On July 5, 2022 Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., and Pierre Fabre Médicament reported they have entered into an exclusive license agreement for Pierre Fabre to register and commercialize vibegron for the treatment of Overactive Bladder (OAB) in the European Economic Area, UK, and Switzerland, with some option territories, which notably include French-speaking countries of Sub-Saharan Africa, Turkey, and certain Eastern European countries (Press release, Pierre Fabre, JUL 5, 2022, View Source [SID1234616481]). Urovant will retain full rights in the United States and other select markets.

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"We are thrilled to partner with Pierre Fabre, a leader in the international biopharmaceutical space," said Jim Robinson, Chief Executive Officer of Urovant Sciences. "Their experience in the global OAB and Benign Prostatic Hyperplasia (BPH) market make them uniquely suited to deliver vibegron to more patients who need it across Europe and surrounding areas."

Under the terms of the agreement, Urovant Sciences will receive payments up to USD $75 million, based on upfront, regulatory, and sales milestone payments. Additionally, Urovant will receive royalties based on sales performance.

Urovant Sciences and Pierre Fabre will share responsibility for vibegron clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.

"We are delighted to enter into this partnership with Urovant, which will bring effective treatment and improved quality of life to all patients suffering from Overactive Bladder (OAB) in Europe. This partnership confirms Pierre Fabre’s extensive expertise in urology and in women’s health for five decades and the group’s ambitions to offer therapeutic solutions to chronic diseases that are very disabling in everyday life," said Eric Ducournau, group CEO at Pierre Fabre.

About Overactive Bladder

Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1

While 33 million US adults experience the bothersome symptoms of OAB, approximately 546 million people ≥ 20 years are affected by OAB worldwide. 1,2

On July 5, 2022 Aurigene’s small molecule drug discovery platform reported The collaboration combines EQRx’s pioneering business model to accelerate the development of drug candidates in the areas of oncology and immune-inflammatory diseases and improve global access to innovative medicines (Press release, Aurigene Discovery, JUL 5, 2022, View Source [SID1234616480]).

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Under the terms of the collaboration agreement, Aurigene and EQRx will collaborate on drug discovery, pre-clinical and clinical development and commercialization. Aurigene will lead drug discovery and pre-clinical development efforts, and EQRx will assume responsibility for clinical development, manufacturing, regulatory and commercialization efforts. The parties would share both funding for the discovery and development of the programs and financials resulting from the commercialization of any eventual drug candidates.

"This agreement with EQRx further validates Aurigene’s proven expertise in discovery and preclinical development of novel therapeutics and moves Aurigene forward into building a global oncology franchise participating in the end-to-end value chain," said Murali Ramachandra, Ph.D., Chief Executive Officer of Aurigene. "We are excited to collaborate with EQRx and contribute to developing and delivering innovative medicines to patients at more affordable prices."

"We are pleased to partner with Aurigene to expand our future pipeline and accelerate the discovery of next-generation therapeutics," said Carlos Garcia-Echeverria, PhD, chief of Rx creation at EQRx. "Our combined efforts will focus on some of the most high-impact therapeutic targets across oncology and immune-inflammatory diseases. Given our mission, we believe these future programs hold the potential to create important treatments for patients and drive meaningful savings for healthcare systems around the world."

On July 5, 2022 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported that company management will participate in a fireside chat and one-on-one meetings at the William Blair Biotech Focus Conference 2022, which is taking place at The St. Regis New York on July 12 – 13, 2022 (Press release, Cardiff Oncology, JUL 5, 2022, View Source [SID1234616479]).

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The fireside chat will be pre-recorded and available on-demand beginning on Monday, July 11, 2022. A link to the recording will available on the "Events" section of the Cardiff Oncology website.

On July 5, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the results of a study to determine whether a previous established quantitative real-time PCR (qRT-PCR) could be used as a quality control test for its CypCaps product candidate (Press release, PharmaCyte Biotech, JUL 5, 2022, View Source [SID1234616478]). The qRT-PCR was used to gain data from testing of syringes from clinical batches of PharmaCyte’s cGMP production for its planned clinical trial in locally advanced, inoperable pancreatic cancer.

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented on this new confirming assay, saying, "With the completion of this study, the Company has fulfilled one more important item from the long list of required U.S. Food and Drug Administration (FDA) tasks for our pancreatic cancer product candidate. We are particularly pleased that this independently performed qRT-PCR shows yet again the stability at the genetic level of the cytochrome P450 expressing cells which form the engine for our CypCaps clinical trial product. Additionally, we continue to make uninterrupted progress and remain steadfast in our efforts to resubmit an Investigational New Drug Application to the FDA and have our clinical hold lifted."

The study, performed by a third-party laboratory, confirmed that the qRT-PCR can be successfully implemented for testing, and it also confirmed the identity and stability of the cytochrome P450 expression construct in the cells used for the production of CypCaps both before and after encapsulation in the cGMP batches. The qRT-PCR will thus be used as a quality control (QC) release assay on future cGMP-grade clinical batches of CypCaps. The results obtained from the newly reported study also serve as additional evidence that the integrated cytochrome P450 construct is highly stable in the clinical cell line used for CypCaps.

PharmaCyte is at the tail end of its process of fulfilling the FDA’s requests to enable the clinical hold to be lifted, having now successfully completed almost two dozen studies with only a few remaining to be completed. The Company expects to commence its two-phase pig study shortly, which is the last major study from the FDA.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On July 5, 2022 Spago Nanomedical reported that the company raised 58.4 MSEK in the completed capital round. The proceeds give the company the resources to maintain the pace in its two projects – SpagoPix in cancer diagnostics and Tumorad, in which it is developing a new radionuclide cancer treatment (Press release, Spago Nanomedical, JUL 5, 2022, View Source [SID1234616476]). BioStock reached out to CEO Mats Hansen for comments on recent events and what awaits in the coming six months.

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Spago Nanomedical recently raised 58.4 MSEK before costs in a completed rights issue. The capital will primarily be used to initiate a clinical phase I/II trial with the company’s radionuclide treatment for cancer, the Tumorad candidate drug 177Lu-SN201.

The SpagoPix project has also advanced during the year. The new gadolinium-free contrast agent for magnetic resonance imaging has shown positive clinical results in the company’s ongoing study on breast cancer. The study has been expanded to also include pancreatic cancer and Spago Nanomedical expects to complete the study before the end of the year. Read more.

The potential of Tumorad
The cancer treatment project Tumorad is based on Spago’s physiological targeting of cancer tumours with functional nanoparticles, which makes the treatment independent of the biology of tumour cells. This means that the potential application area for Tumorad is broad and not limited to a specific form of cancer, as a biological approach often is.

During the year, Spago has also become interested in using 177Lu-SN201 for ovarian cancer – the seventh most common cancer in women and the fifth most fatal. This direction allows Spago to apply for Orphan Drug Designation (ODD) for the candidate, providing benefits during the development phase and market exclusivity for an approved drug.

CEO on the progress towards clinical phase
The company is now working to produce materials according to Good Manufacturing Practice and to complete documentation to apply to start the phase I/IIa study with Tumorad.

BioStock reached out to CEO Mats Hansen to comment on the company’s past six months, the issue and what to expect during the rest of 2022.

Mats, the first half of 2022 is recently concluded – what milestones have been the most important to achieve for Spago Nanomedical so far this year?

– Last winter, we achieved good interim results in our clinical study with SpagoPix. The results are not only beneficial for our new contrast agent. Equally important, we have been able to clinically validate our technology platform – that our functional nanomaterial combined with physiological targeting of cancer tumours works in humans.

– Another milestone was the preclinical results with Tumorad. We successfully conducted the preclinical toxicology studies and presented promising efficacy data with the candidate in a preclinical model for colorectal cancer.

– Tumorad’s potential within cancer is wide, only within the ODD indication ovarian cancer is the commercial opportunity significantly greater than for SpagoPix in the contrast agent market.

The rights issue went ahead in difficult market conditions, how would you like to comment on it?

Mats Hansen, CEO Spago Nanomedical
Mats Hansen, CEO Spago Nanomedical
– It is obvious to everyone what the investment climate is like right now and given that, we are extremely happy and grateful for the support of our existing shareholders in this rights issue.

– With the financing in place, we now have the resources to keep up the pace and can hopefully start our clinical study with Tumorad around the end of the year.

Preparations are in full swing for the clinical study with Tumorad – what are the most important events in the coming six months for Spago Nanomedical?

– As mentioned, the preclinical data package is ready, right now we are finalising the application for our phase I/II study with 177Lu-SN201 and securing the manufacturing process for the candidate.

– At the same time, we are waiting for preclinical data with the candidate in ovarian cancer. These results will be significant for our ODD application, which we plan to submit in the autumn.

– With good results in SpagoPix, preparatory work according to plan in Tumorad and a completed capital round, we are confidently progressing the development.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.