On March 24, 2020 NANO-X IMAGING LTD ("Nanox" or the "Company"), an innovative medical imaging company, reported its collaboration with CureMetrix, a global healthcare technology company that develops AI-driven software for radiology, to integrate the CureMetrix advanced AI diagnostics solution into Nanox’s planned cloud-based software platform, the Nanox.CLOUD (Press release, Nanox, MAR 24, 2020, View Source [SID1234555796]).

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Nanox is working to expand the range of medical imaging services it intends to provide to improve the accessibility and affordability of early-detection services. The Nanox.CLOUD is designed to provide an end-to-end medical imaging service, including services such as image repository, radiologist matching, online and offline diagnostics review and annotation, connectivity to diagnostic assistive AI systems, billing and reporting.

The goal of screening exams for breast cancer detection is to identify breast abnormalities as early as possible since the likelihood of survival increases the earlier the cancer is detected. Some of the reasons that breast cancer is missed at initial screening include the high-level of difficulty and complexity in reading mammographic images, the fact that dense breast tissue can obscure anomalies, and the limited number of certified mammographers globally.

Understanding the challenges facing radiologists who read mammograms, CureMetrix has developed AI-based computer-aided diagnostic (CAD) solutions that assist radiologists in detecting cancer earlier.

Almost 2% of screening mammograms in the United States result in a biopsy, and approximately 70% of these biopsies are found to be benign (Taplin, 2010). Approximately $4 billion is spent annually in the U.S. on mammography false positives, breast cancer overdiagnosis, invasive breast cancer and ductal carcinoma (Ong, 2015). However, mammography remains the only early detection screening method shown in randomized clinical trials to decrease breast cancer mortality.

CureMetrix aims to leverage its proprietary algorithm to help reduce unnecessary biopsies. In a recent study of biopsy benign cases, CureMetrix’s cmAssist software was able to correctly classify 70% of the biopsies as benign. As a result, CureMetrix’s AI CAD could potentially reduce unnecessary biopsies and therefore improve cost efficiencies. In addition, studies have shown that false-positive findings on screening mammography could cause long-term psychosocial harm to patients (Brodersen, 2013). As a result, CureMetrix’s AI CAD could also help alleviate patient anxiety about breast cancer screening.

"The planned integration of advanced AI technologies, such as those of CureMetrix, with our planned imaging platform aims to decrease diagnostic results turnaround time, increase diagnostic accuracy, and help radiologists deal with the rising screening demands and workload," said Ran Poliakine, Founder and CEO of Nanox. "We believe the decision assistive information that the CureMetrix AI provides will potentially help the radiologists who we expect to use our platform to deliver a faster, more accurate diagnosis to medical facilities and patients."

"With our aligned goals of increasing the accessibility and affordability of early-detection medical imaging systems worldwide, the integration of CureMetrix with Nanox technologies aims to increase patient access to mammography services and improve breast cancer survival rates across the globe," said Kevin Harris, President of CureMetrix, "We look forward to working with Nanox on this important project."

On March 24, 2020 Samsung Bioepis Co., Ltd. reported that the U.S. Food and Drug Administration (FDA) has approved a 420 mg multi-dose vial of ONTRUZANT (trastuzumab-dttb), a biosimilar referencing HERCEPTIN i (trastuzumab) (Press release, Samsung Bioepis, MAR 24, 2020, View Source [SID1234555795]).

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ONTRUZANT was first approved as a 150 mg single-dose vial by FDA in January 2019 across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease. Please see Boxed Warnings and Important Safety Information for ONTRUZANT below.

ONTRUZANT will be marketed and distributed in the United States (US) by Merck (known as MSD outside the US and Canada), which announced on February 5, 2020, that it intends to spin-off products from its biosimilars businesses, including ONTRUZANT, into a new, independent, publicly-traded company. Merck will continue to fully support the commercialization of ONTRUZANT until the spinoff, which is intended to take place in the first half of 2021, at which time ONTRUZANT will become a product of the new company.

About ONTRUZANT (trastuzumab-dttb)
ONTRUZANT is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
With docetaxel and carboplatin
As a single agent following multi-modality anthracycline-based therapy
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

ONTRUZANT is indicated:

In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
ONTRUZANT is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Select Important Safety Information

Cardiomyopathy

Administration of ONTRUZANT can result in sub-clinical and clinical cardiac failure.
Evaluate left ventricular function in all patients prior to and during treatment with ONTRUZANT. Discontinue ONTRUZANT treatment in patients receiving adjuvant therapy and withhold ONTRUZANT in patients with metastatic disease for clinically significant decrease in left ventricular function
Infusion Reactions; Pulmonary Toxicity

Administration of ONTRUZANT can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt ONTRUZANT infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
Embryo-Fetal Toxicity

Exposure to ONTRUZANT during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Exacerbation of Chemotherapy-Induced Neutropenia

In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab products in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not
Most Common Adverse Reactions

The most common adverse reactions for trastuzumab products in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
The most common adverse reactions for trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

On March 24, 2020 Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the fourth quarter and year ended December 31, 2019 and provided a business update (Press release, Gossamer Bio, MAR 24, 2020, View Source [SID1234555794]).

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"Our hearts are with the patients, families, caregivers and medical professionals suffering and sacrificing in the ongoing Covid-19 viral pandemic. We are monitoring the situation on a daily basis to understand the impact on Gossamer and our programs and are taking the necessary actions now to do what is best for our patients, employees and company," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer Bio.

"2019 was a year of execution for Gossamer Bio, as we continued to advance all four of our clinical-stage product candidates in our target areas of immunology, inflammation and oncology. Notwithstanding the Covid-19 pandemic, we expect to continue our momentum in 2020, with data from all of our candidates expected this year. We are committed to advancing our product candidates and the field of medicine for the betterment of patients and their families, and we look forward to providing updates on these efforts throughout the year."

Clinical-Stage Product Candidate Updates

GB001: Oral DP2 Antagonist for Eosinophilic Asthma and Chronic Rhinosinusitis (CRS)

Gossamer has made available three poster presentations from its GB001 program for patients with asthma. All three posters, which Gossamer had planned to present at the now cancelled 2020 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, can be found in the Posters and Publications section of Gossamer’s website:
"Effect of the DP2 Antagonist GB001 on Asthma Worsening in Patients with Mild-Moderate Asthma" showed that GB001 treatment is associated with longer time to asthma worsening / exacerbation and observed treatment effects were greater in the populations with higher baseline FeNO and / or eosinophils.
"In Vitro and In Vivo Profile of GB001, a Potent and Selective DP2 Antagonist for the Treatment of Moderate-Severe Asthma" demonstrates that, in pre-clinical studies, GB001 is an insurmountable antagonist and compares favorably to other DP2 antagonists in functional residence time and prolonged pharmacodynamic effects, while inhibiting immune cell infiltration and improving airway function.
"Corticosteroid Use Across Asthma Healthcare Providers: A Real-world Experience." The widespread use of OCS revealed by this claims analysis underscores the high level of unmet need for these patients and the need for new therapies.
Enrollment in the ongoing Phase 2b LEDA study in patients with moderate-to-severe eosinophilic asthma has been completed. We are on track to conduct an interim analysis in the second quarter of this year, following study completion by approximately two thirds of patients. Topline results are expected in the second half of this year.
Enrollment in the ongoing Phase 2 TITAN proof-of-concept study in chronic rhinosinusitis, both with and without nasal polyps has been completed. Topline data from the TITAN study are expected in the second half of this year.
We continue to evaluate the possibility of initiating a Phase 2 study in chronic spontaneous urticaria and expect to make this decision in the second half of the year following a review of available data and the competitive landscape.
GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

Enrollment is underway in the Phase 1b study of GB002 in patients with PAH. Gossamer expects to report initial topline results from the study in the second quarter of this year.
Due to the ongoing Covid-19 viral pandemic, the Phase 2 study in patients with PAH will likely commence in the second half of this year. This trial will enroll functional class II and III PAH patients. Patients will remain on their background therapies throughout the study. The primary endpoint for this 24-week study will be change in PVR from baseline. A key secondary endpoint will be change from baseline in 6-minute walk distance at week 24.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

Enrollment is complete in the Phase 1b study of GB004 in patients with active mild-to-moderate ulcerative colitis (UC). The primary goals of the study are to assess safety, tolerability, PK, PD and target engagement in patients with active disease. Gossamer expects to report topline results from this Phase 1b study in the second quarter of this year.
GB1275: Oral CD11b Modulator for Oncology Indications

Enrollment for the KEYNOTE-A36 Phase 1/2 study to evaluate GB1275 as a monotherapy and in combination with either KEYTRUDA (pembrolizumab) or chemotherapy in patients with selected advanced solid tumors is underway, and we expect to report initial Phase 1 data in the second half of this year.
Financial Results for Quarter and Full Year Ended December 31, 2019

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2019, were $401.8 million. In response to the ongoing Covid-19 viral pandemic and anticipated potential challenges to clinical trials globally, Gossamer has planned a series of cost-optimization initiatives. As a result, we currently expect cash, cash equivalents and marketable securities, and access to our debt facility will be sufficient to fund operating and capital expenditures to the middle of 2022.
Research and Development (R&D) Expenses: For the quarter ended December 31, 2019, R&D expenses were $42.6 million, compared to R&D expenses of $25.9 million for the same period in 2018. R&D expenses for the full year ended December 31, 2019, were $143.4 million compared to $55.3 million for the full year ended December 31, 2018. The increases were primarily due to an increase in expenses for GB001, GB002, GB004 and GB1275 and increased headcount.
In-Process Research and Development (IPR&D) Expenses: For the quarter ended December 31, 2019, IPR&D expenses were $1.6 million, compared to $0.0 million for the same period in 2018. IPR&D expenses for the full year ended December 31, 2019, were $3.6 million compared to $49.7 million for the full year ended December 31, 2018.
General and Administrative (G&A) Expenses: For the quarter ended December 31, 2019, G&A expenses were $11.6 million, compared to $13.9 million for the same period in 2018. G&A expenses for the full year ended December 31, 2019, were $39.1 million compared to $44.1 million for the full year ended December 31, 2018. The decreases were primarily attributable to a decrease in stock-based compensation costs, which was partially offset by increases in personnel-related costs, professional and legal fees, costs associated with insurance, and facility and office-related costs.
Net Loss: Net loss for the three months ended December 31, 2019, was $54.7 million, or $0.89 per share, compared to a net loss of $38.8 million, or $4.92 per share, for the same period in 2018. Net loss for the full year ended December 31, 2019, was $180.3 million, or $3.29 per share compared to a net loss of $147.0 million, or $22.59 per share, for the full year ended December 31, 2018.

On March 24, 2020 IASO Biotherapeutics (IASO BIO) reported the completion of $60 million in series B financing led by GL Ventures, which is a venture capital fund of Hillhouse Capital focusing on early-stage innovative companies (Press release, IASO BioMed, MAR 24, 2020, View Source [SID1234555793]). Biomedicine and medical devices are its key investment areas. This new funding will go toward expanding the company’s product pipeline, promoting the progress of current projects (including regulatory applications and clinical trials in China and the United States), improving the technology of a fully-human antibody development platform, expanding cooperation with leading international research and development institutions, and accelerating the construction of commercial facilities.

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IASO BIO is a clinical-stage biotechnology company dedicated to the development of innovative cell therapies for cancer. Founded in March 2017, the company is developing over 10 pipeline products, focusing on autologous and universal CAR-T products for hematological tumors. All products are based on fully-human sequence. Additional development efforts include unique TCR-like CAR-T cell therapy products for solid tumor indications such as viral infection related gastric cancer and nasopharyngeal carcinoma.

IASO BIO owns a proprietary phage display library（>2×1011）that supports the demand for fully-human antibodies required for CAR-T and lays the foundation for the development of antibody drug pipelines as well. Its in-house plasmid, lentivirus and CAR-T production technology platforms can meet the requirements of IND submissions and clinical research for multiple products.

In September 2019, IASO BIO received NMPA approval of a phase Ib/II IND application for CT103A, an anti-BCMA CAR-T co-developed with Innovent Biologics for the treatment of relapsed refractory multiple myeloma (rr/mm). In addition, a number of new drug candidates have entered the pre-clinical stage or are involved in investigator-initiated clinical trials, with several of these drugs expected to enter clinical trials in the next two years.

"IASO BIO welcomes the support and investment from Hillhouse Capital, and we view them as our long-term partner," said Brian Hall, co-Founder and Executive Vice President of Business Development, IASO BIO. "With their support and guidance, we are very confident in our ability to execute on our vision for the company. Their commitment enables us to accelerate the progress of research projects, enhance the team’s capabilities globally, bring new hope to patients, and attract the right talent with ambition to join us."

Michael Yi, Co-CIO of Hillhouse Capital, stated, "Biomedicine is one of the areas that is most thoroughly investigated and heavily involved in by Hillhouse. We are dedicated to creating value in this industry and promoting the growth of companies with ingenuity, innovation, vision and devotion. We are deeply impressed by IASO BIO’s diverse team and proactive culture. IASO BIO boasts a unique development platform for fully-human antibody, a solid CMC process for plasmid viruses and cell products, efficient corporate governance, and innovative products with excellent clinical data. IASO BIO also has strategic collaborations with leading international research institutions. What an achievement to have built up such capability and potential in a time span of just three years! It gives us great pleasure to cooperate with IASO BIO and we hope to contribute to their becoming an internationally competitive company with a portfolio of innovative drugs."

On March 24, 2020 BioInvent International AB ("BioInvent") (OMXS: BINV) reported an agreement with SkylineDx to characterize the gene expression and immunological signatures in tumors of patients pre- and post-treatment with BI-1206 (Press release, BioInvent, MAR 24, 2020, View Source [SID1234555792]).

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SkylineDx is a molecular diagnostics company which focuses on the discovery of novel gene-based biomarkers with high clinical utility for patient targeting and stratification. Headquartered in Rotterdam, the Netherlands, SkylineDx operates a CAP/CLIA certified laboratory in San Diego, California, USA.

Together the companies will research and develop predictive immunological signatures to help identify patients with non-Hodgkin lymphoma (NHL) and solid cancers who are likely to show clinical responses if treated with BI-1206, BioInvent’s lead product candidate.

Martin Welschof, CEO of BioInvent, said: "We are delighted to be working with SkylineDx, a company that has built up a great deal of expertise in molecular diagnostics, which is essential for the development of targeted cancer therapies. Identifying the right patients who are likely to respond to treatment with BI-1206 will constitute a major asset in the development of this promising treatment and, along with FcγRIIB expression levels, should support the extension of its use to other malignancies."

Dharminder Chahal, CEO of SkylineDx, said: "It is a real pleasure to announce our collaboration with Bioinvent, a true pioneer in promising new cancer treatments. As a diagnostics company, we always strive for precision medicine. Joining forces to identify true responders in early phase pharmaceutical trials, will make mark an important milestone towards that goal."