Oncology biotech Prelude guns for $100M IPO

On September 8, 2020 Prelude Therapeutics reported that it is going for a $100 million IPO, a pretty common goal for biotechs in 2020, as it looks to finish off early clinical work for its cancer candidate PRT543 (Press release, Prelude Therapeutics, SEP 8, 2020, View Source [SID1234564988]).

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The biotech is targeting PRMT5, an enzyme related to treatment resistance and oncogenesis in both solid and hematological cancers, although it has stayed mum on exact oncologic targets.

While several epigenetic-focused biotechs have zeroed in on lysine and its effects on DNA regulation, Prelude Therapeutics is taking a different tack by aiming at the methylation of arginine—specifically, the enzyme PRMT5 and its effects on the cell cycle, RNA splicing and signaling.

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By blocking it, Prelude hopes to starve treatment-resistant cancers of the splicing and proliferative mechanics necessary for tumor growth and survival.

PRMT5 is overexpressed in several types of cancer, including solid and blood-based disease. Those with sensitive pathways include bladder cancer and triple-negative breast cancer, as well as lymphoma and myeloid malignancies.

Prelude’s lead inhibitor, PRT543, is in a phase 1, with data expected to be out next year, according to its SEC filing. It has revealed interim phase 1 results, which it says "indicate dose-dependent increases in exposure and target engagement, and we have observed early signs of clinical activity, including a confirmed complete response, or CR, in a patient with HRD+ high grade serious ovarian cancer."

It’s also working on pushing two other candidates into the clinic using its platform, including PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a phase 1 hitting solid tumors, including tough-to-treat brain tumors. "We expect to begin enrolling patients in the expansion portion of the phase 1 clinical trial in the first half OF 2021," the company said in its SEC-1.

It’s also got FDA clearance to start a third trial for PRT1419, which is designed to be a potent and selective inhibitor of the anti-apoptotic protein, MCL1. "We are initiating a phase 1 clinical trial in relapsed/refractory patients with myelodysplastic syndrome, or MDS, acute myeloid leukemia, or AML, non-Hodgkin’s lymphoma, or NHL, and multiple myeloma, or MM, in the second half of 2020," it added.

There has been a small stampede to the public markets this year, with many riding the wave of positivity for the sector amid its fight against COVID-19, at the expense of almost every other industry.

Almost all biotechs have set $100 million as their initial IPO targets, though many have gone well beyond this. Prelude, which actually has a drug in the clinic (unlike so many preclinical biotechs this year), with more to come in the next year, will hope to do the same.

The Wilmington, Delaware-based biotech was founded back in 2016 and plans to list on the Nasdaq under the symbol PRLD.

Diffusion Pharmaceuticals Names Director Dr. Robert Cobuzzi as President and Chief Executive Officer

On September 8, 2020 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) ("Diffusion" or "the Company"), reported that Robert ("Bob") J. Cobuzzi Jr., Ph.D., who has served as a member of the Company’s Board of Directors since January 2020, will succeed David G. Kalergis as President and Chief Executive Officer effective immediately (Press release, Diffusion Pharmaceuticals, SEP 8, 2020, View Source [SID1234564927]). Mr. Kalergis will retire from his operational responsibilities but continue to serve as Chairman of the Board.

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Dr. Cobuzzi is an accomplished pharmaceutical executive with significant and successful experience in the areas of drug development, business development and operational leadership across multiple therapeutic areas. Since joining the Diffusion board in January 2020, Bob has immersed himself in the science and development of Diffusion’s lead-product candidate, trans sodium crocetinate ("TSC"), providing significant support to management as the Chairman of the Science and Technology Committee.

"Bob is uniquely qualified to lead Diffusion as it expands efforts to develop TSC for life-threatening medical conditions where the body has a decreased ability to deliver oxygen to the areas where it is needed most," said David Kalergis, Diffusion’s Chairman. "His deep leadership expertise and broad industry experience make him the ideal leader to drive product development and Company growth."

"I am honored to build on David’s legacy and excited to lead Diffusion into its next phase of development. I believe Diffusion has a significant opportunity with TSC to develop a unique and clinically meaningful asset that we believe will address an unmet medical need and create shareholder value," said Dr. Cobuzzi. "I would like to thank David and the Board for the opportunity to serve Diffusion, its patients and its shareholders."

David G. Kalergis has retired as president and chief executive officer of the Company but will continue to serve as chairman of the board of the Company. "It has been a tremendous privilege, first to work with Dr. John Gainer on the development of TSC, and then to work with the entire Diffusion team to bring this exciting new drug to its current inflection point," said Mr. Kalergis. "Speaking on behalf of the entire board, we welcome Bob as president and CEO."

Dr. Cobuzzi has 25 years of cross-functional leadership experience in the pharmaceutical and biotechnology industries. He currently serves as a Venture Partner and chairman of the Business Development Board of Sunstone Life Sciences Ventures. From 2005 until 2018, Dr. Cobuzzi held senior leadership roles with Endo International PLC (Nasdaq: ENDP), most recently as President of Endo Ventures Ltd. headquartered in Dublin, Ireland. Prior to joining Endo, Dr. Cobuzzi’s experience included significant scientific licensing, regulatory, and clinical program experience with Adolor Corporation, Centocor Inc., and AstraMerck, Inc./Astra Pharmaceuticals LP. Dr. Cobuzzi graduated from Colby College with an A.B. in Biochemistry and Art History, received his Ph.D. in Molecular and Cellular Biochemistry from Loyola University Chicago and completed a post-doctoral fellowship in Experimental Therapeutics at Roswell Park Comprehensive Cancer Center in Buffalo, New York.

Sysmex Inostics’ Liquid Biopsy Testing Benefits Metastatic Pancreatic Cancer Patient Management

On September 8, 2020 Sysmex Inostics, Inc., a global leader and pioneer in blood-based circulating cell-free tumor DNA (ctDNA) analysis for oncology, reported the publication of a clinical study investigating the utility of cfDNA-based markers using the highly sensitive OncoBEAM RAS assay, an enhanced digital PCR test optimized for high sensitivity blood-based mutation detection, as a prognostic tool in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Sysmex Inostics, SEP 8, 2020, View Source [SID1234564798]).

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Pancreatic cancer is the fourth leading cause of cancer related death worldwide. Moreover, PDAC accounts for 90% of all pancreatic cancers with an overall 5-year survival of less than 8%, the lowest survival rate of all cancers. Patients diagnosed with PDAC suffer from a poor prognosis which is attributed to diagnosis at an advanced stage, due to late onset of symptoms and lack of reliable biomarkers for early detection. Moreover, most patients with late stage disease exhibit resistance to available therapy modalities.

The primary initiating genetic event for PDAC is a KRAS mutation, occurring in 94% of pancreatic ductal tumors. KRAS mutational status is typically analyzed in tumor tissue but obtaining biopsy specimens from pancreatic lesions – especially during chemotherapy treatment – may be difficult and requires invasive procedures. Tumor tissue for biomarker testing is only available at diagnosis and is not feasible to access during treatment. CfDNA-based liquid biopsy analysis of KRAS mutations using OncoBEAM technology represents a minimally-invasive tool to measure levels of circulating KRAS mutations to assist in the prognosis determination and management of PDAC patients.

The study published by investigators at the University of Córdoba, Spain indicates that the dynamics of circulating RAS mutations may better correlate with patient outcomes and survival compared with CA19-9 protein blood-based marker testing. CA19-9 is usually found in higher concentrations in pancreatic cancer, however, it is not a tumor specific biomarker and can be elevated for reasons unrelated to cancer. In this comparative analysis, a significant correlation was found between the increase in RAS mutation levels detected in plasma by the OncoBEAM RAS test (r = 0.65, p = 0.02), but not in CA19-9 (r = 0.09, p = 0.78) and survival time. Overall, greater increases in levels circulating KRAS mutation during patient monitoring predicted shorter survival time, with researchers noting that KRAS mutant cfDNA shows great promise as real-time biomarker of tumor response.

Lead author Dr. Toledano-Fonseca of Maimónides Biomedical Research Institute of Córdoba (IMIBIC), said, "Remarkably, sensitive plasma KRAS mutation testing using OncoBEAM alongside of CA19-9 and fragmentation analysis greatly helped prognosis stratification of metastatic PDAC patients. Our results support KRAS MAF as a valuable complementary tool for monitoring the response to chemotherapy treatment in metastatic PDAC patients."

The publication, titled "Circulating Cell-Free DNA-Based Liquid Biopsy Markers for the Non-Invasive Prognosis and Monitoring of Metastatic Pancreatic Cancer" was published in Cancers, July 1, 2020, by Marta Toledano-Fonseca et al.: View Source

Protalix BioTherapeutics to Present in the H.C. Wainwright 22nd Annual Global Investment Virtual Conference

On September 8, 2020 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that Dror Bashan, the Company’s President and Chief Executive Officer will present in the H.C. Wainwright 22nd Annual Global Investment Virtual Conference on Tuesday, September 15, 2020 at 12:00 PM, Eastern Time (Press release, Protalix, SEP 8, 2020, View Source [SID1234564796]). The conference will be held virtually on September 14-16, 2020.

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A live webcast of the presentation will be available at www.protalix.com on the event calendar page, View Source A replay of the presentation will be archived and available for at least 15 days following the presentation.

Milestone Pharmaceuticals to Present at Upcoming Investor Conferences

On September 8, 2020 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported that Joseph Oliveto, President and Chief Executive Officer, will present at the following investor conferences (Press release, Milestone Pharmaceuticals, SEP 8, 2020, View Source [SID1234564795]):

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The H.C. Wainwright & Co. 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 11:30 a.m. Eastern Time
The Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Wednesday, September 23, 2020 at 2:30 p.m. Eastern Time
A live webcast of the presentations can be accessed in the News & Events section of Milestone’s website at www.milestonepharma.com. An archived replay of the webcasts will be available on the same website for approximately 30 days following the presentations.