On September 22, 2021 Theragnostics, which is developing molecular radiotherapy for imaging and treating a broad range of cancers, reported that it has signed a global licensing agreement with Advanced Accelerator Applications S.A. ("AAA"), a Novartis company, to develop and commercialise Gallium-68 (Ga-68) one-step PET radiopharmaceuticals (Press release, Theragnostics, SEP 22, 2021, View Source;utm_medium=rss&utm_campaign=theragnostics-announces-licensing-agreement-for-development-and-commercialization-of-one-step-pet-radiopharmaceuticals [SID1234590131]).

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Under the terms of the agreement, Theragnostics receives an upfront payment and is eligible for future royalties on sales of resulting products. AAA has exclusive rights to commercialise the one-step PET radiopharmaceuticals developed under the licensed patent.

In the context of nuclear medicine, the use of targeting molecules labelled either with diagnostic imaging radioisotopes such as Ga-68 or with therapeutic radioisotopes such as Lutetium 177 (Lu-177) are used for precision imaging and therapy of a particular disease.

To date, the production of Ga-68 radiopharmaceuticals has involved a multi-step approach limiting the number of patient doses produced at any one time. Theragnostics’ Ga-68 technology platform enables the production of Ga-68 radiopharmaceuticals in a single multi-dose vial in one simple step. With an ever-increasing number of promising cancer targets radiolabelled with Ga-68, it is important to maximise the Ga-68 supply. With several Ga-68 radiopharmaceuticals being commercialised, the demand for Ga-68 radiopharmaceuticals is rapidly growing and potentially a multi-billion-dollar market.

Greg Mullen, Chief Executive Officer of Theragnostics, said: "Theragnostics’ strategy is to develop novel diagnostic imaging agents and targeted radionuclide therapies to improve treatment for a broad range of cancers. This agreement enables us to accelerate the development of our own novel radionuclide therapy and diagnostic portfolio and has the potential to offer new and expanded treatment options to patients in several cancers."

Ken Herrmann, Board Member of Theragnostics, added: "Recent positive data for radioligand therapy in prostate cancer will likely lead to an increased demand of PSMA PET imaging. This agreement with AAA represents another important pathway to meet the potential demand of PSMA PET imaging of patients in need."

On September 22, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported the completion of the part A portion of a safety and tolerability study of iopofosine I-131 (iopofosine) in combination with external beam radiation (EBRT) in relapsed or refractory head and neck cancer (Press release, Cellectar Biosciences, SEP 22, 2021, View Source [SID1234590130]). This Investigator initiated study is being conducted by the University of Wisconsin as part of a prestigious Specialized Program of Research Excellence (SPORE) grant awarded by the National Cancer Institute.

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The University of Wisconsin clinical trial under direction of principal investigator, Dr. Justine Yang Bruce is evaluating the potential for iopofosine in combination with EBRT to reduce the total dose (Grays) and number of fractions of external beam radiation while maintaining favorable tumor response rates.

The reduction in the amount or fractions (doses) of EBRT has the potential to diminish the (number and severity of) adverse events associated with EBRT. Patients with head and neck cancer typically receive approximately 60-70 Grays (Gy) of EBRT given as 2 – 3 Gy daily doses over a 6 week timeframe. Patients can experience long-term tumor control following re-irradiation in this setting; however, this approach can cause severe injury to normal tissue structures, significant adverse events and diminished quality of life. Part B of the study will further assess the safety and potential benefits of iopofosine in combination with EBRT in a cohort of up to 24 patients.

"These preliminary study results support the potential promise of iopofosine. We are pleased that the early phase of the University of Wisconsin study has demonstrated good tumor uptake of iopofosine at the planned doses as well as safety of this unique treatment approach in Head & Neck cancer patients," said John Friend, CMO of Cellectar. "We remain cautiously optimistic that iopofosine in combination with external beam radiation may offer improved outcomes for patients in this highly challenging to treat disease."

Dr. Justine Yang Bruce stated "Iopofosine offers a novel investigational approach for patients with difficult to treat tumors such as head and neck cancer. The ability to potentially reduce the total external beam radiation doses is meaningful and we look forward to continue exploring iopofosine’s potential as a combination treatment in this indication."

In addition to head and neck cancer, Cellectar is currently investigating iopofosine in a global, pivotal expansion cohort in relapsed or refractory Waldenstrom’s macroglobenemia (WM) patients who have received at least two prior lines of therapy, including those who have failed or had a suboptimal response to Bruton tyrosine kinase inhibitors. The WM cohort will enroll up to 50 patients to evaluate the efficacy and safety of iopofosine for marketing approval. The company is also evaluating iopofosine in highly refractory multiple myeloma patients in its Phase 2 CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the Phase 1 CLOVER-2 study.

On September 22, 2021 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside (Press release, Alkermes, SEP 22, 2021, View Source [SID1234590128])chat at the Cantor Virtual Global Healthcare Conference on Wednesday, Sept. 29, 2021 at 8:40 a.m. ET (1:40 p.m. BST). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On September 22, 2021 Amgen (NASDAQ:AMGN) reported that it will present at the Cantor Global Healthcare Conference at 2:00 p.m. ET on Monday, Sept. 27, 2021 (Press release, Amgen, SEP 22, 2021, View Source [SID1234590127]). Susan Sweeney, senior vice president, Global Marketing, Access and Capabilities and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for seven days after the event.

On September 22, 2021 EXACT Therapeutics AS (‘EXACT-Tx’) reported its interim results for the first half 2021 (Press release, Exact Therapeutics, SEP 22, 2021, View Source [SID1234590126]).

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The Interim Report for half year 2021 is also available on the company’s website: www.exact-tx.com