On April 17, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported the presentation of new VISTA biomarker data and an update on the KVA12123 Phase 1/2 clinical trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 (Press release, Kineta, APR 17, 2023, View Source;utm_medium=rss&utm_campaign=kineta-unveils-new-vista-biomarker-data-and-kva12123-phase-1-2-clinical-trial-update-at-aacr-annual-meeting-2023 [SID1234630160]). Thierry Guillaudeux, Ph.D., Chief Scientific Officer at Kineta, presented the company’s poster unveiling the new data in the AACR (Free AACR Whitepaper) poster session entitled "Biomarkers of Therapeutic Benefit 1".

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"These biomarker data provide additional compelling rationale supporting VISTA as a promising new immuno-oncology target for patients with a range of different cancers" said Dr. Guillaudeux. "A better understanding of VISTA expression in the tumor microenvironment as well as in the blood could potentially inform patient selection and treatment optimization with KVA12123 in the future"

Key results from the AACR (Free AACR Whitepaper) poster presentation:

VISTA expression was detected by immunohistochemistry on tumor infiltrating immune cells, especially in non-small cell lung cancer, colorectal cancer, ovarian cancer, cervical cancers, melanoma and hepatocellular carcinomas and
VISTA expression was also detected on rare tumor cells in lung, head and neck, ovary and kidney malignancies
Multiplex IHC will be performed to confirm VISTA-positive tumor-infiltrating myeloid cells
High levels of soluble VISTA were found in colorectal, head & neck, kidney, lung and ovarian cancer patient serum samples
In the ongoing Phase 1/2 clinical trial, tumor tissues and serum samples will be collected from cancer patients prior to treatment with KVA12123 to inform the possible significance of these biomarkers
This work will help to better understand the clinical response to KVA12123 in relation to the expression level of VISTA in cancer tissues as well as in the blood and opens the possibility to consider VISTA expression as a potential biomarker for efficacy
Presentation Details:
Poster Title: VISTA expression in patients with advanced solid tumors: A potential biomarker in VISTA-101 clinical trial
Abstract Number: 972
Session Title: Biomarkers of Therapeutic Benefit 1
Session Date and Time: Sunday, April 16, 2023 at 1:30 P.M. – 5:00 P.M. Eastern Time
Location: Section 39

The poster presentation is available for viewing under Publications in the KVA12123 section of the company’s website at www.kinetabio.com.

On April 13, 2023 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies, reported positive preclinical data for its novel non-signaling CAR (nsCAR) platform and the launch of its INB-330 program in AML (Press release, In8bio, APR 17, 2023, View Source [SID1234630159]). The new data included preliminary results for the nsCAR platform targeting CD33, a challenging but potentially impactful target in AML. The data were presented in a poster session (abstract #1777) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023.

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"The pairing of an nsCAR with the innate killing ability of gamma-delta T cells has the potential to become a cornerstone in the treatment of both solid and liquid cancers, given the increased anti-tumor efficacy and preservation of healthy cells," remarked William Ho, CEO and co-founder of IN8bio. "IN8bio’s unique knowledge of the biology and manufacturing of gamma-delta T cells positions it as a leader in next generation CAR platforms for the treatment of previously undruggable targets."

IN8bio’s nsCAR platform is based on the natural ability of gamma-delta T cells to distinguish between healthy and malignant tissue. By using a CAR that lacks a signaling domain, IN8bio believes it has created a technology that enables these cells to differentiate between tumor and healthy tissue, even when both express the CAR-targeted antigen. The power of the nsCAR technology to selectively target tumor cells was shown in proof-of-concept studies against the validated target of CD19. Preliminary data showed a gamma-delta CD19 nsCAR (ns19CAR) killed 80% of leukemia cells versus only 5% of healthy B cells, which both express the CD19 target.

The new data presented at AACR (Free AACR Whitepaper) includes early preclinical results for the INB-330 program targeting CD33 for AML, an important but challenging target due to its expression on both leukemic cells and hematopoietic stem cells (HSCs). Previous therapies targeting CD33 were limited due to the significant side effects resulting from the unintended targeting of these HSCs. The data presented at AACR (Free AACR Whitepaper) showed that a CD33 targeting nsCAR construct (ns33CAR) was successfully engineered into gamma-delta T cells. The ns33CAR cells were able to distinguish

between leukemic cells and healthy monocytes isolated from peripheral blood, both of which express CD33. The ns33CAR demonstrated anti-leukemic activity against AML, B-cell acute lymphoblastic leukemia (B-ALL), and chronic myeloid leukemia (CML) cell lines. These preliminary findings support the ongoing evaluation of INB-330 in AML and improvements in transduction and CAR optimization are ongoing.

"We are thrilled to present this promising preclinical data from our next-generation nsCAR platform, which shows the potential of our INB-300 platform and INB-330 program to differentiate between cancerous and healthy tissue," said Lawrence Lamb, Ph.D., co-founder and Chief Scientific Officer of IN8bio. "Our goal is to improve upon existing technologies with a targeted but potentially less toxic approach for patients who require more innovative therapies. The ability of this platform to avoid on-target off-tumor killing also allows us to explore previously "undruggable" targets in complex diseases such as AML and solid tumors. We are encouraged by these results and look forward to seeking potential partners and further evaluating the nsCAR platform with additional targets."

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.

On April 17, 2023 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported a poster presentation providing additional mechanistic insights into its Goldspire platform based on preclinical studies of its lead product candidate, IGV-001, for the treatment of glioblastoma (GBM) (Press release, Imvax, APR 17, 2023, View Source;utm_medium=rss&utm_campaign=imvax-presents-new-data-at-aacr-2023-supporting-the-mechanism-of-action-of-its-lead-program-igv-001-for-glioblastoma [SID1234630158]). These data are being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Orlando, FL, running from April 14-19, 2023.

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"These new data provide us with deeper insights into the unique mechanism of our personalized immunotherapy platform, Goldspire, that combines whole-tumor derived cells with an antisense nucleotide in proprietary implanted chambers," said Mark A. Exley, Ph.D., Chief Scientific Officer. "The Goldspire platform is designed to induce a durable, broad-spectrum immune response against tumors, and additional studies like this one are key to furthering our understanding of both IGV-001 and our platform."

The data published in the AACR (Free AACR Whitepaper) poster presentation examined the effect on tumor cells of the Goldspire process, the release of subcellular immunogenic particles, their transit across the diffusible membrane of the implanted chambers and related immunological changes. IGV-001 was found to impose oxidative and endoplasmic reticulum stress onto GBM cells. Particle analysis confirmed that a human variant of IGV-001 prepared with human GBM cells produced particles that can efficiently diffuse through the membrane of the implanted chambers. Finally, the results indicated that lymph nodes through which IGV-001 drains are enriched in mature antigen-presenting cells and lymphoid effector cells.

The poster can be found on the Imvax website and the details for the presentation are below:

Title: ROS-dependent activation of immunogenic glioblastoma cell death & release of immunogenic particles by an autologous cell-based immunotherapeutic platform
Number: 1812
Timing: Monday, April 17, 2023, 9:00 AM – 12:30 PM
Presenter: Jenny Zilberberg, Ph.D.

About IGV-001
IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b study in newly diagnosed GBM (ndGBM) patients also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC. In March 2023, Imvax initiated a Phase 2b clinical trial of IGV-001 in ndGBM patients (NCT04485949).

On April 17, 2023 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena"), a targeted oncology company forging new territory in patient-directed cancer treatment, reported that it will present preclinical data in two poster presentations highlighting the Company’s novel Hippo pathway inhibitor, IK-930, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Orlando, FL from April 14-19, 2023 (Press release, Ikena Oncology, APR 17, 2023, View Source [SID1234630157]).

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Data being shared today reveals that IK-930 selectively binds and inhibits TEAD1 and further describes the mechanism for its antitumor activity. Key advantages demonstrated in the nonclinical studies include IK-930’s superior tolerability and comparable antitumor activity compared to panTEAD inhibition, resulting in a significantly improved projected therapeutic window in cancer patients. IK-930 was designed as a TEAD1-selective inhibitor to avoid on-target renal toxicity expected from panTEAD inhibition. TEAD1 is the most highly expressed TEAD paralog in mesothelioma and epithelioid hemangioendothelioma (EHE). The data being presented support the ongoing IK-930 Phase 1 program in patients with Hippo mutated cancers and the planned expansion into combinations of IK-930 with other targeted therapies in multiple cancer types, including across EGFR and RAS mutated cancers, to potentially delay or even reverse therapeutic resistance.

"IK-930’s selectivity profile is the ultimate example of what we are aiming to do at Ikena – creating effective and safe targeted oncology treatments that have the potential to benefit both patients with primary-defined cancers and prevent resistance to other targeted therapies. Targeted oncology came to fruition as a way to develop highly specific therapies that can benefit patients — to spare healthy tissue instead of causing widespread toxicity — it is crucial to take into account a target’s function outside of a patient’s cancer," said Mark Manfredi, Ph.D., Chief Executive Officer of Ikena Oncology. "Tolerability across multiple nonclinical species, including non-human primates, was central to our design of IK-930 and our enthusiasm about its potential in the clinic."

Highlights from the data in today’s poster include:

In nonclinical models and species, IK-930 demonstrated selective inhibition of TEAD1 with equivalent activity to broad TEAD inhibitors and a significantly improved tolerability profile

IK-930 promotes repressive TEAD1 activity by driving interactions with VGLL4, a signaling partner that reduces expression of pro-growth and anti-apoptotic genes

Through its binding with TEAD1 and VGLL4, IK-930 potentially blocks chromatin binding of other TEAD paralogs

In assessing the potential on-target renal toxicity of targeting TEAD, average urinary protein-to-creatinine ratios and histopathology in non-human primates predicted a therapeutic index of less than one for panTEAD inhibitions and a broad therapeutic window for IK-930

In addition, tomorrow the Company will present a poster that highlights IK-930’s ability to reduce and reverse resistance to other targeted therapies in preclinical models. Highlights include:

Treatment with IK-930 in combination with multiple targeted agents, such as EGFR, KRAS G12C, and MEK inhibitors, demonstrated a reduction in emergence of drug resistant "persister" cells

"IK-930 was designed by leveraging TEAD biology to rebalance the oncogenic activity of the Hippo pathway, providing a potentially differentiated and tolerable therapeutic option for patients," added Jeff Ecsedy, Ph.D., Ikena Chief Development Officer. "The data presented at AACR (Free AACR Whitepaper) today demonstrate the beauty of IK-930’s ability to preferentially keep TEAD1 in a transcriptionally repressive state, and to likely block other TEAD paralogs from activating oncogenic transcription. We are thrilled to be able to share this essential differentiation today and look forward to sharing more later this year from our progress with IK-930 in the clinic."

Presentation Details:

Poster Title: IK-930 A TEAD Paralog Selective Inhibitor for Treating YAP/TAZ-TEAD Dependent Cancers

Session: Novel Antitumor Agents 4

Presenter: Nathan Young, Ph.D., Associate Director of Molecular and Cellular Oncology at Ikena Oncology

Date: Monday, April 17, 2023

Time: 9:00 AM – 12:30 PM ET

Poster Title: IK-930, A Paralog Selective Novel TEAD-Inhibitor, Effectively Attenuates Drug-Tolerant Persister Cell Proliferation

Session: Drug Resistance in Molecular Targeted Therapies 3

Presenter: Daniel Hidalgo, Ph.D., Scientist I, Translational Science at Ikena Oncology

Date: Tuesday, April 18, 2023

Time: 9:00 AM – 12:30 PM ET

Both posters will be available on Ikena’s Resources Page on their website following the conference.

About IK-930

IK-930 is an oral, paralog-selective TEAD inhibitor targeting the Hippo signaling pathway. IK-930 selectively binds to TEAD1 and prevents transcription of multiple genes that drive cancer progression. By targeting the Hippo pathway, a key driver of cancer pathogenesis that is genetically altered in approximately 10% of all cancer types, IK-930 could have a differentiating impact across many cancers with high unmet need. Ikena is advancing IK-930 both as a monotherapy in patients with Hippo pathway mutated cancers and in combination with other approved targeted therapies to combat therapeutic resistance. IK-930 is currently being studied in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors with or without gene alterations in the Hippo pathway, including NF2-deficient malignant mesothelioma, Epithelioid Hemangioendothelioma (EHE) with documented TAZ/CAMTA1 fusion genes as well as other solid tumors with either NF2 deficiency or with YAP/TAZ genetic fusions (NCT05228015).

On April 17, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Craig Collard, Chief Executive Officer of Heron, will participate in a fireside chat on Thursday, April 20, 2023, at 11:45 AM ET at the 22nd Annual Needham Virtual Healthcare Conference (Press release, Heron Therapeutics, APR 17, 2023, View Source [SID1234630156]). The conference is being held in a virtual format, April 17-20, 2023.

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A live webcast of the fireside chat will be available on the Company’s website at www.herontx.com in the Investor Resources section.