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.

On December 1, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Inc.(hereinafter referred to as "ImmuneOnco") reported that phase II clinical studies of the first domestic SIRPαFc fusion protein targeting human CD47, IMM01，combined with PD-1 monoclonal antibody for solid tumors and lymphomas were officially launched (Press release, ImmuneOnco Biopharma, DEC 1, 2022, View Source [SID1234655667]).

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The data from clinical phase I study of IMM01 monotherapy is encouraging. From a quite low dose level, some patients with advanced lymphoma have been clinically benefited with good safe profile. IMM01 does not bind to human red blood cells, avoiding the "antigen sink effect", due to its differential molecular design. The molecule weight of IMM01 is only about half of the antibody so has better tissue permeability and bioavailability. What is more, preclinical in vivo drug efficacy test showed that IMM01 was very useful to combine with other targeting agents and immunotherapy drugs to gain synergic tumor suppressive activity.

PD-1 monoclonal antibody has been proven to have superior curative effect on a variety of tumors, but only responsive to small portion of patients due to limitation by the content of infiltrated T cells in tumor tissue, lack of infiltrated T cell is called "cold tumor". Macrophages are innate immune cells and antigen-presenting cells. After activated, they can turn ‘cold tumor’ to ‘hot tumor’ so as to improve curative effect of PD-1 monoclonal antibody and maintain for a long time.

1) Macrophages directly ‘swallow’ tumor cells and present tumor antigens to T cells to induce tumor antigen-specific T cell responses.

2) Macrophages release chemokines (such as CXCL9/CXCL10) to induce T cell motion to tumor tissue, thereby transforming "cold tumor" into "hot tumor".

Dr. Tian，Wenzhi, founder and chairman of ImmuneOnco, said，"I am very pleased to see that the phase II clinical trial of our IMM01 combined with PD-1 monoclonal antibody against solid tumors and lymphoma has been officially launched. Preclinical studies have shown that IMM01 combined with PD-1 monoclonal antibody has strong synergistic effects. Among patients enrolled in the phase I, it demonstrated good safety profile and tolerance. We are confident about clinical studies, IMM01 combined with PD-1 monoclonal antibody will show superior clinical efficacy and good safety. We hope to bring good news to more cancer patients as well."

Dr. Qiying Lu, Chief Medical Officer/Senior Vice President of ImmuneOnco said: "This is an important milestone. IMM01 is our key product and one of the important cornerstones of our company in the field of anti-tumor immunotherapy. This product has a variety of combination therapies (including AZA, PD-1 monoclonal antibody and other drugs) ) has entered phase II clinical development in multiple indications, covering hematological tumors and solid tumors. At present, more than 150 patients have been enrolled in multiple indications including solid tumors, lymphoma, AML, MDS, and CMML. It showed good safety and tolerability, as well as encouraging preliminary efficacy in various tumor indications. We look forward to rapidly advancing the clinical development of IMM01 products, bringing new treatment options to tumor patients to meet unmet clinical needs."

On December 1, 2022 PrimeLink reported the company has completed a financing of several hundred million RMB, led by Xiangfeng Investment and co-invested by Fosun Pharma and Kaitai Capital (Press release, PrimeLink Biotherapeutics, DEC 1, 2022, View Source [SID1234651598]). This round of financing will mainly be used for technology research and development, talent introduction, and laboratory construction.

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Pulin Bio was founded in 2021. Its R&D center is located in Suhua Science and Technology Park, Suzhou Industrial Park. It is a biopharmaceutical company focusing on the establishment of drug delivery platforms and the development of antibody-drug conjugates (ADCs). It aims to use international cutting-edge technology concepts and technology platforms to develop, screen and industrialize a new generation of ADCs .

Regarding the new generation of ADC drugs, Dr. Yin, the company’s founder and chief technology officer, explained to 36Kr that the company has established a flexible and modular technology platform to synthesize ADC drug pools, and screened the optimal ADC drug composition for each target through a unique screening platform. "Because any target has a specific and suitable ADC, its structure is different, and the same set of drug compositions cannot be used for different targets." To this end, Pulin Bio has built a connector platform with independent intellectual property rights . Based on this set of technology, Pulin Bio focuses on creating a "First in class & Best in class" product pipeline.

Regarding the new generation of ADC drugs, Dr. Yin, the company’s founder and chief technology officer, explained to 36Kr that the company has established a flexible and modular technology platform to synthesize ADC drug pools, and screened the optimal ADC drug composition for each target through a unique screening platform. "Because any target has a specific and suitable ADC, its structure is different, and the same set of drug compositions cannot be used for different targets." To this end, Pulin Bio has built a connector platform with independent intellectual property rights . Based on this set of technology, Pulin Bio focuses on creating a "First in class & Best in class" product pipeline.

Under this set of R&D concepts, Dr. Yin revealed that the company follows the product pipeline development strategy of "stability and innovation" in the selection of targets and indications , that is, walking on two legs:

First, focus on clinically validated targets, especially those that have failed in Phase II and Phase III clinical trials, and analyze the reasons for failure to optimize them;
Second, develop "First in class" products.

According to Dr. Yi, the company’s founder and chief operating officer, the company’s technology platform has been verified by experimental data at the cellular level . These results suggest ample potential and prospects for the company to develop a differentiated ADC platform. It is expected that one drug will complete IND submission in 2024.

When talking about the industry prospects, Dr. Yin said that in the entire field of medical innovation, ADC drugs have unique advantages: first, small molecule drugs and antibody drugs seem to have entered a "bottleneck period". In comparison, ADC drugs have better drugability, which is also the core reason why many antibody drug companies have started to make ADCs; in addition, in terms of indications, ADCs are currently better than the popular gene and cell therapy (CGT) in terms of efficacy in treating solid tumors.

In addition, he also said that ADC drugs are also the fastest-growing sector in the pharmaceutical field, which can be reflected in the sales data of recent years: global annual sales in 2022 will be US$8.08 billion, and it is expected to reach US$22.87 billion in 2023. The compound growth rate from 2021 to 2030 will reach 16.4%, and the market prospects are excellent.

Behind the advantages, industry barriers also exist. Dr. Yin said, "Whether it is upstream target discovery, drug development, or downstream CMC and other production links, they are all very complicated and require the participation of very experienced people. However, experienced talents are scarce, and those with successful experience are even scarcer."

As a startup company, the core task of Pulin Biotech in the initial stage is to establish a new ADC drug toolbox and verify a new technology platform with independent intellectual property rights. It is worth mentioning that in order to improve Pulin Biotech’s toolbox, Pulin Biotech has reached an agreement with a US company to authorize the introduction of its antibody sugar modification and site-specific coupling technology, which enables Pulin Biotech to synthesize homogenized ADC drugs, thus providing a necessary technical option for optimizing the therapeutic window of ADC candidate drugs. According to Dr. Yin, "This technology will make it easier for us to produce ADC drugs in the future, saving a lot of time and money."

Finally, let me introduce the company team. The founder, Dr. Yin, has nearly 20 years of experience in ADC drug development, including the design and development of payloads and connectors, coupling process development, etc. He has worked at Mersana Therapeutics for 15 years and has dozens of international patents. Dr. Yin is the number one employee of Mersana and the core inventor of Mersana’s first and second generation linkers. He has led the team through the cycle from early exploration to IND research, forming Mersana’s unique technology platform. At present, Mersana’s technology platform has derived a rich product line. The core product has completed phase III clinical trials and will submit a BLA application. There are also multiple pipelines that are undergoing clinical research or forming strategic cooperation with international pharmaceutical companies.

In addition, Dr. Yi, the company’s founder and COO, has 15 years of experience and knowledge in antibody and ADC drugs, and has participated in the research and development of two ADC drugs. Currently, the company has more than 20 people, with a "Bo content" of more than 50% .

The company has now launched a new round of financing.

On December 1, 2022 Optieum Biotechnologies reported that the company has entered into a research collaboration agreement with the National Cancer Center Japan("NCC") to initiate multiple projects to discover and develop innovative CAR-T cell therapy assets targeting solid tumors (Press release, Optieum Biotechnologies, DEC 1, 2022, View Source [SID1234639141]).

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Optieum has a platform technology to elicit functional and improved scFvs that can lead to superior antitumor reactivity of CAR-T cells. NCC, Exploratory Oncology Research and Clinical Trial Center (NCC-EPOC) has expertise in clinical research and development of cancer immunotherapy, and is capable of accelerating translational research by integrating its clinical resources into this collaboration.

With the completion of signing, Optieum and Division of Cancer Immunotherapy (Chief, Dr. Tetsuya Nakatsura) of NCC-EPOC, will begin joint research to develop CAR-T cell therapies for patients with solid tumors.