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CASI PHARMACEUTICALS ANNOUNCES PARTNER JUVENTAS COMPLETES $65 MILLION FINANCING AND INITIATES REGISTRATION STUDY FOR CNCT19 (CD19 CAR-T)

On November 19, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported partner Juventas has completed the equivalent of $65 million financing and has initiated and enrolled the first patient in a Phase II registration study for CNCT19 (CD19 CAR-T) in China in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) (Press release, CASI Pharmaceuticals, NOV 19, 2020, View Source [SID1234571426]).

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Dr. Wei-Wu He, CASI’s Chairman, and CEO, commented, "Initiating the Phase II B-NHL registration study and enrolling the first patient is an exciting milestone for the development of CNCT19. Our partner Juventas is also making good progress in the Phase I clinical trial for the treatment of relapsed or refractory acute lymphoblastic leukemia (B-ALL) and is expecting to start the Phase II study by the end of 2020. Its financing provides Juventas with resources to continue moving CNCT19 through registration and we remain excited about its potential as a first-line treatment for B-NHL. In addition, as a large (16%) shareholder of Juventas, we are pleased to see Juventas’ progress in their pipeline and expect its financing to help accelerate its pipeline development. Juventas is an example of CASI’s entrepreneurial partnership model that is built on two components, co-development and equity investment. We believe investments in our partners deepen our collaboration and provides additional potential return to our shareholders. With this approach, we will continue to build CASI’s pipeline, one asset at a time."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas with co-commercialize together under the direction of the program’s joint steering committee.

About Juventas

Juventas Cell Therapy Ltd. is a China-based domestic company located in Tianjin City, China focused on cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma.

Immutep completes a A$29.6 million placement to accelerate and broaden its clinical development

On November 19, 2020 Australian biotechnology company Immutep Limited ("Immutep" or the "Company"), which is listed on NASDAQ and the Australian Securities Exchange, reported that it has today successfully completed a A$29.6 million a private placement of ordinary shares to professional and institutional investors (Placement) (Press release, Immutep, NOV 19, 2020, View Source [SID1234571464]).

Use of Funds

The Company will use the proceeds from the Placement to finance its LAG-3 related clinical programs in immuno-oncology and autoimmune disease. This includes the ongoing clinical development of eftilagimod alpha ("efti" or "IMP321), including the expansion of the Phase II TACTI-002 study through an additional 74 patients with 1st line NSCLC and a new Phase II clinical trial in 1st line HNSCC. Details of these expansion plans were also announced today.

The funds will also be used for the cell-line development of IMP761, R&D, manufacturing, the offering costs and working capital purposes.

Placement

123.2 million new fully paid ordinary shares ("New Shares") will be issued under the Placement at an issue price of A$0.24 per New Share (representing a 11.2% discount to the volume weighted average price ("VWAP") of the Company’s ordinary shares as traded on ASX over the 30 days up to and including Tuesday, November 17, 2020), raising a total of A$29.6 million before transaction-related expenses.

Timetable

Settlement of the Placement is expected to occur on Tuesday, 24 November 2020 with the issue of New Shares expected to occur on Wednesday 25 November 2020. The New Shares issued under the Placement will rank pari passu with the Company’s existing fully paid ordinary

Alphamab and 3D Medicines File China NDA for PD-L1 Therapy

On November 19, 2020 Alphamab Oncology and 3D Medicines reported that it filed a China NDA for their partnered anti-PD-L1 therapy as a treatment for MSI-H/dMMR cancer (Press release, Alphamab, NOV 19, 2020, View Source [SID1234571462]). In a Phase II registration trial, patients with MSI-H/dMMR colorectal cancer experienced an objective response rate of 32%. The patients had previously failed a fluoropyrimidine, oxaliplatin and irinotecan regimen. The results were roughly equivalent to those produced by BMS’s Opdivo and Merck’s Keytruda. In the US, Tracon Pharma partners the candidate with the two China pharmas

Lantern Pharma AI milestone will cut cost, time and risk in developing new drug therapies

On November 19, 2020 Lantern Pharma reported that it has reached a significant milestone by surpassing one billion curated data points on its RADR platform, a total it believes is the most amassed by any company in the biotech sector (Press release, Lantern Pharma, NOV 19, 2020, https://www.ddw-online.com/lantern-pharma-ai-platform-milestone-will-cut-cost-time-and-risk-in-developing-new-drug-therapies-8292-202011/#new_tab [SID1234571458]). The milestone, which was reached well ahead of schedule, enables new opportunities in Lantern’s work to identify and suggest combination cancer therapy programs, and the ability to compare and contrast biomarker signatures generated by a variety of machine learning algorithms.

The significance of one billion data points provides Lantern Pharma the opportunity to transform the pace, risk, and cost of oncology drug discovery and development. Current failure rates and prolonged processes have led to high developmental costs that are not sustainable for cancer patients. Utilising the RADRplatform, one billion data points brings real-world oncology data together with large-scale biomarker analytics to establish a sustainable route in oncology drug development.

The one billion data points are composed of genomic, transcriptomic and drug sensitivity data points that have been curated from both Lantern’s internal studies as well as relevant published studies and cancer datasets. These data points collected on the RADR platform allow Lantern to predict combinations of drugs that can be used together, such as Lantern’s pipeline of drug therapies, an existing drug already on the market, or an existing drug with a new type of compound that can improve efficacy in cancer patients.

"Since our IPO in June, our proprietary RADR platform has quadrupled its collection of curated data points and allowed us to meet our goal a year ahead of schedule," said Panna Sharma, CEO of Lantern Pharma. "Our growing AI platform will be pivotal in uncovering potential new therapeutic opportunities and developing insights into the creation of combination-therapy programs."

Achieving more than one billion data points in RADR enables Lantern to reduce the timeline in identifying new cancer therapies and in discovering how existing compounds can be aimed at the right subtypes of cancer. This is a process that can typically take years, but now, with large scale data and powerful new algorithms this process can be cut down to weeks. The growth in data points also positions Lantern for increased research activity in key cancer indications that the company is pursuing, including glioblastoma, lung cancer, prostate cancer, pancreatic cancer, and most recently, ovarian cancer. In fact, RADRis already beginning to predict how Lantern’s drugs will work with these types of cancer. The one billion, and counting, data points have saved months of time for Lantern’s team in understanding how their targeted therapies could be used with cancer patients.

The RADR platform has already provided Lantern with their three current drug compounds as well, where genomics and data-driven methods have been used to refine and accelerate the development process. These include: LP-100 in a Phase II trial for the treatment of metastatic, hormone-refractory prostate cancer (MHRPC) which is partnered with an European biotech; LP-300 which is preparing to enter into a Phase II trial for non-small cell lung cancer (NSCLC) as a combination therapy; and LP-184 which is in preclinical development for genomically-defined cancers, including prostate, pancreatic and glioblastoma multiforme (GBM).

The University of Verona and IntraOp® Announce PancFORT Trial for Pancreatic Cancer

On November 19, 2020 IntraOp Medical Corporation and the University of Verona in Italy reported the enrollment of the first patient in the PancFORT Trial: A phase II study of primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma (Press release, IntraOp Medical, NOV 19, 2020, View Source [SID1234571454]).

Globally, over 460,000 patients are diagnosed with pancreatic cancer every year. Approximately 30% of those patients are diagnosed as having borderline resectable disease with an expected five-year survival rate of less than 15%.

The Pancreas Institute of the University of Verona is a world-renowned center of excellence for the treatment of pancreatic cancer with a dedicated multidisciplinary team that includes Gastroenterologists, Radiologists, Pathologists, and Oncologists. The General and Pancreatic Surgery Unit is led by Professor Claudio Bassi, MD, FRCS, FACS, FEBS, FASA (Hon.) and comprises a team of surgeons highly experienced in the treatment of all the inflammatory and neoplastic diseases of the pancreas, with a yearly operative caseload exceeding 400 pancreatic resections.

The PancFORT Trial is a prospective clinical trial led by principle investigators Salvatore Paiella, MD, PhD and Giuseppe Malleo, MD, PhD, that will explore the clinical benefits of delivering IORT in patients who’ve been diagnosed with borderline resectable pancreatic cancer and have undergone "total neoadjuvant" treatment including FOLFIRNOX and SBRT with a primary endpoint of three-year disease-specific survival. With the addition of electron beam IORT, the researchers anticipate the escalated dose will potentially improve survival with reduced likelihood of local recurrences and minimal side effects to the patients.

"Despite recent improvements in oncologic treatments, the prognosis for patients diagnosed with borderline resectable pancreatic cancer remains quite poor." stated Professor Claudio Bassi, MD, Chairman of the Surgery Unit of the Pancreas Institute of the University of Verona in Italy. "However, based on early results from PREOPANC trial, we see a promising opportunity to further improve clinical outcomes by combining a total neoadjuvant approach with an ablative dose of electron IORT delivered after resection or as an in situ treatment."

"The overall radiotherapy dose administered in this study corresponds to an ablative biologically effective dose, which could significantly increase the tumor local control rate and finally improve patients’ survival." stated Renzo Mazzarotto, MD, PhD, Chairman of the Radiation Oncology Department at the University Hospital of Verona, "Moreover, for patients whose tumors are determined to be not operable at the time of surgery, delivering IORT as in situ treatment could prevent possible disorders related to tumor progression, such as pain, duodenal/stomach infiltration and bleeding, thus improving patient’s quality of life."

"We are honored to be joining forces with Professor Bassi, Dr Mazzarotto, Drs Paiella and Malleo, and the rest of the team at the University Hospital of Verona to bring new treatment options to patients suffering from pancreatic cancer," said Derek T. DeScioli, Chief Executive Officer of IntraOp Medical Corporation. "As one of the most experienced and innovative pancreatic centers in Europe, they are a perfect partner for advancing the science and clinical evidence supporting the role of IORT in treating this dreadful disease. We look forward to the ongoing collaboration."