On March 29, 2021 Herantis Pharma Plc ("Herantis or the Company"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative therapies, reported that the Board of Directors has decided to focus all company resources on Herantis’ CDNF and xCDNF assets and to commence seeking out-licensing partners for the Lymfactin program in the treatment of Breast Cancer Related Lymphedema (BCRL) (Press release, Herantis Pharma, MAR 29, 2021, View Source,c3316583 [SID1234577488]).

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As previously announced in a press release on March 2, 2021 that while a favourable safety profile for Lymfactin has been established, and important observations on the potential activity of Lymfactin were made, the efficacy data from the Phase II Lymfactin program was inconclusive.

This prompted a full evaluation of the overall program and the company resources required to move the program forward. The review focused on learnings from this pioneering study and how best to address them to accurately capture treatment effect, implications for the overall program, resourcing requirements for the Lymfactin program moving forward, and strategic considerations together with Herantis’ central nervous system (CNS) assets. As a result of this comprehensive evaluation, Herantis’ Board of Directors have concluded that the best course of action for the Company is firstly to focus all activities, strategy and resources solely on the exciting CNS portfolio, and secondly to seek a suitable partner to take over further development of the innovative Lymfactin program.

Craig Cook CEO commented "We are at an inflection point and this is an important strategic decision. It is the right time to separate the Company assets and move forward as a pure play Neuroscience company focusing on our CDNF and xCDNF portfolios. We are very grateful to the patients, investigators and medical professionals involved in the Lymfactin program, without their contributions, we would not have been able to advance this ground-breaking research into the treatment of BCRL with Lymfactin."

In-line with this decision, Herantis will structure all its research and operations on neurodegenerative diseases, accelerating its programs in Parkinson’s Disease and other neurodegenerative diseases.

Herantis will host a live session 30th March at 10am CET/11am EET with Craig Cook, CEO and Antti Vuolanto, COO, to further discuss the company’s new strategic focus.

About Cerebral Dopamine Neurotrophic Factor – CNDF and xCDNF

Herantis focuses on disease modifying therapies for debilitating neurodegenerative diseases by restoring the neuronal protective mechanism of proteostasis, a key system in neurodegenerative disease. Proteostasis regulates proteins within the body and influences the fate of every protein from synthesis to degradation. Its failure results in a vicious cycle of pathological accumulation of protein aggregates, neuroinflammation and various forms of cellular stress that is widely implicated with the development of many neurodegenerative diseases including Parkinsons Disease, Alzheimers and other diseases. CDNF is a natural protein that occurs naturally in the body whose natural role is to protect neurons by balancing and supporting proteostasis, thereby preventing and counteracting disease generating mechanisms. Herantis is taking this natural ability and harnessing it as a treatment for neurodegenerative disease. CDNF – a biological protein – is Herantis’ lead program and a clinical stage asset; and xCDNF – a synthetic peptide version of CDNF – is Herantis’ follow-on program. Both CDNF and xCDNF have, via their multimodal mechanism of action, the potential improves neuronal survival and to stop the progression of Parkinson’s and other neurodegenerative disease and have a significant therapeutic impact on the lives of patients.

About Lymfactin

Lymfactin is the world’s first and only clinical stage gene therapy that repairs damages of the lymphatic system. It expresses the human growth factor VEGF-C, which is naturally associated with the development of lymphatic vessels. Based on preclinical studies, Lymfactin triggers the growth of new functional lymphatic vasculature in the injured area and thus repairs the underlying cause of secondary lymphedema. The first target indication for Lymfactin is Breast Cancer Associated Lymphedema; Herantis believes that Lymfactin may also be suitable for the treatment of other forms of secondary lymphedema if its safety and efficacy are established in the first indication.

Lymfactin, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national center of excellence at the University of Helsinki.

On March 29, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAR 29, 2021, View Source [SID1234577319]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 3 February 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.0 billion in the period from 3 February 2021 to 3 May 2021.

Since the announcement as of 22 March 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 43,154,586 B shares of DKK 0.20 as treasury shares, corresponding to 1.8% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 3 February 2021. As of 26 March 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 4,251,974 B shares at an average share price of DKK 444.02 per B share equal to a transaction value of DKK 1,887,954,182.

On March 29, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported a business update on its ongoing programs (Press release, Sonnet BioTherapeutics, MAR 29, 2021, View Source [SID1234577318]).

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"Last year we continued execution across our pipeline, and I am excited to share an update on our ongoing activities," commented Pankaj Mohan, Ph.D., Founder and CEO. "This year we expect to be in the clinic with multiple programs, which we believe is an important milestone for patients."

SON-1010 (FHAB-IL12): Sonnet has completed nonhuman primate (NHP) GLP toxicity studies with SON-1010 and is awaiting data to prepare an IND submission, while working in parallel to initiate clinical trials during the second half of this year. Prior to IND submission, the Company will initiate pre-IND interactions with FDA, which are expected during the second quarter, and will work to finalize the first-in-human protocol, along with selecting a CRO to perform the studies. CMC activities are on schedule to deliver GMP material prior to the IND filing.

SON-080 (Fully Human IL-6) – Chemotherapy Induced Peripheral Neuropath (CIPN): With successful GLP toxicity studies completed, the CMC manufacturing is well underway, and product is expected to be available for a clinical trial commencing during the second half of this year. Plans have been initiated to complete the study design protocol for a Phase 1b/2a study, as well as the completion of diligence and selection of a CRO.

SON-081 (Fully Human IL-6) – Diabetic Peripheral Neuropathy (DPN): Sonnet anticipates completing the partnership deal in South East Asia during April 2021 that Sonnet expects will position New Life Therapeutics (NLT) to fund and progress the asset forward into a Phase 1b/2a clinical trial. NLT has elected to focus on the acceleration of the development of low dose IL-6 for DPN at this time, and to hold an option to the CIPN indication for several months following the execution of a definitive agreement. Sonnet anticipates that clinical trial initiation will occur during the second half of this year. Sonnet has recently obtained positive initial comparability data from the new batch being manufactured using an updated process and awaits final study completion and reports of product comparability, prior to IND filing.

SON-1210 (IL12-FHAB-IL15): Sonnet’s first bispecific candidate is undergoing cell line and process development. Sonnet has engaged a novel intensified perfusion manufacturing process to generate clinical grade material and expects completion of NHP studies in the second half of this year with an IND submission during the first half of 2022.

SON-2014 (GMcSF-FHAB-IL18): In addition to GMcSF-FHAB-IL18, Sonnet has manufactured bi-specific preclinical constructs of IL18-FHAB-IL12 and IL12-FHAB-GMcSF that are being evaluated for in vivo efficacy, biomarker profiles and fluorescence-activated cell sorting (FACS) assessment in single dose and multi-dose preclinical studies.

Upon completion of the preclinical efficacy evaluation in the second quarter of this year, Sonnet intends to initiate commercial cell line development necessary for future clinical trials. An IND submission for SON-2014 is currently targeted for the second half of 2022.

SON-3015 (Anti-IL6-FHAB-Anti-TGFβ): Sonnet is in the discovery phase of SON-3015 development and is currently panning the candidate for binding and stability, after which the preclinical bispecific product will be evaluated in a mice model, expected during the second half of 2021. Sonnet is planning to initiate commercial cell line development in the first quarter of 2022.

INTELLECTUAL PROPERTY: Sonnet has received Notice of Allowance from the USPTO for its first issued patent on the FHAB delivery technology. Formal issuance is expected during the balance of 1H21.

On March 29, 2021 Jacobio Pharmaceuticals (1167.HK) reported its first annual results after its Hong Kong listing (Press release, Jacobio Pharmaceuticals, MAR 29, 2021, View Source [SID1234577304]). By the end of December 31, 2020, its annual revenue was 486 million yuan and R&D expenses exceeded 230 million yuan and increased 66% compared to 2019. As a clinical-stage biotech company, Jacobio has made progress in a number of its pipelines.

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Jacobio focuses on in-house research and development of global first-in-class drugs. Its pipelines target critical cancer cellular pathways, including RAS, MYC, RB, I/O, etc.. Jacobio has expertise in developing allosteric inhibitors against protein tyrosine phosphatase, KRAS and transcriptional factors.

Jacobio generated revenue through licensing out its SHP2 inhibitors to a global partner. "As a clinical-stage biotech company, this licensing deal shows our in-house R&D capabilities," said Dr. Wang Yinxiang, Founder, Chairman and CEO of Jacobio. "We hope to launch our drugs as soon as possible with our partner, to benefit more patients, and realise our commercial value."

Besides SHP2 inhibitors, the clinical-stage pipelines of Jacobio also include the KRAS G12C inhibitor JAB-21000, and BET inhibitor JAB-8263. IND (investigational new drug) applications have been submitted. Five other programs are in the IND-enabling stage.

In terms of the operations, Jacobio’s number of employees has expanded from 130 to about 180 employees in 2020, and the number will continue to grow in 2021. The 20,000 square meter GMP factory in Beijing is under construction and is expected to be completed before the end of 2023. Jacobio has a R&D center with a clinical team in Boston. The Shanghai office will be put into operations in the first half of 2021.

Jacobio was listed on the Hong Kong Stock Exchange Main Board in December 2020 and raised nearly US$200 million (CNY1.3 billion). The company was officially included in the Hang Seng Composite Index on March 15, 2021, and enrolled into the Shenzhen-Hong Kong Stock Connect trading list.

"In 2021, Jacobio will continue investing in R&D. We expect more partnerships with global MNCs to enhance all aspects of drug R&D capabilities, and obtain more global presence," said Dr. Wang Yinxiang.

For more information, please refer to the company’s 2020 annual results announcement published on the Hong Kong Stock Exchange and the company’s official website.

On March 29, 2021 The Menarini Group reported that it has entered into an exclusive license agreement for the development and commercialization of ELZONRIS (tagraxofusp) in the territory of Japan with Nippon Shinyaku Co., Ltd. ELZONRIS is approved for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) by the U.S. Food and Drug Administration and the European Medicines Agency (Press release, Menarini, MAR 29, 2021, View Source [SID1234577303]).

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BPDCN is a rare, aggressive hematologic malignancy with historically poor outcomes. ELZONRIS (tagraxofusp) is the first approved treatment for patients with BPDCN, and the first approved CD123-targeted therapy, in both the United States and Europe. Elzonris was originally developed by Stemline Therapeutics, now part of the Menarini Group.

"Partnering with Nippon Shinyaku marks another important step forward in our effort to meet the needs of patients with difficult-to-treat diseases and underscores our commitment to delivering innovative medicines for people around the globe," commented Elcin Barker Ergun, CEO of the Menarini Group. "Patients with BPDCN have limited treatment options and we are excited to be collaborating closely with Nippon Shinyaku to make ELZONRIS (tagraxofusp) available to patients in Japan."

"Nippon Shinyaku’s focus and expertise in hematologic malignancies makes the company an excellent partner for ELZONRIS (tagraxofusp)," commented Ivan Bergstein, M.D., President and CEO of Stemline Therapeutics, now part of the Menarini Group. "Through this development and commercial partnership, we look forward to advancing ELZONRIS as a potential new treatment option for patients suffering from BPDCN."

About ELZONRIS in the European Union

ELZONRIS (tagraxofusp) is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). ELZONRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents.

About ELZONRIS in the USA

ELZONRIS (tagraxofusp), a targeted therapy directed to CD123, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with BPDCN. For full prescribing information in the U.S., visit www.ELZONRIS.com.

ELZONRIS is also being evaluated in additional clinical trials in other indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and others are planned.

About BPDCN

BPDCN, formerly blastic NK-cell lymphoma, is an aggressive hematologic malignancy, often with cutaneous manifestations, with historically poor outcomes. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. The World Health Organization (WHO) termed this disease "BPDCN" in 2008; previous names included blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic neoplasm. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123

CD123 is a cell surface target expressed on a wide range of malignancies including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123+ cells have been detected in the tumor microenvironment of several solid tumors as well as in certain autoimmune disorders including cutaneous lupus and scleroderma.

Important Safety Information from EU SmPC

Warnings and precautions

Capillary leak syndrome (CLS), including life-threatening and fatal cases have been reported with most events occurred during the first five days of the first cycle of treatment. Before initiating therapy, it should be ensured that patients have adequate cardiac function and serum albumin ≥ 3.2 g/dL. During treatment, serum albumin levels should be monitored prior to the initiation of each dose, or more often as clinically indicated. Additionally, patients should be assessed for other signs/symptoms of CLS. Patients should be made aware of identifying CLS symptoms and when to seek immediate medical attention. Intravenous albumin supplementation and dosing interruptions may be required.
Severe hypersensitivity reactions have been reported with ELZONRIS.
Thrombocytopenia and neutropenia have been reported in patients treated with ELZONRIS monotherapy. The majority of events were reported in cycle 1 and cycle 2 of treatment, were not dose-limiting and did not recur in subsequent cycles.
ELZONRIS can cause tumour lysis syndrome (TLS).
Treatment with ELZONRIS has been associated with elevations in liver enzymes. Acute hepatic failure and liver encephalopathy has been reported in a patient treated with ELZONRIS at a higher dose (16 mcg/kg).
Summary of the Safety Profile

The most serious adverse reaction that may occur during ELZONRIS treatment is CLS which was reported in 18% of patients with a median time to onset of CLS of 6 days.
Adverse reactions occurring in ≥ 20% of patients treated with ELZONRIS were hypoalbuminemia, increased transaminases, thrombocytopenia, nausea, fatigue and pyrexia.
Adverse reactions grade 3 and above according to the Common Terminology Criteria for Adverse events (CTCAE) and occurring in > 5% of patients were increased transaminases, thrombocytopenia and anaemia.