Tuesday, September 13, 2016 1:40:45 PM
by Ben Adams | Sep 13, 2016 4:03am
Click For Article
Small cap Geron was down by nearly 20% at the end of Monday after releasing new data with partner Janssen ($JNJ) that showed a low-dose arm of its experimental med imetelstat flopped, with the higher dose arm also coming up short.
The IMbark study was assessing patients with myelofibrosis (MF) taking a high- and low-dose form of its treatment who have relapsed after or are refractory to prior treatment with a marketed JAK inhibitor.
Its low-dose formulation (4.7 mg/kg) missed the mark, with Geron ($GERN) saying that arm now does “not warrant further investigation” and will be closed off.
Patients using the low dose can be moved over to the higher dose (9.4 mg/kg) should they want to, although data released for this arm was also poor, as “an insufficient number of patients met the protocol defined interim criteria,” according to the biotech’s statement.
However, it plans to push on with this part of the trial as it saw “encouraging trends in the efficacy data.”
Janssen, which did not post a direct comment in the release and left the publication of the bad news to its partner, posted these data from an interim review at the early 12-week point of the study that looked at safety and efficacy from 20 patients from each dosing arm. So far, 90 patients have been enrolled across the study.
Geron said that new enrollment in the higher dose arm will be suspended while the trial continues in order to obtain “additional and more mature data,” which includes a longer follow-up of patients at 6 months.
After looking at the longer-term data, Geron said its Big Pharma partner would then decide whether to restart enrollment, add in a new dosing arm, or stop the test entirely.
A second Phase II/III trial, known as IMerge, was looking at imetelstat in patients with low/intermediate risk myelodysplastic syndromes who have relapsed or failed to respond to an erythropoiesis-stimulating agent. This will go on unmodified, Geron said.
The drug, a telomerase inhibitor, has had a long and rocky path to this point, dogged by safety issues and clinical failures that have repeatedly forced Geron to pause development. But in November 2014 the FDA finally removed a long-standing clinical hold on imetelstat, and this is when Janssen stepped in with a licensing deal worth as much as $935 million, with the two splitting R&D costs 50-50.
Janney’s Roy Buchanan, who maintained a Buy rating with a $5 fair value estimate (down from $6.50), said: “Geron announced a set of changes to the ongoing Phase II study of imetelstat in Jakafi-relapsed/refractory myelofibrosis (MF) (IMbark study), some not too surprising like dropping the 4.7 mg/kg dose. The companies’ (including partner Janssen--not covered) halting enrollment in IMbark to evaluate the 24-week data at 9.4 mg/kg in 2Q17 is being interpreted as a sign of caution, we think. That’s a reasonable interpretation, and we’re lowering our probabilities of success in MF from ~60% to ~40%, and increasing our discount rate to 20%, resulting in a new fair value of $5 from $6.50. The lack of changes to IMerge is encouraging and apparently overlooked by the market at this point.”
Geron was down 19.5% at close yesterday to $2.30 and fell by 0.4% afterhours. It currently has a market cap of $343 million.
It all looked so different nearly a year ago when in two small Phase II studies published in The New England Journal of Medicine, Geron's intravenous imetelstat charted a disease-modifying effect on MF and essential thrombocythemia.
In the 33-patient MF study, the California biotech’s drug led to a 21% rate of complete or partial remissions, and response to the treatment was particularly high among patients with certain genetic mutations.
The pair of studies sent Geron's shares up about 13%, as investors grew more optimistic about imetelstat's odds of success in some ongoing and future clinical trials.
There is a sense of déjà vu with its latest problem as, after more than two decades in drug development, Geron has never found its way to the finish line in R&D.
The company backed away from its ambitions in stem cells in 2011 and rebranded itself as a cancer-focused outfit, but a slew of clinical setbacks has reduced its pipeline to imetelstat alone and pared down that drug's potential indications in the process.
Blessings to All
TRUTH
I've never claimed to have all the answers but feel i'm beginning to corner the market in questions worthy of them.
Recent GERN News
- Geron Corporation Reports First Quarter 2024 Financial Results and Business Highlights • Business Wire • 05/02/2024 11:00:00 AM
- Geron to Announce First Quarter 2024 Financial Results on May 2, 2024 • Business Wire • 04/25/2024 08:30:00 PM
- Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 04/18/2024 08:30:00 PM
- Geron to Participate at Upcoming Investor Conferences in April • Business Wire • 04/03/2024 08:30:00 PM
- Geron Corporation Announces Pricing of $150 Million Underwritten Offering of Common Stock and Pre-Funded Warrants • Business Wire • 03/19/2024 01:07:00 PM
- Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS • Business Wire • 03/14/2024 07:54:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/28/2024 12:20:38 PM
- Geron Corporation Reports Business Highlights and Fourth Quarter and Full Year 2023 Financial Results • Business Wire • 02/28/2024 12:05:00 PM
- Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 02/22/2024 09:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 09:11:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 09:10:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 09:09:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 09:08:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 09:07:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 09:06:08 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 10:01:37 PM
- Geron to Announce Fourth Quarter and Full-Year 2023 Financial Results on February 28, 2024 • Business Wire • 02/14/2024 09:30:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 01:44:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/30/2024 01:00:12 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/26/2024 04:49:40 PM
- Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 01/18/2024 09:30:00 PM
- Geron to Participate in the B. Riley Securities Virtual Oncology Conference • Business Wire • 01/12/2024 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2024 01:25:16 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:04:57 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:04:09 AM
FEATURED Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • May 8, 2024 9:05 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM
Moon Equity Holdings, Corp. Announces Acquisition of Wikolo, Inc. • MONI • May 7, 2024 9:48 AM
Cannabix Technologies Launches New Compact Breath Logix Workplace Series and Prepares for Delivery to South Africa • BLOZF • May 7, 2024 8:51 AM