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Onconova Therapeutics’ Preclinical Narazaciclib Data at SABCS Highlights Differentiated Anti-Tumor Activity v. Other CDK4/6i’s
Differentiated profile of narazaciclib supported by positive results of studies demonstrating broad multi-kinase activity, with significant anti-tumor activity and increased anti-tumor immunity, compared to approved CDK4/6 inhibitors
Data support the potential use of narazaciclib in breast and ovarian cancers
Narazaciclib progressing towards RP2D and preparation for registrational studies, with a planned update in H1 2024
NEWTOWN, Pa., Dec. 08, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced preclinical data highlighting narazaciclib’s multi-kinase profile, broad anti-tumor activity and increased anti-tumor immunity, compared to palbociclib and other CDK4/6 inhibitors, in a poster presented at the San Antonio Breast Cancer Symposium (SABCS) on December 8, 2023.
“We are very pleased to share new data characterizing narazaciclib’s differentiated activity, compared to palbociclib and other CDK4/6 inhibitors, especially in breast and ovarian cell lines, in a poster presentation at this year’s San Antonio Breast Cancer Symposium (SABCS 2023),” said Steve Fruchtman, M.D., President and Chief Executive Officer.
Dr. Fruchtman continued, “Narazaciclib impacts a wider array of kinase targets and produced a more substantial reduction in cell viability across several large panels of breast and ovarian cell lines carrying a range of mutations, compared to palbociclib. In addition, narazaciclib treatment induced higher levels of T-cell recruiting chemokines, supporting greater anti-tumor immune activity.”
“We believe that the totality of the data presented at SABCS supports narazaciclib’s multi-kinase activity, its ability to target resistance pathways missed by other CDK4/6 inhibitors, and its differentiated anti-tumor and immunomodulatory activity. We hope to further demonstrate the promise of narazaciclib’s differentiated profile in patients as we progress the clinical program in 2024 towards the definition of a recommended Phase 2 dose (RP2D). We are also preparing to initiate pivotal studies in the lead indication of low grade endometrioid endometrial cancer (LGEEC), and to expand into investigator-sponsored studies in breast and ovarian cancers,” concluded Dr. Fruchtman.
Poster Overview
Title: Narazaciclib’s differential targets and kinase inhibitory activity compared to the approved CDK4/6 inhibitors (CDK4/6is) contribute to the enhanced inhibition of tumor growth in preclinical models
Objectives: To explore the activity of narazaciclib and its metabolite, ON1232580, in comparison to the FDA-approved CDK4/6 inhibitor (CDK4/6i) palbociclib, and identify additional targets engaged by narazaciclib. Activity was measured by exposing narazaciclib and other CDK4/6 inhibitors (CDK4/6i’s) to panels of resistant, mutated, or modified tumor cell lines to evaluate each agent’s activity and potency to inhibit growth and reduce cell line viability.
Results:
Comprehensive analysis of cellular targets: “Thermal Shift” assays affirmed that while narazaciclib and palbociclib impact a handful of similar, expected cell pathway targets, including Rb, Akt, and mTOR, narazaciclib and its main metabolite impact more kinases than palbociclib. We believe this observation could contribute to improved efficacy for narazaciclib by overcoming cancer resistance pathways not targeted by other CDK4/6i’s.
Deeper analysis in human breast and ovarian cells/cell lines: Using bioinformatics data from human cancer databases showed that high BUB1 kinase expression is associated with low survival in patients with breast and uterine corpus endometrial carcinomas (UCEC) and was degraded by low doses of narazaciclib. Western blot analysis of data from several breast cancer cell line panels (including those with known mutations or the overexpression of the membrane receptor, FGFr, an independent prognostic factor in some solid tumor cancers and a driver of resistance to CDK4/6 inhibitors), showed that narazaciclib and its metabolite resulted in a more substantial reduction in cell viability compared to other CDK4/6i’s dosed as monotherapy or in combination with autophagy inhibitors. These data support the potential use of narazaciclib in breast cancer and UCEC, either as monotherapy or in combination with other agents.
Ability to induce senescence and T-cell recruiting chemokines: Treatment with narazaciclib/metabolite produced more profound reductions in cell viability in PYMT murine breast cancer cells, compared to palbociclib and other CDK4/6i’s (combined with autophagy inhibitors). In addition, narazaciclib treatment produced significantly higher increases in T-cell recruiting chemokines, including CXCL10, than palbociclib. These results suggest that narazaciclib has the differentiated potential to promote greater levels of anti-tumor immunity, which could enhance its efficacy.
Conclusions: Expansive analysis of narazaciclib and its metabolite, compared to palbociclib and other CDK4/6i’s, shows that narazaciclib has the potential to be differentiated by its:
Multi-kinase profile, including its impact on BUB1 which is associated with poor prognosis in breast and uterine cancers;
Potent ability to inhibit cell viability in a wide range of breast and ovarian cancer cell panels, including those with common mutations and over-expression of the FGFr, with or without autophagy inhibitors;
Ability to produce significantly higher increases in T-cell recruiting chemokines and promote greater anti-tumor immunity.
These data support the potential use of narazaciclib in patients with breast and ovarian cancer, as well as its potential in LGEEC, based on broad, differentiated multi-kinase activity, supported by potential anti-tumor activity and anti-tumor immunity, compared to palbociclib and other CDK4/6i’s. Evaluation across a range of cell lines, mutations, and prognostic factors, with or without autophagy inhibitors, underscores the strength and consistency of these data.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer, ovarian cancer, and mantle cell lymphoma.
Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).
For more information, please visit www.onconova.com.
Forward Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," “preliminary,” “encouraging,” "approximately" or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova's clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading "Risk Factors" in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/
Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com
Looks like a Bait and rug pull set up for fraud market makers to steal your money
this is a fraud company, clearly a scam!
Onconova Therapeutics (ONTX) has 3 splits in our ONTX split history database. The first split for ONTX took place on June 01, 2016. This was a 1 for 10 reverse split, meaning for each 10 shares of ONTX owned pre-split, the shareholder now owned 1 share. For example, a 1000 share position pre-split, became a 100 share position following the split. ONTX's second split took place on September 26, 2018. This was a 1 for 15 reverse split, meaning for each 15 shares of ONTX owned pre-split, the shareholder now owned 1 share. For example, a 100 share position pre-split, became a 6.66666666666667 share position following the split. ONTX's third split took place on May 21, 2021. This was a 1 for 15 reverse split, meaning for each 15 shares of ONTX owned pre-split, the shareholder now owned 1 share. For example, a 6.66666666666667 share position pre-split, became a 0.444444444444444 share position following the split.
$ontx is working on something; quote:(nitial single patient data in this ultra-rare indication show that rigosertib monotherapy led to sustained complete response of all target lesions without signs of metastatic disease
NEWTOWN, Pa., Dec. 02, 2021 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that early preliminary data from an investigator-initiated Phase 2 open label trial of rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) were presented at the Austrian Society of Dermatology and Venerology Annual Conference 2021, which took place from November 25 – 27, 2021.”)
Hopefully ontx may have something here.
Glta!!
Analyst said $17 before reverse split was announced
Undervalued here?
I'd say heck yes or he was waaaaaay wrong!
$ONTX: She's due for a reversal bottom bounce, now $3.80
That was a monster buy of 80Milly shares on September 22, 2021
Overall this looks like it could turn back up for the next few weeks from these levels
GO $ONTX
Right now it's fricken shorters love Fest!!!!!!!!!!!!1111111111111
Time to bail!!!!!!!!!!!!!!!!!!!!!!!!!!!!!1
Management F shareholders by bragging great results then the next day diluted many million shares,
Bring PPS down!!!!!! F the management team!
Level 2 showing bounce?
I totally agree. Corruption and scamming investors. I'm now going to hold my short position till $2.50... This CEO is a fricken terrible
This is a scam! Shame on them. Screwing up every share holder, once again. ??
This company just screwed shareholders again. For the 3rd time!!!
I will cover my short in the 3.00s
Yeah ONTX management team are ignorant. They can't even promote their company prior and after a public offering. I'm now waiting for 3s.
yeah they are scum and scam artists
These scum bags just keep screwing their SH. Glad i never got back into this turd
For sure it was a pump and dump before the public offering.
Waiting for 5.00. Yesterday volume was over 80 million shares today so far only 2.6 million ...Hmm, was it a pump and dump?
ONTX 6.7 ++++ wwwwwwwweeeeeeeeeeeeeeee
I will get in if PPS dips to 5.5-
Yes, Volume is four times higher then current OS.
Good News and so far a good run up!
Onconova Therapeutics, Inc. (NASDAQ: ONTX) will present at the RAS-targeted Drug Development Summit Presentation preliminary data from the Phase 1/2 study of rigosertib plus Opdivo in advanced KRAS-mutated NSCLC.
Next SH meeting 7/30/21
Reconvened Annual Meeting until July 30, 2021 at 11:00 a.m. Eastern Daylight Time (the “Reconvened Annual Meeting”).
The Reconvened Annual Meeting will be held at the same virtual meeting location, www.virtualshareholdermeeting.com/ONTX2021.
This group is dead, and so in ontx. Although, they have been working tirelessly, they don’t show any progress based on sales. Here is what they got: Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks signaling by targeting RAS effeccellular tor pathways.
They all should be fired!
Biotechs have really taken a drubbing recently. Even ones with no bad news out like ONTX.
It is going to take some time for the company to have real news again to replace all these sellers wanting to move on.
If they want, they can stay in the biotech sector and get inito a company that is down WITHOUT bad news.
JMO
What do you know ? All indicators show ontx is not doing well. It is very risky investment.
That’s complete bs
$ONTX There is one readon why the R/S and the dropping of the p/s of this stock, in addition to the dumping that is going on
Read this;
“Onconova Therapeutic Probability Of Bankruptcy is used to show its chance of financial distress over the next two years of operations under current economic and market conditions. Onconova Therapeutic Probability Of Bankruptcy is determined by interpolating and adjusting Onconova Altman Z Score to account for off-balance-sheet items and missing or unfiled public information. All items used in analyzing the odds of distress are taken from the Onconova balance sheet as well as cash flow and income statements available from the company's most recent filings. Please check Onconova Therapeutic Piotroski F Score and Onconova Therapeutic Altman Z Score analysis.”
Welcome to the world of RS. This'll drop at least 60% from it's RS price before it starts trying to find a bottom. I could see it going back under a $1 though given the way they screwed their investors with an unnecessary RS
Whats wrong with this pos?? keeps going down??