On March 23, 2020 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported the extension of the expiration date of the offers to exchange (each, an "Exchange Offer" and, collectively, the "Exchange Offers") any and all outstanding notes of certain series issued by Allergan Finance, LLC ("Allergan Finance"), Allergan, Inc. ("Allergan Inc"), Allergan Sales, LLC ("Allergan Sales") and Allergan Funding SCS ("Allergan Funding" and, together with Allergan Finance, Allergan Inc and Allergan Sales, "Allergan") (the "Allergan Notes") for new notes to be issued by AbbVie (the "AbbVie Notes") and the related consent solicitations (each, a "Consent Solicitation" and, collectively, the "Consent Solicitations") being made by AbbVie on behalf of Allergan to adopt certain amendments to each of the indentures (each, an "Allergan Indenture") governing the Allergan Notes (Press release, AbbVie, MAR 23, 2020, View Source [SID1234555743]). AbbVie hereby extends such expiration date from 5:00 p.m., New York City time, on March 27, 2020 to 5:00 p.m., New York City time, on April 10, 2020 (as the same may be further extended, the "Expiration Date").

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On the early participation date of November 7, 2019, requisite consents were received and supplemental indentures were executed eliminating substantially all of the covenants, restrictive provisions, events of default and any guarantees of the related Allergan Notes in each Allergan Indenture. Such supplemental indentures will become operative only upon settlement of the Exchange Offers.

The Exchange Offers and Consent Solicitations were commenced in connection with AbbVie’s previously announced proposed acquisition of Allergan plc (the "Acquisition") and are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal, each as amended by the press releases dated November 18, 2019, December 20, 2019, January 27, 2020, February 24, 2020 and March 9, 2020 and as amended hereby (collectively, the "Offering Documents"), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and the Expiration Date of each of the Exchange Offers is expected to be extended to occur on or about the closing date of the Acquisition. As a result, the Expiration Date may be further extended one or more times. AbbVie currently anticipates providing notice of any such extension in advance of the Expiration Date.

On March 23, 2020 A study jointly conducted by Dean and Professor Takuya Fukushima, M.D., Ph.D., Graduate School of Health Sciences, University of the Ryukyus, and NEC Corporation reported that it has discovered a novel diagnostic biomarker for acute adult T-cell leukemia/lymphoma and been published in Blood Advances, a medical journal from the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, NEC, MAR 23, 2020, View Source [SID1234555742]).

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Key points of the announcement:

A comprehensive proteomic analysis of samples from the Okinawa HTLV-1/ATL Biobank revealed that the expression level of soluble tumor necrosis factor receptor 2 (sTNFR2) was elevated in ATL patients compared to asymptomatic HTLV-1 carriers
As a biomarker, sTNFR2 in the blood plasma of ATL patients is expected to be more sensitive and more specific than other biomarkers previously reported. Although it is known that several proteins are found at higher levels in ATL patients, this study has discovered a proteomic biomarker with enhanced sensitivity and specificity
Observation of sTNFR2 expression levels may help in the early diagnosis of ATL onset in HTLV-1 carriers. This may also help ATL patients through improvement of therapeutic outcomes, evaluation of treatment response, and prediction of prognosis

Adult T-cell leukemia/lymphoma (ATL) is a mature T-cell neoplasm associated with human T-cell leukemia virus type-1 (HTLV-1). Studies have shown that Japan has the largest population of HTLV-1 carriers, especially the Okinawa and Kyushu regions, and correspondingly a high incidence of ATL (reference 1, 2). The main routes of transmission of HTLV-1 are vertical transmission from an infected mother to child through breastfeeding, and horizontal (sexual) transmission.

A 2008 to 2010 nationwide survey conducted by the scientific research arm of Japan’s Ministry of Health, Labor and Welfare estimated that there is a total of 1,080,000 carriers in Japan, and that the proportion of carriers in the metropolitan Kanto and Kinki regions has been on the rise (reference 3). The majority of HTLV-1 carriers remain asymptomatic throughout their lives, with only 5% exhibiting clinical features of ATL.

Nevertheless, treatment of ATL remains exceptionally challenging, and the acute and lymphoma subtypes are known to be aggressive. Aggressive ATL patients typically have a poor prognosis, with a median survival time of 8 to 10 months. To diagnose early ATL onset and improve the treatment of ATL, research is being conducted to identify ATL risk factors among HTLV-1 carriers, and although a high proviral load is known to be a risk factor for ATL progression, a definitive factor that can be used to predict the onset of ATL has yet to be identified. Moreover, ATL is known to increase the levels of plasma proteins such as lactase dehydrogenase and soluble interleukin-2 receptor, but this increase is not specific to ATL and is not as useful as a predictor of ATL onset.

According to the Okinawa HTLV-1/ATL Research Network, a research group which is connected to various hospitals in Okinawa, there are approximately 70 aggressive ATL cases annually in Okinawa. Professor Takuya Fukushima and his colleagues partnered with NEC Corporation to form a joint research team with the objective of discovering a new biomarker that will enable the early detection of ATL. This was achieved by performing a comprehensive blood-based proteomic analysis of blood plasma specimens from the Okinawa HTLV-1/ATL biobank to compare asymptomatic HTLV-1 carriers (AC) and ATL patients.

Through SOMAscan, a proteomic analysis platform provided by US-based SomaLogic Inc., expression levels of 1,305 plasma proteins were analyzed in 40 AC and 40 ATL patients. From this study, 333 types of proteins were found to have significantly different levels in the two study groups. Subsequently, those proteins with especially large differences were further analyzed using ELISA. Results showed that soluble tumor necrosis factor receptor 2 (sTNFR2) was found in remarkably elevated levels in ATL patients, especially acute ATL, compared to AC subjects.

Tumor necrosis factor (TNF) is a cytokine, and the subtype, TNF-α, induces apoptosis of solid tumor cells. TNF-α is also known to be involved in the induction of inflammation and apoptosis, and the inhibition of tumorigenesis. TNFR2 is one of the receptors of TNF-α, and is involved in the proliferation of tumors. sTNFR2 refers to TNFR2 that have shed from the surface of cells and are freely floating in the blood. This study has also revealed that TNFR2 are highly expressed on acute ATL cell surfaces. To date, there have been no research findings indicating elevated TNFR2 levels in ATL patients, and the results of this study represent the potential clinical utility of sTNFR2 as a biomarker to diagnose acute ATL.

Looking ahead, the clinical significance of elevated sTNFR2 levels in onset prediction, early diagnosis, and prognosis prediction should be examined. Moreover, analyzing the mechanism by which TNFR2 is released from the surface of cells may prove to be important in paving the way for new treatment options.

References

Gessain A, Cassar O (2012) Epidemiological aspects and world distribution of HTLV-1 infection. Front Microbiol 3: 388.
Nosaka K, Iwanaga M, Imaizumi Y, Ishitsuka K, Ishizawa K, Ishida Y, Amano M, Ishida T, Uike N, Utsunomiya A, Ohshima K, Kawai K, Tanaka J, Tokura Y, Tobinai K, Watanabe T, Uchimaru K, Tsukasaki K (2017) Epidemiology and clinical features of adult T-cell leukemia-lymphoma in Japan, 2010-2011: A nationwide survey. Cancer Sci 108(12): 2478-2486
Satake M, Yamaguchi K, Tadokoro K (2012) Current prevalence of HTLV-1 in Japan as determined by screening of blood donors. J Med Virol 84: 327-335.

On March 16, 2020 NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, reported a corporate update highlighting the continued commercial progress of its RadioGenix System (technetium Tc 99m generator) (Press release, NorthStar Medical Radiostopes, MAR 23, 2020, View Source [SID1234555616]). NorthStar’s RadioGenix System is an innovative, high tech radioisotope separation platform indicated for use in producing the widely used medical radioisotope Tc-99m from non-uranium based molybdenum-99 (Mo-99). Since becoming commercially available in 2018, NorthStar has provided RadioGenix System customers with reliable Mo-99 production and supply, despite ongoing industry supply shortages incurred with legacy, uranium-based production methods. NorthStar also announced progress in its multi-pronged expansion efforts to ensure a reliable, domestically produced Mo-99 supply for the U.S. healthcare system, an expanded product portfolio and deployment of its technological expertise in scaling up commercial production for therapeutic radioisotopes copper-67 (Cu-67) and actinium (Ac-225).

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"Since the RadioGenix System became commercially available in 2018, NorthStar has demonstrated strong, consistent progress in advancing our plans to ensure reliable, non-uranium based radioisotope supply for the United States," said Steve Merrick, President and CEO of NorthStar Medical Radioisotopes. "During the past 16 months and despite disruptive supply shortages from other Mo-99 producers, NorthStar’s RadioGenix System customers have experienced reliable Mo-99 supply, enabling U.S. healthcare providers and their patients to have ready access to medically important Tc-99m diagnostic imaging studies, on time and when they need them. Recent FDA approval of two state-of-the-art filling lines at our Columbia, Mo. facility substantially increases our Mo-99 production efficiencies in filling Mo-99 source vessels that we provide to our customers. In line with our multi-pronged strategy to deploy dual Mo-99 processing hubs in Columbia and Beloit, Wis., we have completed construction of the isotope processing facility in Beloit. Upon completion of equipment installation and qualification, appropriate licensure and FDA approval, the isotope processing facility will augment current processing in Columbia, Mo. and provide dual production hubs for source vessels used by radiopharmacies having RadioGenix Systems. We would like to recognize the support that our partners at the University of Missouri Research Reactor (MURR), with whom we jointly produce Mo-99 in Columbia, Mo., continue to provide to NorthStar. Construction of NorthStar’s electron accelerator facility expansion in Beloit is well underway, with the first pair of accelerators being built in Belgium and planned for installation in Q4 2020. The accelerators will be used to convert Mo-100 to medically useful Mo-99, which will be processed in the adjacent isotope processing facility. This will enhance production efficiencies and complete the creation of dual manufacturing operations to further secure reliable, non-uranium based Mo-99 radioisotope supply for U.S. customers and patients."

"In further planning for future growth, NorthStar has expanded our product portfolio through acquisition of exclusive worldwide rights to an investigational fibrin-targeted cardiac diagnostic imaging agent, known as FibroScint, from Capella Imaging," added Mr. Merrick. "This Tc-99m agent may have potential applications across multiple cardiovascular conditions, and we intend to use RadioGenix System-produced Tc-99m in planned clinical studies. Additionally, NorthStar is broadening its technology platform to address important unmet needs in radioisotope supply. We are applying our development expertise towards commercial-scale production of promising therapeutic radioisotopes such as Cu-67 and Ac-225, which may have potential in treating a range of cancers. As recently announced, NorthStar and Clarity Pharmaceuticals signed a Letter of Intent for U.S. clinical and commercial supply of Cu-67, and the company has similar arrangements in place to supply Ac-225 to several undisclosed customers."

Mr. Merrick concluded, "Through successful financing efforts, and in conjunction with the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) Cooperative Agreement awards, NorthStar is strongly positioned to continue its momentum towards being an industry leader in radioisotope technology, production and supply. DOE/NNSA has been instrumental in development of the RadioGenix System, system enhancements and our Mo-99 production activities. We are grateful for the efforts of all our government and business partners, and in particular, the team at MURR, and the many contributions that they have had on our programs. Together with our talented team of more than 200 employees, supply chain partners and our customers, we are working together to provide U.S. patients with reliable access to radioisotopes that can make a difference in healthcare for patients in the United States."

RadioGenix System commercial progress

NorthStar’s successful commercialization of the RadioGenix System continues its steady, planned growth with U.S. radiopharmacy customers.

Since becoming commercially available 16 months ago, RadioGenix Systems have provided customers with reliable Tc-99m supply through U.S. production of Mo-99, despite ongoing shortages from suppliers using legacy, uranium-based production methods.
The number of patient doses available from RadioGenix Systems continues to increase, with tens of thousands of doses provided for patients’ diagnostic imaging studies to date, and product growth continuing to track with the company’s plan.
Ongoing product development programs such as the FDA-approved RadioGenix System version 1.2 continue to help maximize operational utility and efficiency for customers in the production of Tc-99m.
Progress on initiatives to increase U.S. Mo-99 manufacturing and production

In its efforts to support increased Mo-99 production efficiencies and capacity, NorthStar is aggressively expanding for the future to ensure continued reliable domestic Mo-99 supply for the U.S. healthcare system. The company is executing on its multi-pronged expansion strategy for dual production hubs in Beloit, Wis., and Columbia, Mo.

In February, 2020, the FDA approved the addition of two Mo-99 filling lines at NorthStar’s facility in Columbia, Mo., enabling an immediate and significant increase in the speed in which RadioGenix System source vessels are filled, and thus increasing production efficiency and output. NorthStar produces non-uranium based Mo-99 in collaboration with its manufacturing partner, MURR.
NorthStar has two ongoing expansion projects underway in Beloit. The company’s isotope processing facility is nearing completion, and will augment processing at MURR once approved. Upon appropriate licensure by Wisconsin DHS and FDA approval, the facility will enable NorthStar to more than double its production of source vessels, which are used by radiopharmacies with RadioGenix Systems to produce Tc-99m for physicians and their patients.
In March 2019, NorthStar signed a contract with IBA for eight electron beam accelerators. Groundbreaking on its accelerator production facility took place in September 2019, and construction in Beloit is well underway. The initial pair of accelerators is being assembled in Belgium, with installation planned for Q4 2020. Like other NorthStar processes, accelerator production of Mo-99 using the "neutron knock-out" method is non-uranium based, highly efficient and, pending FDA approval, can provide customized scheduling flexibility and minimize supply risks for customers.
In mid-2020, NorthStar anticipates submitting a Prior Approval Supplement (PAS) to the FDA for concentrated Mo-98 (cMo-98). Pending FDA approval, the cMo-98 production process will improve Mo-99 specific activity concentration up to four-fold, and immediately enable larger capacity and multiple sizing options for Mo-99 source vessels for RadioGenix System customers.
NorthStar currently has the capability to meet up to approximately 10% of the U.S. demand for Mo-99. The company’s production capacity is expanding approximately every six months, with the expectation that within three to five years, it will have the capability to regularly supply an estimated 65% of U.S. Mo-99 demand, and up to 100% of U.S. demand in an emergency.
Strategic product portfolio expansion

NorthStar is expanding its company portfolio through strategic acquisitions that complement its current products.

In March 2020, NorthStar announced exclusive, worldwide licensing of an investigational fibrin-targeted cardiac diagnostic imaging agent, from Capella Imaging. The agent, known as FibroScint, may have potential applications across multiple cardiovascular conditions. Clinical investigation of FibroScint will begin with an exploratory Phase 1 study for its potential use in identifying thrombus (blood clots) in patients with serious heart failure who use a left ventricular assist device (LVAD). This Tc-99m imaging agent complements the commercially available RadioGenix System, and NorthStar intends to use RadioGenix System-produced Tc-99m in planned clinical studies.
Development of commercial-scale therapeutic radioisotope production

NorthStar is applying its expertise in the development and commercialization of innovative radioisotope technologies to advance commercial-scale production of therapeutic radiopharmaceuticals such as copper-67 (Cu-67) and actinium-225 (Ac-225).

In February 2020, NorthStar and Clarity Pharmaceuticals signed a Letter of Intent for NorthStar to supply Clarity with Cu-67, a radiopharmaceutical with potential for treating a range of cancers. NorthStar will be a major U.S. supplier of Cu-67 for Clarity in its clinical development and commercialization plans.
Additionally, NorthStar will supply Ac-225 to several undisclosed companies to support their clinical development and commercialization plans for therapeutic radiopharmaceuticals.
Corporate development and industry leadership activities

NorthStar is firmly positioned for sustained growth and increasing industry leadership.

NorthStar completed a $100 million financing with Oberland Capital in July 2019, with proceeds to be used to increase domestic production capacity efforts for Mo-99, implement additional RadioGenix System enhancements and advance its R&D activities.
In July 2019, NorthStar was awarded an additional $30 million Cooperative Agreement by DOE/NNSA to accelerate domestic Mo-99 production, as part of DOE/NNSA’s objective to establish reliable domestic Mo-99 production without the use of highly enriched uranium. NorthStar will use funds from the award to further advance its current neutron capture technology for domestic, non-uranium based Mo-99 production, and to continue development of enhancements for the RadioGenix System.
With an eye to the future, NorthStar is highly engaged in advancing educational initiatives for the nuclear medicine community and widely regarded/recognized as a leader in radioisotope technology development and commercialization.
At the June 2019 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging, the company presented information about the RadioGenix System and Tc-99m production using non-uranium based Mo-99 to an audience of nuclear medicine technologists, and provided an update on the outlook for current and future Mo-99 supply in the general session.
In August 2019, NorthStar and Purdue University College of Pharmacy announced a collaborative agreement expanding the College’s nuclear pharmacy training curriculum. NorthStar provided the College of Pharmacy with a RadioGenix System to enable nuclear pharmacy students the opportunity to become familiar with the advanced yet easy to operate equipment, and the College will provide NorthStar with feedback about the RadioGenix System and early testing of planned enhancements.
In August 2019, NorthStar participated in the Atoms for Humanity Summit, a forum of nuclear experts convened to look at the future of nuclear energy, and participated in a panel discussion around the next generation of nuclear medicine and health.
In February 2020, NorthStar was awarded the World Council on Isotopes’ President’s Award, which recognizes outstanding contributions to the promotion of isotope technologies and the use of isotopes to benefit mankind.
About the RadioGenix System (Technetium Tc 99m Generator)

The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium/non-highly enriched uranium molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium/non-highly enriched uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.

Indication and Important Risk Information about the RadioGenix System and Sodium Pertechnetate Tc 99m Injection USP

INDICATION

The RadioGenix System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.

Sodium Pertechnetate Tc 99m Injection is also indicated in

Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION

Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Discard the first eluate from every new Potassium Molybdate Mo 99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.
Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 12 hour expiration time from elution is reached, whichever occurs earlier.

On March 20, 2020 STELLA PHARMA CORPORATION (Head office: Chuo-ku, Osaka City, President: Tomoyuki Asano) hereby reported that its drug for Boron Neutron Capture Therapy (BNCT [Note * 1 ]) Steboronine intravenous drip bag 9000mg/300mL (Generic name: Borofalan [10B]; hereinafter referred to as Steboronine) was approved by the Ministry of Health, Labour and Welfare of Japan for the treatment of locally unresectable recurrent or unresectable advanced head and neck cancer (Press release, Stella Chemifa, MAR 20, 2020, View Source [SID1234638634]).

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Head and neck cancer is a group of cancers that develop below the brain, ranging from the cranial base to the collarbone (such as the ear, nose, mouth, jaw and throat areas). The head and neck areas contain organs necessary for everyday activities, and therefore there is a need for the establishment of treatment that can both control the cancer and preserve such functions after the treatment. BNCT is a treatment in which the radiation destroys 10B-loaded cancer cells only, and is therefore expected to control the cancer while having less impact on peripheral normal tissues and their functions.

STELLA PHARMA CORPORATION conducted a Japanese phase II study (Note *2) with head and neck cancer patients in collaboration with Sumitomo Heavy Industries Ltd. (Head office: Shinagawaku, Tokyo; President: Shinji Shimomura), and filed for approval to manufacture and sell Steboronine based on the phase II results in October 2019. Steboronine was approved today by the Ministry of Health, Labour and Welfare of Japan as the world’s first boron drug for BNCT. Sumitomo Heavy Industries Ltd. obtained medical device approval for manufacturing and sales of an accelerator-based BNCT system on March 11, 2020 from the Ministry of Health, Labour and Welfare of Japan (Note *3). STELLA PHARMA CORPORATION has been developing Steboronine through industryacademia-government collaboration with support from Osaka Prefectural University (Location: Sakai City Naka-ku; President: Masahiro Tatsumisago), the Japan Science and Technology Agency, and the Japan Agency for Medical Research and Development, using the boron isotope enrichment technology (Note *4), established by our parent company STELLA CHEMIFA CORPORATION (Head office: Chuo-ku, Osaka City; Representative Director, President and Chief Executive Officer: Aki Hashimoto). In April 2017, the product was designated as a product subject to the "SAKIGAKE Designation System" by the Ministry of Health, Labour and Welfare. STELLA PHARMA CORPORATION will continue to work toward having Steboronine listed in the National Health Insurance drug price list and toward further development to expand the drug’s indications. STELLA PHARMA CORPORATION will continue to contribute to global medical care through the development of innovative pharmaceuticals and new treatment options for patients. Product Outline Product Name Steboronine intravenous drip bag 9000mg/300mL Generic Name Borofalan [10B] Indications Locally unresectable recurrent or unresectable advanced head and neck cancer Dosage & Administration For adult patients, administer Steboronine intravenously at 200 mg/kg/h as Borofalan(10B) for 2 hours, followed by neutron irradiation to the cancer lesion with continuous infusion at 100 mg/kg/h. SUPPLEMENTARY INFORMATION *1 Boron neutron capture therapy Boron-neutron capture therapy (BNCT) is a type of radiotherapy and a new way to treat cancer. Boron (10B) accumulates in cancer cells, when 10B compound is administered to patients and a neutron beam then is irradiated to the cancerous area from outside the body. The irradiated neutron-beam has very low-energy and has little effect on the human body. When the neutrons collides with the boron (10B) in the cancer cells, nuclear fission occurs so as to generate radiation (alpha-rays and 7Li-nuclei). BNCT is a treatment in which the radiation destroys cancer cells only. *2 Japanese phase II study A Japanese phase II study was conducted in 21 patients with locally unresectable recurrent squamous cell carcinoma of the head and neck or unresectable non-squamous cell carcinoma of the head and neck with the primary endpoint of tumor response (response rate) based on RECIST (Response Evaluation Criteria in Solid Tumors) v 1. 1. Overall response rate (95% CI) at 90 days after neutron irradiation was 71.4 (47.8-88.7) %. No dead or discontinued cases were observed during the primary endpoint evaluation period (90 days after neutron irradiation). *3 Medical devices for BNCT in combination with Steboronine  BNCT System NeuCureTM（Approval No.：30200BZX00084000）  BNCT dose calculation program NeuCureTM Dose Engine (Approval No. 30200BZX00083000) *4 Isotope enrichment technology for boron Naturally occurring boron contains 10B with a mass of 10 and 11B with a mass of 11. 10B contains only about 20%. Nuclear fission by neutrons used in the BNCT to destroy cancer cells is caused only by 10B, but not by 11B. Boron isotope enrichment technology is indispensable for BNCT. In Japan, STELLA CHEMIFA CORPORATION is the sole owner of boron isotope enrichment technology for separating and concentrating only 10B at high concentrations. STELLA PHARMA CORPORATION-Company Info STELLA PHARMA CORPORATION is committed to implementing its own corporate mission of "we shed new light on medical practice world-wide to save every irreplaceable life" as a principle of its corporate philosophy. In order to realize this corporate philosophy, we have been working to deliver BNCT to the market as a new treatment for incurable cancer since the founding of our company. We have decided to contribute to the prosperity and health of society through the development of innovative pharmaceuticals and new treatment options for cancer patients. For more information, please refer to the STELLA PHARMA website at View Source Precaution The information contained in this document is intended to disclose management information and is not for advertising or promotional purposes.

On March 20, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), is reported that it has been informed its Chinese partner, EOC Pharma, has completed patient recruitment for the ongoing EOC202A1101 study being conducted in China (Press release, Immutep, MAR 20, 2020, View Source [SID1234555745]). EOC Pharma is an oncology focused specialty pharmaceutical company headquartered in Shanghai, China, and is the exclusive licensee of eftilagimod alpha ("efti" or "IMP321") from Immutep for the Chinese market. The last patient was enrolled and safely dosed in February 2020, bringing the total number of participating patients to 12.

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The EOC202A1101 study is taking place at the Fudan University Shanghai Cancer Center in China and is a single-center, open label, fixed dose-escalation phase I study in MBC patients. Under the license, EOC Pharma is evaluating Immutep’s lead product candidate, efti, in combination with chemotherapy agent, paclitaxel, in Chinese patients. Participants are receiving either 6 mg or 30 mg doses of efti over the six-month treatment period to determine the safety, tolerability and efficacy of the combination treatment, along with the appropriate dose for a potential phase II study.

Efti continues to have a good safety profile supported by the interim safety data from the trial. No serious adverse events were reported from the combination therapy and no dose limiting toxicity events were observed in either dose group. Based on interim data and Immutep’s published MBC data from Caucasian patients, the 30 mg dose of efti has already been recommended for a registration clinical trial in Europe (Immutep’s AIPAC trial).

EOC Pharma CEO, Xiaoming Zou, said: "Our EOC202A1101 study is progressing well. The safety data so far is supportive of the 30 mg dose of efti for a potential registration trial in China. We look forward to seeing the readout of Immutep’s phase IIb AIPAC trial in MBC patients in March. If the AIPAC results are also positive, we will have confidence to move forward with our plans for the registration trial, deepening our partnership with Immutep."

EOC202A1101 Principle Investigator, Prof. Xichun HU, Director of Medical Oncology at Fudan University, said: "It is encouraging to see the combination therapy continues to demonstrate a good safety profile, consistent with other trials. As the study continues and more patients complete their treatment courses, we will be able to report efficacy data."

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

Immutep CEO, Marc Voigt stated: "EOC Pharma are our partner for efti in China and we are excited to see such strong progress being reported from their trial in MBC, particularly as we prepare to report results from our own late-stage breast cancer trial, AIPAC, this month."

Data is expected to be reported from EOC202A1101 during 2020, with study completion in Q4 CY2020. EOC Pharma holds the exclusive development and commercialisation rights for efti in China, including Hong Kong, Macau, and Taiwan via a licensing agreement with Immutep. EOC Pharma will make further milestone payments to Immutep if efti achieves specific development milestones as well as undisclosed royalties on sales. EOC Pharma refers to efti as "EOC202".

About the EOC202A1101 Trial

The EOC202A1101 study is taking place at the Fudan University Shanghai Cancer Center in China and is a single-center, open label, fixed dose-escalation phase I study in 12 metastatic breast carcinoma patients. The study is evaluating Immutep’s lead product candidate, eftilagimod alpha ("efti" or "IMP321"), in combination with chemotherapy agent, paclitaxel, in Chinese patients. Participants are receiving either 6 mg or 30 mg doses of efti over the six-month treatment period to determine the safety, tolerability and efficacy of the combination treatment, along with the appropriate dose for a potential phase II study. The Chinese IND application for EOC202 (efti) was approved by the Chinese National Medical Products Administration (NMPA) in December 2017.