGFR exon 20 and EGFR atypical mutations, 80 mg QD oral enozertinib has been selected as the dose for potential Phase 3 development. Enrollment and follow-up continues in 1L NSCLC patients with EGFR exon 20 and EGFR P-loop and alpha C-helix compressing (PACC) mutations, with the next update expected in mid-2026, ahead of initiation of potential Phase 3 trial(s). Enrollment in HER2 exon 20 has been completed with no further development planned in this patient population.

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 [SID1234661169])

On December 5, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported that it has agreed to sell 12,500,000 ordinary shares at $10.00 per share in an underwritten offering. The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be $125 million. The offering is expected to close on December 8, 2025, subject to customary closing conditions.

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Jefferies, Leerink Partners and Cantor are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on April 3, 2025. The offering is being made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained free of charge from

Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, telephone: (877) 821-7388, email: [email protected];
Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525, ext. 6105, email: [email protected];
Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, e-mail: [email protected].
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

(Press release, Immatics, DEC 5, 2025, View Source [SID1234661168])

On December 4, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs, and Crescent Biopharma, Inc. ("Crescent") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported that the companies have entered into a strategic partnership to develop and commercialize oncology therapeutics, including novel combinations.

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The partnership involves Crescent’s CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech’s SKB105, an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload. Both candidates are being developed for the treatment of solid tumors and are expected to enter Phase 1/2 monotherapy clinical trials in the first quarter of 2026.

Under the terms of the collaboration, Crescent has granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize CR-001 in Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Kelun-Biotech has granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105 in the United States, Europe and all other markets outside of Greater China. The partnership includes the development of these candidates as monotherapies, and also the evaluation of CR-001 in combination with SKB105. Both Crescent and Kelun-Biotech have the right to independently develop CR-001 in additional combinations, including combinations of CR-001 with proprietary ADC pipeline assets.

Dr. Michael Ge, chief executive officer of Kelun-Biotech, said, "We are pleased to have entered into a partnership with Crescent for two innovative assets, CR-001 and SKB105. This collaboration complements and strengthens our differentiated oncology pipeline by the addition of CR-001 and also enables us to advance the development of SKB105 in the global market, bolstering its potential commercial value and our global collaboration network. Our creative global partnership combines the capabilities of both companies to explore novel monotherapies and combination strategies for tumor treatments with SKB105 and CR-001. By leveraging China’s abundant clinical resources and execution efficiency, we aim to expedite clinical development while rigorously maintaining the highest global standards. We believe this partnership creates a powerful synergy to maximize the potential of these two drug candidates for the treatment of patients in both China and the rest of the world."

"We are thrilled to be partnering with Kelun-Biotech, an established leader in the development and commercialization of ADCs who shares our commitment to bringing next generation therapeutics that can improve outcomes for people living with cancer," said Joshua Brumm, chief executive officer of Crescent. "This collaboration expands our pipeline with the addition of SKB105, furthers our strategy of advancing multiple modalities across our portfolio, and accelerates our efforts to deliver synergistic combinations with CR-001, which has the potential to be a foundational backbone therapy. We look forward to working with Kelun-Biotech to drive innovative therapeutics with the potential to address multiple tumor types and transform cancer care."

Under the collaboration, Kelun-Biotech will receive an upfront payment of US$80 million from Crescent and is also eligible to receive additional milestones of up to US$1.25 billion, plus tiered middle single-digit to low double-digit royalties on net sales of SKB105. Kelun-Biotech is also eligible to receive additional payment from Crescent if Crescent undergoes a near-term change of control or enters into a sublicense agreement with a third party. Crescent will receive an upfront payment of US$20 million from Kelun-Biotech and is also eligible to receive additional milestones of up to US$30 million, plus tiered low to middle single digit royalties on net sales of CR-001.

About CR-001 (also known as SKB118)

CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with antibody-drug conjugates (ADCs). A global Phase 1/2 trial of CR-001 in patients with solid tumors is anticipated to commence in the first quarter of 2026.

About SKB105 (also known as CR-003)

SKB105 is a differentiated ADC targeting integrin beta-6 (ITGB6) with a topoisomerase 1 inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker. The molecule incorporates proprietary Kthiol irreversible conjugation technology, designed to enhance stability and tumor-specific payload delivery while reducing adverse effects. SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile in preclinical models. A Phase 1/2 clinical trial of SKB105 in patients with solid tumors is anticipated to commence in the first quarter of 2026.