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Momelotinib Pivotal Phase 3 Data Receives Oral Presentation at American Society of Clinical Oncology Annual Meeting

On May 26, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver transformative therapies for rare cancers, reported two abstracts have been accepted into the program for the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held June 3-7, 2022, in Chicago and online (Press release, Sierra Oncology, MAY 26, 2022, View Source [SID1234615118]). An abstract presenting the full data from the pivotal phase 3 MOMENTUM study in myelofibrosis patients who are symptomatic and anemic has been selected for an oral presentation on June 7. An additional subset analysis from the trial evaluating safety and efficacy for patients with low platelet counts has been selected for poster presentation.

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"Receiving an oral presentation at ASCO (Free ASCO Whitepaper) for our pivotal Phase 3 study data—which demonstrated that momelotinib achieved statistically significant and clinically important efficacy across all prespecified and key secondary endpoints—is truly a momentous occasion for Sierra Oncology. Further, we are excited to present a subset analysis in a poster presentation examining the use of momelotinib in thrombocytopenic patients with platelet counts as low as 25 x 109/L," said Barbara Klencke, MD, Chief Medical Officer at Sierra Oncology. "Together, these abstracts demonstrate the true potential use of momelotinib as the treatment of choice across a range of myelofibrosis patients who are symptomatic and cytopenic, including those with anemia and thrombocytopenia."

Abstract: 7002: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor

The primary and all key secondary results, as well as safety data, from the MOMENTUM pivotal Phase 3 trial of momelotinib will be presented in an oral presentation by Ruben Mesa, MD, co-Principal Investigator of the study. Key data to be presented include:

Primary Endpoint of Total Symptom Score (TSS) of >50%: 25% in the MMB arm vs. 9% in the control arm (p=0.0095)
Secondary Endpoint of Transfusion Independence (TI): 31% in the MMB arm vs. 20% in the control arm (one-sided p=0.0064; non-inferiority)
Secondary Endpoint of Splenic Response Rate (SRR) >35%: 23% in the MMB arm vs. 3% in the control arm (p=0.0006)
SRR of >25% was 40% in the MMB arm and 6% in the control arm
A trend toward improved overall survival is demonstrated in the MMB arm based on data up to Week 24 (p=0.0719) and overall (p=0.3510)
The rate of Grade 3 or worse adverse events in the randomized treatment period was 54% in the MMB arm and 65% in the control arm. Serious treatment emergent adverse events were 35% in the MMB arm and 40% in the control arm. The most frequent non-hematologic adverse events were diarrhea, nausea, asthenia, pruritis and increased blood creatinine
Mean baseline characteristics for all patients were TSS of 27, Hemoglobin (Hgb) of 8 g/dL and platelet count of 145 x 109/L
Abstract 7061: Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]

Abstract 7061 will highlight an analysis of MOMENTUM patients with baseline platelet counts as low as 25 x 109/L on study endpoints, including Week 24 TSS reduction of >50% from baseline, transfusion independence rates, and SRR of >35% from baseline. Results to be presented include:

Of the 195 patients enrolled in the MOMENTUM study, 124, 100 and 31 patients had baseline platelet counts of less than 150, 100, and 50 x 109/L, respectively.
In patients with baseline platelets <100 x 109/L (MMB: n=66; DAN: n=34): TSS responder proportion was 29% in the MMB arm and 15% in the control arm; TI response proportion was 27% in the MMB arm and 21% in the control arm; SRR was 20% in the MMB arm and 6% in the control arm
In patients with baseline platelets <50 x 109/L (MMB: n=18; DAN: n=13): TSS responder proportion was 22% in the MMB arm and 8% in the control arm; TI response proportion was 17% in the MMB arm and 15% in the control arm; SRR was 22% in the MMB arm and 0% in the control arm
The broader thrombocytopenic subgroup with baseline platelets <150 x 109/L demonstrated similar efficacy and safety as described in the published abstract
In patients with baseline platelets below 50 x 109/L, mean platelet levels remained stable over time in both the MMB and control arms
Overall Survival directionally favored the MMB arm, consistent with the survival results in the intent-to-treat population
The proportion of patients who experience Grade 3 or higher treatment-emergent adverse events were comparable between the study arms
Mean baseline characteristics for patients with baseline platelets <100 x 109/L included TSS of 28 and 25 and Hgb of 8.1 and 7.8 g/dL for the MMB and control arms, respectively.
In thrombocytopenic, symptomatic and anemic patients with myelofibrosis, including those with platelets as low as 25 x 109/L, momelotinib was administered safely and demonstrated improvements in symptom responses, transfusion independence rates and spleen responses as compared to danazol. Consistent with the overall intent-to-treat MOMENTUM population, platelets levels remained stable over time, survival favored momelotinib versus danazol, and the safety profile was generally maintained in thrombocytopenic myelofibrosis patients receiving momelotinib.

Presentation Details

Abstract 7002
Title: MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor
Presenter: Ruben Mesa, MD, FACP, Executive Director of the Mays Cancer Center, home to UT Health San Antonio, MD Anderson Cancer Center
Session Title: Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presentation Date and Time: Tuesday, June 7, 2022, 10:33 am CT

Abstract 7061
Title: Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]
Presenter: Aaron Gerds, MD, MS, Taussig Cancer Institute, Cleveland Clinic
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session Date and Time: Saturday, June 4, 2022, 8:00 am – 11:00 am CT

About Momelotinib
Momelotinib is a potent, selective and orally bioavailable ACVR1 / ALK2, JAK1, JAK2 inhibitor under investigation for the treatment of myelofibrosis in symptomatic, anemic patients previously treated with an approved JAK inhibitor. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including approximately 1,000 patients treated for myelofibrosis, several of whom remain on treatment for over 11 years. Momelotinib is the first and only JAK inhibitor to demonstrate positive data for all key hallmarks of the disease—symptoms, splenic response and anemia.

About Myelofibrosis
Myelofibrosis is a rare blood cancer that results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia. From prior studies with momelotinib, we know approximately half of myelofibrosis patients are moderately to severely anemic when eligible for JAK inhibitor treatment. Furthermore, currently approved JAK inhibitors only address symptoms and splenomegaly and are myelosuppressive. This can lead to worsening anemia, resulting in dose reductions that potentially reduce treatment effect.

About the Pivotal MOMENTUM Clinical Trial
MOMENTUM is a global, randomized, double-blind Phase 3 clinical trial of momelotinib versus danazol in patients with myelofibrosis who were symptomatic and anemic, and had been previously treated with an FDA-approved JAK inhibitor. The study was designed to evaluate the safety and efficacy of momelotinib for the treatment and reduction of the key hallmarks of disease: symptoms, blood transfusions (due to anemia) and splenomegaly (enlarged spleen).

The primary endpoint of the study is Total Symptom Score (TSS) reduction of >50% over the 28 days immediately prior to the end of Week 24 compared to baseline TSS, using the Myelofibrosis Symptom Assessment Form (MFSAF). Secondary endpoints included Transfusion Independence (TI) rate for >12 weeks immediately prior to the end of Week 24 with Hgb levels ≥ 8 g/dL, and Splenic Response Rate (SRR) based on splenic volume reduction of >35% at Week 24. The study enrolled 195 patients based on a planned 180 patients across 21 countries.

Danazol was selected as the treatment comparator given its use to ameliorate anemia in patients with myelofibrosis, as recommended by National Comprehensive Cancer Network (NCCN) and European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) guidelines. Patients were randomized 2:1 (MMB n = 130 and DAN n = 65) to receive either momelotinib or danazol. After 24 weeks of treatment, patients on danazol were allowed to crossover to receive momelotinib. Early cross-over to momelotinib was available for confirmed symptomatic splenic progression.

Novocure Announces Clinical Collaboration with MSD on a Registrational-Intent Study to Evaluate Tumor Treating Fields Together with KEYTRUDA® (pembrolizumab) in Newly Diagnosed Glioblastoma

On May 26, 2022 Novocure (NASDAQ: NVCR) reported it has entered into a clinical trial collaboration agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA, to study the use of Tumor Treating Fields (TTFields) concomitant with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of patients with newly diagnosed glioblastoma (GBM) (Press release, NovoCure, MAY 26, 2022, View Source [SID1234615117]). This is the second clinical collaboration between Novocure and MSD.

"We are excited to collaborate again with global oncology leader, MSD, in the pursuit of extending survival in some of the most aggressive forms of cancer," said William Doyle, Novocure’s Executive Chairman. "EF-41/Keynote D58 will build on encouraging preliminary data from the 2-THE-TOP phase 2 pilot study and will further explore recently published data suggesting the potential for a therapeutic benefit when TTFields are used together with immunotherapy due to TTFields’ downstream immune system activation and anti-tumor cell response. Through the EF-41/Keynote D58 trial, we hope to identify a potential new treatment option for solid tumor cancers and we are thrilled at the prospect of improving outcomes for patients in need."

Novocure and MSD plan to conduct a double-blind, placebo-controlled study of TTFields concomitant with KEYTRUDA and maintenance temozolomide (TMZ) versus TTFields together with placebo and maintenance TMZ for the treatment of adult patients with newly diagnosed GBM. Novocure intends to engage FDA in the near term in a pre-submission discussion regarding the details of the agreed upon study.

ABOUT 2-THE-TOP

The EF-41/Keynote D58 trial will build on encouraging preliminary data from the 2-THE-TOP phase 2 pilot study. The 2-THE-TOP trial is an investigator-initiated, phase 2 pilot trial evaluating the use of TTFields therapy together with pembrolizumab and chemotherapy (temozolomide) for the treatment of 26 adult patients with newly diagnosed GBM. In March 2022, updated data from the ongoing 2-THE-TOP study was presented at the World Federation of Neuro-oncology Societies (WFNOS) 2022 Quadrennial Meeting, comparing outcomes for 26 patients in the 2-THE-TOP study versus a historical, matched-control group of 26 patients from the TTFields plus temozolomide arm of the phase 3 pivotal EF-14 clinical trial. Patients in the 2-THE-TOP trial displayed median progression-free survival (primary endpoint) of 12.1 months and median overall survival of 25.2 months, which are based on a median follow-up time of 16.8 months. Additionally, 193,760 peripheral blood mononuclear cells were sequenced in 12 patients before pembrolizumab was administered and detected robust post-TTFields T cell activation in 11 of 12 patients via the T1IFN trajectory with a strong correlation with the TCRαβ clonal expansion Simpson index (Spearman coefficient r=-0.8, P=0.014).

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 24,000 patients have been treated with TTFields therapy.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

CARVYKTI® (ciltacabtagene autoleucel) Granted Conditional Approval by the European Commission for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

On May 26, 2022 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported that the European Commission (EC) has granted conditional marketing authorization of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel in December 2017 (Press release, Legend Biotech, MAY 26, 2022, View Source [SID1234615116]).

CARVYKTI is a chimeric antigen receptor T-cell (CAR-T) therapy featuring two B-cell maturation antigen (BCMA)-targeting single domain antibodies.1 CAR-T therapy is specifically developed for each individual patient, and it is administered as a single infusion.1,2

"The approval of CARVYKTI by the European Commission marks Legend’s first approval in the region and is a significant milestone as we advance our commitment to bring innovative cell therapies to patients with the highest unmet need," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "The CARTITUDE-1 data showed that CARVYKTI provides the potential for long, treatment-free intervals for heavily pre-treated patients, and is a valuable treatment option for patients with multiple myeloma. We look forward to working with Janssen to bring this new option to patients across Europe."

This approval was supported by the pivotal CARTITUDE-1 study, including patients who had received a median of six prior treatment regimens (range, 3-18), and had previously received an IMiD, PI and anti-CD38 monoclonal antibody.3 Findings showed that at a median duration of 18 months follow-up (range, 1.5-30.5), a one-time treatment with cilta-cel resulted in deep and durable responses, with 98 percent (95 percent confidence interval [CI], 92.7-99.7) of patients with RRMM responding to therapy (98 percent overall response rate [ORR] (N=97)).3,4 Notably, 80 percent of the patients achieved stringent complete response (sCR), a measure in which a physician is unable to observe any signs or symptoms of disease via imaging or other tests after treatment.3

The safety of cilta-cel was evaluated in 179 adult patients across two open-label clinical trials (MMY2001 and MMY2003). The most common adverse reactions (≥20 percent) were neutropenia (91 percent), cytokine release syndrome (CRS) (88 percent), pyrexia (88 percent), thrombocytopenia (73 percent), anemia (72 percent), leukopenia (54 percent), lymphopenia (45 percent), musculoskeletal pain (43 percent), hypotension (41 percent), fatigue (40 percent), transaminase elevation (37 percent), upper respiratory tract infection (32 percent), diarrhea (28 percent), hypocalcemia (27 percent), hypophosphatemia (26 percent), nausea (26 percent), headache (25 percent), cough (25 percent), tachycardia (23 percent), chills (23 percent), encephalopathy (22 percent), decreased appetite (22 percent), oedema (22 percent), and hypokalemia (20 percent).4

"There continues to be an unmet need for patients with relapsed or refractory multiple myeloma who have exhausted existing treatment options. Data from the CARTITUDE-1 trial have shown that cilta-cel provides deep and durable responses for heavily pre-treated patients. Today’s approval by the European Commission reinforces the potential of this new treatment option for multiple myeloma patients in Europe," said Hermann Einsele, Full Professor of Internal Medicine and Director of the Medizinische Klinik und Poliklinik II of the Julius Maximilian University, Würzburg, Germany.*

As a highly personalized medicine, where a patient’s own T-cells are reprogrammed to target and kill cancer cells, administration of CAR-T therapy requires extensive training, preparation, and certification to ensure the highest quality product and experience for patients.2 Through a phased approach, Legend Biotech’s strategic partner, Janssen, will work diligently to activate a limited network of certified treatment centers and will aim to increase availability of cilta-cel across Europe, in an effort to provide oncologists and patients with treatment in a reliable manner.

This EC Marketing Authorization follows the approval of CARVYKTI by the U.S. Food and Drug Administration (FDA) on February 28, 2022.

*Hermann Einsele, M.D., FRCP has not been paid for contributing to this press release.

About CARVYKTI (ciltacabtagene autoleucel; cilta-cel)

CARVYKTI is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.4 BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.4 The CARVYKTI CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA.4 Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.4

In December 2017, Legend Biotech Corporation entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel.5

In April 2021, Legend announced the submission of a Marketing Authorisation Application to the European Medicines Agency seeking approval of cilta-cel for the treatment of patients with relapsed or refractory multiple myeloma. In addition to U.S. Breakthrough Therapy Designation granted in December 2019, cilta-cel also received Breakthrough Therapy Designation in China in August 2020. In February 2019, cilta-cel received Orphan Drug Designation from the U.S. FDA from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In May 2022, the Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained, on the basis of clinical data demonstrating improved and sustained complete response rates following treatment.6 Cilta-cel was approved the U.S. Food and Drug Administration (FDA) in February 2022.5

About CARTITUDE-1

CARTITUDE-1 (NCT03548207)7 is an ongoing Phase 1b/2, open-label, single arm, multi-center trial evaluating cilta-cel for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received at least three prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody. Of the 97 patients enrolled in the trial, 99 percent were refractory to the last line of treatment and 88 percent were triple-class refractory, meaning their cancer did not respond, or no longer responds, to an IMiD, a PI and an anti-CD38 monoclonal antibody.4

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.8 In Europe, it is estimated that more than 50,900 people were diagnosed with multiple myeloma in 2020, and approximately 32,500 patients died.9 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.10 Although treatment may result in remission, unfortunately, patients will most likely relapse.11 Patients who relapse after treatment with standard therapies, including protease inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody, have poor prognoses and few treatment options available.12,13

Alchemab Appoints Young T. Kwon as Chief Executive Officer

On May 26, 2022 Alchemab Therapeutics, a biotechnology company focused on the discovery and development of naturally-occurring protective antibodies and immune repertoire-based patient stratification tools, reported that Young T. Kwon, PhD, Alchemab’s Chief Financial and Operating Officer, has succeeded Douglas A. Treco, PhD as Chief Executive Officer and member of the Board, who resigned for personal reasons (Press release, Alchemab Therapeutics, MAY 26, 2022, View Source [SID1234615115]).

Houman Ashrafian, Chairman of the Board said, "Doug was instrumental to our successful Series A financing and has made significant contributions to Alchemab. He led us in advancing our novel platform and our lead programs in neurodegeneration and cancer, and has helped build out an extremely talented team and established a solid operational foundation, including new operations in the U.S. We are extremely fortunate that he has been a part of Alchemab during this period of rapid growth and scientific progress."

"We are delighted that Young will lead our Company and join our Board," Dr. Ashrafian continued. "He has established himself as an outstanding leader and we are thrilled that he will be driving the Company forward during this exciting phase of growth. In addition to building transformative biotech companies, Young’s track record working with and developing talented teams will build on and shape Alchemab’s diverse, ambitious and unique culture. As the Company continues to grow its footprint in the U.S. and the U.K., we look forward to working with Young to advance our novel programs to the clinic and build out our highly differentiated platform."

"I am excited by Alchemab’s potential," said Dr. Kwon, "Over the last six months I have seen how combining experienced drug discovery capabilities with the latest computational approaches pave a new era in therapeutics discovery. I am grateful to Doug for his support and guidance and I look forward to the challenge of building upon the outstanding foundations that he has established."

Dr. Kwon has served as Alchemab’s Chief Financial and Operating Officer since November 2021. Dr. Kwon previously served as Chief Financial and Business Officer of Momenta Pharmaceuticals until its acquisition by Johnson & Johnson in October 2020. Prior to Momenta, Dr. Kwon was a business development professional at Biogen and worked at the venture capital firm Advanced Technology Ventures, investing in early-stage biotech and medical device companies. Dr. Kwon received a B.S. in biology from Massachusetts Institute of Technology and a Ph.D. in Biological Chemistry and Molecular Pharmacology from Harvard University.

Propanc Biopharma Presents 100 Years of Clinical Evidence for “Novel” Enzyme Therapeutic Approach to Treat Cancer

On May 26, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that 100 years of clinical evidence supporting the use of proenzymes as a new therapeutic approach to treat cancer can be considered ‘compelling’ (Press release, Propanc, MAY 26, 2022, View Source [SID1234615114]). Chief Scientific Officer and Co-Founder, Dr Julian Kenyon MD, MB, ChB, has researched the effects of proenzymes against cancer for over 15 years and first came across the technology in his search to extend the life of several late-stage patients suffering from malignant solid tumors in the mid 2000’s. It was Professor John Beard from Edinburgh University who first proposed that pancreatic enzymes represent the body’s primary defense against cancer and would be useful as a cancer treatment. Since then, several scientists have endorsed Beard’s hypothesis with encouraging data from patient treatment.

In 1902, in an article published in The Lancet, Professor Beard proposed that the answer to questions about the origin of cancer could be found in the field of embryology. Professor Beard tested his theory in a mouse model of cancer. After injections of commercially available pancreatic enzyme trypsin, the tumor in a treated mouse was much smaller than that in an untreated control. Over several years, a number of physicians in the UK and US injected enzyme preparations with some remarkable success stories. As a result, the physicians began writing letters to the editor summarizing their clinical cases, such as Medical Record in the early 1900’s.

For example, Dr Campbell wrote about a 56-year-old male with a malignant left tonsil the size of a hen’s egg, experiencing left facial paralysis and constant pain. After periodic injections for a month, the infiltrations in the tongue and tonsil were greatly decreased, pain free and felt well. A second example, Dr Oldfield, reported a 65-year-old male with an abdominal tumor with secondary metastases in the stomach, full of solid tumor and in great pain. After daily injections for 3 months, the patient was reported to eat and sleep well, returned to a normal weight. Dr Outfield concluded that "No-one…can doubt the immense improvement that has taken place." However, mixed results in the early stages of treatment were observed and attributed by Beard to the wide variation in the quality of enzymes of available enzymes at the time.

Over the years, there have been further clinical cases investigated into the use of enzymes as a way to treat cancer. Of particular note was the work undertaken by molecular biologist from Bucknell University, Dr Josef Novak and a retired Czech oncologist, Dr Frantisek Trnka. Drs Novak and Trnka undertook extensive laboratory work in the late ‘90s and 2000s, publishing their work in the journal Anticancer Research in the mid 2000s, where they first proposed that the enzyme extracts as recommended by Beard, must be used in the "proenzyme" form to ensure their selective activation at the tumor site. They also undertook clinical research, administering a proenzyme treatment via a suppository formulation to 20 late-stage cancer patients, with a range of malignancies, of which 10 survived, ranging from 8 months to 10 years, with minimal, or non-existent side effects normally seen with current standard therapies. The conclusion of Drs Novak and Trnka from this work was the discovery "that proenzyme therapy mandated first by John Beard nearly one hundred years ago, shows remarkable selective effects that result in growth inhibition of tumor cells with metastatic potential."

As a result of the clinical evidence observed throughout the years, Dr Kenyon decided to undertake his own investigation motivated by the condition of a number of late-stage cancer patients he treated in his clinical practice at The Dove Clinic, in Hampshire, UK. Consequently, the clinical efficacy of a suppository formulation containing pancreatic proenzymes was evaluated in the context of a UK Pharmaceuticals Special Scheme and results published in a peer reviewed journal, Scientific Reports. Clinical effects were studied in 46 patients with advanced metastatic cancers of different origin (prostate, breast, ovarian, pancreatic, colorectal, stomach, non-small cell lung, bowel cancer and melanoma) after treatment with a rectal formulation consisting of pancreatic proenzymes trypsinogen and chymotrypsinogen.

Dr Kenyon concluded that no severe or serious adverse events related to the rectal administration were observed. Patients did not experience any hematological side effects as typically seen with classical chemotherapy regimens. No allergic reactions after rectal administration of suppositories were also observed. In order to assess the therapeutic activity of rectal administration, overall survival of patients under treatment was compared to the life expectancy assigned to a patient prior to treatment start. Nineteen (19) from 46 patients (41.3%) with advanced malignant diseases, most of them suffering from metastases, had a survival time significantly longer than their expected, in fact, for the whole set of cancer types, mean survival (9.0 months) was significantly higher than mean life expectancy (5.6 months). Although the number of patients per cancer indication was naturally quite low, 3 out of 8 patients with prostate cancer and 5 out of 11 patients with gastrointestinal cancers appeared to particularly benefit from the treatment with the proenzyme suppositories.

"As a result of my research over the last 15 years, as well as the clinical evidence over the last 100 years, proenzyme therapy can have a meaningful and long-lasting clinical benefit on patients suffering from solid tumors, but without the side effects associated with standard therapies, which is simply compelling," said Dr Kenyon. "Since the pioneering work undertaken by Professor John Beard and his medical colleagues, in the early 1900’s, their approach was ahead of their time, but since then, our understanding of tumor cell biology means we have elucidated how the activated enzymes works against solid tumors and in particular, cancer stem cells, optimized the formulation and its clinical effects, and developed a product candidate to pharmaceutical standard which can be administered by I.V. injection to maximize the exposure at the tumor site. My scientific and clinical research team at Propanc Biopharma are preparing to take our lead product candidate, PRP, into a world first, Phase I, First-In-Human study in advanced cancer patients suffering from solid tumors. The 100-year history of enzyme therapy gives me confidence we are on the right pathway with an exciting approach for the treatment and prevention of metastatic cancer from solid tumors, which is the main cause of patient death for sufferers."

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.