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.

On July 17, 2023 Evogene Ltd. ("Evogene") (Nasdaq: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science-based product discovery and development utilizing cutting-edge computational biology technologies across multiple market segments, reported that it has entered into securities purchase agreements with institutional investors (including SilverArc Capital Management, Altium Capital Management, LP and CVI Investments, Inc.) for the purchase and sale of 8,500,000 ordinary shares in a registered direct offering at a purchase price of $1.00 per ordinary share (the "offering") (Press release, Evogene, JUL 17, 2023, View Source [SID1234633260]).

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The closing of the offering is expected to occur on or about July 19, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $8,500,000 before deducting placement agent fees and other offering expenses. Evogene intends to use the net proceeds of this offering to further develop its and its subsidiaries’ product pipelines, to further enhance and expand its CPB (Computational Predictive Biology) platform and technological engines and for working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

The ordinary shares will be issued in a registered direct offering pursuant to an effective shelf registration statement on Form F-3 (File No. 333-253300) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), under the Securities Act of 1933, as amended (the "Securities Act"), and was declared effective by the SEC on March 3, 2021. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and once filed, will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 17, 2023 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. And a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for its investigational drug rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment option for unresectable hepatocellular carcinoma (uHCC) (Press release, Elevar Therapeutics, JUL 17, 2023, View Source [SID1234633259]). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 16, 2024.

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"Rivoceranib plus camrelizumab has demonstrated the potential to improve the lives of those confronted with unresectable hepatocellular carcinoma," said Saeho Chong, Elevar chief executive officer. "With the FDA’s acceptance of our new drug application, we are pleased to reach another milestone in the development of this combination therapy. We look forward to working closely with the FDA during this review process and are focused on making the combination commercially available as quickly as possible should we gain approval."

The NDA is supported by clinical data from the Phase 3 CARES 310 study (NCT03764293), in which rivoceranib plus camrelizumab demonstrated statistically significant and clinically meaningful prolonged overall survival (OS) and progression-free survival (PFS), and improved overall response rate versus sorafenib, a standard first-line treatment for uHCC.

Results from the randomized, open-label, international trial, which included 543 patients and was conducted at 95 study sites across 13 countries/regions, demonstrated median OS for camrelizumab + rivoceranib of 22.1 mos. [95% CI 19.1-27.2] vs. 15.2 mos. [13.0-18.5] for sorafenib; hazard ratio 0.62 [95% CI 0.49-0.80]; 1-sided p<0.0001. Median PFS for camrelizumab + rivoceranib was 5.6 mos. [95% CI 5.5-6.3] vs. 3.7 mos. [2.8-3.7]; HR 0.52 [95% CI 0.41-0.65]); 1-sided p<0.0001, and confirmed objective response rate for camrelizumab + rivoceranib was 25.4% (95% CI 20.3-31.0), compared to 5.9% (3.4-9.4) for sorafenib.

With efficacy results generally consistent across all subgroups, the data suggested the combination confers a benefit in a global uHCC population. Also, it demonstrated efficacy among those with hepatitis C virus-based etiology and non-viral etiology, which comprises the majority of U.S. HCC cases1.

In February 2023, the combination therapy of rivoceranib and camrelizumab was approved by the National Medical Products Administration (NMPA) as a first-line treatment for liver cancer in China.

Elevar is also developing rivoceranib as a monotherapy treatment option for adenoid cystic carcinoma (ACC), and as mono and combination therapies in other tumor cell types.

To learn more, visit ElevarTherapeutics.com.

1Ghouri YA, Mian I, Rowe JH. Review of hepatocellular carcinoma: Epidemiology, etiology, and carcinogenesis. J Carcinog. 2017 May 29;16:1. doi: 10.4103/jcar.JCar_9_16. PMID: 28694740; PMCID: PMC5490340.

About Hepatocellular Carcinoma (HCC)

HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.

About Rivoceranib

Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression.

Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China as a first-line treatment for uHCC (February 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.).

Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer) and treatment settings.

Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.