On January 12, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it will provide a preliminary update on its fourth-quarter and full-year 2020 financial results and the continued pace of its business recovery from the COVID-19 pandemic tomorrow, Jan. 13, 2021, during a fireside chat at 10 a.m. ET at the 39th Annual J.P. Morgan Healthcare Conference (Press release, Bausch Health, JAN 12, 2021, View Source [SID1234573927]).

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Bausch Health expects its revenue in the fourth quarter of 2020 will be greater than $2.20 billion. For the full year of 2020, the Company anticipates it will outperform the high end of its latest revenue guidance range of $7.80 – $8.00 billion.1

"Bausch Health’s preliminary fourth-quarter and full-year 2020 financial results demonstrate that our Company is continuing its business recovery from the effects of the COVID-19 pandemic driven by strong execution across our businesses. For the full year of 2020, we anticipate our revenue will outperform the high end of our latest revenue guidance range, and we also expect a strong finish to the year with regard to Adjusted EBITDA (non-GAAP)," said Joseph C. Papa, chairman and CEO, Bausch Health. "We look forward to releasing our full financial results for the fourth quarter and full year of 2020 next month."

Additionally, due to strong cash flow in the fourth quarter of 2020, Bausch Health expects to exceed $1 billion in cash generated from operations for the full year of 2020. In total, the Company repaid approximately $900 million of debt in 2020 from cash generated from operations and more efficient cash management, and has no debt maturities or mandatory amortization payments until 2024.

Bausch Health Will Publish Company Update Presentation on Jan. 13, 2021 at 7:00 a.m. ET
Bausch Health will publish a brief company update presentation tomorrow, Jan. 13, 2021, at 7 a.m. ET, that is designed to complement the remarks provided by management at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will provide an overview of the Company’s recent performance and offer insight into future catalysts for 2021 and beyond.

The presentation will be available on the Investor Relations page of the Bausch Health Companies Inc. website at: View Source A live webcast and audio archive of the fireside chat will also be available on the Investor Relations page of the Company’s website.

On January 12, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that eight company-sponsored presentations, including two oral presentations, will be featured at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore taking place virtually January 28-31, 2021 (Press release, Johnson & Johnson, JAN 12, 2021, https://www.prnewswire.com/news-releases/janssen-to-highlight-commitment-to-lung-cancer-science-and-innovation-with-eight-data-presentations-at-the-international-association-for-the-study-of-lung-cancers-2020-world-conference-on-lung-cancer-301207007.html [SID1234573926]). The presentations include updated data from the Phase 1 CHRYSALIS study (NCT02609776) evaluating amivantamab in patients with NSCLC and EGFR exon 20 insertion mutations and two studies that characterize the high unmet need and lack of standard of care in patients with exon 20 insertion mutations and the underdiagnosis of these patients in real-world settings.

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Amivantamab is an investigational, fully human bispecific antibody that targets tumors by directing immune cell activity against tumors with activating and resistance EGFR mutations and mesenchymal epithelial transition factor (MET) mutations and amplifications.1,2,3,4 Janssen has filed regulatory submissions in the U.S. and Europe seeking approval of amivantamab for the treatment of patients with NSCLC and EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.5 These applications mark the first-ever regulatory submissions of a treatment for patients with NSCLC and EGFR exon 20 insertion mutations.6

"We see an important opportunity to improve the diagnosis and treatment of patients with EGFR-mutated non-small cell lung cancer, especially for individuals with exon 20 insertion mutations. To that end, we look forward to presenting data highlighting the potential of amivantamab in this patient population, and the importance of genetic testing to identify mutations that may impact treatment outcomes," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. "We are focused and committed to transforming the trajectory of lung cancer through improved diagnostics, novel therapeutics and interception strategies."

Lung cancer is one of the most common cancers and is the leading cause of cancer deaths worldwide, with NSCLC making up 80 to 85 percent of all lung cancers.7,8 Patients with EGFR exon 20 insertion mutations have a median survival of less than 17 months9, which is much shorter than patients with EGFR exon 19 deletions or L858R mutations, who have a median survival of 32-39 months on current therapies.10

Amivantamab Phase 1 CHRYSALIS Study Shows Promise for Patients with NSCLC and EGFR Exon 20 Insertion Mutations
New data from the Phase 1 CHRYSALIS study evaluating the safety and efficacy of amivantamab in patients with metastatic NSCLC and EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy will be presented as an oral presentation (Abstract #3031). Early results from the CHRYSALIS study were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Abstract #9512).11

Mini-Oral Presentation Underscores Unmet Need of Patients with EGFR Exon 20 Insertion Mutations
A mini-oral presentation based on real-world data will provide new insights into the differences in prognoses for patients with NSCLC and EGFR exon 20 insertion mutations compared to those with other EGFR mutations (Abstract #3390).

Real-World Datasets Spotlight Underdiagnosis for Patients with Lung Cancer with Genetic Alterations
Accurate identification of driver mutations is an important part of lung cancer diagnostic and staging processes.12 A new analysis of real-world genomic data that will be presented at the meeting (Abstract #3399) estimates that genetic tests using polymerase chain reaction (PCR) may miss up to 50 percent of tumors with EGFR exon 20 insertion mutations, suggesting significant underdiagnosis exists.

Further details about these data and the science that Janssen is advancing for patients with lung cancer will be made available throughout the IASLC 2020 WCLC via the Janssen Oncology Virtual Newsroom.

Company-sponsored abstracts to be presented at the meeting include:

Abstract No.

Title

Date/Time

Oral Presentation

Abstract #3031

Amivantamab, an EGFR-MET Bispecific Antibody, in EGFR Exon 20 Insertion Mutant Non-Small Cell Lung Cancer

Thursday, January 28th

10:55 pm – 11:05 pm EST / Friday, January 29th 11:55 am – 12:05 pm Singapore Standard Time (SST)

Mini-Oral Presentation

Abstract #3390

Comparative Clinical Outcomes for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutations and Common EGFR Mutations

Friday, January 29th

4:20 am – 4:25 am EST / Friday, January 29th 5:20 pm – 5:25 pm SST

Featured Poster

Abstract #3399

Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-Based Real-World Datasets

Thursday, January 28th EST / Friday, January 29th SST

Poster Displays

Abstract #3380

PAPILLON: Randomized Phase 3 Study of Amivantamab Plus Chemotherapy vs Chemotherapy Alone in EGFR Exon20ins NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #1247

Cardiac Safety Assessment of Lazertinib in Patients with EGFR Mutation-Positive Advanced NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #1405

A Phase 1/1b Study of Lazertinib as Monotherapy and in Combination with Amivantamab in Advanced EGFR-Mutated NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #3374

MARIPOSA: Randomized Phase 3 Study of First-Line Amivantamab + Lazertinib vs Osimertinib vs Lazertinib in EGFR-Mutant NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #1271

Epidemiological and Clinical Burden of EGFR Exon 20 Insertion in Advanced NSCLC: Results of a Systematic Literature Review

Thursday, January 28th EST / Friday, January 29th SST

About Amivantamab
Amivantamab is an investigational, fully human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications.1,2,3,4 Companion diagnostics using Next Generation Sequencing, which are necessary to identify patients with EGFR exon 20 insertion mutations, have been an integral part of the development program for amivantamab. The bispecific antibody is being studied as a monotherapy in patients with EGFR exon 20 insertion mutations. Amivantamab is also being studied in combination with lazertinib, a third-generation tyrosine kinase inhibitor (TKI)13, in adult patients with advanced NSCLC.14 The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.

About Lazertinib
Lazertinib is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR.15 Interim safety and efficacy results from the lazertinib Phase 1-2 study were published in The Lancet Oncology in 2019. In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

About Non-Small Cell Lung Cancer (NSCLC)
Worldwide, lung cancer is one of the most common cancers, and NSCLC makes up 80 to 85 percent of all lung cancers.7,8 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.8 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.16 EGFR mutations are present in 10 to 15 percent of patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC.17 The five-year survival rate for all patients with metastatic NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent.18,19 Estimated median overall survival for patients with NSCLC and EGFR exon 20 insertion mutations is shorter than in patients with common EGFR mutations.16

On January 12, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab injection) as first-line therapy for patients with hepatocellular carcinoma (HCC) (Press release, Innovent Biologics, JAN 12, 2021, View Source [SID1234573925]). This is the fifth NDA application of TYVYT that has been accepted for review by NMPA. Meanwhile, this application also seeks the fourth indication for BYVASDA.

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TYVYT was approved by the NMPA in December 2018 for the treatment of relapsed or refractory classical Hodgkin’s lymphoma. In April 2020, the NMPA accepted the sNDA for TYVYT in combination with platinum-containing chemotherapy as first-line therapy in nonsquamous non-small cell lung cancer (NSCLC). In August 2020, the NMPA accepted the sNDA for TYVYT in combination with platinum-containing chemotherapy as first-line therapy for squamous NSCLC (NSCLC). In January 2021, the NMPA accepted the sNDA for TYVYT as second-line therapy in squamous NSCLC. Meanwhile, BYVASDA was previously approved by NMPA for the indications of advanced non-small cell lung cancer, metastatic colorectal cancer and adult recurrent glioblastoma.

The sNDA application was based on the pre-specified interim analysis of a randomized, open-label, Phase 3 clinical trial (ORIENT-32)—TYVYT in combination with BYVASDA as first-line therapy for unresectable HCC. Based on the interim analysis conducted by the Independent Data Monitoring Committee (iDMC), TYVYT in combination with BYVASDA demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) compared with sorafenib, which met the pre-defined efficacy criteria.

The principal investigator of the ORIENT-32 study, Professor Fan Jia from Zhongshan Hospital of Fudan University, stated: "We are very pleased to see that TYVYT plus BYVASDA can significantly improve the overall survival and progression-free survival compared to Sorafenib, which meet the pre-defined statistical superiority criteria. ORIENT-32 study was released in a late-breaking proffered oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia ("ESMO Asia") Virtual Congress 2020. This is the first randomized controlled trial using PD-1 inhibitor-based combination therapy that has improve the overall survival and progression-free survival in the first-line treatment of advanced HCC，which represents great significance."

Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: "HCC is the fourth most common malignancy with the second highest mortality rate in China. Despite treatment advancements, there remains significant unmet need for additional effective treatment options for HCC patients. The acceptance of this sNDA by the NMPA represents an important milestone in demonstrating the potential value of TYVYT in combination with BYVASDA in HCC. We look forward to working with the China regulatory authorities on the sNDA review and we hope to bring this therapy as a first-line treatment option to patients with unresectable HCC as early as possible."

About the ORIENT-32 Trial

ORIENT-32 is a Phase 3 randomized, open-label，multi-center study in China to evaluate the efficacy and safety of TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) compared to sorafenib in the first-line treatment of patients with advanced hepatocellular carcinoma（ClinicalTrials.gov, NCT 03794440）. The primary endpoints of the trial are overall survival (OS) and progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1.

A total of 571 subjects were enrolled in the ORIENT-32 Phase 3 study. Enrolled patients were randomly assigned 2:1 to receive TYVYT (sintilimab injection) combination with BYVASDA (bevacizumab biosimilar injection) or sorafenib, until disease progression, unacceptable toxicity, withdrawal of consent, death, or other reasons stated in the protocol, whichever occurs first.

About HCC

Primary liver cancer（PLC）is a common malignancy of the digestive system worldwide, among which about half new cases and deaths occur in China. The main pathological types of liver cancer are hepatocellular carcinoma (HCC), accounting for 85 to 90 percent, and a small number of cases of intrahepatic cholangiocarcinoma（ICC） and HCC-ICC mixed liver cancer. In China, HCC is primarily caused by hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT was included in the National Reimbursement Drug List (NRDL) in November 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

In April 2020, the NMPA accepted the sNDA for TYVYT in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In January 2021, the NMPA accepted the sNDA for TYVYT as second-line therapy for squamous NSCLC and the sNDA for TYVYT in combination with BYVASDA as first-line therapy in HCC.

TYVYT, is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, block the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivate T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT worldwide.

About BYVASDA (Bevacizumab Injection)

BYVASDA is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide.

On January 12, 2021 DermTech, Inc. (NASDAQ: DMTK) ("DermTech"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, reported that non-invasive genomic patch testing for melanoma, like DermTech’s Pigmented Lesion Assay ("PLA"), has received a recommendation from the National Comprehensive Cancer Network ("NCCN") (Press release, DermTech International, JAN 12, 2021, View Source [SID1234573923]). The recommendation indicates that there is uniform NCCN consensus that the intervention is appropriate. The NCCN Clinical Practice Guidelines in Oncology (the "NCCN Guidelines") for cutaneous melanoma recognize the use of noninvasive genomic patch testing to help guide biopsy decisions for cutaneous melanoma.

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The NCCN Guidelines are the recognized standard for clinical policy in cancer care and the most detailed clinical practice guidelines available in any area of medicine. The recommendation for pre-diagnostic non-invasive genomic patch testing can be found in the latest edition, NCCN Guidelines Version 1.21, Melanoma: Cutaneous, section ME-11, Common Follow-Up Recommendations for All Patients. The updated guidance now states: "Pre-diagnostic noninvasive genomic patch testing may also be helpful to guide biopsy decisions."

As a not-for-profit alliance of 30 leading cancer centers, the core resources made available by the NCCN are the NCCN Guidelines. These guidelines are decision tools created by leading clinicians to explain a disease and help determine the best way to treat a patient, depending on their diagnosis, disease stage and other factors, such as age. The NCCN Guidelines also help doctors make decisions, by explaining the pros and cons of each option.

"I laud the NCCN for recognizing the value of non-invasive genomic patch testing and including it in the current guidelines. This non-invasive genomic patch testing is a revolutionary change in the assessment of lesions suspicious for melanoma. Many commercial payors rely on guidelines from organizations such as NCCN as benchmarks for coverage decisions, and this NCCN recommendation indicates there is consensus that recognizes the value of the noninvasive genomic patch testing to guide biopsy decisions," said Daniel M. Siegel, M.D., Clinical Professor of Dermatology at SUNY Downstate and former President of the American Academy of Dermatology. "We are thrilled that the NCCN Guidelines recognize technology like DermTech’s as helpful in guiding biopsy decisions and foster earlier melanoma detection," said Burkhard Jansen, M.D., chief medical officer of DermTech. "Using genomic information provides clinicians with data even expert eyes cannot see and benefits patients with skin lesions clinically suspicious for melanoma. This is a significant milestone for precision genomics, and further substantiates the utility of our DermTech melanoma test, the Pigmented Lesion Assay, or PLA."

Covering 97 percent of all cancers affecting patients in the United States and updated on a continual basis, the NCCN Guidelines are developed through explicit review of evidence (clinical trials, existing treatment protocol, etc.) integrated with expert medical judgment and recommendations by panels that are made up of representatives from the 30 NCCN Member Institutions.

There are currently 73 NCCN Guidelines available free-of-charge that cover cancer detection, prevention and risk reduction, work-up and diagnosis, treatment and supportive care issues. To download the latest NCCN Guidelines, please visit: View Source

On January 12, 2021 TTC Oncology ("TTC" or the "Company") CEO and CMO Arek Dudek, MD, PhD, reported that it will be participating in the Biotech Showcase virtual conference occurring January 11-15, 2021 (Press release, TTC Oncology, JAN 12, 2021, View Source [SID1234573922]). Dr. Dudek will be providing a Company overview and update on the Company’s financing needs as well as TTC’s lead product candidate, TTC-352.

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TTC-352 is a novel, first-in-class and best-in-class orally available small molecule being developed as a treatment for patients with metastatic estrogen receptor-positive (ER+) breast cancer who have failed 2 or more prior therapies. TTC-352 is a selective human ER partial agonist (ShERPA) that induces unfolded protein response leading to breast cancer cell death and acts in a similar manner as hormone therapy by modulating estrogen actions.

Breast cancer afflicts approximately 2.1 million women in the US yearly with the majority of these cases being ER+ in which the hormone estrogen promotes tumor growth. Typically, patients with ER+ breast cancer are initially treated with hormonal therapy which blocks the tumorigenic actions of natural estrogen. However, many patients are unable to tolerate hormonal therapy which leads to discontinuation of treatment. Up to half of all patients who undergo this treatment develop resistance to therapy which can lead to cancer recurrence.

TTC Oncology has completed a Phase I human clinical trial where TTC-352 was shown to have only minimal side effects. In several women participating in the trial, TTC-352 successfully treated breast tumors resistant to multiple lines of hormonal and chemotherapy treatments. The best responders from the study include:

A 49-year-old woman with ER+, progesterone receptor-positive (PR+), HER2-breast cancer with visceral metastases. After progressing on multiple prior lines of hormonal and chemotherapies (12 total), TTC-352 induced 6% tumor shrinkage and controlled disease for 309 days with negligible toxicity
A 77-year-old woman with ER+, PR+, HER2-breast cancer with bone metastases. After trying 16 prior lines of hormonal and chemotherapy, TTC-352 treatment resulted in stable disease for 280 days with negligible toxicity
Based on these encouraging results, TTC Oncology are planning to develop TTC-352 to be commercially indicated as a second-line therapy of ER+ breast cancer.

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry’s largest gatherings and busiest weeks.

ABOUT BIOTECH SHOWCASE

Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place. Investors and biopharmaceutical executives from around the world gather in San Francisco during this bellwether week which sets the tone for the coming year. Now in its 13th year, this well-established, highly respected conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings. Biotech Showcase is produced by Demy-Colton and EBD Group. Both organizations have a long history of producing high-quality programs that support the biotechnology and broader life sciences industry.