Orionis Biosciences Announces Strategic Partnership with Genentech to Discover and Develop Molecular Glue Class Medicines for Cancer

On May 21, 2025 Orionis Biosciences, a privately held, clinical-stage life sciences company focused on the rational discovery and development of drug modalities with induced proximity mode of action, reported a second multi-year collaboration with Genentech, a member of the Roche Group, to discover small-molecule monovalent glue medicines for novel and challenging targets in oncology (Press release, Orionis Biosciences, MAY 21, 2025, View Source [SID1234653273]). Orionis announced its first collaboration with Genentech, to discover novel small-molecule medicines for challenging targets in major disease areas, including oncology and neurodegeneration, in September 2023.

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Orionis’s small-molecule Allo-Glue platform integrates multiple proprietary technologies to advance the
discovery and design of molecular glues for highly challenging disease targets. It combines advanced
chemical biology tools, engineered cellular assay systems, custom-built high-throughput robotic
automation and specialized artificial intelligence infrastructure, and enables the generation and analysis of hundreds of millions of in-cell protein interaction events. The AI-driven chemistry stack integrates
predictive modeling, generative design, and a compound interrogation engine operating across a vast
chemical space. Collectively, these capabilities accelerate the systematic discovery and simultaneous
optimization for potency, selectivity, and synthetic accessibility of monovalent molecular glue modalities.

Under the terms of the agreement, Orionis will be responsible for the discovery and optimization of
molecular glues, while Genentech will be responsible for subsequent later-stage preclinical and clinical
development, regulatory filing, and commercialization of such small molecules. Orionis will receive an
upfront payment of $105 million and is eligible for potential research, development, commercial and net
sales milestone payments, whose total could exceed $2 billion as well as potential tiered royalties upon sale of collaboration products.

"We are thrilled about this second collaboration with Genentech, which expands our collaborative efforts
in applying induced proximity concepts to include molecular glue types beyond targeted protein degraders," said Niko Kley, Co-Founder and CEO of Orionis Biosciences. "The expansion of our existing strategic alliance underlines a strong alignment in vision for molecular glues, and the excellent work by both teams during the past year".

"By integrating advanced cellular sensing technologies, large-scale robotic automation and specialized
artificial intelligence, at Orionis we have built a unique capability for discovery of new drug modalities to
rationally reprogram protein networks," said Riccardo Sabatini, Orionis Chief Data Scientist. "It’s an
exciting time in small-molecule drug development".

"Molecular glues, including protein degraders and non-degraders, are an exciting therapeutic modality,
providing access to disease-related proteins that have proven challenging and elusive to more traditional
treatment modalities," said Boris L. Zaïtra, Head of Roche Corporate Business Development. "This new collaboration with Orionis has the potential to significantly enhance our innovation to bring transformative cancer medicines to patients".

Olema Oncology to Participate in Upcoming Investor Conferences

On May 21, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported that the Company will participate in the following upcoming investor conferences (Press release, Olema Oncology, MAY 21, 2025, View Source [SID1234653272]):

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Jefferies Global Healthcare Conference
Date and Time: Wednesday, June 4, 2025 at 11:40 a.m. ET
Format: Fireside Chat
Location: New York, NY

Goldman Sachs 46th Annual Global Healthcare Conference
Date and Time: Wednesday, June 11, 2025 at 8 a.m. ET
Format: Fireside Chat
Location: Miami, FL

Live webcasts and recordings of these presentations will be available, as permitted by the event host, in the Events and Presentations section of Olema’s investor relations website at ir.olema.com.

Nanobiotix Provides First Quarter 2025 Operational and Financial Update

On May 21, 2025 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported an update on operational progress and announced financial results for the first quarter of 2025 (Press release, Nanobiotix, MAY 21, 2025, View Source [SID1234653271]).

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"We are pleased with the execution across the JNJ-1900 (NBTXR3) development programs and are excited for the important milestones ahead. NANORAY-312 continues to advance in head and neck cancer, with our ongoing global transfer of sponsorship moving toward completion, and the recent expansion of development into lung cancer through the CONVERGE study. We were also pleased by the updated clinical data further supporting expansion into indications including lung cancer amenable to re-irradiation recently presented by MD Anderson at ESTRO and ELCC, respectively and locally advanced or borderline resectable pancreatic cancer," said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board.

Operational Highlights

Ongoing Randomized Phase 2 Study in Unresectable Stage 3 NSCLC (CONVERGE)
First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer ("NSCLC") in 1Q2025
NSCLC Amenable to Re-irradiation (Phase 1 Study MDA 2020-0123 sponsored by MD Anderson)
Presented first data showing a favorable safety profile and early signals of efficacy from the completed dose escalation part of a Phase 1 study evaluating radiotherapy-activated JNJ-1900 (NBTXR3) as a second or later line (2L+) therapy at the 2025 European Lung Cancer Conference (ELCC).
Amendment to global licensing agreement for JNJ-1900 (NBTXR3) extended cash runway to mid-2026 with a meaningful reduction in cash burn expected moving forward
Removed the vast majority of the funding obligation for NANORAY-312 and released Johnson & Johnson from select future potential milestone payments, while safeguarding hundreds of millions in potential milestone and royalty payments for lead programs for Nanobiotix
Subsequent events

Locally Advanced or Borderline Resectable Pancreatic Cancer (Phase 1 Study MDA 2019-1001 sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson"))
Presented full results from the completed dose escalation and dose expansion parts of a Phase 1 study evaluating JNJ-1900 (NBTXR3) demonstrating encouraging oncologic outcomes and a favorable safety profile supporting further exploration in a randomized study at the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO 2025)
Recruitment ongoing in new cohort evaluating JNJ-1900 (NBTXR3) combined with standard-of-care chemotherapy followed by concurrent chemoradiation ("CCRT" – with capecitabine or 5-FU) with first patient already injected
First Quarter Financial Updates

Cash and Cash Equivalents: based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of €39.8 million as of March 31, 2025, will fund its operations into mid-2026.

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 physical 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 Janssen Pharmaceutica NV, a Johnson & Johnson company.

Immix Biopharma to Host KOL Event to Discuss NXC-201 Clinical Data Presented at ASCO 2025 in relapsed/refractory AL Amyloidosis

On May 21, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, reported that it will host a virtual Key Opinion Leader (KOL) event to discuss interim clinical data from the NEXICART-2 Phase 1/2 clinical trial of cell therapy NXC-201 in patients with relapsed/refractory AL Amyloidosis following its 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Oral Presentation in Chicago, IL (Press release, Immix Biopharma, MAY 21, 2025, View Source [SID1234653270]).

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The virtual KOL event will take place on Tuesday, June 3, 2025 at 3:00pm ET.

A live question and answer session will follow the discussion.

The event will feature Heather Landau, MD (Memorial Sloan-Kettering Cancer Center), Shahzad Raza, MD (Cleveland Clinic), and Jeffrey Zonder, MD (Karmanos Cancer Institute) who will discuss their clinical experience with NXC-201 cell therapy and the evolving treatment landscape for relapsed/refractory AL Amyloidosis.

Investors and other interested parties may join the live webcast through this weblink or visit the Immix website under Presentations & Events.

About Heather Landau, MD
Heather Landau, MD, is the Director of Amyloidosis Program and a Bone Marrow Transplant Specialist & Cellular Therapist at Memorial Sloan-Kettering Cancer Center in New York, with extensive experience designing clinical trials in hematology and oncology, novel treatment approaches for AL amyloidosis, and thought leadership.

Dr. Landau has authored more than 100 peer-reviewed publications. Dr. Landau received her medical degree from SUNY Upstate Medical University, completed her Internal Medicine residency at University of Colorado and her Hematology & Oncology fellowship at Memorial Sloan Kettering Cancer Center. Dr. Landau is board certified in Internal Medicine, Medical Oncology and Hematology.

About Shahzad Raza, MD
Shahzad Raza, MD is a hematologist/oncologist at Cleveland Clinic specializing in plasma cell dyscrasias, including AL Amyloidosis. Dr. Raza has authored numerous peer-reviewed publications over the last decade in academic medical practice. Dr. Raza completed his residency in internal medicine at the Brookdale Hospital Medical Center and his fellowship at the University of Missouri Hospitals & Clinics.

About Jeffrey Zonder, MD
Jeffrey Zonder, MD leads the Amyloidosis multi-disciplinary team at the Barbara Ann Karmanos Cancer Institute. He is Professor, Department of Oncology, Wayne State University School of Medicine, Detroit, MI. Dr Zonder is also the co-leader and a scientific member of the Molecular Therapeutics Program at the Barbara Ann Karmanos Cancer Institute. Dr. Zonder received his medical degree from Wayne State University, completed his residency at Strong Memorial Hospital of the Univ. of Rochester and his fellowship at Wayne State University.

About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. U.S. Phase 1/2 study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

About AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading to high mortality rates.

The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

Genmab to Participate in a Fireside Chat at the 2025 Jefferies Global Health Care Conference

On May 21, 2025 Genmab A/S (Nasdaq: GMAB) reported that its Chief Development Officer Judith Klimovsky will participate in a fireside chat at the 2025 Jefferies Global Health Care Conference in New York City, New York at 9:20 EDT (3:20 PM CEST) on June 5, 2025 (Press release, Genmab, MAY 21, 2025, View Source [SID1234653269]). A webcast of the fireside chat will be available on Genmab’s website at View Source

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