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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On January 26, 2021 Invitae Corporation (NYSE: NVTA) reported the closing of its underwritten public offering of 8,932,038 shares of its common stock, including 1,165,048 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares, at the public offering price of $51.50 per share (Press release, Invitae, JAN 26, 2021, View Source [SID1234574294]). As a result of the underwriters’ option exercise, the aggregate gross proceeds to Invitae from the offering, before deducting underwriting discounts and commissions and other offering expenses, was approximately $460.0 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

J.P. Morgan Securities LLC, Morgan Stanley, Cowen and Company, LLC and SVB Leerink LLC acted as the book-running managers for the offering. William Blair & Company, L.L.C. acted as co-manager for the offering.

An automatic shelf registration statement relating to the shares was filed with the Securities and Exchange Commission and became effective on March 4, 2019. A copy of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY, 10014, Attention: Prospectus Department; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; or from SVB Leerink LLC, One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7535, ext. 6132, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 26, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of onvansertib in metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Cardiff Oncology, JAN 26, 2021, View Source [SID1234574292]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This Phase 2 clinical trial is designed to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide), 5-FU and leucovorin as a second-line treatment in patients with metastatic PDAC who have failed first-line gemcitabine-based therapy. The trial is expected to enroll approximately 40 patients across six sites in the U.S. including the three Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Emory University, Kansas University Medical Center and Inova Schar Cancer Institute.

"We are excited about the potential of onvansertib in PDAC and originally proposed this trial to Cardiff Oncology because of the results we are seeing in patients treated in our ongoing Phase 1b/2 trial in KRAS-mutated mCRC, which is also evaluating onvansertib in combination with nanoliposomal irinotecan and 5-FU," said Dr. Daniel H. Ahn, medical oncologist at the Mayo Clinic Cancer Center (Arizona), principal investigator for the Phase 2 PDAC trial and lead investigator for the Phase 1b/2 KRAS-mutated metastatic colorectal cancer (mCRC) trial. "These data show promising response rates with impressive durability across several KRAS variants following treatment. We believe these clinical benefits can be extended to PDAC, as approximately 95% have a KRAS mutation and onvansertib inhibits the proliferation and survival of KRAS-mutated tumor cells. We are looking forward to starting this important trial and providing our PDAC patients with a new second-line therapy with the potential to change the course of this devastating cancer."

"The FDA’s clearance of our Investigational New Drug application for a Phase 2 clinical study in patients with metastatic pancreatic cancer is an important milestone for onvansertib and represents a significant step forward in our development of a potential new treatment in an indication where current therapeutic options are limited and patient prognosis is poor," said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "By parlaying the known synergy between onvansertib and standard-of-care nanoliposomal irinotecan and 5-FU therapy, we believe we can offer a promising new treatment option that has the potential to improve patient outcomes."
About the Phase 2 Trial of Onvansertib in Metastatic PDAC
This trial is a multi-center, open-label, single-arm study designed to assess the safety and efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide), leucovorin,

and 5-FU as a second-line treatment in patients with metastatic PDAC. The trial is expected to enroll approximately 40 patients with histologically confirmed measurable and metastatic PDAC who have failed treatment with one prior line of gemcitabine-based chemotherapy. Patients will receive nanoliposomal irinotecan, leucovorin, and 5-FU on Day 1 of 14-day cycles, plus 12 mg/m2 onvansertib on Days 1-10, or 15 mg/m2 onvansertib on Days 1-5 of each 14-day cycle. The study will be conducted at six clinical trial sites across the U.S.: Mayo Clinic (Arizona, Minnesota, Florida), Emory University, Kansas University Medical Center and Inova Schar Cancer Institute. The primary endpoint will be overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Key secondary and exploratory endpoints include duration of response, median overall survival, ORR in patients receiving greater than two treatment cycles, disease control rate (defined as complete response, partial response or stable disease by RECIST v1.1 over the entire treatment period), and assessment of KRAS allelic burden in liquid biopsies as measured by circulating tumor DNA (ctDNA).