On November 5, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that results from the Phase III study of orelabrutinib, its novel BTK inhibitor, in chronic primary immune thrombocytopenia (ITP) have been selected for oral presentation at the 2026 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). The abstract is now available on the official ASH (Free ASH Whitepaper) website.

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The Phase III study of orelabrutinib in adult patients with chronic ITP met its primary endpoint. The study demonstrated that orelabrutinib induced rapid and durable platelet responses, reduced the need for rescue therapy, and confirmed the drug’s safety over the full treatment period, which will offer a better treatment option for ITP patients.

Oral presentation

Orelabrutinib, an oral BTK inhibitor, for previously treated chronic primary immune thrombocytopenia in Chinese adults: A phase 3, placebo-controlled, multicenter trial (Abstract Number : abs26-2333)

A total of 196 participants were randomized in a 2:1 ratio to once-daily oral orelabrutinib 50 mg (n=131) or placebo (n=65) for a 24-week double-blind treatment period. The primary endpoint was durable response, defined as a platelet count of ≥50×10⁹/L for 4 of the 6 scheduled visits during the final 12 weeks of the double-blind period without rescue therapy.

The results showed that the Phase III study of orelabrutinib in patients with chronic ITP met its primary endpoint. The orelabrutinib group achieved a durable response rate of 32.8%, representing an improvement of 25.5% over the placebo group (P=0.0001).

The study results also met multiple secondary efficacy endpoints. Orelabrutinib demonstrated rapid response for ITP patients. Orelabrutinib group showed rapid efficacy in ITP patients, with significant superiority over placebo as early as day 7 post-treatment initiation. Among responders, orelabrutinib shortened the median time to initial platelet response to 14 days, compared with 42 days for placebo. Moreover, orelabrutinib significantly reduced the need for rescue therapy.

Orelabrutinib was safe and well tolerated in all participants. The safety profile was comparable to that of placebo, with no obvious evidence of elevated safety risk. Most treatment-emergent adverse event (TEAEs) were grade 1–2.

Data from the Phase III study of orelabrutinib in ITP will be presented in an oral session at the 68th Annual Meeting of ASH (Free ASH Whitepaper). Details are as follows:

Date & Time: December 14, 2026, 14:45–15:00 (Central Standard Time, CST)

Location: Room 217–219, Ernest N. Morial Convention Center (MCCNO)

Presenter: Prof. Yu Hou

The NDA submission for orelabrutinib in ITP was accepted in China, marking the first NDA acceptance for orelabrutinib in autoimmune diseases and a significant milestone in expanding its use beyond hematologic malignancies into autoimmune diseases.

ITP is an acquired immune mediated disorder characterized by a decrease in peripheral blood platelet count. ITP ranges in severity from asymptomatic thrombocytopenia to life-threatening hemorrhage, which can substantially affect patients’ quality of life. With over 200,000 new cases globally each year, including 60,000 in China, ITP represents a significant unmet medical need.

The 2026 ASH (Free ASH Whitepaper) Annual Meeting, one of the world’s premier conferences in hematology, will be held in New Orleans, USA, from December 12 to 15, 2026.

(Press release, InnoCare Pharma, NOV 5, 2026, View Source [SID1234674374])

On November 5, 2026 Kayak Therapeutics, Inc. ("Kayak" or the "Company"), a clinical-stage biotechnology company developing novel approaches to targeted cancer therapy, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KT-300, an oral small-molecule inhibitor of TRIM7 and a potential first-in-class therapy for the treatment of RAS-driven cancers.

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Kayak expects to initiate a first-in-human Phase 1 dose-escalation clinical trial in late 2026. The trial, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of KT-300, will enroll patients with advanced RAS mutant solid tumors, including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and others.

"FDA clearance of the IND for KT-300, a potential first-in-class TRIM7 inhibitor, is an important milestone for Kayak and brings our novel approach to RAS-driven cancers into the clinic," said Josiah Hornblower, CEO of Kayak Therapeutics. "TRIM7 sits at a critical downstream node of the RTK–RAS signaling cascade, and its hyperactivation drives tumor proliferation across a broad spectrum of cancers. Preclinical data demonstrate KT-300 not only blocks TRIM7 activity but does so in a way that is agnostic to the RAS-pathway mutation, and demonstrates anti-tumor activity in the setting of KRAS inhibitor resistance. These data underscore KT-300’s potential as a new therapeutic strategy for patients with RTK–RAS-driven cancers, a population with significant unmet medical need. We are excited to initiate our first study as we work toward initial clinical readouts anticipated in 2027."

About KT-300

KT-300 is an investigational, potentially first-in-class oral small-molecule inhibitor of TRIM7, a key mediator of RTK–RAS-driven tumor cell proliferation. Preclinical studies from Kayak demonstrate that KT-300 induces robust tumor growth inhibition in both in vitro and in vivo models. KT-300’s anti-tumor activity is RAS-pathway–mutation agnostic, offering broad therapeutic potential for cancers driven by hyperactivated RTK–RAS signaling. Kayak expects to initiate its first-in-human Phase 1 dose-escalation clinical trial by the end of the fourth quarter.

(Press release, Kayak Therapeutics, NOV 5, 2026, View Source [SID1234674373])

On November 5, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX, "Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, reported financial results for the quarter ended September 30, 2026, and provided recent corporate and clinical updates.

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"We are excited by the new Phase 2 AMPLIFY-7P findings in adjuvant PDAC, which provide encouraging direction and important insights as we advance camupepimut toward late-stage development and refine our Phase 3 strategy in adjuvant PDAC," said Robert Connelly, President and Chief Executive Officer of Elicio. "The 49% lower risk of disease recurrence or death among patients with undetectable ctDNA at baseline, alongside a 43% reduction in risk among ctDNA-positive patients, reinforces the encouraging clinical activity observed across both subgroups. These findings provide compelling signals that will help guide patient stratification and dosing in the planned Phase 3 adjuvant study. We are also enthusiastic about the opportunity to combine camupepimut’s potent KRAS-specific immune activation together with direct RAS inhibition in a planned Phase 1 study in metastatic PDAC, evaluating camupepimut with daraxonrasib, with or without nivolumab. Together, these efforts underscore camupepimut’s therapeutic potential across the pancreatic cancer treatment continuum, where substantial unmet medical needs remain."

Recent Highlights

Phase 2 AMPLIFY-7P Results Inform Planned Phase 3 Development in Adjuvant PDAC

Elicio presented new pre-specified analyses from the randomized Phase 2 AMPLIFY-7P trial in resected pancreatic ductal adenocarcinoma ("PDAC") as a late-breaking Proffered Paper oral presentation at ESMO (Free ESMO Whitepaper) Congress 2026. Analyses demonstrated a 49% reduction in the risk of disease recurrence or death in ctDNA-negative patients, a 43% reduction of risk in ctDNA-positive patients, and a 41% reduction in patients without prior radiation.
Although AMPLIFY-7P did not meet its primary disease-free survival ("DFS") endpoint in the intent-to-treat population, a supportive multivariable analysis adjusting for baseline prognostic imbalances estimated a 53% reduction in the hazard of recurrence or death (HR 0.47; p=0.0086).
Peer-reviewed Phase 2 findings published in Nature Medicine further characterize camupepimut’s clinical activity and mutant KRAS-specific immune responses. Collectively, these findings inform patient stratification and dosing considerations for the planned Phase 3 study.
Additional Clinical and Preclinical Data at SITC (Free SITC Whitepaper) 2026

Additional Phase 2 AMPLIFY-7P clinical and translational findings will be presented by Elicio in plenary oral and late-breaking poster presentations at SITC (Free SITC Whitepaper) 2026.
New preclinical data will also be presented which evaluates intratumoral AMP-CpG and shows complete tumor responses in 50% of treated animals in head and neck cancer models and 100% of treated animals in melanoma models, supporting further investigation of the AMP platform in combination with checkpoint inhibition.
Advancing Camupepimut Combination Strategies in Metastatic and Neoadjuvant PDAC

Previously reported three complete radiographic (RECIST) and metabolic (PERCIST) responses in three patients with metastatic PDAC following camupepimut and subsequent nivolumab-based therapy provide support for combination approaches involving direct RAS inhibition and mutant KRAS-specific immune activation.
Elicio is targeting a Q4 2026 initiation of a Phase 1 study evaluating camupepimut with daraxonrasib, with or without nivolumab, in metastatic KRAS-mutated PDAC. The study will explore the complementary potential of direct RAS inhibition, KRAS-specific immune activation and checkpoint blockade.
An investigator-initiated Phase 1 neoadjuvant study evaluating camupepimut with chemotherapy and anti-PD-1 therapy in resectable and borderline resectable PDAC is ongoing. The multicenter study is led by Memorial Sloan Kettering Cancer Center and funded through a strategic partnership between The Lustgarten Foundation and Break Through Cancer.
Third Quarter 2026 Financial Results

R&D expense for the third quarter of 2026 was $4.9 million, compared to $5.0 million for the third quarter of 2025. The decrease of $0.1 million was primarily due to lower clinical trial costs as the Phase 2 study of camupepimut continues and the patients moved out of the active dosing phase and into the follow-up phase of the trial, partially offset by increased personnel costs.

G&A expense for the third quarter of 2026 was $3.6 million, compared to $3.0 million for the third quarter of 2025. The increase of $0.6 million was primarily due to increased personnel costs and an increase in professional fees.

Net loss for the third quarter of 2026 was $8.0 million, compared to $10.1 million for the third quarter of 2025. Net loss per share for the third quarter of 2026 was $0.30, compared to $0.60 for the third quarter of 2025.

Cash and cash equivalents were $30.9 million as of September 30, 2026.

The Company raised net proceeds of $4.3 million in the third quarter of 2026, for aggregate net proceeds of approximately $28.6 million year to date, through its established at-the-market program.

In July 2026, the Company raised aggregate net proceeds of approximately $13.6 million in a registered direct offering after deducting the placement agents’ fees and related offering expenses.

The Company expects that its current cash and cash equivalents will support operations into the second quarter of 2027.

(Press release, Elicio Therapeutics, NOV 5, 2026, View Source [SID1234674372])

On November 5, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that new and updated clinical data from its ongoing Phase 1a/1b study evaluating bexobrutideg (NX-5948), the Company’s investigational oral Bruton’s tyrosine kinase (BTK) degrader, will be presented in a poster session at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 12-15, 2026 in New Orleans, Louisiana.

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The presentation abstract was released today by ASH (Free ASH Whitepaper) and highlights new and updated data in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with efficacy data reported for those previously treated with covalent BTK inhibitors (cBTKi). Results demonstrate continued evidence of durable clinical activity and favorable tolerability with bexobrutideg administered at the recommended Phase 2 dose of 600 mg once daily. Additional analyses, including data from BTK inhibitor-naïve and treatment naïve patients and efficacy in patients with high-risk molecular features, will be presented at the meeting.

"Patients with relapsed or refractory CLL/SLL continue to face significant challenges as resistance and intolerance emerge with currently available therapies," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix Therapeutics. "We are encouraged by the growing body of clinical evidence supporting bexobrutideg’s potential to address important unmet needs in patients at early as well as late stages of their therapeutic journeys. The updated data being presented at ASH (Free ASH Whitepaper) further underscore the differentiated mechanism of our BTK degrader, including its ability to target both wild-type and mutant forms of BTK, and reinforce our confidence in the ongoing development of bexobrutideg as a potential best-in-class therapy for patients with B-cell malignancies."

Poster Presentation Details
Title: New and updated efficacy and safety data on bexobrutideg (NX-5948), a novel BTK degrader, in patients with relapsed/refractory CLL/SLL and prior cBTKi exposure from an ongoing Phase 1a/b trial
Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II
Presenter: Nirav Shah, M.D., Medical College of Wisconsin
Session Date: December 13, 2026
Presentation Time: 12/13/2026 6:00:00 PM – 12/13/2026 8:00:00 PM
Room: Hall F

About Bexobrutideg (NX-5948)

Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.

​​​Bexobrutideg is currently being evaluated in a broad clinical development program in patients with CLL, including the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed/refractory CLL previously treated with covalent and noncovalent BTKi and a BCL2i; the DAYBreak CLL-306 clinical trial (NCT07516093), a randomized Phase 3 trial comparing bexobrutideg to pirtobrutinib in patients with relapsed/refractory CLL previously treated with a covalent BTKi; the NX-5948-203 Phase 1b/2 clinical trial (NCT07520006), assessing the combination of bexobrutideg with venetoclax in patients with relapsed/refractory CLL and potentially treatment-naïve CLL; and the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed/refractory B-cell malignancies. Additional information about these clinical trials can be found at clinicaltrials.gov.

(Press release, Nurix Therapeutics, NOV 5, 2026, View Source [SID1234674371])

On November 5, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage immunotherapy company targeting cancer and autoimmune diseases, reported that data from two clinical trials of its first-in-class MHC Class II agonist, eftilagimod alfa ("efti"), will be presented in poster presentations at two international congresses in November and December 2026.

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At the Connective Tissue Oncology Society (CTOS) 2026 Annual Meeting, taking place 18–21 November 2026 in Seoul, South Korea, survival data will be presented from the investigator-initiated EFTISARC-NEO Phase II trial evaluating efti in combination with KEYTRUDA (pembrolizumab) and radiotherapy in the neoadjuvant treatment of patients with resectable soft tissue sarcoma.

At the ESMO (Free ESMO Whitepaper) Immuno-Oncology & Advanced Therapies Congress 2026, taking place 14–16 December 2026 in London, United Kingdom, final median overall survival results will be presented from Part B of the TACTI-003 Phase IIb trial evaluating efti in combination with KEYTRUDA in first-line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in patients with a PD-L1 combined positive score (CPS) of less than 1.

CTOS 2026 Annual Meeting

Title Disease Free Survival (DFS) in Patients with Resectable Soft Tissue Sarcoma (STS) from Eftisarc-Neo Phase II Trial of Neoadjuvant Eftilagimod Alfa (Efti), Pembrolizumab and Radiotherapy (Rth)
Trial EFTISARC-NEO (investigator-initiated Phase II; NCT06128863)
Session category Poster Discussion (SESSION 6)
First Author Pawel Sobczuk, MD PhD; Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Mazowieckie, Poland
Poster session 19 November 2026, 04:30 p.m. KST (19 November, 06:30 p.m. AEDT)

ESMO Immuno-Oncology & Advanced Therapies Congress 2026

Title Eftilagimod Alfa and Pembrolizumab in First-Line Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with PD-L1 CPS <1: Final Results from the TACTI-003 Study
Trial TACTI-003 Part B (Phase II; NCT04811027)
Session category Poster Display session
First Author Claus A. Kristensen, MD PhD, Copenhagen University Hospital, Copenhagen, Denmark
Poster session 14 December 2026, 17:30 GMT (15 December 2026, 4:30am AEDT)

Details of the presentations are set out below. The data will be made available on the Posters & Publications page of Immutep’s website following their presentation.

(Press release, Immutep, NOV 5, 2026, View Source [SID1234674370])