Sunday, January 6, 2019
Syros announces strategic priorities, milestones ahead of JPMorgan conference
Syros Pharmaceuticals outlined its strategic priorities and expected upcoming milestones. The Company will review these priorities in a presentation at the 37th Annual JPMorgan Healthcare Conference on Thursday, January 10, 2019. The company expects to complete enrollment in mid-2019 in the ongoing Phase 2 study cohort evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with newly diagnosed acute myeloid leukemia who are not suitable candidates for standard chemotherapy. Syros also expects to report updated clinical data in the second half of 2019 on SY-1425 in combination with azacitidine, and report initial clinical data in the fourth quarter of 2019 from the expansion portion of the ongoing Phase 1 trial, which is assessing SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. Additionally, the company expects to complete IND-enabling studies to support initiation of a Phase 1 oncology trial in early 2020. Syros also announced that it has made a portfolio prioritization decision not to pursue further development of SY-1425 in combination with daratumumab beyond completion of the ongoing pilot cohort in the Phase 2 trial. Based on its current operating plans, Syros expects that its existing cash, cash equivalents and marketable securities will enable it to fund its anticipated operating expenses and capital expenditure requirements into 2020. Syros had approximately $113.2M in cash, cash equivalents and marketable securities as of September 30, 2018.
https://thefly.com/landingPageNews.php?id=2844141
Gilead, Yuhan Corp announce collaboration, license agreement
Gilead Sciences and Yuhan Corporation announced that the companies have entered into a licensing and collaboration agreement to co-develop novel therapeutic candidates for the treatment of patients with advanced fibrosis due to nonalcoholic steatohepatitis. Under the agreement, Gilead will acquire global rights to develop and commercialize novel small molecules against two undisclosed targets in all countries, with the exception of the Republic of Korea where Yuhan will retain certain commercialization rights. Yuhan and Gilead will jointly conduct preclinical research, and Gilead will be responsible for global clinical development. Gilead will also be responsible for commercialization worldwide, outside of Yuhan’s rights in the Republic of Korea. In connection with this agreement, Yuhan will receive an upfront payment of $15M and is eligible to receive up to an additional $770M in potential milestone payments upon achievement of certain development and commercial milestones, as well as royalties on future net sales. This agreement builds on the companies’ existing commercial collaboration to support the promotion of Gilead’s medicines in the Republic of Korea.
https://thefly.com/landingPageNews.php?id=2844143
Biotech week ahead: Jan 7
The new year kick started with a bumper deal in the pharma space, with Bristol-Myers Squibb Co BMY 3.95% agreeing to buy Celgene Corporation CELG 5.58%.
Can the deal infuse some momentum into the space following a down year? Here are some key catalysts of the upcoming week that could provide an answer.
Conferences
- 6th Annual Dermatology Summit – Jan. 6, in San Francisco, California
- Biotech Showcase – Jan. 7-9, in San Francisco
- 37th Annual JPMorgan Healthcare Conference – Jan.7-10, in San Francisco
- 11th Annual T-cell Lymphoma Forum – Jan. 10-12, in La Jolla, California
Clinical Trials
Axsome Therapeutics Inc AXSM 0.75% is due to release Phase 2 data for AXS-05 which is being evaluated in a study dubbed ASCEND for treating major depressive disorder. The release is scheduled for early January.
Miragen Therapeutics Inc MGEN 21.07% will present updated Phase 1 data for Cobomarsen at the 11th annual T-cell Lymphoma Forum at 6 pm PT Jan. 11. Cobomarsen is being evaluated for a variety of blood cancer types such as chronic lymphocytic leukemia, diffuse large B-cell lymphoma and cutaneous T-cell lymphoma.
IPO Quiet Period Expiry
Hong Kong-based pharma company Aptorum Group Ltd APM 0.19% offered 1.9 million shares in an IPO in December, with the offering priced at $15.80. The shares were listed on the Nasdaq Dec. 18 and closed the debut session at $14.35.
New mechanism to ‘activate’ the immune system against cancer
A new mechanism for activating the immune system against cancer cells allows immune cells to detect and destroy cancer cells better than before, according to a study published this week in the journal Nature.
The study was led by Prof. Nick Haining, of Harvard Medical School, and co-authored by Prof. Erez Levanon, doctoral student Ilana Buchumansky, of the Mina and Everard Goodman Faculty of Life Sciences at Bar-Ilan University, and an international team.
The focus of the study is a mechanism that routinely serves the cell by marking human virus-like genes in order to avoid identifying them as viruses. Now, Prof. Levanon, together with the Harvard team, has discovered that when inhibiting this mechanism, the immune system can be harnessed to fight cancer cells in a particularly efficient manner, and most effectively in lung cancer and melanoma.
“We found that if the mechanism is blocked, the immune system is much more sensitive. When the mechanism is deactivated, the immune system becomes much more aggressive against the tumor cells,” said Levanon.
In recent years, a new generation of cancer drugs has been developed which blocks proteins that inhibit immune activity against malignant tumors. These drugs have shown remarkable success in several tumor types. This year’s Nobel Prize in Medicine was awarded to James Allison and Tasuku Honjo, who discovered the key genes of this mechanism. Despite this achievement, the current generation of drugs helps only a small number of patients, while most of the drugs fail to cause the immune system to attack the tumor. It is hoped that the new discovery will allow enhanced activity of the immune system to attack cancer cells. A number of companies have already begun research to screen for drugs that will operate on the basis of this discovery.
Explore further: Cancer under pressure: Visualizing the activity of the immune system on tumor development
More information: Jeffrey J. Ishizuka et al, Loss of ADAR1 in tumours overcomes resistance to immune checkpoint blockade, Nature (2018). DOI: 10.1038/s41586-018-0768-9
Alliqua Biomedical provides update to shareholders
The Company completed sale of asset and rights relating to UltraMist Therapy System on May 7, 2018 to Celularity Inc.
On October 11, 2018, the Company signed merger agreement with Adynxx, Inc. The transaction is expected to close in Q1 2019.
On November 28, 2018, Alliqua announced to spin off its contract-manufacturing subsidiary Aquamed Technologies, and merge the business with TO Pharmaceuticals (OTCPK:TGLP) to establish a clinical-stage pharmaceutical company focused on commercializing cannabinoid-based therapies. The transaction will close in Q1 2019.
The company also intends to pay a special dividend in the range of $1.00 to $1.20 per share.
Heron gains on positive pain med combo data
Heron Therapeutics (HRTX +2.6%) is up on average volume in response to its announcement of positive results from pain management study evaluating the combination of HTX-011 and over-the-counter pain meds (acetaminophen and ibuprofen) for managing postoperative pain.
90% of patients receiving the combo regimen did not need opioids for postoperative pain through 72 hours after surgery, superior to 51%, 40% and 22% of patients receiving HTX-011, bupivacaine and placebo, respectively.
81% of patients receiving the combo remained opioid-free through 28 days after surgery.
The company’s U.S. marketing application seeking approval for HTX-011 + meloxicam is currently under FDA review with an action date of April 30.
The Ten Biggest Private Equity Deals In Healthcare In 2018
As 2018 was a banner year for venture capital funding in the healthcare sector, it was also a record for private equity deals. 715 private equity deals had closed as of mid-December for a combined value of $103.72 billion, according to PitchBook. In 2017 there were 709 deals worth $88.87 billion, and 651 deals worth $70.5 billion in 2016. That’s up from 413 deals worth $31.52 billion in 2013.
The Healthcare Research Institute of Pricewaterhousecoopers expects the trend to continue in 2019, as private equity investments have increased across the economy and the healthcare sector is in a phase of management teams looking to sell parts of a company that aren’t deemed essential to its main business. “We’ve seen a high level of divestitures, offloading a lot of non-core assets, and private equity has been there to be great partner,” says Karen Young, PwC’s U.S. pharma and life sciences leader. But the growth is from firms that have been in and around the industry making more bets, not from new players getting involved, she thinks. “They’re looking to become more of a collaborator in the industry versus just a banker, and I think that’s what’s driving a better relationship, as well as better outcomes on those transactions with higher values,” Young says.
2018’s biggest private equity deals in healthcare include such collaborations as health insurer Humana’s $4.1 billion partnership with firms TPG Capital and Welsh, Carson, Anderson & Stowe to buy Kindred Healthcare, which provides home health services and operates facilities for long-term acute care and rehabilitation. But it also includes more traditional deals such as controversial emergency room outsourcing company Envision Healthcare’s going private.
Here’s the rundown of the top ten, according to PitchBook:
- Envision Healthcare; $9.9 billion; Kohlberg Kravis Roberts
- Athenahealth; $5.7 billion; Veritas Capital, Evergreen Coast Capital
- LifePoint Health; $5.6 billion; Apollo Global Management, ATP Private Equity Partners, RCCH HealthCare Partners
- Kindred Healthcare; $4.1 billion; Welsh, Carson, Anderson & Stowe, TPG Capital, Humana
- American Medical Response; $2.4 billion; Air Medical Group Holdings, Kohlberg Kravis Roberts, Ardian, Koch Equity Development
- Sound Physicians; $2.15 billion; Revelstoke Capital Partners, Athyrium Capital Management, Summit Partners, Silversmith Capital Partners
- Lifescan; $2.1 billion; Platinum Equity
- Curo Health Services; $1.4 billion; TPG Capital, Welsh, Carson, Anderson & Stowe, Humana
- Juice Plus; $1.235 billion; Altamont Capital Partners
- Analogic; $1.1 billion; Altaris Capital Partners
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