On April 8, 2021 Stockholm-based Sprint Bioscience, which conducts early preclinical drug development primarily targeting cancer, reported that it had raised 20.7 MSEK in a share issue directed at a group of existing and external investors (Press release, Sprint Bioscience, APR 8, 2021, View Source [SID1234577884]). BioStock has contacted the company’s CEO Erik Kinnman to find out more about what it means for the company.

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The biotechnology company Sprint Bioscience specialises in early preclinical development of drug candidates, primarily aimed at treating cancer. Today, the company’s portfolio consists of five development projects, where the goal is to reach early outlicensing to partners who can advance them to clinical testing and onwards.

So far, two projects from the company’s existing portfolio have been outlicensed; oncology project PETRA01, where the company collaborates with the cancer drug developer HiberCell, and a NASH project that is being developed together with South Korean biotech company LG Chem.

Strengthened cash position with directed issue
On Thursday, Sprint Bioscience announced that it had completed a directed issue of 20.7 MSEK. This corresponds to a discount of approximately 12 per cent compared to the closing price on April 7. For shareholders who did not participate in the issue, the issue will mean a dilution of approximately 16 per cent in total. In connection with the issue, the company pays back an outstanding loan of 10 MSEK.

You have now strengthened the cash position by 20.7 MSEK. Why did you choose to strengthen the company’s financial situation through a directed issue?

– With this issue, we have been able to increase the company’s shareholding among qualified investors, both existing and new. The interest is a sign of an understanding of the potential of our portfolio of innovative drug candidates and our business model.

What does this latest capital injection mean for the company?

– The strengthened cash position allows us to accelerate activities in our various projects as well as in business development. All to build shareholder value and continue to deliver drug candidates that are attractive to potential licensees and that could eventually become new unique drugs for cancer patients with medical needs who need alternative treatments.

How would you describe the financial situation in the company in relation to the capital requirement going forward?

– The capital requirements are now met for the near future. This enables continued value-building development of our portfolio and strengthens opportunities for deliveries in terms of our licensing activities.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

On April 8, 2021 Context Therapeutics, a clinical-stage women’s oncology company developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers, and Integral Molecular, the leader in discovering antibodies against multipass membrane proteins, reported a research collaboration and licensing agreement for the development of an anti-claudin 6 (CLDN6) bispecific monoclonal antibody (BsMAb) for gynecologic cancer therapy (Press release, Context Therapeutics, APR 8, 2021, View Source [SID1234577714]).

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CLDN6 is a membrane protein expressed in multiple cancers, including ovarian, endometrial, lung and gastric cancers. The protein is absent from healthy adult tissues and high levels in patient tumors are correlated with poor prognosis.

Under the terms of the agreement, Integral Molecular and Context will develop CLDN6 bispecific antibodies that trigger the activation of T cells and eliminate cancer cells displaying CLND6. Context will conduct preclinical and all clinical development, as well as regulatory and commercial activities through exclusive worldwide rights to develop and commercialize the novel CLDN6 candidates. Integral Molecular will receive an undisclosed upfront payment and will be eligible to receive development, regulatory and sales milestone payments and high-single-digit to low-double-digit percent royalties on net sales. IND-enabling studies of the first BsMAb candidate are expected to commence in 2022, with advancement to clinical stage anticipated in 2023.

"The structural complexity of CLDN6 and its similarity to proteins expressed on healthy tissue have previously limited its exploitation for targeted oncology therapies," said Martin Lehr, chief executive officer of Context. "By combining Integral Molecular’s expertise in the field of antibody discovery and Context’s experience developing therapies for women’s cancers, we hope to develop a best-in-class targeted therapeutic for CLDN6-positive gynecologic tumors."

To overcome the challenges associated with antibody discovery against CLND6, Integral Molecular employed its MPS antibody discovery platform designed to isolate antibodies against the most challenging membrane protein targets.

"Our CLDN6 monoclonal antibody exhibits best-in-class target selectivity," said Benjamin Doranz, Ph.D., chief executive officer of Integral Molecular. "There is a strong need for therapies that provide more specific and less toxic treatments for gynecologic cancers, and we look forward to our partnership with Context that will enable better treatments for women."

On April 8, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, reported that the Company will report first quarter 2021 financial results on Thursday, April 22, 2021, after market close (Press release, Cytori Therapeutics, APR 8, 2021, View Source [SID1234577730]). Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. Eastern Time to discuss the financial results and provide a corporate update.

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A live webcast will be available at ir.plustherapeutics.com/events

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: 877-402-3914
International dial-in: 631-865-5294
Conference ID: 3084418
Conference Call Name: Plus Therapeutics First Quarter 2021 Results Conference Call
Following the live call, a replay will be available on the Company’s website under the ‘Investor Relations’ section. The webcast will be available on the Company’s website for 90 days following the live call.

On April 8, 2021 NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, reported the highlights of spatial biology abstracts that will be presented at the 2021 meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper), which will be held virtually from April 10 – 15, 2021 (Press release, NanoString Technologies, APR 8, 2021, View Source [SID1234577746]).

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The GeoMx Digital Spatial Profiler (DSP) enables researchers to characterize tissue morphology to rapidly and quantitatively profile RNA and proteins. To date, NanoString and its collaborators have presented DSP data in dozens of abstracts at major scientific meetings and more than 45 peer-reviewed publications, demonstrating DSP’s utility to address a wide range of biological questions in formalin-fixed paraffin-embedded (FFPE) and frozen tissues. At AACR (Free AACR Whitepaper) 2021, eight abstracts that used GeoMx DSP will be presented during the poster session on Saturday, April 10.

Four of the eight abstracts will be presented by investigators from the GeoMx Breast Cancer Consortium (GBCC), an international network of breast cancer researchers. Their goal is to apply innovative approaches and decipher the spatial context of breast cancer to develop a comprehensive atlas and database of novel biomarkers for the disease.

GBCC Abstracts

Poster 2718: Digital spatial profiling in HER2 positive breast cancer: The road to precision medicine

In this work, the GeoMx DSP was used to profile 71 protein targets and gene expression profiling was done using NanoString’s nCounter PanCancer IO360 assay for primary and metastatic tissues from human epidermal growth factor 2 positive (HER2+) breast cancer (BC) patients. A detailed characterization of carefully chosen immune cold, warm and hot regions of interest (ROI) in the tumor and tumor immune microenvironment of (HER2+) of these samples established that primary tumors had a higher number of immune cells than the metastatic sites. These findings, therefore, suggest that immunotherapy in early-stage BC could be more effective than in advanced BC.

Poster 2701: Molecular profiling to assess the immune response to neoadjuvant SABR in early breast cancer

NanoString’s Human PanCancer immune profiling panel was used to assess the impact of localized radiotherapy to elicit an immune response in primary breast carcinomas before lumpectomy. They analyzed 25 patient samples for low-risk primary breast carcinomas from the SIGNAL 2.0 clinical trial using the GeoMx DSP platform, pre, and post stereotactic body radiation therapy (SBRT). Significant differences were found in the gene expression patterns in the immune microenvironment gene expression patterns and cellular composition after radiotherapy, demonstrating that SBRT treatment indeed evokes an immune response, increasing the innate immune response.

Poster 2698: Spatial gene expression profiling in breast cancer

Transcriptome profiling was performed for a cohort of breast cancer lumpectomies using the Cancer Transcriptomic Atlas (CTA) assay on the GeoMx DSP platform. Analysis of 60 patient samples revealed region-specific heterogeneity in unifocal and multifocal cancer tumors. This study demonstrates and establishes the importance of interactions between immune and tumor cells in the tumor microenvironment and the need to develop a strategy to stratify patients to available targeted therapies.

Poster 2726: Characterization of immune microenvironment and heterogeneity in breast cancer subtypes

In this work, the immune microenvironment of Luminal A, Luminal B, Basal, and HER2 tumor subtypes in a cohort of early breast cancer patients was studied using protein biomarkers. The markers were delineated in a spatial context using the GeoMx DSP. Characterization of the immune microenvironment subtypes provided evidence for potential clinical use for GeoMx DSP in diagnosing and better stratifying breast cancer patients based on spatial heterogeneity in tumor and tumor microenvironment.

Other spatial abstracts

Poster 339: Resistance to trastuzumab is associated with alpha-smooth muscle actin expression in the stroma of patients with HER2+ breast cancer

GeoMx DSP was used to identify biomarkers for resistance to trastuzumab in HER2+ breast cancer. Fifty-eight protein targets were analyzed in three different regions of interest (tumor [PanCK+], leukocyte [CD45+/CD68-], and macrophage [CD68+]) in a cohort of 151 breast cancer patients that received trastuzumab. The study uncovered a-SMA as a potential biomarker to augment the predictive value of the current standard of care HER2 assay and justifies its further validation in the light of the many new HER2 targeted therapies.

Poster 705: SARS-CoV-2 infection of the human heart governs intracardiac innate immune response

Spatial profiling of human post-mortem cardiac samples of SARS-CoV-2 infected myocardium was carried out using NanoString’s Whole Transcriptome Analysis (1,864 genes) panel, along with a matching proteome panel on the GeoMx digital spatial profiler. The purpose of their investigation was to elucidate the molecular mechanisms underlying cardiac toxicity, a severe cause of morbidity and mortality in patients on DOX therapy. The study showed interesting gender-specific differential gene expression patterns in the myocardium between SARS-CoV-2 infected and control regions of interest. Signatures of enhanced innate and acquired immune signaling, apoptosis and autophagy, chromatin remodeling, reduced DNA repair, and reduced oxidoreductase activity were all observed in regions of infection. Additionally, DOX-induced increase in the expression of TMPSS2 and cathepsins A, B, and F, clearly indicated enhanced SARS-CoV-2 susceptibility in the myocardium, thus placing cancer patients on DOX therapy at increased risk of cardiac damage.

Poster 2731: Cell-type deconvolution of African American breast tumors reveals spatial heterogeneity of the immune microenvironment

Researchers at the University of Chicago carried out spatial gene expression analysis within localized segments of TNBC tumors from a cohort of self-reported African American patients in the Chicago Multi-Ethnic Breast Cancer Study (ChiMEC). Regions of interest for spatial characterization of tumor and tumor microenvironment using the GeoMx DSP Cancer Transcriptome Atlas assay were manually selected based on the specific morphologies. The 1,825 genes interrogated in the CTA assay provided a granular understanding of the immune landscape’s heterogeneity within tumors.

Poster 2771: Comprehensive analysis of immuno oncology markers in the tumor microenvironment of solid tumor samples using GeoMxTM digital spatial profiler (DSP) and MultiOmyxTM hyperplexed immunofluorescence (IF)

This study describes a multi-faceted highly multiplexed tissue analysis of critical Immuno oncology (IO) protein markers in a pan-cancer cohort of up to 35 FFPE samples originating from breast, head, and neck, prostate, non-small cell lung cancer (NSCLC), endometrial and colorectal indications using NanoString human IO panel on GeoMx DSP in combination with a complementary MultiOmyx Hyperplexed Immunofluorescence (IF) assay. The spatial and quantitative data outputs from DSP nCounter system and cell classification information from the MultiOmyx assay provided the researchers an ability not only to characterize the immunophenotypes but also to visualize the spatial distribution of tumor-infiltrating immune cells at a single-cell resolution within the TME.

Spotlight Theaters at AACR (Free AACR Whitepaper)

NanoString will be hosting two spotlight theaters during AACR (Free AACR Whitepaper) 2021. The first spotlight theater presentation is April 11 from 1:00-2:00 pm EDT, featuring Joseph Beechem, Ph.D., senior vice president of R&D and chief scientific officer for NanoString, with an overview of the latest developments in spatial biology, True spatial genomics: Measuring the transcriptome in regions, cell and sub-cellular compartments. Dr. Beechem will explain spatial technologies’ evolution and their applications from multi-cell to single-cell and subcellular resolution, using the GeoMx DSP and the company’s Spatial Molecular Imager.

The second NanoString spotlight theater is Tuesday, April 13, from 11:00-12:00 pm EDT, and is entitled: New Approaches for Cellular Therapies: Technology Symposium Featuring the GeoMx DSP and nCounter CAR-T Characterization. This panel will include three speakers, Dr. Ryan Golden, Resident Physician in Clinical Pathology, Carl June Lab, University of Pennsylvania; Dr. Marco Ruella, Assistant Professor of Medicine, University of Pennsylvania; and Ghamdan Al-Eryani, Ph.D. Student, Tumor Progression Group from the Garvan Institute. Each speaker will discuss new approaches to CAR-T characterization using the spatially-resolved and bulk RNA analysis, from understanding resistance in CART immunotherapy in lymphoma to TCR diversity in melanoma.

NanoString has launched a Technology Access Program (TAP) for the recently announced single and subcellular Spatial Molecular Imager to complement the existing TAP program for GeoMx. Under the program, customers can submit tissue samples to NanoString for analysis using the spatial profiling platforms and receive a complete data package. Researchers interested in participating in NanoString’s Technology Access Program should contact the company at [email protected].

On April 8, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary NK cell engager (TriKE) protein biologic technology platform, reported the enrollment of Patient 10 in its GTB-3550 TriKE first-in-human Phase I/II clinical trial for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML) (Press release, GT Biopharma, APR 8, 2021, View Source [SID1234577763]). Patient 10 will be dosed at 100mcg/kg/day.

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Highlights from the first nine patients treated with GTB-3550 TriKE include:

Up to 63.7% Reduction in Bone Marrow Blast Levels
Restores Patient’s Endogenous NK Cell Function, Proliferation and Immune Surveillance
No Progenitor-derived or Autologous/Allogenic Cell Therapy Required
No Cytokine Release Syndrome Observed
3 out of the Last 5 Patients Treated (25mcg/kg/day to 100mcg/kg/day) Respond
"We are pleased with the continued clinical performance of our lead TriKE product candidate, and in reaching this important patient enrollment milestone," said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer. "The data from the first nine patients treated with GTB-3550 indicates significant bone marrow blast level reductions in AML and MDS patients without the need for expensive progenitor-derived or autologous/allogenic cell therapies."

About High-Risk Myelodysplastic Syndromes
MDS is a rare form of bone marrow-related cancer caused by irregular blood cell production within the bone marrow. As a result of this irregular production, MDS patients do not have sufficient normal red blood cells, white blood cells and/or platelets in circulation. High-risk MDS is associated with poor prognosis, diminished quality of life, and a higher chance of transformation to acute myeloid leukemia. Approximately 40% of patients with High-Risk MDS transform to AML, another aggressive cancer with poor outcomes.

About Acute Myeloid Leukemia
Acute myeloid leukemia is a type of cancer in which the bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells, or platelets. According to the National Cancer Institute (NCI), the five-year survival rate is about 35% in people under 60 years old, and 10% in people over 60 years old. Older people whose health is too poor for intensive chemotherapy have a typical survival of five to ten months. AML accounts for roughly 1.8% of cancer deaths in the United States.

About GTB-3550 TriKE
GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment of AML and MDS, and other CD33+ hematologic cancers. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of Interleukin 15 (IL-15). The natural killer (NK) cell-stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

About GTB-3550 TriKE Clinical Trial
Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible (NCT03214666). The primary endpoint is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells.