On November 9, 2026 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) ("Biodexa" or "the Company"), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers reported further progress in both its lead programs; eRapa for familial adenomatous polyposis ("FAP") and MTX240 molecular glue for gastrointestinal stromal tumors ("GIST").

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Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said "Database lock and topline data for our registrational FAP trial around the end of next year is now tantalizingly close. Also, around the same time, we should know whether we have a viable dose for MTX240 in TKI-resistant patients. If we do, MTX240 has the potential to alter standard of care for all GIST patients ".

eRapa for FAP
The Company has enrolled 112 of an expected 168 participants in its registrational Phase 3 trial of eRapa, the Company’s reformulation of rapamycin, in FAP (NCT06950385). The trial, branded "Serenta" is recruiting at 29 clinical sites across the US and five countries in Europe with further sites in North America and Continental Europe expected to be initiated shortly.

The Serenta protocol provides for a pre-specified futility analysis after 25 progression free survival ("PFS") events and database lock after 75 PFS events. The Serenta protocol includes a composite endpoint which defines the nature of the PFS events. Based on the current rate of PFS event accrual, the futility analysis could take place early in 2027 with database lock potentially occurring around the end of 2027, both significantly sooner than originally anticipated.

MTX240 molecular glue for GIST

Non-resectable and/or metastatic GIST is generally treated with tyrosine kinase inhibitors ("TKIs"). While TKIs have improved outcomes, resistance almost always develops through either secondary (or tertiary) KIT or PDGFR mutations or activation of alternative signalling pathways resulting in limited therapeutic options for patients once they have cycled through the available TKIs. In multiple patient-derived xenograft models, MTX240 has been shown to be effective in TKI-resistant GIST tumors1.

The Company is planning a Phase 1a dose escalation study followed immediately by a Phase 1b dose optimization study with a view to establishing a maximum tolerated dose and, based on efficacy signals, an optimized dose for MTX240. Both Phase 1a and 1b will recruit patients who have demonstrated TKI-resistance. GMP drug substance has been manufactured by our CDMO partner and they are moving ahead with GMP finished product. A preferred CRO has been identified and the Phase 1a is expected to begin recruiting in South Korea mid-2027. A pre-IND meeting with the FDA is scheduled for December 10, 2026.

(Press release, Biodexa Pharmaceuticals, NOV 9, 2026, View Source [SID1234674480])

On November 9, 2026 Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a precision guided, biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, reported key highlights for its third quarter 2026 financial performance and business update conference call at 11:30 a.m. Eastern Time today, following the filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026.

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Management will explain the scientific and clinical rationale for the Company’s CD228V agreement with Pfizer Inc. ("Pfizer"), the proposed transaction between its wholly owned subsidiary, SkinJect, Inc. ("SkinJect"), and an undisclosed special purpose acquisition company ("SPAC") (the "Transaction" or the "Business Combination") and the Company’s approach to capital efficiency.

Medicus’ strategy is to concentrate incremental development investment on CD228V, pursue a separate public listing and dedicated financing for SkinJect and preserve Teverelix’s readiness for partnering. The Company believes this approach can advance its precision oncology focus while preserving Medicus shareholders’ participation in the potential value of its broader portfolio.

Conference Call Details

Date and time: Monday, November 9, 2026, at 11:30 a.m. ET

Dial-in (U.S./Canada, toll-free): 1-833-890-6070

Dial-in (international): 1-412-504-9736

Webcast: Access the live webcast

Participants will include Raza Bokhari, MD, Executive Chairman and Chief Executive Officer; Carolyn Bonner, President and Chief Financial Officer; and Faisal Mehmud, MD, Chief Medical Officer.

CD228V Agreement Rationale, Melanoma Focus and ADC Opportunity

Dr. Raza Bokhari, Executive Chairman and CEO, is expected to describe how Medicus’ review of the clinical evidence for the predecessor molecule, SGN-CD228A, Pfizer’s refinement of the ADC construct and a focused initial development strategy informed the Company’s decision to enter the CD228V co-development and license agreement.

Clinical foundation. The decision was informed by Medicus’ review of clinical data from Seagen’s open-label Phase 1 study of SGN-CD228A, which enrolled 88 patients with advanced solid tumors, including melanoma and non-small cell lung cancer. This data provided preliminary clinical observations and insights into the CD228 target, safety and biomarkers. Detailed findings from that study have not yet been publicly disclosed.

Construct rationale. CD228V (PF-08046031) is a second-generation, clinical-stage antibody-drug conjugate directed against CD228, also known as melanotransferrin. The molecule uses Pfizer’s established vedotin linker-payload platform, with changes to the linker and the amount of payload carried by each antibody. Medicus understands that these refinements were designed to improve the balance between drug exposure, tolerability and anti-tumor activity. Vedotin technology has clinical and regulatory precedent in FDA-approved ADC therapies.

Focused melanoma strategy. Medicus intends to prioritize melanoma that has relapsed, become refractory or resisted immunotherapy. Based on its assessment of the predecessor clinical evidence from SGN-CD228A and the potential benefit of Pfizer’s linker-payload reconstruction, the Company believes CD228V has the potential to achieve an objective response rate exceeding 30% in melanoma. This potential remains to be demonstrated in clinical trials of CD228V. Any future monotherapy registration strategy would depend on durable responses, an acceptable safety profile and applicable regulatory requirements.

The ADC opportunity. Medicus is emerging as part of approximately 30 clinical-stage ADC developers across the globe. At one end of this field are established companies with approved products and extensive development capabilities; at the other are companies with programs still in clinical research and development. The CD228V agreement also places Medicus amongst a handful of companies advancing Seagen-linked ADC assets through Pfizer collaborations. The rights, economics and clinical maturity of those relationships differ.

The Company believes that worldwide rights, a defined initial clinical objective and evidence generated through development could support future licensing, co-development and other strategic opportunities.

Rationale for the Proposed SkinJect SPAC Transaction

The proposed SkinJect Transaction is intended to establish a separately listed company with its own access to public capital markets and dedicated financing for Gorlin syndrome development, while Medicus seeks to retain majority economic and voting ownership of the combined company. The Company believes this structure could support SkinJect’s advancement while allowing Medicus to concentrate incremental investment on precision oncology.

The non-binding letter of intent ("LOI") with the SPAC contemplates an approximately $135 million pre-money enterprise valuation for SkinJect. Under the proposed terms, the SPAC would acquire 100% of SkinJect in exchange for newly issued common shares of the combined company. Concurrent equity financing is contemplated at closing of the Transaction to support the SKNJCT-005 study in Gorlin syndrome and preparation and submission of a potential New Drug Application (NDA).

The Company currently projects approximately $3 million over the next two years for that program. This is a projected program cost, subject to execution and regulatory requirements. Medicus will continue allocating essential resources to maintain program readiness as the proposed Transaction progresses.

The Company currently anticipates completing the proposed Transaction during the first half of 2027. The LOI is non-binding, and there can be no assurance that definitive agreements will be signed, financing will be secured, Medicus will retain majority ownership, or the Transaction will close within that timeframe or at all.

Capital Efficiency and Portfolio Execution

Medicus intends to align organizational costs and development spending with its portfolio priorities. Incremental capital will be directed toward CD228V, with essential resources allocated to maintain Teverelix’s value and partnering readiness and pursue the proposed SkinJectTransaction. Management anticipates a substantial reduction in operating expenses in the coming quarters.

For Teverelix, Medicus is seeking partners with the capabilities and resources to advance opportunities in urology, advanced prostate cancer and women’s health. The optimized prostate cancer protocol remains subject to FDA feedback. Maintaining program readiness while pursuing partnerships is intended to preserve the asset’s potential value within the Company’s capital allocation strategy.

Financial Performance Supporting the Strategic Update

Ms. Carolyn Bonner, President and CFO, is expected to describe the Company’s financial results for the third quarter and nine months ended September 30, 2026. During the nine-month period, Medicus raised approximately $42.6 million through equity and secured debt financings, net of issuance costs. After approximately $6.4 million in debt repayments, net cash provided by financing activities was $36.2 million. This capital supported the CD228V license and development across the portfolio.

Selected financial results in U.S. dollars in millions for periods ended September 30

Metric Q3 2026 Q3 2025 Nine months
2026 Nine months
2025
Operating expenses 14.5 15.4 34.5 26.6
Net loss (15.2) (16.0) (35.9) (27.3)
Nine-month operating expenses included $9.6 million of research and development expense and a $10.0 million acquired in-process research and development charge.

On September 30, 2026, Medicus held $5.0 million in cash and cash equivalents and $8.1 million in restricted cash, for a combined total of $13.1 million. Cash and cash equivalents on December 31, 2025, were $8.7 million.

(Press release, Medicus Pharma, NOV 9, 2026, View Source [SID1234674479])

On November 9, 2026 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation and immunology (I&I), reported interim results from the Phase 1b/2 STARt-002 trial evaluating invikafusp alfa, a first-in-class dual T-cell agonist, in combination with sacituzumab govitecan-hziy (Trodelvy; SG). Results from patients with metastatic triple-negative breast cancer (mTNBC) and HR-positive/HER2-negative metastatic breast cancer (HR+/HER2− mBC) were presented in an oral session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting.

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The presentation, titled "Initial clinical results from STARt-002: A Phase 1b/2 study of invikafusp alfa, a first-in-class dual T-cell agonist, in combination with sacituzumab govitecan in triplenegative or HR+/HER2− mBC," highlighted interim results from the first clinical trial evaluating a Vβ-directed selective T-cell agonist in combination with an antibody-drug conjugate (ADC), advancing a next-generation precision IO–ADC combination approach.

STARt-002 is evaluating the combination across two biologically distinct metastatic breast cancer populations: TNBC and HR-positive/HER2-negative disease. The combination is designed to bring together two complementary mechanisms. SG provides Trop-2-directed tumor-cell killing and antigen release, which may prime less immunogenic tumors, while invikafusp alfa selectively activates and expands functional Vβ T cells to amplify the resulting antitumor immune response.

"The interim STARt-002 findings provide encouraging evidence that invikafusp alfa retains its selective immunologic mechanism when combined with SG while generating antitumor activity across two difficult-to-treat metastatic breast cancer populations," said Steven J. Isakoff, M.D., Ph.D., Director of Breast Cancer Clinical Research at Mass General Brigham Cancer Institute and presenter of the study. "Most notably, confirmed complete responses were observed in both triple-negative and HR-positive/HER2-negative metastatic breast cancer, including a response continuing beyond one year in a patient with PD-L1-negative metastatic TNBC. These findings support further evaluation of this novel combination for patients who need new treatment options."

Highlights from the STARt-002 Presentation

As of the October 16, 2026, data cutoff, 48 patients had been enrolled across the metastatic TNBC and HR+/HER2− mBC cohorts, representing heavily pretreated populations. Fifty percent of patients had received three or more prior lines of therapy in the metastatic setting, including 67% of patients in the HR+/HER2− cohort. Key findings include:

Reductions in target lesions were observed in 71% (27/38) of efficacy-evaluable patients, with disease control achieved in 74% (28/38) overall and 83% among ADCnaïve patients across mTNBC and HR+/HER2− mBC.

Confirmed complete responses were observed in both the mTNBC and HR+/HER2− mBC cohorts, including a response continuing beyond 12 months in a patient with PDL1-negative mTNBC.

• Objective responses were observed in both breast cancer subtypes:
o 25% ORR (5/20) and 80% DCR (16/20) in HR+/HER2− mBC.
o 28% ORR (5/18) and 67% DCR (12/18) in mTNBC.
o 36% ORR (5/14) and 79% DCR (11/14) in ADC-naïve mTNBC.

Translational analyses demonstrated selective expansion of Vβ6-positive T cells in all eight patients assessed during the first treatment cycle, consistent with observations previously reported for invikafusp alfa monotherapy

The combination demonstrated a manageable safety profile consistent with the known profiles of each agent:

o Cytokine release syndrome was primarily low-grade and medically manageable.
o Adverse events commonly associated with SG were managed using established
supportive-care measures and dose modifications.
o No unexpected toxicities or treatment-related deaths were observed.

"These interim results reinforce our conviction that selective activation of Vβ T-cell populations can broaden the reach of immunotherapy, particularly in less immunogenic tumors that derive limited benefit from checkpoint inhibition," said Zhen Su, M.D., President and Chief Executive Officer of Marengo Therapeutics. "The confirmed complete responses in both metastatic breast cancer cohorts, together with reductions in target lesions in 71% of efficacy-evaluable patients, are particularly encouraging. STARt-002 is the first clinical study to combine a dual T-cell agonist with an ADC, and these data provide important clinical support for invikafusp alfa’s potential as a precision immune amplifier and IO backbone for rational combinations in broader patient populations.

The STARt-002 results highlighted here expand upon the initial Phase 2a findings presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, providing a larger and more mature dataset with quantified activity across both metastatic breast cancer cohorts. The data also complement Phase 2 STARt-001 findings recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Congress, which demonstrated tissue-agnostic, single-agent efficacy signals for invikafusp alfa across eight distinct TMB-H solid tumor types.

First-in-human data supporting this approach were recently published in Nature Medicine2 , demonstrating that invikafusp alfa can selectively activate and expand Vβ-positive T-cell populations in the blood and tumor and generate antitumor activity across advanced solid tumors. Together, STARt-001 and STARt-002 provide converging clinical and translational evidence supporting invikafusp alfa as a precision immune amplifier with potential applicability across tumor types and therapeutic combinations.

Marengo continues to advance invikafusp alfa through a focused development strategy that translates the broad potential of selective T-cell activation into prioritized programs, spanning biomarker-selected monotherapy and rational combinations in broader all-comer populations.

The use of invikafusp alfa and sacituzumab govitecan in patients with metastatic TNBC and HR+/HER2- metastatic breast cancer is investigational, and the safety and efficacy of this combination has not been established.

(Press release, Marengo Therapeutics, NOV 9, 2026, View Source [SID1234674478])

On November 9, 2026 Johnson & Johnson (NYSE:JNJ) reported promising first-in-human Phase 1 results for the investigational combination of pasritamig and JNJ-9401, two bispecific antibodies designed to work together to drive the body’s immune response against advanced prostate cancer. At the recommended regimen, 73 percent (11 of 15 patients) achieved reductions of at least 50 percent in prostate-specific antigen (PSA), a marker used to monitor prostate cancer activity, including 47 percent (7 of 15 patients) who achieved reductions of at least 90 percent. Results were presented in a late-breaking oral session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting (Abstract #1175).1

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The combination represents the first dual-tumor-antigen-targeted bispecific antibody regimen clinically evaluated in prostate cancer, targeting kallikrein-related peptidase 2 (KLK2) and prostate-specific membrane antigen (PSMA) through complementary T-cell signals designed to activate and enhance the function of immune cells against cancer. In the study, deep and sustained PSA responses were observed, with all seven patients who achieved reductions of at least 90 percent remaining on treatment for more than six months without disease progression. No Grade 3 or higher treatment-related adverse events were reported in this early analysis.1

A first-of-its-kind approach: targeting two prostate cancer proteins with complementary T-cell signals

For patients with metastatic castration-resistant prostate cancer (mCRPC), treatment remains challenging as the disease progresses and available options become more limited.2 Median overall survival is approximately two to three years, highlighting the need for continued innovation.3,4 While immunotherapies have transformed the treatment of some cancers, their role in prostate cancer has historically been limited, and immune checkpoint inhibitors have shown minimal clinical benefit.5

Bispecific antibodies are designed to help the immune system recognize and attack cancer by activating T cells, a process that can be enhanced by generating two complementary signals.6,7 Pasritamig, a first-in-class bispecific antibody targeting KLK2, has demonstrated single-agent antitumor activity,8 and is designed to provide the first signal by directing T cells toward prostate cancer cells. JNJ-9401, a novel bispecific antibody targeting PSMA, provides a second signal designed to strengthen and sustain T cell activity.

Expert and company perspectives on the potential of this dual-antigen targeted bispecific regimen

"Prostate cancer has long been difficult to treat with immunotherapy, which makes the activity we’re seeing particularly interesting," said Laura Graham, M.D.,* Assistant Professor of Medicine-Medical Oncology at the University of Colorado School of Medicine. "By combining two complementary approaches to T-cell activation, we are exploring a new way to engage the immune system against this disease. The depth of PSA reductions observed in this study, including responses sustained for six months or longer, provides encouraging early evidence for the pasritamig-JNJ-9401 combination that warrants further investigation in a larger Phase 3 study."

"This novel dual-antigen-targeted bispecific regimen combines pasritamig, a foundational component of our prostate cancer pipeline, with JNJ-9401, highlighting the potential of complementary mechanisms working together," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "With this combination now in Phase 3 development, we are building on the early promise of this approach as we work to bring new treatment options to patients with advanced disease."

Early results show promising deep and sustained PSA reductions

The ongoing, open-label, multicenter Phase 1 study is evaluating the safety and preliminary clinical activity of pasritamig in combination with JNJ-9401 in patients with metastatic castration-resistant prostate cancer (mCRPC), also known as metastatic androgen pathway modulation-resistant prostate cancer (mAPMR).1

These preliminary findings are based on a small number of patients at the recommended regimen, and further evaluation is needed to determine the clinical benefit and safety of the combination in a larger population.1

As of June 15, 2026, 144 patients had enrolled in the study. Patients treated at the recommended regimen were heavily pretreated, having received a median of four prior lines of systemic therapy (range, two to six). Among the 15 patients treated at this regimen, 73 percent achieved PSA reductions of at least 50 percent and 47 percent achieved reductions of at least 90 percent. Four patients achieved undetectable PSA levels. All seven patients who achieved PSA reductions of at least 90 percent remained on treatment for more than six months without disease progression.1

At the recommended regimen, no Grade 3 or higher treatment-related adverse events, dose-limiting toxicities, or treatment-related adverse events leading to discontinuation or death were reported. Cytokine release syndrome (CRS), an inflammatory reaction that can occur when T cells are activated, was observed in three patients (20 percent). All cases were mild (Grade 1), presenting as temporary fever, and none required treatment with tocilizumab. No cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported.1

The recommended regimen consists of JNJ-9401 200 mg administered subcutaneously every six weeks in combination with pasritamig 300 mg administered intravenously every six weeks, following two initial weekly pasritamig step-up doses. The findings suggest the combination has potential to be administered on this schedule in an outpatient setting.1

Advancing a new generation of immunotherapy combinations into Phase 3

The combination is being evaluated in the ongoing Phase 3 KLK2-comPAS (NCT07164443) study, which is investigating whether adding JNJ-9401 to pasritamig can improve outcomes for patients with mCRPC.[9] The study represents an important next step in Johnson & Johnson’s broader development program for pasritamig, which is being evaluated both as a single agent and in combination with other therapies across advanced prostate cancer.

About the study
The Phase 1 study (NCT06095089) is an open-label, multicenter trial evaluating the safety and clinical activity of pasritamig in combination with JNJ-9401 in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received at least one prior systemic therapy. In Part 1, JNJ-9401 was dose escalated in combination with fixed-dose pasritamig, with primary objectives of evaluating safety and determining the recommended regimen. Dose expansion was initiated at the recommended regimen, including a frontline mCRPC cohort. The recommended regimen is JNJ-9401 200 mg administered subcutaneously every six weeks in combination with pasritamig 300 mg administered intravenously every six weeks, following two weekly pasritamig step-up doses. Treatment is administered in an outpatient setting.10

About pasritamig and JNJ-9401
Pasritamig and JNJ-9401 are investigational bispecific antibodies designed to work together to activate and enhance the immune response against prostate cancer. Pasritamig, a first-in-class KLK2xCD3 bispecific antibody, is designed to direct T cells to prostate cancer cells, while JNJ-9401, a PSMAxCD28 costimulatory bispecific antibody, is designed to provide an additional signal that enhances T-cell activation and function. By targeting two different prostate cancer proteins, KLK2 and PSMA, the combination is designed to deliver complementary signals to T cells.

Pasritamig is being studied as a monotherapy and in combination with other therapies across advanced prostate cancer. Pasritamig with or without JNJ-9401 is being evaluated in the Phase 3 KLK2-comPAS study in metastatic castration-resistant prostate cancer and pasritamig plus docetaxel is being evaluated in the Phase 3 KLK2-PASenger study in first-line mCRPC.

About metastatic castration-resistant prostate cancer (mCRPC)
Metastatic castration-resistant prostate cancer (mCRPC), also known as metastatic androgen pathway modulation-resistant prostate cancer (mAPMR), is an advanced form of prostate cancer that continues to progress despite treatments that target the androgen receptor pathway.2 As the disease progresses, it can spread to other parts of the body, including the bones and lymph nodes, and patients may receive additional treatments such as chemotherapy and radioligand therapy targeting prostate-specific membrane antigen (PSMA).11

Patients with metastatic prostate cancer that has become resistant to androgen pathway modulation face poor outcomes, with survival varying based on factors including the location and extent of disease, prior treatment history and response to therapy. Median overall survival ranges from approximately 13.5 to 31.6 months depending on the site of metastasis.

(Press release, Johnson & Johnson, NOV 9, 2026, View Source [SID1234674477])

On November 9, 2026 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported management will participate at the following conferences in November.

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UBS Global Biopharma Conference 2026
Fireside Chat: Tuesday, November 17, 2026, at 3:20 p.m. GMT

Jefferies London Global Healthcare Conference
1×1 and small group meetings: Wednesday, November 18, 2026

The presentation will be webcast live and can be accessed by visiting ‘Events & Presentations’, under ‘Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentation will be made available for a limited time.

(Press release, Immunocore, NOV 9, 2026, View Source [SID1234674476])