On March 5, 2024 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients, reported that preclinical data will be presented in five posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 to be held on April 5-10 in San Diego, California (Press release, Verastem, MAR 5, 2024, View Source [SID1234640811]). The presentations will highlight anti-tumor efficacy of GFH375 (VS-7375), a potent and selective orally bioavailable KRAS G12D (ON/OFF) inhibitor, and will also show data of RAF/MEK clamp plus FAK inhibition in pancreatic ductal adenocarcinoma (PDAC) models supporting the ongoing RAMP 205 trial. Additional presentations will support the use of avutometinib and FAK inhibitor combination in cutaneous melanoma models to overcome resistance to BRAF and MEK inhibitors, resistance to immunotherapy, and brain metastasis.

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"For the first time, GenFleet and Verastem will present potency, selectivity, anti-tumor efficacy, and bioavailability data on GFH375 (VS-7375), a potential best-in-class orally active KRAS G12D (ON/OFF) inhibitor. We look forward to an IND submission by GenFleet in China in H1 2024," said Jonathan Pachter, Ph.D., chief scientific officer of Verastem Oncology. "Additionally, preclinical data will be presented demonstrating that the combination of avutometinib and a FAK inhibitor with standard-of-care chemotherapy can induce tumor regressions in pancreatic cancer models, providing the scientific rationale for the ongoing RAMP 205 Phase 1/2 study evaluating the combination of avutometinib, defactinib, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma. Collectively, these data from the five posters build on our desire to advance treatments that target the RAS/MAPK pathway and provide new options for patients with RAS/MAPK driven cancers."

Key Data Presentations:

Title: GFH375 (VS-7375): An oral, selective KRAS G12D (ON/OFF) inhibitor with potent anti-tumor efficacy
Abstract #: 3318
Date/Time: Monday, April 8, 2024, 1:30 – 5:00 p.m. PDT
Sponsor: GenFleet Therapeutics

Title: Combined inhibition of RAF, MEK and FAK increases PDAC responsiveness to cytotoxic- and immune therapy
Abstract #: 2899
Date/Time: Monday, April 8, 2024, 1:30 – 5:00 p.m. PDT
Institution: Siteman Cancer Center, Department of Medicine, Washington University School of Medicine

Title: Combined Inhibition of RAF, MEK, and FAK attenuates melanoma brain metastases and prolongs survival in preclinical models
Abstract #: 4127
Date/Time: Tuesday, April 9, 2024, 9:00 a.m. – 12:30 p.m. PDT
Institution: Huntsman Cancer Institute, Department of Surgery, University of Utah School of Medicine

Title: A novel combination therapy targeting RAF, MEK, and FAK to overcome skin cutaneous melanoma treatment resistance
Abstract #: 4745
Date/Time: Tuesday, April 9, 2024, 9:00 a.m. – 12:30 p.m. PDT
Institution: Moores Cancer Center-Department of Pharmacology, University of California San Diego

Title: The SOS1 Inhibitor MRTX0902 Demonstrates Activity Across Cancer Models with Mutations in Proximal Components of the RAS-MAPK pathway
Abstract #: 7268
Date/Time: Wednesday, April 10, 2024, 9:00 a.m. – 12:30 p.m. PDT
Sponsor: Mirati Therapeutics, Inc.
The accepted abstracts are available on the AACR (Free AACR Whitepaper) conference website: View Source

About GFH375 (VS-7375)

GFH375 (VS-7375) is a potential best-in-class, potent and selective oral KRAS G12D (ON/OFF) inhibitor, identified as the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. GenFleet plans to submit an IND in China for GFH375 (VS-7375) in the first half of 2024, and upon approval GenFleet is expected to initiate a Phase 1 trial in China in the second half of 2024. The collaboration includes three discovery programs, the first being the KRAS G12D inhibitor, and will provide Verastem Oncology with exclusive options to obtain licenses to each of the three compounds in the collaboration after successful completion of pre-determined milestones in Phase 1 trials. The licenses would give Verastem Oncology development and commercialization rights outside of the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan.

About the Avutometinib and Defactinib Combination

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS/MAPK pathway inhibition. In contrast to currently available MEK-only inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other MEK-only inhibitors. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, a selective FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS/MAPK driven tumors as part of its (Raf And Mek Program). RAMP 301 (NCT06072781) is a Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent LGSOC. RAMP 201 (NCT04625270) is a Phase 2 registration-directed trial of avutometinib in combination with defactinib in patients with recurrent LGSOC and has completed enrollment in the dose optimization, expansion phase, and low-dose evaluation cohorts.

Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 (NCT05074810) and RAMP 204 (NCT05375994) trials, respectively. Supported by the "Therapeutic Accelerator Award" Verastem Oncology received from PanCAN, the Company is conducting RAMP 205 (NCT05669482), a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer.

On March 5, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported the Company will present a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 5-10, 2024, in San Diego, CA (Press release, Candel Therapeutics, MAR 5, 2024, View Source [SID1234640810]). The presentation will describe the second candidate from the enLIGHTEN Discovery Platform, a first-in-class multimodal immunotherapy candidate for induction of tertiary lymphoid structures as a novel therapeutic strategy for solid tumors. This abstract presentation at AACR (Free AACR Whitepaper) accelerates the milestone associated with the unveiling of the second enLIGHTEN program, which was originally planned for the third quarter of 2024.

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Presentation details are as follows:

Presentation Title: A first-in-class multimodal immunotherapy for induction of tertiary lymphoid structures as a novel therapeutic strategy for solid tumors
Presenter: Anne R. Diers, PhD, Senior Director, Research, Candel Therapeutics
Abstract Number: LB263
Session Date and Time: Tuesday, April 9, 2024; 9:00 AM – 12:30 PM PT
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Location: San Diego Convention Center
All regular abstracts are available for viewing via AACR (Free AACR Whitepaper)’s online itinerary planner, located here.

About the enLIGHTEN Discovery Platform

The enLIGHTEN Discovery Platform is a systematic, iterative herpes simplex virus (HSV)-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These discoveries are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations. In 2022, the Company announced a discovery partnership with the University of Pennsylvania Center for Cellular Immunotherapies to create new viral immunotherapies that could enhance the efficacy of chimeric antigen receptor T cell (CAR-T) therapy in solid tumors. During the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting and the 2023 International Oncolytic Virus Conference, Candel presented encouraging data on the first candidate from this platform, Alpha 201-macro-1, which was designed to interfere with the CD47/SIRP1a pathway, in mouse models of breast cancer and lung cancer.

On March 5, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported additional data from its diagnostic 64Cu-SAR-bisPSMA trial, COBRA (NCT05249127) (Press release, Clarity Pharmaceuticals, MAR 5, 2024, View Source [SID1234640807]).

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COBRA was a multi-centre, single-arm, non-randomised, Phase 1/2 diagnostic imaging study of 64Cu-SAR-bisPSMA administered to participants with BCR of PC following definitive therapy and who had a negative or equivocal SOC scan at screening. The primary objectives of the trial were to investigate the safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of PC. Patients underwent PET/computed tomography (CT) scans with 64Cu-SAR-bisPSMA on Day 0 and Day 1 (1-4h and 24±6h post-dose, respectively), which were interpreted by three blinded central readers. Following the recent announcement of positive results from the COBRA trial2, which began showcasing the many benefits of 64Cu-SAR-bisPSMA, further analysis of the data reveals additional advantages of this optimised PSMA product.

64Cu-SAR-bisPSMA was able to detect much smaller lesions than anticipated, including a lesion with a diameter of less than 2 mm. This compares favourably against the current SOC PSMA PET imaging agents, including PYLARIFY and the generic product 68Ga-PSMA-11, with which the detection of lesions smaller than 5 mm is challenging. Sensitivity is a known challenge for the existing PSMA PET agents, particularly for lesions <5 mm3-6. This suggests that lesions are missed by current SOC imaging, which can have significant implications on accurate staging and subsequent treatment decisions. For those undergoing initial staging of their disease, missing lesions may lead to unnecessary surgery resulting in long-lasting side effects (e.g. impotence and/or incontinence following the removal of the prostate)7. In patients with BCR of PC, it is also crucial to identify their cancer early to avoid disease progression and the side effects of systemic treatments that accompany such therapies8.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The cornerstone of better therapy is better diagnosis, and we are incredibly excited about the substantial degree of improvement in detection of lesions with our bisPSMA product compared to SOC imaging. This difference is similar to comparing the old Hubble telescope to the new James Webb telescope, allowing us to visualise with much greater clarity, and to effectively change the paradigm of treatment to considerably improve the outcomes for patients with PC. Innovative products like 64Cu-SAR-bisPSMA may prevent many millions of men from receiving inappropriate treatments and suffering substantial debilitating side effects from surgery or other therapies.

"When combining the optimised dual PSMA targeting agent with the ideal half-life of copper-64 (64Cu), we continue to observe higher uptake and retention of 64Cu-SAR-bisPSMA in PC lesions. We believe the ability of 64Cu-SAR-bisPSMA to detect such small lesions is due to the higher uptake and retention of the product over time with high contrast (parameters measured by mean standardised uptake value [SUVmean], maximum standardised uptake value [SUVmax] and tumour-to-background ratio [TBR]). Small lesions become more readily detectable if the uptake of the product in the lesion is high and the background noise on the image is low. This effect enhances the contrast, making the lesion easier to detect, providing clinicians with valuable information on how to best treat their patients."

The size of the PC lesions detected by 64Cu-SAR-bisPSMA was recorded on the same-day (Day 0) and next-day (Day 1) imaging. Lesions with less than 5 mm in size were identified across readers among 14% (7/50) of patients (Figures 1 and 2). These lesions were located in the bone, pelvic and extra-pelvic lymph node regions. The smallest lesion (pelvic lymph node) identified in the study was 2.6 x 1.9 mm.

The SUVmax, SUVmean and TBR were assessed in up to 25 lesions per patient on the same-day and next-day 64Cu-SAR-bisPSMA PET imaging. Mean SUVmean and SUVmax increased more than 80% (82% and 87% average increase across all readers, respectively) and TBR increased almost 5 times (4.8x average increase across all readers) comparing same-day with next-day imaging (ranges among readers, Day 0 and Day 1, respectively: SUVmean 6.6-9.9 and 14.7-15.8; SUVmax 13.9-14.0 and 22.2-33.4; TBR 23.2-25.4 and 118.1-181.7) (Graphs 1 and 2). Lesions of less than 5 mm in size had SUVmean, SUVmax and TBR value of 16.3, 16.8 and 90.1, respectively (mean values across all readers).

The ability of 64Cu-SAR-bisPSMA to detect lesions less than 5 mm is a result of a few factors unique to the product. 64Cu has a longer half-life (12.7 h) than the isotopes used in currently approved PSMA PET agents, such as gallium-68 (68Ga) and fluorine-18 (18F) (<2 h), enabling next-day imaging, which is impossible with 18F- and 68Ga-based agents. Clarity’s SAR Technology holds isotopes of copper securely inside a cage, preventing their leakage when administered to patients. Pre-clinical and clinical evidence has demonstrated that the optimised dual targeting molecule connected to the cage, bisPSMA, ensures increased targeting and retention of the product in PC tumours compared to its single targeting molecule counterpart and approved PSMA agents9,10. Results from Clarity’s Phase I PROPELLER trial substantiated this hypothesis as 64Cu-SAR-bisPSMA showed detection of additional lesions and 2-3 times greater uptake within the same PC lesions compared to the generic SOC imaging agent, 68Ga-PSMA-11. Furthermore, the initial positive results from the COBRA study, announced on the 15th of February 20242, showed that delayed imaging with 64Cu-SAR-bisPSMA is able to detect PC lesions in up to 80% of patients with BCR of PC, who demonstrated negative or equivocal SOC imaging at screening. It also showed that the number of lesions detected by 64Cu-SAR-bisPSMA almost doubled on delayed imaging compared to same-day imaging.

"The COBRA trial was designed to showcase the true benefits of bisPSMA compared to current SOC imaging, implementing a high standard of study design to validate our findings and utilise an unbiased view of assessment. The results are nothing short of extraordinary, and as we continue to adhere to best practice in clinical development, our science at Clarity is clearly differentiating us from our competitors. Combined with our clinical and pre-clinical evidence to date, this data further validates SAR-bisPSMA as a potential best-in-class PSMA agent for the diagnosis (with 64Cu) and subsequent treatment (with copper-67 [67Cu]) of PC. The benefits of 64Cu-SAR-bisPSMA are now even more evident, given the highest scientific rigour applied to the COBRA study design, and confirmed by clinicians who reported that they would change their treatment plan in response to the 64Cu-SAR-bisPSMA scan results in approximately half of their trial patients. Our COBRA trial was an exploratory first-in-human Phase 1/2 trial in BCR to generate information to allow us to meticulously design a Phase 3 registrational trial. Now that we know what we are looking for, including lesions in the 2 mm range, we can structure a Phase 3 trial in the BCR of PC indication to clearly differentiate ourselves from the first-generation PSMA agents as we head towards our ultimate goal of improving treatment outcomes for people with cancer," Dr Taylor said.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) Technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR Technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide11. The American Cancer Institute estimates in 2024 there will be 299,310 new cases of prostate cancer in the US and around 35,250 deaths from the disease.

On March 5, 2024 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that multiple abstracts have been accepted for presentation, including two oral presentations on ORIC-944, a potent and selective allosteric inhibitor of PRC2, at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 5-10, 2024, in San Diego, CA (Press release, ORIC Pharmaceuticals, MAR 5, 2024, View Source [SID1234640804]).

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Invited speaker presentation details:
Title: Discovery of ORIC-944, a novel inhibitor of PRC2 with best-in-class properties for the treatment of prostate cancer
Session Title: New Drugs on the Horizon: Part 1
Date & Time: Sunday, April 7, 2024, 1:00 p.m. – 2:30 p.m. PT
Presenter: Lori Friedman, Ph.D., Chief Scientific Officer
Abstract: Embargoed until April 7, 2024

Oral presentation details:
Title: ORIC-944, a potent and selective allosteric PRC2 inhibitor with best-in class properties, demonstrates combination synergy with AR pathway inhibitors in prostate cancer models
Abstract Number: 6856
Date & Time: Tuesday, April 9, 2024, 2:30 p.m. – 4:30 p.m. PT
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 5
Presenter: Anneleen Daemen, Ph.D., Executive Director of Translational Medicine

Abstract Highlights

ORIC-944, a potent, highly selective, orally bioavailable inhibitor of PRC2 demonstrated single agent tumor growth inhibition in a spectrum of AR-positive in vivo prostate cancer models, including those expressing AR mutants or ARv7. Combining ORIC-944 with an AR inhibitor was synergistic in multiple prostate cancer cell line models, and combination efficacy for ORIC-944 with AR inhibition was confirmed in vivo. RNA-seq analysis of transcriptional changes induced by ORIC-944 provided mechanistic insight into the role of PRC2 in prostate cancer lineage plasticity and combination response. These results position ORIC-944 as a potential best-in-class PRC2 inhibitor for combination with AR inhibitors in patients with prostate cancer.

Poster presentation details:
Title: ORIC-613, a potential first- and best-in-class, orally bioavailable, potent and selective PLK4 inhibitor with synthetic lethality in TRIM37 high cancer models
Abstract Number: 594
Date & Time: Sunday April 7, 2024, 1:30 p.m. – 5:00 p.m. PT
Session Category: Experimental and Molecular Therapeutics
Session Title: Kinase and Phosphatase Inhibitors 1
Location: Poster Section 25

Abstract Highlights

ORIC-613 is an orally bioavailable, potent and exquisitely selective small molecule inhibitor of PLK4, which is synthetic lethal in tumor cells with high levels of TRIM37. ORIC-613 is highly selective against the kinome, including against the closely related aurora kinases and other PLK family members. Preclinical assessment in cancer cell lines revealed the synthetic lethality, with ORIC-613 having stronger potency in TRIM37-high cells as evidenced by inducing tumor cell death specifically in TRIM37-high versus TRIM37-wildtype cells. Analysis of genomic data from adult tumors indicates that increased TRIM37 copy number is found across a breadth of cancers, with notable prevalence in breast cancer. Oral dosing of ORIC-613 resulted in tumor growth inhibition and regressions in TRIM37-high xenograft breast tumors. These results position ORIC-613 as a potential first- and best-in-class development candidate, which demonstrates synthetic lethality in TRIM37-high tumors and has the potential to benefit these patients.

All regular abstracts are available for viewing via AACR (Free AACR Whitepaper)’s online itinerary planner located, here. Invited speaker abstracts will be available for viewing the morning of their associated session.

On March 5, 2024 IN8bio, Inc. (Nasdaq: INAB) a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported the presentation of new preclinical data for its non-signaling gamma-delta T cell based Chimeric Antigen Receptor T cell (CAR-T) platform, INB-300 (Press release, In8bio, MAR 5, 2024, View Source [SID1234640803]). The data will be presented at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 5-10, 2024 in San Diego, California.

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The current generation of CAR-T technology eliminates the target antigen regardless of whether it is expressed on tumor or healthy tissue. IN8bio’s nsCAR platform, INB-300, uses the CAR to traffic and bind to cells expressing the target and leverages the natural innate immune recognition abilities of gamma-delta T cells to distinguish between tumor and healthy tissue. This allows the cells to selectively eliminate cancer cells while leaving healthy cells intact, even when both express the CAR-target.

"We’re excited to share this new data from our nsCAR platform, INB-300, which enables next-generation precision CAR-T therapy by selectively targeting leukemia cells while preserving healthy tissues," said Lawrence Lamb, Ph.D., co-founder and Chief Scientific Officer, IN8bio. "We are using gamma-delta T cells to treat a wide variety of cancers, including myeloid malignancies and solid tumors, where current CAR-T therapy has historically faced significant challenges due to on target, but off tumor toxicities. We look forward to advancing our pipeline of novel gamma-delta based nsCAR therapies for patients with significant unmet need."

AACR Poster Presentation Details

Poster Title: Gamma-delta (γδ) CAR-T cells lacking the CD3ζ signaling domain enhance targeted killing of AML cells and preserve healthy tissues

Abstract Presentation Number: 5227

Session Title: Adoptive Cell Therapies 4

Session Date and Time: Tuesday, April 9, 2024, 1:30pm-5:00pm PT (4:30pm-8:00pm ET)

About INB-300
INB-300 is a non-signaling CAR (nsCAR) gamma-delta T cell platform with several preclinical product candidates, including the INB-330 program against AML targets, that combine our expertise in gamma-delta T cells and genetic engineering. These nsCAR constructs lack signaling domains in order to take advantage of the unique properties of gamma-delta T cells to differentiate between healthy and tumor tissues. IN8bio is advancing new nsCAR constructs against multiple targets to treat both solid and liquid tumors.