Oncolytics Biotech Inc T.ONC

Background to Gilead's $21 Bln acquisition of Immunomedics

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"Gilead had a very clear ambition to move into oncology," Andrew Dickinson, the company's chief financial officer, told BioPharma Dive.

The deals are a starting point ... Dickinson and his team see dealmaking as a vital tool for achieving Gilead's goals and note their work isn't over.

"What you can't do is stop doing deals," he said.

For most of its 33-year run, Gilead wasn't a big dealmaker. But by 2016, attitudes were changing. The company's hepatitis C business had peaked, and a staggering sales drop was fast approaching. Gilead needed new drugs, and dealmaking was one of the quicker ways to get them. 

Dickinson joined the company that year, assuming the role of senior vice president of corporate development after nearly a decade in the investment banking unit at Lazard, where he advised large biotechs such as Celgene and Amgen.

In 2017, Gilead made its most significant investment in cancer drugs with the $12 billion acquisition of Kite Pharma, which launched the company to the front of an emerging field of research focused on engineering immune cells to better fight cancer.

Soon after Kite, changes had come to more than just the deals team.

Many of Gilead's top executives were replaced throughout 2019. Daniel O'Day, the former head of pharmaceuticals at Roche, came on as CEO in March. In the months that followed, Gilead appointed a new chief medical officer, Merdad Parsey; a new chief commercial officer, Johanna Mercier; and a CEO for Kite, Christi Shaw. Dickinson rounded out the list, moving into the chief financial officer role in October of that year.

The appointments set the stage for Gilead's reinvigorated push into cancer. O'Day, Parsey, Mercier and Shaw had each worked at top oncology companies, and brought with them experience developing, selling and managing cancer drugs that Gilead didn't have before. 

Under this new team, Gilead solidified another piece of its cancer strategy. Instead of pursuing many types of research, the company would specifically keep its sights on immuno-oncology, an area of study which looks at how the body's infantry of immune cells can be deployed against cancer. 

Gilead wasn't original in its focus: immunotherapy had grown to be one of the industry's hottest areas of research over the past several years, helping to reinvent the way many tumor types are treated. Yet, Gilead was familiar with the immune system from its work in viruses, and the thinking, according to Dickinson, was the company could use that knowledge as a foothold in cancer drug development. 

With the team and the strategy in place, Gilead went about turning the relationships it had cultivated with young biotechs over the past few years into deals.

Early in March (2020), the company agreed to acquire Forty Seven, a cancer drugmaker located about 10 miles south of Gilead's Foster City headquarters, for nearly $5 billion. 

"Quite frankly, we needed to make up for where our pipeline was," said Devang Bhuva, Gilead's current head of corporate development, who joined the company this April after his own yearslong stint at Lazard, where he worked alongside Dickinson advising biotechs.

Gilead would soon get its hands on another important cancer drug, as the company's biggest deal ever was right around the corner. 

In the beginning of 2019, at a popular industry conference where seeds for future deals are frequently planted, Dickinson met with representatives from a New Jersey biotech called Immunomedics. Gilead wouldn't be the only company interested in Immunomedics ..... that April, the biotech reached out to Gilead and almost a dozen other pharmaceutical firms looking for a partner to help market it. One of those other firms came back with a counter offer: an all-out acquisition.

Dickinson said the offer took Gilead by surprise, especially considering that Immunomedics was just weeks away from presenting more detailed data on Trodelvy. Gilead, having seen the data early because of the partnering talks, knew they were strong and would likely bump up the price on any potential takeover bid.

"We expected it to turn from partnering discussions to an M&A transaction," he said, "but we didn't think it was likely that someone would try to do that a week before the company's key data was going to be publicly disclosed." 

Trodelvy wasn't the neatest fit for Gilead's strategy, either, since it's not by definition an immuno-oncology drug.

On the other hand, analysts expect Trodelvy to become a billion-dollar drug based solely on its first approval. If it were cleared for use in more cancers, sales could skyrocket.

"This is exactly what we have been waiting for," wrote the team at Piper Sandler, following the Immunomedics deal announcement. 

Trodelvy also provides Gilead, which had mostly worked in blood cancers, a foundation in solid tumors. According to Dickinson, Gilead envisions the drug pairing well with immuno-oncology medicines or targeted therapies, like the so-called PARP inhibitor class of medicines that's been used to treat prostate, breast and ovarian cancers.

"Sometimes you have to start investing in those smaller pipeline assets, where the science is great and where they match your overall strategy, and then you find the bigger pieces around which to build. Trodelvy is a perfect example," he said. 

Ten years from now, Dickinson pictures a more balanced Gilead. 

Virology would remain a core pillar, but share the weight with immuno-oncology ....

https://www.biopharmadive.com/news/gilead-deal-cancer-drug-andrew-dickinson/588835/

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While studies are underway to move Trodelvy into earlier lines of TNBC treatment, the drug may have potential outside of TNBC, too; Immunomedics is looking at urothelial cancer, HR+/HER2- breast cancer and lung cancer as possible areas for expansion. The TROP-2 cell surface protein is found in more than 90% of TNBC cases, and its expression is also high in the large market of

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Despite the recent FDA approval of targeted therapy for BRCA gene mutation (that is, the use of immune checkpoint inhibitor pembrolizumab and Trop-2 antibody drug conjugate), the majority of patients continue to progress after the first two lines of therapy. Consequenlty, there is an unmet need for patients whose triple-negative breast cancer has progressed despite previous treatment regimens

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Additionally. chimeric antigen receptor (CAR)-T cell therapy, a type of adoptive cell therapy that combines the antigen specificity of an antibody with the effector functions of a T cell, has emerged as a promising immunotherapeutic strategy to improve the survival rates of patients with TNBC. Unlike the remarkable clinical success of CAR-T cell therapies in hematologic cancers with Kymriah and

[inthno]

Wow , amazing such good news about all these other companies and that is why we are trading at a whopping 2.19 canadian. As canada fan says, just gotta wait a couple days for the news to filter out and then we are off to the races.

[inthno]

also I have been told many times in the past to not rely on clinical trials.gov for updates as they are usually 2-3 months behind or more on the proper updates, this info from when onc used to talk to shareholders.

[canadafan]

Onc is not followed by a huge base. so....when news comes out. For example the upcoming Dec 9th presentation, little happens. Quickly that is. countless times, I have seen Onc release news. Price goes down that day, only to recover leading into the expected outcome. Will Dec 9th be another let down? Not likely. major milestone? amything is possible. I still feel, there are a few more chips to fall

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Gilead is presenting at SABC 2021 on December 07-10, 2021 on Trodelvy in TNBC while ONCY presents on its Phase 2 IRENE study also in TNBC. https://www.biospace.com/article/releases/gilead-s-bold-ambition-of-transforming-triple-negative-breast-cancer-treatment-to-be-highlighted-with-new-data-at-sabcs/

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and whilst Gilead will be presenting Phase III data. ONCY will be presenting safety run in data from maybe 1 patient, if we're lucky... the conclusion will be that it's safe and well tolerated... It'll take more then rat's backside data like this to move the pps...

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 Well well "R" ... you don't have much to say. Will your incessant uninformed bashing really end? 

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Taken from yahoo.com message board : ONCY's AWARE-1 WoW study's primary endpoint was CeLTiLs score, a metric for quantifying the changes in tumor cellularity (Cel) and tumor infiltrated lymphocytes (TILs), where an increase in CelTIL is associated with a favorable response to treatment in early breast cancer. To date a 72% CelTIL response rate has been reported. More to come on this study

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Briliant... and only 5 years since Phase III green light... just remind us all again of how much time ONCY has saved by setting up for a shorter Phase III..? I thought the point of statistically significant data from a randomised trial meant it only had to be repeated at scale to satisfy the FDA... which is exactly what ONCY recieved by way of a SPA. So, ONCY could have run a Phase III without a

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YES - Brilliant - since ONCY has setup the dynamics for its Big Pharma acquirer to run a faster and cheaper Phase 3 registration study thus making ONCY more attractive to multiple bidders rather than just one or three who are presently involved and working with ONCY.

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With Roche’s HER2-positive breast cancer drug Herceptin (trastuzumab) patent expired in 2019 the company along with others are accelerating to develop antibody-drug conjugates (ADCs) incorporating trastuzumab into a proprietary combination oncology product. Consequently Roche appears to have consulted ONCY and SOLTI to initiate cohort 6 in the AWARE-1 study to further determine the synergy of

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Dec. 10, 2021 - Gilead'sTrodelvy® Demonstrates Clinical Benefit for Black Patients Consistent with Full Metastatic Triple-Negative Breast Cancer Population in ASCENT Study Gilead's interests in TNBC match those of Roche and Merck USA's and therefore ONCY's work in TNBC particularly match those of the aforementioned companies since pelareorep can be combined their respective

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April 08, 2022 -    " In draft guidance, the National Institute of Health and Care Excellence has rejected Gilead Sciences’ Trodelvy for use against triple negative breast cancer (TNBC), saying it is too expensive for use by the National Health Service (NHS)." “Given the lack of treatment options for people with this type of breast cancer, we’re very