On Decenber 8, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported that interim results from a Phase II clinical trial of Puma’s investigational drug PB272 (neratinib) were presented at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) that is currently taking place in San Antonio, Texas (Press release, Puma Biotechnology, DEC 8, 2016, View Source [SID1234517004]). The presentation entitled, "Incidence and severity of diarrhea with neratinib plus intensive loperamide prophylaxis in patients with HER2-positive early-stage breast cancer (EBC): Interim analysis from the multicenter, open-label, phase II CONTROL trial" was presented as a poster presentation.

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The main adverse event that has been seen to date in clinical trials of neratinib is diarrhea and more specifically grade 3 diarrhea. In the Phase III ExteNET trial of neratinib as extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with adjuvant Herceptin, 95.4% of the patients experienced all grade diarrhea and 39.8% of the patients experienced grade 3 or higher diarrhea (there was one event of grade 4 diarrhea). The CONTROL trial is an international, open-label, phase II study investigating the use of loperamide prophylaxis with or without other agents in the prevention and reduction of neratinib-associated diarrhea and more specifically grade 3 diarrhea.

In the trial, patients with HER2-positive early-stage breast cancer who had completed trastuzumab-based adjuvant therapy received neratinib daily for a period of one year. High dose loperamide prophylaxis was given for the first 2 cycles (56 days) of treatment. Initially, the loperamide dosing used was 16 mg on day 1, then 12 mg on days 2 and 3 and then 6-8 mg on days 4-56 (original dosing). The protocol was later amended to simplify the regimen such that patients took 12 mg on days 1-14 and 8 mg on days 15-56 (modified dosing). The CONTROL trial has recently been expanded to include prophylaxis with the combination of loperamide and budesonide, a locally acting corticosteroid that the Company believes targets the inflammation identified in a preclinical model of neratinib-induced diarrhea.

The interim analysis of the trial presented in the poster included a total of 135 patients who received neratinib plus loperamide prophylaxis (28 patients taking the original dosing and 107 patients taking the modified dosing) and 40 patients who received neratinib plus loperamide prophylaxis for 2 cycles and budesonide for 1 cycle.

The results of the trial showed that the incidence of grade 3 diarrhea for the total 135 patients who received the loperamide prophylaxis was 28.1%. For the 28 patients who received loperamide using the original dosing regimen the grade 3 diarrhea rate was 25.0% and for the 107 patients who received the modified loperamide dosing regimen the grade 3 diarrhea rate was 29.0%. For the patients in the original dosing group, 71% of the patients who experienced grade 3 diarrhea were known to be non-compliant with the loperamide regimen and for the patients in the modified loperamide dosing regimen, 35% of the patients were known to be non-compliant with their loperamide dosing regimen. For the 135 patients who received the loperamide prophylaxis, the median number of grade 3 diarrhea episodes per patient was 1 and the median cumulative duration of grade 3 diarrhea was 3 days. For the 135 patients who received loperamide prophylaxis, 18.5% discontinued neratinib due to diarrhea.

For the 40 patients who received the combination of loperamide plus budesonide, the results of the trial showed that the incidence of grade 3 diarrhea was 15.0%. None of the patients who experienced grade 3 diarrhea were non-compliant with the loperamide plus budesonide regimen. The median number of grade 3 diarrhea episodes per patient was 1 and the median cumulative duration of grade 3 diarrhea was 2.5 days. For the 40 patients who received loperamide plus budesonide prophylaxis, 5.0% discontinued neratinib due to diarrhea. Further information is provided in Table 1 below:

Table 1: Characteristics of Treatment-Emergent Diarrhea

Study
CONTROL

ExteNET
Loperamide cohort

Budesonide
cohort
Neratinib
arm
Prophylaxis Original Modified Loperamide Loperamide + Loperamide
schedule schedule total budesonide prn
(n=28) (n=107) (N=135) (N=40) (N=1408)
Diarrhea, %
Any grade 82.1 73.8 75.6 65.0 95.4
Grade 1 35.7 21.5 24.4 32.5 22.9
Grade 2 21.4 23.4 23.0 17.5 32.5
Grade 3a 25.0 29.0 28.1 15.0 39.8
Grade 4 0 0 0 0 0.1

Median cumulative duration, days
Grade ≥2 5.0 4.0 4.0 3.0 10.0
Grade ≥3b 2.0 3.0 3.0 2.5 5.0

Median diarrhea episodes/patient
Any grade 2 2 2 2 8
Grade ≥2 2 1 2 1 3
Grade ≥3b 1 1 1 1 2

Action taken, %
Dose hold 7.1 12.1 11.1 7.5 33.9
Dose reduction 10.7 7.5 8.1 5.0 26.4
Discontinuation 28.6 15.9 18.5 5.0 16.8
Hospitalization 0 1.9 1.5 0 1.4

Duration of neratinib treatment, months
Median 9.7 7.4 7.5 1.8 11.6
Range 0.1‒13.1 0.1‒12.8 0.1‒13.1 0.1‒6.3 0.03‒13.3

a
Non-compliance with loperamide prophylaxis in patients with grade 3 diarrhea was 71% with the original loperamide schedule, 35% with the modified loperamide schedule, and 0% with loperamide prophylaxis plus budesonide.

b
No grade 4 events in the CONTROL study; one grade 4 event in the ExteNET study.

In the ExteNET trial, higher grade (grade 2 and grade 3) diarrhea occurred early and persisted throughout the duration of the 12-month treatment period. In the CONTROL trial, in both the loperamide prophylaxis and loperamide plus budesonide prophylaxis arms, the results showed that higher grade diarrhea (grade 2 and 3) occurred early but did not typically recur. This is shown in more detail in Figure 1: Treatment Emergent Diarrhea, which is attached to this news release.

The grade 3 diarrhea rates seen in the loperamide cohort have increased over what was previously reported in December 2015 (n=50, grade 3 diarrhea rate 16%). During the course of the CONTROL trial there has been an increase in the proportion of patients previously treated with pertuzumab (mainly in the neoadjuvant setting). More specifically in the data reported in December 2015, 18% (9 of 50 patients) had previously received pertuzumab. In the current data set 40% (54 of 135 patients) of the patients in the combined loperamide prophylaxis arms received prior pertuzumab and 55% (22 of 40 patients) received prior pertuzumab in the budesonide arm.

For the 54 patients in the loperamide prophylaxis cohort who received prior pertuzumab, the grade 3 diarrhea rate was 35.2% (Table 2). For the 81 patients who did not receive prior pertuzumab, the grade 3 diarrhea rate was 23.5%. For the 22 patients in the budesonide cohort who received prior pertuzumab, the grade 3 diarrhea rate was 13.6%. For the 18 patients in the budesonide cohort who did not receive prior pertuzumab, the grade 3 diarrhea rate was 16.7%. This analysis suggests that prior pertuzumab exposure may have led to a higher rate of grade 3 diarrhea in CONTROL that was not effectively managed by loperamide prophylaxis alone but was more effectively managed by loperamide plus budesonide.

Table 2: Incidence of Grade 3 Diarrhea in CONTROL by Prior Pertuzumab Treatment

Loperamide Cohort

Budesonide Cohort

Yes No Yes No
(n = 54)
(n = 81)
(n = 22)
(n = 18)

Grade 3 Diarrhea 35.2% 23.5% 13.6% 16.7%

Dr. Carlos H. Barcenas, Assistant Professor, Department of Breast Oncology and Associate Medical Director, Breast Cancer Survivorship for the University of Texas MD Anderson Cancer Center, said, "We are pleased to see the reduction in incidence, severity and duration of neratinib-associated diarrhea when using the loperamide prophylaxis and the loperamide plus budesonide prophylaxis. When using either the loperamide prophylaxis or the loperamide plus budesonide prophylaxis there appears to be a reduction in the incidence and severity of grade 3 diarrhea with neratinib. Importantly, the severe grade 2 and grade 3 diarrhea, when using the prophylaxis, appears to be acute, self-limiting and manageable. We look forward to completing the loperamide plus budesonide cohort and to the testing of additional investigational agents as well."

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are pleased to see the reductions in the incidence of severe neratinib-related diarrhea in the CONTROL trial when using the loperamide and/or loperamide plus budesonide combination. We are further pleased to see the severe diarrhea become more acute, whereby it does not typically recur after the first month."

On December 8, 2016 Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), and POETIC, The Pediatric Oncology Experimental Therapeutics Investigators Consortium, a group of 10 top-tier academic medical centers developing new pediatric cancer therapies, reported a joint research agreement focused on pediatric applications of PV-10, an investigational ablative immunotherapy, as a potential treatment for childhood cancers (Press release, Provectus Pharmaceuticals, DEC 8, 2016, View Source [SID1234517003]).

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Peter Culpepper, Interim CEO of Provectus, and Tanya Trippett, M.D., Co-Founder and Executive Director of POETIC, announced the signing of the agreement to establish a framework for collaborative pre-clinical research projects the Company may conduct with members of POETIC within the field of pediatric oncology.

The program will involve collaboration with a number of NCI Cancer Centers that are part of the POETIC group including Memorial Sloan Kettering Cancer Center (MSK), Alberta Children’s Hospital, and other top-tier cancer centers of excellence.

"We are pleased to collaborate with Provectus on this shared vision to advance promising new approaches for cancer that ultimately could lead to new treatments for pediatric patients, leveraging PV-10’s novel characteristics and mechanism of action," said Dr. Trippett.

PV-10 is an injectable formulation of Rose Bengal that is under investigation as an ablative immunotherapy for solid tumor cancers. Provectus has received orphan drug designations of PV-10 from the FDA for melanoma and hepatocellular carcinoma indications. The company is conducting a Phase 3 clinical trial of PV-10 for locally advanced cutaneous melanoma.

"Like many companies in our industry, our development efforts have historically focused on adult cancers," observed Dr. Eric Wachter, Ph.D., Chief Technology Officer of Provectus. "While we remain firmly committed to that core program, this collaboration allows us to team up with top researchers in pediatric oncology to comprehensively assess whether PV-10 has additional potential for pediatric cancers. If this proves successful, we look forward to working with POETIC to move promising indications from the lab to the clinic as quickly as possible, building upon our experience with adult cancers to make this happen."

For more information on this partnership, visit View Source

About POETIC

The Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC) was founded in February 2003 by Dr. Lia Gore at the University of Colorado Cancer Center and Dr. Tanya Trippett at Memorial Sloan Kettering Cancer Center. POETIC is composed of ten large academic medical centers in North America with a major emphasis on comprehensive cancer care and research that provide the collaborative and research strength needed to complete intensive phase I and II studies. Each of the institutions is uniquely suited to complete early studies in the pediatric and adolescent populations. POETIC’s assets include membership in NCI-designated Comprehensive Cancer Centers, on-site NIH- funded pediatric and/or general clinical translational research centers (CTRCs/CTSAs), and active collaborations with developmental therapeutics programs for adults at a majority of its member institutions. The availability of strong basic science and translational research programs at the institutions allows focus on the development and evaluation of new therapeutic strategies for patients with cancer and related disorders. POETIC’s pediatric oncology studies focus on the biologic basis for anti-cancer therapy, and in particular, attempt to explore and evaluate new agents and novel combinations of therapies early in clinical development.

On December 8, 2016 GTx, Inc. (Nasdaq: GTXI) reported positive initial data from its ongoing open-label enobosarm Phase 2 clinical trial in women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer (Press release, GTx, DEC 8, 2016, View Source;p=RssLanding&cat=news&id=2228459 [SID1234517002]). The pre-specified threshold for success of the trial was met early in the 9 mg cohort with 9 patients achieving a clinical benefit response at 24 weeks among the first 22 evaluable patients in that cohort, as reported by the Company on November 28, 2016. Clinical Benefit Response (CBR) is defined as a complete response (CR), partial response (PR) or stable disease (SD), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of treatment.

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For the 9 patients achieving CBR in the 9 mg cohort, the results are as follows:

2 patients demonstrated a PR with a mean reduction in tumor size of 44.4% from baseline;
7 patients exhibited SD; and of these patients:
3 patients had measurable disease with an average reduction in tumor size from baseline of approximately 13%. One of these 3 patients, whose tumor size was reduced by 25% from baseline at 24 weeks, had demonstrated a PR (≥ 30% reduction) at 12 weeks.
4 patients with SD had bone-only disease, which made them unevaluable for PR.
The mean duration of response at the time of the Company’s November 28, 2016 announcement for the 9 responders was 31 weeks, with 7 of the 9 patients still on study drug.
Based on a current CBR of 41%, the Company estimates the 95% confidence interval for the CBR rate in the 9 mg cohort to be 22% to 62% at study completion.
In addition to the CBR, the trial is evaluating the Best Overall Response (BOR) rate of the patients, defined as a CBR at any time point during treatment with enobosarm. Of the 22 evaluable patients:

7 patients who did not show CBR at 24 weeks had stable disease earlier at 12 weeks, corresponding to an approximately 73% (16/22) BOR;
3 patients discontinued early due to reasons other than progression, and therefore did not have post treatment scans; and
When the analysis is performed with those patients who had post treatment follow-up scans, the CBR is 47% (9/19), with a BOR of 84% (16/19).
The baseline demographics for the 22 evaluable patients are consistent with advanced breast cancer patients who typically undergo multiple treatments. The majority of the 22 patients in the 9 mg dose cohort were heavily pretreated prior to study entry. On average, these patients had 4 prior hormonal therapies for the treatment of their breast cancer and 91% also received prior chemotherapy. Eight of the 22 evaluable patients (36%) had bone-only disease, while the remaining patients had measurable disease per RECIST.

Enobosarm 9 mg appears to be safe and generally well tolerated. The majority of adverse events are grade 1 and 2. The most common adverse events (occurring in ≥10% of patients) reported include nausea (31%), fatigue (18%), and arthralgias (13%). Elevations in transaminases (ALT and AST) during enobosarm treatment were mild with the majority being grade 1 or 2. The independent Safety Monitoring Committee met on December 1, 2016, and recommended that the clinical trial continue as planned.

The trial will continue as planned with a daily dose of either enobosarm 9 mg or 18 mg until 44 evaluable patients in each cohort have been enrolled to better characterize the CBR, evaluate secondary endpoints and describe the safety profile of the dose levels. The Company plans to report top-line clinical results following completion of the clinical trial, which is anticipated to occur in mid-2017.

"From my perspective as a clinician, the results with enobosarm in treating advanced breast cancer are encouraging. The goal for treating advanced breast cancer patients who have exhausted other hormonal therapies for metastatic disease and whose only treatment alternative is chemotherapy, is to achieve stabilization of their disease," said Dr. Beth Overmoyer, from the Dana Farber Cancer Institute and the Harvard Medical School, who is the lead investigator for the clinical trial. "Stabilization of disease and delaying subsequent chemotherapy treatment while maintaining quality of life benefits a large population of patients with hormone-receptor positive metastatic breast cancer."

"We are pleased that the study has demonstrated an acceptable clinical benefit rate sooner than initially anticipated in the 9 mg cohort, which we believe warrants further development of the drug candidate for the treatment of advanced metastatic breast cancer," said Robert J. Wills, Ph.D., Executive Chairman of GTx.

About the Phase 2 Clinical Trial in ER+/AR+ Breast Cancer

The open-label, multi-center, multinational Phase 2 clinical trial (NCT02463032) will assess the efficacy and safety of orally administered enobosarm in up to 88 evaluable patients with metastatic or locally advanced, ER+/AR+ breast cancer. Patients will receive orally-administered enobosarm (9 mg or 18 mg) daily for up to 24 months. The two dose cohorts in the trial will be treated independently for the purpose of assessing efficacy. The first stage of evaluation will be assessed among the first 18 evaluable patients for each cohort. If at least 3 of 18 patients achieve CBR at week 24, then the trial will proceed to the second stage of enrollment for that cohort to assess CBR in a total of 44 evaluable patients per arm. As reported in September and November, 2016, respectively, patients in both the 9 mg and 18 mg cohorts demonstrated sufficient CBR among the first 18 evaluable patients in each such cohort to advance to the second and final stage of the clinical trial.

About Enobosarm

Enobosarm, a selective androgen receptor modulator (SARM) has been evaluated in 24 completed or ongoing clinical trials enrolling over 1,500 subjects, of which approximately 1,000 subjects were treated with enobosarm at doses ranging from 0.1 mg to 100 mg. At all evaluated dose levels, enobosarm was observed to be generally safe and well tolerated. Previously, enobosarm 9 mg has been tested in a Phase 2, proof of concept clinical trial of 22 postmenopausal women with ER+ metastatic breast cancer who have previously responded to endocrine therapy. 17 of the 22 patients were confirmed to be AR+, and 6 of those 17 patients demonstrated CBR at six months. In total, 7 patients (one patient with indeterminate AR status) achieved CBR at six months. The results also demonstrated that, after a median duration on study of 81 days, 41 percent of all patients (9/22) achieved CBR as best response . Enobosarm was well tolerated. The most common adverse events reported were pain, fatigue, nausea, hot flash/night sweats, and arthralgia.

About ER+/AR+ Breast Cancer

Breast cancer is the most commonly diagnosed cancer in women, and one in eight women will develop invasive breast cancer in their lifetime. In 2012, 1.7 million women world-wide were diagnosed with breast cancer, and there were 6.3 million women alive who had been diagnosed with breast cancer in the previous five years. Clinical assessment of breast cancer provides for routine characterization of receptor status, including the presence or absence of estrogen receptor (ER), progesterone receptor, and human epidermal growth factor receptor 2 (HER2) in the tumor tissue. Receptor status is used to assess metastatic potential as well as to guide treatment decisions. The majority of breast cancers are considered hormone receptor positive (expressing ER or progesterone receptor). Approximately 70 percent of women in the U.S. with breast cancer have ER+ tumors, and 75 to 90 percent of these cancers are also AR+.

Estrogen promotes the growth of breast cancers that are hormone receptor positive. Therefore, treatment is directed at blocking the effects of estrogen on the breast cancer either through blocking the estrogen receptor or minimizing the production of estrogen. This endocrine therapy is the cornerstone of treatment for the majority of women with hormone receptor positive advanced breast cancer and is the preferred initial treatment over alternative approaches such as chemotherapy, due to its efficacy and favorable safety profile. Patients who respond to one endocrine therapy are likely to respond to subsequent hormonal therapies. Therefore, the standard of care for women with hormone receptor positive breast cancer typically involves the sequencing of endocrine agents until intolerance or development of resistance occurs, or metastatic progression necessitates a transition to chemotherapy. Enobosarm may offer an alternate hormonal approach for the treatment of endocrine sensitive advanced breast cancer prior to the introduction of chemotherapy.

On December 7, 2016 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported the following key highlights from its R&D Day that took place this morning in NYC:

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·
Disclosure of a therapeutic antibody program targeting TIGIT to complement the Company’s CGEN-15029 program, following new data recently generated for the CGEN-15029/PVRIG program. TIGIT and PVRIG represent two distinct arms of the same biological pathway. Based on this and experimental data, the Company believes there is significant added value to developing both arms as a potential combination therapy. Compugen expects to select the lead antibody for CGEN-15137/TIGIT by end of Q1 2017.

·
COM701, clinical candidate antibody targeting CGEN-15029/PVRIG, is currently undergoing process development as part of the manufacturing activities to generate clinical material. IND-filing for COM701 is anticipated in Q4 2017.

·
Update on status of cancer immunotherapy partnership with Bayer entered in August 2013. As previously disclosed, after achieving all preclinical stage milestones for CGEN-15001T immune checkpoint, this program was transferred to Bayer for further development. To date, preclinical activities are on track, and pivotal toxicity studies and GMP clinical trial material production are ongoing. As previously disclosed, the second program under the partnership, CGEN-15022, is at an earlier stage and further characterization studies of its role in anti-cancer immune responses are ongoing.

·
Disclosure of a new therapeutic program focusing on a protein target expressed in various cancers, and which is highly correlated with an M2 macrophages marker. The target was also shown to inhibit T cell activation in cell-based studies. Macrophages are immune cells that are highly immune suppressive in the tumor microenvironment, and targeting such cells offers the potential for efficacy in patients non-responsive to checkpoint inhibitors. Therapeutic antibody discovery activities have been initiated for this program.

·
Overview of the Company’s immuno-oncology target validation pipeline activities, which primarily focus on myeloid targets. With an aim to complement and expand the patient population responsive to checkpoints inhibitors, blocking myeloid targets may serve as the next wave of cancer immunotherapies. Myeloid CGEN-target candidates have been identified within the tumor microenvironment of multiple cancers and are aggressively pursued by the Company and in collaboration with Prof. Drew Pardoll.

§
The event also featured a presentation by Prof. Drew Pardoll, Chairman of Compugen’s Scientific Advisory Board and Abeloff Professor of Oncology, Medicine, Pathology and Molecular Biology and Genetics at Johns Hopkins University of Medicine, and Director of the Bloomberg~Kimmel Institute for Cancer Immunotherapy at the Sidney Kimmel Cancer Center, Johns Hopkins. The presentation included an overview of the immune checkpoint inhibition landscape, including both T cells and myeloid cells. Prof. Pardoll further presented in vitro and in vivo data demonstrating the importance of PVRIG/CGEN-15029 as a significant T cell immune checkpoint as well as evidences that PVRIG-blockage synergizes with PD1/PDL1 in unleashing T cell activity.

On December 8, 2016 The Cancer Research Technology (CRT) Pioneer Fund reported an investment to develop a promising new class of drugs for blood cancer (Press release, Cancer Research Technology, AUG 8, 2016, View Source [SID1234523175]).

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The funding will support Cancer Research UK-funded scientists at The Institute of Cancer Research, London, who are designing the drugs, to treat patients with Diffuse Large B-Cell Lymphoma – a sub-type of Non-Hodgkin Lymphoma.

The CRT Pioneer Fund was launched in 2012 by CRT, the commercialisation arm of Cancer Research UK, and the European Investment Fund (EIF) in 2012 to bridge the funding gap between cancer drug discovery and early drug development. It is managed by Sixth Element Capital LLP and has received additional investment from investment company BACIT Limited.

The drugs will target a protein called B-Cell Lymphoma 6 (BCL6). It plays an important role in maintaining levels of antibody-secreting B-cells in the blood, and is an essential part of the body’s immune defences. Research shows that BCL6 is overactive in patients with Diffuse Large B-Cell Lymphoma and that this helps drive cancer growth. This suggests that drugs designed to inhibit BCL6 could help to treat the disease.

Ian Miscampbell, managing partner of Sixth Element Capital LLP, said: "We’re delighted to announce the CRT Pioneer Fund’s investment in the BCL6 project and to be collaborating with the Institute of Cancer Research and their world class team once again. This investment will pave the way for potential new cancer drugs to be developed and taken into phase I clinical trials."

Non-Hodgkin Lymphoma affects around 13,400 people in the UK each year and around 4,800 people die from it. Diffuse Large B-Cell Lymphoma is the most common type of Non-Hodgkin Lymphoma, accounting for about 40 per cent of cases.

Professor Paul Workman, chief executive of The Institute of Cancer Research, London, said: "Diffuse Large B-Cell Lymphoma is a fast-growing and all-too-often deadly cancer. Current therapies for the disease have serious side effects and many patients relapse. We need innovative new ways of treating the disease to give patients their best chance of overcoming it.

"The support from the CRT Pioneer Fund will help us to make progress with this challenging project, with the aim of designing a whole new class of potential cancer drugs that target BCL6 – a protein that is crucial for the cancer’s rapid progression."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted that the CRT Pioneer Fund is providing key investment exactly where it’s needed, to help accelerate this potential new treatment through to early clinical trials, so it can start to benefit patients as quickly as possible. This announcement marks the ninth investment made by the CPF, providing potential new options for patients that might otherwise never have made it beyond the lab."