On March 28, 2023 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a corporate update (Press release, Vincerx Pharma, MAR 28, 2023, View Source [SID1234629453]).

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"Vincerx made great progress in 2022, advancing multiple programs while moving closer towards achieving our mission of improving outcomes for patients with cancer," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "We are particularly excited with the advancements we have made with our bioconjugation platform. This quarter, we started dosing the first cohort in our Phase 1 dose-escalation study in advanced solid tumors for VIP236, our first-in-class, front-runner αvβ3 SMDC with a tailored design to efficiently target aggressive and metastatic cancers. To date, we have generated robust preclinical results demonstrating how VIP236 can deliver up to 40 times more drug to the cancer, while sparing the surrounding tissues and normal organs. We look forward to sharing preclinical data at the upcoming AACR (Free AACR Whitepaper) meeting, highlighting how VIP236 showed monotherapy efficacy in non-small cell lung cancer (NSCLC), gastric cancer, triple negative breast cancer (TNBC), renal cell carcinoma (RCC), colorectal cancer (CRC), and metastatic TNBC in vivo cancer models. Additionally, we will share exciting preclinical data in gastric cancer, where VIP236 showed improved efficacy in vivo compared with ENHERTU, an approved ADC."

"There have been some exciting developments in the ADC space recently, and our team has done great work positioning Vincerx to be a key player through the development and advancement of our next-generation, modular bioconjugation platform. Our lead ADC is VIP943, a novel anti-CD123 antibody that combines a unique payload class of kinesin spindle protein inhibitors (KSPi), a proprietary legumain-cleavable linker, and our CellTrapper modification of the KSPi, which allows for intracellular accumulation. CD123 is a validated target in myeloid malignancies, including higher-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), which are the first indications we are pursuing. MDS and AML are aggressive and heterogeneous in their genetic makeup, and current treatments are quite toxic with high rates of relapse. This past ASH (Free ASH Whitepaper), we presented exciting preclinical data where, for the first time, we showed that our KSPi payload, linker and CellTrapper technology had a significant improvement in safety over Mylotarg, an approved ADC for the treatment of AML. We also showed that VIP943 did not cause cytokine release in human blood cells. This indicates a potential reduced risk in the clinic for cytokine release syndrome, which is a common side effect of other CD123 targeting dugs (eg, ADCs and bispecifics). We believe these preclinical results, especially the improved safety over Mylotarg, demonstrate the benefit of our technology, which was designed to address some of the well-known challenges of existing ADCs. We remain on track to file the IND for VIP943 by mid-2023 and expect to get VIP943 into the clinic in the second half of this year," added Dr. Hamdy.

"We also remain excited about enitociclib, our CDK9 inhibitor, and anticipate dosing the first patient in our Phase 1b enitociclib combination study with an approved BTK inhibitor in CLL next quarter. While great progress has been made in the treatment of CLL, limiting patients’ exposures to toxicities, preventing resistance, and minimizing risk of relapse and death following prolonged BTK inhibition monotherapy remain unmet needs. Our objective in the Phase 1b study is to put patients on a time-limited treatment, thus reducing their exposure to toxicities and preventing resistance to the BTK inhibitor," concluded Dr. Hamdy.

FOURTH QUARTER AND FULL YEAR 2022 CORPORATE HIGHLIGHTS

Bioconjugation Platform

VIP236, an αvβ3 integrin binder linked to an optCPT payload SMDC:
Company published preclinical data in the Journal Cancers:
Compelling proof-of-concept data demonstrated that VIP236 can direct a potent cancer chemotherapy drug to tumors while sparing healthy tissues.
Compared with commonly used chemotherapeutics, VIP236 showed effective tumor targeting, better tumor regression, and better tolerability in mouse models of TNBC, SCLC, and CRC.
In December, the Company received U.S. Food and Drug Administration (FDA) safe-to-proceed letter for Investigational New Drug (IND) application for VIP236 for the treatment of advanced solid tumors; initiated dosing the first cohort of the Phase 1 first-in-human dose-escalation study with VIP236 monotherapy in the first quarter 2023 (ClinicalTrials.gov NCT05712889).

VIP943, CD123-KSPi ADC:

Company presented preclinical data on VIP943 in AML models at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrating superiority with significantly improved safety in monkeys when compared with Mylotarg (gemtuzumab ozogamicin), AML ex vivo and in vivo monotherapy activity, no signs of cytokine release in human blood cells, and significant tumor regression in combination with venetoclax and azacytidine in a patient-derived AML model.
IND-enabling studies continue to advance, with IND filing expected mid-2023.

VIP924, CXCR5-KSPi ADC:

IND-enabling studies continue to advance, with IND filing on track for mid-2024.
Enitociclib, Positive Transcription Elongation Factor b (P-TEFb)/CDK9 inhibitor

Orphan Drug Designation was granted by the FDA for the treatment of high-grade B-cell lymphoma characterized by translocations of MYC and BCL2/BCL6 (double-hit lymphoma).
Phase 1b study of enitociclib in combination with an approved BTK inhibitor in patients with high-risk CLL expected to start after assessing the safety of enitociclib monotherapy in patients with high-risk CLL (NCT04978779) at the once-weekly 30mg dose. Anticipate dosing first patient in Phase 1b study in second quarter 2023.
Company presented preclinical and preliminary clinical data on enitociclib in gynecologic malignancies at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. In a preliminary monotherapy clinical study in patients refractory to multiple lines of prior therapy, treatment with enitociclib showed an early signal with stable disease in 3 out of 3 patients with gynecologic cancer as well as 1 out of 4 patients with ovarian cancer unselected for MYC.
Company presented preclinical and clinical data on enitociclib in multiple tumor types at the 2022 ASH (Free ASH Whitepaper) Annual Meeting. In a multiple myeloma (MM) preclinical study, potent monotherapy and combination antitumor efficacy was observed with enitociclib.
National Institutes of Health collaboration Phase 1 combination study with venetoclax and prednisone (VVIP) in peripheral T-cell lymphoma (NTC05371054) ongoing.
A recent publication from Dr. Steven Johnsen’s lab at the Robert Bosch Center of Tumor Diseases, Germany, identified that epigenetic reprogramming and transcriptional changes in metastatic pancreatic ductal adenocarcinoma (PDAC) are factors in therapy resistance and can be targeted by enitociclib.
These data along with our phase 1 clinical data, where we observed 2 patients with pancreatic cancer treated for 3 and 14 cycles achieve stable disease, support a potential clinical trial in metastatic PDAC in combination with chemotherapy.
Additional Corporate Highlights:

Company announced receipt of a one-year extension of Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency’s (EMA) Micro, Small and Medium-Sized Enterprise, enabling Vincerx to become eligible for EMA fee reductions and waiver and other financial incentives.
In June, Company announced key strategic update with realignment of resources to support key indications and programs, advancement of the bioconjugation platform, and extension of cash runway.
Company invited to talk on "ADCs with KSP-Inhibitor Payloads and a Tailored Design of Linker and Metabolite Profile," at the Festival of Biologics meeting.
In the first quarter 2023, Company announced upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023.
VIP236: A small molecule drug conjugate with an optimized camptothecin payload has significant activity in patient-derived and metastatic cancer models.
Targeting CDK9 via the small-molecule inhibitor enitociclib as a therapeutic strategy to treat MYCN-amplified rhabdomyosarcoma and neuroblastoma in children.
Synthesis and characterization of novel small molecule drug conjugates with different payloads designed to be released in tumor microenvironment by neutrophil elastase.
CXCR5 is a very promising drug target for the development of antibody-drug conjugates to treat patients with lymphoma.
Expected cash runway into late 2024.
FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

Vincerx had $52.5 million in cash, cash equivalents and marketable securities as of December 31, 2022, as compared to $111.5 million as of December 31, 2021. Based on its current business plans and assumptions, Vincerx believes its available capital will be sufficient to meet its operating requirements into late 2024.

Research and development (R&D) expenses for the fourth quarter and full year 2022 were $11.4 million and $52.2 million, respectively, as compared to $12.3 million and $40.1 million, respectively, for each of the same periods in 2021. The annual increase was primarily driven by increases in manufacturing services, including the ongoing services associated with our ADC program, third party research and preclinical work, new employee salaries, and clinical services in connection with our preclinical studies and clinical trials, partially offset by a decline in stock-based compensation expense.

General and administrative (G&A) expenses for the fourth quarter and full year 2022 were $4.1 million and $19.0 million, respectively, as compared to $5.4 million and $22.6 million for the same periods in 2021. The quarterly and annual decreases were primarily driven by decreases in stock-based compensation expense.

For the fourth quarter and full year 2022, Vincerx reported a net loss of $13.6 million, or $0.65 per share, and a net loss of $65.4 million, or $3.11 per share, respectively. For the fourth quarter and full year 2021, Vincerx reported a net loss of $6.5 million, or $0.31 per share, and a net loss of $39.3 million, or $2.29 per share, respectively.

On March 28, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s chief executive officer and president, will present at Guggenheim’s Genomic Medicines and Rare Disease Days on Monday, April 3, 2023, at 10:45 a.m. ET (Press release, Ultragenyx Pharmaceutical, MAR 28, 2023, View Source [SID1234629452]).

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The live and archived webcast of the panel will be accessible from the company’s website at View Source The replay of the webcast will be available for one year.

On March 28, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for full-year 2022 and provided recent business updates (Press release, Sensei Biotherapeutics, MAR 28, 2023, View Source [SID1234629450]).

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"Over the last year the team has worked with urgency to test the biological rationale for our lead product candidate, SNS-101, as a potentially transformative therapeutic option for patients with solid tumors," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We remain committed to the belief that VISTA has tremendous potential as an immune checkpoint target and continue to take steps to prioritize the advancement of SNS-101. We are pleased that, despite industry headwinds, our work has culminated in the recent submission of an IND to begin a Phase 1/2 clinical trial with the support of our partners. We’re also excited about the overall progress of programs generated through our TMAb platform, including SNS-102 and SNS-103, and look forward to advancing other conditionally active antibodies that ignite and deploy the immune system’s full potential to fight cancer."

Added Mr. Celebi, "Following the streamlining and realignment of the Company’s resources to support its key indications and programs, including reductions in operating expenses, employee-related costs and occupancy costs, our programs are supported by a healthy cash position that provides runway into the second half of 2025. We are confident in our strategy and expect to continue achieving critical near-term milestones across our pipeline."

Highlights and Milestones

SNS-101

Sensei continues to advance SNS-101, a conditionally active antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), which is implicated in resistance to PD-1/PD-L1 therapy and whose expression correlates with poor survival across numerous cancers. Recent updates for SNS-101 include:

In March 2023, Sensei submitted an IND application to the U.S. Food and Drug Administration for the planned Phase 1/2 clinical trial of SNS-101 in patients with solid tumors.
In November 2022, Sensei presented preclinical data on SNS-101 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, highlighting the antibody’s potentially improved safety, pharmacokinetic and efficacy profile over non-conditionally active VISTA-blocking antibodies. Presented data showed a significantly lower risk of inducing cytokine release syndrome (CRS), linear elimination kinetics and avoidance of target-mediated drug disposition and significant enhancement of anti-tumor effects in combination with anti-PD-1 antibodies.
Additional preclinical data presented at the Keystone Symposia on Next-Generation Antibody Therapeutics in February 2023 included crystal structure analysis further elucidating SNS-101’s mechanism of action, showing that the antibody directly blocks the pH-dependent interaction between VISTA and PSGL-1.
New preclinical efficacy data support a rationale for SNS-101 both as monotherapy and in combination with PD-1 blockade for patients with solid tumors.
Key Collaborations Supporting SNS-101

Sensei recently announced three collaborations key to the development of SNS-101 and the planned Phase 1/2 clinical trial in solid tumors:

A Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), executed in February 2023, is designed to further demonstrate the role of VISTA in checkpoint resistance and will enable Sensei to explore SNS-101’s potential as a combination therapy beyond anti-PD-1.
In January 2023, the Company signed a clinical supply agreement with Regeneron that will enable Sensei to evaluate SNS-101 in combination with the anti-PD1 therapy Libtayo (cemiplimab).
In November 2022, Sensei announced a Sponsored Research Agreement with Washington University in St. Louis to support research into the underlying molecular mechanisms that enable SNS-101 to overcome myeloid cell-driven immunosuppression within the tumor microenvironment.
Additional TMAb Platform Updates

Through its proprietary Tumor Microenvironment Activated biologics (TMAb) platform, Sensei is also advancing several pH-sensitive antibodies, including SNS-102 targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4) and SNS-103 targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39).

SNS-102: Eight parental pH-sensitive VSIG4 antibodies have been selected for lead optimization. Data on this program presented at SITC (Free SITC Whitepaper) in November 2022 characterized endogenous expression patterns of VSIG4 in polarized macrophage populations and showed robust VSIG4-mediated suppression of primary human T-cells. Additionally, Sensei reported that a ligand receptor capture-trifunctional chemoproteomic (LRC-TriCEPS)-based proteomics strategy identified receptors on primary human T-cells that interact with recombinant VSIG4 protein.
SNS-103: Sensei has identified eight parental pH-sensitive CD39 antibodies and begun further optimization on a lead antibody set.
Upcoming Milestones

Sensei will present preclinical data on its SNS-103 program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in a poster session on April 18, 2023.
Sensei remains on track to select product candidates for both SNS-102 and SNS-103 in 2023. Upon successful candidate selection, Sensei expects to advance at least one product candidate to IND-enabling studies.
The Company has initiated early discovery efforts for a fourth TMAb program.
Cost Savings

Following the streamlining and realignment of the Company’s resources to support its key indications and programs, including reductions in operating expenses, employee-related costs and occupancy costs, Sensei projects it has a cash runway into the second half of 2025.
As a result of the Company’s prudent fiscal strategy, Sensei expects significant cost savings while preserving the ability to fund development and continuation of programs for potential nearer-term data catalysts.
Corporate Updates

In December 2022, Sensei promoted Edward van der Horst, Ph.D., to Chief Scientific Officer.
Year End 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $107.1 million as of December 31, 2022, as compared to $147.6 million as of December 31, 2021. Sensei expects its current cash balance to fund operations into the second half of 2025.

Research and Development (R&D) Expenses: R&D expenses were $30.4 million for the year ended December 31, 2022, compared to $21.7 million for the year ended December 31, 2021. The increase in R&D expenses was primarily attributable to increased manufacturing and early development activities for the Company’s lead program SNS-101, partially offset by a decrease in clinical trial expenses.

General and Administrative (G&A) Expenses: G&A expenses were $19.8 million for the year ended December 31, 2022, compared to $15.8 million for the year ended December 31, 2021. The increase in G&A expense was primarily attributable to external professional services and personnel costs.

Net Loss: Net loss was $48.6 million for the year ended December 31, 2022, compared to $36.8 million for the year ended December 31, 2021.

Condensed Statements of Operations
(Unaudited, in thousands except share and per share data)

Twelve Months Ended
December 31,
2022 2021
Operating expenses:
Research and development $ 30,383 $ 21,662
General and administrative 19,805 15,820
Total operating expenses 50,188 37,482
Loss from operations (50,188 ) (37,482 )
Total other income 1,600 688
Net loss (48,588 ) (36,794 )
Net loss per share, basic and diluted $ (1.58 ) $ (1.33 )
Weighted-average common shares outstanding, basic and diluted 30,703,295 27,710,686

Selected Condensed Balance Sheet Data
(Unaudited, in thousands)


December 31,
2022 December 31,
2021
Cash and cash equivalents $ 17,795 $ 7,159
Marketable Securities 89,321 140,462
Total assets 118,375 153,225
Total liabilities 14,968 6,712
Total stockholders’ equity (deficit) 103,407 146,513

On March 28, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sonoma Biotherapeutics, Inc. reported a collaboration to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T cell (Treg) therapies for autoimmune diseases (Press release, Regeneron, MAR 28, 2023, View Source [SID1234629449]). The collaboration will bring together Regeneron’s industry-leading VelociSuite technologies for the discovery and characterization of fully human antibodies and T cell receptors (TCRs) with Sonoma Biotherapeutics’ pioneering approach to developing and manufacturing gene-modified Treg cell therapies.

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Under the terms of the agreement, Sonoma Biotherapeutics will receive $75 million in upfront payments, which includes a $30 million equity investment in Sonoma by Regeneron. Sonoma is also eligible to receive a $45 million development milestone payment. Regeneron and Sonoma will jointly research and develop Treg cell therapies for ulcerative colitis, Crohn’s disease and two other undisclosed indications, with a Regeneron option for a fifth indication. The parties will equally co-fund research and development for all potential products and share equally any future commercial expenses and profits. Regeneron will have the option to lead late-stage development and commercialization on all products globally, with Sonoma retaining rights to co-promote all such products in the United States. Sonoma will also retain full ownership of its lead cell therapy candidate, SBT-77-7101, and other programs in development.

"We are thrilled to collaborate with Regeneron with the goal of developing best-in-class Treg therapies for ulcerative colitis, Crohn’s, and other diseases," said Jeff Bluestone, Ph.D., Co-founder and Chief Executive Officer of Sonoma Biotherapeutics. "Regeneron has a track record of seeking out pioneers in their fields and forging successful partnerships. This collaboration will combine Regeneron’s proven technology and clinical expertise with Sonoma Bio’s proprietary Treg platform and Treg research enterprise to develop therapies that restore balance to the immune system and potentially cure disease."

"Regeneron’s investigational pipeline includes a diverse range of cutting-edge scientific approaches, and we are pleased to expand this toolkit further through a partnership with Sonoma to explore the potential of engineered Treg cell therapies with enhanced functionality and the ability to target specific tissues," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. "Both Regeneron and Sonoma have strong foundations in basic scientific research, and by bringing together our complementary expertise, we hope to harness the power of Tregs to make further progress in the treatment of autoimmune and inflammatory diseases."

Treg cells act as sentinels that survey the body for unwanted immune attacks and rebalance the immune system. Tregs as a therapeutic modality potentially possess multiple therapeutic effects, within a single medicine, helping overcome the multifaceted nature of autoimmune and inflammatory disease. Emerging research shows that enhanced Treg cells work directly at the site of inflammation and have the potential to create a durable response. This paradigm-shifting approach could possibly transform treatments for autoimmune and inflammatory diseases.

On March 28, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that PRP suppresses the TGF-β pathway and the tumor microenvironment in pancreatic cancer, elucidated by one of the Company’s joint researchers, Mrs. Belén Toledo Cutillas MSc, at the laboratory of Professor Macarena Perán, PhD, University of Jaén, Granada, Spain (Press release, Propanc, MAR 28, 2023, View Source;pathway-tumor-microenvironment-in-pancreatic-cancer [SID1234629447]). The experiments were conducted with a well-known small molecule inhibitor of the same pathway, comparing it against the effects of PRP, with results showing an even greater suppression by Propanc’s novel cancer therapy. TGF-β is a growth factor molecule involved in cell proliferation, migration and survival, and death that influences tumor growth in advanced forms of cancer.

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In addition, Mrs. Cutillas also analyzed the same pathway comparing (i) a pancreatic tumor cell line along with a chemoresistant pancreatic tumor cell line with (ii) the same line treated with PRP. It was observed the TGF-β pathway, which is overexpressed in the chemoresistant cell line, decreased drastically when treated with PRP. Mrs. Cutillas concluded that the results appear to confirm that PRP can suppress not only the tumor microenvironment, but also chemoresistant tumor cells, which also plays a key role in how a malignant tumor grows and spreads. Further experiments will be conducted by developing a series of immunofluorescence and western blot studies that complement these results with other biomarkers.

Dr Julian Kenyon, MD, MB, ChB, Propanc’s Chief Scientific Officer said, "These results confirm that PRP exerts significant effects on the tumor microenvironment and the TGF-β pathway, which is a key biomarker for the way tumors become malignant, grow and spread, and develop resistance to standard treatments over time. I am convinced that PRP has the potential to act as an effective chemosensitizing agent against resistant solid tumors to standard treatment regimens, which often leads to a poor prognosis for cancer sufferers. We continue to generate convincing scientific evidence supporting PRP as a novel cancer therapy for the treatment of solid tumors, but without the side effects normally associated with standard treatment approaches. Our joint research team will continue to explore these opportunities with great interest as we advance to early-stage clinical development for PRP."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers.