Northwest Bio and Shuttle Pharmaceuticals Combo Could be the Giant Leap to New Standard of Care for Glioblastoma and Solid Tumor Cancers

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• Northwest Biotherapeutics' DCVax-L and Shuttle Pharmaceuticals' Ropidoxuridine show groundbreaking results in treating glioblastoma, potentially setting new standards in cancer care.

• DCVax-L's Phase 3 trial significantly extended survival rates for glioblastoma patients, with regulatory approval from MHRA expected soon, possibly triggering a major share price surge.

• Remarkably undervalued stock Shuttle Pharmaceuticals' Ropidoxuridine enhances radiation therapy efficacy, showing a 60% increase in median survival, with strong financials, ongoing Phase 2 trials and accelerated Orphan Drug pathway with exclusivity advantages.

• Combining DCVax-L and Ropidoxuridine in trials could revolutionize GBM and solid tumor cancer treatment, offering substantial benefits for patients and investors.

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Northwest Biotherapeutics (OTCQB: NWBO) and Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) are each developing very different and very promising treatment solutions for Glioblastoma and solid tumor cancers.  

 

Northwest Biotherapeutics is developing immunotherapies that trigger the patient’s immune system to seek and destroy cancer cells and Shuttle Pharmaceuticals is developing a breakthrough radiation sensitizer that makes radiation kill more cancer cells while harming fewer healthy cells.

 

The benefits of immunotherapy from DC Vax-L combined with the radiation enhancing benefits of Ropidoxuridine suggest combining both in a combination trial that if successful, could significantly alter the landscape of cancer therapeutics.  Cancer patients could have real hope for longer lives and investors could have the potential for hitting “the big one” of their dreams. 

 

Northwest Biotherapeutics DC Vax-L

November 17, 2022, Northwest Biotherapeutics reported that in its Phase III clinical trial both median survival and the “long tail” of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. The trial met both the primary and the secondary endpoints under the Statistical Analysis Plan for the trial.

 

The trial results were co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany, and published in the peer reviewed cancer journal JAMA Oncology, entitled “Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination with Extension of Survival Among Patients with Newly Diagnosed and Recurrent Glioblastoma”.

 

The Company believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma.

 

Glioblastoma is the most common and most lethal form of primary brain cancer.  Standard of care (SOC) treatments have been virtually unchanged for nearly 20 years.  With SOC treatments, patients typically survive for only about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence.  Five-year survival from diagnosis is only about 5%.

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In the Phase III trial of DCVax®-L, median Overall Survival (mOS) for newly diagnosed GBM patients (n=232) was 19.3 months from randomization (22.4 months from surgery) with DCVax-L vs. 16.5 months from randomization in the controls (HR=0.80, p=0.002).  Survival at 48 months from randomization was 15.7% vs. 9.9%, and at 60 months was 13% vs. 5.7%.  For recurrent GBM (n=64), mOS was 13.2 months from relapse vs. 7.8 months (HR = 0.58, p<0.001). Survival at 24 and 30 months post-recurrence was 20.7% vs. 9.6%, and 11.1% vs 5.1%, respectively. In newly diagnosed GBM patients with methylated MGMT, mOS was 30.2 months from randomization (33 months from surgery) with DCVax-L (n=90) vs. 21.3 months in controls (n=199) (HR=0.74, p=0.027).

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Out of more than 2,100 doses of DCVax-L administered during the Phase III trial, there were only 5 serious adverse events that were deemed at least possibly related to the treatment.  There were 3 cases of intracranial edema, 1 case of nausea and 1 case of lymph node infection.

Northwest Biotherapeutics investors are sitting on the edge of their seat as they await the upcoming decision from the UK regulatory body, the MHRA.

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The short interest is rumored to be unusually high and many post on message boards that they believe the naked short position could be high enough that if approval is granted, it could send shares flying to very lofty prices.  According to Les Goldman, he believes the MHRA decision will likely be granted by late fall 2024.  If this turns out to be accurate, then we could be within 30 days of catalytic news.

Shuttle Pharmaceuticals Holdings, Inc. Ropidoxuridine

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SHUTTLE PHARMACEUTICALS ROPIDOXURIDINE

NIH sponsored clinical trials found that a drug called Iododeoxyuridine (IUdR) (Prodrug Ropidoxuridine) made cancer cells more susceptible to radiation therapy when used to treat glioblastoma and anaplastic astrocytoma and sarcoma patients.  The problem with IUdR is that is must be delivered intravenously for several consecutive days which is not only inconvenient, but also increased the risk of infections.

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Shuttle Pharmaceuticals is developing a drug called Ropidoxuridine to replace iododeoxyuridine that has demonstrated even greater efficacy than IUdR.  Ropidoxuridine exhibits fewer side adverse side effects than IUdR and has demonstrated a remarkable 60% increase in Median Survival.

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If this is proven in clinical trials, Ropidoxuridine could replace Iododeoxyuridine and become a new standard of treatment in radiation therapy which could transform Shuttle Pharmaceuticals into a large pharma provider.

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A recent announcement from Shuttle Pharmaceuticals puts everyone on notice that this underfollowed and undervalued biotech play is progressing rapidly and solidly and is one worthy of following.

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Shuttle Pharma Provides Third Quarter 2024 Corporate Update

Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the third quarter ended September 30, 2024.

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Shuttle Pharma’s recent highlights include the following:

• Successfully dosed first three patients in the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with brain tumors (glioblastoma). Ropidoxuridine is Shuttle Pharma’s lead candidate radiation sensitizer for use in combination with RT to treat glioblastoma, a deadly malignancy of the brain with no known cure. Additional patients are currently undergoing screening for enrollment in the trial.

• Finalized agreements with all six of the planned site enrollment locations which will be administering the Phase 2 clinical trial following the Company’s entry into agreements with Georgetown University Medical Center and UNC Medical Center. The Company previously entered agreements with the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute, part of Baptist Health South Florida.

• Paid off the entirety of the outstanding balance due under Shuttle Pharma’s Senior Secured Convertible Note issued on January 11, 2023. The initial balance of the Note was $4.3 million and was originally repayable over a 26-month period ending March 11, 2025.

• Completed a $4.5 million public offering priced At-The-Market under Nasdaq rules. The Company intends to use the net proceeds from this offering to fund IND-enabling and Phase 1 and 2 clinical trials of product candidates, including payments that will be made to the clinical research organization supporting the Phase 2 clinical trial for Ropidoxuridine, and for working capital and general corporate purposes.

• The Company also closed on a convertible note and warrant offering, receiving a total of $790,000 in gross proceeds, including $237,500 invested by the Company’s Chief Executive Officer, Dr. Anatoly Dritschilo.

• Cash balance as of October 31, 2024 was $4.1 million.

 

“We made tremendous progress over the past few months to advance our Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma, with the first three patients dosed in October 2024,” stated Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D.

 

“The initial patient dosing followed the successful engagement of all six of the planned clinical trial site locations, each of which are nationally recognized cancer centers that are most likely to treat IDH wild-type, methylation negative glioblastoma patients – the target of the clinical trial.

 

The initiation of the Phase 2 trial is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies.”

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“Beyond these critical clinical developments, we also made progress in improving our balance sheet and funding the Phase 2 clinical trial. I want to thank all of the investors who have committed to helping us advance our mission to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma,” Dr. Dritschilo concluded.

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About the Phase 2 Clinical Trial

The Phase 2 clinical trial has begun enrolling patients with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma. Presently, radiation is the only approved standard of care for this particular group of patients, with more than half of the patients surviving for less than 12 months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial will initially consist of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company determines the optimal dose, it will then add an additional 14 patients on the optimal dosage allowing for the achievement of statistical significance with the end point being that of survival as compared to historical controls. The Company expects the trial to be completed over a period of 18 to 24 months.

An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% are treated for curative purposes and the balance for therapeutic care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes, with this number expected to grow by more than 22% over the next five years.

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More information about Shuttle Pharma’s Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.

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Shuttle Pharmaceuticals Ropidoxuridine extended glioblastoma and anapestic astrocyoma cancer patient's median survival by a remrkable 60%.