GSK plc (LSE/NYSE: GSK) reported that it has acquired Elsie Biotechnologies, a San Diego-based private biotechnology company dedicated to unlocking the full potential of oligonucleotide therapeutics, for up to $50 million (approximately £39 million) (Press release, GlaxoSmithKline, JUN 6, 2024, View Source [SID1234644170]).

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Oligonucleotides have a unique ability to modulate gene expression, making them an attractive modality to address a significant proportion of therapeutic targets that are not amenable to traditional small molecules or biologics.

This acquisition allows GSK to integrate Elsie’s oligonucleotide discovery, synthesis, and delivery technologies to enhance GSK’s platform R&D capabilities. This follows a successful research collaboration with Elsie, announced in July 2023, in which GSK was able to explore and validate the technology.

Tony Wood, Chief Scientific Officer, GSK, said: "We have already made great strides in oligonucleotide drug development through our work in chronic hepatitis B and steatotic liver disease, and are thrilled to work alongside the talented team at Elsie to accelerate a next-generation oligonucleotide platform. By bringing together Elsie’s expertise and our internal capabilities, we can design and develop oligonucleotides for difficult-to-treat diseases of scale with larger patient populations."

Data generated with the Elsie platform, combined with GSK’s expertise in the use of artificial intelligence and machine learning, will support the development of predictive models for future oligonucleotide design.

Kevin Green, Chief Operating Officer, Elsie, said: "We are thrilled to be a part of GSK and work alongside the talented R&D team dedicated to oligonucleotide drug development. We believe our platform will make significant contributions to the field and we believe GSK is the best partner to help advance this effort."

The acquisition is aligned to GSK’s approach of uniting Science and Technology, including advancing novel platform technologies, to accelerate drug development and ultimately deliver innovative medicines to patients, better and faster. Currently GSK is advancing oligonucleotide therapeutics in chronic hepatitis B and steatotic liver disease as well as other therapeutic areas beyond liver disease.

This agreement is not subject to closing conditions and the acquisition has been completed.

On June 6, 2024 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported the publication of a study detailing the discovery of TB206-001, a first-in-class antibody targeting adenosine A2A receptor (A2AR), a promising molecular target that could enhance cancer immunotherapy (Press release, Twist Bioscience, JUN 6, 2024, View Source [SID1234644188]). The study titled, "Discovery of a potent, selective, and tumor-suppressing antibody antagonist of adenosine A2A receptor", was published in the journal PLOS ONE.

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A2AR is an emerging immune checkpoint that plays a role in the immunosuppression of the tumor microenvironment. It is part of an important class of therapeutic targets, called G protein-coupled receptors (GPCRs), which are found on most immune cells and highly expressed in certain cancers. Tumors commonly produce excess adenosine, which activates A2A receptors and suppresses immune cells. Blocking A2AR could alleviate the suppressive environment and restore tumor immunity. A2AR has been shown to play a role in various cancers including colorectal cancer, gastric cancer, lymph node metastasis, breast cancer and melanoma as well as in autoimmune diseases and Parkinson’s.

"The majority of current therapies in clinical trials targeting A2AR are small molecules, as it has been traditionally difficult to discover antibodies that block GPCRs; however, antibodies have greater affinity for target molecules, do not cross into the central nervous system and could be dosed less frequently," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "With the right partner to take it forward, TB206-001, our Twist-discovered first-in-class antibody antagonist of A2AR, could be developed as a powerful inhibitor to restore immune responses in immunosuppressive environments that allow cancer to grow."

In the study, the researchers immunized two different sets of animals with DNA encoding wildtype or mutant hA2AR (C144S, S334A, S338A) modified to minimize the impact of the receptor’s natural signaling on its expression. Once the animals generated antibodies to the receptor, the researchers built immune and synthetic single-chain variable fragment (scFvs) phage display libraries from the immune repertoire. The libraries were subsequently screened against detergent solubilized A2AR, and positive hits were reformatted into monoclonal antibodies for further testing. The result was TB206-001, which directly targets A2AR and activates immune cells. In preclinical studies, the antibody has shown high affinity and specific activity for A2AR over other adenosine receptors and shows tumor-suppressing activity in colon tumor-bearing HuCD34-NCG mice. Additional studies in animal models found that TB206-001 reduced tumor volume better than PD-1 inhibitors.

"There is still tremendous potential for immunotherapies either in combination with or in addition to those targeting PD-1 and CLTA-4," said Gregory Carven, Ph.D., one of the original inventors of Keytruda. "Using the ability to create large antibody libraries enabling discovery of novel and highly specific therapeutics, Twist has discovered an antibody that blocks A2AR, a promising checkpoint target and demonstrated its activity in preclinical models. The antibody could be further developed as a standalone therapy, bispecific or combination therapy to bring potential therapeutic benefit to patients."

On June 6, 2024 TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics ("BBOT" or the "Company"), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported that the first patient has been dosed in the ONKORAS-101 trial for its lead program, BBO-8520 (Press release, BridgeBio, JUN 6, 2024, View Source [SID1234644189]). BBO-8520 is a first-in-class orally bioavailable and highly potent small molecule direct inhibitor of KRASG12C (ON) state. BBO-8520 binds covalently to the Switch II pocket in both the GTP-bound (ON) and GDP-bound (OFF) state conformations of KRASG12C, leading to rapid and sustained inhibition of KRASG12C activity.

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On dosing the first patient, Professor Benjamin Solomon, head of lung medical oncology at the Peter MacCallum Cancer Center, said, "We are excited to partner with BridgeBio Oncology Therapeutics to bring a transformative new therapy to patients. Non-small cell lung cancer is among the most prevalent malignancies globally and there is a significant need for new precision oncology medicines to improve outcomes for patients in the metastatic setting. BBO-8520 promises to have a substantial impact in improving outcomes and prognosis for this group of patients."

BBO-8520 was designed to inhibit the (ON) state to provide optimal target coverage and to address KRASG12C amplification and receptor tyrosine kinase activation – the two key mechanisms of adaptive resistance to current (OFF) state inhibitors. BBO-8520 drives substantial tumor growth inhibition in multiple preclinical models, even after emergence of resistance to sotorasib, an FDA approved (OFF) state inhibitor of KRASG12C. BBO-8520’s discovery was the result of a collaboration between the National Cancer Institute RAS Initiative at Frederick National Laboratory for Cancer Research, Lawrence Livermore National Laboratory, and BridgeBio Oncology Therapeutics.

The ONKORAS-101 study will enroll patients pre-treated with first generation KRASG12C (OFF) inhibitors as well as patients with no prior KRASG12C targeted therapy experience. The trial will enroll across the US, Australia, Canada, and the EU.

BridgeBio Oncology Therapeutics’ CEO, Eli Wallace, PhD, added, "The initiation of the Phase 1 clinical trial of BBO-8520 represents an important advancement for BBOT, as we are now a clinical-stage organization. We are grateful for the opportunity to offer patients with KRASG12C-driven lung cancer a targeted therapy that is expected to provide a significant improvement over current standards of care."

On June 6, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable six-month follow-up results from the first patient enrolled in the Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, JUN 6, 2024, View Source [SID1234644172]). This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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Scans taken six months post-treatment showed the patient’s tumor size had decreased by 13% compared with the pre-treatment size, and no new tumor lesions were detected, which translates into a six-month progression-free survival. In addition, no dose-limiting toxicities were reported, reinforcing the safety profile of Deltacel observed in previous follow-up visits. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

"We are delighted to report that Patient 1 in the Deltacel-01 clinical trial has achieved six-month progress-free survival, and that they continue to do well with no side effects. This is an important clinical milestone that underscores the potential of Deltacel in treating advanced cancers," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "Notably, we observed a 13% decrease in tumor size. These results are encouraging and support our belief in the potential of Deltacel to provide an effective new treatment for patients with advanced cancers. We are committed to advancing this trial and bringing hope to those with limited treatment options."

Kiromic continues to expect to report long-term follow-up results for the other two subjects in the first cohort and the first subject in the second cohort by the end of June.

Additionally, the fifth patient in Deltacel-01 began treatment in May, is currently doing well without any signs of toxicity and is expected to have their first efficacy assessment in July. The sixth patient is currently undergoing pre-enrollment screening and is projected to start treatment in mid-June.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On June 6, 2024 Lava Therapeutics presented its corporate presentation (Presentation, Lava Therapeutics, JUN 6, 2024, View Source [SID1234644173]).

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