On September 30, 2025 Toragen, Inc., a clinical-stage biotechnology company developing a first-in-class, oral small molecule HPV E5 protein inhibitor targeting cancers caused by the human papillomavirus ("HPV"), reported the successful completion of a $12 million convertible note financing (Press release, Toragen, SEP 30, 2025, View Source [SID1234656363]).

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The financing was led by Steven Lebow, who will join Toragen’s Board of Directors along with his designee, Dr. Scott Rasgon. GenHenn Capital also participated with a significant investment and will be represented on the Board by Bill Hagaman, COO of GenHenn Capital. In addition, Cathleen May, PhD, will assume the Board seat of the late Paul Engler, representing the Paul F. and Virginia J. Engler Foundation.

"This financing enables us to advance the next critical steps in developing TGN-S15, our lead candidate, and prepare for our upcoming clinical trial," said Sandra Coufal, MD, CEO of Toragen. "We are grateful for the support of our investors and are excited to welcome four distinguished new members to our Board who bring deep expertise and commitment to our mission of developing an effective treatment for HPV-driven cancers."

The majority of proceeds from this financing will support CMC and IND-enabling studies for TGN-S15.

About Steven E. Lebow

Steven Lebow is widely recognized in the investment banking community for his 21-year tenure as Managing Director at Donaldson, Lufkin & Jenrette (DLJ), where he led the Retail Investment Banking Group and advised clients across the U.S., Europe, and Latin America.

He has been an early investor in companies including Costco, Starbucks, PetSmart, Dick’s Sporting Goods, and Ulta Beauty, generating returns between 100x and 600x and helping drive their combined market capitalization above $600 billion. In recognition of his achievements, Steven was inducted into the DLJ "Hall of Fame" in 1995.

He later co-founded Global Retail Partners, a venture capital firm that became GRP Partners, and has continued to be a prominent figure in finance and investment. Steven earned his BA in Economics and Political Science, magna cum laude and Phi Beta Kappa, from UCLA and an MBA from the Wharton School at the University of Pennsylvania, where he was awarded the Exxon Fellowship.

On September 29, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported subgroup analyses focused on the radiation regimen from the Company’s positive phase 3 clinical trial of CAN-2409 (aglatimagene besadenovec) in patients with intermediate-to-high-risk localized prostate cancer at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Press release, Candel Therapeutics, SEP 29, 2025, View Source [SID1234656327]).

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Current standard-of-care radiation therapy for intermediate-to-high-risk localized prostate cancer has remained largely unchanged, with a significant unmet medical need, as approximately ~30% of patients experience disease recurrence within 10 years.

The Company has previously presented data from a randomized phase 3 clinical trial of CAN-2409 plus valacyclovir vs. placebo added to standard of care radiotherapy with curative intent in patients with localized prostate cancer. The press release is posted on the investor relations section of our website, available here. The randomized, double-blind, placebo-controlled, multicenter phase 3 trial (NCT01436968) enrolled 745 patients with intermediate-to-high-risk localized prostate cancer randomized 2:1 to either CAN-2409 plus valacyclovir in combination with standard of care or standard of care alone, with experimental treatment administered before and during radiation therapy. The trial achieved its primary endpoint with a 30% improvement in disease-free survival (HR 0.7, p=0.0155) and demonstrated a 38% improvement in prostate cancer-specific disease-free survival (HR 0.62, p=0.0046). At two years, pathological complete response rates were 80.4% as compared to 63.6% observed in the control arm (p=0.0015).

This study represents the first potential advancement in localized, non-metastatic prostate cancer in more than 20 years. The Company today released additional information from its subgroup analysis of the phase 3 data showing that CAN-2409’s activity was independent of the radiation modality used in the trial.

Key Highlights from ASTRO 2025 Presentation:

CAN-2409 significantly improved prostate cancer-specific outcomes (HR 0.62; p=0.0046). Effects observed in both moderate hypofractionated EBRT (HR 0.52, CI 0.30 – 0.93, p=0.0236) and conventional EBRT (HR 0.76, CI 0.53 – 1.07, p=0.1131)
Demonstrated safety and compatibility across radiation therapy modalities, with both conventional radiation therapy (~78 Gy in 2 Gy fractions, ~72% of patients) and moderate hypofractionated radiation therapy (60 Gy in 3 Gy fractions, ~25% of patients) showing similar tolerability profiles
Grade ≥ 3 treatment related adverse events were similar in the CAN-2409 plus valacyclovir and control arms with both hypofractionated (1.6% vs. 1.9%) and standard EBRT (1.8% vs. 1.1%), respectively
"These additional analyses suggest that the efficacy of CAN-2409 is independent of the modality of radiation used. Most importantly, the activity of CAN-2409 was maintained with moderate hypofractionated radiation, which is more convenient for patients," said Glen Gejerman, M.D., M.B.A., Co-Director of Urologic Oncology at Hackensack Meridian Health and one of the principal investigators of the study.

Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel said, "These new insights presented at ASTRO further support the broad therapeutic potential of CAN-2409 in localized prostate cancer treated with curative intent. Previously, we have shown the benefit of CAN-2409 compared to placebo in patients treated with standard of care radiotherapy, independent of the use of short-term androgen deprivation therapy. The consistency of benefit, across radiation therapy modalities, supports the therapy’s potential as the first major advancement in localized prostate cancer treatment in over 20 years. Our regulatory strategy remains on track with Biologics License Application submission expected in the fourth quarter of 2026."

About CAN-2409

CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.

On September 29, 2025 Children’s Hospital of Philadelphia (CHOP) reported that Theodore W. Laetsch, MD, a pediatric oncologist and principal investigator in the Advanced Personalized Therapeutics and Precision Surgery Program, was awarded a $1 million multi-year grant from the National Cancer Institute (NCI) (Press release, CHOP, SEP 29, 2025, View Source [SID1234656328]). The grant will advance research and treatment of rare tumors, which are responsible for 25% of cancer-related deaths.

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Historically understudied, rare tumors have seen less improvement in outcomes compared to more common cancers due to numerous obstacles in clinical research. Additionally, most rare pediatric cancers occur in the adolescent and young adult population, where treatment is often dispersed across various subspecialties.

The grant supports Laetsch’s commitment to tackling these challenges and advancing the understanding and precision medicine approach to treating rare tumors across the Children’s Oncology Group (COG), within CHOP, at the University of Pennsylvania, and in mentoring junior investigators. Laetsch, who also leads CHOP’s Developmental Therapeutics Program and Very Rare Malignant Tumors Program, and holds national leadership roles within COG, has been instrumental in addressing myriad challenges facing the field. These include the limited availability of biospecimens, small patient numbers, and the complexity of designing novel clinical trials.

"This grant represents a pivotal milestone in our quest to transform rare tumor research and enhance patient outcomes," said Laetsch. "Our mission is to bridge gaps in clinical research and ensure that children and adolescents have access to cutting-edge precision treatment options."

The grant will allow Laetsch and his team to focus on immunotherapy trials and molecularly targeted therapies for rare cancers. This initiative will oversee the development of novel studies for patients never previously researched within COG, such as those with thyroid cancer and melanoma.

The funding will also help establish the Advanced Personalized Therapeutics and Precision Surgery Program, a pediatric-adult rare tumor program at the Leonard and Madlyn Abramson Pediatric Research Center. The program aims to increase enrollment in both the National Clinical Trials Network (NCTN) and investigator-initiated precision medicine trials for children and adults with rare tumors and help physicians find appropriate trials for their patients.

The grant is expected to expand the pipeline of rare tumor clinical trials within the NCTN. It will boost participation in NCI-funded rare tumor clinical research across all age groups at the Abramson Cancer Center and enhance both institutional and COG biobanks.

Dr. Laetsch will also mentor the next generation of clinicians specializing in rare tumors and developmental therapeutics. Through the COG/NCTN, he will guide young researchers in designing and leading future studies.

"The award underscores the importance of fostering new talent in the field and ensuring a sustained focus on rare tumor research," said Laetsch.

On September 29, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported updated data from cohorts 1 and 2 of Study 1100, a multicenter Phase 1 dose escalation and expansion trial evaluating JNJ-1900 (NBTXR3) activated by radiation therapy ("RT") followed by anti-PD-1 immune checkpoint inhibitors (pembrolizumab or nivolumab; "ICIs") in patients with recurrent and/or metastatic head and neck squamous cell carcinoma ("R/M-HNSCC") that is naïve (cohort 1) or resistant (cohort 2) to prior anti-PD-1 therapy (Press release, Nanobiotix, SEP 29, 2025, View Source [SID1234656347]). Study results were presented as a "Top-rated Abstract in Head and Neck Cancer" by Study 1100 Coordinating Investigator Colette Shen, MD, PhD, Assistant Professor of Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, at the 2025 Annual Meeting of the American Society of Radiation Oncology (ASTRO).

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ABSTRACT #245: PHASE 1 DOSE ESCALATION/DOSE EXPANSION TRIAL OF NBTXR3/SBRT IN COMBINATION WITH NIVOLUMAB OR PEMBROLIZUMAB FOR TREATMENT OF ANTI-PD-1 NAÏVE OR RESISTANT PATIENTS WITH RECURRENT/METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA
Colette Shen1, Ammar Sukari2, William A. Stokes3, George Yang4, Nabil F. Saba3, Jared Weiss1, Jessica Frakes4, Jimmy Caudell4, Paul Chang5, Septimiu Murgu5, Michele Lohr6, Jason Chan7, Kedar Kirtane4, David Rolando8, Omar I. Vivar8, Zhen Gooi5, Aditya Juloori5, Trevor Hackman1, Ari Rosenberg5
1University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA; 2Karmanos Cancer Institute, Detroit, MI, USA; 3Emory Winship Cancer Institute, Atlanta, Georgia, USA; 4Moffitt Cancer Center, Tampa, Florida, USA; 5The University of Chicago, Chicago, Illinois, USA; 6Sanford Cancer Center, Sioux Falls, South Dakota, USA; 7UCSF, San Francisco, CA, USA; 8Nanobiotix, SA, Paris, France

The efficacy of ICI monotherapy remains limited in R/M-HNSCC, with objective response rates between approximately 13% and 18%, and median Overall Survival ("mOS") between approximately 8 months and 12 months. As approximately 66% of patients with R/M-HNSCC experience disease recurrence locally or loco-regionally, addition of RT to the treatment regimen is often recommended to improve local control and as a potential option for stimulating immune responses. However, to date, the addition of RT has not significantly improved ICI efficacy in R/M-HNSCC. As such, patients with R/M-HNSCC have an unmet need for novel treatment strategies that can improve local tumor control and potentiate systemic immune response.

Safety and Feasibility

JNJ-1900 (NBTXR3) activated by RT followed by anti-PD-1 was consistently well-tolerated and remained feasible in this heavily pre-treated patient population (n=103):

Injection remained consistently feasible at the recommended Phase 2 dose (33% GTV)
Favorable safety profile including no additional toxicities in lesions that were injected after re-irradiation
27 patients experienced treatment-emergent adverse events (TEAEs) of any grade (1, 2, or 3+) related to JNJ-1900 (NBTXR3) and 32 patients experienced TEAEs of any grade related to the injection procedure
Of these patients, 5 experienced grade 3+ TEAEs related to JNJ-1900 (NBTXR3) and 4 experienced grade 3+ TEAEs related to the injection procedure
In total, 71 patients experienced TEAEs of any grade related to the overall therapeutic regimen
Patients were deemed non-evaluable for efficacy (n=12) if more than one RT session was missed and/or a post-treatment tumor response assessment was unavailable
Signals of Efficacy

Potential enhancement of local responses:

Evaluable Anti-PD-1 Naïve Patients (n=41)
Injected-lesion Disease Control Rate ("DCR"): 95% (39/41)
Injected-lesion Overall Response Rate ("ORR"): 66% (27/41)
Local Progression-free Survival ("LPFS"): 34.4 months [95% CI: 12.8; Not Reached]
Evaluable Anti-PD-1 Resistant Patients (n=50)
Injected-lesion DCR: 94% (47/50)
Injected-lesion ORR: 50% (25/50)
LPFS: 7.3 months [95% CI: 5.7; Not Reached]
Systemic responses beyond potential enhanced local control:

Evaluable Anti-PD-1 Naïve Patients
DCR per RECIST 1.1: 63% (26/41)
ORR per RECIST 1.1: 37% (15/41)
Evaluable Anti-PD-1 Resistant Patients
DCR per RECIST 1.1: 74% (37/50)
ORR per RECIST 1.1: 32% (16/50)
Early signals of Overall Survival that is expected to mature with additional follow up:

Evaluable Anti-PD-1 Naïve Patients
Median Overall Survival: 15.5 months [95% CI: 11.0; Not Reached]
Evaluable Anti-PD-1 Resistant Patients
Median Overall Survival: 11.4 months [95% CI: 7.8; 16.7]
Notably, survival data in anti-PD-1 resistant patients suggests JNJ-1900 (NBTXR3) activated by RT followed by anti-PD-1 may overcome prior resistance to immune checkpoint inhibitors. Overall, these results show strong local control, with an aggregate DCR of 95% (86/91) in JNJ-1900 (NBTXR3)-injected lesions in evaluable patients, representing a critical potential outcome for patients with R/M-HNSCC. Moreover, the results suggest that the antitumoral activity of JNJ-1900 (NBTXR3) activated by RT may occur beyond the injected lesion. Investigators concluded that these promising results warrant further exploration in randomized controlled trials.

"Through the evaluation of JNJ-1900 (NBTXR3) cohorts 1 and 2 of Study 1100, we are ensuring that we prioritize the clinical development of innovation that acts both locally and systemically to address the unmet needs of patients with R/M-HNSCC," said Study 1100 Coordinating Investigator Colette Shen, MD, PhD. "Our findings from Study 1100 have consistently supported a well-tolerated safety profile with early efficacy signals, and I look forward to further investigation of JNJ-1900 (NBTXR3) as a potentially new and complementary therapeutic option for patients."

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Johnson & Johnson.

On September 29, 2025 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported updates on the company’s Phase 2 clinical program evaluating JK07 in heart failure with reduced ejection fraction (HFrEF), heart failure with preserved (HFpEF) and Group 2 pulmonary hypertension (PH), as well as its Phase 1 clinical study of JK06 in solid tumor indications (Press release, Salubris Biotherapeutics, SEP 29, 2025, View Source [SID1234656329]).

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"We are thrilled to have two clinical-stage programs both progressing and expanding in development. Importantly, we have now completed enrollment for the HFrEF cohort in the ongoing Phase 2 RENEU-HF study, putting us on track for a topline readout of the primary endpoint in the first half of 2026. We continue to believe that JK07, the first and only clinical-stage selective ErbB4 agonist, has the potential to be the first disease-modifying biologic for heart failure, and we very much look forward to these results. We are also pleased to announce that we have initiated the open-label Phase 2a RENEU-PH study evaluating JK07 in patients with combined pre- and post-capillary Group 2 pulmonary hypertension due to heart failure, a population with no approved treatment options and a poor prognosis. JK07’s potential to target both myocardial dysfunction and the pulmonary vasculature may provide a unique dual benefit in this population," said Sam Murphy, Chief Executive Officer of SalubrisBio.

"We are also eagerly anticipating the European Society for Medical Oncology Congress next month, where we will present initial data from our ongoing first-in-human study evaluating JK06, our novel, first-in-class biparatopic antibody-drug conjugate (ADC) targeting 5T4, and are excited to now be moving into the expansion cohort stage of the study."

JK07 Phase 2 (RENEU-HF) Study

RENEU-HF (NCT06369298) is a global Phase 2, randomized, double-blind, placebo-controlled, multiple-dose study designed to evaluate the efficacy and safety of JK07 in patients with HFrEF and HFpEF in 282 subjects. The study has two cohorts: cohort 1, which has completed enrollment, is comprised of patients with HFrEF; cohort 2 is currently enrolling patients with HFpEF. The primary endpoint of the study for the HFrEF cohort is change in left ventricular ejection fraction (LVEF) at 26 weeks. The HFrEF cohort enrolled 215 subjects, randomized 1:1:1 to high or low dose JK07 or placebo. Results of the primary endpoint analysis are expected in the first half of 2026.

Heart failure affects an estimated 6.7 million Americans1 and more than 64 million people worldwide2, with HFrEF and HFpEF each affecting over 3 million patients in the US alone. HF is a chronic condition in which patients experience progressively worsening symptoms and quality of life, hospitalizations and death. In HFrEF, the left ventricle loses its ability to contract normally, and the heart cannot pump with sufficient force to push enough blood into circulation. In HFpEF the heart becomes stiff and loses its ability to function properly.

JK07 Phase 2a (RENEU-PH) Study
The Phase 2a, open-label, multiple-dose study is designed to evaluate the safety, efficacy, and tolerability of JK07 in patients with combined pre- and post-capillary Group 2 pulmonary hypertension (cpcPH) due to HF. This 6-month study is expected to enroll up to 30 patients who will receive four every-4-week (QW4) doses of JK07, over the course of 13 weeks, with a 12-week follow-up period.

Chronic pulmonary hypertension (PH) due to left heart disease represents a significant complication in patients with HF. Epidemiologic studies suggest that up to 50% of patients with HFrEF or HFpEF exhibit some degree of PH, and cpcPH is associated with markedly worse outcomes, including increased hospitalizations and mortality3.

JK06 Phase 1 Study
The ongoing Phase 1, open-label, dose escalation and expansion study (EUCT2024-512421-92-00) is designed to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 in a basket of solid tumors known to express the protein 5T4, with a target enrollment of up to 155 patients. Enrollment has now been completed in the dose escalation phase of the study, and initial data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress taking place on October 17-21, 2025, in Berlin, Germany. Details of the presentation are as follows:

Title: A Phase 1/2 Study of JK06, a 5T4-Targeted Antibody Drug Conjugate (ADC), in Patients with Unresectable Locally Advanced or Metastatic Cancer
Presenter: Nuria Kotecki, M.D. at Institut Jules Bordet, Anderlecht, Belgium
Abstract #: 961P
Session: Developmental Therapeutics
Date/Time: Sunday, October 19, 2025

About JK07
JK07 is a recombinant antibody fusion protein consisting of an active polypeptide fragment of the human growth factor neuregulin (NRG-1) and a fully human immunoglobulin IgG1 monoclonal antibody targeting ErbB3. NRG-1 is a clinically validated growth factor that has shown promising activity in HF, but also undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – ErbB3 and ErbB4. The ErbB4 pathway appears to be responsible for the regenerative effects in the heart, while the ErbB3 pathway appears primarily responsible for the safety and tolerability limitations of recombinant NRG-1. By blocking ErbB3 signaling with an antibody fusion design, JK07 selectively stimulates the ErbB4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects. JK07 is in clinical development for the treatment of HFrEF, HFpEF, and cpcPH.

About JK06
JK06 is a first-in-class quadrivalent, biparatopic antibody drug conjugate (ADC) that selectively targets 5T4 with a monomethyl auristatin E (MMAE) payload. 5T4 is an oncofetal protein that is overexpressed in a wide range of tumor types, including lung and breast cancers, and is associated with more aggressive tumor progression and reduced survival. JK06 has demonstrated picomolar affinity for 5T4 and rapid internalization due to the biparatopic design. Together with stable, site-specific payload conjugation, JK06 has further demonstrated robust efficacy and a clean safety profile in non-clinical studies.