On January 5, 2023 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule cancer therapeutics, reported interim data from its ongoing Phase 1b/2 clinical trial of abequolixron in patients with non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) (Press release, Inspirna, JAN 5, 2023, View Source [SID1234625943]).

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Abequolixron (RGX-104) is a first-in-class, small molecule liver X receptor (LXR) agonist designed to target APOE dysregulation and enhance anti-tumor immunity by inhibiting tumor angiogenesis, depleting myeloid derived suppressor cells (MDSC), and activating cytotoxic T lymphocytes (CTL). Abequolixron is currently being evaluated in a Phase 1b/2 clinical trial in combination with docetaxel in second- or third-line (2/3L) NSCLC as well as second-line (2L) SCLC. The primary objectives of the study include characterizing the safety profile and the antitumor activity of the abequolixron and docetaxel combination.

"The data thus far demonstrate that abequolixron is well tolerated in combination with full dose docetaxel, while showing encouraging clinical activity suggesting that this drug candidate could be a valuable addition to a current standard of care chemotherapy in heavily-pretreated patients with lung cancer," said Hossein Borghaei, D.O., M.S., Chief of the Division of Thoracic Medical Oncology at Fox Chase Cancer Center and Principal Investigator on the study. "I am very encouraged by the overall response rate, disease control rate, and time to progression so far seen in the study and I look forward to further evaluation of this unique compound as the clinical trial progresses."

"These data, while early, clearly show the potential that abequolixron may have in driving deep responses in patients with heavily-pretreated lung cancer," said Masoud Tavazoie, M.D., Ph.D., Chief Executive Officer of Inspirna. "We are excited to begin the new year by announcing these promising data for abequolixron and look forward to sharing more updates as we continue advancing our novel pipeline in difficult-to-treat cancers."

Key findings from the data

As of December 2, 2022, 17 patients were treated at the Recommended Phase 2 Dose (RP2D) as determined in the dose escalation stage, with 120mg abequolixron twice daily (BID), 5 days on/2 days off, plus docetaxel. Thirteen patients were evaluable for response per RECIST v1.1, including five patients with 2/3L NSCLC and eight patients with 2L SCLC.
The ORR across all evaluable patients was 38% (n=13), with a disease control rate (DCR) of 77%, including five patients who achieved partial response (PR).
In the 2/3L NSCLC cohort, of five evaluable patients, four patients achieved PRs with two patients achieving confirmed partial responses. Four of the five patients were on study treatment for > 19 weeks, including one patient for 25 weeks, one patient for 28 weeks and one ongoing patient at 37 weeks.
In the 2L SCLC cohort, of eight evaluable patients, one patient achieved a PR and five patients had a best overall response (BoR) of stable disease (SD). Four patients (50%) were on study drug progression free for > 24 weeks. One of the patients with a BoR of SD, although experiencing CNS progression at week 12, stayed on therapy for clinical benefit for 30 weeks without experiencing systemic PD.
Across the two cohorts (N=17), the most common TEAEs were fatigue in 12 patients, diarrhea and nausea in 9 patients, decreased appetite in 8 patients and neutropenia and weight loss in 7 patients. Of the most common TEAEs, Grade 4 events were neutropenia (2 patients) and Grade 3 events were fatigue (2 patients), diarrhea (1 patient), nausea (1 patient), decreased appetite (1 patient) and the others were Grade < 2.
The expansion stage of the study is ongoing and continues to enroll patients with 2/3L NSCLC. In addition, this Phase 1b/2 study includes an ongoing expansion arm of abequolixron in combination with Yervoy (ipilimumab) in second- or third-line endometrial cancer as part of a clinical collaboration with Bristol Myers Squibb.

About Abequolixron (RGX-104)

Abequolixron is an orally administered small molecule agonist of the Liver X Receptor (LXR) which activates expression of the APOE tumor suppressor protein. APOE expression becomes dysregulated (silenced) in the tumors of select patients with solid cancers. APOE dysregulation results in increased tumor angiogenesis (tumor blood vessel growth) as well as a shifting of the tumor myeloid cell population from immune-stimulatory to immune-suppressive, which are both counteracted by abequolixron. Abequolixron is currently being tested in a Phase 1b/2 clinical trial in combination with standard-of-care regimens in several lung cancer indications that are enriched for APOE dysregulation, including SCLC and NSCLC.

On January 5, 2023 Arsenal Biosciences, Inc. (ArsenalBio), a privately held, clinical stage, programmable cell therapy company engineering advanced CAR T cell therapies for solid tumors, repored that the first patient has been dosed with AB-1015 in a Phase 1, first-in-human clinical trial for patients with ovarian cancer that is resistant to platinum-based regimens (Press release, Arsenal Bio, JAN 5, 2023, View Source [SID1234625942]). AB-1015 is ArsenalBio’s first internally discovered T cell medicine to enter clinical development and uses synthetic DNA programming to overcome tumor defenses, increase potency, and target ovarian cancer cells without harming normal tissues.

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"The initiation of this first-in-platform trial marks the beginning of a new chapter in the story of cell therapy and will enable ArsenalBio to validate our Integrated Circuit T (ICT) cell technology in humans," said Ken Drazan, M.D., ArsenalBio’s co-founder and Chief Executive Officer. "To date, first generation T cell-based technologies have failed to drive deep and durable responses in solid tumors, leaving a large unmet need for effective immunotherapies across many types of solid tumor cancers. We hope this study succeeds in identifying a safe and therapeutic dose to further study in larger patient cohorts; thereby demonstrating the utility of our technology platform and the benefit of our pipeline of potential medicines."

Dr. Drazan will provide a business overview and update inclusive of information about the clinical trial during the company’s upcoming presentation on January 10th at the 41st Annual J.P. Morgan Healthcare Conference.

On January 5, 2023 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors, reported that on January 3, 2023 the United States Patent and Trademark Office issued US patent number 11,541,211 broadly covering methods for treating cholangiocarcinoma (bile duct cancer) by selectively delivering one or more therapeutic agents into targeted regions of the bile duct (Press release, Renovorx, JAN 5, 2023, View Source [SID1234625941]). This is RenovoRx’s eighth US patent.

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Our newest patent builds upon our strong IP portfolio, which now consists of eight US method and device patents, one EU delivery system patent, and eight additional pending patents in the US, EU, and Asia," said Shaun Bagai, CEO of RenovoRx. "Additionally, this additional patent bolsters the seven years of post-approval market exclusivity that we currently have with our lead oncology product candidate, RenovoGem, through the Orphan Drug designation granted by the FDA for our first two indications."

On January 5, 2023 Tempus, a leader in artificial intelligence and precision medicine, reported a prospective study (NCT05257551), in collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN), that aims to identify biomarkers of response in patients with small cell lung cancer (SCLC) (Press release, Tempus, JAN 5, 2023, View Source [SID1234625940]). The study, titled Sculptor, is co-sponsored by Tempus and AstraZeneca’s Personalize SCLC Initiative and is currently open for enrollment.

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"This type of early-stage, prospective study is only possible when combining Tempus’ comprehensive sequencing capabilities, multimodal database, and just-in-time clinical trial network."

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In the United States, lung cancer is the second most common cancer, and approximately 13% of people diagnosed with lung cancer have SCLC, according to the American Cancer Society. SCLC is an aggressive disease characterized by rapid growth, early metastasis, and acquired therapeutic resistance in which there is a high unmet need for therapeutic targets. To date, there are limited ways to stratify this specific patient population and limited defined therapeutic targets or associated treatments.

The Sculptor study is leveraging Tempus’ comprehensive portfolio of molecular profiling offerings to gather the insights necessary to support this kind of early research, with the goal of identifying distinct segments that may benefit from emerging therapies, or a treatable target from which to develop an associated therapy to treat patients with SCLC. This study is currently active at five TIME Trial Network sites, with plans to expand to additional providers across the country to ensure the study’s dataset is representative of the overall SCLC patient population in the United States.

"This collaborative study will facilitate the investigation of SCLC patient populations to provide us with key insights in hopes of enabling pharmaceutical solutions that increase the overall survival of this disease," said Kate Sasser, PhD, Chief Scientific Officer at Tempus. "This type of early-stage, prospective study is only possible when combining Tempus’ comprehensive sequencing capabilities, multimodal database, and just-in-time clinical trial network."

"We are excited to announce commencement of the first clinical trial stemming from our strategic collaboration with Tempus," said Cristian Massacesi, Chief Medical Officer & Oncology Chief Development Officer, AstraZeneca. "AstraZeneca’s investigation of novel therapies for SCLC sub-populations is another example of our precision medicine approach and mission to put patients first and follow the science."

On January 5, 2023 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints reported the close of an additional $25 million through a Series B extension, for a total of $131 million in Series B financing (Press release, Immune-Onc Therapeutics, JAN 5, 2023, View Source [SID1234625939]). This extension was led by existing investor Triwise Capital and with participation from new investors including Proxima Ventures, among others. In addition, the company has received continued strategic capital investments from The Leukemia & Lymphoma Society’s Therapy Acceleration Program (LLS TAP) and Wuxi Biologics HealthCare Venture.

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Proceeds from the financing will be used to accelerate development of Immune-Onc’s lead clinical candidates, IO-108 and IO-202, and advance the selection of additional novel myeloid checkpoint inhibitor programs. Immune-Onc will provide additional corporate and clinical progress updates during 1:1 investor and prospective partner meetings at the upcoming J.P. Morgan 41st Annual Healthcare Conference.

"Immune-Onc had an incredible year of growth and development with two myeloid-checkpoint inhibitor programs progressing in the clinic in the U.S. and China for multiple types of cancer where great unmet needs remain," said Charlene Liao, Ph.D., founder, chief executive officer and board chair of Immune-Onc. "We are confident in the long-term growth prospects for Immune-Onc and believe that our progress this past year provides a compelling foundation for continued success in 2023. We are on track to deliver on several key milestones for our lead clinical candidates, including obtaining proof-of-concept results in leukemia and solid tumor expansion cohorts for IO-202 and IO-108, respectively, completing dose escalation for IO-202 in solid tumors, and further characterizing clinical biomarkers and/or mechanisms of actions for our checkpoint inhibitors that may ultimately lead to new clinical programs."

2022 Clinical & Corporate Highlights:

Clinical:

Dosed the first patient in the expansion cohorts of the company’s ongoing Phase 1 study for IO-108, a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) in adult patients with advanced or refractory solid tumors
Dosed the first patient with IO-108 in a Phase 1 clinical trial in China for patients with advanced solid tumors following the Center for Drug Evaluation of the China National Medical Products Administration approving the company’s Investigational New Drug application
Dosed the first solid tumor patient in the company’s Phase 1 clinical trial of IO-202, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3)
Granted Fast Track designation by the U.S. Food and Drug Administration for IO-202 for the treatment of patients with relapsed or refractory acute myeloid leukemia

Corporate:

Entered a clinical supply agreement with Regeneron Pharmaceuticals, Inc. ("Regeneron") to evaluate IO-108 in combination with Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab), as part of its ongoing clinical development program in the U.S.
Entered into a clinical trial collaboration and supply agreement to evaluate IO-108 and IO-202 in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, as part of its clinical development programs in China
Appointed Austin L. Gurney, Ph.D., and Barbara J. Klencke, M.D., to the company’s Board of Directors and Christopher Whitmore as chief financial officer
Won the 2022 BayHelix "R&D Achievement of the Year" award
Named the top 5 woman-led life science companies in the San Francisco Bay Area
Participation at upcoming industry panel:

The Future of Checkpoint Inhibitors and Immuno-Oncology at Fierce JPM Week on Jan 10.