On November 22, 2024 The Children’s Inn at the National Institutes of Health (NIH) reported that Gilead Sciences Inc. has awarded The Inn a $1 million grant to support its renovation and expansion (Press release, Gilead Sciences, NOV 22, 2024, View Source [SID1234648584]). The grant will fund a welcome center in the new wing of The Inn of Tomorrow, a $50-plus million project for which The Inn recently held a groundbreaking ceremony. As the first point of contact, The Gilead Sciences Welcome Center is designed to ensure young patients from around the world participating in groundbreaking clinical trials at NIH feel welcomed immediately upon their arrival at The Inn.

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"Gilead is a valued partner whose therapeutic interests have intersected with The Inn’s since our beginning. With this grant, we look forward to transforming our space with new capabilities to support young patients, their families, and NIH researchers at every step along the journey from hopes to cures."

"We are grateful for Gilead’s continuing partnership with The Inn," said Jennie Lucca, The Inn’s CEO. "Gilead is a valued partner whose therapeutic interests have intersected with The Inn’s since our beginning. With this grant, we look forward to transforming our space with new capabilities to support young patients, their families, and NIH researchers at every step along the journey from hopes to cures."

A commitment to health equity and equitable access to NIH pediatric clinical trials are driving forces behind The Inn of Tomorrow. The Inn seeks to remove barriers to potentially lifesaving clinical research studies for diverse families, ensure all families find a "place like home" at The Inn by designing culturally inclusive programs, and use the health equity lens to determine how environment helps patients in their journey to optimal health.

"Gilead is proud to work with The Children’s Inn on their ongoing efforts to provide essential support services to these young patients and their families," said Carmen Villar, Vice President, ESG and Corporate Citizenship, Gilead Sciences. "Our contribution demonstrates our continued commitment to supporting communities and advancing health equity."

Construction on the project is scheduled to start in early 2025. In addition to the new welcome center in the 15,000-square-foot addition, The Inn of Tomorrow will incorporate improved accessibility features throughout, resulting in a state-of-the-art residential facility that reflects best practices in healthcare and hospitality. When completed in 2027, the project will expand The Inn’s capacity to serve more and younger patients – increasing annual capacity by 25% from 2,400 to 3,000 families.

On November 22, 2024 OverT Bio, an NYC-based cell therapy company, reported that it has been awarded a $120,000 G-Rex Grant from ScaleReadyTM, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH), and CellReadyTM (Press release, OverT Bio, NOV 22, 2024, View Source [SID1234648585]). This grant will support OverT Bio’s ongoing development efforts that will lead to next generation cell therapies for solid tumors, based on innovative data-driven discovery platforms OverTargetTM and OverTCRTM.

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"This grant, including its access to newly developed GMP closed system products and ScaleReady’s expertise, will help us accelerate the development of our products in a way that will ensure future scalability and cost-effectiveness of these potential medicines."

The G-Rex Grant is part of ScaleReady’s $20 million grant program aimed at advancing Cell and Gene Therapy (CGT) development and manufacturing. The G-Rex Grant Program offers recipients significant no-cost support allowing for expeditious optimization of cell manufacturing processes.

"We are pleased to receive ScaleReady’s support and their recognition of the potentially high impact our technology has to advance our shared mission of bringing new life-saving therapeutics to cancer patients," stated Mat Legut, PhD, CEO of OverT Bio. "This grant, including its access to newly developed GMP closed system products and ScaleReady’s expertise, will help us accelerate the development of our products in a way that will ensure future scalability and cost-effectiveness of these potential medicines."

"Our support of OverT Bio is yet another example of how our G-Rex Grant Program is being used to facilitate advancement of the field of cell and gene-modified cell therapy," said Josh Ludwig, Commercial Director of ScaleReady. "The G-Rex Grant Program augments ScaleReady’s primary purpose of providing every CGT company with the ability to save time and money while building a strong value proposition for continued investment on favorable terms."

On November 22, 2024 CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), reported data from the FORESEE trial showcasing the CNSide CSF Assay Platform’s utility in diagnosing and guiding clinical decision making for breast cancer and non-small cell lung cancer patients with LM (Press release, Plus Therapeutics, NOV 22, 2024, View Source [SID1234648586]). The data will be presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas.

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"Current gold standard CSF cytology lacks the sensitivity needed to reliably diagnose LM in most clinical situations and lacks utility for disease monitoring," said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. "The FORESEE trial shows that CNSide may be a useful tool in accurately identifying all patients with LM, ruling out patients at risk, and enhancing the disease management and monitoring of LM."

Key highlights:

The FORESEE trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases evaluated, surpassing the predetermined 20% primary endpoint target
CNSide demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM
CNSide identified actionable mutations in the CSF, such as HER2 amplification, influencing 24% of therapeutic selection decisions
CNSide exhibited high specificity, with no tumor cells detected in patients without LM
CNSide demonstrated improved Negative Predictive Value in ruling out LM (25%) vs. CSF cytology (10%)
CNSide revealed HER2 positivity in LM tumors in 60% of breast cancer patients with HER2-negative primary tumors, informing physician treatment strategies
The data will be presented on Sunday, November 24, at 10:15 a.m. CST in a session titled, "CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease (FORESEE Study, NCT-5414123)," by Priya Kumthekar, M.D., Associate Professor of Neurology and Hematology/Oncology, and Director of Brain Metastases Program at Northwestern, University, Chicago, Illinois.

About CNSide Test
The CNSide Cerebrospinal Fluid (CSF) Assay Platform consists of four laboratory developed tests (LDTs) used for diagnosis, treatment selection, and treatment monitoring of patients with Leptomeningeal Metastases (LM) from carcinomas or melanoma. The CNSide platform facilitates tumor cell detection / enumeration and biomarker identification using cellular assays (immunocytochemistry (ICC) and fluorescence in situ hybridization (FISH)) and molecular assays (next generation sequencing (NGS)). The CNSide CSF tumor cell enumeration LDT is currently being used in the ReSPECT-LM trial as an exploratory endpoint, and is anticipated to become commercially available in 2025.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells; yet, there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About FORESEE Clinical Trial

The FORESEE Study is a multi-center, prospective clinical trial enrolled patients with Breast or Non-Small Cell Lung Cancer (NSCLC) who have suspicious or confirmed Leptomeningeal Metastases (LM). Standard of Care methods to diagnose or assess the treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. The goal of the FORESEE Study was to evaluate the performance of CNSide in monitoring the LM’s response to treatment and to assess the impact of CNSide on treatment decisions made by physicians.

On November 22, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported the pricing of its "reasonable best efforts" public offering with participation from the CEO and existing and new healthcare focused investors for the purchase and sale of up to 40,000,000 shares of common stock and warrants to purchase up to 20,000,000 shares of common stock at a combined offering price of $0.20 per share and accompanying warrant (the "Offering") (Press release, Aptose Biosciences, NOV 22, 2024, View Source [SID1234648572]). The Company expects to receive aggregate gross proceeds of approximately $8 million, before deducting placement agent fees and other offering expenses, and assuming no exercise of the warrants. The warrants will have an exercise price of $0.25 per share, will be exercisable immediately and will expire five years from the issuance date.

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The closing of the Offering is expected to occur on or about November 25, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this Offering for working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as the sole placement agent for the Offering.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-281201) previously filed with the Securities and Exchange Commission ("SEC") on August 2, 2024, as amended, which was declared effective on November 21, 2024. This Offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the Offering has been filed with the SEC. An electronic copy of the final prospectus relating to the Offering may be obtained, when available, on the SEC’s website located at View Source and may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 22, 2024 Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") reported that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by the company with global intellectual property rights for the treatment of neuroendocrine cancer, has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) (Press release, Nanjing Leads Biolabs, NOV 22, 2024, View Source [SID1234648556]). This marks another significant milestone following the Breakthrough Therapy Designation granted to LBL-024 by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) in China.

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Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said "LBL-024 obtained Breakthrough Therapy Designation from CDE in October this year for the treatment of advanced extrapulmonary neuroendocrine cancer. Our clinical data to date has been very encouraging, suggesting that LBL-024 could meaningfully improve outcomes of patients living with this devastating disease. The grant of ODD from FDA further underscores the exceptional potential of LBL-024 to address a critical gap in this therapeutic area. These policy supports for obtaining Orphan Drug qualification will greatly expedite the commercialization of LBL-024, potentially changing the treatment landscape for patients with advanced neuroendocrine cancer who currently have few therapeutic options."

Dr. Xiaoqiang Kang, founder, chairman and CEO of Leads Biolabs, said "The receipt of ODD for LBL-024 from FDA represents a pivotal milestone in our global strategy. This designation not only enables LBL-024 to receive additional policy support and resource allocation during its development, accelerating its path to market and positioning it as a potential first-in-class therapeutic antibody targeting 4-1BB worldwide, but also provides us with greater market opportunities and avenues for growth on a global scale."

About LBL-024

LBL-024 is a tetravalent bispecific antibody that simultaneously targets PD-L1 and 4-1BB, serving dual functions: blocking the immunosuppressive PD-1/PD-L1 pathway, and selectively co-stimulating 4-1BB in the tumor microenvironment to enhance immune responses. The dual functions of LBL-024—lifting PD-1/PD-L1 immune inhibition and intensifying 4-1BB modulated T cell activation—synergistically enhance the anti-tumor immune response.

LBL-024 received IND approvals from both FDA and NMPA on July 30, 2021 and September 9, 2021 respectively to conduct phase Ⅰ/Ⅱ clinical research, and has achieved outstanding results. Sponsored by Leads Biolabs, led by Professor Shen Lin from Beijing Cancer Hospital with participation of multiple clinical trial centers, the current clinical data demonstrate that LBL-024 monotherapy has more than doubled both the Objective Response Rate (ORR) and Overall Survival (OS) compared to existing treatments for this disease. Based on the current treatment status and the available safety and efficacy data, LBL-024 has entered into a single-arm pivotal trial for extrapulmonary neuroendocrine carcinomas in July 2024 and stands as the globally first 4-1BB-targetd drug candidates to have reached pivotal stage, according to Frost & Sullivan.

About Neuroendocrine Cancer

Neuroendocrine carcinoma (NEC) is a class of poorly differentiated, high-grade neuroendocrine neoplasms (NEN), which originate in the diffuse neuroendocrine cell system and may occur in many different sites. Its molecular characteristics are significantly different from those of neuroendocrine tumors (NET). NEC can be divided into pulmonary NEC and extrapulmonary NEC, among which pulmonary NEC includes small cell lung cancer (SCLC) and pulmonary large cell neuroendocrine carcinoma (p-LCNEC). According to previous data collected, the number of new cases of SCLC is about 98,193, p-LCNEC is about 19,639, and extrapulmonary NECs is about 9,820 in the United States every year. As a result, there are an estimated 127,652 new cases of NECs in the United States each year, meeting the FDA’s definition of a rare disease.

Symptoms of NEC can vary depending on the type of tumor, its location in the body and the hormone released. The survival rate of NEC varies according to the type of cancer and whether it spreads. Specifically, the 5-year survival rate of pulmonary NECs is 5.6%, digestive tract NECs is 13.1%, and other primary NECs are 26.0%. Due to the limited effective treatment options available for patients, the overall survival rate of NEC is low, and more effective new treatment options are urgently needed.

About Orphan Drug Designation

Orphan drugs are medications used for the prevention, treatment, and diagnosis of rare diseases. According to the Orphan Drug Act of the United States, Orphan Drug Designation is established to encourage the development of drugs for treating rare diseases. It provides a series of incentives for new drug development, including but not limited to: (1) tax credits for clinical trial expenses; (2) specific guidance from FDA on all stages of clinical research; (3) exemption of the application fee for new drug registration; and (4) 7 years of market exclusivity after listing.