On January 26, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has commenced additional studies to determine the exact sequence of the DNA encoding of the enzyme in the cells of its CypCaps product for pancreatic cancer and the stability of the sequences, in line with the requests provided by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, JAN 26, 2021, View Source [SID1234574308]).

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The cell clone used to produce the CypCaps product has been augmented to produce the cytochrome P450 enzyme. This enzyme converts ifosfamide from its inactive form to its cancer-killing form and is the basis for how CypCaps works. PharmaCyte has already shown that the enzyme is produced, that the expression of the enzyme is stable over time and that the enzyme is functional. The FDA has now asked PharmaCyte to provide the exact DNA sequence and configuration of the genetic augmentation responsible for the production of cytochrome P450 in the cells. This requires additional studies that necessitates a multi-prong approach, including the employment of a new, state of the art, technique.

The information provided by these analyses will also strengthen and extend the already existing data that has been presented to the FDA by PharmaCyte on (i) the site of integration of the DNA encoding of the cytochrome P450 enzyme; and (ii) the data on the stability of the cells, even before they are encapsulated using the Cell-in-a-Box to produce the CypCaps product. Thus, these new studies will add to the data that PharmaCyte already has on the long-term stability and shelf life of the final CypCaps product.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "Our team is pleased that we’ve commenced these additional studies and that we’re on a path to address more of the FDA’s comments regarding our treatment for locally advanced, inoperable pancreatic cancer (LAPC). As well as addressing the FDA’s comments, the information that will be created by these studies will bolster and augment our existing data on the stability of the cells used in the CypCaps product. While the data generated will not change the fact that the CypCaps product is functional, biologically active, and effective, it will generate further data on the exact configuration of the DNA that gives rise to the therapeutic effects of CypCaps."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On January 26, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that three abstracts from multiple clinical studies will be featured at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC), scheduled for January 28-31, 2021 (Press release, Biodesix, JAN 26, 2021, View Source [SID1234574307]). Findings from these recent studies demonstrate that an individual patient’s immune profile can provide information to support treatment decisions for patients diagnosed with advanced non-small cell lung cancer (NSCLC).

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"These results further demonstrate the importance of understanding a patient’s immune profile as a part of determining appropriate treatment for patients with NSCLC"

MA08.03: Immunotherapy alone or with chemotherapy in advanced NSCLC? Utility of clinical factors and blood-based host immune profiling.
An abstract authored by Wallace Akerley, MD, of the University of Utah Huntsman Cancer Institute demonstrates that host immune classifier (HIC) testing can equip physicians with key information to help guide treatment decisions for patients with newly diagnosed advanced NSCLC.

The prospectively designed INSIGHT observational study (NCT03289780) found that a clinically validated, blood-based HIC successfully helped to predict Immune Checkpoint Inhibition (ICI) therapy outcomes. The HIC test accurately stratified survival for patients receiving ICI but not ICI in addition to platinum-doublet chemotherapy. This suggests that HIC testing can be used to determine the appropriate treatment course for advanced NSCLC patients by identifying patients who may benefit from more aggressive treatment strategies, including ICI plus platinum-based chemotherapy combinations. The highly anticipated abstract for this presentation is part of the conference press program, and therefore under embargo until the presentation at 3:45 a.m. EST on January 30, 2021.

P33.06: Utilizing serum proteome to understand response and resistance to immune checkpoint inhibitors in advanced non-small cell lung cancer
An abstract presented by Won Kyung Hur, MD, of Olive View-UCLA Medical Center, reports data from a study on the Primary Immune Response (PIR) test, a proteomic classifier that identifies an aggressive disease state associated with resistance to ICI therapy. While treatment options for patients with advanced NSCLC have evolved significantly with the introduction of ICI, many patients develop either primary or secondary resistance to ICI, making them unable to benefit from this therapy. Response and resistance to ICI treatment for NSCLC are poorly understood.

This presentation will report findings from an independent validation of the PIR test, led by Young Kwang Chae, MD, which identifies an aggressive NSCLC disease state associated with resistance to ICI therapy. Findings from the study suggest that the PIR test can help predict patient survival with ICI therapy and guide treatment decisions for patients with advanced NSCLC. The data will be available for viewing at 11:00 a.m. EST on January 27, and Dr. Hur will present the data on January 28, 2021.

FP07.17: The Impact of Blood Based Host Immune Profile to Identify Aggressive Early Stage NSCLC
The abstract, authored by Eric Schaefer, MD, of Highlands Oncology Group, reports findings from the INSIGHT study, which is evaluating the utility of the Biodesix Lung Reflex testing strategy. The data suggest that using blood-based immune profiling with proteomic testing can help to identify patients with aggressive lung disease at an early stage. This early identification can benefit patients significantly by prompting either enhanced surveillance or additional treatment and may lead to more accurate determination of patient prognosis and classification of disease stages. Dr. Schaefer will present the data on January 28, 2021.

"These results further demonstrate the importance of understanding a patient’s immune profile as a part of determining appropriate treatment for patients with NSCLC," said Scott Hutton, CEO of Biodesix. "By pursuing personalized testing approaches to help guide treatment decisions, we strive to help prevent patients from receiving ineffective and costly care. More than ever, we’re focused on and committed to relentlessly seeking the best treatment plan for every patient with lung cancer. We are tremendously proud to share these new and important study results with the medical community."

On January 26, 2021 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX) a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the successful completion of its capital increase by issuing new ordinary shares with exclusion of pre-emptive subscription rights, via a private placement to European investors through an accelerated book building process, for approximately €6.4 million (Press release, NOXXON, JAN 26, 2021, View Source [SID1234574306]).

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"The significant support that we have received from new European institutional investors who represent the majority of this financing is a mark of confidence in NOXXON’s plans for future development. This capital increase further strengthens NOXXON’s financial visibility and allows us to focus on achieving key operational goals including completion of the ongoing NOX-A12 brain cancer trial and advancement of business development discussions," said Aram Mangasarian, CEO of NOXXON.

The Supervisory Board decided on January 25, 2021 to proceed with a capital increase excluding shareholders’ pre-emptive rights, in accordance with the delegation granted to it by the sixth resolution of the extraordinary general meeting of Shareholders of January 02, 2019. All the subscriptions were received and the final completion of the capital increase was acknowledged by the Board of Directors at its meeting held on January 25, 2021.

The total amount of the capital increase amounts to €6,424,748 and corresponds to the issue of 14,277,219 new shares at a subscription price of €0.45 per new share, i.e. a dilution rate of 23% of the capital after operation on a non-diluted basis. The subscription price of €0.45 per new share represents a discount of 22.5% on the average closing price of the shares over the five trading days from January 19-25, 2021.

Settlement of the transaction will take place on January 28, 2021. The new shares will carry current dividend rights and will be admitted to trading on the Euronext Growth Paris market, on the same trading line as the existing shares, under ISIN code NL0012044762, as of January 29, 2021.

The company’s issued share capital, which is currently composed of 47,178,313 shares, will therefore be composed of 61,455,532 shares after the transaction. As an indication, the participation of a shareholder holding 1% of the company’s issued share capital prior to the capital increase (calculated on the basis of the number of shares of the company’s issued share capital as of January 25, 2021), would be, after the issuance of the 14,277,219 new shares, 0.77% of the capital. The issued share capital prior to this financing was €471,783.13 and will therefore become €614,555.32.

The capital increase was advised by Champeil SA, and Marsac Advisors, and managed by Champeil SA acting as Lead Manager and Bookrunner.

Detailed information about NOXXON, including information about its business, results and corresponding risk factors, was presented in the Half-Year Financial Report for 2020 as well as its related press release on October 29, 2020 and the Annual Report 2019 and in the related press release dated April 22, 2020. The company’s press releases as well as other regulated information can be found on the company’s website (www.noxxon.com).

On January 26, 2021 BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported the enrollment of the first patient in a Phase I/IIa, first-in-human study of BI-1808 as monotherapy and in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL) (Press release, BioInvent, JAN 26, 2021, View Source [SID1234574303]). The first patient in the Phase I/IIa study has been enrolled in Denmark.

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BI-1808 is the lead development candidate from a panel of TNFR2-specific antibodies that BioInvent has generated from its proprietary n-CoDeR library and unique F.I.R.S.T discovery tool. TNFR2 is particularly upregulated on tumor-associated regulatory T cells (Tregs) and has been shown to be important for tumor expansion and survival, representing a new and important target for cancer immunotherapies.

"The start of this Phase I/IIa trial of BI-1808 is an important milestone for BioInvent’s third program in clinical development. It also further validates BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms and their ability to produce novel, differentiating drug candidates. We have generated a solid preclinical data set for BI-1808, showing exceptionally strong anti-tumor effect in several murine tumor models, and we are excited to now evaluate the potential of this unique antibody in the clinic," said Martin Welschof, CEO of BioInvent.

The Phase I/IIa study will evaluate the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent, and in combination with Keytruda in patients with ovarian cancer, non-small cell lung cancer and CTCL. It will also investigate the expression of immunological markers that may predict clinical responses. The trial will be conducted at several sites across Europe and the U.S. and is expected to enroll approximately 120 patients.

The Phase I stage is divided into two parts. Part A is a dose escalation study of BI-1808 to assess safety, tolerability, pharmacokinetics/pharmacodynamics, and to determine the recommended dose as a single agent for Phase II trials. Part B will explore the safety, tolerability and recommended dose of BI-1808 in combination with Keytruda. The Phase IIa stage will consist of expansion cohorts to assess signs of efficacy of BI-1808 as single agent, and in combination with Keytruda in lung cancer and ovarian cancer patients. Another cohort will explore the activity as single agent in CTCL.

On January 26, 2021 Varian (NYSE: VAR) reported its first quarter fiscal year 2021 results (Press release, Varian Medical Systems, JAN 26, 2021, View Source [SID1234574301]).

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"I am pleased with our solid start to the fiscal year, especially given the current global landscape due to the pandemic. Our performance in the quarter reflects the unwavering focus of our employees to deliver critical cancer care solutions for our customers," said Dow Wilson, Chief Executive Officer of Varian. "Our long-term fundamentals remain strong and we are excited about the opportunity to shape the future of cancer care with the pending combination with Siemens Healthineers."

As previously announced on August 2, 2020, Varian entered into a definitive agreement to combine with Siemens Healthineers AG (Frankfurt: SHL) in an all-cash transaction valued at $16.4 billion on a fully diluted basis. On October 15, 2020, Varian’s stockholders voted in favor of the proposal to adopt the merger agreement with Siemens Healthineers. The transaction is expected to close in the first half of calendar year 2021, subject to regulatory approvals and other customary closing conditions.

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Non-GAAP net earnings and non-GAAP net earnings per diluted share are defined as GAAP net earnings and GAAP net earnings per diluted share adjusted to exclude the amortization of intangible assets and amortization of inventory step-up, acquisition and integration-related expenses or benefits and in-process research and development, impairment charges, restructuring charges, significant litigation charges or benefits, legal costs, gains and losses on equity investments, and significant non-recurring tax expense or benefits. Reconciliation of GAAP and non-GAAP financial measures can be found at the end of the press release.

The company ended the quarter with $773 million in cash and cash equivalents and $210 million in debt. Net cash provided by operating activities was $141 million in the quarter.

Oncology Systems Segment
Oncology Systems revenues totaled $744 million, down 5%. Gross orders were $789 million, up 2%. Gross orders in the Americas were down 4%, with flat growth in North America. In EMEA, gross orders grew 21%. In Asia-Pacific, gross orders were down 12%.

Proton Solutions Segment
Proton Solutions revenues totaled $26 million, down 7%. The company received one new system order in the quarter.

Other Segment
Revenues for the Other segment were $9 million, down 54%. The Other segment is comprised of the Interventional Solutions business, including cryoablation, embolic microspheres, and microwave ablation. Additionally, it includes investments in cardiac radioablation.

Non-GAAP Adjustments
This quarter, our GAAP net earnings and GAAP EPS included a $9.4 million benefit from change in fair value from our public equity investments and $4.9 million in costs related to the proposed acquisition by Siemens Healthineers. As a reminder, in the first quarter of fiscal year 2020, GAAP net earnings and GAAP EPS included a charge of $8.8 million for a change in the fair value of contingent consideration.

Investor Conference Call
In light of the pending transaction with Siemens Healthineers, Varian will not be hosting a conference call for its first quarter of fiscal year 2021 earnings.