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Ipsen Data Presented during ENETS Annual Conference 2020 Capture New Patient and Healthcare Professional Insights in the Treatment of NETs and Acromegaly

On March 11, 2020 Ipsen (Euronext: IPN; ADR: IPSEY) reported the presentation of 13 new abstracts 1 during the 17 th European Neuroendocrine Tumor Society (ENETS) Annual Conference, taking place virtually worldwide, (March 11-13, 2020) and the simultaneous publication of the PRESTO study in the medical journal, Advances in Therapy (Press release, Ipsen, MAR 11, 2020, View Source [SID1234555381]). 2 These data reinforce Ipsen’s personal approach to working with patients living with neuroendocrine tumors (NETs) and acromegaly, and healthcare professionals treating these conditions.

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NETs are rare tumors, but incidences are increasing,3 partly due to improvements in diagnosis and increased awareness4. NETs and the symptoms associated with them have a substantial negative impact on patients’ overall health, quality of life and work life.

Acromegaly is a rare, chronic pituitary hormonal disorder with physical, neuropsychiatric and neurocognitive symptoms. Due to the insidious onset, slow progression and lack of awareness of the disease, acromegaly often takes 5–10 years to diagnose. Diagnostic delays can lead to an increased number and more severe symptoms and comorbidities that can become difficult to manage, reduce the quality of life and increase the risk of mortality.5

Among the results to be showcased by Ipsen during ENETS 2020, several studies featured the Somatuline Autogel (lanreotide autogel) new syringe. Alongside PRESTO, these included a patient and nurse satisfaction appraisal of use related to the Somatuline Autogel new syringe compared with the previous syringe (SONATE), an evaluation of patient satisfaction with the new syringe when self-injecting (AUTOSOMA) and more broadly, novel perspectives on healthcare professional preferences for different somatostatin analogs in the management of NETs and acromegaly.

Amauri Soares, Vice-President, Medical Affairs Oncology at Ipsen commented: "Transforming the lives of patients living with debilitating conditions such as NETs and acromegaly requires a joined-up, co-creating approach and the Somatuline Autogel new syringe was developed based on feedback from physicians, nurses, caregivers and patients who use these delivery systems every day. So, we are proud to be sharing new data during ENETS that demonstrates our commitment beyond clinical studies to uncover patient and nurse preferences, and to better understand patient treatment administration needs whether in hospital or at home. Ultimately, we are committed to ensuring these insights will continue to help us address the high unmet needs of these patients living with rare diseases."

Among the Ipsen data to be showcased during ENETS 2020, key presentations include:

PRESTO: Evaluation of Nurse Preferences Between the Lanreotide Autogel (LAN) New Syringe and Octreotide Long-Acting Release (LAR) Current Syringe: An International Simulated Use Study
Patient and Healthcare Practitioner Perspectives of Somatostatin Analogs in the Management of Neuroendocrine Tumors and Acromegaly: A Systematic Literature Review (SLR)
SONATE: Patient and nurse satisfaction with the new Lanreotide Autogelpre-filled syringe in neuroendocrine tumors: a prospective study (France)
AUTOSOMA: Development and initial validation of a brief questionnaire to assess patient satisfaction with self-injection of Lanreotide Autogel: Results during a home training programme (Spain)
EXPLAIN: Evaluating the use of Plasma Proteins to Predict Progressive Disease in Patients with Small Intestinal Neuroendocrine Tumours
Ipsen also announced the parallel publication of the multinational, simulated-use PRESTO study in the peer-reviewed medical journal, Advances in Therapy.2 The PRESTO study design included the international recruitment of nurses experienced in performing injections in patients with NETs and/or acromegaly, which limited a center or country effect.

The study questionnaire was carefully designed through a systematic literature search and developed with input from end users (nurses/patients) and an expert in patient-reported outcomes to ensure consistency with real-life decision-making. Nurses participating in the PRESTO study rated and ranked the importance of nine attributes for the Somatuline Autogel new syringe and the Octreotide LAR current syringe.

"The experiences, attitudes and knowledge of both patients and healthcare practitioners such as nurses are essential for meaningful progress in complex disease management," said Daphne T Adelman, Clinical Nurse Specialist from Northwestern University in Chicago, U.S. and a lead author on the PRESTO study. "In the absence of head-to-head clinical trials, these data give healthcare professionals important and meaningful insights for the optimal management of patients. The ENETS poster presentation and the Advances in Therapy publication for the PRESTO study further validate the new syringe design enhancements and have broader implications for optimizing patients’ treatment experience."

Overview of Ipsen presentations featuring Somatuline Autogel (lanreotide autogel) during the ENETS 2020 Annual Conference:1

Abstract title

Poster number

Evaluation of Nurse Preferences Between the Lanreotide Autogel New Syringe and Octreotide Long-Acting Release Syringe: An International Simulated Use Study (PRESTO)

H29

Quality of Life, Tumour Heterogeneity and Biomarker Levels in Patients with Progressive Pancreatic or Midgut Neuroendocrine Tumours: Baseline Data from CLARINET FORTE

H25

Patient and Healthcare Practitioner Perspectives of Somatostatin Analogs in the Management of Neuroendocrine Tumors and Acromegaly: A Systematic Literature Review

H13

OPERA: Observational study of Perception of information and quality of life in patients with gastroEnteropancreatic neuRoendocrine tumors starting lAnreotide autogel – Baseline characteristics

D23

Patient and nurse satisfaction with the new lanreotide autogel pre-filled syringe in neuroendocrine tumors (NET): a prospective study (SONATE)

H30

Effectiveness of Lanreotide 120 mg (LAN) in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (panNET) in Routine Clinical Practice

P09

Development and initial validation of a brief questionnaire to assess patient satisfaction with self-injection of lanreotide autogel: Results during a home training programme (AUTOSOMA)

H16

Somatostatin analogs: the economic value of lanreotide autogel delivery attributes in the treatment of GEP-NET versus octreotide LAR – a UK budget impact analysis

H14

Lanreotide autogel and octreotide LAR treatment patterns: results from a nationwide French retrospective study

H12

Longitudinal Changes in Plasma 5-hydroxyindoleacetic Acid (5-HIAA) and Other Biomarkers during Treatment of Functional Midgut Neuroendocrine Tumours (NETs) with Lanreotide Autogel: CALM NET Study Results

F22

Use of Plasma Proteins to Predict Progressive Disease in Patients with Small Intestinal Neuroendocrine Tumours – The Nordic NET Biomarker Group (EXPLAIN)

F12

Oral presentation

Resource use in patients with carcinoid syndrome: a retrospective analysis using the French health insurance national (SNDS) database

P11

Progression-Free Survival and Clinical Outcomes with Long-Term Use of Telotristat Ethyl in US Clinical Practice

H21

Follow Ipsen on Twitter via @IpsenGroup and keep up to date with ENETS 2020 Conference news and updates by using the hashtag #ENETS20.

Cantargia acquires Cellerant IP on IL1RAP

On March 10, 2020 Cantargia AB reported the acquisition of a patent portfolio from Cellerant Therapeutics Inc covering aspects around the interleukin 1 receptor accessory protein (IL1RAP) (Press release, , MAR 10, 2020, View Source [SID1234638816]). The acquired IP includes a US patent on IL1RAP as a target for antibody therapy in leukemia. Thereby, Cantargia has broadened its IP portfolio and secured ownership of the key patents around IL1RAP as a target for cancer therapy.

Cantargia develops antibody-based pharmaceuticals against the interleukin 1 receptor accessory protein (IL1RAP). In the most advanced program, the antibody CAN04 binds IL1RAP with high affinity and its anti-tumor activity consists of stimulation of immune cells to eradicate cancer cells as well as blockade of interleukin 1 signaling. CAN04 is being investigated in an open label phase I/IIa clinical trial, CANFOUR, examining first line chemotherapy combination with two different standard regimes in patients with non-small cell lung cancer (NSCLC) or pancreatic cancer (PDAC), as well as monotherapy in late stage patients (www.clinicaltrials.gov).

Cantargia has a broad patent protection, including IP on the antibody CAN04 valid until 2035, and other IL1RAP binding antibodies. In addition, Cantargia also has patents on antibody therapy targeting IL1RAP in both solid tumors and in hematological cancer. Besides the patents that Cantargia already owns, there is one additional patent on IL1RAP as target for antibody-based therapy in hematological cancer: US patent no. 8,715,619 from Cellerant, valid until 2029. Although hematological cancer is outside Cantargia’s current development focus, Cantargia has now acquired this and remaining patents and patent applications in this family as well as some additional IP from Cellerant’s IL1RAP portfolio. The additional IP concerns a few novel antibodies against IL1RAP that may be further evaluated in Cantargias CANxx program. Under the terms of the agreement, Cellerant will receive an insignificant upfront purchase payment and will also be entitled to a low single digit royalty on sales covered by claims in the acquired Cellerant patents, until they expire. No other milestone payment is included in the agreement.

"Cantargia has focused the CAN04 development on solid tumors and the clinical data we have generated in patients with NSCLC or PDAC are encouraging. By acquiring this IP, we have secured all relevant IP on IL1RAP as a target for cancer therapy", said Göran Forsberg, CEO of Cantargia.

POINT Biopharma and SCINTOMICS Announce License Agreement

On March 10, 2020 POINT Biopharma Inc. reported that it has entered into an agreement with SCINTOMICS GmbH for the exclusive use and development of a family of more than seventy patented next generation PSMA radioligands for targeted radiotherapy of prostate cancer (Press release, Point Biopharma, MAR 10, 2020, View Source [SID1234561513]). Under the terms of the agreement, POINT has acquired both North American and broad international rights to the compounds. SCINTOMICS is eligible to receive milestone payments and royalties over the life of the collaboration.

The announcement of this acquisition complements POINT Biopharma’s PNT 2002 clinical program set to begin in 2020.

According to Michael Gottlieb, POINT Biopharma’s Chief Commercial Officer, "The breadth of this acquisition provides POINT with a clear strategic pathway of patient focused differentiation. POINT is committed to novel treatments and continued innovation of radiopharmaceutical assets."

Joe McCann, POINT Biopharma CEO adds, "We are excited to bring these compounds to patients. We anticipate commencement of a phase 1/2 clinical program in 2021."

Saskia Kropf, SCINTOMICS CEO stated, "We are delighted that in POINT Biopharma we have found an excellent partner for the clinical development of this unique targeting technology. We are certain that in the experienced leadership team from North America and Europe, POINT is well equipped to make this innovative radioligand therapy rapidly accessible to prostate cancer patients."

Dr. Vikas Prasad, (Vice Chair and Senior Physician Department of Nuclear Medicine University Hospital of Ulm Germany) a scientific advisor to POINT Biopharma adds, "Radiomolecular compounds for prostate cancer diagnosis and treatment have been used in Germany for many years with much success. They are positioned to revolutionize the global treatment landscape for patients around the world."

Entry into a Material Definitive Agreement

On March 10, 2020, Rexahn Pharmaceuticals, Inc. ("Rexahn") and BioSense Global LLC ("BioSense") reported that it has entered into an amendment (the "Amendment") to the Collaboration and License Agreement, dated as of February 25, 2019, by and between Rexahn and BioSense, as previously amended (the "Original Agreement" and, as amended by the Amendment, the "Amended Agreement") (Filing, 8-K, Rexahn, MAR 10, 2020, View Source [SID1234555611]). Under the terms of the Amended Agreement, the aggregate upfront payments were reduced to $1.65 million, $1.5 million of which had previously been paid as part of the upfront payment under the Original Agreement. Upon payment in full of the remaining unpaid portion, Rexahn will (i) grant an exclusive license to develop and commercialize pharmaceutical products containing RX-3117 ("Licensed Products") for any indication in the Republic of Singapore, China, Hong Kong, Macau and Taiwan (the "Territory") and (ii) assign and transfer to BioSense all of Rexahn’s patents and patent applications related to RX-3117 in the Territory.

Pursuant to the Amendment, BioSense has agreed to use commercially reasonable efforts to develop a Licensed Product in the Territory, file an investigational new drug application relating to a Licensed Product in China, and take certain other actions relating to commercialization upon any regulatory approval.

The Amendment reflects the agreement of the parties to terminate and remove collaboration provisions under the Original Agreement, reflects the intention of Rexahn not to conduct or sponsor any additional trials with RX-3117, and reduces the milestone payments and royalties payable under the Original Agreement. Under the Amended Agreement, Rexahn is eligible to receive milestone payments in an aggregate of up to $74.5 million upon the achievement of development, regulatory and commercial goals and will also be eligible to receive tiered royalties in the mid-single digits to low tens on annual net sales in the Territory.

Until March 31, 2020, pursuant to the Amended Agreement, BioSense has the option to obtain an exclusive license to develop and commercialize Licensed Products outside the Territory upon the payment of an additional upfront fee.

Axial Biotherapeutics to Present at the Chardan 2nd Annual Microbiome Medicines Virtual Summit

On March 10, 2020 Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted programs for neurodegenerative diseases and neurodevelopmental disorders, reported that David H. Donabedian, Ph.D., Co-founder and Chief Executive Officer of Axial Biotherapeutics will present a virtual company overview and participate in a virtual panel on "Modulating the Microbiome" at the Chardan 2nd Annual Microbiome Medicines Summit on Monday, March 16, 2020 at 8:45 AM ET and 12:40 PM ET, respectively (Press release, Axial Biotherapeutics, MAR 10, 2020, View Source [SID1234555563]).