On February 11, 2020 Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, reported upcoming presentations of additional analyses from the FALCON clinical trial (NCT02578940) of Axumin (fluciclovine F18) injection), which evaluated its impact on the management of patients with recurrent prostate cancer (Press release, Blue Earth Diagnostics, FEB 11, 2020, View Source [SID1234554177]). The presentations are part of the scientific programs for the ASCO (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium (ASCO GU), February 13 – 15, 2020, in San Francisco, Calif., and the Radiation Oncology Summit: ACRO 2020, February 26 – 29, 2020, in Fort Lauderdale, Fla. Details of the presentations to be given by Blue Earth Diagnostics and its collaborators are listed below.

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Blue Earth Diagnostics also provided an update that full results from the FALCON study will be published in an upcoming issue of the International Journal of Radiation Oncology, Biology, Physics.

ASCO 2020 Genitourinary Cancers Symposium (ASCO GU), February 13 – 15, 2020

Date:

Thursday, February 13, 2020 11:30 a.m. − 1:00 p.m. and 5:30 − 6:30 p.m. PT

Presentation:

Impact of 18F-fluciclovine PET on salvage radiotherapy plans for men with post-radical prostatectomy recurrence of prostate cancer

Abstract Number:

19

Presenter:

Professor Heather Payne, FRCP, FRCR, University College Hospital, London

Session Title & Times:

Prostate Cancer and Trials in Progress

Poster Session A:

Prostate Cancer, Board A7

11:30 a.m. – 1 p.m., 5:15 – 6:15 p.m. PT

Location:

Moscone West Building, San Francisco, Calif.

Blue Earth Diagnostics invites participants at the ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium 2020 to attend the presentation above and to visit the company at Exhibit Booth 46.

Radiation Oncology Summit: ACRO 2020, February 26 – 29, 2020, Fort Lauderdale, Fla.

Date:

Saturday, February 29, 2020

Presentation:

The impact of prior prostatectomy on the detection of prostate cancer recurrence with 18F-fluciclovine: Imaging results from the FALCON trial

Abstract Number:

20

Presenter:

Eugene Teoh, MD, Blue Earth Diagnostics (Oxford University Hospitals NHS Trust at time of study)

Session Title & Times:

Poster Presentations

8:00 a.m. – 1:30 p.m. ET

Location:

Westin Fort Lauderdale Beach Foyer, Las Olas ballrooms, Fort Lauderdale, Fla.

Blue Earth Diagnostics invites participants at ACRO 2020 to attend the presentation above and to visit the company at Exhibit Booth 27. The company is also hosting a satellite symposium event, "Detecting and Localizing Recurrent Prostate Cancer with Axumin (fluciclovine F 18)," with invited speaker Dr. Steven Finkelstein, MD, DABR, FACRO, Florida Cancer Affiliates, US Oncology Network, which will be held on Thursday, February 27, 2020, from 12:00 – 1:00 p.m. ET, in the Rio Vista room.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On February 11, 2020 Pinpoint Therapeutics, Inc. ("Pinpoint"), a privately held biopharmaceutical company focused on the development of novel autophagy inhibitors to treat cancer, reported that it has raised $1 million in debt financing led by Kairos Ventures of Beverly Hills, California (Press release, Pinpoint Therapeutics, FEB 11, 2020, View Source [SID1234554193]).

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Pinpoint was founded by researchers Ravi K. Amaravadi, M.D., and Jeffrey D. Winkler, Ph.D., from the University of Pennsylvania’s Abramson Cancer Center and the Department of Chemistry, to develop new autophagy inhibitors for cancer treatments. Autophagy is a well-established mechanism of cancer cell survival and drug resistance. Pinpoint’s novel compounds target a recently discovered enzyme in the autophagy pathway called PPT1, which is highly expressed across most cancers. These inhibitors could be applied to a broad range of cancers alone or in combination with other treatments to overcome therapy resistance. Pinpoint will develop first-in-class autophagy inhibitors into clinical drugs for testing in a range of treatment-refractory cancers.

"This initial round of financing will allow us to develop a new approach to drugging autophagy, which until now seemed difficult to target in cancer. The activity of PPT1 inhibitors in cancer models has not been seen before in the autophagy space," said Christian Peters, M.D., Ph.D., Chief Executive Officer of Pinpoint.

"Pinpoint has developed best-in-class compounds with unprecedented therapeutic potential and we are thrilled to support their efforts as they develop these novel drug-candidates for treatment of colon cancer, pancreatic cancer, melanoma, and other major unmet needs in oncology," said Jim Demetriades, founder and Managing Partner of Kairos Ventures.

On February 11, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the SVB Leerink 9th Annual Global Healthcare Conference on Tuesday, February 25 (Press release, AbbVie, FEB 11, 2020, View Source [SID1234554143]). Michael Severino, M.D., vice chairman and president and Robert A. Michael, executive vice president and chief financial officer, will present at 9:30 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On February 11, 2020 Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Japan, reported that the U.S. FDA has accepted for Priority Review its NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk MDS including CMML (Press release, Astex Pharmaceuticals, FEB 11, 2020, View Source [SID1234554160]). The NDA submission is based on data from the ASCERTAIN phase 3 study which evaluated the 5-day decitabine exposure equivalence of oral C-DEC and IV decitabine.

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"We are very pleased that the FDA has accepted our NDA for Priority Review," said Dr Mohammad Azab, MD, president & chief medical officer of Astex Pharmaceuticals, Inc. "Subject to FDA review and regulatory approval, oral C-DEC may offer a new option for patients with MDS and CMML that saves them the burden of 5-day IV infusions every month during their treatment period. We are grateful to all the patients, investigators and other healthcare providers, and partner research and manufacturing organizations, who contributed to the clinical development program of oral C-DEC."

The FDA grants Priority Review to applications for drugs that, if approved, would provide significant improvements in the safety and effectiveness of the treatment, diagnosis or prevention of serious conditions. The Priority Review designation means FDA’s goal is to take action on an NDA application within six months (compared to the ten months under standard review).

Oral C-DEC is an investigational compound and is not currently approved in any country.

Astex’s parent company, Otsuka Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd. previously announced that, subject to regulatory approvals, commercialization of oral C-DEC in the U.S. and Canada will be conducted by Taiho Oncology, Inc. and Taiho Pharma Canada, Inc. respectively. Astex, Otsuka and Taiho are all members of the Otsuka group of companies.

About C-DEC (Cedazuridine 100 mg and Decitabine 35 mg) Fixed-Dose Combination

C-DEC is a novel, orally administered fixed dose combination of cedazuridine, an inhibitor of cytidine deaminase,1 with the anti-cancer DNA hypomethylating agent, decitabine.2 By inhibiting cytidine deaminase in the gut and the liver, C-DEC is designed to allow for oral delivery of the approved DNA hypomethylating agent, decitabine, at exposures which emulate exposures achieved with the approved intravenous form of decitabine administered over 5 days.3

C-DEC has been evaluated in a phase 1/2 pharmacokinetics-guided dose escalation and dose confirmation study in patients with MDS and CMML (see View Source NCT02103478) and a pivotal phase 3 study (ASCERTAIN) (see View Source NCT03306264) conducted at investigator sites in the US and Canada and designed to confirm the results from the phase 1/2 study. The phase 3 study is now being extended to include patients with acute myeloid leukemia (AML) unsuitable to receive intensive induction chemotherapy.

In September 2019 Astex announced that C-DEC had received orphan drug designation for the treatment of MDS and CMML from the U.S. FDA.

The concept of using cedazuridine to block the action of cytidine deaminase is also being evaluated in a low dose formulation of cedazuridine and decitabine for the treatment of lower risk MDS (see View Source NCT03502668).

About the Phase 3 ASCERTAIN Study

The study was designed as a randomized crossover study comparing oral C-DEC (cedazuridine 100 mg and decitabine 35 mg fixed-dose combination tablet given once daily for 5 days on a 28-day cycle) to IV decitabine (20 mg/m2 administered as a daily, 1-hour IV infusion for 5 days on a 28-day cycle) in the first 2 cycles with patients continuing to receive oral C-DEC from Cycle 3 onwards. The data from the ASCERTAIN study was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in Orlando, Florida in December 2019 by Dr Guillermo Garcia-Manero, MD, professor and chief of section of myelodysplastic syndromes, Department of Leukemia at The University of Texas MD Anderson Cancer Center, on behalf of the study investigators.4 The data demonstrated that the ASCERTAIN study met the primary endpoint of total 5-Day decitabine Area-Under-The-Curve (AUC) equivalence of oral C-DEC and IV decitabine. Safety findings from the study were consistent with those anticipated with IV decitabine, with no significant differences in the incidence of most common adverse events between oral C-DEC and IV decitabine in the first 2 randomized cycles. The most common adverse events of any grade >20% regardless of causality in patients in the first 2 randomized cycles who received oral C-DEC were thrombocytopenia (43.8%), neutropenia (35.4%), anemia (36.9%), and fatigue (23.8%). The ASH (Free ASH Whitepaper) presentation can be downloaded from the Astex website at View Source ASCERTAIN Presentation – ASH (Free ASH Whitepaper) – December 2019

About Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and associated with cytopenias affecting one or more of the three lineages. U.S. incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.5,6 The prevalence has been estimated to be from 60,000 to 170,000 in the U.S.7 MDS may evolve into acute myeloid leukemia (AML) in one-third of patients.8 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML. CMML is a clonal hematopoietic malignancy characterized by accumulation of abnormal monocytes in the bone marrow and in blood. The incidence of CMML in the U.S. is approximately 1,100 new cases per year,9 and CMML may transform into AML in 15% to 30% of patients.10 The hypomethylating agents decitabine and azacitidine are effective treatment modalities for hematologic cancers and are FDA-approved for the treatment of higher-risk MDS and CMML. These agents are administered by IV infusion, or by large-volume subcutaneous injections.

On February 11, 2020 Elicio Therapeutics, a next generation immuno-oncology company, and Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported their collaboration in a prospective, multicenter Phase 1/2 study of ELI-002, an Amphiphile immuno-oncology therapeutic targeting KRAS mutations in the adjuvant setting for patients with pancreatic ductal adenocarcinoma (PDAC) who have undergone neoadjuvant chemotherapy followed by pancreatectomy (Press release, Elicio Therapeutics, FEB 11, 2020, View Source [SID1234554178]). IND submission for the 108-patient trial which will open at 10-12 US sites will be in the first half of 2020.

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Natera’s tumor-informed and personalized ctDNA platform, Signatera, will be used to select eligible patients whose tumors harbor a mutant KRAS allele and are at high risk for relapse because they have detectable molecular residual disease (MRD) post-surgery. Signatera will also be used to perform serial monitoring to assess the percentage of patients achieving MRD clearance throughout the study.

"This study addresses an unmet need in the adjuvant setting for PDAC patients," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "Pancreatic cancer remains one of the deadliest forms of cancer, with a high rate of relapse post-surgery and 90% of patients are affected by KRAS mutations. ELI-002 brings the common KRAS mutated peptides together with a powerful immune activating adjuvant and Elicio’s proprietary lymph node targeting technology. Potent immune responses from sending the T cells for education in the lymph node hold promise to stop recurrence. We are excited to partner with Natera to select and monitor patients using breakthrough Signatera technology."

ELI-002 targets all seven position 12 and 13 KRAS mutations, representing approximately 25% of all human solid tumors. Elicio believes that ELI-002 has the potential to become a universal mKRAS therapy with the ability to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal and lung cancer.

"I think this is a unique clinical trial implementing novel trial design and a novel therapeutic vaccine approach to address an unmet need in the treatment of pancreas cancer," said Colin Weekes, M.D., Ph.D., Director for Medical Oncology Research for Pancreatic Cancer at Massachusetts General Hospital and the principal investigator for the ELI-002 study.

"We are proud to partner with Elicio Therapeutics on this groundbreaking research," said Alexey Aleshin, M.D., MBA, Natera’s Senior Medical Director. "We’re confident that this study will further demonstrate Signatera’s ability to enrich clinical trials and accelerate the development of much needed therapies, like the ELI-002 KRAS-targeted Amphiphile."

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.