On October 19, 2021 Cerus Corporation (Nasdaq: CERS) reported that its third quarter 2021 financial results will be released on Tuesday, November 2, 2021, after the close of the stock market (Press release, Cerus, OCT 19, 2021, View Source [SID1234591510]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 3970817. The replay will be available approximately three hours after the call through November 16, 2021.

On October 19, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) and ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company, reported the signing of a clinical supply agreement that provides Clovis Oncology with ITM’s therapeutic radioisotope no-carrier-added Lutetium-177 (n.c.a. 177Lu), EndolucinBeta, for use in the clinical development of FAP-2286, Clovis’ fibroblast activation protein (FAP)-targeting therapeutic candidate (Press release, Clovis Oncology, OCT 19, 2021, View Source [SID1234591509]). FAP-2286 is the first peptide-targeted radionuclide therapeutic (PTRT) candidate directed against fibroblast activation protein undergoing clinical testing and is currently being investigated in the Phase 1/2 LuMIERE study for patients with advanced solid tumors. The agreement covers an initial period of five years. Further details of the agreement were not disclosed.

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"Clovis Oncology is committed to advancing FAP-2286’s clinical development program and emerging as a leader in targeted radionuclide therapy. A critical element to advance this program is ensuring long-term supply of radioisotopes, and this agreement allows us to achieve that goal," said Patrick Mahaffy, President and CEO of Clovis Oncology. "In particular, we value ITM’s radiopharmaceutical expertise and global reach as we advance our targeted radionuclide therapy program into the clinic."

"This agreement underscores the potential of our n.c.a. Lutetium-177 to provide therapeutic value to patients with hard-to-treat tumors. Through our proprietary pipeline of Targeted Radionuclide Therapies and our agreements with other oncology leaders, we are establishing a new era of precision oncology treatments and we are happy to contribute to this exciting Clovis program," commented Steffen Schuster, CEO of ITM.

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting FAP. FAP is highly expressed by cancer-associated fibroblasts (CAFs) which are found in the majority of cancer types, but with limited expression in healthy fibroblasts, potentially making it a suitable target across a wide range of tumors. FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach medical radioisotopes, such as Lutetium-177 for therapeutic use, or Gallium-68 for imaging use.

ITM’s n.c.a. 177Lu (EndolucinBeta) is a high-purity version of the beta-emitting radioisotope Lutetium-177, that can be linked to a variety of tumor-specific targeting molecules for Targeted Radionuclide Therapy and has demonstrated significant anti-tumor effects in clinical and commercial use. ITM has developed a unique methodology to produce the highly pure form of Lutetium-177, without metastable Lutetium-177m, and manufactures n.c.a. 177Lu for development partnerships, distribution to clinics worldwide, and its own growing precision oncology pipeline.

In June 2021, Clovis initiated the Phase 1/2 LuMIERE clinical study of FAP-2286 in advanced solid tumors. The Phase 1 portion of the LuMIERE study (NCT 04939610) will evaluate the safety of the FAP-targeting investigational therapeutic agent and identify the recommended Phase 2 dose and schedule of Lutetium-177 labeled FAP-2286 (177Lu-FAP-2286), for which ITM will provide its n.c.a. 177Lu. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, and squamous head and neck cancers. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

For more information about FAP-2286, Targeted Radionuclide Therapy (TRT), or Clovis’ TRT development program, CLICK HERE.

About n.c.a. Lutetium-177 / EndolucinBeta

No carrier-added Lutetium-177 (n.c.a. 177Lu) chloride, is a radiopharmaceutical precursor used in Targeted Radionuclide Therapy for the treatment of various diseases, like cancer. When labeled with a tumor-specific targeting molecule (e. g. peptide or antibody), the targeted radiopharmaceutical binds to a tumor-specific receptor, according to the lock and key principle. N.c.a. 177Lu has a half-life of 6.647 days and provides the highest specific activity of more than 3,000 GBq/mg at Activity Reference Time (ART). Optimal preconditions for efficient radiolabeling of biomolecules over its entire shelf-life of 9 days after production are ensured. N.c.a. 177Lu exhibits an extraordinary level of radionuclidic purity and does not contain metastable Lutetium-177m circumventing cost intensive clinical disposal management.

About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclide therapies are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds. ITM is developing a proprietary precision oncology pipeline of targeted radiopharmaceuticals for diagnostics and treatment of a range of hard-to-treat cancer indications, such as neuroendocrine tumors, prostate cancer, glioblastoma, osteosarcoma and bone metastases, as well as folate receptor α positive tumors like lung, ovarian or breast cancer. Additionally, ITM supplies partners with its high-purity n.c.a. 177Lu for clinical and commercial development.

On October 19, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that it has submitted an Investigational New Drug application (IND) and an accompanying application for Fast Track status with the U.S. Food and Drug Administration (FDA) for a planned Phase 2 study of the company’s drug Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer (Press release, AIM ImmunoTech, OCT 19, 2021, View Source [SID1234591508]).

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The planned AMP-270 clinical trial of approximately 250 subjects will be a Phase 2, randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen when added to SOC (standard of care) versus SOC alone for subjects with advanced pancreatic carcinoma recently treated with FOLFIRINOX chemotherapy regimen. Secondary objectives include comparing safety and tolerability.

Amarex Clinical Research will manage the AIM-sponsored study. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in The Netherlands are expected to be the primary study sites, although additional sites are anticipated.

Key support for both the study and the application for Fast Track status includes statistically significant clinical data in an Erasmus MC early-access program of 27 subjects where the overall survival of the Ampligen-treated cohort was 19.2 months from the start of FOLFIRINOX, compared to 12.5 months in the historical control group, for an increase in survival of 6.7 months. Additionally, several subjects are still alive more than three years later.

AIM believes that the clinical significance of these data as a treatment for pancreatic cancer provide Ampligen with a strong case for FDA Fast Track designation, which is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill unmet medical needs. A drug that has been granted FDA Fast Track status is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
AIM Chief Scientific Officer David Strayer, MD, commented, "Given the extensive work to date, we are well positioned to move aggressively and launch the Phase 2 trial of Ampligen upon approval of the IND. We could not be more enthusiastic about the outlook for this program given the compelling prior clinical data from Erasmus MC, which demonstrated a significant improvement in median overall survival, compared to a matched historical control group. Ampligen has also demonstrated a strong safety profile in numerous trials. At the same time, we are excited to have submitted our Fast Track application, which would confer a number of important benefits and potentially help accelerate approval."

AIM CEO Thomas K. Equels further commented, "Submission of our IND and Fast Track application are very significant milestones for the company and I would like to thank our entire team, as well as our clinical and regulatory advisors, for their tremendous efforts in preparing these carefully planned submissions. The rapid progress we have made is especially important given the devastating nature of pancreatic cancer. Further, both the FDA and the EMA have granted Ampligen orphan drug status in pancreatic cancer. This creates the potential for several years of market exclusivity. There is a significant unmet need for a safe and effective therapy for these patients, and we believe Ampligen holds enormous promise."

See:

AIM ImmunoTech Inc.’s Drug Ampligen Awarded FDA’s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer
AIM ImmunoTech’s Subsidiary Receives Orphan Medicinal Product Designation by the European Medicines Agency for Ampligen to Treat Pancreatic Cancer

On October 19, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported results from the Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy (Press release, Galera Therapeutics, OCT 19, 2021, View Source [SID1234591507]). The trial did not meet its primary endpoint of reduction in the incidence of SOM. The Company is continuing to analyze the results.

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"While the data, as in previous trials, showed reductions in the incidence, duration and severity of SOM, we are surprised and disappointed that the trial did not achieve statistical significance in its primary endpoint," said Mel Sorensen, M.D., Galera’s President and CEO. "We would like to extend our heartfelt thanks to the patients who participated in this trial while they underwent radiotherapy for head and neck cancer. As we evaluate next steps for this program, we remain committed to our goal of transforming radiotherapy in cancer treatment with our selective dismutase mimetics."

Key findings include:

16% relative reduction in the incidence of SOM in the avasopasem treatment group (54%) vs. placebo group (64%) (p=0.113) (primary endpoint)

56% relative reduction in the number of days of SOM in the avasopasem treatment group (8 days) vs. placebo group (18 days) (p=0.011) (secondary endpoint)

27% relative reduction in the severity (incidence of Grade 4 OM) of SOM in the avasopasem treatment group (24%) vs. placebo group (33%) (p=0.167) (secondary endpoint)

Avasopasem was generally well tolerated with similar rates of adverse events in the active and placebo arms

Dr. Sorensen continued, "We continue to be excited about the potential of our second dismutase mimetic product candidate, GC4711, in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer (NSCLC) and locally advanced pancreatic cancer (LAPC). We recently initiated a Phase 2b trial of GC4711 in combination with SBRT in LAPC based on promising tumor and survival outcome benefits observed in a Phase 1/2 pilot trial. In addition, enrollment is ongoing in a Phase 1/2 trial of GC4711 in combination with SBRT in patients with NSCLC. We look forward to providing updates as these trials progress."

The ROMAN trial is a randomized, double-blind, placebo-controlled trial in 455 patients with locally advanced HNC receiving seven weeks of standard-of-care radiotherapy plus cisplatin. Patients were randomized to one of the two treatment groups (3:2) to receive 90 mg of avasopasem or placebo by infusion on the days they receive their radiation treatment.

About Oral Mucositis

Oral mucositis is a side effect of radiation therapy characterized by severe pain, inflammation, ulceration and bleeding of the mouth. In patients with head and neck cancer, radiotherapy is a mainstay of treatment. Approximately 70 percent of patients receiving radiotherapy for head and neck cancer develop severe oral mucositis (SOM), defined by the inability to eat solid food (Grade 3) or drink liquids (Grade 4). The impact on patients who develop SOM is substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration are required. SOM can adversely affect cancer treatment outcomes by causing interruptions in radiotherapy, which may compromise the otherwise good prognosis for tumor control in many of these patients. There is currently no drug approved to prevent or treat SOM.

About Avasopasem

Avasopasem manganese (avasopasem, or GC4419) is a selective small molecule dismutase mimetic in development for the reduction of radiation-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiation-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.

About the Phase 3 ROMAN Trial

The ROMAN trial is a randomized, double-blind, placebo-controlled trial designed to evaluate the ability of avasopasem to reduce the incidence and severity of radiation-induced SOM in patients with locally advanced head and neck cancer, receiving seven weeks of radiotherapy plus cisplatin. For more information, please visit View Source

On October 19, 2021 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 1,580 million in the third quarter of 2021 (Press release, Genmab, OCT 19, 2021, View Source [SID1234591506]). Net trade sales were USD 841 million in the U.S. and USD 739 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC formulations, under the exclusive worldwide license to Janssen Biotech, Inc. (Janssen) to develop, manufacture and commercialize daratumumab. As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.

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About DARZALEX(daratumumab)
DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat multiple myeloma and has become a backbone therapy in the treatment of this disease. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of multiple myeloma and the first and only approved treatment for patients with light-chain (AL) amyloidosis. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). 1,2,3,4,5,6,7

Please see local country prescribing information for all labeled indication and safety information.