On December 2, 2022 Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, reported that Jin-Chen Yu, SVP, Research will present a talk on BAT8009 (B7-H3-ADC) at the 2nd Annual ADC Target Selection Summit taking place December 6 – 8, 2022 in Boston, MA (Press release, BioThera Solutions, DEC 2, 2022, View Source [SID1234624714]).

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The talk, entitled "A Novel B7-H3 ADC With Strong Bystander Effect Demonstrates Superior Tumor-Inhibition Activity," will present preclinical data that highlight advantages demonstrated by BAT8009 as a potential treatment for cancer patients. BAT8009 is currently being evaluated in a Phase 1 clinical trial.

BAT8009 is a new ADC being developed with Bio-Thera’s next-gen ADC platform that utilizes a systemically stable cleavable linker, a potent Topoisomerase 1 inhibitor (Exatecan) as the payload, and high DARs that takes advantage of the bystander effect to increase efficacy. Other new ADC assets developed using this next-gen ADC platform include BAT8006 (Folate-Receptor-alpha-ADC), BAT8007 (Nectin4-ADC), BAT8008 (Trop2-ADC) and BAT8010 (Her2-ADC). All of these ADC assets are currently in, or about to begin, Phase 1 clinical trials.

About BAT8009

BAT8009 is an investigational B7-H3-ADC being evaluated in multiple tumor types. B7-H3 is a naturally occurring receptor that is overexpressed in many types of cancer, including lung, liver, esophageal and ovarian cancer. BAT8009 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8009 is currently being evaluated in a Phase 1 evaluating the pharmacodynamics and safety of BAT8009 (more information on the Phase 1 clinical trial is available at View Source).

On December 2, 2022 Focus-X Therapeutics (referred to here as "Focus-X"), a nuclide drug company that was invested in and incubated by Viva Biotech, reported that it has successfully reached an acquisition agreement with Full-Life Technologies Co., Ltd. (referred to here as "Full-Life") (Press release, Focus-X Therapeutics, DEC 2, 2022, View Source [SID1234624713]). Under the terms of the acquisition, Full-Life will acquire Focus-X for US$245 million, including an upfront payment, potential development, regulatory, and sales-based milestone fees, and royalties on commercial sales. The acquisition is expected to close in the first quarter of 2023. When finished, this will be another pre-clinical acquisition of one of Viva’s portfolio companies, after Dogma and Totient, which once again verifies the capabilities of project discovery and the professional post-investment support of Viva’s investment team.

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Focus-X develops targeted radiopharmaceuticals to treat cancer based on its proprietary peptide engineering technology. They completed their angel round in the third quarter of 2020, which was led by Viva. In addition to financial support, Viva also provided Focus-X with comprehensive incubation services to help it realize the transformation from "concept to product."

Dr. Zhixiong Ye, CSO of Viva, stated, "Since investing in and incubating Focus-X in July 2020, Viva has worked closely with Focus-X on the screening and synthesis of peptides, which is an enriching experience for our team. Highly selective peptides can tackle the pain point of peptide-conjugated nuclide drugs – the toxicity caused by ‘healthy tissue distribution’. Viva provides efficient and high-quality screening and synthesis services for Focus-X with the help of its peptide research and development platform. It also assists Focus-X in obtaining multiple high-quality clinical drug candidates."

Dr. Han Dai, CIO and head of Viva BioInnovator, said, "Relying on the founding team’s years of extensive research and accumulation, Focus-X has successfully developed an innovative peptide-drug conjugate (PDC) platform for the coupling of radionuclides in just two years. This development has advanced multiple nuclide-PDC pipelines into PCC and IIT stages, forming synergy with Full-Life Technology’s international layout in R&D, clinical, and supply chain of radiopharmaceutical drugs."

Fa Liu, Ph.D., co-founder and CEO of Focus X, commented, "I am very grateful for the trust and support of Viva and other investment institutions. Within two years, we have achieved breakthroughs and transformations from zero to multiple clinical candidate molecules, some of which have shown very positive early human data. We have accelerated all the processes from verifying scientific hypotheses, transformation, and optimization, to determining clinical candidate molecules through Viva’s peptide and synthetic chemistry capabilities. Full-Life’s integrated platforms will provide the manufacturing technology, logistics, and clinical development expertise to accelerate the development of our compounds as well as expand our discovery efforts."

"The Focus-X acquisition perfectly leverages Full-Life’s radiotechnology and development platform.This deal will bring two development ready compounds, including a lead with initial human data, a robust pipeline and world class peptide discovery capabilities to Full-Life," said Lanny Sun, Co-founder, Chairman and CEO of Full-Life.

On December 2, 2022 Qilu Pharmaceutical, one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures, and distributes both finished formulations and Active Pharmaceutical Ingredients, reported that the results of the phase II study evaluating QL1706 plus chemotherapy +/- bevacizumab for the treatment of non-small cell lung cancer (NSCLC) were released on 2 December 2022 in poster presentations (325P and 332P) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress 2022 (Press release, Qilu Pharmaceutical, DEC 2, 2022, View Source;bevacizumab-for-the-treatment-of-non-small-cell-lung-cancer-in-the-phase-ii-study-at-esmo-asia-congress-2022-301692344.html [SID1234624707]).

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QL1706 is a novel dual immune checkpoint blockade containing a mixture of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 antibodies, showing promising antitumor efficacy in advanced solid tumors including NSCLC in a phase I study. This is a phase II, open-label, single-center study of QL1706 plus chemotherapy +/- bevacizumab in patients with advanced NSCLC (NCT05329025). In this study, advanced NSCLC patients with wild-type and mutated epidermal growth factor receptor (EGFR) were enrolled.

As of the data cutoff, 29 patients with advanced NSCLC with wild-type EGFR and naïve to systemic treatment were enrolled to receive QL1706 (5 mg/kg) plus chemotherapy (paclitaxel plus carboplatin or pemetrexed plus carboplatin) once every 3 weeks (Q3W) for 2 cycles and then QL1706 5 mg/kg Q3W for maintenance therapy until disease progression or other discontinuation events. The median follow-up was 9.17 months. The objective response rate (ORR) was 58.6% (squamous NSCLC cohort: 70.6%; non-squamous NSCLC cohort: 41.7%). The disease control rate (DCR) was 93.1% (27/29). The median progression-free survival (mPFS) was 6.97 months.

A total of 31 patients with advanced NSCLC with mutated EGFR, having disease progression after or not tolerating EGFR tyrosine kinase inhibitors with or without bevacizumab/anlotinib were also enrolled to receive QL1706 (5 mg/kg) plus chemotherapy (pemetrexed plus carboplatin) and bevacizumab Q3W for 4 cycles and then QL1706 5 mg/kg plus pemetrexed and bevacizumab Q3W for maintenance therapy until disease progression or other discontinuation events. The median follow-up was 5.75 months. The ORR was 64.5% (20/31) and DCR was 93.5% (29/31). PFS was not yet mature. The 6-month PFS rate was 61.3%.

Overall, QL1706 plus chemotherapy showed a good safety profile. Adverse events were manageable and the safety profile was consistent with that reported for chemotherapy or anti-PD-1 and anti-CTLA-4 therapy.

Ms. Xiaoyan Kang, Head of Qilu Pharmaceutical clinical research center, stated, "We are pleased to release the latest study results of QL1706 plus chemotherapy +/- bevacizumab for the treatment of advanced NSCLC. Based on results from this study, we are planning several phase III studies of QL1706 for the treatment of NSCLC and we hope to bring a new treatment option to patients with advanced NSCLC in the future."

On December 1, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, reported new data from the OLYMPUS registration trial designed to obtain long-term follow-up data on JELMYTO (mitomycin) for pyelocalyceal solution that shows median durability of response (DOR) of 28.9 months (Press release, UroGen Pharma, DEC 2, 2022, View Source [SID1234624705]). The study (Abstract #158) was presented at SUO on December 1.

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"The clinical benefit of JELMYTO was demonstrated in the Phase 3 OLYMPUS study and data presented today highlighted the long-term durability of that benefit," said Dr. Phillip Pierorazio, M.D., Chief, Section of Urology at Penn Presbyterian Medical Center, Philadelphia, PA. "JELMYTO provides an effective and durable kidney-sparing treatment option and should be considered as primary therapy for adult patients with LG-UTUC."

Patients who completed OLYMPUS were eligible to participate in this rollover study. Outcomes of interest include DOR in patients who remain in complete response (CR) at the end of OLYMPUS, events of disease recurrence and progression, post-study treatments and death.

At the time of data cut off (February 25, 2022), data were available for 16 of 23 patients who had remained in CR at the end of the OLYMPUS study. The median DOR among the 16 patients was 28.9 months (14.6 to 47.6 months). Thirteen patients remained in CR, two patients had recurrence of low-grade upper tract urothelial carcinoma (LG-UTUC) on the same side as treated in OLYMPUS, and one patient underwent radical nephroureterectomy (RNU) due to ureteral stricture without evidence of UTUC at the time of surgery. No patient had progressed to high-grade disease.

"JELMYTO is an important addition to the urologist’s tool kit for treating LG-UTUC," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. "These data are the first to show the potential for long-term recurrence free survival in patients treated with JELMYTO. We look forward to additional independent validation of this important observation."

About the Pivotal OLYMPUS Study

OLYMPUS (Optimized DeLiverY of Mitomycin for Primary UTUC Study) was an open-label, single-arm Phase 3 clinical study of UGN-101 JELMYTO (mitomycin) for pyelocalyceal solution, to evaluate the safety, tolerability and tumor ablative effect of JELMYTO in patients with LG-UTUC. Seventy-one patients were treated at clinical sites across the United States and Israel. Study participants were treated with six weekly instillations of JELMYTO administered via a standard catheter. Four to six weeks following the last instillation, patients underwent a Primary Disease Evaluation (PDE) to determine CR, the primary endpoint of the study. PDE involved a ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine to detect cancer and for cause biopsy. Patients who achieved a CR at the PDE timepoint were eligible for the maintenance phase of the trial, during which they could receive monthly maintenance instillations for up to 12 months and were assessed quarterly to determine the durability of response with JELMYTO.

In the OLYMPUS study, data was generated for the retrograde administration of JELMYTO. In that study population ureteric stenosis was reported in 58% (n=41) of patients receiving JELMYTO, with only 17% (n=12) of patients experiencing a Grade 3 event.

About LG-UTUC

LG-UTUC is a rare disease managed by endoscopic methods and radical nephroureterectomy. Endoscopic resection and laser ablation attempt to preserve the kidney, though there is a high risk of recurrence that may eventually necessitate removal of the kidney. Although kidney removal is the current standard for treatment of high-grade UTUC, it may be over-treatment in LG-UTUC, as kidney removal offers similar five-year survival as kidney-sparing procedures but is associated with significant morbidity.

On December 1, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported the grant of inducement stock options exercisable for 14,400 shares of G1’s common stock and 9,400 restricted stock units (RSUs) to five hired employees under the Amended and Restated G1 Therapeutics, Inc. 2021 Inducement Equity Incentive Plan (the "Amended and Restated 2021 Plan") (Press release, G1 Therapeutics, DEC 2, 2022, View Source [SID1234624674]). These equity awards were granted as an inducement material to the new employee’s becoming an employee of G1 in accordance with Nasdaq Listing Rule 5635(c)(4).

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The Amended and Restated 2021 Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of G1 (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with G1, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The stock options are exercisable at a price of $5.85 per share, the closing price of G1’s common stock on December 1, 2022, the grant date. The stock options have up to a ten-year term and vest over four years, with 25% of the award vesting on the first anniversary of the employee’s employment, and as to an additional 1/48th of the shares monthly thereafter, subject to continued service through the applicable vesting dates (subject to the terms and conditions of the stock option agreement covering the grant). The RSUs have a four-year term, with 25% of the award vesting on the first anniversary of the grant date, and the remainder vesting 12.5% semi-annually over the remaining three years, subject to continued service through the applicable vesting dates (subject to the terms and conditions of the RSU agreement covering the grant). The stock options and RSUs are subject to the terms and conditions of the Amended and Restated 2021 Plan.