Amphista Therapeutics announces AMX-883 data to be presented at the ASH Annual Meeting and Exposition and provides a business progress update

On November 25, 2025 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery of next generation targeted protein degradation (TPD) medicines, reported the presentation of new preclinical data with its lead Targeted Glue AMX-883, an orally bioavailable, potent and selective degrader of BRD9 at the upcoming 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Florida, 6-9 December 2025, and provides a business progress update ahead of its leadership team attending the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, 12-15 January 2026.

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The abstract reports:

AMX-883 time dependently increases the expression of key proteins associated with myeloid cell differentiation and maturation in vitro.
Using patient derived samples in disseminated xenograft models, AMX-883 significantly reduced leukemic burden in bone marrow and blood over the treatment period and resulted in a significant increase in survival compared to venetoclax.
The combination of AMX-883 with venetoclax resulted in synergistic efficacy in leukemic cell lines. AMX-883 co-dosed with venetoclax and azacitidine resulted in synergy with significant cell death at therapeutically relevant concentrations. Combination benefit was also observed with a range of other commonly used AML therapies in vitro.
A cell line co-cultured with venetoclax and AMX-883 did not develop resistance to venetoclax and had comparable sensitivity to cells on their first exposure to venetoclax. The venetoclax-resistant line exhibited a significant increase in the anti-apoptotic proteins MCL-1 and BCL-2, an effect that was prevented when AMX-883 was included during venetoclax treatment.
The data demonstrates the potent, selective BRD9 degrader AMX-883 induces significant differentiation and preclinical efficacy in AML cell lines and in primary AML cell lines.
"There is a critical unmet need for novel therapies that can augment the efficacy of anti-proliferative and cytotoxic agents in AML. The data to be presented at ASH (Free ASH Whitepaper) demonstrates that AMX-883 prevented the development of resistance to venetoclax in vitro and AMX-883 delivered synergistic efficacy when combined with venetoclax, achieving significant cancer cell death at therapeutically relevant concentrations," said Martin Pass, Chief Development Officer at Amphista Therapeutics. "These compelling results provide further strong preclinical evidence supporting the advancement of AMX-883 into the clinic for AML patients."

"Amphista has made significant progress this year in advancing a new generation of targeted protein degraders designed to address serious diseases with high unmet need," said Antony Mattessich, Chief Executive Officer of Amphista Therapeutics. "This is exemplified by the key data to be presented at ASH (Free ASH Whitepaper), alongside the nomination of AMX-883 as our first clinical candidate and the unveiling of distinct mechanisms of action across BRD9, SMARCA2, and TEAD. We look forward to 2026 when we will advance AMX-883 into the clinic and nominate our next clinical candidates."

2025 business highlights:

Nominated AMX-883, an orally available Targeted Glue degrader of BRD9, as the Company’s first clinical development candidate for the treatment of AML.
Amphista received additional funding as part of its Series B financing following AMX-883 nomination, supporting plans to initiate the Company’s first clinical trial in H2 2026.
Disclosed a novel mechanism of action for TEAD degradation by selectively inducing its proximity to FBXO22 as a targeted molecular glue, resulting in strong and rapid degradation.
Reported first data from the SMARCA2 program, demonstrating exquisite selectivity of Amphista’s bifunctional Targeted Glues for SMARCA2 over the closely related homolog, SMARCA4.
Achieved a discovery milestone under Amphista’s exclusive research collaboration and license agreement with Merck KGaA.
Showcased Amphista’s cryo-EM enabled Eclipsys platform at SLAS Europe 2025, highlighting its unique approach to constructing novel, orally bioavailable Targeted Glue degraders with mechanisms distinct from traditional cereblon (CRBN) or VHL approaches.
Presented a differentiated mechanism for BRD9 degradation distinct from CRBN- or VHL-based PROTACs using Amphista’s Targeted Glue technology at the 2nd SMR Molecular Glues Meeting and the 5th Annual TPD and Induced Proximity Summit Europe.
Poster presentation details:

Title: AMX-883, a Potent and Selective Degrader of BRD9 Drives Differentiation in Acute Myeloid Leukaemia and Shows Synergistic Efficacy in Combination with venetoclax In Vivo and Prevents the Emergence of Resistance to venetoclax In Vitro.
Speaker: Martin Pass
Session Name: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster I
Session Date and Time: December 6, 2025 at 5:30 PM – 7:30 PM
Room: OCCC – West Halls B3-B4
Presentation ID: 1489
Abstract Number: abs25-2358

The online abstract is available on the ASH (Free ASH Whitepaper) website here.

Ends

About BRD9 and Acute Myeloid Leukaemia

Acute myeloid leukaemia (AML) is one of the most aggressive blood cancers and despite the availability of anti-proliferative treatments, patient survival rates remain alarmingly low. The disease is characterized by a differentiation block which prevents myeloid cell maturation and results in an accumulation of immature cells/AML blasts. Therapies which remove the differentiation block and allow maturation of these AML blasts including ATRA, FLT-3 inhibitors, and most recently Menin inhibitors have demonstrated clinical benefit in several sub-sets of AML. However, there is a pressing need for broader-acting treatments that can benefit patients regardless of their genetic profile.

BRD9 is a subunit of the non-canonical BAF complex where it plays a key structural and functional role, being linked to regulation of chromatin structure and maintaining genomic stability in AML. Degradation of BRD9 releases the differentiation block and leads to the differentiation and death of AML blasts.

(Press release, Amphista Therapeutics, NOV 25, 2025, View Source [SID1234660929])

Verastem Oncology to Present at the 8th Annual Evercore Healthcare Conference

On November 25, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that its management team is scheduled to participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Tuesday, December 2, 2025, at 10:25 am ET in Miami, Florida.

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A live webcast of the fireside chat can be accessed under "Events & Presentations" on the Company’s website at www.verastem.com. A replay of the webcasts will be archived on the website for approximately 90 days following the presentation.

(Press release, Verastem, NOV 25, 2025, View Source [SID1234660945])

Data from Genprex’s Acclaim-1 Phase 1 Gene Therapy Clinical Trial Published in Clinical Lung Cancer

On November 24, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with Tagrisso (osimertinib) in patients with advanced non-small cell lung cancer (NSCLC) in the peer-reviewed journal Clinical Lung Cancer.

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"We believe REQORSA is an innovative gene therapy that may benefit many lung cancer patients, and we are pleased to see these data for REQORSA published and shared with the scientific community," said Ryan Confer, President and Chief Executive Officer at Genprex. "Genprex is thankful to the patients who participated in this study, along with the investigators who made the completion of the study possible. We believe this new mechanism and novel approach targeting lung cancer, which comes with a strong safety profile and early signs of efficacy, is paving new ground in the fight against lung cancer."

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with osimertinib in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with osimertinib (osimertinib monotherapy or osimertinib combination therapy).

The Phase 1 dose escalation portion of the trial was designed primarily to assess safety, however, the Company believes promising efficacy results were also observed. The reported results showed no Dose Limiting Toxicities (DLTs), established a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg (the highest dose level administered in the trial) and provided data showing early efficacy of REQORSA in combination with osimertinib.

Of the 12 patients treated with escalating doses of REQORSA and standard doses of osimertinib, all of whom had progressed on osimertinib containing regimens, three patients had experienced prolonged time to progression, including one with continuing partial response.

Specifically, one patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed and osimertinib, had a partial remission by investigator evaluation, and as of the data from April 2025 used in the published manuscript had continued to receive study treatment for 47 cycles over 32 months. The patient continues to receive REQORSA and osimertinib treatment in the trial more than three years after enrolling.A second patient at the 0.12 mg/kg dose level who was previously treated with cisplatin, pemetrexed, carboplatin and osimertinib had stable disease and received REQORSA for 32 cycles, or approximately 24 months, until disease progression occurred.

A third patient who was at the 0.09 mg/kg dose level, previously treated with osimertinib, had stable disease and received 14 cycles over approximately 10 months before disease progression occurred.

The extended Progression Free Survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early-stage clinical trials of REQORSA and is not expected with treatment with osimertinib alone after progression on osimertinib.

REQORSA administration was generally well tolerated and there were no DLTs. The administration was associated with a delayed infusion-related reaction of muscle aches, fever and chills in some patients, which we believe is similar to reactions seen with the administration of antibodies routinely used in oncology treatment. This was managed with prophylactic steroids, acetaminophen and diphenhydramine, and symptoms decreased with repeat cycles.

(Press release, Genprex, NOV 24, 2025, View Source [SID1234660897])

Theralase(R) Announces Brokered LIFE Financing to Further Advance its Phase II Non-Muscle Invasive Bladder Cancer Clinical Study

On November 24, 2025 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses reported that it has entered into an agreement with Research Capital Corporation ("RCC") as the sole agent and bookrunner on a commercially reasonable "best efforts" agency basis, for a brokered private placement offering ("Offering") of units of the Company ("Units") at a price of C$ 0.17 per Unit to raise a minimum of C$ 4,500,000 and up to a maximum of C$5,500,000 in aggregate gross proceeds.

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Each Unit will consist of one common share of the Company ("Common Share") and one Common Share purchase warrant ("Warrant"). Each Warrant shall entitle the holder thereof to purchase one Common Share ("Warrant Share") at an exercise price of $CAN 0.21 per Warrant Share at any time for a period of 60 months following the closing of the Offering. The Company will use commercial reasonable efforts to obtain the necessary approvals to list the Warrants on the TSX Venture Exchange ("TSXV").

The Company will grant the Agent an option ("Agent’s Option") to increase the size of the Offering by up to C$1,000,000 in Units by giving written notice of the exercise of the Agent’s Option, or a part thereof, to the Company at any time up to 48 hours prior to closing of the Offering.

The Company plans to use the minimum proceeds of the financing for:

Furtherance of a Phase II non-muscle invasive bladder cancer clinical study
Good Laboratory Practice ("GLP") toxicology studies to support clinical development for the intravenous use of Rutherrin (Ruvidar + transferrin) in the treatment of various cancers
working capital and general corporate purposes
If the maximum proceeds are achieved, then the following strategic initiatives will be added:

GLP toxicology studies to support clinical development for the topical use of Ruvidar in the treatment of herpes simplex virus induced cold sores
design, development and commercialization of products in the device division
The Offering is scheduled to close on or about the week of December 1, 2025, or such other date as the Company and the Agent may agree upon, and is subject to the receipt of all necessary approvals; including, the approval of the TSXV.

The Offering will take place by way of:

a private placement pursuant to National Instrument 45-106 – Prospectus Exemptions under Part 5A, as amended by CSA Coordinated Blanket Order 45-935 – Exemptions from Certain Conditions of the Listed Issuer Financing Exemption ("Listed Issuer Financing Exemption" or "LIFE"), to qualified investors in all the provinces of Canada, except Québec and
in other jurisdictions where the Offering can lawfully be made; including, the United States under applicable private placement exemptions. Such sales to investors in the United States will be subject to applicable United States securities laws and restrictions on its securities purchased.
The Units issued under the Listed Issuer Financing Exemption will not be subject to resale restrictions pursuant to applicable Canadian securities laws.

The LIFE offering document ("Offering Document") related to the Offering can be accessed under the Company’s profile at www.sedarplus.ca or on the Company’s website at: www.theralase.com.

Prospective investors should read this Offering Document before making an investment decision.

Upon closing of the Offering, the Company shall pay to RCC:

a cash commission equal to 7% of the aggregate gross proceeds of the Offering payable in cash (subject to a reduction for orders on the "president’s list"); and
non-transferrable broker warrants of the Company exercisable to acquire that number of Units equal to 7% of the number of Units issued under the Offering (subject to a reduction for orders on the "president’s list"), at an exercise price of C$0.17 per Unit, expiring 60 months after the date of the closing of the Offering.

(Press release, Theralase, NOV 24, 2025, View Source [SID1234661918])

Summary of Clinical Update from Phase 1 Trial of INB-200 and Phase 2 Trial of INB-400

On November 24, 2025 IN8bio, Inc. (the "Company") reported consolidated data, a summary of which is located below, from its investigator-sponsored Phase 1 single-center clinical trial of INB-200 and its Company-sponsored Phase 2 multi-center clinical trial of INB-400 for the treatment of patients with newly diagnosed glioblastoma ("GBM") in poster and oral presentations at the 2025 Society for Neuro-Oncology ("SNO") Annual Meeting on November 21 and 22, 2025.

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Summary of Clinical Update from Phase 1 Trial of INB-200 and Phase 2 Trial of INB-400

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Across the two trials, 17 patients were treated with the Company’s DeltExTM Drug Resistant Immunotherapy ("DeltEx DRI") gamma-delta T cells, with 14 patients receiving repeated (3 up to 6) doses. 10 additional patients were consented contemporaneously but received only the standard-of-care Stupp protocol ("SOC") and were monitored for progression and survival.

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Patients treated with repeated doses of DeltEx DRI cells achieved a median progression-free survival ("mPFS") of 13.0 months (n=14), compared to the mPFS of 6.6 months for patients receiving only SOC (n=10).

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Patients receiving repeated doses of DeltEx DRI cells have not yet reached median overall survival ("mOS"), which continues to climb at 16.4+ months as of October 31, 2025, while SOC patients attained a mOS of 11.0 months.

(Press release, In8bio, NOV 24, 2025, View Source [SID1234660898])