On June 3, 2021 Resverlogix Corp. ("Resverlogix") (TSX:RVX) and EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported a partnership to support planned commercialization of apabetalone in the United States, Canada (where authorization has been granted to conduct clinical studies of apabetalone for COVID-19) and/or potentially expanding to additional global markets, as Emergency Use Authorization and/or a New Drug Application or equivalent is issued or approved (Press release, EVERSANA, JUN 3, 2021, View Source [SID1234583609]).

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In preparation for launch, Resverlogix will utilize EVERSANA’s fully integrated commercialization services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, patient services, health economics and outcomes research, and compliance, with each service optimized by data and predictive analytics.

Apabetalone is an investigational, phase 3 clinical candidate with safety data in more than 4,200 man years of treatment. As previously published, apabetalone has the potential to combat COVID-19 through a unique dual mechanism. First, apabetalone treatment prevents SARS-CoV-2 from infecting human cells; and second, it reducesthe inflammation and cytokine storm response, which can result in organ damage and long-term negative impacts. Apabetalone is also being studied for important benefits for patients with high-risk cardiovascular disease, chronic kidney disease and other indications while maintaining a well-described safety profile.

"With EVERSANA’s integrated commercialization solution, we are poised to swiftly and efficiently deliver apabetalone to patients who desperately need it," said Donald McCaffrey, President and CEO of Resverlogix. "We are proud to be on the front line with the global scientific medical community as we fight the ongoing threat of this and future pandemics."

"We believe in apabetalone’s potential to save the lives of patients still facing the tragic impact of COVID-19 and its numerous growing variants as well as the millions of patients facing multiple diseases that have the potential to be treated by this much-needed therapy," said Jim Lang, Chief Executive Officer of EVERSANA. "Our COMPLETE end-to-end commercialization engine is mobilized and ready to move swiftly in anticipation of authorizations and approvals."

There can be no assurance that regulatory approval will be obtained.

On June 3, 2021 Novartis reported that results of the Phase III VISION study evaluating 177Lu-PSMA-617, a targeted radioligand therapy, plus best standard of care (SOC) demonstrated significant improvement in overall survival (OS) compared to SOC alone, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)1 (Press release, Novartis, JUN 3, 2021, View Source [SID1234583443]). The difference in OS between study arms was statistically significant (one-sided p<0.001), with an estimated 38% reduction in risk of death in the 177Lu-PSMA-617 arm (n=551) compared to the best standard of care only arm (n=280) (hazard ratio: 0.62 with 95% confidence interval (CI): (0.52, 0.74))1. These results will be presented during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting plenary session on June 6.

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Patients receiving 177Lu-PSMA-617 also demonstrated a statistically significant (one-sided p<0.001) 60% risk reduction for radiographic progression-free survival or death (rPFS), compared to the best standard of care only arm (hazard ratio: 0.40 with 99.2% CI: (0.29 0.57))1. There was a higher rate of drug-related treatment emergent adverse events reported in the 177Lu-PSMA-617 treatment arm (85.3%) compared to standard of care alone (28.8%)1.

Across both arms of the study, rates of treatment discontinuation associated with treatment-emergent adverse events occurred as follows: In the 177Lu-PSMA-617 plus standard of care (SOC) arm, 11.9% of patients discontinued 177Lu-PSMA-617 and 8.5% discontinued SOC; while in the SOC alone arm 7.8% of patients discontinued treatment1.

"Patients suffering from metastatic CRPC who have progressed through contemporary hormonal treatments and chemotherapy have few meaningful therapeutic options," said Michael J. Morris, MD, who chaired the study’s Scientific Committee and is the Prostate Cancer Section Head, Genitourinary Oncology Service, Division of Solid Tumor Oncology at Memorial Sloan Kettering Cancer Center. "The study demonstrated that 177Lu-PSMA-617 improves disease progression and prolongs survival, which are key measures of clinical benefit in the mCRPC population. I am grateful to be a part of this study that may lead to additional therapeutic options for these patients."

"Men with metastatic prostate cancer have an approximately 3 in 10 chance of surviving 5 years2. These data from the first Phase III study of a radioligand therapy in this advanced prostate cancer setting confirm the potential of 177Lu-PSMA-617 targeted therapy to improve clinical outcomes," said John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis. "Our comprehensive development program for this targeted therapy seeks to reach eligible patients with advanced prostate cancer, who express the PSMA biomarker1,3-6. And, we won’t stop with prostate cancer, our team is exploring next generation RLT across a number of tumor types."

Two additional studies with 177Lu-PSMA-617 radioligand therapy in earlier lines of treatment for metastatic prostate cancer are planned to start in the first half of 2021, investigating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition).

Additional VISION data
Median OS (95% CI) for the 177Lu-PSMA-617 plus best standard of care arm in the VISION study was 15.3 months (14.2, 16.9), compared to 11.3 months (9.8, 13.5) in the best standard of care arm only1. The median rPFS (99.2% CI) was 8.7 months (7.9, 10.8) for the 177Lu-PSMA-617 arm compared to 3.4 months (2.4, 4.0) for the best standard of care only arm1.

Key secondary endpoints were also met. The median time to first symptomatic skeletal event was 11.5 months (95% CI: 10.3, 13.2) in 177Lu-PSMA-617 arm compared to 6.8 months (95% CI: 5.2, 8.5) in the best standard of care only arm (hazard ratio: 0.50 (95%CI: 0.40, 0.62)); two-sided p-value: <0.0011. Significant differences were also seen in overall response rate in patients with measurable or non-measurable disease at baseline (29.8% partial or complete response in the 177Lu-PSMA-617 arm compared to 1.7% partial response in the best standard of care only arm (two-sided p-value: <0.001)) and disease control rate (89.0% in 177Lu-PSMA-617 arm compared to 66.7% in the best standard of care only arm (two-sided p-value: <0.001))1.

Grade ≥3 drug-related treatment emergent adverse events occurred in 28.4% of the 177Lu-PSMA-617 arm compared to 3.9% in the best standard of care only arm1. The most common treatment emergent adverse events regardless of drug relatedness (above 2% respectively for the 177Lu-PSMA-617 and best standard of care arm) were anemia (12.9% vs. 4.9%), thrombocytopenia (7.9% vs. 1%), lymphopenia (7.8% vs. 0.5%), fatigue (5.9% vs. 1.5%), urinary tract infection (3.8% vs 0.5%), neutropenia (3.4% vs 0.5%), hypertension (3.2% vs 1.5%), back pain (3.2% vs. 3.4%), acute kidney injury (3.0% vs 2.4%), leukopenia (2.5% vs. 0.5%), bone pain (2.5% vs. 2.4%), hematuria (2.5% vs 0.5%), and spinal cord compression (1.3% vs. 5.4%)1.

Serious drug-related treatment emergent adverse events occurred in 9.3% of patients in the 177Lu-PSMA-617 arm compared to 2.4% in the best standard of care only arm1.

Visit View Source for the latest information from Novartis, including our commitment to the Oncology community, and access to our ASCO (Free ASCO Whitepaper)21 Virtual Scientific Program data presentations (for registered participants).

About Advanced Prostate Cancer
Prostate cancer is a form of cancer that develops in the prostate gland, a small walnut shaped gland in the pelvis of men. In castration resistant prostate cancer (CRPC), the tumor shows signs of growth, such as rising Prostate Specific Antigen (PSA) levels, despite the use of hormone treatments that lower testosterone7. In metastatic CRPC (mCRPC), the tumor spreads to other parts of the body, such as neighboring organs or bones and remains unresponsive to hormone treatment7. The five-year survival rate for patients with metastatic prostate cancer is approximately 30%2.

About Phenotypic Precision Medicine in Advanced Prostate Cancer
Despite advances in prostate cancer care, there is a high unmet need for new targeted treatment options to improve outcomes for patients with mCRPC. More than 80% of prostate cancer tumors highly express a phenotypic biomarker6 called Prostate Specific Membrane Antigen (PSMA) 3-5,8-9, making it a promising diagnostic (through positron emission tomography (PET) scan imaging) and potential therapeutic target for radioligand therapy10. This differs from ‘genotypic’ precision medicine which targets specific genetic alterations in cancer cells6.

About 177Lu-PSMA-617
177Lu-PSMA-617 is an investigational PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer. It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)11-13. After administration into the bloodstream, 177Lu-PSMA-617 binds to prostate cancer cells that express PSMA14, a transmembrane protein, with high tumor-to-normal tissue uptake11,15,16. Once bound, emissions from the radioisotope damage tumor cells, disrupting their ability to replicate and/or triggering cell death17-19. The radiation from the radioisotope works over very short distances to limit damage to surrounding cells10,11,15.

About VISION
VISION is an international, prospective, randomized, open-label, multicenter, phase III study to assess the efficacy and safety of 177Lu-PSMA-617 (7.4 GBq administered by intravenous infusion every 6 weeks for a maximum of 6 cycles) plus investigator-chosen best standard of care in the investigational arm, versus best standard of care in the control arm20. Patients with PSMA PET-scan positive mCRPC, and progression after prior taxane and androgen receptor pathway inhibitors, were randomized in a 2:1 ratio in favor of the investigational arm20. The alternate primary endpoints were rPFS and OS20. The study enrolled 831 patients1.

On June 3, 2021 Guided Therapeutics, Inc. or the "Company" (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, reported that it has raised an additional US $1.13 million under the terms of a 3-year convertible debenture (Press release, Guided Therapeutics, JUN 3, 2021, View Source [SID1234583476]). The proceeds are intended to pay off an existing convertible note that matures at the end of 2021. The convertible note that is being repaid included a highly dilutive discounted variable conversion mechanism based on the trading price of our common stock over the term of the note. In contrast, the new debenture has a fixed conversion price of $0.50. As a result, if converted, the new debenture will result in significantly less dilution than that produced by the retired note. Aspen Capital and Fieldhouse Capital Management advised the company for this financing.

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Additionally, the new debenture will automatically convert into the securities issued in a subsequent financing if that financing is undertaken in connection with an uplisting to Nasdaq.

"Over the past two years, we have made considerable progress in reducing our liabilities and increasing our assets. We believe that these efforts put us in a strong position to obtain a Nasdaq listing for our common stock this year" said Gene Cartwright, CEO of Guided Therapeutics. "Additionally, we are pleased with recent progress toward regulatory approvals of our products in the US and China that continue to improve the Company’s future prospects".

On June 3, 2021 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that its CEO, Dr James Garner, will be presenting virtually at the upcoming LD Micro Invitational XI (Press release, Kazia Therapeutics, JUN 3, 2021, View Source [SID1234583492]).

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Dr Garner commented, "this is a particularly exciting time for Kazia, with our lead program, paxalisib, now well-advanced in a pivotal study, and a promising new program, EVT801, due to enter the clinic this year. We look forward to updating the attendees on our progress, and on the rich slate of news flow anticipated for the second half of the year."

Event:

Kazia Presentation at the LD Micro Invitational XI

Date:

Wednesday 9 June 2021

Time:

5pm, Eastern Time

Investors may register for free to attend the event by using the following link:-

View Source

The 2021 LD Micro Invitational will be held on the Sequire Virtual Events platform on Tuesday, June 8th – Thursday, June 10th, 2021, running from 7:00 AM PT – 3:00 PM PT / 10:00 AM ET – 6:00 PM ET each day.

This three-day, virtual investor conference is expected to feature around 180 companies, presenting for 25 minutes each, as well as several influential keynotes. The first day of this conference will also feature an exceptional one-time event: the LD Micro Hall of Fame.

On June 3, 2021 Novartis reported that More than two years after splashing out $2.1 billion on Endocyte, is pulling the curtain on full phase 3 data for the radiopharmaceutical it picked up in that deal (Press release, Novartis, JUN 3, 2021, View Source [SID1234583610]).

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The treatment, given alongside standard of care, added four months to the lives of patients with metastatic castration-resistant prostate cancer, helping them live a median of 15.3 months and reducing the risk of death by 38%. The combination nearly doubled the time patients had before their disease got worse, staving off cancer progression for a median of 8.7 months, while standard of care alone kept cancer at bay for 3.4 months.

It could help patients whose "prognosis isn’t terrific" and who have run out of treatment options, said Michael Morris, M.D., the lead author of the study and head of the Prostate Cancer Section at Memorial Sloan Kettering Cancer Center.

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RELATED: Novartis’ radioligand hits goal in phase 3 prostate cancer trial

The phase 3 data, to be presented this weekend at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), come from 831 patients who received standard of care alone or along with the treatment, known by the unwieldy moniker of 177-Lu-PSMA-617.

The patients were "at the end of this disease’s course," Morris said. They had undergone chemotherapy and treatment with androgen receptor pathway inhibitors, a family of drugs that "works quite well." But after their cancer outsmarts those treatments and develops resistance, as many as 90% of these patients have no other options.

"Most of these patients will not have particularly good treatment options at all, save for a handful of those who might be receiving genetically defined therapies or radium," Morris said. "This is a space where a lot of people get supportive care … This drug will fill a real unmet medical need."

Side effects struck more patients taking 177Lu-PSMA-617 than those taking standard of care alone, with severe effects affecting about half of patients taking the radiopharmaceutical and just over two-thirds of those taking standard of care alone.

RELATED: Novartis bolsters radioligand stable with iTheranostics deal

That said, those effects were unsurprising, given the nature of the treatment and how sick the patients were, Morris said. The most common side effects affected nearly half of the patients and included fatigue and bone marrow suppression, which causes patients to produce fewer blood cells. About 40% of patients suffered dry mouth, but that’s typical for treatments that target the PSMA membrane protein because it is also found in the salivary glands, Morris said.

"We have experience in this drug from several other studies, both single-arm and comparison studies, that have been done previously … There was no new [safety] signal here," said Morris, who compared the treatment’s safety profile favorably to that of chemotherapy.

Radiotherapy is not new to cancer, but treatments like Novartis’ 177Lu-PSMA-617 deliver radiation more precisely than traditional radiotherapy, killing cancer cells while sparing healthy cells. Known as radioligand therapies, these medicines combine a small molecule or peptide that targets a protein found in cancer cells with a radioactive material that blocks tumor growth by damaging DNA. In the case of 177Lu-PSMA-617, the ligand zeroes in on PSMA in prostate cancer cells to deliver radiation from a radioactive isotope of lutetium.

"It allows us to actually deliver this high-dose radioactive lutetium directly to a cancer cell—very similar to DoorDash," said Jeff Legos, Ph.D., senior vice president, global head of oncology development at Novartis, during a press briefing.

RELATED: Novartis inks $2.1B Endocyte buyout, furthering radiotherapy push

As Novartis prepares a regulatory submission for the treatment, it has already set up its on-demand manufacturing process, which can deliver a treatment course two weeks after it’s ordered, said Susanne Schaffert, Ph.D., president of Novartis Oncology, during the briefing.

It’s not as simple as manufacturing small molecules or biologics, which can be stored on a shelf or in a refrigerator. Because the radiopharmaceutical decays so quickly, Novartis must account for the journey the treatment takes through the manufacturing site, to the hospital and the patient’s bedside.

"Time is of [the] essence given the short shelf life of the radioligand therapy, because it’s dependent on the level of decay," Schaffert said.