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.

On September 22, 2023 Hillstream BioPharma Inc., (NASDAQ:HILS), a biotechnology company developing innovative therapeutic candidates in rare immune, inflammatory and oncologic diseases reported a corporate name change to Tharimmune, Inc., ("Tharimmune"). The corporate name change is based on the Greek word "thárros", translated to mean courage and reflects the transformation of the Company into a patient-focused, clinical development organization (Press release, Hillstream Biosciences, SEP 22, 2023, View Source [SID1234656413]). The Company’s common stock will trade on The Nasdaq Capital Market under a new ticker symbol, THAR, effective as of Monday, September 25, 2023.

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"Over the past few months, we have made significant progress in shifting the focus of the Company to align with our future vision to impact patients in serious need of new treatment options," said Randy Milby, Chairman and CEO of Tharimmune, Inc. Our new name, dedicated to the courage of all people diagnosed with diseases of high unmet need, aligns with this focus as we shift into a patient-centric organization striving towards developing impactful and accessible products."

Tharimmune is progressing towards acquiring a clinical stage asset, TH104, with a recently approved IND. TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis or "uncontrollable itching". The Company expects to close the acquisition in the fourth quarter as well launch and complete a phase 1 pharmacokinetic trial by year-end. The clinical data package is strengthened by the phase 1 clinical trials already conducted ex-US, which showed reliable bioavailability of the active ingredient in TH104 via transmucosal film technology in both healthy volunteers as well as people diagnosed with liver disease, including primary biliary cholangitis.

On September 22, 2023 Chime Biologics, a leading CDMO that enables biologic therapeutics development reported a strategic cooperation agreement with Panolos Bioscience, a South Korean biotech company to accelerate multi-specific protein development, at a signing ceremony held in Optics Valley Wuhan, Hubei Province on the 19th of September (Press release, Panolos Bioscience, SEP 22, 2023, View Source [SID1234656258]). Dr. HyeSeong Lim, Founder and CEO of Panolos Bioscience, and Mr. YoungHoon Cho, Chief Business Officer of Panolos Bioscience, as well as Chime Biologics’ team attended the signing ceremony.

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Panolos Bioscience, located in the suburb of Seoul, Korea, is a biopharmaceutical company focused on the development of multi-specific therapeutics to treat cancer, auto-immune diseases and rare diseases. Panolos Bioscience has entered into a collaboration with Chime Biologics for a novel multi-specific protein drug, PB203, for solid tumors (PDAC/ICC), which is in the preclinical stage with plans to conduct clinical trial Phase I in the US. Chime Biologics will provide an one-stop biologic CMC solution for the development and manufacturing of PB203 from cell line development, process development, and GMP manufacturing service. And it will be based on the unique Chime’s CHOrus platform, which has a highly productive, rapid, and stable cell line development capability to select the optimal stable expression clones based on expression titer and quality.

The leaders from the Consulate General of the Republic of Korea, Wuhan, Foreign Affairs Office of Wuhan Municipal People’s Government, Wuhan East Lake High-tech Development Zone, and Wuhan National Bio-Industry Base Construction Management Office witnessed the signing ceremony, and this agreement underlines the strong collaboration between China and Korea.

Dr. HyeSeong Lim, Founder and CEO of Panolos Bioscience, said, "We are pleased to be a global strategic partner with Chime Biologics, and the co-development of PB203 is an important start in establishing our long-term strategic cooperation in Wuhan, China, covering commercial manufacturing. This is the first step in our shared mission to the commercialization of innovative medicines, starting from China and spreading to the world. By partnering with global CDMO Chime Biologics, we will do our best to bring hope and a new life to our patients."

Dr. Jimmy Wei, President of Chime Biologics, said, " We are very excited to work with Panolos Bioscience to drive the project to Wuhan, China, taking unique advantage of Chime’s CHOrus cell line development platform that enables the US clinical trials and global sampling. This is not only a recognition of Chime Biologics’ new business model and international quality system, but also an important development journey for Chime Biologics to go globally. We believe that Chime Biologics’ high-quality platform and rich experience will facilitate the global R&D, clinical trials and future commercial manufacturing of multi-specific therapeutic proteins."

About PB203
PB203, a multi-specific protein targeting VEGF, PIGF, and PD-L1, is currently in pre-clinical development as a potential remedy for solid tumors, notably pancreatic cancer. Its promising efficacy, published in Nature Communication in 2022, was further accentuated during an oral presentation at this year’s Immuno-Oncology Summit in the US. This notable discourse emphasized its clear therapeutic mechanism and potential impact on pancreatic cancer treatment.