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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On January 26, 2021 Johnson & Johnson (NYSE: JNJ) reported results for fourth-quarter and full year 2020 (Press release, Johnson & Johnson, JAN 26, 2021, View Source [SID1234574295]). "Our notable full year performance reflects the continued confidence from patients, physicians, customers and consumers in our life-enhancing products and medicines, particularly throughout the COVID-19 pandemic," said Alex Gorsky, Chairman and Chief Executive Officer. "I’m incredibly proud of our Johnson & Johnson teams around the world for going above and beyond to meet stakeholder needs. These efforts, and our commitment to families around the world as the largest broad-based healthcare company, enabled us to lead in the fight against COVID-19. We continue to progress our COVID-19 vaccine candidate and look forward to sharing details from our Phase 3 study soon. Johnson & Johnson was built for times like these, and I am extremely confident in our ability to deliver lasting value and continued innovation in 2021 and for years to come."

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FULL-YEAR 2020 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 3.1%* driven by U.S. growth in over-the-counter products including TYLENOL analgesics, PEPCID and ZYRTEC; LISTERINE mouthwash in oral care products; OGX in skin health/beauty products and wound care products. Growth was negatively impacted by COVID-19 primarily in skin health/beauty and international baby care partially offset by increased COVID-19 demand in oral care products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 8.4%* driven by STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, DARZALEX (daratumumab), for the treatment of multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression and UPTRAVI (selexipag), an oral prostacyclin receptor agonist used to treat pulmonary arterial hypertension and reduce hospitalization. This growth was partially offset by the negative impact of COVID-19 as well as biosimilar and generic competition, with declines primarily in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer, and international VELCADE (bortezomib), a proteasome inhibitor for the treatment of multiple myeloma.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined by 10.5%*. The decline was primarily driven by the negative impact of the COVID-19 pandemic and the associated deferral of medical procedures to our Surgery, Orthopaedics, and Vision businesses. The decline was partially offset by growth in the Interventional Solutions business led by electrophysiology products. Results reflect market recovery in the second half of 2020.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the company’s website at news releases.

FULL-YEAR 2021 GUIDANCE:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.