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).

On August 28, 2020 CollPlant (NASDAQ: CLGN), a regenerative and aesthetics medicine company, reported financial results for the second quarter ended June 30, 2020 and provided an update on the Company’s business developments (Press release, CollPlant, AUG 28, 2020, View Source [SID1234564144]). Certain metrics, including those expressed on an adjusted basis, are non-GAAP measures. See "Use of Non-GAAP Measures" below.

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CollPlant’s rhCollagen based BioInk – the ideal building block for tissue and organ manufacturing (PRNewsfoto/CollPlant)
CollPlant reported revenues of $823,000 for the second quarter of 2020, a 36% increase from the $606,000 recorded in the second quarter of 2019. The Company ended the second quarter of 2020 with $3.7 million in cash and cash equivalents. Comprehensive loss for the second quarter of 2020 was $2.0 million on a GAAP basis, or adjusted comprehensive loss of $1.4 million, on a non-GAAP basis.

"We continue to make major strides in revolutionizing the fields of regenerative and aesthetic medicine through our first-in-class, recombinant human collagen (rhCollagen) platform technology. First, we are partnering with United Therapeutics Corporation (NASDAQ: UTHR) in efforts to address global organ shortages. We plan to leverage this experience in 3D bioprinting of lung scaffolds to explore other life-saving organs and tissues in the future," stated Yehiel Tal, the Chief Executive Officer of CollPlant. "Second, the combination of hyaluronic acid and rhCollagen in our next-generation, regenerative, photocurable dermal fillers will provide superior skin rejuvenation inclusive of the ability to inject into deep wrinkles, as well as other key attributes. Moreover, we are looking forward to sharing new data on our innovative photocurable dermal fillers and additional updates on our breast implant product pipeline at the exclusive Science of Aging Virtual Symposium 2020, which will be held digitally on September 16, 2020. Third, we continue to abide by Israeli Health Ministry guidelines for optimal protection of our employees. To accommodate heightened social distancing policies amid the ongoing pandemic, we have concentrated efforts on amplifying corporate visibility through a stronger online and social media presence. Finally, we remain committed to bolstering our workforce with brilliant scientists and support staff from prestigious institutions here in Israel. We are opportunistic about establishing relationships with new strategic partners who can support our pipeline development efforts."

Financial Results

Second Quarter 2020 Financial Results on US GAAP basis ("GAAP")

Revenues for the three months ended June 30, 2020 increased by 36% to $823,000, compared to $606,000 in the second quarter of 2019. Revenues were derived mainly from CollPlant’s BioInk for the development of 3D bioprinting of human organs, and from sales of rhCollagen for medical aesthetics product development.

Cost of revenue was $748,000 in the three months ended June 30, 2020, an increase of 62% compared to $463,000 in the same period in 2019. The increase is primarily related to differences in the mix of products sold, different profitability and the different capacity of production in the reported periods presented.

The Company’s gross profit for the three months ended June 30, 2020 decreased by $68,000 to $75,000 compared to $143,000 in the second quarter of 2019.

Total operating expenses for the three months ended June 30, 2020 were $2.0 million, an increase of 5% compared to $1.9 million in the second quarter of 2019.

Operating loss for the three months ended June 30, 2020 was $1.9 million, an increase of 6% compared to an operating loss of $1.8 million in the second quarter of 2019.

Financial expense, net for the three months ended June 30, 2020 was $58,000 compared to financial income, net of $513,000 in the second quarter of 2019. Financial expense in the three months ended June 30, 2020 derived from non-cash exchange differences of operating lease liabilities under ASC 842, compared to financial income in the three months ended June 30, 2019 which derived from re-evaluation of financial instruments.

Comprehensive loss for the second quarter of 2020 was $2.0 million, or $0.28 per share, compared to a comprehensive loss of $1.2 million, or $0.27 per share, for the second quarter of 2019.

Cash used in operating activities during the six months ended June 30, 2020 was $4.3 million compared to $2.7 million in the six months ended June 30, 2019. As of June 30, 2020, cash and cash equivalents totaled $3.7 million.

Cash used in investing activities during the six months ended June 30, 2020 was $246,000 compared to $1.1 million in the six months ended June 30, 2019. The decrease is mainly attribute to costs incurred in the establishment in 2019 of CollPlant’s new HQ and R&D center in Rehovot, Israel.

Cash provided by financing activities during the six months ended June 30, 2020 was $4.5 million compared to cash used in financing activities of $18,000 in the six months ended June 30, 2019. The increase is mainly attribute to proceeds from issuance of shares in a private placement in February 2020.

Second Quarter 2020 Financial Results on Non-US GAAP Basis ("non-GAAP")

On a non-GAAP basis, the operating expenses for the second quarter of 2020 were $1.4 million, compared to $1.5 million for the second quarter of 2019.

Comprehensive loss for the second quarter of 2020 was $1.4 million, or $0.20 per share, compared to $1.5 million, or $0.31 per share, for the second quarter of 2019.

Non-GAAP measures exclude certain non-cash expenses. The table on page 10 includes a reconciliation of the Company’s GAAP results to non-GAAP results. The reconciliation reflects non-cash expenses in the amount of $555,000 with respect to (i) change in fair value of financial instruments, (ii) share-based compensation to employees, directors and consultants and (iii) change of operating lease accounts, including related financial expenses.