On June 7, 2024 Calyx / Invicro, a global leader in providing medical imaging solutions and development services to the clinical research community, reported a strategic partnership with BAMF Health, a world leader in molecular imaging and theranostics (Press release, Invicro, JUN 7, 2024, View Source;invicro-forges-a-strategic-collaboration-with-bamf-health-to-accelerate-clinical-translation-of-radioligand-therapies-and-immuno-oncology-agents-302167367.html [SID1234644201]). The partnership aims to accelerate the clinical translation of radioligand therapies (RLT) and immuno-oncology (IO) agents.

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This collaboration addresses challenges caused by fragmented service ecosystems, which have led to duplicative efforts, slow knowledge transfer, and prolonged development timelines. By combining Calyx / Invicro’s radiochemistry and imaging biomarker solutions with BAMF Health’s advanced radiopharmacy facility—which supports a range of alpha, beta, and gamma agents, and molecular imaging and therapy clinics—biotech and pharmaceutical companies now have an end-to-end resource for translating these advanced programs into clinical trials.

A catalyzing project for this partnership is an actinium-225 initiative, for which TerraPower is supplying actinium-225, and BAMF is leveraging its GE HealthCare StarGuide SPECT/CT and dosimetry expertise to enhance the study and application of actinium-225 in RLT.

This association represents a key moment in our industry, as contract research organizations, contract manufacturing organizations, and imaging clinics must collaborate more than ever to support these complicated and technically demanding RLT and IO programs. This collaboration and working relationship streamlines operations with easier contracting and communication, brings together knowledge across scientific, regulatory, and operational areas, and provides access to the latest technologies from early preclinical research to patient imaging.

"The success of Calyx / Invicro’s translational model in the CNS field, demonstrated at our London and New Haven clinics, shows the effectiveness of an integrated service approach. We believe our partnership with BAMF Health will bring the same level of innovation and acceleration to oncology," said Edward Hogan, COO of Calyx / Invicro.

BAMF Health’s Director of Clinical Trials, Dan Rogers, added, "Combining our strengths with Calyx / Invicro allows us to tackle the unique challenges of developing radioligand and immuno-oncology therapies. This collaboration is set to enhance and speed up the development process, towards our mission of making precision medicine available and affordable to everyone."

Through this partnership, Calyx / Invicro and BAMF Health aim to tackle key hurdles in the clinical translation of radioligand and immuno-oncology treatments. Their combined efforts highlight a commitment to advancing these therapies, redefining oncology care standards, and ensuring faster access to promising treatments for patients.

On June 7, 2024 SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, reported that clinical data from its first-in-class autologous hepatitis B virus (HBV)-specific T-cell receptor-engineered T Cell (TCR T) therapy – SCG101 – was featured in a late-breaking session during the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy (Press release, SCG Cell Therapy, JUN 7, 2024, View Source [SID1234644200]). The presentation was selected for inclusion in the Best of EASL Congress Wrap-Up summary, distilling the best, the most memorable highlights, the future trends and the most noteworthy contributions to the program at EASL.

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Results from the first-in-human clinical trial showed that SCG101 exhibited promising antiviral and antitumor dual activities in patients with advanced HBV-related hepatocellular carcinoma (HCC). In six patients with advanced HBV-HCC who received SCG101 at 5.0×107 ~ 1.0×108 TCR+ T cells/kg, the objective response rate (ORR) is 33%. All patients who achieved partial responses (PR) maintained remission for over 6 months, and one had complete remission of the target lesion and remained progression-free for 27 months.

The tumor responses were highly correlated with the antiviral activities of SCG101. As of the data cutoff, 4 out of 6 patients (67%) achieved serum HBsAg reduction of 1~4 log10 after single SCG101 infusion. The HBsAg level maintained ≤15 IU/mL throughout the follow up period for up to 27 months. Tumor reduction was observed in all patients with serum HBsAg reduction ≥1 log10, and the median progression free survival (PFS) and overall survival (OS) were prolonged (mPFS: 5.9 vs 0.7 months, mOS:19.0 vs 6.3 months) in patients with HBsAg reduction ≥1 log than in those without.

The safety analysis revealed that SCG101 was generally well tolerated with no cases of serious adverse events (SAE) or immune effector cell-associated neurotoxicity syndrome (ICANS). The most common SCG101-related adverse events were transient liver enzymes evaluation, cytokine release syndrome (CRS) and fever, which were expected due to SCG101’s mechanism of clearance of HBsAg-expressing cells.

HBV infection is a leading cause of liver cancer and accounts for 50%-80% of HCC cases worldwide.[1] HBV DNA integrates into the host genome and leads to genetic instability of the host cell and epigenetic remodelling of host DNA, resulting in abnormal expression of oncogenes and HBV antigens.[2] SCG101 can specifically target an HBV peptide presented on HBV-HCC tumor cells, HBV-DNA integrated premalignant hepatocytes, and HBV-infected cells, triggering cytolytic and non-cytolytic mechanisms to eliminate tumor cells and HBV-infected cells.

"We are excited that our late-breaking data was featured at the EASL Wrap-up session, presenting compelling dual antiviral and antitumor profile of SCG101 with sustained HBsAg reduction and prolonged progression-free survival and overall survival in patients with HBV-HCC," said Christy Ma, Chief Executive Officer of SCG Cell Therapy. "These data highlight the strength of our GianTCRTM platform to generate promising TCR-based therapeutic candidates across a broad range of therapeutic areas and, in particular, for the treatment of infectious diseases and its associated cancer. We look forward to further investigating SCG101 as well as other TCR candidates, bringing positive impact to patients with unmet needs."

About SCG101
SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product targeting a specific epitope of hepatitis B surface antigen (HBsAg). Utilizing SCG’s proprietary GianTTM technology, high affinity and high avidity natural TCRs can be identified against intracellular antigens presented through major histocompatibility complex (MHC) in solid tumours. Preclinical and clinical studies of SCG101 demonstrated tumour inhibition and HBV cccDNA eradication. SCG101 was granted clinical trial approvals by the U.S Food and Drug Administration (FDA), China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) and Hong Kong Department of Health (DOH) for patients with HBV-related HCC. A Phase 1/2 clinical trial evaluating SCG101 is ongoing (NCT05417932).

About Hepatocellular carcinoma
Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It is estimated that more than 905,000 new cases of liver cancer and more than 830,100 deaths from the disease globally in 2020, making it one of the leading causes of cancer deaths around the world.[3] Chronic HBV infection accounts for at least 50% of cases of HCC worldwide.[1] HCC is typically diagnosed at an advanced stage and is associated with a poor prognosis. The five-year survival rate of less than 15%.

On June 7, 2024 Qilu Pharmaceutical reported that three clinical studies were selected for poster sessions at ASCO (Free ASCO Whitepaper) 2024 (Press release, Qilu Pharmaceutical, JUN 7, 2024, View Source [SID1234644199]). These studies introduced novel immunotherapeutic agents, specifically QLF31907, a bispecific antibody targeting PD-L1/4-1BB; iparomlimab and tuvonralimab, a MabPair product targeting PD-1/CTLA-4; and iparomlimab, a monoclonal antibody targeting PD-1. The research involved treatments for advanced solid tumors and lymphoma, nasopharyngeal carcinoma, as well as solid tumors characterized by either DNA mismatch repair (dMMR) deficiency or high microsatellite instability (MSI-H).

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QLF31907, developed by Qilu Pharmaceutical, combines two mechanisms: blockade of PD-L1 to restore T-cell receptor (TCR) signaling, while binding to 4-1BB to provide costimulatory signals essential for T-cell activation. This dual-action mechanism fosters T-cell proliferation and activation, enhancing the anti-tumor immune response. The study, led by Professor Tongyu Lin from Sichuan Cancer Hospital, is a phase I dose-escalation/expansion trial focusing on QLF31907 (PD-1/4-1BB dual antibody) in patients with advanced solid tumors and lymphoma (Abstract No. 2534).

Iparomlimab and tuvonralimab, representing an innovative immunotherapeutic approach, comprises a unique combination of PD-1 antibody IgG4 and CTLA-4 antibody IgG1 in a predetermined ratio, with the latter engineered to have a reduced half-life. This allows sustaining normal PD-1 antibody levels in vivo while minimizing CTLA-4 antibody exposure and is a potential therapy with lower toxicity and improved tolerability. In the phase 1 study, iparomlimab and tuvonralimab exhibited encouraging anti-tumor activity in patients with advanced nasopharyngeal carcinoma. The ongoing multicenter, single-arm, phase II trial (DUBHE-N-302, Abstract No. 6026) led by Professor Yan Huang from Sun Yat-sen University Cancer Center, explores iparomlimab and tuvonralimab in combination with gemcitabine and cisplatin for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

In this study, 29 patients were enrolled, with 7 (24%) having a baseline ECOG PS score of 1. After a median follow-up duration of 15.5 months, 18 (62%) patients reported grade 3-4 treatment-related adverse events (TRAEs), and the most common TRAE was neutrophil count decreased (41%). A total of 28 patients had at least 1 post-baseline tumor assessment. The objective response rate (ORR) was 82.1% (95% CI: 63.1%-93.9%). Median progression-free survival (mPFS) was 12.5 months (95% CI: 5.7-NE), and in 13 patients with high PD-L1 expression (CPS≥50), mPFS reached 16.2 months (95% CI: 9.9-NE). Median overall survival was not reached. The findings suggested that iparomlimab and tuvonralimab plus chemotherapy was well-tolerated and demonstrated promising anti-tumor activity in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma.

Iparomlimab is a highly selective humanized monoclonal antibody targeting PD-1. Updated results from a pivotal single-arm, phase II clinical study (Abstract No. 3578), led by Professor Weijian Guo of Fudan University Shanghai Cancer Center and Professor Feng Bi of West China Hospital of Sichuan University, were presented at ASCO (Free ASCO Whitepaper) 2024. The updated results with 1-year follow-up after enrollment of last patient revealed that iparomlimab monotherapy showed promising efficacy in this patient population. Among those with solid tumors who had failed standard treatment, the ORR, assessed by the Independent Radiology Review Committee (IRRC), reached 50.0%, higher than the prespecified primary endpoint. The ORR was 57.9% in patients with colorectal cancer. At the time of data cutoff, the median duration of response (DOR), median progression-free survival (mPFS), and median overall survival had not yet been reached. These findings underscore the robust and durable efficacy of iparomlimab in patients with advanced dMMR/MSI-H solid tumors who have failed in standard treatment. Notably, prolonged treatment with iparomlimab remained safe and well-tolerated, without any new safety concerns emerging.

On June 7, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported the appointment of Dr. Greg Fuller as the Company’s Vice President of Medical Affairs and Medical Director (Press release, Plus Therapeutics, JUN 7, 2024, View Source [SID1234644198]). Additionally, the Company received notice of an advance payment of $3.3 million from CPRIT, part of the $17.6 million award granted in September 2022.

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Dr. Fuller will help lead the implementation of the recently acquired CNSide cerebrospinal fluid cancer diagnostic portfolio, ensuring its successful transition to commercial use under the current Laboratory Developed Test (LDT) requirements. Currently utilized in the CPRIT-funded ReSPECT-LM clinical trial, CNSide is on track for commercial launch as soon as Q4 2024. Next-generation diagnostic testing, such as CNSide, is vital for improving patient care for leptomeningeal metastases (LM) and advancing the Company’s broader LM program for several reasons:

Recently published data indicated that CNSide is over 90% sensitive for detecting LM, significantly outperforming MRI and cytology
Autopsy studies suggested LM incidence is underdiagnosed by 2-4 times and the increased diagnostic sensitivity of CNSide could expand the total addressable market for the Company’s lead radiotherapeutic candidate rhenium (Re186) obisbemeda
CNSide potentially addresses a total commercial market of over 500,000 tests annually
The CNSide test demonstrated clinical utility in 40 patients with LM from breast or non-small cell lung cancer in the FORESEE trial; a presentation of the full analysis is planned for the SNO/ASCO Meeting in Denver, Colorado, on August 8-10
"I am excited to join the Plus team and to dedicate my expertise to accelerating the adoption of CNSide in a clinical and commercial setting," said Greg Fuller, M.D., Ph.D. "Driving the availability of this testing to our patients is imperative, especially given the complexities of treating LM."

Furthermore, the Company also received notice of a $3.3 million advance grant payment from CPRIT in June 2024. This funding supports the clinical development of rhenium (Re186) obisbemeda for LM as well as CNSide testing in the RePSECT-LM trial. In addition to determining the safety and potential efficacy of rhenium (Re186) obisbemeda for LM, data gathered from the RePSECT-LM trial will further validate CNSide’s clinical utility and support commercialization. An update on enrollment and safety data from the ReSPECT-LM trial is planned for the August SNO/ASCO Meeting in Denver.

New Employment Inducement Grants
In connection with Dr. Fuller’s hire, on June 6, 2024, the Company granted option awards to Dr. Fuller to purchase up to 13,116 shares of the common stock of the Company. The Company agreed to grant these option awards as an inducement of Dr. Fuller commencing employment with the Company. The options are scheduled to vest over four years, with one-fourth of the options vesting on the first anniversary of the grant date with the remaining options vesting thereafter in equal monthly installments. The vesting of the options is also subject to certain requirements, including Dr. Fuller’s continued service as an employee of the Company through the applicable vesting dates. The exercise price of the options is equal to the closing price of the Company’s common stock on June 6, 2024, the grant date.

The Company believes that these equity grants create a strong alignment of interests between Dr. Fuller and Company shareholders. The equity awards were granted with terms and conditions consistent with the Company’s 2015 New Employee Incentive Plan.

About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential. Although breast cancer is the most common cancer linked to LM, with ~10-15% of all breast cancer patients developing LM (and ~25% for inflammatory breast cancer), lung cancer, GI cancers, and melanoma can also spread to the CSF and have high LM risk. LM occurs in approximately 5% of all people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

About CNSide Test
CNSide is a laboratory developed test (LDT) based on proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the CNS, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay is designed to be used in a serial fashion to monitor the response to therapy more effectively than other current methods.

On June 7, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the grants of inducement restricted stock units ("RSUs") and an option ("Option") to 15 new employees in connection with their employment with UroGen (Press release, UroGen Pharma, JUN 7, 2024, View Source [SID1234644197]). These new team members will support the ongoing commercialization of Jelmyto (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

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Up to 52,500 ordinary shares of UroGen are issuable upon the vesting and settlement of RSUs granted to 14 of the 15 new employees. The RSUs will vest equally over three years, with one-third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

In addition, up to 13,041 ordinary shares of UroGen are issuable upon the vesting and settlement of RSUs and up to 71,942 ordinary shares are issuable upon the vesting and exercise of an Option granted to the remaining new employee, David Lin, UroGen’s Chief Commercial Officer. The exercise price of the Option is $13.13, which was the closing price of the ordinary shares on June 3, 2024, the date of grant, as reported on The Nasdaq Stock Market. The RSUs and Option granted to Mr. Lin will vest over three years, with one-third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to Mr. Lin’s continued service relationship with UroGen.

The RSUs and Option are subject to the terms and conditions of UroGen’s 2019 Inducement Plan, RSU grant notice and agreement thereunder and stock option grant notice and agreement thereunder. The RSUs and Option were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq Listing Rule 5635(c)(4).