Member Info for Krone

Trusting that SAR is not reliant on China for any raw materials or other aspects of current development!

FDA goes on high alert as coronavirus raises threat to drug manufacturing and clinical trials grind to a halt
The FDA isn’t quite sure just what the coronavirus outbreak in China will mean for the US pharma industry, but it has the potential to trigger a host of troublesome issues around the supply chain the country is directly plugged into.

I don't recall who previously mentioned sepsis as a possible target however interesting to note the 2013 reference by SRI to sepsis and wondering whether the selection of of most efficacious/lucrative target is the reason for the ongoing delays in publication of the SRI DoD paper?
http://www.sareum.com/news/press-releases-and-news/2013/sareum-and-sri-international-announce-co-development-agreement/
Because of TYK2’s critical role in the signalling of inflammatory cytokines, there is strong scientific rationale for developing TYK2 inhibitors for the treatment of autoimmune and inflammatory diseases such as multiple sclerosis, rheumatoid arthritis, sepsis, and Crohn’s Disease,” said Annalisa D’Andrea, Ph.D., senior director of SRI’s Center for Immunology and Infectious Diseases. “Combining SRI’s expertise in autoimmune and inflammatory diseases with Sareum’s experience in compound design will enable us to develop much-needed products that may benefit people throughout the world.”
D'Andrea currently CSO at Kiniksa - KNSA

A novel TYK2 inhibitor may provide clinicians with another treatment option along the janus kinase pathway in patients with severe #psoriasis, said Dr. George Martin at #RWCS2020 @RWCSmtg
Novel TYK2 inhibitor may be a ‘game changer’ for psoriasis

February 14, 2020
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George Martin
MAUI, Hawaii — A novel TYK2 inhibitor may provide clinicians with another treatment option along the janus kinase pathway in patients with severe psoriasis, according to a presentation at the 2020 Rheumatology Winter Clinical Symposium.

“This is causing a lot of excitement, this BMS oral TYK2 inhibitor,” George Martin, MD, of Dr. George Martin Dermatology Associates in Hawaii, told attendees of BMS-986165 (Bristol-Myers Squibb). “When you look at the JAK/STAT pathway and what molecules they affect, you look at TYK2 and you see IL-12 and IL-23, as well as interferon alpha and beta. They are all affected if, in fact, you block TYK2.”

TYK2 signaling mediates fewer cytokines compared with JAK 1-3 inhibitors, according to Martin. He added that these are important cytokines that drive psoriasis.

While he presented on a broad range of topics pertaining to the rheum-derm continuum, Martin focused on data from a phase 2 study conducted by Papp and colleagues in patients with severe psoriasis. “They selected a wide range of your standard psoriasis patients,” Martin said. “A lot of body surface area, and there was prior biologic use in roughly half of them. These patients had a lot of disease.”


A novel TYK2 inhibitor may provide clinicians with another treatment option along the janus kinase pathway in patients with severe psoriasis, according to Martin.
Source: Healio Rheumatology
The study included 45 participants receiving placebo and 44 participants receiving 3 mg active therapy with BMS-986165 every other day, 44 receiving 3 mg once a day, 45 receiving 3 mg twice a day, 45 receiving 6 mg twice a day and 44 receiving 12 mg once a day.

Results showed that almost 75% of the cohort reached PASI 75 response, while half reached PASI 90 response, according to Martin. “This is a blowaway slide,” he said. “But check out the results for PASI 100. About 25% of patients were totally clear.”

Safety data showed three serious adverse events in the active therapy arm. The drug was also associated with acne, particularly in patients who received the 6 mg and 12 mg doses.

Martin said that the researchers also looked at how the drug impacted hemoglobin, NK cell count, neutrophil count and total cholesterol. “When you look at it, there was no impact on any of them,” he said. “If you talk to the scientists who whipped up this molecule, they are really trying to distance themselves from the regular JAK inhibitors.”

In addition to the potential improvements in psoriasis, Martin believes that BMS-986165 may also have utility in invasive bowel disease.

“This is really exciting,” Martin said. “We can’t wait to get our hands on this.

Filgotinib: Gilead’s primed and ready to roll, but the headwinds could be intense
Peak sales: $1.42B
Company: Gilead $GILD
Condition: Rheumatoid arthritis
Mechanism: JAK1
Stage of development: The application for filgotinib was filed December 20, 2019

Num4 - not doubting the potentially very wide ranging application of 737, especially given the very enthusiastic support from Johan De Bono et al. Just not good at being patient during the interminable wait.... Conscious also that Tim’s significant shareholder value has only 4 months until expiry.

Rio - SRA737/Gemcitabine combination 'estimated completion date' March 2020. It must absolutely be in Sierra's best interests to get the data published ASAP.
https://www.sierraoncology.com/development/sra737/clinical-trials/
https://clinicaltrials.gov/ct2/show/NCT02797977
https://clinicaltrials.gov/ct2/show/NCT02797964

Coincidence.....
Tweet - 'PARP inhibitors such as niraparib - have revolutionised ovarian cancer treatment. The MONITOR-UK study will give us important information on niraparib in real-world UK clinical practice, helping us to better support patients through treatment." -@BanerjeeSusana

How much clout to we have with CRT re rescheduling milestones? Parker at al will surely want to hold the line given the very limited runway.

No mention of SRA737!!

Sierra Oncology Completes Conversion of Preferred to Common Stock and Issues Stock to Gilead

VANCOUVER, Feb. 6, 2020 /CNW/ - Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the development and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, today announced that the Series A convertible voting preferred stock issued in its recently completed $103.0 million financing (gross proceeds) have been fully converted into shares of common stock.
In addition, Gilead Sciences, Inc. (Gilead) has been issued 725,283 shares of common stock and a warrant to purchase an equivalent amount of common stock, in consideration for meaningfully reduced royalty rates and elimination of a near term milestone in an amendment to the Asset Purchase Agreement with Gilead for momelotinib, as previously announced.
"These announcements bring clarity to Sierra's simplified go-forward capital structure. We are fortunate to have built both a healthy balance sheet and a critical mass of high quality, supportive shareholders, led by Vivo Capital, Longitude Capital, OrbiMed and Abingworth, investors in our recent financing and from which we appointed four new directors to Sierra's Board, as well as Gilead. These stakeholders are aligned with Management in our focus on achieving regulatory and commercial success with our Phase 3 drug candidate, momelotinib, which has the potential to become an important therapeutic for both first and second line myelofibrosis patients, including the majority that suffer from anemia and thrombocytopenia," said Dr. Nick Glover, President and CEO of Sierra Oncology.
There are now 10,395,732 total shares of common stock outstanding and warrants to purchase 11,102,251 shares of common stock, with an exercise price equal to $13.20 per share. Of these warrants, warrants to purchase approximately 2,574,727 shares of common stock (the Series B warrants) may only be exercised by paying the exercise price in cash, and will expire on the 75th day anniversary following the announcement of top-line data from MOMENTUM, Sierra Oncology's ongoing Phase 3 clinical trial of momelotinib. If these Series B warrants are fully exercised, the company will receive approximately $34.0 million in proceeds.
Sierra Oncology previously reported its cash and cash equivalents totaled $67.7 million as of September 30, 2019, and that subsequently it had closed an underwritten public offering with gross proceeds to Sierra Oncology of $103.0 million. Prior to the end of 2019, a term loan of $5.0 million was repaid to Silicon Valley Bank.
About Sierra Oncology

Coldfishpie- more chance of hearing from Arne Saknussemm!

Iamhappy - According to JR In respect of 1801/Lupus the data are in, SRI have drafted the paper...discussions are underway with potential license partners....we are just waiting on the nod from the DoD....

Apparently we’ll connected... Join us on January 14th, 2020 at the Intercontinental Hotel, San Francisco for the inaugural Medicxi Summit meeting…Guest panellists including CEOs and R&D chiefs from $NVS $BMY $GSK $SNY $PFE & $REGN.

Life sciences venture capital firm....

Stephen Parker following Medicxi......

We have potential best in class molecules, we have big pharma interest (reportedly) we have BoD commitment, we still don’t have effective, consistent marketing PR or institutional investors.......

RMM - precisely, well not until 2021 at least.
The 737 non-dilutive funding exercise is now 7 months down the track. Mindful of the ‘every chance’ of success as per TM and reiterated by SP at the AGM.....
Also JR’s 1801 data in the ‘near future’.....
And as you say RMM we need at least 1p if we are to stand a chance of achieving full value.
This will be the first month for a long time without an RNS....what’s the likelihood that the next one will announce a share issue?

Iamhappy - yes, interesting thought, and if they do they’ll want to get moving quickly, presumably.

Hi CFP - no, I'm maxed out for now. I fail to understand that the SP is just dragging on the bottom when there is allegedly soooo much potential. I hope you are right and that Feb brings some life changing news!

Note the insertion of the word ‘rapidly’!