On January 24, 2022 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported an upcoming presentation at the 6th Tumor Models for Immuno-Oncology Summit 2022 (Press release, Kineta, JAN 24, 2022, View Source;utm_medium=rss&utm_campaign=kineta-to-present-on-the-companys-piioneer-platform-at-the-6th-annual-tumor-models-for-immuno-oncology-summit [SID1234607393]). Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, will be presenting an overview of the company’s proprietary PiiONEER Platform and the use of human knock-in models for selecting next generation immunotherapies.

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Kineta’s immuno-oncology PiiONEER Platform was designed for the discovery and development of first or best-in-class immunotherapies that address the major challenges with cancer resistance to current therapies. Utilization of the innate immunity focused PiiONEER Platform has resulted in the development of novel, well characterized fully human antibody therapeutics that are being advanced into formal IND enabling and clinical studies.

"We have developed a world-class innate immunity-focused platform for developing important new immunotherapies to treat patients with cancer" said Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta. "A core component of our PiiONEER Platform is our in vivo knock in models which are the foundation for the development of our novel VISTA and CD27 antibody programs."

Presentation Details:
Title: Use of Human Knock-in Models for Selecting New Generation of Immune Checkpoint Inhibitors
Date: January 26, 7:30AM Pacific Time
Presenter: Thierry Guillaudeux, PhD

On January 24, 2022 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, reported that the Company has completed enrollment of the Phase 1/2a study of its innovative intratumoral cancer vaccine candidate, AGI-134, designed to evaluate the safety and biological activity of AGI-134 in patients with unresectable metastatic solid tumors (Press release, BioLineRx, JAN 24, 2022, View Source [SID1234606705]). Results of AGI-134’s safety and proof of mechanism are anticipated in the first half of 2022.

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"The completion of enrollment of the AGI-134 first-in-man study is a very significant milestone for our Company, especially taking into account the difficulties caused by the COVID-19 pandemic on patient recruitment," stated Philip Serlin, Chief Executive Officer of BioLineRx. "AGI-134, our second clinical-stage oncology asset, has a unique mode of action, applicable to all injectable tumor types. In preclinical models, AGI-134 led to regression of primary tumors, prevented growth of secondary tumors via an abscopal effect, and triggered a vaccine effect that we believe may prevent the development of metastases. This clinical study aims to confirm the proposed mechanism of action and safety profile of AGI-134 in humans, based on which we also plan to explore potential combinations as part of its future clinical development program."

The Phase 1/2a study is a multicenter, open-label study, which recruited a total of 38 patients in the UK, Spain and Israel, and is comprised of two parts. Part 1 was completed, and was an accelerated dose-escalation study in five patients, to determine the maximum tolerated dose and the recommended dose for part 2 of the study. Part 2 is a dose expansion study at the recommended dose in 33 patients, designed to evaluate the safety and tolerability of AGI-134, and to validate AGI-134’s mechanism of action using a wide array of biomarkers. For more information on this Phase 1/2a study, see NCT03593226.

On December 15, BioLineRx announced the formation of an Immuno-Oncology Scientific Advisory Board (SAB) to provide insight and guidance on the Company’s immuno-oncology activities. The SAB, which has provided valuable guidance to the AGI-134 development program, is comprised of recognized key opinion leaders in the fields of cancer immunology, intra-tumoral cancer treatments and clinical development.

About AGI-134
AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intra-tumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.

AGI-134 has been evaluated in numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumors and suppression of secondary tumor (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

On January 24, 2022 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development reported that the U.S. Food and Drug Administration (FDA) has granted both Rare Pediatric Disease Designation and Orphan Drug Designation for the company’s drug candidate LP-184 for the treatment of pediatric patients with ATRT (Press release, Lantern Pharma, JAN 24, 2022, View Source [SID1234606724]). LP-184 is being pursued as a potential new therapy across a range of genetically defined solid tumors, including pancreatic cancer, GBM (Glioblastoma Multiforme) and ATRT (Atypical Teratoid Rhabdoid Tumor).

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"Historical approaches to treating pediatric ATRT such as surgery, radiation, and chemotherapy have had largely unfavorable long term outcomes for children, and new options are urgently needed," said Kishor Bhatia, Ph.D., chief scientific officer of Lantern Pharma. "The gene SMARCB1 was included among several genes whose expression negatively correlated with LP-184 sensitivity in tumors. This in silico correlation was convincingly confirmed by in vitro and in vivo assessments of LP-184 in ATRT. The highest potency of LP-184 in-vivo has been seen in ATRT xenografts." Dr. Bhatia continued, "Based on both the in-silico and in-vivo observations, LP-184 has the potential to become a critical part of the armamentarium of approved treatment options specifically for these patients. Receiving Rare Pediatric Disease Designation from the FDA underscores the critical value of our growing focus on pediatric oncology indications at Lantern and represents another significant milestone for the LP-184 program."

The National Cancer Institute (NCI) classifies ATRT as Grade IV tumors, meaning they are malignant (cancerous), aggressive and fast-growing. ATRTs are very aggressive childhood malignancies of the central nervous system. The underlying genetic cause are inactivating bi-allelic mutations in SMARCB1 (also called INI1) or in SMARCA4. Nearly 90 percent of pediatric ATRTs are caused by changes in the gene known as SMARCB1.

The FDA grants rare pediatric disease designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the United States. The Rare Pediatric Disease Priority Review Voucher Program is intended to address the challenges that drug companies face when developing treatments for these unique patient populations. Under this program, companies are eligible to receive a priority review voucher following approval of a product with rare pediatric disease designation if the marketing application submitted for the product satisfies certain conditions, including approval prior to September 30, 2026 unless changed by legislation. If issued, a sponsor may redeem a priority review voucher for priority review of a subsequent marketing application for a different product candidate, or the priority review voucher could be sold or transferred to another sponsor.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to investigational treatments that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States. The program was developed to encourage the development of medicines for rare diseases, and benefits include tax credits and application fee waivers designed to offset some development costs, as well as eligibility for market exclusivity for seven years post approval.

LP-184 is being developed for multiple targeted oncology indications. Lantern Pharma intends to further advance LP-184 as a new, potent treatment option in genetically defined subsets of patient populations in areas of high unmet clinical need, including pancreatic cancers, GBM, and other cancers that are DNA damage repair deficient. The U.S. Food and Drug Administration (FDA) has previously granted LP-184 Orphan Drug Designation for the treatment of pancreatic cancer, and for the treatment of malignant glioma, including GBM.

On January 24, 2022 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported the publication of preclinical data evaluating the company’s lead asset NT-I7 (efineptakin alfa), a novel T cell amplifier, in mouse models of glioblastoma (GBM) (Press release, NeoImmuneTech, JAN 24, 2022, View Source [SID1234606742]). The data come from a publication titled "Long-acting recombinant human interleukin-7, NT-I7, increases cytotoxic CD8 T cells and enhances survival in mouse glioma models," in the Clinical Cancer Research journal. The paper was published in collaboration with lead author Dr. Jian Li Campian, M.D., Ph.D., of the Mayo Clinic and Principal Investigator of this study, along with additional authors from NeoImmuneTech. These data show that NT-I7, in combination with radiation therapy, significantly prolonged survival in two glioma models dependent on the NT-I7-driven increase of CD8 T cells.

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This study utilized a murine model of glioblastoma, in which one dose of NT-I7 significantly boosted lymphocyte levels in the blood, lymphoid organs and tumor and enhanced the anti-tumor response in animal. When NT-I7 was combined with radiation therapy, this translated to a significant improvement in mouse survival; the addition of temozolomide (TMZ) offered no additional survival improvement.

"The standard of care for glioblastoma patients is radiation and TMZ, a treatment regimen which causes severe prolonged lymphopenia that is associated with lower patient survival," said Dr. Campian. "NT-I7 demonstrated the ability to correct this treatment-related lymphopenia in our study, and this potential is extremely promising in the pursuit to improve outcomes for patients with glioblastoma."

In addition, data showed that NT-I7 promoted an inflamed tumor microenvironment by significantly increasing the CD8 to Treg ratio, and enhanced the anti-tumor response by increasing the infiltration of IFNγ-expressing T cells in the tumor. While chemoradiation caused a notable decrease in the number of CD4 and CD8 T cells in the lymph nodes, the addition of NT-I7 not only restored these numbers but in some cases surpassed the levels seen in untreated controls.

NT-I7 is currently under evaluation for the treatment of glioblastoma in an ongoing Phase 1/2 trial (NCT03687957).

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On January 23, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported the presentation of interim clinical data from its Phase 1b combination therapy study of SBP-101, a proprietary polyamine analogue, with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Meeting that took place January 20-22, 2022 (Press release, Panbela Therapeutics, JAN 23, 2022, View Source [SID1234606716]).

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Jennifer K. Simpson, PhD, MSN, CRNP President & Chief Executive Officer of Panbela Therapeutics, commented, "We are excited to share interim data from cohort 4 and the expansion. A median overall survival (OS) of 12.0 months which is not yet final, and an objective response rate (ORR) of 48%, both exceeded historical rates reported for gemcitabine + nab paclitaxel and supports the continued development of SBP-101 as an addition to first-line treatment for advanced PDA and as neo-adjuvant treatment for patients with potentially resectable disease."

"The conclusion of the abstract is that SBP-101 may enhance first-line treatment with gemcitabine and nab-paclitaxel patients with metastatic PDA. We are encouraged by this conclusion even under sub-optimal conditions, including dose interruptions, which confounded results. Cohorts 2 and 3 did not have the dose interruptions that cohort 4 had, and cohort 2 had an objective response rate of 71%," continued Dr. Simpson. "We intend to continue development of SBP-101 and look forward to executing our global randomized phase 2 study in metastatic PDA."

At the Phase 1b dose and schedule (N=30), CA19-9 levels decreased 60-99% in 70% of evaluable patients, with 1/29 (3%) achieving a complete remission, 13/29 evaluable patients achieving partial responses (45%) and 10/29 achieving stable disease at 8 weeks (34%). PFS was 6.0 months. While PFS may be confounded by SBP-101 dosing holds implemented to investigate potential toxicity, the rates for 6-month PFS was 52% and for 12 month PFS was 10%. Nine subjects are in survival follow up as of the date the poster was presented at the ASCO (Free ASCO Whitepaper) GI meeting. Median OS is 12.0 months and is not final.

The safety population includes all subjects who received at least one dose of SBP-101 (N=50). The most common Grade ≥3 adverse events (AEs) related to any study medication were neutropenia in 20 subjects (19 attributed to G+A and 1 attributed to all 3) and elevated liver function tests in 14 subjects (5 attributed to SBP-101 and 9 attributed to all 3). SBP-101-related increases in LFTs were asymptomatic in all but 2 subjects and reversed in all subjects when SBP-101 administration was interrupted and dose-reduced or discontinued. Additionally, seven subjects experienced serious vision adverse events (4 possibly related to SBP-101, 1 related to gemcitabine and 2 related to all 3 based on PI assessment). All were considered by the sponsor to be possibly related to SBP-101; 5 had findings consistent with retinopathy.

The company has just begun a randomized trial to study SBP-101, as an addition to first-line treatment for metastatic PDA, will begin a neoadjuvant pancreatic trial this quarter and will begin an Ovarian Cancer program mid-year.

Additional meeting information can be found on the ASCO (Free ASCO Whitepaper) website at View Source . After presenting at ASCO (Free ASCO Whitepaper) GI, the poster will be available on the company’s website on January 24, 2022.

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown potential signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen, if SPB-101 receives approval in the US. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events observed in the Company’s recently completed Phase 1a/1b clinical trial have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .