On November 14, 2024 GordonMD Global Investments LP reported that its portfolio company, Flare Therapeutics Inc., has entered into a strategic discovery collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY). Flare will lead discovery and preclinical activities targeting multiple transcription factor targets in oncology, while Roche will pursue the further preclinical and clinical development and commercialization of potential products from the collaboration, leveraging its industry-leading capabilities in oncology (Press release, Flare Therapeutics, NOV 14, 2024, View Source [SID1234648424]).

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Combining Flare’s advanced proteomic and mass spectrometry platform — powered by its proprietary library of electrophilic compounds — to discover small molecule drugs targeting transcription factors previously deemed yet to be affected by drugs in oncology with Roche’s experience in developing and manufacturing medicines, this collaboration seeks to advance potentially transformative therapies for patients living with cancer.

Flare will receive a US$70 million upfront cash payment and is eligible to receive discovery, development, and commercialization milestone payments potentially exceeding US$1.8 billion and royalties. Additionally, Flare retains a right to co-fund development for one target under the collaboration in exchange for increased royalties in the United States for this target. Flare will retain ownership of its existing pipeline, including its lead clinical-stage program, FX-909, in advanced urothelial cancer, its prostate cancer program entering IND-enabling studies, and other programs in discovery and early development in oncology and other therapeutic areas.

"This collaboration reinforces Flare’s capacity to advance its breakthrough science," said Dr. Craig Gordon, Chief Executive Officer of GordonMD.

"We look forward to our partnership with Roche because we share a commitment to tackling the most challenging disease areas with novel approaches and overcoming the difficulties of drugging transcription factors," said Rob Sims, Ph.D., Chief Scientific Officer and Co-founder of Flare Therapeutics.

On November 14, 2024 CureLab Oncology, a clinical-stage biotech company dedicated to pioneering innovative therapies, reported a patent application for an innovative chronic pain treatment centered on its p62/SQSTM1 DNA plasmid (Press release, CureLab Oncology, NOV 14, 2024, View Source [SID1234648423]). This development, which leverages CureLab’s chronic inflammation therapeutic, Elenagen, signifies a potential paradigm shift in addressing chronic pain, a pervasive health challenge that affects millions globally.

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With this patent, CureLab Oncology aims to address the limitations of existing chronic pain treatments, such as NSAIDs (nonsteroidal anti-inflammatory drugs), acetaminophen, COX-2 inhibitors, antidepressants, anti-seizure medications, and opioids. While these medications offer varying degrees of pain relief, they often come with a range of side effects, including gastrointestinal problems, kidney problems, stomach bleeding, ulcers, dizziness, drowsiness, nausea, and potential addiction. The patent emphasizes the urgent need for more effective chronic pain medications with fewer side effects.

The patent application encompasses the utilization of p62/SQSTM1 DNA to combat a wide spectrum of chronic pain conditions, including arthritis, back pain, headaches, cancer pain, neuropathic pain, and fibromyalgia. This therapeutic strategy operates by modulating the body’s inflammatory response, a critical factor in the development and persistence of chronic pain.

"Chronic pain often stems from persistent inflammation, a complex biological response that can disrupt the body’s natural healing processes," explained Dr. Alexander Shneider, CEO of CureLab Oncology. "Elenagen, our innovative p62-based therapy, targets this underlying inflammation, promoting resolution and potentially alleviating pain at its source."

This groundbreaking therapy holds immense promise for both humans and animals suffering from chronic pain. Preclinical investigations employing animal models have illuminated the efficacy of this therapy in mitigating pain severity and augmenting the quality of life. Notably, the therapy exhibits a favorable safety profile, with no substantial adverse effects detected in the studies.

The global chronic pain treatment market is expected to reach $131.4 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.3% from 2023 to 2030. This growth is driven by the increasing prevalence of chronic pain, the aging population, and the rising demand for effective and non-addictive pain management options. With its potential for fewer side effects and broader applications compared to current treatments, CureLab’s p62-based therapy is positioned to meet the growing demand of the growing chronic pain market.

"Our patenting strategy for this chronic pain treatment aligns with our successful approach for other therapies," said Ilya Lapshin, general counsel for CureLab Oncology. "By initially filing a provisional patent application in the USA and subsequently seeking worldwide protection, we aim to secure comprehensive intellectual property rights for this groundbreaking innovation."

To see CureLab’s portfolio of patents, visit curelaboncology.com/ip and curelabveterinary.com/ip.

About Elenagen
CureLab’s lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In clinical studies conducted ex-US, Elenagen demonstrated desirable safety profile and statistically significant clinical benefit for cancer patients enhancing the anti-cancer effects of chemotherapy. Experimental results also demonstrate mitigation of chronic inflammation, anti-aging effects, and stimulation of an immune response to the tumor.

On November 14, 2024 Flashpoint Therapeutics, a clinical-stage therapeutics company pioneering structural nanomedicine, reported significant expansion of its therapeutic pipeline through strategic acquisitions and a new partnership valued at $50M with The King Abdullah International Medical Research Center (KAIMRC) in Saudi Arabia (Press release, Flashpoint Therapeutics, NOV 14, 2024, View Source [SID1234648422]).

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Structural nanomedicine is an innovative therapeutic approach that enables the creation of precisely engineered nanostructures combining multiple drug components in optimized configurations. This platform technology significantly enhances target cell delivery, therapeutic potency, and safety profiles compared to conventional treatment methods.

"Complex diseases remain inadequately addressed by traditional drugs," said Chad Mirkin, PhD, scientific founder of Flashpoint Therapeutics. "Structural nanomedicines allow us to arrange medicinally active components into configurations that can treat previously undruggable diseases. This represents a fundamental shift in therapeutic development."

The newly announced partnership with KAIMRC establishes the state-of-the-art Flashpoint-KAIMRC Center of Excellence (COE) in Structural Nanomedicine. The Flashpoint-KAIMRC COE is expected to receive funding up to $50M in the next five years to conduct clinical trials on structural nanomedicine candidates and advance structural nanomedicine drug discovery programs targeting diseases prevalent in Saudi Arabia and globally.

Through strategic licensing and acquisition deals with Northwestern University, Holden Pharmaceuticals, and Exicure, Flashpoint has assembled over 150 issued patents and patent applications covering nucleic acid, protein, and CRISPR gene editing therapeutics.

Flashpoint’s lead program, FLASH-001, is a structural nanomedicine incorporating toll-like receptor 9 agonists for immuno-oncology applications. In phase 1b/2 trials, FLASH-001 has demonstrated a curative effect in a small subset of Merkel Cell Carcinoma patients. Flashpoint plans to expand the study in 2025 to larger patient cohorts and additional cancer types. The company’s pipeline includes clinical stage programs targeting skin disorders and multiple preclinical programs in immuno-oncology, neurology, and other indications.

"The establishment of our Center of Excellence with KAIMRC and our growing clinical pipeline demonstrate the momentum behind Flashpoint’s structural nanomedicine platform," said Adam Margolin, PhD, Chief Executive Officer of Flashpoint Therapeutics. "We’re executing a dual strategy of internal development and pharmaceutical partnerships to advance first-in-class structural nanomedicines that could fundamentally change how we treat complex diseases."

On November 14, 2024 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has received IND approval for two clinical studies (Press release, Mabwell Biotech, NOV 14, 2024, View Source [SID1234648421]). The first will explore its use in combination with a PD-1 monoclonal antibody in the treatment of perioperative urothelial carcinoma, while the second will investigate its combination with other antitumor agents for the treatment of advanced solid tumors.

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The recent approval of a multi-drug combination treatment program for cervical cancer and esophageal squamous cell carcinoma, along with the expansion of 9MW2821’s indication to include the perioperative stage for urothelial carcinoma, is anticipated to significantly broaden the therapeutic reach of 9MW2821, potentially benefiting a larger patient population.

9MW2821 is a novel Nectin-4 targeting ADC developed by Mabwell. It stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. Clinical studies for 9MW2821 are underway across a range of tumor indications:

Urothelial Carcinoma (UC):

Monotherapy has advanced to Phase III clinical trials and is included in the CDE’s Breakthrough Therapy Designation (BTD) list.
Combination therapy with PD-1 has entered Phase III clinical trials.
Combination therapy with PD-1 for perioperative UC has been approved for clinical research.
Cervical Cancer (CC):

The first drug candidate targeting Nectin-4 to enter Phase III clinical trials globally.
Combination therapy with PD-1 and other drugs has been approved for clinical research.
Received FDA Fast Track Designation (FTD).
Triple-Negative Breast Cancer (TNBC):

Monotherapy (post-chemotherapy and topoisomerase ADC treatment) has entered Phase II clinical trials.
Combination therapy with PD-1 has entered Phase II clinical trials.
Received FDA FTD.
Esophageal Cancer (EC):

Monotherapy has entered Phase II clinical trials.
Combination therapy with PD-1 and other drugs has been approved for clinical research.
Received FDA FTD for esophageal squamous cell carcinoma (ESCC); received FDA Orphan Drug Designation (ODD).

On November 14, 2024 Azurity Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib (Press release, Azurity Pharmaceuticals, NOV 14, 2024, View Source [SID1234648420]).

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"Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna," said Richard Blackburn, CEO of Azurity Pharmaceuticals, Inc. "Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions."

Tasigna has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP.1 However, Tasigna has variable bioavailability that considerably increases when taken with food. In a concentration dependent manner, Tasigna may significantly prolong QT interval on surface electrocardiogram (ECG) when inappropriately taken with food. As such, strict fasting with Tasigna is crucial to avoid cardiotoxicity.2

Danziten is a re-engineered formulation of nilotinib without mealtime restrictions that offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose.1,3,4 Danziten demonstrates consistent pharmacokinetics, with no clinically significant differences in nilotinib exposure regardless of fasting state or meal type, while offering the proven efficacy expected from nilotinib.1,5,6 With optimal tyrosine kinase inhibitor (TKI) therapy, patients can achieve deep molecular responses, and some may even attain treatment-free remission.7 The life expectancy of newly diagnosed CP-CML patients who have responded to appropriate treatment is now approaching that of the general population. However, challenges remain, including patient adherence to treatment. Danziten has the potential to improve adherence due to the removal of fasting requirements.7,8

Danziten will be available in the coming weeks through Biologics by McKesson and Limited Specialty Distribution. For full prescribing information including boxed warning, please visit www.Danziten.com.

Azurity will offer patient support through DanzitenCONNECT, a comprehensive program, subject to terms and conditions, that includes Prior Authorization support and Benefits Investigation, a free first month of Danziten, a co-pay of as little as $0, and a Patient Assistance Program (PAP).