On November 6, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported the Company will present six posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 39th Annual Meeting taking place November 6-10, 2024 at the George R. Brown Convention Center in Houston, Texas (Press release, BostonGene, NOV 6, 2024, View Source [SID1234647868]). The research, conducted in collaboration with leading cancer centers, showcases the impact of BostonGene’s technology in advancing cancer treatment strategies, from deep molecular insights to predictive biomarkers. BostonGene will also exhibit at booth 514.

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BostonGene session details are below:

Abstract number: 135
Title: Multiplex immunofluorescence of whole slide images for enhanced tumor microenvironment immune cell characterization in multiple cancer types
Date & time: Friday, November 8 | 9:00 AM to 7:00 PM CST
Presenter: Vladimir Kushnarev, MD, PhD, BostonGene

This study used BostonGene’s MxIF pipeline that combines cell segmentation and spatial analysis to identify the immune cell types in various tumor microenvironment (TME) subtypes across multiple cancer types. The findings revealed the diverse nature of TME landscapes across cancers and the necessity for tailored immunotherapeutic approaches.

Abstract number: 161
Title: The predictive role of comprehensive genomic profiling in angiosarcoma immunotherapy
Date & time: Friday, November 8 | 9:00 AM to 7:00 PM CST
Presenter: Nikita Kotlov, BostonGene

Comprehensive genomic profiling (CGP) of angiosarcomas, a rare and aggressive form of cancer, revealed genetic changes critical for targeted therapy selection. Transcriptomic analysis also uncovered possible associations between tumor microenvironment (TME) subtypes and immunotherapy response, highlighting the importance of CGP in aiding treatment selection and expanding treatment options for angiosarcomas.

Research conducted in collaboration with The University of Texas MD Anderson Cancer Center

Abstract number: 183
Title: Comprehensive molecular profiling in the management of patients with diverse sarcoma subtypes
Date & time: Friday, November 8 | 9:00 AM to 7:00 PM CST
Presenter: Francesca Paradiso, PhD, BostonGene

Comprehensive molecular profiling (CGP) of sarcomas, which are highly heterogeneous, uncovered over 1,000 genetic alterations across 47 histological subtypes among 356 patients. Whole exome sequencing revealed approximately 400 actionable findings that are associated with approved therapy or inclusion criteria in clinical trials, and RNA-seq-based analysis identified diagnostic fusions and unique compositional features of various TME subtypes. These findings underscore a potential role of CGP in guiding treatment options for rare sarcomas.

Research conducted in collaboration with Massachusetts General Hospital Cancer Center and Sarcoma Oncology Center

Abstract number: 46
Title: Comprehensive machine learning-driven platform infers key tumor characteristics from blood-derived cfRNA
Date & time: Saturday, November 9 | 9:00 AM to 8:30 PM CST
Presenter: Andrey Shubin, PhD, BostonGene

A comprehensive machine learning platform was constructed to analyze the transcriptomic data from blood-derived cell-free RNA (cfRNA) of healthy donors and cancer patients to infer clinically important features and biomarkers of malignancies. Coupled with robust cell-free DNA (cfDNA) harvesting protocols, this universal platform offers unprecedented insights into tumor biology and can potentially characterize any tumor-associated transcriptomic changes reflected in the cfRNA.

Abstract number: 144
Title: Identifying a composite signature for predicting immune-related adverse events in advanced melanoma patients treated with immune checkpoint blockade
Date & time: Saturday, November 9 | 9:00 AM to 8:30 PM CST
Presenter: Michael Goldberg, PhD, BostonGene

Using flow cytometry and bulk RNA-seq to analyze blood cells of advanced melanoma patients collected before immune checkpoint blockade (ICB) treatment, we examined if the occurrence of immune-related adverse events (irAEs), severe and potentially fatal side effects of ICB, can be predicted. irAE signatures were constructed and used to detect distinct cellular and gene expression patterns among patients who developed severe irAEs post-ICB treatment. These signatures can potentially identify patients likely to develop irAEs, enabling timely mitigation to improve patient outcomes.

Abstract number: 170
Title: Identifying novel targets for antibody-drug conjugates in sarcomas using RNA sequencing
Date & time: Saturday, November 9 | 9:00 AM to 8:30 PM CST
Presenter: Vladimir Kushnarev, MD, PhD, BostonGene

RNA sequencing uncovered the expression landscape of potential antibody-drug conjugate (ADC) targets in sarcomas, particularly those lowly expressed in normal tissues. The combined expression of ADC targets with tertiary lymphoid structure and immune checkpoint gene signatures also depicts the immune landscape of sarcomas and can guide the development of immunotherapy approaches. Our findings revealed many genes that are precluded from existing clinical trials, underscoring the need to advance clinical trials and precision oncology in sarcoma therapies that prioritize safety and efficacy.

Research conducted in collaboration with The University of Texas MD Anderson Cancer Center, Massachusetts General Hospital Cancer Center, Memorial Sloan Kettering Cancer Center and Sarcoma Oncology Center

On November 6, 2024 Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported its financial results for the third quarter ended September 30, 2024, and provided business highlights (Press release, Tango Therapeutics, NOV 6, 2024, View Source [SID1234647867]).

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"We have made great progress with our PRMT5 development program, including positive data from the TNG462 phase 1/2 clinical trial that showcase the best-in-class potential of TNG462 in multiple tumor types, including pancreatic and non-small cell lung cancers (NSCLC). Based on these early data, we are advancing TNG462 into trials with multiple targeted and standard of care combinations, including two RAS(ON) tri-complex inhibitors from Revolution Medicines. Given that nearly all MTAP-deleted pancreatic cancer has a co-occurring RAS mutation, we believe this could be a powerful approach to changing the treatment landscape for this challenging cancer," said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. "As part of the expanded capabilities needed to rapidly move TNG462 development forward, Dr. Maeve Waldron-Lynch, M.D. is joining Tango as Senior Vice President, Head of Clinical Development. Dr. Waldron-Lynch has extensive late-stage oncology clinical development and regulatory experience and will be invaluable as we prepare to advance TNG462 to registration."

In a separate press release issued earlier today, Tango Therapeutics provided an update on its ongoing PRMT5 clinical development program:

Data from the ongoing phase 1/2 clinical trial of TNG462, a potentially best-in-class MTA-cooperative PRMT5 inhibitor, demonstrate clinical activity across multiple tumor types, including NSCLC and pancreatic cancer. Of note, this includes an ORR of 43% in cholangiocarcinoma (n=7). Substantive durability and a good safety and tolerability profile also were observed in this ongoing trial. The next clinical update is expected in 2025.
The Company plans to initiate multiple targeted and standard of care combinations with TNG462 including RAS(ON) multi-selective and RAS(ON) G12D-selective inhibitors (Revolution Medicines), osimertinib (AstraZeneca) and pembrolizumab (Merck). These studies are expected to begin enrolling in 1H 2025.
TNG908, an MTA-cooperative brain-penetrant PRMT5 inhibitor, is clinically active and well-tolerated across non-CNS cancers in the phase 1/2 clinical trial. In particular, there were a total of nine evaluable pancreatic cancer patients, two with partial responses (ORR 22%) and five with stable disease as best response to date. The five ongoing pancreatic cancer patients have been on study for an average of 24 weeks, the longest for 72 weeks.
TNG908 did not demonstrate activity in glioblastoma (n=23 at active doses) likely because CNS exposure did not meet the required exposure threshold for clinical efficacy.
TNG908 enrollment is being stopped to allow full resourcing of TNG462 as a potential best-in-class molecule. In particular, the notably longer time on treatment observed – 24 weeks and still increasing for TNG462 versus 16 weeks for TNG908 – the superior target coverage, and the safety and tolerability profile all support selection of TNG462 for further development.
TNG456 is a next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor that is 55X selective for MTAP deletion with 20 nM potency. Preclinical studies suggest TNG456 central nervous system exposure has the potential to be sufficient for meaningful efficacy in glioblastoma and brain metastases.
The Company expects to begin enrolling patients in the planned phase 1/2 trial during 1H 2025.
Business Highlights

Clinical collaboration with Revolution Medicines

In November 2024, the Company entered into a clinical collaboration with Revolution Medicines to evaluate the efficacy and safety of TNG462 in combination with RMC-6236, a RAS(ON) multi-selective inhibitor, and with RMC-9805, a RAS(ON) G12D-selective inhibitor.
The agreement provides that Revolution Medicines will supply RMC-6236 and RMC-9805 to Tango and that Tango will be the sponsor of any combination trials. Each company will retain commercial rights to their respective compounds and the agreement is mutually non-exclusive.
TNG260, a first-in-class, highly selective CoREST complex inhibitor

The TNG260 phase 1/2 clinical trial is ongoing, evaluating safety, pharmacokinetics, pharmacodynamics and efficacy of TNG260 in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors with an STK11 loss-of-function mutation. To date, safety, tolerability and pharmacokinetic profiles are favorable.
STK11 mutations occur in approximately 15% of non-small cell lung, 15% of cervical, 10% of carcinoma of unknown primary, 5% of breast and 3% of pancreatic cancers.
Upcoming Milestones

TNG462 clinical data update expected in 2025
TNG462 combination trial enrollment expected to begin 1H 2025
TNG456 phase 1/2 trial enrollment expected to begin 1H 2025
TNG260 clinical data expected in 2025
Additional Business and Pipeline Highlights

Leadership Update

Maeve Waldron-Lynch, M.D. will join Tango as Senior Vice President, Head of Clinical Development later this month. In this role, Dr. Waldron-Lynch will lead clinical development functions under Adam Crystal, M.D., Ph.D., President of Research and Development at Tango. Dr. Waldron-Lynch most recently served as VP and Global Clinical Program Head at MorphoSys, where she oversaw the clinical program for tafasitamab. Prior to MorphoSys, she was a Clinical Development Medical Director at Novartis. Dr. Waldron-Lynch also has served as Senior Clinical Director, Oncology at Roche, and as Associate Director of Medical Science, Oncology at Mundipharma. Dr. Waldron-Lynch graduated from the University College Cork School of Medicine and served as a Specialty Registrar Medical Oncology at the Royal College of Physicians of Ireland, and a Clinical Fellow in Medical Oncology at the Yale University School of Medicine.

Financial Results

As of September 30, 2024, the Company held $293.3 million in cash, cash equivalents and marketable securities, which the Company expects to be sufficient to fund operations into the third quarter of 2026, including for additional planned TNG462 and TNG456 clinical trials.

Collaboration revenue was $11.6 million for the three months ended September 30, 2024, compared to $10.7 million for the same period in 2023, and $25.9 million for the nine months ended September 30, 2024 compared to $26.1 million for the same period in 2023. Collaboration revenue increased due to changes to estimated costs expected to be incurred under the collaboration during the three months ended September 30, 2024.

License revenue was $0 and $12.1 million for the three and nine months ended September 30, 2024, respectively, compared to $0 and $5.0 million for the three and nine months ended September 30, 2023, respectively. The year-to-date increase is primarily due to licensing a drug discovery program to Gilead for $12.0 million during the second quarter of 2024 as compared to Gilead licensing a program for $5.0 million during the second quarter of 2023.

Research and development expenses were $33.3 million for the three months ended September 30, 2024, compared to $27.1 million for the same period in 2023, and $110.0 million for the nine months ended September 30, 2024 compared to $83.9 million for the same period in 2023. The change is due to increased spend related to the advancement of TNG462, preclinical programs and personnel-related costs to support our research and development activities.

General and administrative expenses were $11.2 million for the three months ended September 30, 2024, compared to $9.2 million for the same period in 2023, and $32.7 million for the nine months ended September 30, 2024 compared to $26.4 million for the same period in 2023. The change was primarily due to increases in personnel-related costs.

Net loss for the three months ended September 30, 2024 was $29.2 million, or $0.27 per share, compared to a net loss of $22.3 million, or $0.23 per share, in the same period in 2023. Net loss for the nine months ended September 30, 2024 was $92.6 million, or $0.85 per share, compared to a net loss of $71.0 million, or $0.78 per share, in the same period in 2023.

On November 6, 2024 Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported an update on its PRMT5 program (Press release, Tango Therapeutics, NOV 6, 2024, View Source [SID1234647866]). Based on positive data from the dose escalation and early dose expansion cohorts of the TNG462 phase 1/2 clinical trial, the Company has selected TNG462 to move forward into full development. TNG908, an MTA-cooperative brain penetrant PRMT5 inhibitor, is clinically active and well-tolerated in non-CNS solid tumors including NSCLC and pancreatic cancer. However, TNG908 did not meet the pharmacokinetic exposure threshold for clinical efficacy in glioblastoma (GBM) in the phase 1/2 trial. Thus, the Company is introducing TNG456, a next-generation brain penetrant MTA-cooperative PRMT5 inhibitor with enhanced potency and selectivity for the treatment of GBM, NSCLC and selected other solid tumors. TNG908 enrollment is being stopped in order to fully resource TNG462 and TNG456.

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"Early data from the TNG462 phase 1/2 clinical trial demonstrate activity, durability and tolerability, with the potential to be a best-in-class molecule. In this ongoing clinical trial, patients remain on treatment with a current median of 24 weeks and is still increasing," said Adam Crystal, M.D., Ph.D., President, Research and Development of Tango Therapeutics. "In addition, we are introducing TNG456, our next-generation brain-penetrant molecule, which is anticipated to enter the clinic in the first half of next year. Given the increased potency, selectivity and predicted brain penetrance of TNG456, we expect CNS exposure to be in the range needed for meaningful efficacy in glioblastoma and brain metastases. While it’s disappointing that, unlike in other solid tumors, TNG908 is not active in GBM, we believe this is due to lower-than-predicted central nervous system exposure. We remain steadfastly committed to bringing an effective treatment to people with glioblastoma and we are strongly positioned to achieve our goal of reaching as many patients as possible with MTAP-deleted cancers."

"Clinical data from the phase 1/2 trial demonstrate that TNG462 has potentially best-in-class characteristics including clinical activity across multiple tumor types included in the trial, substantive durability, and a good safety and tolerability profile, thus we are moving rapidly into the next phase of development. This includes clinical evaluation of TNG462 as a monotherapy and in multiple combinations of both targeted and standard of care agents to begin in 1H 2025, in preparation for registrational trials in NSCLC and pancreatic cancer. It also includes building key capabilities within Tango to bring TNG462 to a broad range of patients in the coming years. As part of this effort, we have entered into a clinical collaboration with Revolution Medicines under which we plan to conduct the first combination trials of an MTA-cooperative PRMT5 inhibitor with the exciting class of RAS(ON) tri-complex inhibitors. Given that nearly all MTAP-deleted pancreatic cancers have a co-occurring RAS mutation, we believe this could be a powerful approach to changing the treatment landscape for this challenging cancer," said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics.

TNG462, a potentially best-in-class MTA-cooperative PRMT5 inhibitor

TNG462 dose escalation began in July 2023 and enrollment in the dose expansion cohorts began in June 2024. With a data cutoff of 20 October 2024, a total of 59 patients have been enrolled, 39 evaluable patients across 13 histologies at active doses (160-300 mg QD).
TNG462 is active and well-tolerated across multiple tumor types, including NSCLC and pancreatic cancer, with a current median time on treatment of 24 weeks, and is still increasing.
As has been reported with other MTA-cooperative PRMT5 inhibitors, tumors continue to shrink over time in multiple tumor types. Median time to response is 16 weeks (8-32 weeks) and ~60% of patients with partial responses were initially assessed with stable disease.
While there is not yet a sufficient number of evaluable patients and follow-up to accurately estimate ORR for most cancer types, we have enrolled seven cholangiocarcinoma patients and observed confirmed partial responses in 3/7 of these patients (ORR 43%). 4/7 cholangiocarcinoma patients are ongoing with a median time on study of 24 weeks, and is still increasing.
TNG462 has a good safety profile and is well-tolerated at active doses, with thrombocytopenia as the dose limiting toxicity. Other adverse events reported for the class, including nausea, vomiting, diarrhea, and fatigue, occurred in less than 20% of patients and were predominantly grade 1. Dysgeusia has not been reported with the doses being evaluated in expansion.
TNG462 efficacy and tolerability continue to be evaluated at 200 mg, 250 mg and 300 mg daily, predominantly in NSCLC and pancreatic cancer. The next clinical update is planned for 2025.
Development plans for TNG462 being implemented include targeted combinations with two RAS(ON) inhibitors – RAS(ON) multi-selective inhibitor, RMC-6236, and RAS(ON) G12D-selective inhibitor, RMC-9805 (Revolution Medicines) – osimertinib (AstraZeneca) and pembrolizumab (Merck), with enrollment planned to start in 1H 2025.
Combinations of TNG462 and standard of care chemotherapy for NSCLC and pancreatic cancer also are being planned as potential paths to approval in the first line setting and we are initiating conversations with the FDA in preparation for multiple registrational studies.
TNG908, a blood-brain barrier penetrant, MTA-cooperative PRMT5 inhibitor

TNG908 dose escalation began in August 2022 and enrollment in the dose expansion cohorts began in April 2024. With a data cutoff of 20 October 2024, a total of 103 patients have been enrolled, 70 non-CNS patients across 24 histologies and 33 glioblastoma patients.
TNG908 is active and well-tolerated across multiple non-CNS solid tumors, including NSCLC and pancreatic cancer, with a median time on study of 16 weeks.
Of the 70 patients with non-CNS solid tumors, 31 were treated at active doses (400-600 mg BID) and had at least one tumor assessment. Four partial responses were observed. Responses occurred in pancreatic cancer (2/9), NSCLC (1/4) and urothelial cancer (1/1).
Of note, there were a total of nine evaluable pancreatic cancer patients, two with partial responses (ORR 22%) and five with stable disease as best response to date. The five ongoing pancreatic cancer patients have been on study for an average of 24 weeks, the longest for 72 weeks.
Of the 33 patients with glioblastoma, 23 were treated at active doses (400-600 mg BID) and had at least one tumor assessment. No partial responses by RANO criteria were observed and median time on study was less than 8 weeks.
In preclinical primate studies of TNG908, cerebral spinal fluid (CSF) exposure was 50-70% of plasma exposure. In CSF samples from three glioblastoma patients on study, exposure was ~30% of plasma exposure and below the threshold required for efficacy.
Dose-limiting toxicities were elevated creatine kinase and aspartate aminotransferase in one patient and altered mental status in a second patient, both at 900 mg BID. Nausea and fatigue were reported in ~40% of patients at 600 mg BID, the expansion dose.
While TNG908 is an active and well-tolerated MTA-cooperative PRMT5 inhibitor in non-CNS solid tumors, enrollment is being stopped to allow full resourcing of TNG462 as a potential best-in-class molecule. In particular, the notably longer time on treatment observed – 24 weeks and still increasing for TNG462 versus 16 weeks for TNG908 – the superior target coverage and the safety and tolerability profile all support selection of TNG462 for further development.
TNG456, a next-generation, brain penetrant MTA-cooperative PRMT5 inhibitor

TNG456 is a novel, brain-penetrant MTA-cooperative PRMT5 inhibitor that is 55X selective for MTAP deletion with 20 nM potency (GI50) in preclinical studies.
Based on primate CSF exposure that is 50%-110% of plasma levels and the markedly increased potency and selectivity of TNG456 compared to TNG908 (GI50 120 nM, 15X MTAP-deleted selectivity), TNG456 CNS exposure is predicted to be in the range needed for efficacy in glioblastoma and brain metastases.
TNG456 will be evaluated in glioblastoma, NSCLC and select other solid tumors as a monotherapy and in combination with the brain-penetrant CDK4/6 inhibitor abemaciclib (Lilly). The combination with abemaciclib is based on the co-deletion of CDKN2A and MTAP in essentially all MTAP-deleted cancers and on strong synergy observed in preclinical models.
The Company plans to begin enrolling patients in the TNG456 phase 1/2 study in 1H 2025.

On November 6, 2024 QureBio Ltd., a clinical-stage biopharmaceutical company focusing on development of bispecific antibodies and other engineered Biopharmaceuticals for the treatment of cancer, inflammation, and other serious disorders, reported that Phase Ⅱ Clinical Data of its Q-1802 program will be presented at SITC (Free SITC Whitepaper) 39th annual meeting hold at Houston on November 8–9, 2024 (Press release, QureBio, NOV 6, 2024, View Source [SID1234647864]). The abstract will be found in 39th SITC (Free SITC Whitepaper) annual meeting abstract (#1500), meanwhile the poster will be presented on November 9 at George R. Brown Convention Center level 1 exhibit Halls AB, Houston. A brief of the abstract information is shown as below:

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A phase II trial of bispecific antibody Q-1802 in patients with relapsed or refractory solid tumors

Authors: Yakun Wang, Jifang Gong, Xiangdong Qu, Lin Shen

Q-1802 can target both the tumor-specific antigen Claudin18 isoform 2 (CLDN18.2) and the immune checkpoint PD-L1.
The objective response rate (ORR) is approximately 70.0% (14/20) in the 10 mg/kg group.
The proportion of Grade 3 and above adverse events in the 10 mg/kg group is approximately 55%, with good safety profile. There is no adverse events above Grade 3 and Q-1802 related death.
Clinical Data shows that Q-1802 has significant anti-tumor activity.
About Q-1802

Q-1802, a humanized bispecific antibody, is the first FDA-approved and the first enter clinical trial Claudin18.2/PD-L1 bispecific antibody. It recruits multiple immune mechanisms to kill tumor cells, such as antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell-mediated phagocytosis (ADCP), offering a novel therapeutic opportunity for Claudin18.2 positive solid tumors. Q-1802 exhibits high affinity and selectivity, and patients with low or high expression of CLDN18.2 can benefit from it. The molecular design of Q-1802 is rational and effective, the production process is robust with high yield.

Also in this conference, QureBio revealed its T-cell engage and T cell engager enhancer platforms, which can be used to develop bispecific antibodies to treat cancer and autoimmune diseases.

On November 6, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the presentation of additional data from the Phase 1 clinical trial of its breast cancer vaccine at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, will be made publicly available on the Company’s website at 12:15pm CT on November 8, 2024 (Press release, Anixa Biosciences, NOV 6, 2024, View Source [SID1234647863]). Concurrently, the Company will issue a press release providing an analysis of the data.

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As previously announced, the presentation, titled "Phase I Trial of alpha-lactalbumin vaccine in high risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC," will be presented at 12:15pm CT on November 8, 2024 at the SITC (Free SITC Whitepaper) 39th Annual Meeting.

The poster presentation can be viewed starting at 12:15pm CT on November 8, 2024 at View Source