On January 28, 2021 The Board of Directors of McKesson Corporation (NYSE: MCK) reported a regular dividend of 42 cents per share of common stock (Press release, McKesson, JAN 28, 2021, View Source [SID1234574391]). The dividend will be payable on April 1, 2021, to stockholders of record on March 2, 2021.

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On January 28, 2021 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform the treatment of cancer, reported that the first patient has been injected in a phase I study evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer (Press release, Nanobiotix, JAN 28, 2021, View Source [SID1234574390]). The trial is being conducted at The University of Texas MD Anderson Cancer Center (MD Anderson) as part of an ongoing clinical collaboration.

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Background and Opportunity

According to the World Health Organization, esophageal cancer is currently the sixth most common cause of cancer death in the world and is estimated to have caused over 508,585 deaths in 2018. The American Cancer Society estimates that in 2020 in the United States, there were approximately 18,440 new esophageal cancer cases diagnosed, and approximately 16,170 deaths due to esophageal cancer. Approximately 20% of patients survive esophageal cancer at least five years after diagnosis.

Phase I Study of NBTXR3 Activated by Radiotherapy with Concurrent Chemotherapy for Patients with Esophageal Cancer (MD Anderson Study 2020-0122)

This study is an open-label, single-arm, prospective phase I study consisting of two parts: (i) dose-escalation to determine the RP2D of NBTXR3 activated by radiotherapy with concurrent chemotherapy, and (ii) expansion at RP2D with toxicity monitoring.

The patient population will include adults (age ≥ 18 years) with stage II-III adenocarcinoma of the esophagus that are treatment-naïve and radiographically non-metastatic at screening. The number of participants enrolled will be determined based on the maximum number required to establish the RP2D of NBTXR3 activated by radiation therapy. Up to 24 subjects will be enrolled, including a maximum of 12 subjects for the dose-escalation part. Twelve additional subjects will be enrolled for the RP2D expansion part. Recruitment is ongoing and the planned enrollment period is 24 months.

Updates on this trial will be provided as they are made available by MD Anderson.

On January 28, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported new data from the Phase 1/2 trial of mobocertinib (TAK-788) orally administered in previously treated patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) will be presented as a late-breaking oral session at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) on Friday, January 29 SGT (Press release, Takeda, JAN 28, 2021, View Source [SID1234574389]).

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"Results show mobocertinib demonstrated clinically meaningful responses and a noteworthy duration of response in patients with EGFR Exon20 insertion+ mNSCLC who received prior platinum-based therapy," said Pasi A. Jänne, M.D., Ph.D., Dana-Farber Cancer Institute. "These data are promising and provide further evidence for mobocertinib as a potential oral treatment for patients with EGFR Exon20 insertion+ mNSCLC, who are in critical need of targeted treatment options."

The analysis of platinum-pretreated patients included patients with EGFR Exon20 insertion+ mNSCLC who received prior platinum therapy from the Phase 1/2 trial. All patients were treated at the 160 mg once daily oral dose. Key findings from this population include:

Parameter

Results in Platinum-Pretreated Population (N=114)

Confirmed objective response rate (ORR) per investigator

35% (40/114; 95% CI 26-45)

Confirmed ORR per IRC

28% (32/114; 95% CI 20-37)

Median duration of response (DoR) per IRC

17.5 months (95% CI 7.4-20.3)

Median progression-free survival (PFS) per IRC

7.3 months (95% CI 5.5-9.2)

Disease control rate (DCR) per IRC

78% (89/114; 95% CI 69-85)

The safety profile observed was manageable. The most common treatment-related adverse events (TRAEs; ≥ 20%) in platinum-pretreated patients from the May data cutoff were diarrhea (90%), rash (45%), paronychia (34%), nausea (32%), decreased appetite (32%), dry skin (30%) and vomiting (30%). Grade ≥3 TRAEs (≥5%) included diarrhea (21%). Nineteen patients (17%) discontinued due to AEs, most commonly diarrhea (4%) and nausea (4%). The safety profile from the November data cutoff was consistent with that of the May data cutoff.

"The importance of advancing research for people living with EGFR Exon20 insertion+ mNSCLC – a complex and devastating disease with no approved targeted therapies – cannot be overstated, as existing treatment options provide limited benefit and patients often have poor survival outcomes," said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. "We’re proud of these positive results from mobocertinib, the first oral therapy designed to selectively target their disease, and we look forward to submitting data from the platinum-pretreated population analysis to the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the globe."

Mobocertinib is currently not approved for EGFR Exon20 insertion+ mNSCLC.

Takeda will host a briefing for analysts and investors on Friday, January 29, at 5:00 p.m. ET to discuss these data and the mobocertinib program. Please contact [email protected] for further details. Presentation slides and an archived replay of the webcast will be available at View Source

About the Phase 1/2 Trial

The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). The trial is comprised of a Phase 1 dose-escalation, evaluating mobocertinib as a monotherapy and in combination with chemotherapy, and a Phase 2 expansion, which includes seven different cohorts, as well as an extension cohort, investigating the anti-tumor activity of mobocertinib in various trial populations.

The platinum-pretreated population analysis investigated 114 patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC) who received prior platinum-based therapy from the escalation and expansion phases of the Phase 1/2 trial and were treated with mobocertinib at the 160 mg once daily dose.

The Phase 2 extension cohort, known as EXCLAIM, investigated 96 previously treated patients with EGFR Exon20 insertion+ mNSCLC who were treated with mobocertinib at the 160 mg once daily dose.

About Mobocertinib (TAK-788)

Mobocertinib, an oral therapy, is a potent, small-molecule tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with human EGFR 2 (HER2) mutations or EGFR mutations including Exon20 insertion mutations. In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. In October 2020, mobocertinib was designated as a Breakthrough Therapy in China by the Drug Review Center (CDE) for the same indication.

About EGFR Exon20 Insertion+ mNSCLC

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 1.8 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.1,2 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC) make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.3-7 This disease carries a worse prognosis than other EGFR mutations because there are currently no FDA-approved therapies that target Exon20 insertions, and current EGFR TKIs and chemotherapy provide limited benefit for these patients.

Takeda is committed to continuing research and development in EGFR Exon20 insertion+ mNSCLC with the hope of introducing a targeted treatment option for the approximately 30,000 patients diagnosed with the disease worldwide each year.3,4

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

On January 28, 2021 Bio-Thera Solutions (SHA: 688177), a commercial-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin (bevacizumab) (Press release, BioThera Solutions, JAN 28, 2021, View Source [SID1234574388]). The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is November 27, 2021.

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The BLA seeks approval of BAT1706 for the following indications: 1) treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, 2) first-line treatment for patients with non-squamous non-small cell lung cancer, 3) recurrent glioblastoma, 4) metastatic renal cell carcinoma in combination with interferon alfa and, 5) persistent, recurrent or metastatic cervical cancer.

"The FDA’s acceptance of our BLA is a significant achievement that brings Bio-Thera closer to providing cancer patients in the USA with a high-quality, low-cost treatment option," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. "Regulatory filings for BAT1706 have now been accepted by the China National Medical Products Administration (NMPA), European Medicines Agency (EMA) and FDA, demonstrating Bio-Thera’s commitment to developing BAT1706 to global standards so that BAT1706 can be made available to the global cancer patient community."

The BLA submission is based on data from a series of preclinical comparison studies, clinical pharmacokinetic comparison studies, and an international multi-center Phase III clinical comparison study that demonstrated that BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. Biosimilarity has not yet been established by any regulatory authorities.

BAT1706 is Bio-Thera Solutions’ second proposed biosimilar submitted for regulatory approval. The company’s first biosimilar product, QLETLI (格乐立), a biosimilar to Humira (adalimumab), has received marketing authorization and is available in China. Bio-Thera Solutions is developing several additional proposed biosimilars, including tocilizumab, golimumab, ustekinumab and secukinumab, and mepolizumab among others.

On January 28, 2021 Artiva Biotherapeutics, Inc., an oncology company focused on developing and commercializing primary allogeneic natural killer (NK) cell therapies to treat cancer, reported that it has entered into an exclusive worldwide collaboration and license agreement with Merck, known as MSD outside the United States and Canada, to develop novel chimeric antigen receptor (CAR)-NK cell therapies targeting solid tumor-associated antigens (Press release, Artiva Biotherapeutics, JAN 28, 2021, View Source [SID1234574386]). The collaboration will leverage Artiva’s off-the-shelf allogeneic NK cell manufacturing platform, along with its proprietary CAR-NK technology. The collaboration initially includes two CAR-NK programs with an option for a third, none of which are in Artiva’s current or planned pipeline. The agreement provides that Artiva will develop the CAR-NK programs through the first GMP manufacturing campaign and IND preparation, followed by transfer to Merck for clinical and commercial development.

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Under the terms of the agreement, Artiva will receive a $30 million upfront payment for the first two programs and an additional $15 million payment if Merck exercises its option for a third program. Artiva is also eligible to receive future development and commercial milestones of up to $612 million per program and royalties are payable by Merck on worldwide sales of any product derived from the collaboration. Merck agreed to provide research funding to Artiva for each of the programs under the collaboration.

"Our NK platform has been developed to be truly off-the-shelf and we believe it will be further validated by this exclusive collaboration with Merck, as we work together to bring cell therapies to all patients who may benefit," said Dr. Peter Flynn, COO of Artiva. "This collaboration will combine Merck’s leading immuno-oncology expertise and capabilities with our highly scaled and optimized CAR-NK platform," added Dr. Fred Aslan, CEO of Artiva.

"At Merck, we continue to explore new ways to transform the most innovative science into better therapies for patients who need them most," said Dr. Nick Haining, Vice President, Head of Discovery Oncology and Immunology, Merck Research Laboratories. "We look forward to working with the team at Artiva with the hope of developing new NK cell-based treatments for cancer."

Artiva’s targeted NK cell therapies leverage the innate anti-tumor biology and safety features of NK cells. The therapies are optimized for enhanced efficacy through CARs, therapeutic antibody combination therapy, and genetic engineering. The Merck CAR-NK collaboration programs will leverage Artiva’s novel NK-specific CAR costimulatory structures and highly scaled, proprietary NK cell manufacturing platform. Artiva’s manufacturing platform supports large-scale production and cryopreservation of off-the-shelf allogeneic NK cell therapies and proprietary CAR-NK and NK-specific gene-editing technologies to augment therapeutic activity.