On January 8, 2025 Vividion Therapeutics, Inc., a clinical-stage biopharmaceutical company utilizing novel discovery technologies to unlock high-value, traditionally undruggable targets and develop small molecule precision therapeutics for devastating cancers and immune disorders, reported the acquisition of Tavros Therapeutics, Inc., a precision oncology platform company (Press release, Vividion Therapeutics, JAN 8, 2025, View Source [SID1234649513]). Vividion is a wholly owned and independently operating subsidiary of Bayer AG.

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The addition of Tavros greatly expands Vividion’s functional genomics expertise and capabilities, bringing proprietary methods for genomic screening that can identify new target opportunities, as well as support discovery and translational efforts towards known targets. Combining the Tavros platform with Vividion’s chemoproteomics expertise and capabilities will greatly enhance Vividion’s efforts to generate potential best- and first-in-class drug targets across oncology and immunology.

Vividion and Tavros have been working together for the past two years under a strategic collaboration to discover and develop novel precision therapeutics capable of addressing cancer-causing proteins that have eluded traditional small molecule drugs.

"The addition of Tavros will expand and strengthen our chemoproteomics drug screening capabilities and open up a new target space to fuel the growing pipeline of novel therapies across oncology and immunology", said Aleksandra Rizo, M.D., Ph.D., Chief Executive Officer of Vividion. "We have already seen the power of combining Vividion’s platform and compound library with Tavros’s functional genomics capabilities in uncovering druggable vulnerabilities in tumor cells. We are excited to take this next step to unlock the full potential of our work together for the patients in need."

"The acquisition of Tavros is an exciting next step as we seek to accelerate the development of previously undruggable targets to improve outcomes for patients with significant high unmet medical needs", said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division. "It is also the first acquisition in the history of Bayer Pharmaceuticals for one of our ‘arms-length’ model companies, demonstrating the flexible operating model while Vividion continues to operate autonomously to drive breakthrough innovations in precision oncology and immunology."

"We are thrilled for the opportunity to combine forces with Vividion. We have enjoyed a highly productive partnership over the past two years and have seen the clear synergy between our platforms", said Eoin McDonnell, Ph.D., Chief Executive Officer and co-founder of Tavros. "We look forward to building on our success to date to develop novel small molecule therapeutics against elusive protein targets and maximize our ability to bring new treatment options to patients."

Financial terms are not disclosed.

On January 8, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported corporate updates on its lead program, solnerstotug (SNS-101) and upcoming milestones (Press release, Sensei Biotherapeutics, JAN 8, 2025, View Source [SID1234649512]).

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"2024 was a noteworthy year for Sensei and our pioneering lead program, solnerstotug. We demonstrated that solnerstotug can overcome the safety and pharmacological hurdles associated with first-generation antibodies targeting the immune checkpoint VISTA, positioning it as the first program in its class with potential to demonstrate clinically meaningful antitumor responses. Moreover, despite enrolling a predominantly ‘cold’ tumor patient population that was unlikely to respond to immunotherapy, solnerstotug demonstrated promising early signs of activity," said John Celebi, President and Chief Executive Officer. "Looking ahead, 2025 is set to be a pivotal year as we seek to share our first significant efficacy data at optimal doses that include a ‘hot’ tumor patient population more likely to respond to immunotherapy that nonetheless has primary or acquired resistance to PD-1 inhibitors. With cash runway into the second quarter of 2026, we are positioned to advance solnerstotug through the completion of the Phase 1 portion of this study."

Highlights and Milestones

Solnerstotug (SNS-101)

Solnerstotug is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.

Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug (SNS-101) as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors. Key findings and updates as of January 1, 2025 include:

A total of 45 patients have been enrolled in the dose expansion portion of the Phase 1/2 clinical trial.
The majority of the "hot" tumor patients enrolled in the combination dose expansion to date have progressed on a prior anti-PD-1 therapy or are PD-L1 negative, making it highly unlikely that these patients would respond upon re-challenge with anti-PD-1 alone.
Sensei expects to complete enrollment of the dose expansion with approximately 60 patients by the end of Q1 2025.
The Company expects to report data from evaluable patients in Q2 2025. Patient follow-up data from the dose escalation cohorts will also be presented.
Solnerstotug continues to be well tolerated with a best-in-class pharmacokinetic profile.
Dose optimization is now focused on dose levels of 3 and 15 mg/kg Q3W to support the Phase 2 doses in several patient populations under consideration.
Efforts are ongoing to explore biomarker correlates of clinical benefit using peripheral immunophenotyping and tumor genomic and transcriptomic analyses.

On January 8, 2025 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentation at the 43rd Annual J.P. Morgan Healthcare Conference at 9:00 a.m. PT on Wednesday, January 15, 2025 (Press release, Sana Biotechnology, JAN 8, 2025, View Source [SID1234649511]). The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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The webcast will be accessible on the Investor Relations page of Sana’s website at View Source A replay of the presentation will be available at the same location for 30 days following the conference.

On January 8, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that Raul Rodriguez, the company’s president and CEO, will present a company overview at the 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2025 at 8:15 a.m. PT (11:15 a.m. ET) in San Francisco, CA (Press release, Rigel, JAN 8, 2025, View Source [SID1234649510]).

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To access the live webcast or archived recording, visit the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website prior to the start of the live webcast to allow for any software downloads.

On January 8, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the first patients have been enrolled in studies evaluating RP2 in two different settings: checkpoint naïve metastatic uveal melanoma; and second-line recurrent or metastatic hepatocellular carcinoma (HCC) (Press release, Replimune, JAN 8, 2025, View Source [SID1234649509]).

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"On the heels of our BLA submission for RP1 and designation as breakthrough therapy, we are pleased that the first patients have been enrolled in both the RP2 HCC clinical trial and the registration intended study of RP2 in metastatic uveal melanoma," said Sushil Patel, Ph.D., CEO of Replimune. "We are excited to explore the broader potential of the RPx platform and these RP2 clinical trials will play an important part of our future development plans."

RP2-202 Clinical Trial in Metastatic Uveal Melanoma
Uveal melanoma is a type of cancer that occurs in the tissues of the eye. Up to 50 percent of patients with uveal melanoma may develop metastatic disease. The most common site of metastasis for uveal melanoma is the liver and is estimated to occur in 90-95% of cases.1

"We are honored and excited to be able to offer this clinical trial to our patients with uveal melanoma, a group of patients for whom treatment options are very limited," said Dr. Justin Moser, an associate clinical investigator in the Cancer Research Division of HonorHealth Research Institute, where he specializes in uveal melanoma. "We hope that, by providing our patients with early access to treatments through clinical trials, that we will be able to help give them longer, higher-quality lives."

During ASCO (Free ASCO Whitepaper) 2024, results from an open-label, multicenter, Phase 2 study of RP2 alone or combined with nivolumab in a cohort of patients with uveal melanoma (n=17) were presented. RP2 administered as monotherapy or in combination with nivolumab demonstrated an overall response rate of 29.4%, with a disease control rate of 58.8%.

The RP2-202 trial (NCT06581406) is a randomized, phase 2/3 study that will enroll approximately 280 patients and evaluate RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in immune checkpoint inhibitor-naïve adult patients with metastatic uveal melanoma. The primary endpoints of the study are overall survival and progression free survival. Key secondary endpoints are overall response rate and disease control rate. For additional information about the RP2-202 clinical trial and to learn more about eligibility, please visit our clinical trials page here.

RP2-003 Clinical Trial in Hepatocellular Carcinoma
HCC is the third leading cause of cancer-related deaths in the world. Prognosis is generally poor with the majority of HCC cases diagnosed in the advanced stage. HCC comprises approximately 75 to 85 percent of primary liver cancer cases.

The RP2-003 trial (NCT05733598) is an open label trial that will enroll 30 patients and evaluate RP2 combined with the second-line therapy of atezolizumab and bevacizumab in patients with locally advanced unresectable, recurrent and/or metastatic HCC. The primary endpoint of the study is overall response rate (ORR) per modified RECIST 1.1 criteria. Key secondary endpoints are ORR per RECIST modified for HCC and duration of response. The study is being conducted under a collaboration and supply agreement with Roche. For additional information about the RP2-003 trial and to learn more about eligibility, please visit our clinical trials page here.

About RP2
RP2 is a derivative of RP1, Replimune’s lead product candidate that is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP-R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.