On September 19, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the upcoming Cantor Global Healthcare Conference 2023 being held in New York (Press release, Kura Oncology, SEP 19, 2023, View Source [SID1234635245]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a fireside chat at 10:55 a.m. ET / 7:55 a.m. PT on September 26, 2023.

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A live audio webcast of the fireside chat will be available in the investor section of Kura’s website at www.kuraoncology.com with an archived replay available following the live event.

On September 19, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported significant updates to its foundational IP portfolio (Press release, In8bio, SEP 19, 2023, View Source [SID1234635244]). The company was recently granted patents around the world that cover use of the combination of its proprietary DeltEx DRI platform with CAR-T and CPI’s.

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IN8bio’s DRI platform uses genetic engineering to empower gamma-delta T cells with resistance to the killing effects of chemotherapy enabling them to be more effective at killing cancer cells. This innovative approach allows synergistic combinations with standard-of-care chemotherapy regimens to strengthen the immune response and broadly eliminate cancer cells. The technology covered by the newly granted patents enhance the therapeutic potential of DRI cells by enabling their integration with CAR-T technology and CPIs, thereby bolstering the potential effectiveness of the drug therapy against solid tumor cancers.

William Ho, CEO and co-founder of IN8bio, stated, "Establishing a robust IP foundation is pivotal to the successful growth and expansion of our business. Our proprietary DRI technology, which generates chemotherapy-resistant cells, allows for the synergistic combination with front-line chemotherapies to break down barriers preventing a robust immune response. Our technology, supported by these newly granted patents opens avenues for expanding the application of these cells in conjunction with CAR-T technologies and checkpoint inhibitors to advance the fight against cancer. By harnessing these cells, we can bring cell therapy to the forefront of treatment options and offer new hope towards realizing our mission of achieving ‘Cancer Zero,’ our goal of pursuing the safe eradication of all tumor cells in patients fighting cancer."

IN8bio’s DRI platform has enabled a deep pipeline of product candidates. The Company has initiated a Phase 2 clinical trial (NCT05664243) of a genetically modified autologous gamma-delta T cell therapy, INB-400, targeting newly diagnosed glioblastoma (GBM). The trial, cleared by the Food and Drug Administration (FDA) in December 2022, will be conducted at multiple centers across the United States and is open for enrollment. IN8bio is also conducting Phase 1 clinical trials of INB-200 for the treatment of newly diagnosed GBM and INB-100 for the treatment of patients with leukemias undergoing haploidentical stem cell transplantation (HSCT). Clinical updates in both programs are expected to be presented at major medical meetings this fall.

IN8bio boasts a strong IP portfolio of granted patents encompassing the DRI, CAR-T and HSCT families, with multiple additional applications pending globally to further expand its patent portfolio and IP position.

On September 19, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH"), fibrotic diseases, hepatocellular carcinoma ("HCC"), and other chronic diseases, reported new research findings uncovering a previously unknown mechanism by which Hepion’s lead drug candidate, rencofilstat, may exert anti-cancer activity (Press release, Hepion Pharmaceuticals, SEP 19, 2023, View Source [SID1234635243]).

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The research involved a technique called ATAC-Seq ("assay for transposase-accessible chromatin with sequencing") that determines what specific DNA sequences are in open or closed states. Gene expression occurs from DNA sites that are in an open state, whereas genes within closed regions are silent. Hepion’s ATAC-Seq experiments on two liver cancer cell lines revealed that rencofilstat significantly changed the open-closed state of DNA. Approximately 4,500 sites were altered within one hour of treatment in both cell lines, which was slightly more than a chemotherapeutic compound, azacytidine, known to alter DNA structure. The predominant effect of rencofilstat – opening or closing – depended on the cell line. Rencofilstat predominantly closed DNA in the cell line in which it also suppressed cell growth, suggesting that the drug candidate’s anti-cancer effect on the cells resulted in part from DNA closure and gene silencing.

Another interesting finding was the types of genes that became accessible/inaccessible due to rencofilstat treatment. DNA sites that were opened by rencofilstat were enriched for several well-known tumor suppressor genes such as CDKN1A (p21), PTEN, HINT1, KLF6 and SOCS1; whereas a tumor-promoting oncogene, NOTCH1, was predicted to be silenced by rencofilstat. Accessibility also changed for many genes related to apoptosis, consistent with increasing cancer cell death. Thus, changes in gene accessibility produced by rencofilstat favored an anti-cancer mode of action. Follow-up experiments are planned to further understand the impact on cancer cell growth.

"Anti-tumor effects of rencofilstat and other cyclophilin inhibitors observed in many preclinical studies have been attributed to several mechanisms, but changes in DNA accessibility and especially those that potentially limit oncogenesis have never before been reported for this class of drug," explained Dr. Daren Ure, Hepion’s Chief Scientific Officer. "Knowing now that rencofilstat can modify DNA chromatin structure and regulate what genes are turned on and off gives us new appreciation for the scope of rencofilstat’s actions."

"Rencofilstat previously received Orphan Drug designation for the treatment of NASH. Hepion has also received FDA clearance to begin a Phase 2 clinical trial of rencofilstat in HCC, which remains the most common type of liver cancer, accounting for up to 90% of all primary liver cancers. We believe rencofilstat may be well-positioned to offer a unique approach to treating both NASH and HCC, as these diseases are often intertwined," commented Hepion’s CEO, Robert Foster. "These newest findings reported today strengthen our resolve to initiate Phase 2 HCC trials pending adequate financial resources. More broadly, rencofilstat’s cumulative properties – liver-targeting, antifibrotic, anti-cancer, antiviral – reinforce Hepion’s focus on two of the most serious liver diseases of the day, NASH and HCC."

On September 19, 2023 Heidelberg Pharma AG (FSE: HPHA) reported that the clinical Phase I/IIa study with the lead development candidate HDP-101 has already started to recruit patients for the fifth patient cohort with a dosing of 100 µg/kg (Press release, Heidelberg Pharma, SEP 19, 2023, View Source [SID1234635242]). The Safety Review Committee’s (SRC) evaluation of patient data concluded that no dose-limiting toxicities have occurred to date. The first four dose levels have shown to be safe and well tolerated. So far 12 patients have been treated in the trial.

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With the expansion of study sites this summer, patient enrollment has significantly accelerated. One patient from the third cohort has now been on HDP-101 monotherapy for over nine months and has been treated with eleven doses.

Dr. András Strassz, Chief Medical Officer of Heidelberg Pharma, commented: "We are delighted that our first Amanitin-based antibody drug conjugate HDP-101 is well tolerated and does not show any dose-limiting toxicities to date. The dose escalation will continue as planned with the fifth cohort."

The BCMA antibody Amanitin conjugate HDP-101 is being tested in an open-label, multicenter study for the treatment of relapsed or refractory multiple myeloma, a cancer of the bone marrow.

About the Phase I/IIa study with HDP-101

The first part of the study is a Phase I dose escalation study to determine the maximum tolerated dose of HDP-101. These findings will be used to determine the dose for the Phase IIa part, the primary objective of which is to initially evaluate the anti-tumor activity of HDP-101.

The open-label, multicenter Phase I/IIa trial is expected to enroll up to 36 patients in the first part and up to 30 patients in the second part. Patients in Phase IIa will be stratified based on 17p deletion status. Preclinical data show that Amanitin has the potential to work particularly well on those tumors that have been genetically altered by a so-called 17p deletion to bypass a particular protective mechanism of cells. Patients with such a deletion generally respond less well to standard therapies and have a significantly poorer prognosis. Phase IIa will not only validate the efficacy of HDP-101 in patients with multiple myeloma, but also the clinical relevance of the 17p deletion.

On September 19, 2023 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that pilot phase data from an investigator-initiated, open-label, multicenter Phase 2 clinical trial with motixafortide in first-line pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts, September 27-30, 2023 (Press release, BioLineRx, SEP 19, 2023, View Source [SID1234635241]). The Phase 2 clinical trial is designed to evaluate the company’s CXCR4 inhibitor motixafortide in combination with PD-1 inhibitor cemiplimab and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).

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Sponsored by Columbia University, the single-arm pilot phase of the Phase 2 trial focused on the safety of the drug combination. Additionally, based on the original protocol, if ≥3 of the planned 10 patients within the pilot phase experienced a partial response (PR) by RECIST criteria within 16 weeks, the combination would be considered promising and an expansion cohort of an additional 30 patients would be initiated for enrollment. Earlier this year, following a review of the pilot phase data, the trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).

Presentation at AACR (Free AACR Whitepaper) Special Conference in Cancer Research: Pancreatic Cancer

Westin Copley Place, Boston Massachusetts

Plenary Session Details

Title: CheMo4METPANC: Combination Chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) Motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in METastatic treatment-naïve PANCreatic adenocarcinoma

Presenter: Gulam A. Manji, MD, PhD, Columbia University Irving Medical Center/New York Presbyterian, New York, N.Y.

Session: Plenary Session 3: Clinical Updates

Date: Thursday, September 28, 2023

Time: 2:30-4:40 pm EDT

About Pancreatic Cancer

Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2023, an estimated 64,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths. Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of people who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.[i] These data highlight the need for the development of new therapeutic options.

About Motixafortide in Cancer Immunotherapy

Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.