On June 14, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales for EXPAREL (bupivacaine liposome injectable suspension) and iovera° for the month of May 2022 (Press release, Pacira Pharmaceuticals, JUN 14, 2022, View Source [SID1234615959]). EXPAREL net product sales were $44.9 million, compared with $41.2 million for May 2021. The company also reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL average daily sales for the month of May 2022 were 104 percent of May 2021. The number of EXPAREL selling days were 22 in May 2022 and 21 in May 2021. Net product sales of iovera° were $1.1 million for the month of May 2022, compared with $1.0 million for May 2021.

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"EXPAREL utilization continues to expand and support the market’s transition to outpatient sites of care. Importantly, EXPAREL is consistently and significantly outperforming the elective surgery market’s recovery, which is facing pockets of persistent pandemic-related disruptions and labor shortages," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "In addition, ZILRETTA is performing well, with a steady increase in new users and more than 220 accounts added year-to-date. For iovera°, the broad rollout of our Generation-2 device is now underway, and we expect the product to return to more robust year-over-year growth later this year."

"Our state-of-the-art training facility in Tampa continues to broaden interest in all three products and accommodates the market’s growing demand for best-practice education around regional blocks.
With the established growth and long-term potential of our product portfolio, we remain highly confident in our outlook for strong revenue and earnings growth as we further cement our leadership position in non-opioid pain management," continued Mr. Stack.

Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.

The company is not providing 2022 revenue or gross margin guidance at this time given the continued uncertainty around COVID-19 and the pace of recovery for the elective surgery market. To provide

greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for EXPAREL and iovera° until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira is currently not reporting preliminary monthly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter. Pacira completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA (triamcinolone acetonide extended-release injectable suspension) to its commercial offering.

The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the second quarter or full year 2022.

On June 14, 2022 Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, reported results from a series of preclinical analyses designed to evaluate the biodistribution and potential therapeutic efficacy of 177Lu-rhPSMA-10.1 and 177Lu-PSMA-I&T in the treatment of prostate cancer preclinical models (Press release, Blue Earth Therapeutics, JUN 14, 2022, View Source [SID1234615976]). Results from preclinical biodistribution studies demonstrated that 177Lu‑rhPSMA-10.1 performed favorably when compared with 177Lu-PSMA-I&T, with an improved tumor:kidney uptake ratio. Therapeutic efficacy was evaluated in a preclinical prostate cancer xenograft model which showed that 177Lu‑rhPSMA‑10.1 significantly suppressed tumor growth relative to control, and to a greater extent than 177Lu-PSMA-I&T. The data were presented in an oral presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. 177Lu-rhPSMA-10.1 is an investigational radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted therapeutic radiopharmaceutical, and the lead candidate in Blue Earth Therapeutics’ oncology development program of next generation therapeutic radiopharmaceuticals.

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"Radioligand therapy targeting prostate-specific membrane antigen (PSMA) has been shown to be an effective therapy in men with metastatic castration-resistant prostate cancer," said Caroline Foxton, Ph.D., Vice President R&D Strategy and Collaboration at the Blue Earth Group. "However, optimizing tumor uptake and accelerating renal clearance for this class of compounds could improve the therapeutic index, achieve better clinical outcomes and effectively manage radiation exposure to patients. Blue Earth Therapeutics’ next generation therapeutic rhPSMA compound has been optimized for favorable biodistribution properties to enhance delivery of therapeutic radiation to tumors while minimizing kidney uptake and retention. Supported by these preclinical data, 177Lu‑rhPSMA-10.1 was selected as our lead therapeutic candidate for progression to the clinic."

"We are pleased that the first presentation of preclinical results from Blue Earth Therapeutics’ rhPSMA-10.1 program in prostate cancer is being made to the nuclear medicine community at the SNMMI 2022 Annual Meeting," said David E. Gauden, D.Phil., Chief Executive Officer of the Company. "Radiohybrid PSMA technology enables utility as a theranostic because the molecule may be modified and deployed for either diagnostic PET imaging or therapeutic applications. This optimized rhPSMA technology can also be developed with both beta- and alpha-emitting therapeutic radioisotopes, with the potential to deliver personalized, targeted therapy specific to each patient’s condition. We are closely collaborating in the development of 177Lu-rhPSMA-10.1 with our sister company, Blue Earth Diagnostics, by incorporating its investigational 18F-rhPSMA-7.3 PET agent into our clinical development program."

Dr. Gauden continued, "Results from these analyses demonstrate the attractive preclinical biodistribution and potential therapeutic efficacy profile of 177Lu-rhPSMA-10.1, and were included in our Investigational New Drug application to the U.S. Food and Drug Administration. Blue Earth Therapeutics’ Phase 1/2 clinical trial for 177Lu-rhPSMA-10.1 in treating men with metastatic castrate‑resistant prostate cancer was recently cleared to proceed, and we expect patient enrollment to commence shortly."

Results
The findings presented at SNMMI included biodistribution data from preclinical models which evaluated 177Lu-rhPSMA-10.1 and 177Lu-PSMA-I&T uptake and tumor:kidney ratio, and therapeutic efficacy analysis in preclinical prostate cancer xenograft models.

Biodistribution
Data from longitudinal biodistribution analyses in preclinical models showed that the most significant organ uptake for both 177Lu-rhPSMA-10.1 and 177Lu-PSMA-I&T was observed in the kidney; however, kidney retention was lower for 177Lu-rhPSMA-10.1 than 177Lu-PSMA-I&T at all timepoints, and 6.5-fold lower than that for 177Lu-PSMA-I&T at 12 hours. No other organ (including the brain) showed any significant uptake of 177Lu-rhPSMA-10.1. A single-timepoint biodistribution study using a PSMA-expressing prostate cancer xenograft model examined the tumor:kidney uptake ratio for both compounds. It also showed lower kidney uptake of 177Lu‑rhPSMA‑10.1, with kidney uptake being 6.4‑fold lower for 177Lu-rhPSMA-10.1 than for 177Lu‑PSMA-I&T at 15 hours post-injection. Higher tumor uptake was seen with 177Lu‑rhPSMA‑10.1 than 177Lu-PSMA-I&T at this timepoint (2.3-fold), resulting in an improved tumor:kidney ratio for 177Lu-rhPSMA-10.1 (2.3±1.14) compared to 177Lu-PSMA-I&T (0.1±0.03).

Efficacy
The potential therapeutic efficacy of 177Lu-rhPSMA-10.1 and 177Lu-PSMA-I&T was compared in a PSMA-expressing prostate cancer xenograft model. Tumor volume was significantly reduced by 177Lu-rhPSMA-10.1 compared with the vehicle control (p=0.045 at 35 days after treatment). When measuring fold-change in tumor volume relative to volume at inclusion, 177Lu-rhPSMA-10.1 showed a statistically significant suppression of tumor growth compared to both non-radiolabeled rhPSMA-10.1 and vehicle control at both 14 days after treatment (p<0.01 both comparisons) and 35 days after treatment (p<0.01 vs non-radiolabeled rhPSMA-10.1 and p<0.001 vs vehicle). 177Lu-PSMA-I&T also reduced tumor growth compared with vehicle control (p<0.05), but to a lesser extent than 177Lu‑rhPSMA‑10.1. No significant effects were noted on any hematological parameters or body weight.

The results were discussed in an oral presentation, "Preclinical evaluation of a novel radioligand therapy for patients with prostate cancer: biodistribution and efficacy of 177Lu-rhPSMA-10.1 in comparison with 177Lu-PSMA-I&T," by Caroline Foxton, Ph.D., Blue Earth Group, Oxford, UK, at the SNMMI 2022 Annual Meeting on June 13, 2022. Full session details and the abstract are available in the SNMMI online program HERE.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses three distinct domains. The first consists of a Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells. It is attached to two labelling moieties which may be radiolabeled with either 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Therapeutics and Blue Earth Diagnostics work closely on the development of 177Lu-rhPSMA-10.1. Currently, rhPSMA compounds have not received regulatory approval.

On June 14, 2022 KBI Biopharma SA (KBI) and Selexis SA, both JSR Life Sciences companies, reported that an expanded, fully-integrated mammalian contract development and manufacturing services facility is now open and operational in Geneva, Switzerland (Press release, JSR, JUN 14, 2022, View Source [SID1234615992]).

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The ~94,000 square-foot integrated KBI/Selexis state-of-the-art facility builds upon the companies’ existing market foothold by combining best-in-class cell line development (CLD) and expert mammalian cell manufacturing in a single location. KBI and Selexis leverage their expertise and efficient end-to-end services for biomanufacturing clients.

This expansion enables industry-leading delivery of client programs through increased quality, efficiency, and time savings across a diverse portfolio of molecule formats. Under one roof, KBI and Selexis provide cell line transfection through cGMP drug manufacturing with Selexis’ specialized high-titer mammalian cell line development technologies and services and KBI’s cGMP bulk drug manufacturing for clinical and commercial requirements.

"This expansion in Geneva will provide our global clients with streamlined capabilities to support mammalian-based therapies," said Mark W. Womack, Chief Executive Officer for KBI Biopharma and Selexis SA. "With a single touchpoint for best-in-class cell line development, process development, and manufacturing, clients experience heightened access to our process and product-based expertise."

He added, "This facility expansion, together with our track record in the space, strengthens our commitment to deliver a seamless experience to the European biopharmaceutical community and clients around the globe."

The fully integrated Selexis and KBI development platform has supported more than 60 clinical development programs with high productivity and robust product quality. The two companies have developed a seamless approach, to optimize the client experience.

"We have always been a science-driven, customer-centric company. This expansion in Geneva helps our clients optimize their complex biomanufacturing processes under accelerated timelines," said Ulrich Valley, Senior Vice President, Operations & Site Head, KBI Biopharma, Geneva.

The KBI Biopharma facility will create more than 200 technical positions in development, operations, and quality assurance. The facility includes a suite of analytical testing laboratories and dual 2,000L single-use cGMP manufacturing trains with downstream processes capable of producing 8-10 kg yields per batch.

With the expanded Geneva facility now operational, KBI and Selexis will celebrate with ribbon-cutting activities and facility tours starting in July 2022.

On June 14, 2022 Proscia, a leader in digital and computational pathology solutions, reported that it has raised $37 million to advance the way we understand and treat diseases like cancer (Press release, Proscia, JUN 14, 2022, View Source [SID1234616029]). The round includes participation from Highline Capital Management, Triangle Peak Partners, and Alpha Intelligence Capital as well as existing investors including Scale Venture Partners, Hitachi Ventures, ROBO Global, Emerald Development Managers, and Razor’s Edge Ventures. This investment brings Proscia’s total funding to $72 million.

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Demand for digital pathology, which shifts the standard of cancer research and diagnosis from microscope to digital image, is rising to tap into the full potential of pathology data. Proscia has established itself as the sole player driving this complete modernization across both life sciences organizations and diagnostic laboratories. Its Concentriq platform combines enterprise scalability with a broad portfolio of AI applications to accelerate breakthroughs and unlock clinical insights that advance precision medicine.

"Proscia is uniquely positioned to enable a new frontier of patient care," said Jacob Doft, CEO of Highline Capital Management. "Digital pathology is a critical catalyst in the acceleration of precision medicine, creating a wealth of new data that is driving novel therapies and optimizing diagnosis so that each patient receives the most individualized treatment. We are excited to be a part of Proscia’s journey as it expands its leadership position with its AI-enabled platform."

Proscia’s user base includes 10 of the top 20 pharmaceutical companies as well as the Joint Pathology Center, which selected Concentriq to digitize the world’s largest human tissue repository of over 55 million slides. Leading reference laboratories and health systems, including LabPON, the first laboratory to reach 100% digital diagnosis, also rely on Concentriq.

"Pathology deserves the same revolutionary technology that has transformed the rest of medicine and our lives," said David West, Proscia’s CEO. "Our Series C will enable us to continue delivering this innovation to the scientists and pathologists who are using it to improve patient outcomes. We are thrilled to partner with incredible investors who believe deeply in our mission as we take the next step in our journey."

The financing will enable Proscia to accelerate adoption of computational pathology, strengthening its market and product leadership. It will use the infusion of capital to scale its commercial operations. This includes expanding its sales, marketing, and support teams as well as growing distribution partnerships following its recent OEM agreement with Siemens Healthineers. Proscia will also increasingly focus on its regulatory strategy on the heels of its CE IVDR certification.

To continue offering the widest variety of AI applications on a single pathology platform, Proscia will invest in broadening its own portfolio of computational solutions and introduce a growing number of third-party applications onto Concentriq. It will build on the success of its DermAI and AI breakthrough in melanoma detection as well as extend digital pathology’s first suite of process automation solutions beyond Automated QC.

"Pathology is a multi-billion dollar market transitioning to digital," said Steve Holloway, Executive Director at Signify Research. "Adoption has moved beyond the largest life sciences organizations and medical centers as the benefits have become increasingly clear, much like we saw when the digitization of radiology crossed an inflection point."

Today’s announcement comes as demand for AI-enabled pathology continues to grow. By breaking free from the limitations of glass slides, research organizations and diagnostic laboratories are overcoming a range of systemic challenges intensified by the rising cancer burden; drug development timelines average 12 years before patients gain access to new therapies, and the number of cancer cases is expected to rise 47% by 2040, putting added burden on a shrinking pathologist population. It is estimated that one billion slides will be digitized each year, fundamentally transforming the way we diagnose and treat patients in fulfilling the promise of precision care.

On June 14, 2022 Dren Bio, Inc. ("Dren Bio" or the "Company") reported the completion of their $65 million Series B financing, pushing the Company’s total capital received to date over $156 million (Press release, Dren Bio, JUN 14, 2022, View Source [SID1234615961]). Following the financing, Dren Bio is well-capitalized to reach multiple key inflection points across both its drug discovery programs over the coming years.

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"We are truly grateful for all the support we continue to receive from such an outstanding syndicate of investors," said Nenad Tomasevic, Ph.D., Chief Executive Officer of Dren Bio. "This financing comes at the perfect time as we prepare to initiate the first clinical trial evaluating DR-01, our lead asset, in patients with Large Granular Lymphocytic leukemia or cytotoxic lymphomas in mid-2022. In addition to advancing DR-01, the proceeds from this latest round will also enable us to further expand the development of our internal pipeline using our proprietary Targeted Myeloid Engager and Phagocytosis Platform."

The Series B financing was co-led by Aisling Capital and HBM Healthcare Investments, with participation by new marquee investors Pfizer, ArrowMark Partners and Revelation Partners. There was also significant participation in the round by Dren Bio’s existing insiders SR One, 8VC, Taiho Ventures, BVF Partners, Mission BioCapital and Alexandria Venture Investments, amongst others. In connection with the closing of the financing, the Company announced that Andrew Schiff, M.D., of Aisling Capital, and Chandra P. Leo, M.D., of HBM Partners, will join its Board of Directors.

"We were thoroughly impressed by Dren Bio’s diversified R&D portfolio that encompasses two distinct therapeutic antibody programs including their attractive proprietary platform," said Dr. Schiff, Managing Partner at Aisling Capital. "We are excited by the opportunity to support Dren Bio in progressing on their mission to deliver revolutionary therapies to patients with severe unmet needs, starting with difficult-to-treat cancers."

Dr. Leo, of HBM Partners, added, "Over the last 18 months, Dren Bio has delivered robust preclinical data for their lead asset DR-01 and for their unique technology to induce myeloid cell engagement and phagocytosis. With this new financing, the Company is well positioned to rapidly advance DR-01 towards clinical proof-of-concept and to demonstrate the broad potential of their highly differentiated platform."

Proceeds from the financing will enable Dren Bio to continue advancement of its broad internal pipeline comprised of multiple development candidates approaching the clinic. The Company’s lead asset, DR-01, is designed to precisely eliminate a subset of immune cells which are the underlying cause of certain hematologic malignancies and well-defined autoimmune disorders, both of which will be evaluated using its current funding. Dren Bio’s position as an emerging leader in the antibody therapeutics space is further strengthened by the exceptional prospects of its Targeted Myeloid Engager and Phagocytosis Platform. Bispecific antibodies generated using the proprietary platform have been shown to produce effects that are well-differentiated from other competing technologies including T cell engagers, antibody-dependent cellular cytotoxicity ("ADCC") antibodies and antibody-drug conjugates. In addition to their profound and multi-pronged mechanism of action, initial development candidates have been very well tolerated in non-human primates, which should enable their utilization in both oncology and non-oncology indications. With its current funding, Dren Bio now has the opportunity to demonstrate the vast potential of its platform to produce therapies for a wide array of patients.