On July 17, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T cell activating technologies, reported that an abstract reporting on interim data from a first-in-human clinical trial evaluating the combination of PDS0301, an IL-12-based immunocytokine, with the chemotherapy medication docetaxel has been accepted for oral presentation at the 11th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2023) (Press release, PDS Biotechnology, JUL 17, 2023, View Source [SID1234633266]).

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The abstract, titled, "Combining an IL-12-based Immunocytokine (PDS0301) with Docetaxel in Metastatic Prostate Cancer: Preliminary Safety and Immune Data", will report interim safety and immune data on 18 patients in the clinical trial being led by the National Cancer Institute (NCI), part of the National Institutes of Health. The trial is investigating the safety, immune responses and clinical activity of PDS0301 and docetaxel in metastatic castration-sensitive and castration-resistant prostate cancer patients. The study is designed to evaluate three dose levels of PDS0301 (8 mcg/kg, 12 mcg/kg, and 16.8 mcg/kg) in combination with docetaxel (75 mg/m2) administered every three weeks.

"We look forward to Dr. Ravi Madan’s presentation of the interim safety, clinical outcomes and immune correlates for PDS0301 administered in combination with standard of care docetaxel in patients with advanced prostate cancer," stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "This clinical trial provides an important opportunity to investigate the potential of PDS0301 combined with docetaxel chemotherapy to offer improved treatment options for patients with metastatic castration-sensitive and castration-resistant forms of prostate cancer. The results of this study could provide insight into the potential use of PDS0301 with chemotherapy across multiple solid tumors."

Abstract Title: Combining an IL-12-based Immunocytokine (PDS0301) with Docetaxel in Metastatic Prostate Cancer: Preliminary Safety and Immune Data
Paper Number: 249
Presenting Author: Head, Prostate Cancer Clinical Research Section, Ravi A. Madan
Authors: Renee Donahue, Yo-Ting Tsai, Mohammad O. Atiq, Elias Chandran, Luke Meininger, Fatima Karzai, Marijo Bilusic, Jennifer Marte, Philip M. Arlen, Lisa Cordes, Megan Hausler, Amy Hankin, Nikki Williams, William D. Figg, Jeff Schlom, James L. Gulley, Ravi A. Madan
Session Details: Plenary 3: Cytokines in Cancer Immunity and Immunotherapy, Mittwoch; Olympia A+B
Session Date and Time: October 18, 2023, 10:00-10:15

For patients interested in enrolling in this clinical trial, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web site: View Source and/or [email protected].

About PDS0301
PDS0301 is a novel investigational tumor-targeting antibody-conjugated Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells and natural killer (NK) cells in the tumor microenvironment. PDS0301 is given by subcutaneous injection and is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.

On July 17, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to the development program of selinexor for the treatment of patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis (Press release, Karyopharm, JUL 17, 2023, View Source [SID1234633264]).

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"Fast Track Designation for selinexor highlights its potential to address the unmet medical need in myelofibrosis, an important acknowledgement as we continue our pivotal Phase 3 study," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "Selinexor’s unique mechanism of action, XPO1 inhibition, is a novel and potentially fundamental mechanism in myelofibrosis. We have been highly encouraged by the efficacy and safety data observed to date [in our Phase 1 study] with selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis and believe selinexor has the potential to shift the treatment paradigm. We look forward to continued interaction with the FDA as we advance the development of this promising treatment for patients in need."

In June 2023, Karyopharm initiated a pivotal Phase 3 clinical trial (XPORT-MF-034) (NCT04562389) to assess the efficacy and safety of once-weekly selinexor 60 mg in combination with ruxolitinib in JAKi-naïve patients with myelofibrosis. Updated data from the Phase 1 study were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 and European Hematology Association (EHA) (Free EHA Whitepaper) 2023, which showed rapid, deep and sustained spleen responses and robust symptom improvement in patients treated with selinexor 60 mg in combination with ruxolitinib as of the April 10, 2023 cut-off date. Top-line data from the Phase 3 study is expected in 2025. The Company plans to expand its clinical development program in myelofibrosis by investigating selinexor in other JAKi-naïve settings, such as novel combinations, to benefit the greatest number of patients.

Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Features of Fast Track Designation include frequent interactions with the FDA review team, and if relevant criteria are met, eligibility for Priority Review and Rolling Review.

Further information about the Phase 3 study can be found at www.clinicaltrials.gov.

On July 17, 2023 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported interim Phase 1 clinical data for PSMA-TRACTr JANX007 in adult subjects with metastatic castration-resistant prostate cancer (mCRPC) and provided a pipeline update (Press release, Janux Therapeutics, JUL 17, 2023, View Source [SID1234633263]). Janux will host a virtual investor event today at 4:00 PM ET. To register for the event, please click here.

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"These data showing tumor-activated T cell engagement in patients with prostate cancer represent the first in-human data for the TRACTr platform and give us confidence for continuing clinical development of JANX007 and advancing future programs from this platform. We are encouraged by these positive interim clinical data for JANX007, which displayed PSA reductions coupled with low-grade and transient CRS, which we believe to be consistent with the TRACTr mechanism of action" said David Campbell, Ph.D. "The concept of tumor-specific activation as a new therapeutic strategy for T cell engagers in solid tumors has taken an important step forward, and the JANX007 program has hit an important milestone in its clinical development."

Interim Clinical Data for PSMA-TRACTr JANX007 in mCRPC as of June 28, 2023

The data from eight patients from the first three cohorts of the dose escalation portion of the Phase 1a clinical trial, as of June 28, 2023 show that JANX007 has been generally well tolerated, with no dose-limiting toxicities. JANX007 has been dosed at 300µg flat dose, which is above the projected maximum tolerable dose of the parental T cell engagers. JANX007 showed clinical activity at both 100µg and 300µg flat doses and yielded best overall PSA reductions between 31% and 67% in four of the five patients who received a flat dose. Grade 1 or 2 cytokine release syndrome (CRS) was observed only in patients who demonstrated PSA reductions, suggesting cytokine release resulting from anti-tumor activity was associated with CRS. No Grade 3 CRS has been observed. The most common, non-CRS related adverse event observations have been generally consistent with tumor-specific activity and reduced PSMA(+) healthy tissue activity. No transaminitis was observed. JANX007 clinical development has moved into step-dosing and dose optimization with the goal to enhance efficacy while maintaining suitable safety results.

The TRACTr technology is designed to create potent T cell engagers (TCEs) by tumor-specific activation via mask cleavage by tumor proteases. Plasma levels in patients exhibited prolonged TRACTr exposure, clear evidence of activation as measured by a specific cleavage fragment, and lack of accumulation of the active TCE in the blood. The lack of TCE accumulation shows consistency with TRACTr design principles and suggest that observed PSA reductions have been a result of tumor activation and not systemic TCE exposure.

On July 17, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering CAR-T cell therapies and tissue specific therapeutics targeting oncology and immuno-dysregulated diseases, reported its 2nd positive IMX-110 interim update from the Company’s ongoing Phase 1b/2a IMMINENT-01 (NCT05840835) study of IMX-110 in combination with BeiGene’s anti-PD-1 antibody tislelizumab (Press release, Immix Biopharma, JUL 17, 2023, View Source [SID1234633262]). As of the July 7, 2023 data cutoff date, out of 4 relapsed/refractory metastatic colorectal cancer patients treated with IMX-110 + tislelizumab:

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3 out of 4 (75%) patients experienced tumor shrinkage at 2 months
1 out of 4 (25%) patients experienced tumor control at 2 months
1 out of 4 patients remain on IMX-110 + tislelizumab therapy as of July 7, 2023
Median progression-free survival and overall survival not yet reached
Patients received a median of 8 earlier anti-cancer treatments that failed to halt cancer growth (lines of therapy) prior to receiving IMX-110 + tislelizumab and all 4 had proficient mismatch repair (pMMR) relapsed/refractory mCRC
IMMINENT-01 continues to enroll the next cohort of patients at a higher dose
"We are encouraged that in these early cohorts of patients receiving just a fraction of what we believe will be the optimal dose, we continue to see signals of activity of IMX-110 in relapsed/refractory metastatic colorectal cancer patients that received a median of 8 lines of anti-cancer therapies that failed to halt cancer growth prior to receiving IMX-110 + tislelizumab," said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma. "In the subsequent higher dose cohorts of IMMINENT-01, we are hopeful that clinical results will further improve. The optimal dose identified in IMMINENT-01 will be utilized in our upcoming Phase 2 IMMINENT-02 clinical trial."

Dosing of the second cohort of three relapsed/refractory cancer patients is complete, as of July 7, 2023, for the ongoing Phase 1b portion of the IMMINENT-01 Phase 1b/2a clinical trial investigating IMX-110 in combination with BeiGene anti-PD-1 antibody tislelizumab in relapsed/refractory solid tumors, including relapsed/refractory colorectal cancer. No dose limiting toxicities have been observed in the first 2 cohorts; the trial is now enrolling the next cohort of three patients at a higher dose of IMX-110 in combination with anti-PD-1 antibody tislelizumab. The efficacy evaluable population in IMMINENT-01 includes patients who have completed at least 1 follow-up RECIST assessment. Tumor growth is assessed every 2 months. To put this clinical trial update in perspective, multi-kinase inhibitor regorafenib (marketed as STIVARGA by Bayer) combined with best supportive care in relapsed/refractory metastatic colorectal cancer patients with median 3 prior lines of therapy produced progression free survival of 2 months and a 1% response rate according to the FDA approval label. This study was not a head-to-head evaluation with IMX-110 and differences exist between trial designs, subject characteristics, and caution should be exercised when evaluating clinical data across studies.

About IMMINENT-01
IMMINENT-01 (NCT05840835) is an ongoing phase 1b/2a clinical trial combining tissue specific therapeutic IMX-110 with BeiGene anti-PD-1 antibody tislelizumab, in patients with relapsed/refractory solid tumors. The novel approach combining TSTx IMX-110 with anti-PD-1 antibody tislelizumab is designed to expand the population of cancer patients experiencing extended remissions from immunotherapies by converting immunologically "cold" tumors "hot".

In Phase 1b of IMMINENT-01, cohorts of 3 patients will receive escalating doses of IMX-110 until the maximum tolerated dose is reached and the recommended phase 2 dose is determined.

Phase 2a will then begin, treating patients in certain solid tumor indications selected based on Phase 1b clinical data collected in a variety of tumor types. 30 patients are expected to be enrolled in IMMINENT-01.

The primary endpoints of IMMINENT-01 are to identify the maximum tolerated dose and recommended Phase 2 dose of IMX-110 + anti-PD-1 antibody tislelizumab, and to evaluate safety. The secondary endpoints of IMMINENT-01 are to evaluate preliminary efficacy and the pharmacokinetics and preliminary efficacy of IMX-110 + anti-PD-1 antibody tislelizumab.

As of the data cutoff of July 7, 2023, the 2nd cohort dosing at the lowest dose of IMX-110 + anti-PD-1 antibody tislelizumab has reached full enrollment.

Immix Biopharma is currently enrolling the 3rd, next higher dose cohort of IMX-110 + anti-PD-1 antibody tislelizumab in advanced solid tumors.

About Colorectal Cancer

According to NIH SEER, there were an estimated 1,388,422 people living with colorectal cancer in the United States as of 2020 and there were roughly 153,020 new cases of colorectal cancer in the United States in 2022. Globally, there are roughly 1,930,000 new cases of colorectal cancer each year, of which 519,500 are in Europe, 148,500 are in Japan, 20,500 are in Australia and New Zealand, and 555,000 are in China. The five-year survival rate in the United States for relapsed/refractory advanced metastatic CRC is 15.6% according to NIH SEER. The colorectal cancer market is estimated to reach approximately $31.2 billion by 2025 from the estimated $26.3 billion in 2019 according to IndustryARC.

On July 17, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted four employees nonqualified stock options to purchase an aggregate of 30,700 shares of its common stock with an exercise price of $2.02, which is equal to the closing price of Gritstone’s common stock on July 10, 2023, the date of the grant (Press release, Gritstone Bio, JUL 17, 2023, View Source [SID1234633261]). These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.