On September 25, 2023 Novartis reported plans for the 100% Spin-off of the Sandoz business, with trading of new Sandoz Group AG shares and ADRs (American Depositary Receipts) to commence on October 4, 2023 (Press release, Novartis, SEP 25, 2023, View Source [SID1234635357]).

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This follows the previously announced Novartis shareholder approval for the Spin-off of Sandoz, at the EGM on September 15 2023. In addition, key regulatory approvals have been obtained, including the approval by SIX Exchange Regulation for the listing of the Sandoz shares on the SIX Swiss Exchange (subject to technical deliveries only).

The shares of Sandoz are expected to be listed and traded from October 4, 2023 on the SIX Swiss Exchange with the symbol "SDZ". Sandoz will be included in the Swiss Performance Index (SPI), Swiss Leader Index (SLI) and other relevant Swiss indices following completion of the Spin-off, as announced by the SIX Swiss Exchange. Sandoz ADRs are envisaged to be traded on the OTCQX, with the symbol to be available shortly before the Spin-off date.

Key ratings agencies have confirmed Sandoz’ credit rating will be investment grade following the Spin-off, placing the company in a strong position among its peers. Moody’s Investors Service and S&P Global Ratings have rated Sandoz Baa2 and BBB, respectively.

Sandoz has secured debt financing of USD 3.75 billion (in various currencies) through a group of banks which will also support Sandoz with a revolving credit facility of USD 1.25 billion to serve as an undrawn backstop facility.

The Spin-off will be completed via distribution of a dividend-in-kind by Novartis, which is expected to occur on October 4, 2023. Each Novartis shareholder will receive one Sandoz share for every five Novartis shares and each Novartis ADR holder will receive one Sandoz ADR for every five Novartis ADRs. Novartis shareholders and ADR holders will receive a cash amount for any fractional interest. The Spin-off is expected to be tax neutral for Swiss tax and US federal income tax purposes.

The listing prospectus of Sandoz and any supplements thereto can be accessed through the following links:

Click here (www.sandoz.com/prospectus) to access the Listing Prospectus,
Click here (www.sandoz.com/sandoz-spin) to access the supplements to the Listing Prospectus and other related documents.
Additional Transaction Details

Completion of the proposed Spin-off is subject to satisfaction of certain conditions, including no event outside of the control of Novartis preventing the Spin-off and no material adverse change. There can be no assurance regarding the ultimate timing of the proposed transaction or that the transaction will be completed.

On September 25, 2023 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage CTCL, reported that renowned dermato-oncology expert and study investigator, Professor Dr. Rudolf Stadler, University Hospital Johannes Wesling, Minden, Germany, presented positive new data from the pivotal RESMAN study of resminostat (Kinselby) at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting, at the Leiden University Medical Center Amsterdam, The Netherlands, 21-23 September (Press release, 4SC, SEP 25, 2023, View Source [SID1234635356]).

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The presented findings show that maintenance therapy is now clinically proven to postpone disease progression in advanced CTCL which could significantly change clinical practice. In RESMAIN, one of the largest randomized, controlled clinical trials in advanced CTCL, resminostat (Kinselby) treatment has shown a statistically significant improvement in progression free survival of 97.6% compared to placebo, with a risk reduction of 38% in recently announced headline trial results (median PFS: 8.3 months versus 4.2 months; p=0.015; HR: 0.623 (95%CI: 0.424, 0.916).

Furthermore, resminostat (Kinselby)’s median time to next treatment (median TTNT) versus placebo showed a significant improvement of 8.8 months compared to 4.2 months; p= 0.002; HR: 0.594 (95% CI: 0.424, 0.916).

The side effects of resminostat were mainly mild to moderate, manageable and reversible and the known safety profile of resminostat (Kinselby) was confirmed in the RESMAIN study.

Additional analyses established that those treated showed a clinically meaningful improvement in median "total" PFS (defined from start of last prior therapy to disease progression) of 24.3 months, compared to 14.9 months for those in the placebo group. It was also noted that there was a significant delay in the development of new, or worsening of existing, skin tumours.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "Positive data from the RESMAIN study demonstrate that resminostat (Kinselby) is effective in significantly slowing disease progression in CTCL patients. This unique treatment, which is the only proven maintenance therapy for CTCL, means that it is well placed to offer significant benefits for patients who would otherwise have no other similar treatment options available to them.

Our focus in the near term is on the registration, approval and commercialization of Kinselby in the European Union, Switzerland and the UK and we are on track to file for European Marketing Approval of Kinselby in Q1 2024, to rapidly bring this therapy into clinical use. 4SC is well positioned for realization of resminostat (Kinselby)’s considerable value through either a sale, licensing, or partnership agreement."

The Company will host a live webinar on Wednesday 4th October to discuss the findings presented at EORTC. Dr. Susanne Danhauser-Riedl, 4SC’s Chief Medical Officer, will be joined by medical experts, Professor Dr. Rudolf Stadler and Professor Julia Scarisbrick, who will provide further detail on these data, with the presentation being followed by the opportunity to ask questions during a Q&A session moderated by Dr. Jason Loveridge, 4SC’s Chief Executive Officer.

Title: Presentation by Professor Rudolf Stadler and Professor Julia Scarisbrick on recent new positive data from the RESMAIN study

Date and Time: Wednesday 4th October, 3.00pm CET

Register and submit questions: View Source

On September 25, 2023 Novartis reported that the Phase III NETTER-2 trial with Lutathera (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) met its primary endpoint (Press release, Novartis, SEP 25, 2023, View Source [SID1234635353]). First line treatment with Lutathera in combination with long-acting octreotide demonstrated a significant improvement in progression-free survival (PFS) in patients with newly diagnosed somatostatin receptor (SSTR)-positive, Grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) versus high-dose long-acting octreotide alone1,2. No new or unexpected safety findings were observed in the study and data are consistent with the already well-established safety profile of Lutathera1-4.

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NETs are a type of cancer that originate in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies. However, some NETs are associated with rapid progression and poor prognosis and in many cases, diagnosis is delayed until patients have advanced disease5-7. Even though NETs are a rare (orphan) disease, their incidence has grown over 500% in the last three decades5-8 and there is an urgent need for additional treatment options for patients newly diagnosed with inoperable or advanced disease.

With these results, NETTER-2 is Lutathera’s second Phase III trial showing clinically meaningful results for patients2,4. The approval of Lutathera was originally based on the pivotal NETTER-1 trial, which demonstrated highly significant and clinically meaningful PFS prolongation for patients treated with Lutathera in combination with long-acting octreotide versus high-dose (60 mg) long-acting octreotide for SSTR-positive, inoperable midgut neuroendocrine tumors (NETs) who were progressing despite standard treatment3-4,9.

"These positive results for Lutathera are quite remarkable and they represent the potential for radioligand therapy to make a meaningful impact for newly diagnosed patients living with advanced GEP-NETs," said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. "Exploring the use of radioligand therapies in earlier lines of treatment for patients with cancer is part of our larger, collaborative effort to precisely deliver novel treatment modalities directly to the cancer cells to improve patient outcomes."

The findings from NETTER-2 will be presented at an upcoming medical meeting and discussed with regulatory authorities.

About NETTER-2
NETTER-2 (NCT03972488) is an open-label, multi-center, randomized, comparator-controlled Phase III trial assessing whether Lutathera plus long-acting octreotide when taken as a first line treatment can prolong PFS in patients with high-proliferation rate tumors (G2 and G3), compared to treatment with high-dose (60 mg) long-acting octreotide2. Eligible patients were diagnosed with SSTR-positive advanced GEP-NETs within 6 months before enrollment2.

About Lutathera
Lutathera (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) is an Advanced Accelerator Applications RLT approved in the United States for the treatment of SSTR-positive GEP-NETs, including foregut, midgut and hindgut neuroendocrine tumors in adults and in Europe for unresectable or metastatic, progressive, well-differentiated (G1 and G2), SSTR-positive GEP-NETs in adults.

On September 25, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that it has closed the Share Purchase Plan (SPP, see ASX Announcement 18 August 2023) component of its capital raising in conjunction with the acquisition of the exclusive licensing rights to azer-cel, raising a further $18.2 million (Press release, Imugene, SEP 25, 2023, View Source [SID1234635350]).

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Under the SPP, approximately 325 million shares will be issued at $0.056 per share, representing the lower of $0.084 and a 2.5% discount to the 5-day VWAP up to and including the closing date of the SPP (21 September 2023).

Under the SPP, Eligible Shareholders will also receive one free option for every New Share subscribed for. The New Options will have an exercise price of $0.118 per option with an expiration of 31 August 2026 and will be subject to shareholder approval. It is intended that the New Options will be quoted on the ASX.

The new ordinary shares subscribed for under the SPP are expected to be issued on Tuesday, 26 September 2023.

Imugene’s Executive Chairman Paul Hopper said: "I want to thank our existing shareholders for their support of the SPP on behalf of the Board and management of Imugene. With a portfolio of world-class assets, backed by an outstanding balance sheet, Imugene is well placed to continue its development and provide shareholder value to our loyal investors in due course."

On September 23, 2023, oncologists and experts from more than 60 clinical research centers across the country gathered in Guangzhou to participate in the YL201 Phase I/II Investigators Meeting hosted by Suzhou MediLink Therapeutics Co., Ltd (Press release, Suzhou Medilink Therapeutics, SEP 23, 2023, View Source [SID1234635352]). The chair of this meeting was Professor Li Zhang, from the Cancer Center of Sun Yat-sen University, who gathered the wisdom and experience of experts, to discuss the development strategy of the clinical trial protocol in depth, and lay a solid foundation for the efficient drug development of YL201.

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Presentation by the Chairperson of the Meeting, Lead Investigator Professor Li Zhang, said that "ADC is currently a highly anticipated field, and the data generated from the early international multi-center clinical trial of YL201 project by MediLink is exciting. There is hope for a breakthrough therapy in the future, and it has provided a solid foundation for the rapid advancement into Phase I/II. Sincere wishes for further progress and breakthroughs in this project, bringing better data and outcomes to the field of cancer treatment".

At the meeting, Professor Hongyun Zhao shared the exciting clinical trial data of the recent successful dose exploration stage.

Sponsor representative, Dr. Tongtong Xue, Chairman and CEO of MediLink Therapeutics, said in his opening remarks that "it is a great honor to invite experts in the field of oncology from all over China to witness the growth and progress of MediLink. As a dynamic young company, through the joint efforts of the team, researchers and collaborators in the past 1.5 years, the YL201 project has been initially confirmed for safety, and the convening of this Investigator’s Meeting marks the initial success of the original TAMLIN antibody conjugation technology of MediLink". Dr. Xue also noted that "MediLink has made great strides to help patients and still has a long way to go", underscoring the belief of MediLink to continue to accelerate the pace of development for YL201, and contribute to new cancer treatment solutions to benefit more patients.