On September 28, 2021 Diaprost reported that it has agreed terms for an exclusive Licensing Agreement with Radiopharm Theranostics (RAD); an Australian based biotech startup, focused on building an innovative and differentiated pipeline of radiopharmaceutical products for both diagnostic and therapeutic uses (Press release, Diaprost, SEP 28, 2021, View Source [SID1234590433]). RAD has recently raised A$20 million to progress a portfolio of radiopharmaceutical assets that have the potential to be first to market or best in class in their respective disease areas. The Diaprost asset is one of four distinct & clearly differentiated platform technologies.

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The Diaprost pipeline is focused on humanised antibodies for diagnostic and therapeutic radiopharmaceutical applications. The hu5A10 antibody enables non-invasive detection and therapy by delivering radionuclides to prostate cancer cells. The platform’s targeting mechanism utilizes binding to Prostate Specific Antigen (PSA), a well-established biomarker previously only applied for diagnostic blood tests.

The imaging modalities based on hu5A10, which were developed together with Lasker Award recipient Charles Sawyers, demonstrate superior specificities in diagnosing prostate cancer cell occurrence and an unparalleled ability to detect disease activity. When employing hu5A10 with a Therapeutic Isotope, results clearly demonstrate specific and effective prostate cancer cell eradication. The combination of imaging and radioimmunotherapy, based on the same antibody, enables a powerful tool for both diagnosis and treatment of prostate cancer.

Under the terms of the agreement RAD will have exclusive responsibility to manufacture, develop and commercialise hu5A10 worldwide. Upfront and near-term payments of US$10M are part of a financial package that over the life of the agreement could exceed US$125M, if all development and regulatory goals are met.

"We believe the Licensing Agreement with Radiopharm Theranostics, founded by the experienced Australian life sciences industry figure Paul Hopper, represents a focused route to maximizing the potential of both Diaprost and the hu5A10 program," said Johan Drott, the CEO of Diaprost. "RAD has established a strong management team with recognised experts to focus on the development of radiopharmaceutical products for diagnostic and therapeutic uses in areas of high unmet medical needs."

On September 28, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has accepted the Company’s IND application to initiate a phase 2 trial for enoblituzumab (also known as TJ271) in combination with pembrolizumab (Keytruda) in patients with selected solid tumors in China (Press release, I-Mab Biopharma, SEP 28, 2021, View Source [SID1234590432]). I-Mab has in-licensed the rights to exclusively develop and commercialize enoblituzumab in Greater China from MacroGenics (Nasdaq: MGNX).

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Enoblituzumab is a highly differentiated humanized monoclonal antibody directed against B7-H3, a member of the B7 family of T-cell checkpoint regulators. B7-H3 plays a key role in regulating immune response against cancers and is widely expressed in multiple cancers. Its presence on tumors is associated with poor clinical prognosis. Enoblituzumab is engineered with an optimized Fc domain that enables a dual anti-tumor mechanism by antibody-dependent cell-mediated killing of cancer cells and enhanced T-cell immune response. There are increasing preclinical data generated by I-Mab and preliminary clinical evidence from MacroGenics supporting increased efficacy for the combination of enoblituzumab and PD-1 antibody against cancers.

Enoblituzumab has become one of the Company’s core clinical assets. The phase 2 clinical trial in China will evaluate the efficacy of the combination of enoblituzumab and pembrolizumab. It is designed as a "basket" clinical trial involving non-small cell lung cancer (NSCLC), urothelial carcinoma, and other selected cancer types based on treatment signals observed in previous studies conducted by MacroGenics.

MacroGenics conducted multiple clinical studies of enoblituzumab for the treatment of cancers including squamous cell carcinoma of head and neck (SCCHN) and NSCLC, demonstrating enoblituzumab is well tolerated with observed efficacy signals. For example, data from a phase 1 cohort expansion study, presented at SITC (Free SITC Whitepaper) 2018, have reported that enoblizutumab in combination with PD-1 antibody achieved an objective response rate (ORR) of 33.3% in SCCHN patients and of 35.7% in NSCLC patients with PD-L1 expression <1%. Currently, MacroGenics is conducting a phase 2 study of enoblituzumab in combination with retifanlimab (PD-1 antibody) or tebotelimab (PD-1 & LAG-3 bispecific DART molecule) for first-line treatment of patients with recurrent or metastatic SCCHN.

"With the initiation of the phase 2 clinical trial we hope to accelerate the clinical development of enoblituzumab in Greater China," said Dr. Joan Shen, CEO of I-Mab. "We will be leveraging the data from clinical trials conducted by MacroGenics to advance the clinical development of enoblituzumab for approval in Greater China."

About Enoblituzumab

Enoblituzumab is an investigational Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of immune regulator proteins. B7-H3 is widely expressed by many different tumor types and may play a key role in regulating the immune response to various types of cancer. Enoblituzumab has been or is currently being evaluated in clinical trials as a monotherapy or in combination with anti-PD-1-based therapies in patients with B7-H3-expressing cancers. I-Mab Biopharma acquired the development and commercial rights from MacroGenics for Greater China.

On September 28, 2021 Genelux Corporation, a clinical-stage immunotherapy company, and Newsoara BioPharma Co., Ltd., reported a collaboration and exclusive license for the development and commercialization of Olvi-Vec and other oncolytic viruses (Press release, Genelux, SEP 28, 2021, View Source [SID1234590431]).

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According to the terms of the agreement, Newsoara shall have exclusive rights in Greater China (mainland China, Hong Kong, Macau and Taiwan) to Olvi-Vec for which Genelux currently is planning a U.S. based Phase 3 registration trial in platinum resistant/refractory ovarian cancer. Newsoara also shall have exclusive rights in Greater China to Genelux’s proprietary oncolytic virus platform, and the parties will collaborate on the development of novel oncolytic immunotherapeutics.

Newsoara, at its cost and expense, will be responsible for development and commercialization and will have the future right to manufacture licensed products in Greater China. The parties also will collaborate on a Phase 2 clinical trial for the intravenous delivery of Olvi-Vec in a new indication using clinical sites in China and the U.S. Newsoara will be responsible for all trial costs.

Under terms of the agreement, Genelux will receive up-front and near-term payments totaling $11 million and will be eligible to receive additional per-product payments of up to $160.5 million, contingent on certain development, regulatory and commercial milestones, plus tiered royalties on net sales ranging from mid-single-digit to mid-double-digit percentages. Genelux shall have an exclusive license outside of Greater China to oncolytic virus products derived by Newsoara and will pay Newsoara milestones and royalties on sales of any such products which Genelux elects to develop.

"We are delighted to be working with Newsoara on developing Olvi-Vec, as well as on our broader collaboration." said Thomas Zindrick, J.D., President and CEO of Genelux. "It is a dynamic organization with a commitment to advancing cutting-edge therapeutics, whose strength in research, development and manufacturing in China is a perfect complement to our focus on the discovery and clinical development of novel virotherapies. Together we look forward to accelerating the development of Olvi-Vec and to strengthening and broadening our pipeline of next-generation oncolytic viral immunotherapies."

Dr. Benny Li, CEO of Newsoara, stated, "We are very pleased to partner with Genelux, a company with deep internal capabilities in the emerging field of oncolytic virotherapies. Olvi-Vec, a late clinical-stage asset with potential utility in multiple tumor types via physician-preferred routes of administration, offers hope to patients with limited or no treatment options. This partnership accelerates our commitment to becoming a fully integrated biopharmaceutical company and addressing significant unmet medical needs."

About Olvimulogene Nanivacirepvec (Olvi-Vec)
Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and therapeutic potential. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Olvi-Vec has been administered to more than 150 patients in clinical studies. In these studies, Olvi-Vec was generally well tolerated and the data provided evidence of clinical benefit.

On September 28, 2021 Nonagen Bioscience Corp, pioneers in the development of liquid biopsy tests for the detection of human cancers, reported Oncuria, their non-invasive bladder cancer test capable of predicting response to therapy, has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation (Press release, Nonagen Bioscience, SEP 28, 2021, View Source [SID1234590430]).

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This designation is granted to technologies that have the potential to provide more effective treatment, diagnosis or prognosis of life-threatening diseases, such as cancer. The designation enables close collaboration with, and expedited review by the FDA, and provides formal acknowledgement of Oncuria’s utility and potential clinical benefit.

FDA Grants Nonagen Bioscience Test Breakthrough Device Designation

Up to 50% of early-stage bladder tumors treated with surgery will recur. Guidelines for the treatment of early-stage bladder cancer recommend the instillation of Bacillus Calmette-Guerin (BCG) into the bladder. BCG is an attenuated tuberculosis vaccine that acts as a non-specific immune system stimulant and as such is one of the first immunotherapies to treat human cancer. It has proven to be a successful treatment, assisting in the eradication of residual bladder cancer, reducing recurrence rates and decreasing the progression to more advanced cancers. However, more than half of patients who receive BCG fail to respond, and in 20% of patients the disease grows and extends during or after BCG, which portends a worse survival. A diagnostic test performed prior to BCG treatment capable of predicting treatment response could be leveraged to avoid a futile treatment regimen and avoid potential delays in the initiation of more appropriate clinical management, which will benefit both patients and the healthcare system.

Oncuria, a multiplex immunoassay measures 10 protein biomarkers in a single voided urine sample. Biomarker levels are combined in a weighted algorithm to aid in the prediction of responding to BCG in patients with intermediate to high-risk, early-stage bladder cancer. "Our algorithm is designed to provide prediction of response to BCG therapy, allowing for timely interventions that could result in more favorable outcomes for our patients," said Charles J. Rosser, CEO of Nonagen. "We are proud that the FDA has decided to grant Breakthrough Device Designation to our lead diagnostic, Oncuria, acknowledging growing recognition of the benefit our test can offer to clinicians and patients."

On September 28, 2021 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported the preliminary results of the Phase Ia study of IBI315 (first-in-class anti-Her2/PD-1 bispecific antibody) in an oral presentation at the 2021 Annual Meeting of Chinese Society of Clinical Oncology (CSCO) (Press release, Innovent Biologics, SEP 28, 2021, View Source [SID1234590427]).

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By data cutoff date of May 25, 2021, 27 patients have been enrolled and received IBI315 at one of seven pre-specified dose levels of 0.03mg/kg QW to 15mg/kg Q3W. No dose limited toxicity (DLT) was observed, and maximum tolerated dose (MTD) has not been reached. Among 15 patients who have completed at least one post-treatment tumor assessment at active dose levels (≥1mg/kg), objective response rate (ORR) was 20%. Biomarker analyses also supported the clinical results that clinical responders showed higher proliferation and activation of peripheral immune cells.

Professor Xichun Hu from Fudan University Shanghai Cancer Center, stated, "The satisfying safety profile and preliminary efficacy data of IBI315 seen in current study support the concept of bispecific antibody designed with targeted- and immune- therapies. We are confident to expect more positive results from the upcoming trials of IBI315 in more types of tumors expressing Her2. "

"IBI315 is a first-in-class anti-Her2/PD-1 bispecific antibody. We are excited to see that IBI315 was well tolerated with a manageable safety profile. The efficacy signal was also encouraging," said Dr. Hui Zhou, Senior Vice President of Innovent. "These results have proved the druggability and developability of IBI315. We will start a phase Ib study of IBI315 promptly to further explore the efficacy of IBI315 monotherapy and in combination with chemotherapy in Her2 positive and low-expressed tumors. We are expecting to enlarge the anti-Her2 therapeutic area with our first-in-class agent IBI315 and benefit more patients in the near future."

About CIBI315A101 Study

CIBI315A101 is a phase Ia/Ib open label, dose escalation and expansion study to evaluate the safety, tolerability and efficacy of IBI315 monotherapy and in combination with chemotherapy in advanced Her2 expressing solid tumors. This is the first-in-human study of IBI315. The phase Ia part of the study has 7 prespecified dose levels from 0.03mg/kg to 15mg/kg with dosing frequencies of QW, Q2W, or Q3W. The dose escalation follows a classic 3+3 design. The phase Ia part is ongoing. The phase Ib part is cohort expansions of IBI315 monotherapy or in combination with chemotherapy in specific tumor types.

About IBI315

IBI315 is developed through the collaboration between Innovent and Hanmi, and Innovent is leading its clinical development in China. IBI315 is a first-in-class recombinant fully human IgG1 bispecific antibody that targets PD-1 on the surface of T cells and HER2 expressed by tumor cells simultaneously. In preclinical studies, IBI315 has demonstrated potent anti-tumor activities with blockade of PD-1/PD-L1 and Her2 pathways, as well as a bridging effect between T cells and tumor cells.