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Verastem Oncology Announces New Data Published in The Lancet Oncology Supports Potential of VS-6766 as Treatment for RAS Muta...
October 28 2020 - 08:01PM
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Investigator-Initiated Phase 1 Study is First to Evaluate a Dual RAF/MEK Inhibitor Using Innovative Intermittent Dosing Schedules in Patients Harboring RAS/RAF Pathway Mutations
Study Finds VS-6766 Regimen is Tolerable and Shows Antitumor Activity in Recommended Phase 2 Single Agent Dose
Phase 2 Registration-Directed Trials with VS-6766 Alone and in Combination with Defactinib in Low-Grade Serous Ovarian Cancer and KRAS Mutant Non-Small Cell Lung Cancer Expected to Commence by Year-End 2020
Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced new data have been published today in The Lancet Oncology. The study evaluated the intermittent dosing schedule of VS-6766 (formerly known as CH5126766) to inform further testing of VS-6766 as both a single agent in RAS/RAF-mutant cancers such as KRAS mutant non-small cell lung cancer (NSCLC) or in combination with small molecules including the FAK inhibitor defactinib in KRAS mutant solid tumors (NCT03875820). In this dose-escalation study, tolerability and antitumor activity were observed across various cancers with RAS/RAF/MEK pathway mutations.
“The positive results observed with this innovative intermittent dosing regimen of VS-6766 demonstrate its significant potential across various cancers with RAS/RAF/MEK pathway mutations,” stated Udai Banerji, Professor of Molecular Cancer Pharmacology at The Institute of Cancer Research, London, and Honorary Consultant in Medical Oncology, MBBS, MD, DNB, PhD, FRCP at The Royal Marsden NHS Foundation Trust, London, and lead investigator of the clinical study. “We were encouraged by the data, demonstrating both antitumor activity and tolerability of VS-6766, and this intermittent schedule can be used alone or for combination therapy schedules with other anticancer agents for a variety of difficult-to-treat cancers.”
The full manuscript, titled “Intermittent schedules of the oral RAF–MEK inhibitor CH5126766/VS-6766 in patients with RAS/RAF-mutant solid tumours and multiple myeloma: a single-centre, open-label, phase 1 dose-escalation and basket dose-expansion study,” can be accessed here.
“These results support the potential of VS-6766 as a treatment for a variety of cancers where conventional approaches have been sub-optimal and there is significant unmet need. We believe VS-6766 has the potential to be the backbone of RAS therapy by addressing the multiple points of resistance and toxicity issues that have made advancing new options difficult,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “Our Phase 2 registration-directed trials with VS-6766 in low grade serous ovarian cancer and KRAS mutant NSCLC are scheduled to begin by the end of this year. These adaptive design trials are a capital efficient approach to rapidly evaluate VS-6766 alone or in combination with defactinib to determine which regimen to take forward into the expansion phase of the trial.”
Results from the Phase 1 Study Investigating Intermittent Dosing of VS-6766 in Patients with RAS/RAF-mutated Solid Tumors and Multiple Myeloma
Between June 2013 to January 2019, 58 patients, including 51 patients with solid tumors and seven patients with multiple myeloma, were enrolled in a study conducted at The Institute of Cancer Research (ICR) and The Royal Marsden Hospital in the U.K. The study consisted of two parts; 1) dose escalation part to determine the recommended dosage (29 patients) and 2) basket expansion part to investigate efficacy and safety of the recommended dosage determined in the dose escalation part (29 patients).
Four mg twice weekly was established as the recommended Phase 2 dose for VS-6766 monotherapy and was deemed tolerable based on clinician’s assessment with several patients remaining on study for more than six months.
In the subsequent basket expansion part, seven (26.9%) of 26 response-evaluable patients with RAS mutations in the basket expansion achieved objective responses, with response rates in patients with NSCLC, gynecological malignancies, colorectal cancer (CRC), melanoma, and multiple myeloma being 3/10 (30%), 3/5 (60%), 0/4 (0%), 0/1 (0%), and 1/6 (16.7%), respectively. In all six responders with solid tumors, tumor shrinkage was observed at the time of the first restaging scan after two cycles of treatment, with partial responses confirmed after two to four cycles. Five of the six responses lasted more than six months.
Among the 57 safety-evaluable patients, the most common Grade 3/4 treatment related adverse events (TRAEs) were rash (19%), CPK elevation (11%), hypoalbuminemia (11%), and fatigue (7%). Five (9%) patients experienced treatment-related serious adverse events. In the study, TRAEs were manageable, resolved spontaneously or reversed with dose modification. There were no treatment-related deaths. The study also confirmed a long half-life of 55 hours and target engagement in the form of reduction of both p-ERK and p-MEK in three patients who underwent paired biopsies, supporting intermittent dosing schedules.
This study was supported by Chugai Pharmaceutical Co., Ltd. Verastem in-licensed VS-6766 from Chugai in January 2020.
About VS-6766
VS-6766 (formerly known as CH5126766 and CKI27) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors.
About Defactinib
Defactinib (VS-6063) is an oral small molecule inhibitor of FAK and PYK2 that is currently being evaluated as a potential combination therapy for various solid tumors. The Company has received Orphan Drug designation for defactinib in ovarian cancer and mesothelioma in the US, EU and Australia. Preclinical research by Verastem Oncology scientists and collaborators at world-renowned research institutions has described the effect of FAK inhibition to enhance immune response by decreasing immuno-suppressive cells, increasing cytotoxic T cells, and reducing stromal density, which allows tumor-killing immune cells to enter the tumor.1,2
About the VS-6766/Defactinib Combination
RAS mutant tumors are present in 30% of all human cancers and have historically presented a difficult treatment challenge and are often associated with significantly worse prognosis. Challenges associated with identifying new treatment options for these types of cancers include resistance to single agents, identifying tolerable combination regimens with MEK inhibitors and new RAS inhibitors in development addressing only a minority of all RAS mutated cancers.
The combination of VS-6766 and defactinib has been found to be clinically active in patients with KRAS mutant tumors. In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with LGSOC, KRAS mutant NSCLC and colorectal cancer (CRC). Updated interim data from this study presented at the 2nd Annual RAS-Targeted Drug Development Summit in September 2020 demonstrated a 56% overall response rate and long duration of therapy among patients with KRAS-G12 mutant LGSOC. Based on an observation of higher response rates seen in NSCLC patients with KRAS-G12V mutations in the study, Verastem will also be further exploring the role of VS-6766 and defactinib in KRAS-G12V NSCLC. The FRAME study was expanded in August 2020 to include new cohorts in pancreatic cancer, KRAS mutant endometrial cancer and KRAS-G12V NSCLC.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a development-stage biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition and focal adhesion kinase (FAK) inhibition. For more information, please visit www.verastem.com.
Woooah. $30? Really
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Verastem Oncology Announces Closing of COPIKTRA® (duvelisib) Sale to Secura Bio
September 30 2020 - 08:54AM
Business Wire
Verastem Now Focused on Development of VS-6766 and Defactinib Combination in Low-Grade Serous Ovarian Cancer and KRAS Mutant Non-Small Cell Lung Cancer
Registration-Directed Clinical Trials in LGSOC and KRAS Mutant NSCLC Expected to Commence by Year End 2020
Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced that it has completed the sale of Verastem's COPIKTRA (duvelisib), a marketed oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma, to Secura Bio, Inc.
In consideration for the COPIKTRA assets, Verastem received from Secura Bio $70 million in cash. Additionally, Verastem is eligible to receive up to a total deal value of $311 million if certain regulatory and sales-based milestones are successfully met by Secura Bio and COPIKTRA’s other rest-of-world partners. Verastem will also receive low double-digit royalties on net sales over $100 million in the U.S., Europe and the United Kingdom. Secura Bio has assumed all operational and financial responsibility for COPIKTRA program activities, including commercialization efforts in the United States and Europe, ongoing clinical trials, development and commercialization partnerships with Yakult, CSPC and Sanofi and existing royalty obligations.
Verastem’s sale of COPIKTRA to Secura Bio follows Verastem’s previously announced new strategic direction focused on development of its RAF/MEK inhibitor (VS-6766) and FAK inhibitor (defactinib) program in KRAS mutant (KRASmt) solid tumors. Verastem’s first potential indications for the VS-6766 and defactinib combination will be in low-grade serous ovarian cancer (LGSOC) and KRASmt non-small cell lung cancer (NSCLC).
“This transaction delivers clear benefits for both Verastem Oncology and Secura Bio. At Verastem, we will now focus all of our efforts and resources on development of the VS-6766 and defactinib combination in LGSOC and KRASmt NSCLC,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “The ongoing Phase 1/2 FRAME study continues to provide encouraging data and we plan to commence registration-directed clinical trials in LGSOC and KRASmt NSCLC by the end of 2020.”
MTS Health Partners, L.P and Ropes & Gray LLP acted as advisors to Verastem Oncology on this transaction.
About VS-6766
VS-6766 (formerly known as CH5126766, CKI27 and RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors.
its recovering nicely. next leg up coming
Kevin_Wolcott
3m
$VSTM ORR % dropped compared to what they reported in April. That's why it's down
67% > 41%
im seem to be the only one watching, but this is bouncing off the 10EMA 1.27 nicely here for the next leg up which it needed to do IMO. VSTM
the CC is GOOD! very positive results. bought more pre market. this will be at 4.00 again soon IMO. VSTM
Def little posters. Big money coming here. Price to book good. Pipeline coming. Could even buy a stage 1 and advance. Immu 30 years to get to market. 2.00 to 90 buyout. Sick
hahahahaha ok! im getting more here at 1.37 btw. new support IMO
Ahh mixed up the dates it’s tomorrow morning
didnt get a chance. you? VSTM
You tune in for the conference call?
im surprised almost no posters here! this is going back over 2.00 soon IMO. VSTM
New Results Evaluating Combination of VS-6766 and Defactinib to be Presented at the 2nd Annual RAS-Targeted Drug Development Summit
Management to Host Investor Conference Call and Webcast on Wednesday, September 16 at 8:00 AM ET
Looks like today might be the day we reverse fingers
They are fundamentally toast after the botched clinical findings release...will be lucky to stay above $1 at this point.
Nine biopharma CEOs pledge to make safety the main focus in coronavirus vaccine development
hopefully this news will spark bios!
wtf! is there ANYONE here interested in this thing anymore? VSTM
ahhh so quiet. buying more here at 1.27 for the push to 3.00 VSTM
this could be a serious indicator of a directional change. if this is above 1.30 by end of week(which i suspect for certain) this could be over 2.00 next IMO. VSTM
most likely a purchase
someone traded 3,878,895 in a block trade at 1.17
earlier today, afternoon
if this is at 1.30 or higher by end of week, that would signal a hard turnaround. lets watch and see. VSTM
Absolutely. I imagine they are dumping shares for this price decline.
IMO, its MM manipulation! I called IR. SS hasnt changed. Noone in the company is selling. Company just got a big cash infusion and will be settled mid Sept. This is a GOOD company . VSTM
someone is dumping shares.. why, no know.
im so taken back my this MM manipulation! this should be at 3.00! anyone?
this MM manipulation on this WAY oversold gem of a company is almost criminal. thoughts anyone? VSTM
no worries. i talked with IR this morning and love my investment now. were good! his name is bob doyle.
Yes, a real pizz off !!
i talked to Bob Doyle IR/finance guy. I loved everything i heard about the amount of cash that they have, their unchanged SS , and their future cash infusion, and the fact that the only convertible debt they have is due all the way in 2022. VSTM
i analyzed this c9mpany. reading filings. looking at SS. look8ng at chart. THIS SHOULD BE A 7.00 STOCK!
that's what i been saying!
doesnt make sense. im bidding 16000 yet the bid only shows 15600 huh?
why would trump have ANYTHING to do w this little company!?
long term yes.
All ears and eyes on Trump at 5:30pm
will they mention
Remdesivir + VS-6766
$GILD $VSTM
is that good for us?
Details of the agreement with Secura Bio on August 10th
Perhaps this is why the the stock didn't move. The deal is spread out. They are burning 13m/Qtr or 52m/yr
Secura Bio has agreed to pay the Company an up-front payment of $70.0 million in cash payable at the closing of the Transaction
After the Closing regulatory milestone payments of $35.0 million upon receipt of regulatory approval of COPIKTRA in the United States for the treatment of peripheral T-cell lymphoma
Payent of $10.0 million upon receipt of the first regulatory approval for the commercial sale of COPIKTRA in the European Union for the treatment of peripheral T-cell lymphoma.
Sales milestone payments consisting of $10.0 million when total worldwide net sales of COPIKTRA exceed $100.0 million,
$15.0 million when total worldwide net sales of COPIKTRA exceed $200.0 million
$25.0 million when total worldwide net sales of COPIKTRA exceed $300.0 million,
low double-digit royalties on the annual aggregate net sales above $100.0 million in the United States and Europe
50% of all royalty, milestone and sublicense revenue payments payable to Secura Bio under the Company’s existing license agreements with Sanofi, Yakult Honsha Co., Ltd. and CSPC Pharmaceutical Group Limited, each of which will transfer to Secura Bio at the Closing.
50% of all royalty and milestone payments payable to Secura Bio under any license or sublicense agreement entered into by Secura Bio after the Closing in certain jurisdictions.
with a lot of luck needed. Maybe this is what Trump will mention Sunday night.
Remdesivir + VS-6766
$GILD+$VSTM
THATS A GREAT THING RIGHT? VSTM
None of the analysts have reported since the cash deal. They are supposed to be independent from the Finance Brokers part of their business. The Brokers sell stock for their clients. Since VSTM doesn't need cash until 2023, the brokers don't have any deals.
Selling COPIKTRA Franchise to Secura Bio in a Deal Totaling $311 Million, Plus Royalties. Verastem recently announced its entry into a definitive agreement to sell its global commercial and development rights to COPIKTRA in all oncology indications to Secura Bio, Inc. The transaction, which carries a total deal value of up to $311 million, plus royalties, will provide Verastem’s current programs with a cash runway until at least 2024
what do you mean?
since they won't need to raise any more money from dilution, the analysts don't seem to care anymore
BTIG, LLC Robert Hazlett
Cantor Fitzgerald Alethia Young
H.C. Wainwright Swayampaukula Ramakanth, Ph.D.
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