On January 30, 2024 The interim analysis results from the phase III INSPIRE study of iruplinalkib developed by Qilu Pharmaceutical, which focuses on the first-line treatment of locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), reported to have recently been featured in the Journal of Thoracic Oncology (Impact Factor=20.4), the official journal of the International Association for the Study of Lung Cancer (IASLC) (Press release, Qilu Pharmaceutical, JAN 30, 2024, View Source [SID1234639724]). The publication of the findings in the prestigious international journal underscores the global academic community’s strong recognition of the clinical value of these results, while significantly enhancing the community’s comprehension of the INSPIRE study and iruplinalkib.

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Iruplinalkib is a next-generation ALK receptor tyrosine kinase inhibitor (TKI) that effectively targets both the wild-type and mutant ALK fusion genes. The study, conducted at 40 centers throughout China and led by Prof. Shi Yuankai from the Cancer Hospital of Chinese Academy of Medical Sciences, showed that iruplinalkib significantly extended progression-free survival (PFS) and demonstrated enhanced intracranial anti-tumor activity relative to the control group.

The INSPIRE study, a randomized, open-label, multicenter Phase III clinical trial compared the efficacy and safety of iruplinalkib against crizotinib in locally advanced or metastatic ALK-positive NSCLC patients who had not previously been treated with an ALK inhibitor. Key findings were presented at the 2023 World Conference on Lung Cancer.

Between September 4, 2019 and December 2, 2020, the trial enrolled 292 patients diagnosed with locally advanced or metastatic ALK-positive NSCLC, including 81 with central nervous system (CNS) metastases.

The results of the INSPIRE study, as published in the Journal of Thoracic Oncology and assessed by the Independent Review Committee (IRC) as of November 13, 2022, indicate that the median PFS was significantly longer in the iruplinalkib group (27.7 months) compared to the crizotinib group (14.6 months), with a hazard ratio (HR) of 0.34 (98.02% CI: 0.23-0.52), demonstrating a 66% reduction in disease progression or death risk. The PFS outcomes assessed by investigators were consistent with those determined by the IRC. As of the data cut-off, the median follow-up time for overall survival (OS) was 26.7 months for the iruplinalkib group and 25.9 months for the control group. The median OS had not yet been reached.

Subgroup analyses and additional secondary endpoints further supported iruplinalkib’s superior efficacy. Iruplinalkib led to longer duration of tumor response compared to the control group (median duration of response: 26.8 months versus 12.9 months; HR: 0.31). In patients with CNS metastases at baseline, the iruplinalkib group exhibited a higher intracranial objective response rate (ORR). The intracranial ORR was 57.9% in the iruplinalkib group versus 25.6% in the control group The intracranial complete response (CR) rate was 31.6% compared to 2.6% in the control group. Furthermore, among those with measurable CNS metastases at baseline, the intracranial ORR for the iruplinalkib group reached 90.9%.

In terms of safety, although patients in the iruplinalkib group underwent treatment for a longer duration than those in the control group (23.9 months versus 12.9 months), the frequency of severe adverse reactions (grade 3 or 4) was comparable between the two groups, with 51.7% in the iruplinalkib group versus 49.7% in the control group.

Following the positive outcomes of the INSPIRE study, iruplinalkib was approved by the China National Medical Products Administration (NMPA) in January of this year for use as a single-agent therapy in treating locally advanced or metastatic ALK-positive NSCLC. Longer follow-up of the study is in progress. Updated results will be presented at upcoming academic conferences.

On January 30, 2024 NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, reported that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer (Press release, NeoImmuneTech, JAN 30, 2024, View Source [SID1234639723]).

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Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.[1],[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer has been labeled as a "silent killer" because it is normally asymptomatic in the early stages which implies that it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. This underscores the critical need for new and more effective therapeutic approaches.2

Dr. Luke Oh, Ph.D., President of NeoImmuneTech, Inc. said: "We are excited that the FDA granted NT-I7 an ODD in the treatment of pancreatic cancer. This decision adds further credibility to our existing evidence that NT-I7 has the potential to bring a much-needed therapy option to people suffering from pancreatic cancer. We look forward to continuing our collaboration with FDA, as we explore the therapeutic benefits of combining NT-I7 with other anti-cancer treatments such as immunotherapies for patients with pancreatic cancer."

NT-I7 has been studied in several robust phase I and II clinical trials and has demonstrated the potential to amplify T cells across the subsets, boost the immune system, and enhance the anti-tumor response in people with pancreatic cancer and other solid tumors.[5]

The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Receiving ODD may help to expedite and reduce the cost of development, approval, and commercialization of a therapeutic agent.

About Pancreatic Cancer
Pancreatic cancer is a malignant, aggressive tumor of the pancreas. More than 90% of cases develop in the exocrine tissue of the pancreas, which makes enzymes to digest food. The less common endocrine tumors, commonly referred to as pancreatic neuroendocrine tumors (NETs), develop in hormone-producing cells.[1} Whilst pancreatic cancer’s low prevalence rate qualifies it as a rare cancer, the aggressiveness of the disease and its high death rate means that patients diagnosed have a very poor prognosis. Every year, 157,107 new patients are diagnosed with pancreatic cancer in the US and Europe Union combined. [1],[4]

About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On January 30, 2024 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Alpha-9 Oncology (Alpha-9), a clinical stage biotechnology company developing differentiated and highly targeted radiopharmaceuticals, reported the signature of a global master clinical supply agreement to support the development of Alpha-9’s Radiopharmaceutical Therapy (RPT) pipeline candidates for the treatment of cancer (Press release, ITM Isotopen Technologien Munchen, JAN 30, 2024, View Source [SID1234639722]). Under the terms of the agreement, ITM will supply its medical radioisotope, non-carrier-added Lutetium-177 (n.c.a. 177Lu) for Alpha-9’s Lutetium-based candidates.

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"Entering this strategic collaboration with Alpha-9 underscores our belief in the value of developing established beta-emitters such as Lutetium-177, to advance the radiopharmaceutical industry and maximize patient benefit," commented Steffen Schuster, CEO of ITM. "Our position as the world’s largest supplier of n.c.a. Lutetium-177 make us an ideal partner for Alpha-9. We look forward to working with a company that shares our vision of improving cancer care and outcomes for patients globally."

"A stable and reliable supply of high-quality isotopes is key to the successful development of our pipeline, and partnering with ITM is a valuable next step in building out our proprietary offering of differentiated and precise radiopharmaceuticals," said David Hirsch, M.D., Ph.D., CEO of Alpha-9.

ITM will supply Alpha-9 with its n.c.a. 177Lu for the clinical development of Alpha-9 radiopharmaceutical candidates comprising n.c.a. 177Lu combined with undisclosed targeting molecules. ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a. 177Lu and has marketing authorization in the EU (brand name EndolucinBeta).

About Radiopharmaceutical Therapy (RPT)

Radiopharmaceutical Therapy (RPT) is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope such as Lutetium-177 or Actinium-225 to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, such as receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, with the goal of destroying tumor tissue. The precise localization enables targeted treatment with potentially minimal impact to healthy surrounding tissue.

On January 30, 2024 Rgenta Therapeutics ("Rgenta" or the "Company") reported that it was selected by The Leukemia & Lymphoma Society (LLS) as a new Therapy Acceleration Program (TAP) portfolio company, and provided with strategic funding to support preclinical and clinical advancement of the Company’s therapeutics in hematologic malignancies utilizing its RNA-targeting small molecule platform to target MYB, an oncogenic transcription factor (Press release, Rgenta Therapeutics, JAN 30, 2024, View Source;lymphoma-society-therapy-acceleration-program-302047063.html [SID1234639721]).

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"We are honored by the support and recognition of LLS’s Therapy Acceleration Program. LLS’s strategic investment in Rgenta continues to bolster our confidence in the potential of our pipeline of oral, small-molecule RNA-targeting medicines," commented Simon Xi, Ph.D., CEO of Rgenta. "We are dedicated to advancing these best-in-class RNA-targeting small molecules and believe they have the potential to make a significant impact in the treatment of multiple high-value disease areas."

"We are excited to partner with LLS TAP to tackle historically undruggable oncogenes implicated in hematologic malignancies using our small molecule RNA-targeting platform", said Travis Wager, Ph.D., President & CSO. "We look forward to tapping into the extensive clinical expertise and resources from LLS to accelerate the development of our RNA-targeting MYB inhibitor molecules."

"LLS has a long-standing history of helping to accelerate development of breakthrough blood cancer treatments, and we’re particularly excited when work like Rgenta’s focuses on key mechanisms in blood cancer that have historically been extremely difficult to target with drugs" said Lore Gruenbaum, Ph.D., Vice President of LLS TAP. "This new partnership is an exciting addition to LLS TAP’s portfolio of companies that are working to provide new hope to all blood cancer patients."

On January 30, 2024 Ichnos Sciences Inc. (Ichnos), a global, fully integrated, clinical-stage biotech company and Glenmark Pharmaceuticals Ltd. (Glenmark), a leading, research-driven, global pharmaceutical company, reported the launch of their alliance – Ichnos Glenmark Innovation – to accelerate new drug discovery in cancer treatment (Press release, Ichnos Sciences, JAN 30, 2024, View Source;ichnos-glenmark-innovation-302048131.html [SID1234639720]). This alliance combines Ichnos’ research and development proficiencies in novel biologics with those of Glenmark in new small molecules, to continue developing cutting-edge therapy solutions that treat hematological malignancies and solid tumors.

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The newly formed IGI features a robust pipeline of three innovative oncology molecules targeting multiple myeloma, acute myeloid leukemia, and solid tumors currently undergoing clinical trials. Two of these molecules have received orphan drug designation from the U.S. FDA. Additionally, IGI has two autoimmune disease assets that have been out licensed to leading companies. The alliance will also further explore the in-licensing of late-stage clinical assets to augment its novel oncology drug pipeline.

Harnessing the combined proficiency of over 150 scientists, IGI will leverage the capabilities of its three global centers of innovation. These comprise the Ichnos’ headquarters in New York City, NY, USA which is focused on clinical development; the biologics research center in Lausanne, Switzerland; and Glenmark’s small molecule research center at Mahape in Mumbai, India.

"We are proud to announce the Ichnos Glenmark Innovation alliance, which brings together the legacy of Glenmark and passion of Ichnos to accelerate the search for curing cancer. Innovation is an integral part of our organization’s fabric and through IGI, we are confident of getting closer to our quest to develop a novel cancer drug for the world. Additionally, this will also enhance shareholder value by optimizing the cost of development." remarked Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals Ltd.

Cyril Konto, President and CEO, Ichnos Glenmark Innovation, said, "Ichnos Glenmark Innovation is a collaborative venture backed by a strong, collective pipeline of novel multispecifics and small molecules. Supported by an experienced leadership and comprising a team that ardently believes in challenging the frontiers of science, IGI seeks to accelerate drug development by combining technologies, expertise, and forces while leveraging Glenmark’s footprint in India. We look forward to joining hands with other like-minded entities, including biotech companies and academia."

IGI – Brand Identity:
IGI’s brand identity succinctly expresses its belief. The letters IGI combine the graphic of a compass to suggest how collaboration guides IGI towards innovation. The brand line ‘Collaboration propels innovation’ completes the message. This new alliance promises myriad new possibilities for Glenmark, Ichnos and the world at large.

IGI – Asset Pipeline:

Oncology Pipeline
Has an exciting platform of novel biologics and small molecules targeting the spectrum of hematological cancers and solid tumors.

Molecule Mechanism / Class

Indication

Phase/Status

ISB 1442 (CD38 x CD47) BEAT biparatopic bispecific antibody

Relapsed / Refractory Multiple Myeloma.

Acute Myeloid Leukemia.

Phase 1

Orphan Drug

ISB 2001 (BCMA x CD38 x CD3) TREAT trispecific antibody

Relapsed / Refractory Multiple Myeloma.

Phase 1

Orphan Drug

GRC 54276 Hematopoietic progenitor kinase 1 inhibitor

Advanced Solid Tumors.

Phase 1 Monotherapy and Combination with PD1 or PD-L1 Inhibitor

Autoimmune Disease Pipeline
The autoimmune disease assets were out licensed to enable greater focus on oncology.

Molecule Mechanism / Class

Indication

Phase/Status

ISB 880 (ALM 27134)

IL-1RAP Antagonist Monoclonal Antibody

Autoimmune Diseases

Phase 1

Licensed to Almirall S.A.

ISB 830

Telazorlimab OX40 Antagonist Antibody

Atopic Dermatitis

Phase 2b

Licensed to Astria Therapeutics.

Rheumatoid Arthritis and other autoimmune diseases

Active U.S. IND

Available for Licensing

Molecule Mechanism / Class

Indication

Phase/Status

ISB 1342 (CD38 x CD3) BEAT bispecific antibody

Relapsed / Refractory Multiple Myeloma.

T-cell Acute Lymphoblastic Leukemia (planned)

Phase 1

Orphan Drug