On August 28, 2020 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported financial results for the quarter ended June 30, 2020 (Press release, Legend Biotech, AUG 28, 2020, View Source [SID1234564149]).

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"Legend Biotech continues to execute on our corporate strategy, advancing the development of our lead product candidate, ciltacabtagene autoleucel (cilta-cel), in collaboration with Janssen Biotech, Inc. as well as our other pipeline programs," said Frank Zhang, Ph.D., Chief Executive Officer and Chairman of the Board of Legend Biotech. "We look forward to presenting data from the CARTITUDE-1 study at a major medical conference in the second half of 2020."

Second Quarter 2020 & Recent Highlights

Collaborative Research and License Agreement with Noile-Immune Biotech. On April 27, 2020, Legend Biotech entered into a collaborative research and license agreement with Noile-Immune Biotech Inc. pursuant to which Legend Biotech obtained a license to develop and commercialize next-generation CAR-T and/or TCR-T cell therapies incorporating Noile-Immune’s PRIME (proliferation-inducing and migration-enhancing) technology for up to two targets for all indications.
Updated Results from Janssen sponsored Phase 1b/2 CARTITUDE-1 study. On May 13, 2020, Legend Biotech announced positive follow up data (median of 11.5 months) from the Phase 1b portion of the CARTITUDE-1 study evaluating cilta-cel1 (JNJ-4528) in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM).
Appointment of Three New Directors. In May 2020, Dr. Corazon (Corsee) Dating Sanders, Dr. Darren Ji, and Mr. Philip Yau joined Legend Biotech’s Board of Directors.
Successful Initial Public Offering. On June 9, 2020, Legend Biotech successfully completed its initial public offering for total gross proceeds of approximately $487.3 million.
Appointment of Dr. Frank Zhang as CEO. On August 1, 2020, the Board of Directors of Legend Biotech appointed Dr. Frank Zhang to serve as Chief Executive Officer, succeeding Dr. Yuan Xu upon her resignation.
First Breakthrough Therapy Designation from China CDE. On August 5, 2020, Legend Biotech announced that the China Center for Drug Evaluation ("CDE"), National Medical Products Administration recommended Breakthrough Therapy Designation ("BTD") for cilta-cel for the treatment of adults with relapsed/refractory multiple myeloma. The designation was granted on August 13, 2020, making cilta-cel the first investigational product to obtain BTD in China.
Key Upcoming Milestones

Legend Biotech, in collaboration with Janssen Biotech, Inc., anticipates the presentation of data from the CARTITUDE-1 study at a major medical conference in the second half of 2020.
Janssen Biotech, Inc., Legend Biotech’s collaboration partner, expects to initiate the BLA filing for cilta-cel to the U.S. FDA by the end of 2020 and also expects that a marketing authorization application will be submitted to the European Medicines Agency ("EMA") in early 2021.
Legend Biotech expects to use the data from CARTIFAN-1 in support of a regulatory submission for approval in China in 2021.
Legend Biotech intends to submit an IND application for LB1901 in relapsed or refractory T cell Lymphoma ("TCL") in the second half of 2020.
The extent to which the COVID-19 may impact our business and clinical trials is highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak and social distancing regulations, travel restrictions, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

Financial Results for the Quarter Ended June 30, 2020

Cash and Cash Equivalents:

As of June 30, 2020, Legend Biotech had approximately $562.4 million of cash and cash equivalents and approximately $75.6 million in time deposits.

Revenue

Revenue for the three months ended June 30, 2020 was $11.6 million compared to $10.1 million for the three months ended June 30, 2019. This increase of $1.5 million was primarily due to additional milestone payments from Janssen Biotech, Inc. that were achieved in late 2019, which resulted in additional consideration being allocated to steering committee service for the three month ended June 30, 2020. Revenue for the three months ended June 30, 2020 and June 30, 2019 consisted of recognition of upfront and milestone payments allocated to steering committee service pursuant to the license and collaboration agreement with Janssen Biotech, Inc. Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended June 30, 2020 were $53.6 million compared to $32.6 million for the three months ended June 30, 2019. This increase of $21.0 million was primarily due to a higher number of clinical trials, a higher number of patients enrolled in those trials and a higher number of research and development product candidates in the three months ended June 30, 2020.

Administrative Expenses

Administrative expenses for the three months ended June 30, 2020 were $4.5 million compared to $1.6 million for the three months ended June 30, 2019. This increase of $2.9 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to aid continued research and development activities.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended June 30, 2020 were $9.6 million compared to $5.0 million for the three months ended June 30, 2019. This increase of $4.6 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel.

Other Income and Gains

Other income and gains for the three months ended June 30, 2020 was $1.3 million compared to $1.2 million for the three months ended June 30, 2019.

Fair Value Loss of Convertible Redeemable Preferred Shares

For the three months ended June 30, 2020, Legend Biotech reported a one-time non-cash charge of $80.0 million caused by changes of fair value of Series A convertible redeemable preferred shares (Series A Preferred Shares). Upon listing on the Nasdaq Global Market, all outstanding Series A Preferred Shares were converted into ordinary shares of Legend Biotech and all accrued but unpaid dividends were settled in the form of ordinary shares of Legend Biotech.

Loss for the Period

For the three months ended June 30, 2020, net loss was $134.9 million, or $0.63 per share, compared to a net loss of $28.8 million, or $0.14 per share, for the three months ended June 30, 2019.

On August 28, 2020 Immunovia AB (publ) ("Immunovia"), reported that the company will be hosting the second webinar in the series on Immunovia’s IMMray PanCan-d (Press release, Immunovia, AUG 28, 2020, View Source;update-on-launch-activities-301120222.html [SID1234564148]). This second webinar will cover the results of the Commercial Test Model Study (link to pr) and updates on the launch activities.

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Event Details:

Immunovia’s IMMray PanCan-d Webinar Series

Webinar No. 2: Commercial Test Model Study & Update on Launch Activities

Date and Time: September 2, 2020 at 16:00 CET

Presenters: Linda Mellby, PhD; Thomas King, MD, PhD, and Laura Chirica, PhD

Immediately after the webinar, the Immunovia team will host a live Q&A session.

On August 28, 2020 Okayama University reported that In a recent study published in Biomaterials, researchers created a new 3D cell culture model of pancreatic cancer that closely mimics the "fibrotic" tissue characteristically observed in patients (Press release, Okayama University, AUG 28, 2020, View Source [SID1234564147]).

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Pancreatic cancer is a lethal condition with a very poor prognosis—only ~9% of patients live to see another 5 years after diagnosis. A prime feature of pancreatic cancer is the presence of fibrotic tissue within the tumors. This fibrotic tissue is akin to the scarring that surrounds a wound. Fibrotic tissue entraps the cancer cells within it, making it difficult to therapeutically target these cells. Thus, understanding the mechanisms behind fibrotic tissue development is imperative for creating effective treatment strategies. Professor Mitsunobu R. Kano and Assistant Professor Hiroyoshi Y. Tanaka from Okayama University and colleagues have now created a three-dimensional (3D) cell culture model of pancreatic cancer in the laboratory which closely replicate the fibrotic nature of the tumors.

Fibrotic tissue develops when cancer cells and specialized cells called fibroblasts closely interact with each other. The patterns of fibrotic tissue seen in pancreatic cancer vary greatly from patient to patient. The researchers started by analyzing patient tumor samples and found that fibrotic tissue took up as little as 40% and as much as 80% of the space within tumors. For the 3D cell culture model to truly mimic the cancer, it would need to reflect this wide range in the amount of fibrotic tissue observed. To achieve this, the team tried seeding pancreatic cancer cells and fibroblasts at different ratios. Indeed, by trying various ratios, the team could create 3D pancreatic cancer tissues with any given amount of fibrotic tissue—most importantly within the clinically observed range.

The fibroblasts within these models were subsequently scrutinized to unravel cellular changes driving fibrotic tissue development. It was found that two proteins, namely, SMAD2/3 and YAP were the driving force behind such changes. These two proteins, however, did not act alone: the combined activity of SMAD2/3 and YAP were necessary for the fibroblasts to acquire the abnormal characteristics seen in tumor tissue. A host of cellular signaling systems were in place to enable the function of SMAD2/3 and YAP—some of these systems were common while others were unique to each protein.

Cell culture models of pancreatic cancer play an indispensable part in understanding the disease since they allow mechanistic analyses at a detail that would otherwise be difficult to achieve in studies using laboratory animals or clinical specimens. However, cell culture models to date generally failed to recreate the characteristic, densely fibrotic tissue observed in pancreatic cancer, much less the variability observed between patients. The 3D cell culture model of pancreatic cancer developed in this study overcomes these issues. The new model may enable researchers to understand the differences between tumors showing various degrees of fibrosis and potentially customize strategies to target them. "Our novel model will be useful in promoting the understanding of the complex mechanisms by which the fibrotic stroma develops and how it might be therapeutically targeted", conclude the researchers.

Background

Pancreatic cancer and fibrotic tissue: Pancreatic cancer is one of the most difficult to treat cancers. This is in large part due to the dense, fibrotic tissue present within the tumor.

Fibrosis is a biological process that occurs in damaged internal organs (such as the pancreas) when wound healing mechanisms go awry. Although fibrosis initiates as a process that protects a damaged organ, it sometimes also ends up creating an environment that promotes the growth of cancer cells. Thus, fibrotic tissue is closely associated with the presence and spread of pancreatic cancer. Fibrotic tissue also facilitates drug resistance thereby preventing the cancer cells from responding to any medication. Fibrotic tissue is therefore a huge barrier to understanding the complexities of pancreatic cancer and developing therapeutic strategies.

On August 28, 2020 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported that holders of its 2.75% Convertible Senior Notes due in December 2021 (the "2021 Notes") and in December 2024 (the "2024 Notes" and together with the 2021 Notes, the "Notes") have the right to require the Company to repurchase for cash such Holder’s Notes on September 29, 2020 (the "Fundamental Change Repurchase Date" at a price equal to (1) with respect to the 2021 Notes, 100% of the principal amount, plus accrued and unpaid interest thereon to, but excluding, the Fundamental Change Repurchase Date, and (2) with respect to the 2024 Notes, 100% of the accreted principal amount as of the Fundamental Change Repurchase Date, which amount is $1,024.659 per $1,000 principal amount of 2024 Notes, plus accrued and unpaid interest thereon to, but excluding, the Fundamental Change Repurchase Date (Press release, PDL BioPharma, AUG 28, 2020, View Source [SID1234564146]). The Notes surrendered for purchase must be in amount that is equal to $1,000 or an integral multiple of $1,000. If all outstanding Notes are validly surrendered for repurchase, the aggregate cash repurchase price will be approximately $13,929,437 with respect to the 2021 Notes and approximately $1,033,740 with respect to the 2024 Notes.

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The right to surrender the Notes for repurchase expires at 5:00 p.m. Eastern time on September 28, 2020. In order to surrender the Notes, holders must provide notice in accordance with The Depositary Trust Company’s applicable procedures to The Bank of New York Mellon Trust Company, N.A., as paying agent (the "Paying Agent"), at any time on or before 5:00 p.m. Eastern time on September 28, 2020.

A Tender Offer Statement on Schedule TO relating to the repurchase will be filed with the Securities and Exchange Commission ("SEC") today. In addition, a Fundamental Change Repurchase Right Notice, Notice of Right to Convert and Offer to Repurchase (the "Fundamental Change Repurchase Notice") and documents specifying the terms, conditions, and Paying Agent are being sent to Note holders. None of the Company, its board of directors, or its employees has made or is making any representation or recommendation to any holder as to whether to exercise or refrain from exercising the repurchase right.

This press release is for information only and is not an offer to purchase, a solicitation of an offer to purchase, or a solicitation of an offer to sell the Notes or any other securities of the Company. The offer to purchase the Notes will be only pursuant to, and the Notes may be tendered only in accordance with, the Fundamental Change Repurchase Notice and related documents. Holders of Notes may request a copy of the Fundamental Change Repurchase Notice from the Paying Agent.

On August 28, 2020 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that the United States Patent and Trademark Office (USPTO) has granted a new patent covering the composition of matter of COM902, its immuno-oncology therapeutic antibody targeting TIGIT (Press release, Compugen, AUG 28, 2020, View Source [SID1234564145]).

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U.S. Patent No. 10,751,415, titled "Anti-TIGIT Antibodies, Anti-PVRIG Antibodies and Combinations Thereof," relates to the composition of matter of COM902, alone or in combination with a second antibody targeting an immune checkpoint, including PD-1 and PVRIG (specifically COM701). This patent is expected to expire no earlier than August 2037 in the United States.

This patent expands intellectual property protection for COM902 in the United States, for which a patent was previously issued in November 2018, relating to the method of use of COM902 for activating T cells in cancer patients, in addition to claims covering the combination of COM902 and COM701 for activating T cells in cancer patients. Similar to this new U.S. patent, in November 2019, Compugen was also granted a European patent relating to the composition of matter of COM902, alone or in combination with a second antibody targeting an immune checkpoint, including PD-1 and PVRIG (specifically COM701), as well as for use in treating cancer by activating T cells.

About COM902
COM902 is a high affinity, fully human antibody that blocks the interaction of TIGIT with PVR, its ligand, and consequently enhances T cell function. It is currently being evaluated in a Phase 1 clinical trial in patients with advanced malignancies who have exhausted all available standard therapies. Compugen has demonstrated in preclinical studies that simultaneous inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM axis, can increase antitumor immune responses, which may be further enhanced with the addition of PD-1 blockade. These data suggest that treatment with COM701 and COM902, targeting PVRIG and TIGIT, respectively, alone or in combination with a PD-1 inhibitor, has the potential to expand immuno-oncology treatment to patient populations who are non-responsive or refractory to existing immunotherapies.

The discovery of TIGIT, using the Company’s computational discovery platform, was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).