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UroGen Announces New Data Presentations at the American Urological Association 2024 Annual Meeting Highlighting Clinical Benefits of Our Portfolio for Urothelial Cancers

On April 17, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that new data on investigational drug UGN-102 (mitomycin) and JELMYTO and will be presented at the American Urological Association (AUA) 2024 Annual Meeting being held in San Antonio, Texas from May 3 – 6 (Press release, UroGen Pharma, APR 17, 2024, View Source [SID1234642141]).

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"We are proud that the AUA selected the ATLAS post-hoc analysis as a podium presentation," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. "The results highlight UGN-102’s potential to help significantly advance treatment for patients with newly diagnosed and recurrent LG-IR-NMIBC, a highly prevalent and recurrent disease. Additionally, we are excited to see additional independent real-world evidence related to JELMYTO treatment of LG-UTUC patients in a diverse patient types."

Key details of UGN-102 and JELMYTO abstracts accepted by AUA:

Abstract Title

Presentation Details

Response to Primary Chemoablation with UGN-102 in Patients with New or Recurrent LG IR NMIBC: Post-hoc Analysis of the ATLAS Trial

Podium Oral Presentation:
Abstract ID 24-6641,
Saturday, May 4,
2:20-2:30 PM CDT,
Location 304A

Presenter: Dr. William Huang

Longitudinal Follow Up of Multicenter Study of UGN-101 for Upper Tract Urothelial Cancer

Podium Oral Presentation:
Abstract ID 24-7470,
Sunday, May 5,
11:10-11:20 AM CDT,
Location 301A

Presenter: Dr. Yair Lotan

Exploring Recurrence After Initial Response to UGN-101 Induction in Expanded Settings

Podium Oral Presentation:

Abstract ID 24-7534,
Sunday May 5,
11:20-11:30 AM CDT,
Location 301A

Presenter: Dr. Adam Feldman

Mitomycin-containing Reverse Thermal Gel UGN-101 for Upper Tract Urothelial Carcinoma: Retrograde Instillation in Clinic and Outcomes

Video Presentation:

Abstract ID 24-7720,
Saturday, May 4,
10:50-11:00 AM CDT,
Location Video Abstract Theater

Presenter: Dr. Golena Moncaleano

UroGen Sponsors AUA Innovation Nexus

UroGen’s President and Chief Executive Officer, Liz Barrett, will participate in a panel discussion about the state of innovation in urology and a reverse pitch on key areas of discovery and collaboration during the AUA Innovation Nexus Conference on May 2. The AUA Innovation Nexus is a powerful forum to advance urologic discovery to solutions that improve patient care and save lives. Register here: View Source

State of Innovation in Urology

Reverse Pitch:
1-2 PM CDT

Showcase Panel:
Thursday May 2 between 2:45-4:45 PM CDT

Liz Barrett, President and CEO, UroGen Pharma & Other Speakers

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates completing its new drug application (NDA) submission for UGN-102 in September 2024 with a potential FDA decision as early as the first quarter of 2025.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

In the U.S. bladder cancer is the second most common urologic cancer in men. LG-IR-NMIBC represents approximately 22,000 newly diagnosed bladder cancer patients each year and an estimated existing 60,000 recurrent patients. Bladder cancer primarily affects older populations with the median age of diagnosis 73 years and an increased risk of comorbidities. Guideline recommendations for managing LG-IR-NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence and LG-IR-NMIBC patients are even more likely to recur and face repeat TURBT procedures.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

About Upper Tract Urothelial Cancer

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 – 7,000 new or recurrent low-grade UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse.

IGM Biosciences Announces Refocusing of Sanofi Collaboration

On April 17, 2024 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported that the Company’s exclusive worldwide collaboration agreement with Sanofi to create and develop IgM agonist antibodies will now focus exclusively on immunology/inflammation targets (Press release, IGM Biosciences, APR 17, 2024, View Source [SID1234642140]). IGM will retain global rights to its proprietary technology related to the oncology targets nominated by Sanofi under the collaboration.

"We are very pleased with our collaboration with Sanofi and with the preclinical data that we have generated in both the immunology/inflammation and the oncology portions of the collaboration," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "As we assess next steps with respect to these oncology targets, our top internal priorities remain our clinical-stage oncology and autoimmune programs."

Terms of the Collaboration
As previously announced, under the terms of the collaboration agreement, for each of the three Sanofi designated immunology/inflammation targets, IGM will lead research and development activities and assume related costs through the completion of a Phase 1 clinical trial for up to two constructs directed to each target, after which Sanofi will be responsible for all future development and commercialization activities and associated costs. IGM will be eligible to receive up to $1,065 million in aggregate development, regulatory and commercial milestones per target as well as tiered high single-digit to low-teen royalties on global net sales.

Halia Therapeutics to Present at Asia BIO 2024

On April 17, 2024 Halia Therapeutics, a clinical-stage biopharmaceutical company pioneering a novel class of small molecule medications designed to combat inflammation, reported that David J. Bearss, Ph.D., President and CEO of Halia Therapeutics, will present at the Asia BIO 2024 Conference on April 24 (Press release, Halia Therapeutics, APR 17, 2024, View Source [SID1234642139]).

The presentation will include recent business updates and anticipated milestones from Halia’s ongoing Phase II clinical trials in multiple indications evaluating its lead asset, HT-6184, a selective and orally bioavailable first-in-class inhibitor of the NLRP3/NEK7 inflammasome. This drug candidate is designed to improve patients’ lives by targeting chronic inflammatory disorders and neurodegenerative diseases.

Details about the presentation are as follow:

• Presenter: David J. Bearss, Ph.D., President and CEO of Halia Therapeutics

• Date: Wednesday, April 24, from 2:00 – 2:15 p.m. SGT

• Location: Marina Bay Sands Convention Center, Singapore

• Room: #3102

• Registration: Here

Asia Bio Partnering Forum continues to build on its strong start to gather biotech and pharma leaders from around the world with hundreds of emerging innovators across Asia Pacific to advance dealmaking in Asia. Dr. Bearss will be available for meetings with registered conference attendees.

Evaxion Announces Phase 2 Clinical Trial Update: First Patient Completed Dosing with Personalized Cancer Vaccine EVX-01

On April 17, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported that the first patient in its EVX-01 Phase 2 trial in metastatic melanoma received the last vaccine dose in combination with KEYTRUDA (NCT05309421) (Press release, Evaxion Biotech, APR 17, 2024, View Source [SID1234642138]).

The Company initiated its Phase 2 clinical study in September 2022 to assess the efficacy, safety and ability to induce a tumor-specific immune response of the EVX-01 cancer vaccine in metastatic melanoma patients. The EVX-01 vaccine was designed using Evaxion’s proprietary AI-Immunology platform and is an individualized therapy matching the unique tumor profile and characteristics of the patient’s immune system. Each patient enrolled in the trial receives a unique vaccine designed and manufactured based on their individual biology. Patients are administered ten EVX-01 doses over a period of 78 weeks in combination with the anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

Birgitte Rønø, CSO of Evaxion, commented, "With the progress made in the Phase 2 study, we are one step closer to fulfilling our mission of saving and improving lives with AI-Immunology. We eagerly anticipate sharing the one-year clinical readout in Q3 this year and look forward to being one step closer to market with a novel personalized cancer vaccine."

Professor Adnan Khattak at One Clinical Research, Hollywood Private Hospital, Western Australia, expresses enthusiasm, stating, "We are now entering into the era of personalized cancer therapies, where we adopt a tailored approach against an individual patient’s tumor. In other words, we are treating each patient with the right drug. As a physician, I firmly believe this is the future."

At the end of 2023, Evaxion reported initial EVX-01 Phase 2 data confirming the favorable safety profile and promising immunological data as observed in the previously successful Phase 1 clinical trial. To learn more, please read the related press release.

About EVX-01 Phase 2 Clinical Trial

EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC that, together with leading principal investigators and research centers from Italy and Australia, aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 therapy KEYTRUDA (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.

Enterome Announces Successful Completion of Phase 2 ROSALIE Study of EO2401 in Recurrent Glioblastoma

On April 17, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported database lock of its Phase 2 study of EO2401, in combination with an immune checkpoint inhibitor (nivolumab) +/- an anti-VEGF therapy (bevacizumab), for the treatment of patients with recurrent glioblastoma (EOGBM1-18/ROSALIE trial) (Press release, Enterome, APR 17, 2024, View Source [SID1234642137]).

A total of 100 patients have been enrolled in ROSALIE, an international, open-label Phase 1/2 trial of EO2401, an innovative, off-the-shelf immunotherapy derived from Enterome’s oncomimicry platform. Interim results have been presented at multiple congresses, most recently at the Society for Neuro-Oncology (SNO) 2023 annual meeting demonstrating a 43.1% survival rate at 18 months in a 26-patient cohort dosed with EO2401 in combination with nivolumab+bevacizumab.

Jan Fagerberg, Chief Medical Officer of Enterome, said: "The achievement of the first trial evaluating EO2401 represents a major milestone for Enterome. With a total of 100 patients enrolled, of which 41 received the combination of EO2401 with nivolumab and bevacizumab, alongside extensive follow-up, we are confident that the ROSALIE study provides a compelling foundation for evaluating this novel immunotherapy as a potential treatment for patients with recurrent glioblastoma. With an encouraging clinical efficacy, we are now looking forward to sharing the final data with the scientific community in the coming months."

OncoMimics immunotherapies utilize bacteria-derived peptide antigens that closely mimic those expressed by tumor cells. In contrast to Tumor-Associated Antigens (TAAs), OncoMimics peptides are recognized as non-self by the immune system, inducing a strong and durable cytotoxic CD8+ immune response stemming from circulating effector memory T cells cross-reacting against the tumor, therefore offering enormous potential to create a new class of immunotherapies.

To date, Enterome has generated a repertoire of OncoMimics peptides targeting TAAs across a wide range of solid and liquid tumors. In addition to EO2401, the other candidates include EO2463, in Phase 2 clinical trial for indolent Non-Hodgkin Lymphomas, and EO4010, in Phase 2 clinical trial for metastatic colorectal cancer.

Pierre Bélichard, Chief Executive Officer of Enterome, said: "T cells are Nature’s most effective weapons against cancer cells, yet their potential is restrained by immunological self-tolerance. The ROSALIE study represents the first demonstration of OncoMimics immunotherapies’ ability to overcome immune tolerance, promising new avenues for targeting cancer cells. The trial provides a strong basis for pursuing a registrational path for EO2401 and expanding our pipeline to other indications. I am proud of the immense work accomplished by the Enterome team since the recruitment of the first patient in 2020. I also would like to thank patients, their families, and investigators whose dedication made this groundbreaking study possible."

About ROSALIE

ROSALIE (EOGBM1-18, ClinicalTrials.gov Identifier: NCT04116658) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo) +/- bevacizumab for the treatment of patients with first progression/recurrence of glioblastoma. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination in 100 patients enrolled at 10 clinical sites in Europe and the US.

Clinical publications on ROSALIE to date include:

Reardon et al., EO2401 Peptide Immunotherapy + Nivolumab +/- Bevacizumad in First Recurrent Glioblastoma: The Phase 1/2 EOGBM1-18/ROSALIE Study, Neuro-Oncology, Volume 25, Issue Supplement_5, November 2023 DOI: 10.1093/neuonc/noad179.0265
Wick et al., EO2401 peptide immunotherapy + nivolumab +/- bevacizumab in recurrent glioblastoma: EOGBM1-18/ROSALIE. Journal of Clinical Oncology 41 2023 DOI:10.1200/JCO.2023.41.16_suppl.2020
Reardon et al., EO2401 Therapeutic Vaccine for Patients with Recurrent Glioblastoma: Phase 1/2 ROSALIE Study, Neuro-Oncology, Volume 24, Issue Supplement_7, November 2022 DOI:10.1093/neuonc/noac209.249
Maia et al., Strong immune response to therapeutic vaccination with EO2401 therapeutic vaccine + nivolumab: interim report of the EOGBM1–18/ROSALIE study, Journal for ImmunoTherapy of Cancer 2022 DOI:10.1136/jitc-2022-SITC2022.0641
Reardon et al., EO2401 therapeutic vaccine for patients with recurrent glioblastoma: Phase I/II ROSALIE study, Annals of Oncology, Volume 33, Supplement 7, September 2022 DOI:10.1016/j.annonc.2022.07.437
Reardon et al., EO2401 microbiome derived therapeutic vaccine + nivolumab, with/without standard continuous, or low-dose symptom directed, bevacizumab, in recurrent glioblastoma: phase 1–2 EOGBM1–18/ROSALIE study, Journal for ImmunoTherapy of Cancer 2022 DOI:10.1136/jitc-2022-SITC2022.0642
Wick et al., EO2401, a novel microbiome-derived therapeutic vaccine for patients with recurrent glioblastoma: ROSALIE study, Journal of Clinical Oncology Volume 40, Number 16_suppl DOI:10.1200/JCO.2022.40.16_suppl.2034
Idbaih et al., EO2401, a novel microbiome-derived therapeutic vaccine for patients with recurrent glioblastoma: ROSALIE study, Neuro-Oncology, Volume 24, Issue Supplement_2, September 2022 DOI:10.1093/neuonc/noac174.004