On October 28, 2020 PeproMene Bio Inc. reported it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to study a novel chimeric antigen receptor (CAR) T cell therapy, PMB-101, the first CAR T cell therapy targeting the B cell-activating factor receptor (BAFF-R) on cancerous cells, for the potential treatment of refractory or relapsed B cell acute lymphoblastic leukemia (r/r B-ALL) (Press release, PeproMene Bio, OCT 28, 2020, View Source [SID1234569274]).

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City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, has licensed intellectual property relating to PMB-101 under a Licensing and Collaboration agreement with PeproMene. City of Hope will also conduct the proposed first in-human, Phase 1 clinical trial.

The proposed trial is a single-center, open-label trial and will examine the safety and preliminary efficacy of BAFF-R-CAR T cells in cancer patients with r/r/ B-ALL who are ineligible for or have failed CD19-targeted immunotherapy in the U.S.

PMB-101 is a novel CAR T cell therapy which has shown synergistic activity in CD-19 resistant or relapsed animal models in preclinical trials. Animal models with CD19 therapy-resistant human-tumors (including Burkitt, mantel cell, and other non-Hodgkin’s lymphoma subtypes and acute lymphoblastic leukemia) received BAFF-R CAR T therapy. Remarkable tumor regression and prolonged survival were observed after treatment with these CAR T cells. In animal models with human Burkitt lymphoma, BAFF-R CAR T therapy achieved complete tumor regression with 100% long-term survival. The research was published in Science Translational Medicine.

"City of Hope is excited to leverage the numerous and very promising pre-clinical model outcomes of our investigational CAR-T project and to explore its effect in cancer patients for whom few treatments are currently available," said Larry W. Kwak, M.D., Ph.D., vice president and deputy director of City of Hope’s comprehensive cancer center, who along with Hong Qin, Ph.D., are inventors on the licensed intellectual property and Scientific Advisory Board members of PeproMene.

Bryan HW Kim, CEO of PeproMene added: "We are very pleased to announce this important milestone after only three years of the company’s existence; we are grateful to the scientific founders for advancing our project and to our shareholders for their support. We look forward to collaborating closely with leading clinical investigators at City of Hope and the FDA to validate the safety of PMB-101 in humans in a controlled clinical setting."

About PeproMene’s PMB-101
BAFF (B cell activating factor), a soluble cytokine expressed by B cells, is known for its proliferation and differentiation. In particular, BAFF-R (B cell activating factor receptor) is an excellent potential target for B-cell cancers not only because of its specificity to BAFF, but also for its expression level by lympho-proliferative as well as leukemia-proliferative disorders. Successful discovery of anti-BAFF-R humanized monoclonal antibodies (humAbs) C55 and C90 demonstrate high binding affinity to various Non-Hodgkin’s Lymphomas (NHLs). The PeproMene BAFF-R CAR-T was constructed based on the single-chain fragment variable (scFv) antibodies using 2nd generation signaling domains. Research has found that BAFF-R CAR-T cells kill lymphomas and leukemias in vitro and kill established lymphomas as well as leukemias in vivo. During the completion of the IND enabling studies, the company’s scientific and medical founders made key publications:

"Antitumor efficacy of BAFF-R targeting CAR T cells manufactured under clinic-ready conditions" (25. May 2020: View Source

and

"CAR-T cells targeting BAFF-R can overcome antigen loss in B cell malignancies" (Sep 2019: View Source)

On October 28, 2020 M.S.Q. Ventures ("MSQ") reported that its client, BioInvent International, AB ("BioInvent"), has successfully entered into a licensing agreement with CASI Pharmaceuticals, Inc. ("CASI") for the development and commercialization of BI-1206 in the Greater China region (Press release, BioInvent, OCT 28, 2020, https://www.prnewswire.com/in/news-releases/bioinvent-completes-first-licensing-agreement-in-greater-china-advised-by-msq-ventures-887248266.html [SID1234569273]). BI-1206 is BioInvent’s proprietary clinical stage anti-FcγRllB antibody developed to treat a variety of cancers including Non-Hodgkin’s lymphoma and advanced solid tumors.

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Martin Welschof, Ph.D., CEO of BioInvent, stated, "The agreement is a further validation of BioInvent’s robust discovery platform and innovative clinical program, where we welcome new opportunities to develop therapeutics for patients in additional regions, as we did here for Greater China in partnership with CASI." Dr. Welschof said, "MSQ team has been working seamlessly as our external team focused on developing and executing China strategy and diligently helped us identify, evaluate and advise on current and future strategic opportunities to continue to expand BioInvent’s capability to deliver for cancer patients in the region. We appreciated MSQ’s help so that we can complete this transaction smoothly and expediently in mostly virtual fashion during this challenging time."

Wei-Wu He, Ph.D., Chairman and CEO of CASI, said, "Our goal at CASI is to pursue innovative drugs to complement our core pipeline and therapeutic areas. BI-1206’s potential to be used in combination with leading immunotherapy agents fits very well with our strategic thinking and is what attracted us to this opportunity. We are impressed with BioInvent team’s accomplishments to date and we look forward to greater success together."

"BioInvent’s lead asset BI-1206 is complementary to CASI’s pipeline. The two teams have a good cultural fit which is important for global clinical development and commercialization of BI-1206. Clinical development in China will accelerate BI-1206’s overall global development timeline, creating significant value," said Echo Hindle-Yang, CEO of MSQ. "We congratulate Martin, Wei-Wu and the team of BioInvent and CASI on this remarkable achievement."

On October 28, 2020 Lannett Company, Inc. (NYSE: LCI) reported that it will report financial results for its fiscal 2021 first quarter on Wednesday, November 4, 2020, after the market closes (Press release, Lannett, OCT 28, 2020, https://www.prnewswire.com/news-releases/lannett-to-report-fiscal-2021-first-quarter-financial-results-host-conference-call-on-wednesday-november-4-301161500.html [SID1234569270]). Lannett management will host a conference call that same afternoon at 4:30 p.m. Eastern Time to review the company’s performance and answer questions.

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The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49992942. The call will be broadcast via the Internet at www.Lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

On October 28, 2020 Rarecells, Inc. (USA), a leading Liquid Biopsy company,reported that National Institute of Integrative Medicine’s (Melbourne, Australia) researchers obtained striking results in a group of Australian men using the ISET test for early prostate cancer diagnosis through the detection of Prostate-Specific Antigen (PSA) positive Circulating Tumor Cells (CTC) (Press release, RARECELLS, OCT 28, 2020, View Source [SID1234569269]).

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The peer-reviewed article published in the journal Frontiers in Oncology (article), shows that the prostate cancer test based on CTC harvested with the ISET technology and identified by the Immuno-Cytochemistry (ICC) PSA marker has an estimated positive-predictive-value (PPV) of 99% and negative-predictive-value (NPV) of 97%, providing a more reliable screening test for prostate cancer than the standard PSA blood test (PPV = 25%; NPV = 15.5%).

Prostate cancer is the second most common cancer and the fifth leading cause of cancer deaths in men worldwide. Due to the limited sensitivity and specificity of the standard PSA test, a relevant proportion, close to 75%, of unnecessary prostate biopsies are performed every year, generating avoidable costs and suffering.

"This new non-invasive test based on ISET technology allows for early detection of prostate cancer more accurately than the standard PSA test. Improving the accuracy of tests for early cancer detection may reduce the burden of unnecessary biopsies," said NIIM Director of Research, and Chief Investigator Associate Professor Karin Ried.

Davide Brechot, Deputy Director and CTO at Rarecells commented: "NIIM’s preliminary data obtained with the ISET technology opens the way to a more reliable prostate cancer screening test driving earlier curative interventions while reducing unnecessary, painful and costly prostate biopsies. They add to the body of published evidence of ISET technology’s excellence in cancer diagnostics and management "

ISET has been validated by more than 85 independent scientific publications on 3,400 cancer patients and more than 1,200 cancer-free individuals (see www.rarecells.com). It demonstrates unparalleled performance for the isolation and characterization of individual CTC and CTC clusters.

On October 28, 2020 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will present a company overview at the following conferences (Press release, PTC Therapeutics, OCT 28, 2020, View Source [SID1234569268]):

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Credit Suisse 29th Annual Virtual Healthcare Conference
Wednesday, November 11th at 9:30 a.m. ET

Barclays Virtual Gene Editing & Gene Therapy Summit
Monday, November 16th at 3:30 p.m. ET

The presentations will be webcast live on the Events and Presentations page under the investor relations section of PTC Therapeutics’ website at www.ptcbio.com and will be archived for 2 weeks following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.