On January 8, 2026 Acuitas Therapeutics, the global leader in lipid nanoparticle (LNP) delivery systems for nucleic acid therapeutics, reported that it has acquired a majority stake in RNA Technologies & Therapeutics (RNA T&T), a company specializing in the design, optimization and manufacture of high-quality RNA constructs. This investment will support the growth and development of RNA T&T, allowing it to further develop and scale its operations.

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Clinical development of RNA therapeutics requires optimization of both the mRNA payload and the LNP carrier to maximize efficacy and safety. An integrated approach for these two key components derisks clinical programs and supports accelerated availability to patients in need.

While the companies will continue to operate independently, this investment will give partners of each company streamlined access to complementary world-class RNA optimization and manufacturing know-how and LNP delivery expertise. By integrating these capabilities, partners can take a more holistic approach to RNA-LNP therapeutics, helping to reduce development complexity, accelerate clinical timelines and preemptively mitigate risk across multiple programs.

"As genetic medicines expand into more complex areas such as personalized therapies, biotechnology and pharmaceutical companies are seeking efficient access to RNA and LNP design and engineering expertise," said Dr. Thomas Madden, CEO of Acuitas Therapeutics. "Having worked extensively with RNA T&T over the last number of years, we are impressed with their scientific approach and technical know-how, which brings a level of precision and consistency that is critical in RNA drug development. Ultimately, this investment gives our partners a coordinated way to engage experts from both companies as they develop next-generation RNA-LNP therapies."

"The synergy between our organizations is a natural result of our shared commitment to scientific integrity and technical excellence," said Pierrino Torbey, Board Member and interim CEO of RNA T&T. "Acuitas is the ideal partner for our next phase of growth, as both companies are deeply rooted in science and equally committed to advance the next generation of RNA-LNP medicines. Acuitas has collaborated with RNA T&T since its inception, and together the two companies have collaborated at both the research and clinical level. This investment deepens the relationship between Acuitas and RNA T&T, while also allowing the latter to grow its operational footprint, further develop its proprietary algorithmic platform for RNA sequence optimization and expand its capabilities in small-batch GMP-grade production of personalized and n-of-few therapies."

"From the beginning, it was clear that both teams are aligned in scientific ethos and in their approach to advancing RNA-LNP therapeutics," said RNA T&T co-founder and Scientific Advisor Mohamad-Gabriel Alameh, Ph.D., who provided the RNA design for the first personalized CRISPR therapy administered to baby KJ Muldoon. "This investment strengthens RNA T&T’s ability to support highly complex and personalized RNA programs, while allowing partners to benefit from seamless access to select the right LNP delivery vehicle from Acuitas’ extensive portfolio of clinically validated LNP."

(Press release, Acuitas Therapeutics, JAN 8, 2026, View Source [SID1234661875])

On January 8, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) reported the Company entered into a global collaboration and exclusive license agreement with Takeda in December 2025. The agreement provides Takeda with access to Halozyme’s ENHANZE drug delivery technology, the leading proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20), for use with vedolizumab. Vedolizumab is marketed globally as ENTYVIO.

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"Our collaboration with Takeda reflects our ongoing commitment to delivering innovative solutions that enhance the patient experience, with the goal of helping patients spend less time managing their therapy and more time living their lives," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "Our new collaboration reinforces the broad applicability and value of the ENHANZE technology across multiple therapeutic areas."

"People living with ulcerative colitis and Crohn’s disease, as well as their health care providers, need flexible treatment options that match evolving needs and priorities in disease management," said Robert Hollowell, M.D., Head of Global Product and Launch Strategy, GI and Inflammation at Takeda. "Our collaboration is another example of our commitment to the IBD community and leadership in this therapeutic area. It is an exciting opportunity to potentially enable vedolizumab to benefit even more patients around the world, and integrate even more seamlessly into patients’ lives."

Under the terms of the agreement, Takeda will make an upfront payment to Halozyme, and potential future development and commercial milestone payments. Halozyme will also be entitled to up to low-mid single digit royalties on sales of products containing vedolizumab in combination with ENHANZE.

Crohn’s disease and ulcerative colitis are the two main forms of inflammatory bowel disease (IBD), characterized by chronic inflammation of the gastrointestinal tract. Both conditions can result in serious complications. It is estimated that more than 10 million people across the globe will be living with IBD within the next decade, reflecting a growing burden of IBD.

Vedolizumab is a biologic therapy approved (under the trade name ENTYVIO) for intravenous (IV) and subcutaneous (SC) administration (approvals vary by market). ENTYVIO is approved for use in adults with moderately to severely active Crohn’s disease or ulcerative colitis. Please click for Entyvio Full U.S. Prescribing Information and for SmPC.

(Press release, Halozyme, JAN 8, 2026, View Source [SID1234661860])

On January 8, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported that eight abstracts have been accepted for presentation at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. The meeting is being held on January 8–10 in San Francisco, California.

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"The research Tempus is presenting at ASCO (Free ASCO Whitepaper) GI reflects our ongoing commitment to advancing progress in gastrointestinal cancers and demonstrates the power of utilizing our multimodal database to uncover novel insights in oncology," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "Across a variety of GI cancers, these studies show how our de-identified clinical and molecular data can be used to better characterize tumors, identify new biomarkers, and in some cases, find patient populations that may benefit from targeted therapies. We are proud to collaborate with all of the investigators who are helping to advance precision medicine."

Tempus will highlight its latest scientific and clinical research findings via the following poster presentations:

Genomic Profiling of Epithelial Neoplasms of the Appendix: Insights Across Histological Subtypes and Histological Grades
Date/Time: Thursday, January 8, 11:30 a.m.–1:00 p.m. and 6:00 p.m.–7:00 p.m. PT
Abstract Number: 847
Summary: Tempus Lens was utilized to analyze de-identified clinical genomic, and transcriptomic information for patients diagnosed with different subtypes of appendiceal epithelial neoplasms (AENs). AENs showed unique DNA alterations by histological subtype, with mutations occurring most frequently in KRAS, TP53, SMAD4, and GNAS. Grade 2 mucinous adenocarcinoma closely resembled Grade 1, not Grade 3, in survival and genomics, supporting a three-tier grading system over a high-grade (G2/G3) grouping in this subtype. Furthermore, patients with KRAS/GNAS co-mutations had better survival and a favorable immune profile in the AEN population overall, supporting further immunotherapy research in this disease.
Impact of Claudin-1 (CLDN1) Expression on Molecular Correlates and Clinical Outcomes in Patients with Advanced Biliary Tract Cancers (BTCs)
Date/Time: Friday, January 9, 11:30 a.m.–1:00 p.m. PT
Abstract Number: 602
Summary: Dysregulation of CLDN1 is associated with invasiveness and migration of cells in many cancers. We examined the molecular and clinical correlates of CLDN1 expression in a real-world cohort of patients (pts) with advanced BTCs across subtypes. We analyzed a cohort of patients with BTC who received xT and xR testing. High CLDN1 expression was associated with immune cell infiltration in this cohort of advanced BTC with improved survival in pts treated with 1L chemo+IO. Furthermore, relevant molecular alterations in BTC differed with high vs low CLDN1 expression. Larger studies are warranted to evaluate the predictive and prognostic role of CLDN1 in BTC to identify novel therapeutic strategies.
Molecular and Immune Landscape of Early-Onset Versus Average-Onset Well-Differentiated Enteropancreatic Neuroendocrine Tumors
Date/Time: Friday, January 9, 11:30 a.m.–1 p.m. PT
Abstract Number: 643
Summary: In the current study, the authors sought to characterize the molecular and immune landscape of early (EO)- versus average-onset (AO) pancreatic (pNETs) and small intestinal NETs (siNETs) by leveraging Tempus Lens. EO pNETs exhibited a significantly lower prevalence of KRAS, TP53, SMAD4 and RB1 alterations and a higher prevalence of LRP1B alterations compared to AO pNETs. EO siNETs showed a significantly higher prevalence of PAX5 and HDAC2 alterations. EO-pNETs were significantly enriched in certain gene sets (VEGF, hedgehog signaling, myogenesis, apical junction) and depleted in others (MYC, E2F, DNA repair, G2M checkpoint), and showed enriched infiltration of M2 macrophages. The findings, from the largest analysis of its kind to date, highlight key molecular and immune differences between age sub-groups in enteropancreatic NETs, suggesting that age at diagnosis may be an important determinant of tumor biology.
Advanced Pancreatic Adenocarcinoma Outcomes in Patients with DDR Deficiencies Outside of BRCA1/2 and PALB2
Date/Time: Friday, January 9, 11:30 a.m.–1:00 p.m. and 5:00 p.m.–6:00 p.m. PT
Abstract Number: 759
Summary: Tempus Lens was used to analyze de-identified clinical, genomic and transcriptomic data for patients diagnosed with advanced pancreatic adenocarcinomas with mutations in the DNA damage repair (DDR) pathway other than BRCA1/2 and PALB2. We compared the outcomes of patients treated with platinum- versus non-platinum chemotherapy regimens in the first line (1L). Patients treated with platinum regimens showed a trend toward improved survival starting around 5 months of treatment (median rwOS 11.7 vs 9.8 months, p=0.471), but this was not statistically significant.
Multiomic Analysis and Oncologic Outcomes in Pancreatic Cancer by PIN1 Expression
Date/Time: Friday, January 9, 11:30 a.m.–1:00 p.m. and 5:00 p.m.–6:00 p.m. PT
Abstract Number: 784
Summary: PIN1 is a novel investigational target and is associated with desmoplastic stroma, an immunosuppressive tumor immune microenvironment (TIME) and worse outcomes in pancreatic ductal adenocarcinoma (PDAC). We characterized PIN1 expression and its impact on the TIME and survival in PDAC patients sequenced with xT and/or xR. Our results demonstrated that PIN1 RNA expression was higher in NLP disease sites and is associated with pro- and anti-tumor immune subsets and a favorable OS, which is contrary to previously published literature.
Molecular Characterization of Resected Non-Metastatic Pancreatic Cancer (PC) Based on KRAS Status
Date/Time: Friday, January 9, 11:30 a.m.–1:00 p.m. and 5:00 p.m.–6:00 p.m. PT
Abstract Number: 776
Summary: This study assessed whether next-generation sequencing (NGS)–based tumor profiling can guide tailoring of CT strategies in resectable pancreatic cancer (PC). Tempus Lens was used to identify PC patients sequenced with xT or xF assays. KRAS mutations did not predict survival benefit from mFOLFIRINOX or gem-nab in resected PC, however we identified distinct profiles of potentially targetable co-alterations in KRAS mutated vs. KRAS WT patients. These findings may suggest the integration of genomic profiling in clinical trials to develop new biomarker-driven targeted strategies in the early stage disease.
Transcriptomic Signatures of RAD51 and GATA6 Predict Improved Real-World Overall Survival with Platinum Therapy in BRCA/PALB2 Wild-Type Metastatic Pancreatic Cancer
Date/Time: Friday, January 9, 11:30 a.m.–1:00 p.m. and 5:00 p.m.–6 p.m. PT
Abstract Number: 679
Summary: In this study the authors postulated that BRCA/PALB2 wildtype mPC may exhibit platinum sensitivity driven by altered HRR gene expression. Tempus Lens was used to identify and analyze mPC pts with wildtype somatic BRCA1/2 and PALB2 who had Tempus xT DNA and xR RNA testing. In BRCA/PALB2wt mPC, transcriptomic profiling identified low RAD51 and high GATA6 expression as predictors for improved rwOS when treated with 1L platinum therapy. Integrating these biomarkers may improve development of DNA-damaging therapies beyond canonically defined HRD.
Coupling Tumor Genomics, Whole Transcriptome Sequencing, and Patient Outcomes to Define the Tumor Microenvironment in Receptor Tyrosine Amplified Gastrointestinal Cancers: Analysis from 24,598 Cases
Abstract Number: 427
Summary: Amplifications of receptor tyrosine kinases (RTKs) such as ERBB2, EGFR, MET, and FGFR2 have been previously linked to an immunosuppressive tumor microenvironment (TME). To further map TME features to tumor genomics across gastroesophageal adenocarcinoma, colorectal carcinoma, and cholangiocarcinoma, researchers utilized Tempus Lens to analyze patients with RTK-amplified and RTK non-amplified GI cancers, leveraging xT and xR testing. RTK amplifications were present in approximately 10% of all samples, consistent with known tumor-specific prevalences. These RTK-amplified tumors were also found to be enriched for MYC and CCNE1 genomic alterations and were associated with altered expression of immunosuppressive regulatory genes, including IDO1, TIM-3, and LAG3.

(Press release, Tempus, JAN 8, 2026, View Source [SID1234661876])

On January 8, 2026 Topos Bio, a biotechnology company pioneering AI-driven drug discovery for intrinsically disordered proteins (IDPs), reported the company emerged from stealth with $10.5M in seed funding from Boldstart, Threshold, and Neo, with participation from notable angel investors including Dara Khosrowshahi (CEO of Uber) and Naveen Rao (CEO of Unconventional AI). The company is also releasing a technology report demonstrating state-of-the-art performance of its AI model on this challenging protein class.

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The Problem: Drugging the Undruggable
Traditional drug discovery relies on the "lock-and-key" model: proteins fold into stable 3D structures, and drugs are designed to fit precisely into their binding pockets. Intrinsically disordered proteins (IDPs) break this paradigm entirely. Rather than adopting a single fixed shape, IDPs rapidly fluctuate through many different conformations. Without stable binding pockets, traditional drugs have nowhere to anchor. Current computational tools fail here because they predict static structures, not dynamic ensembles of constantly shifting shapes. This leaves roughly one-third of the human proteome – including the primary drivers of Alzheimer’s, Parkinson’s, and many aggressive cancers – effectively undruggable by conventional methods.

"Disordered proteins represent one of the last major frontiers in drug discovery – they’re central to devastating diseases but nearly impossible to target with existing methods," said Ryan Zarcone, co-founder and CEO of Topos Bio. "Our platform tackles this by modeling protein dynamics as ensembles rather than static structures. This approach enables rational drug design and opens up an entirely new category of previously undruggable biology."

Topos Bio’s Solution: Frontier AI for disordered proteins
Topos Bio has developed an AI-native integrated discovery platform specifically designed for intrinsically disordered proteins. The company’s AI models generate ensembles that capture how these proteins fluctuate through millions of conformations, then identify binding opportunities within these dynamic structures. Using generative chemistry, the platform designs small molecules optimized to modulate these disordered regions. An integrated wet lab validates and refines these predictions, generating experimental data that continuously improves model accuracy and expands the platform’s capabilities. The company’s initial programs focus on neurodegenerative disorders, followed by oncology and metabolic diseases.

Alongside the announcement, Topos Bio released its first technical report detailing the development and validation behind Topos-1, its foundation model for intrinsically disordered proteins. Across a broad benchmarking suite, Topos-1 outperformed every leading protein foundation model, including AlphaFold, Chai, and Boltz.

"We invested in Topos at inception because Amir and Ryan can solve a fundamental computational problem that’s blocking progress on many of medicine’s most important targets," said Ellen Chisa, Partner at Boldstart. "No one else has the AI and wet lab infrastructure to model disordered proteins, and a reliable model unlocks therapeutic opportunities that no one else can access."

Strategic Collaboration with Gladstone Institutes
To validate its platform in established disease models, Topos Bio is partnering with Gladstone Institutes. The collaboration will focus on discovering novel modulators for α-synuclein, a disordered protein central to Parkinson’s disease pathology.

Steven Finkbeiner, MD, PhD, Director of Gladstone’s Center for Systems and Therapeutics said: "This partnership embodies the spirit of translational collaboration. By combining advanced imaging and disease modeling from our lab with Topos Bio’s novel computational methods, we’re taking a powerful step toward tackling intrinsically disordered proteins, one of the greatest frontiers in neurodegenerative disease biology."

(Press release, Topos Bio, JAN 8, 2026, View Source [SID1234663735])

On January 8, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported 2026 as a program-defining year for allogeneic CAR T, with multiple first-half clinical readouts expected to test, and potentially validate, whether off-the-shelf CAR T can be delivered at biologic-like scale, in real-world settings, across oncology and autoimmune disease.

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After nearly eight years of platform development and treatment of more than 200 patients across six clinical studies, Allogene has built an off-the-shelf CAR T platform designed to deliver clinical utility, broad patient access, predictable manufacturing, and scalable economics which are core requirements for cell therapy to move beyond a bespoke process toward routine medical practice.

"We believe 2026 is a program-defining year for allogeneic CAR T and Allogene with value-defining readouts and clinical maturity unmatched in the allogeneic field," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "With multiple first-half clinical milestones, we aim to demonstrate that CAR T can be delivered at biologic-like scale in real-world settings."

A Biologic-Like CAR T Platform Built for Real-World Demand
The Company’s off-the-shelf approach is purpose-built seeking to deliver the attributes required for sustainable growth and broad patient access, including:

Rapid, on-demand availability
Consistent, predictable product performance
Simplified administration compatible with outpatient use and deployment beyond academic centers into community settings
Manufacturing scalability of approximately 30,000 – 60,000+ doses annually
Efficient cost-of-goods profile (<$10K – 20K/dose)

Together, these attributes will position Allogene’s platform to support broad deployment across hematologic malignancies, autoimmune disease, and solid tumors – enabling CAR T therapy to reach patients earlier, more reliably, and in care settings where most patients are treated.

Cema-Cel: Giving LBCL Patients a Second Chance at First-Line Success
Allogene’s lead program, cemacabtagene ansegedleucel (cema-cel), is being evaluated in the pivotal Phase 2 ALPHA3 trial, a randomized study designed to test whether early, MRD-guided consolidation with cema-cel can prevent recurrence of large B-cell lymphoma (LBCL).

ALPHA3 seamlessly integrates cema-cel as a "7th cycle" of first-line therapy, without altering existing first-line treatment workflows, enabling early, MRD-guided treatment intervention for patients at high risk of relapse. The trial is enrolling patients across both academic and community cancer centers to improve patient access as the majority of LBCL patients are treated in the community cancer setting in the US.

An early Q2 2026 interim futility analysis focused on MRD clearance represents the first program-defining test of whether early, MRD-guided allogeneic CAR T can prevent recurrence of lymphoma. A 25–30% improvement in MRD clearance versus observation could signal one of the most meaningful advances in LBCL since the introduction of rituximab, based on historical benchmarks and growing data linking MRD clearance to long-term outcomes.

ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease with Built-In Lymphodepletion
ALLO-329 is a next-generation dual-targeted CD19/CD70 AlloCAR T incorporating Allogene’s proprietary Dagger technology, which provides built-in, targeted lymphodepletion by selectively depleting cells in the patient that are responsible for rejecting AlloCAR T products: activated CD70-positive T cells.

This approach could reduce or eliminate the need for conventional cytotoxic lymphodepletion and significantly expand access, especially for:

Younger patients and women of child-bearing age for whom cytotoxic lymphodepletion is problematic
Settings where rheumatologists, not oncologists, are the primary treating physicians
Patients with moderate disease where a streamlined treatment could improve adoption

The Phase 1 RESOLUTION trial, a 3+3 dose escalation study, is enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, lupus nephritis, scleroderma, and inflammatory myositis. The trial plans to test up to four cell dose levels from a starting cell dose of 20 million CAR T cells in two parallel cohorts (one with a low intensity lymphodepletion and one with no lymphodepletion).

Initial proof-of-concept data are expected by the end of 1H 2026. Expected to be included in the initial data release are early clinical outcome and supporting translational data covering disease-related biomarkers, CAR T expansion, and immune reconstitution from the first dose level (20 million CAR T cells) cohorts.

If successful, ALLO-329 could open one of the largest new markets in cell therapy, where scalable manufacturing, reduced toxicity, and accessibility to rheumatologists become critical competitive differentiators.

ALLO-316: TRAVERSE Trial Establishes CAR T Potential in Solid Tumors
ALLO-316 has demonstrated early, durable responses in heavily pretreated patients with renal cell carcinoma (RCC), representing one of the first credible signals that CAR T – autologous or allogeneic – may deliver meaningful benefit in solid tumors. The Phase 1 trial demonstrated:

Robust CAR T cell expansion following standard Flu/Cy-based lymphodepletion, providing proof-of-concept for the Dagger technology platform
31% confirmed ORR with a single ALLO-316 dose1 in patients with high CD70 expression, which represents ~2/3 of clear cell RCC
All responses were durable beyond 6 months after ALLO-316 with no further treatment2
The Company continues pathway exploration for its continued development

"Each of our programs represents a different frontier where our products can change the trajectory of disease," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer. "Cema-cel has the potential to reshape first-line lymphoma treatment by reaching patients destined to suffer a cancer recurrence before they relapse. ALLO-329 is designed to bring CAR T into the autoimmune setting with a therapy that is scalable, precise, and potentially deliverable without traditional lymphodepletion. And ALLO-316 has shown promising activity in a metastatic solid tumor context – something many considered unattainable for cell therapy. What these programs collectively demonstrate is that allogeneic CAR T is no longer a theoretical platform. It is a clinical reality advancing across multiple major therapeutic areas."

Cash Runway into 2H 2027
The Company continues to expect its cash runway to extend into the second half of 2027, excluding any impact from potential business development activities.

Together, these catalysts position Allogene to enter 2026 with an increasingly differentiated platform, strengthening fundamentals and the potential to reshape multiple high-value therapeutic categories through scalable, real-world allogeneic CAR T.

(Press release, Allogene, JAN 8, 2026, View Source [SID1234661845])