On November 7, 2022 Therapeutic Solutions International (TSOI) reported that its breast cancer focused spin-off, Res Nova Bio, Inc., initiated a collaboration with Veltmeyer MD Inc. aimed at providing access to the anti-angiogenic immunotherapy ValloVax (Press release, Therapeutics Solutions International, NOV 7, 2022, View Source [SID1234623304]).

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ValloVax was subject of a cleared FDA Investigational New Drug application and has been demonstrated safe in numerous clinical uses.

There are several peer reviewed publications supporting the use of ValloVax: a) Proof of concept that the ValloVax immunotherapy inhibits tumor growth in various animal models of cancer (lung cancer, melanoma, and breast cancer)1; b) Review of independent support for the concept of immunologically killing tumor blood vessels to starve the cancer2; c) Clinical data showing that ValloVax induces immune response to proteins only found on cancer blood vessels3; d) Demonstration of synergy of ValloVax with checkpoint inhibitors and mechanism of action data4.

"Having previously used ValloVax to treat patients under the Right to Try Law, I am excited to offer this new treatment option to patients that currently have no other options," said Dr. James Veltmeyer, Chief Medical Officer of Res Nova Bio. "To my knowledge this is the first clinical therapy that immunologically targets the process of angiogenesis, which is considered the ‘Achilles’ Heel’ of cancer."

Res Nova Bio, Inc. is a spin off company of Therapeutic Solutions International, which is currently running a Phase III stem cell clinical trial in COVID-19 associated acute respiratory distress syndrome (ARDS). Therapeutic Solutions International licensed breast cancer related technologies to Res Nova Bio including StemVacs-V, an inducible pluripotent stem cell derived cancer endothelial cell vaccine which is seen as a "Second Generation ValloVax".

"Therapeutic Solutions International is an ‘innovation factory’ in the area of cellular therapy and immunotherapy," said Timothy Dixon, President, and CEO of the Company. "The ability of Res Nova Bio to rapidly make an impact in the lives of patients while accelerating its pipeline products is unique in biotechnology. Previously the Company has treated COVID-19 patients under Right to Try concurrent with its clearance to enter Phase III. At the end of the day, we are all here for one important cause: to cure the uncurable as quickly and efficiently as possible."

On November 7, 2022 Nucleai, a leader in AI-powered spatial biology, reported the expansion of its spatial biology platform to include a new generation of multiplex immunofluorescence (mIF) analysis that uses deep learning to establish new levels of accuracy, speed, and generalizability, further unlocking the power of mIF data for drug discovery and development (Press release, Nucleai, NOV 7, 2022, View Source [SID1234623303]). Nucleai will present new data demonstrating the power of its new mIF pipeline to correlate spatial features with patient outcomes in colorectal cancer (CRC) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference in Boston this week.

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While mIF is a powerful technology for cancer research, current tools for mIF image analysis are time-consuming, manual, and not robust enough to generalize across different platforms, markers and indications. Nucleai addresses these challenges, bringing 40% improvement in accuracy compared to other solutions, while also reducing mIF analysis time-to-results from months to only weeks. Nucleai’s mIF pipeline, built and trained on millions of annotations across different staining platforms, indications and markers, provides the most comprehensive mIF deep-learning based solution available on market today.

"Nucleai’s platform will revolutionize the reliability and speed of mIF analysis conducted by translational researchers," said Dr. Ken Bloom, Head of Pathology at Nucleai. "Our deep learning approach will enable the standardization of mIF-based analysis and help establish multiplex as common practice throughout drug R&D."

Nucleai’s cutting-edge AI spatial models, which are optimized for multiplex assays, derive new insights from tissue biopsies, including novel drug targets, mechanisms of action, and potential biomarkers to advance the field of precision medicine. The tumor microenvironment is a highly complex ecosystem, and spatial biology can be used to unlock the important relationships and interactions. The spatial analysis that run through Nucleai’s platform enables the discovery of novel tumor microenvironment cell patterns and signatures. The platform is agnostic to staining and scanning platforms and is currently available as a comprehensive service, providing fast turnaround times for large datasets of mid to high plex images.

New Data from CRC Study using Nucleai’s Spatial Biology Platform

Nucleai applied a novel end-to-end deep learning pipeline to mIF tumor-microarray images to predict outcome based on the tumor microenvironment (TME) composition. This novel deep learning pipeline for mIF analysis demonstrated high accuracy on the Nucleai platform in classifying cell types and phenotypic markers, thus enabling the identification of multiple cellular and spatial features associated with prognosis in CRC.

Cell typing model reached a 91.9% accuracy and strong performance by qualitative assessment in 97.7% of cores (>75% accuracy), thereby vastly outperforming current clustering-based cell typing approaches which demonstrated 65.9% accuracy in a paper published in Cell.

Poster Presentation

Nucleai will present the scientific poster on Friday, Nov. 11, 2022 during SITC (Free SITC Whitepaper). The poster number is 1290.

On November 7, 2022 Bayer, a global leader in women’s healthcare, reported that it will extend the Phase III clinical development program OASIS by initiating OASIS 4 – a Phase III non-US study in breast cancer patients and women at risk for breast cancer with vasomotor symptoms caused by endocrine therapy (Press release, Bayer, NOV 7, 2022, View Source [SID1234623302]).

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Breast cancer is the most frequent cancer in women globally with 2.3 million new cases in 2020.1 Almost 70% of breast cancers are hormone-receptor positive 2. The majority of these patients receive well-established adjuvant endocrine therapy (with the goal of reducing estrogen levels) for at least five years in order to decrease the recurrence of their cancer and improve associated mortality.2 Vasomotor symptoms (VMS; also referred to as hot flashes) are a known adverse reaction of endocrine therapy, which strongly impacts the quality of life and treatment continuation.2

"For women treated with endocrine therapy for breast cancer – potentially for numerous years – vasomotor symptoms can intensively affect patients," said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. "By adding OASIS 4 to our Phase III program with elinzanetant, we aim to help patients experiencing vasomotor symptoms caused by their endocrine therapy."

The OASIS-4 Phase III study intends to randomize approximately 400 patients at about 95 centers in 15 countries (excluding the US) and is planned to investigate the efficacy and safety of elinzanetant 120 mg once daily in women at high risk for breast cancer and breast cancer patients with vasomotor symptoms caused by endocrine therapy.

In August 2021, the OASIS Phase III clinical development program started investigating the efficacy and safety of elinzanetant 120 mg once daily in menopausal women with moderate to severe vasomotor symptoms.

About Elinzanetant

Elinzanetant is a non-hormonal, orally administered, dual neurokinin-1,3 receptor antagonist currently in clinical development for the treatment of vasomotor symptoms during menopause. It’s believed that elinzanetant addresses vasomotor symptoms by modulating a group of estrogen sensitive neurons in the hypothalamus in the brain (the KNDy neurons), that due to the absence of estrogen, become hyperactive in menopausal women and consequently disrupt body heat control mechanisms resulting in vasomotor symptoms.

The clinical Phase III development program with elinzantant, OASIS, currently comprises four Phase III studies: OASIS 1,2,3 and 4. OASIS 1, 2 and 3 are part of the US development program. The design and dosing of the Phase III clinical development program is based on the data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study, which investigated the efficacy and safety of four different doses of elinzanetant compared to placebo in patients with vasomotor symptoms.

About Vasomotor Symptoms

Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons due to withdrawal of estrogen, which can result from progressive reduction of ovarian function. Progressive reduction of ovarian function is due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

We are looking to expand treatment options for vasomotor symptoms caused by endocrine therapy.

About Women’s Healthcare at Bayer

Bayer is a recognized leader in the area of women’s healthcare, with a long-standing commitment to delivering science for a better life by advancing a portfolio of treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause symptom management. Through it’s We’re For Her mission Bayer is focused on options to address the unmet medical needs of women worldwide. Today, Bayer’s research and development efforts focus on finding new treatment options for menopause and includes several compounds in various stages of pre-clinical and clinical development. Together, these projects reflect the company’s approach to research, which prioritizes targets and pathways with the potential to alter the way that gynecological diseases are treated. Additionally, Bayer intends to provide 100 million women in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

On November 7, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, reported encouraging preclinical data on GDA-501, a genetically modified NAM (nicotinamide) Natural Killer (NK) pre-clinical cell therapy candidate from Gamida Cell’s expanding pipeline of cell therapy candidates (Press release, Gamida Cell, NOV 7, 2022, View Source [SID1234623301]). The data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting taking place in Boston, MA from November 10-12, 2022.

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NK cells have generated significant interest as potential new treatment options for patients with cancers. In pre-clinical and clinical studies, Gamida Cell’s proprietary NAM technology has demonstrated successful expansion of NK cells, enhanced functionality, increased cytotoxic activity as well as creating a protective effect against oxidative stress and improved homing to targeted blood and solid tumor cancers.

"Our proprietary NAM technology enhances desirable cancer fighting qualities across a broad range of innate and adaptive cell types, including NK cells. As shown in our SITC (Free SITC Whitepaper) poster, by optimizing downstream signaling we were able to directly enhance NK cell activity resulting in potent cytotoxicity against HER2-expressing cells. These results suggest that GDA-501 represents a unique allogeneic cell therapy candidate potentially targeting HER2+ solid tumors," said Yona Geffen, Ph.D., Vice President, Research and Development at Gamida Cell. "These data further validate our NAM technology and our pipeline of genetically modified NK cell therapy candidates that offer the potential to improve clinical outcomes for patients with cancers, including cancers that express HER2."

The success of immune cell therapies has been limited in solid tumors due to multiple barriers, including immunosuppressive tumor microenvironment, inefficient trafficking, and heterogeneity of tumor antigens. In a poster presentation titled, "Engineered NAM-NK cells with HER2-CAR expression demonstrate increased cytotoxicity against HER2-expressing solid tumors", GDA-501, a genetically modified HER2-CAR NAM-NK cell, displayed significantly enhanced and persistent in vitro cytotoxicity and potency when cultured with HER2+ targeted cancer cells. Cryopreserved GDA-501 significantly inhibited tumor growth of a HER2+ solid tumor model in vivo. These preclinical data demonstrate potent antitumor activity and suggest that GDA-501 represents a unique potential treatment option using an allogeneic NAM-enabled cell therapy candidate for this poor prognostic group of patients with cancers that express HER2.

The GDA-501 poster (abstract #273) will be presented in Hall C on Thursday, November 10, 2022, from 9:00 AM EST to 9:00 PM EST. The poster presentation is publicly available at www.sitcancer.org.

About NAM Technology
Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About GDA-501
Gamida Cell expanded the use of its NAM-enabled technology to create GDA-501, an allogeneic innate NK cell therapy candidate for the potential treatment of HER2+ solid tumors. Human epidermal growth factor receptor 2 (HER2) is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers.1 GDA-501 is genetically modified with a chimeric antigen receptor (CAR) to target HER2 by optimizing downstream signaling which directly enhances GDA-501 cytotoxicity. In vitro data demonstrated potent cytotoxicity against HER2-expressing cells. As a result, HER2-CAR may be used to target multiple HER2+ solid tumors. For more information about GDA-501, please visit View Source

On November 7, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, reported that the company will host a conference call and live audio webcast on Monday, November 14, 2022, at 8:00 AM EST to review its third quarter 2022 financial results and provide an update on the company (Press release, Gamida Cell, NOV 7, 2022, View Source [SID1234623300]).

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To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.