On January 13, 2022 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported the publication of positive pre-clinical results using intraoperative high intensity focused ultrasound (HIFU) ablation of the pancreas in the peer-reviewed journal Cancers (Press release, EDAP TMS, JAN 13, 2022, View Source [SID1234605466]).

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The paper, entitled, Intraoperative HIFU Ablation of the Pancreas Using a Toroidal Transducer in a Porcine Model. The First Step towards a Clinical Treatment of Locally Advanced Pancreatic Cancer, describes a pre-clinical study designed to assess the feasibility of using HIFU under Doppler guidance to treat the pancreatic parenchyma and tissues surrounding the superior mesenteric vessels in vivo, in an animal model.

Pancreatic adenocarcinoma is among the most aggressive of all cancers. Regardless of treatment, the overall 5-year survival rate for patients with locally advanced pancreatic adenocarcinoma ("LAPA") is less than 5%. A HIFU approach could help in the treatment of such pathology that is inaccessible by other known therapeutic methods. Apart from palliative chemotherapy, no other curative options have been proven effective for the treatment of LAPA.

During the study, HIFU treatments were performed using an intraoperative HIFU probe which caused irreversible tissue necrosis in only a few seconds by producing sufficiently strong heat in the focal area. This study is the first step toward the launch of a Phase I study to evaluate the safety and feasibility of such a HIFU approach in patients with LAPA and to further confirm these encouraging results.

"The possibility of treating the pancreas using HIFU holds great promise for the treatment of locally advanced pancreatic cancers. If clinically successful, chemotherapy followed by HIFU treatment could rapidly become a novel treatment option of LAPA," concluded the paper’s authors.

Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "We are very excited with these pre-clinical results and the promise they demonstrate for HIFU as a viable treatment for pancreatic cancer and other severe pathologies with low overall survival rates and no effective treatment options. We are proud of the ongoing work of the EDAP research team, who, together with Inserm and Centre Leon Bérard, are advancing the development of HIFU to offer patients a potentially effective treatment alternative for these difficult to treat cancers."

The full text of the paper can be found here.

On January 13, 2022 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the full year 2021 as well as the fourth quarter 2021 (Press release, Biofrontera, JAN 13, 2022, View Source [SID1234605450]).

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Biofrontera AG’s preliminary unaudited revenue for the period January 1 to December 31, 2021 is anticipated to be in the range of EUR 28.7 million to EUR 28.9 million compared to EUR 30.3 million in 2020. Revenue generated from product sales for the full year 2021 were between EUR 28.6 million and 28.8 million compared to EUR 23.9 million in 2020.

Preliminary revenues from product sales in the US are anticipated to be between EUR 20.1 million and EUR 20.3 million, compared to EUR 16.6 million in 2020. In Germany, revenue from product sales amounted to between EUR 5.2 million and EUR 5.4 million, compared to EUR 5.1 million in fiscal year 2020. In the rest of Europe, the Company generated product sales in the range of EUR 3.2 million to EUR 3.4 million, compared to EUR 2.1 million in 2020. No revenue was generated in other regions in 2021 (previous year: EUR 6.5 million).

Total revenue in the fourth quarter was between EUR 10.2 and EUR 10.4 million, compared to EUR 9.5 million in the fourth quarter of 2020, of which between EUR 7.8 million and EUR 8.0 million was generated from product sales in the US (prior-year period: EUR 7.5 million), between EUR 1.2 million and EUR 1.4 million in Germany (prior-year period: EUR 1.3 million), and between EUR 1.0 million and EUR 1.2 million in the remaining European countries (prior-year period: EUR 0.8 million).

On January 13, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Helmholtz Munich (Helmholtz Zentrum München), reported a cooperation agreement for the clinical development of a radiopharmaceutical therapy candidate to treat malignant brain tumor glioblastoma (Press release, ITM Isotopen Technologien Munchen, JAN 13, 2022, View Source [SID1234605467]). ITM and Helmholtz Munich will collaborate to support an upcoming dose-escalation Phase I clinical trial with LuCaFab (ITM-31). LuCaFab is a CA XII-specific antibody Fab fragment targeting molecule, developed by Helmholtz Munich, radiolabeled with ITM’s medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu, EndolucinBeta). The planned multicenter investigator-initiated trial (IIT) will be led by the Westfälische Wilhelms-Universität Münster (University of Münster, Germany).

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Under the terms of the agreement, which formalizes an ongoing collaboration between ITM and Helmholtz Munich, ITM supports the logistics and supply of the clinical trial material and provides funding for the trial, which is designed for the treatment of up to 15 patients. ITM holds the exclusive option, which may be executed at any time, to license the compound, related worldwide patents and know-how for the manufacturing, use and application of LuCaFab from Helmholtz Munich under already agreed upon terms. The option also allows ITM to access and use trial data for research and commercial activities.

Steffen Schuster, CEO of ITM comments: "We are pleased to continue our collaboration with Helmholtz Munich and to further advance ITM’s clinical pipeline. Glioblastoma is among the most malignant and most difficult to treat cancers. A precise radionuclide therapy targeting an antigen highly expressed in glioblastoma, such as CAXII, may inhibit tumor growth after surgical removal. We are dedicated to clinically explore this opportunity for these patients who have such a high unmet medical need."

Reinhard Zeidler, Project Leader at Helmholtz Munich: "We believe that the combination of our tumor-specific targeting molecule and ITM’s medical radioisotope offers a new opportunity to improve the treatment of glioblastoma. After first encouraging studies with other radioisotopes in brain tumors, we expect ITM’s radioisotope lutetium-177 to have particularly favorable medicinal properties. Therefore, we look forward to initiating our collaborative clinical trial with the Departments of Neurosurgery and Nuclear Medicine at the University of Münster."

About Glioblastoma Multiforme

Glioblastoma is one of the most malignant types of primary brain tumors. It is a rare tumor, with about 3-5 new cases per 100,000 individuals per year.1 Even though surgery, chemotherapy, and radiotherapy have advanced over the last decade, resulting in a gradual improvement in the survival and quality of life of glioblastoma patients, the prognosis remains very poor.2 Glioblastoma is a complex tumor which is very difficult to treat. Surgery is rarely curative as the tumor cells infiltrate the surrounding tissue and the blood-brain barrier places a limitation on medical therapies. Even with macroscopic removal of the tumor and subsequent treatment with external beam radiation and chemotherapy, there is a risk that individual tumor cells will remain in the tissue and begin to grow again (relapse). More than 90% of tumor recurrences occur in the immediate vicinity of the primary tumor. Therefore, the treatment of the tissue surrounding the tumor is of great importance.

About LuCaFab (ITM-31)

Glioma cells can selectively express certain surface antigenic proteins such as carbonic anhydrase XII (CAXII), which are not found on healthy brain cells. Targeted molecules which specifically bind to the proteins can be produced to attack these antigens. This approach falls under the category of Targeted Radionuclide Therapy (TRT), an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule that can precisely recognize tumor cells and bind to tumor-specific entities such as receptors expressed on the cell surface. The radioisotope accumulates at the tumor site and decays, releasing a therapeutic amount of ionizing radiation, thereby destroying tumor tissue. Helmholtz Munich has developed a new antibody binding fragment (Fab) against the CAXII antigen, which has been optimized for the treatment of glioblastoma. ITM’s no-carrier-added lutetium-177 (n.c.a. 177Lu, EndolucinBeta) is coupled to the antibody in order to selectively target and irradiate tumor cells. The resulting compound, LuCaFab (ITM-31), is administered via intracavitary injection, meaning it is applied directly into the tumor cavity following the surgical removal of the tumor to attack residual cancerous cells that lead to recurrent disease. LuCaFab thus acts as a complementary, adjuvant therapy to the current standard of care approach to glioblastoma as it is designed to be applied after initial treatment to prevent future tumor growth.

On January 13, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported the commencement of an open label phase II study, in collaboration with GlaxoSmithKline (GSK) to evaluate the efficacy and safety of ZEJULA (niraparib), a poly (ADP-ribose) polymerase (PARP) inhibitor used for patients with advanced or metastatic solid tumors and a germline or somatic PALB2 mutation (Press release, Tempus, JAN 13, 2022, View Source [SID1234605468]). The study, titled "Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors" (the PAVO study, NCT05169437) is sponsored by Tempus and opened for enrollment on January 7, 2022.

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Patients with PALB2 mutations have been shown to be at an increased risk of being diagnosed with breast and pancreatic cancers1. Recent studies demonstrate that patients with metastatic breast and pancreatic cancers with germline PALB2 mutations have benefited from treatment with PARP inhibitors2. ZEJULA is an oral, once-daily PARP inhibitor approved by the FDA in 2017 for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. Phase 3 clinical trials are underway to evaluate the efficacy and safety of niraparib alone or in combination in additional solid tumors, including breast and lung cancers.

The PAVO study applies an innovative, data-driven approach designed to accelerate and streamline study timelines, and the signal-seeking process for niraparib. Additionally, Tempus leveraged its multi-modal dataset to expedite the protocol development and intelligent site selection in under 60 days.

The PAVO study is designed to enroll solid tumor patients with germline or somatic PALB2 mutations. Tempus is leveraging its TIME Trial Program, a just-in-time network of providers, to support rapid patient identification, site activation, and clinical trial enrollment. Under the study protocol, every patient sequenced through Tempus’ genomic sequencing platform will be pre-screened for PALB2 somatic and germline mutations.

"For this collaboration, our data produced insights led to the design of a new trial that we can expedite through our robust diagnostic and just-in-time trial network," said Dr. Kimberly Blackwell, Chief Medical Officer at Tempus. "We look forward to working together to evaluate niraparib’s potential for other populations who could benefit from this treatment."

1Hofstatter, Erin W, et al. "PALB2 Mutations in Familial Breast and Pancreatic Cancer." Familial Cancer, U.S. National Library of Medicine, June 2011, View Source

2Reiss KA;Mick R;O’Hara MH;Teitelbaum U;Karasic TB;Schneider C;Cowden S;Southwell T;Romeo J;Izgur N;Hannan ZM;Tondon R;Nathanson K;Vonderheide RH;Wattenberg MM;Beatty G;Domchek SM; "Phase II Study of Maintenance Rucaparib in Patients with Platinum-Sensitive Advanced Pancreatic Cancer and a Pathogenic Germline or Somatic Variant in BRCA1, BRCA2, or palb2." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), U.S. National Library of Medicine, View Source

On January 13, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has treated the first patient in its Phase 1/1b clinical trial of Corvus’ small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T-cell lymphomas (TCL) in China (Press release, Corvus Pharmaceuticals, JAN 13, 2022, View Source [SID1234605452]).

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"We are excited that Angel has begun to enroll patients in its Phase 1/1b clinical trial of CPI-818, which marks the first clinical use of one of our drug candidates in China," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "There is a significant opportunity to address unmet clinical need in China, where TCL are more common than in North America. In addition, we believe this study will accelerate the global development of CPI-818 for lymphomas and other T cell mediated diseases such as autoimmune disorders."

The Angel Pharma Phase 1/1b clinical trial will evaluate various dosing regimens in patients with a variety of TCL, including peripheral T cell lymphoma, angioimmunoblastic T cell lymphoma, NK T cell lymphoma and other T cell lymphomas. Enrolled patients must have failed standard therapies and will receive CPI-818 as a single agent given orally until disease progression. The trial is designed to assess safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and preliminary efficacy.

Professor Song Yuqin, the lead primary investigator of the CPI-818 Phase 1/1b clinical trial in China and Director of the Chinese Society of Clinical Oncology (CSCO), Secretary-General of the Anti-Lymphoma Alliance of the CSCO, and Deputy Director of Lymphoma Department at Peking University Cancer Hospital, said, "the number of new cases of non-Hodgkin lymphoma in China is about 93,000 per year, of which TCL is a challenging sub-group. We look forward to recruiting more patients that may benefit from this treatment."

Corvus co-founded Angel Pharma to develop its pipeline in greater China and currently holds an equity stake of 49.7% in the company. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize CPI-818 in greater China and is responsible for all expenses related to its development in China.