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.

On January 26, 2021 Teneobio, Inc. and its affiliate TeneoThree, Inc. reported that their investigational new drug application (IND) for TNB-585, a bispecific T-cell engaging antibody for the treatment of metastatic castrate resistant prostate cancer (mCRPC) was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on January 23, 2021 (Press release, TeneoBio, JAN 26, 2021, View Source;utm_medium=rss&utm_campaign=teneobio-announces-fda-clearance-of-ind-for-tnb-585-and-initiation-of-phase-1-clinical-studies-for-metastatic-castrate-resistant-prostate-cancer [SID1234574300]).

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Therapeutic options for mCRPC are limited, and those that are available improve survival for only up to five months. Recent clinical efforts leveraging T-cell redirection via Chimeric Antigen Receptor T-Cells and bispecific antibodies are promising, albeit complicated by frequent and occasionally severe cytokine release syndrome in treated patients. Teneobio has developed a unique anti-CD3 redirection platform that enables potent killing of cancer cells with minimal cytokine release.

Suhasini Iyer, CDO of Teneobio said, "As shown at the recent American Society of Hematology (ASH) (Free ASH Whitepaper) meeting (2020), the phase I data on TNB-383B, our anti-BCMAxCD3 bispecific, validated our hypothesis that uncoupling cytotoxicity from cytokine release was clinically feasible in treating multiple myeloma. We are excited to bring this unique CD3 redirecting platform profile to bear on mCRPC via TNB-585. An improved safety profile in T-cell redirection for mCRPC may enable future more efficacious combination treatments with standard-of-care therapies. Moreover, TNB-585 has a predicted half-life of over two weeks that enables a patient- and provider-focused dosing schedule."

On January 26, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.65 per share of the company’s common stock for the second quarter of 2021 (Press release, Merck & Co, JAN 26, 2021, View Source [SID1234574296]). Payment will be made on April 7, 2021 to shareholders of record at the close of business on March 15, 2021.

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