On March 10, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy (Press release, Janssen Pharmaceuticals, MAR 10, 2020, View Source;jnj-6372-for-the-treatment-of-non-small-cell-lung-cancer-301020992.html [SID1234555384]). JNJ-6372 is an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.1 Currently, there are no FDA-approved targeted therapies for patients with lung cancer who have EGFR Exon 20 insertion mutations.2

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Patients with NSCLC and EGFR Exon 20 insertion mutations have a form of disease that is generally insensitive to EGFR tyrosine kinase inhibitor (TKI) treatments and carries a worse prognosis compared to patients with more common EGFR mutations (Exon 19 deletions/L858R substitution).3 The current standard of care for this patient population is conventional cytotoxic chemotherapy.4

"JNJ-6372 is a novel bispecific antibody that we believe has the potential to benefit patients with Exon 20 mutation insertions who often do not respond to currently available oral EGFR-targeted or immune checkpoint inhibitor therapies," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "This Breakthrough Therapy Designation is a significant milestone in our ongoing efforts to advance JNJ-6372 in clinical development and target genetically-defined lung cancer."

The Breakthrough Therapy Designation is supported by data from a Phase 1, first-in-human, open-label, multicenter study (NCT02609776).5 The study evaluates the safety, pharmacokinetics and preliminary efficacy of JNJ-6372 monotherapy and in combination with lazertinibi, a novel third-generation EGFR TKI, in adult patients with advanced NSCLC.5 The study seeks to determine the recommended Phase 2 dose in patients with advanced NSCLC.5 Enrollment into the Part 2 dose expansion cohorts is ongoing, as the study evaluates JNJ-6372 monotherapy activity in multiple NSCLC sub-populations with genomic alterations such as those with C797S resistance mutation or MET amplification.5

A U.S. FDA Breakthrough Therapy Designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.6 The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.6

i In 2018, Janssen entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

About JNJ-61186372 (JNJ-6372)
JNJ-6372 is an EGFR-MET bispecific antibody with immune cell-directing activity that targets activating and resistant EGFR and MET mutations and amplifications.5,7 The production and development of the antibody followed Janssen’s licensing agreement with Genmab for use of its DuoBody technology platform.

About Non-Small Cell Lung Cancer (NSCLC)
In the U.S., lung cancer is the second most common cancer in both men and women, after skin cancer; NSCLC makes up 80-85 percent of all lung cancers.8,9 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.10 The most common driver mutation for NSCLC is the EGFR genetic alteration, which is a receptor tyrosine kinase that helps cells grow and divide.10 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 adenocarcinoma.11,12,13 EGFR exon 20 insertion mutations identify a distinct subset of lung adenocarcinomas, accounting for at least nine percent of all EGFR mutations.14 The five-year survival rate for patients with metastatic NSCLC is currently six percent.15

On March 10, 2020 Proteostasis Therapeutics, Inc. (Nasdaq: PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) through theratyping, reported financial results for the fourth quarter and full year ended December 31, 2019, and provided a corporate update (Press release, Proteostasis Therapeutics, MAR 10, 2020, View Source [SID1234555383]).

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"Proteostasis made important progress throughout 2019 in delivering on our goal of bringing more treatment choices to patients with CF," said Meenu Chhabra, President and Chief Executive Officer of Proteostasis Therapeutics. "With our Phase 2 trials complete, we are moving forward with a Phase 3 clinical development plan that embraces the pursuit of personalized medicine in CF through theratyping. Our mission is to deliver combinations of our investigational agents to preselected patients identified as responders to our therapies through the ex vivo testing of their own organoids. We believe that the theratyping path, or the process of matching CFTR modulators to individual CF patients based on a laboratory assay regardless of CFTR genotype, has the potential to become a patient-friendly and cost-effective approach to treatment for patients with CF, thereby increasing access to treatment options and optimizing risk-benefit and cost-effectiveness of CFTR modulators."

Ms. Chhabra continued, "Through our next set of clinical trials that may be registrational trials, we will continue to explore the potential of our proprietary CFTR modulators – posenacaftor, dirocaftor and nesolicaftor – in rare and common CF mutations using both traditional and novel study approaches. We look forward to initiating these trials later this year and to providing updates, beginning with the CHOICES trial, soon thereafter."

Fourth Quarter and Recent Highlights

Last month, Proteostasis announced the completion of enrollment of 502 patients with CF in the HIT-CF Europe project, a research project which aims to provide better treatment and improve lives for people with CF and rare mutations. HIT-CF is leading a European-based initiative that is conducting confirmatory trials to assess the predictability of the organoid assay for clinical benefit, such as the CHOICES study (Crossover trial based on Human Organoid Individual response in CF – Efficacy Study). Proteostasis’ drug combinations will be tested first in an ex vivo study expected to be completed in the first half of 2020. Then, responders and non-responders will be selected for the CHOICES study. Dosing in CHOICES is expected to begin in the second half of 2020, with preliminary clinical data anticipated to be reported in early 2021.

In January of this year, Proteostasis announced a regulatory update following the completion of a scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (MHRA) that outlined a path forward for the initiation and execution of our Phase 3 program and the potential filing of a Marketing Authorization Application for posenacaftor, dirocaftor and nesolicaftor. The Company announced that it will continue to seek additional advice from other major regulatory agencies throughout 2020.

In December 2019, Proteostasis announced results from a Phase 2, 28-day clinical trial designed to assess the safety, tolerability and efficacy, of the Company’s once-daily proprietary combinations, 600 mg of posenacaftor (PTI-801) and 300 mg of dirocaftor (PTI-808), with or without 10 mg of nesolicaftor (PTI-428), or placebo. The results demonstrated that the combination was generally well-tolerated in the trial, with the majority of reported adverse events mild to moderate in severity. Homozygous subjects receiving the triple combination experienced a mean absolute improvement in ppFEV1 of 8 percentage points (p ≤ 0.01) and a reduction in sweat chloride concentration of -29 mmol/L (p < 0.0005) at day 28 compared to pooled placebo. In a population with high disease burden, the combination demonstrated compelling improvements in lung function and sweat chloride, including improved outcomes in the most challenging settings, including subjects with at least two pulmonary exacerbations within 12 months prior to study entry.

During the fourth quarter of 2019 through the date of this release, Proteostasis announced several peer-reviewed publications and medical meetings presentations, as well as a Company-hosted event:

In February 2020, the Company co-authored an article, titled "Amplifiers co-translationally enhance CFTR biosynthesis via PCBP1-mediated regulation of CFTR mRNA," which was published in the Journal of Cystic Fibrosis. The publication highlights nonclinical data on the mechanism of action of nesolicaftor (PTI-428).
In January 2020, the Company presented a poster, entitled "Intestinal Organoid Models as a Path for Personalized Therapy Development in Cystic Fibrosis," at the Keystone Symposia on Tissue Organoids. The poster highlighted the results from an ex vivo study of the Company’s proprietary CFTR modulators in organoids from individuals with CF who are ineligible for the current standard of care CFTR modulator therapies due to their genotype, a population of approximately 2,300 adults in Europe alone.
In October 2019, the Company was noted in a presentation highlighting data from the Company’s CF clinical development programs at the North American Cystic Fibrosis Conference that was delivered by Patrick Flume, M.D., Professor of Medicine and Pediatrics, Medical University of South Carolina and Jennifer L. Taylor-Cousar, M.D., M.S.C.S., Associate Professor of Medicine and Pediatrics, and Co-Director and CF Therapeutics Development Network Director of the Adult CF Program at National Jewish Health.
In October 2019, the Company hosted a CF patient summit featuring members of the CF community, including thought leaders, people with CF and CF advocates, and panel discussions focused on current unmet needs in CF.
Year End 2019 Financial Results

Proteostasis reported a net loss of approximately $59.1 million for the year ended December 31, 2019, as compared to a net loss of $61.8 million for the year ended December 31, 2018.

The Company recorded $5.0 million of revenue for the year ended December 31, 2019, as compared to $2.8 million for the same period in the prior year. Revenue for the year ended December 31, 2019 was related to the Company’s agreement with Genentech, Inc., while revenue for the year ended December 31, 2018 was related to the Company’s agreement with Astellas Pharma Inc., which was terminated in the fourth quarter of 2018.

Research and development expenses for the year ended December 31, 2019 were $52.3 million, as compared to $50.3 million for the same period in the prior year. The increase was primarily due to an increase in clinical-related activities.

General and administrative expenses for 2019 were $13.8 million, as compared to $15.7 million for the same period in the prior year. The decrease in general and administrative expenses was due primarily to a decrease in professional fees and facilities-related expenses.

Cash, cash equivalents and short-term investments totaled $69.5 million as of December 31, 2019, compared to $118.4 million as of December 31, 2018. The Company believes that its existing cash, cash equivalents and short-term investments are sufficient to fund operations into the second half of 2021. However, additional funding will be necessary to advance the Company’s proprietary combination therapy candidates through regulatory approval and into commercialization, if approved.

Fourth Quarter 2019 Financial Results

Proteostasis reported a net loss of approximately $11.9 million for the three months ended December 31, 2019, as compared to a net loss of $16.9 million for the same period in the prior year.

There was no revenue in either the three months ended December 31, 2019, or in the same period in the prior year.

Research and development expenses for the three months ended December 31, 2019 were $9.1 million, as compared to $13.7 million for the same period in the prior year. The decrease in research and development expenses for the three months ended December 31, 2019 was primarily due to a decrease in clinical-related activities.

General and administrative expenses for the three months ended December 31, 2019 were $3.1 million, as compared to $3.8 million for the same period in the prior year. The decrease in general and administrative expenses for three months ended December 31, 2019 was due primarily to a decrease in professional fees.

On March 10, 200 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the third quarter of fiscal year 2020 before the market open on Tuesday, April 7, 2020 (Press release, AngioDynamics, MAR 10, 2020, View Source [SID1234555380]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13700177.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, April 7, 2020, until 11:59 p.m. ET on Tuesday, April 14, 2020. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13700177.

On March 10, 2020 McKesson Corporation (NYSE:MCK) reported the completion of the split-off of PF2 SpinCo, Inc. ("SpinCo"), which held McKesson’s interest in Change Healthcare LLC ("Change Healthcare") and which was merged with and into Change Healthcare Inc. (NASDAQ:CHNG) ("Change") through a "Reverse Morris Trust" transaction (Press release, McKesson, MAR 10, 2020, View Source [SID1234555379]). The closing of the merger followed the previously announced expiration of McKesson’s exchange offer. As a result of the merger, participating McKesson stockholders will receive one share of Change common stock in exchange for each whole share of SpinCo common stock they received in the exchange offer.

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"We are pleased to have successfully completed the exit of our investment in Change Healthcare, in line with our stated objective of unlocking value for our shareholders," said Brian Tyler, chief executive officer, McKesson. "We are excited to move forward and execute against our strategic growth initiatives as a more focused organization, and believe McKesson is well positioned with a broad set of differentiated assets and capabilities."

The transactions enabled McKesson to reduce the number of its shares of outstanding common stock by 15,426,537 shares. The exchange offer and merger are expected to be tax-free to participating McKesson stockholders for U.S. federal income tax purposes except to the extent of any cash received in lieu of fractional shares of Change common stock.

McKesson will host a conference call on Tuesday, March 17th at 4:30 PM Eastern Time to discuss the completion of the split-off. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source The conference call can also be accessed by dialing 786-815-8297. The password is ‘McKesson’.

In connection with the transactions, Goldman Sachs & Co. LLC is acting as financial advisor and Davis Polk & Wardwell LLP is acting as legal advisor to McKesson.

On March 10, 2020 McKesson Corporation (NYSE:MCK) reported that its previously announced offer to stockholders to exchange their shares of McKesson common stock on a per-share-basis for 11.4086 shares of PF2 SpinCo, Inc. ("SpinCo") common stock expired at 11:59 p.m., New York City time, on March 9, 2020, and, based on preliminary results, the exchange offer was oversubscribed (Press release, McKesson, MAR 10, 2020, View Source [SID1234555378]). The exchange offer to split-off SpinCo, which holds McKesson’s interest in Change Healthcare LLC ("Change Healthcare"), is part of McKesson’s agreement with Change Healthcare Inc. (NASDAQ:CHNG) ("Change") to merge SpinCo with and into Change (the "Merger").

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According to the exchange agent for the exchange offer, Equiniti Trust Company, 98,165,418 shares of McKesson common stock were tendered prior to the expiration of the exchange offer, including 65,256,714 shares of McKesson common stock validly tendered and 32,908,704 shares of McKesson common stock that were tendered by notice of guaranteed delivery. McKesson has accepted 15,426,537 of the tendered shares of McKesson common stock in exchange for 175,995,192 shares of SpinCo common stock.

Immediately following the consummation of the exchange offer, and by means of the merger of SpinCo with and into Change, each outstanding share of SpinCo common stock will be converted into one share of Change common stock (with cash in lieu of fractional shares).

Because the exchange offer was oversubscribed, McKesson accepted tendered shares of McKesson common stock on a pro rata basis in proportion to the total number of shares tendered and not validly withdrawn. Stockholders who owned fewer than 100 shares of McKesson common stock, or an "odd lot," and who validly tendered all of their shares are not subject to proration in accordance with the terms of the exchange offer.

Based on the total number of shares of McKesson common stock that were reported as tendered prior to the expiration of the exchange offer, it is estimated that approximately 14.70% of the tendered shares of McKesson common stock that are subject to proration will be exchanged for shares of SpinCo common stock, assuming all shares tendered by guaranteed delivery procedures are delivered under the terms of the exchange offer. The preliminary proration factor is subject to change based on the number of tendered shares that satisfy the guaranteed delivery procedures.

McKesson expects to announce the final proration factor as soon as possible following the expiration of the guaranteed delivery period, which will occur on March 11, 2020. Promptly after the final proration factor is announced, shares of McKesson common stock tendered but not accepted for exchange will be returned to the tendering stockholders in book-entry form. Also at that time, the exchange agent for the exchange offer will deliver to Change’s transfer agent a final stockholder list for SpinCo common stock to be received by tendering McKesson stockholders whose shares were accepted for exchange in the exchange offer. Change’s transfer agent will use the final stockholder list to credit such tendering McKesson stockholders with whole shares of Change common stock. Fractional shares of Change common stock deliverable to tendering McKesson common stock holders will be aggregated and sold in the open market by Change’s transfer agent, or otherwise as reasonably directed by McKesson within 20 business days after the effective time of the Merger. Checks in lieu of fractional shares will thereafter be delivered to such tendering McKesson common stock stockholders by Change’s transfer agent, after deducting any required withholding taxes and brokerage charges, commissions and transfer taxes, on a pro rata basis, without interest, as soon as practicable.

In connection with the transactions, Goldman Sachs & Co. LLC is acting as financial advisor and Davis Polk & Wardwell LLP is acting as legal advisor to McKesson.