On May 14, 2018 TP Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company developing oncology therapies with a focus on addressing current drug resistance, reported the appointment of Athena M. Countouriotis, M.D., as Executive Vice President and Chief Medical Officer (Press release, TP Therapeutics, MAY 14, 2018, View Source [SID1234526596]).

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TP Therapeutics Appoints Athena Countouriotis, M.D., as EVP and Chief Medical Officer

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"The Board and I are extremely delighted to have Athena join us as Executive Vice President and Chief Medical Officer," said Dr. J. Jean Cui, founder, President, and Chief Scientific Officer of TP Therapeutics, Inc. "Athena brings extensive and in-depth oncology clinical development experience to TP Therapeutics."

"Athena has a history of success in oncology drug development, including the kinase inhibitor area which TP focuses on, and we are thrilled that she is joining us," commented Dr. Carl Gordon of OrbiMed and director at TP Therapeutics.

"I am very excited to join TP Therapeutics at this critical time and help drive the strategy of our initial asset TPX-0005 (Ropotrectinib) in ALK/ROS/NTRK driven malignancies. I look forward to working closely with Dr. J. Jean Cui and our team as we unveil the Phase 1 clinical data with Ropotrectinib at an upcoming medical conference and we continue to expand our pipeline," added Dr. Countouriotis.

Dr. Countouriotis has 15 years of experience within oncology. Before joining TP Therapeutics, Dr. Countouriotis served as Senior Vice President and Chief Medical Officer at Adverum Biotechnologies and previously at Halozyme Therapeutics. Prior to that, she was Chief Medical Officer at Ambit Biosciences leading the development of Quizartinib through the Company’s initial public offering and acquisition by Daiichi Sankyo. Dr. Countouriotis also worked within Pfizer and Bristol-Myers Squibb in various leading clinical development roles for Sutent, Mylotarg, Bosulif, and Sprycel. Dr. Countouriotis holds an M.D. from Tufts University School of Medicine, completed her pediatric residency at the University of California, Los Angeles, and did additional training at the Fred Hutchinson Cancer Research Center in the Pediatric Hematology/Oncology program.

About TPX-0005 (Ropotrectinib)

TPX-0005 (Ropotrectinib) is a potent and orally bioavailable investigational small molecule kinase inhibitor for ALK, ROS1, and TRK family. The clinical benefits of targeting ALK, ROS1, or TRK fusion kinase have been demonstrated with multiple kinase inhibitors already approved for the treatment of ALK+ non-small cell lung cancer (NSCLC), in addition to crizotinib for ROS1+ NSCLC, and larotrectinib and entrectinib in clinical studies for TRK+ cancers. The successes of these therapies are overshadowed by the development of acquired resistance. The acquired solvent front mutations including ALK G1202R, ROS1 G2032R, TRKA G595R and TRKC G623R render a common clinical resistance to the current ALK, ROS1, and TRK inhibitors. TPX-0005 (Ropotrectinib) is a potent kinase inhibitor against wildtype and mutated ALK, ROS1 and TRK family kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple line treatments. Ropotrectinib may provide new opportunity to inhibit the abnormal signaling of ALK, ROS1, or TRK family in solid malignancies, and overcome multiple resistance mechanisms seen in refractory patients. TPX-0005 (Ropotrectinib) is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1, NCT03093116). For additional information about TPX-0005 (ropotrectinib) trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can also contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email [email protected].

On May 14, 2018 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported financial results and business highlights for the first quarter 2018 (Press release, Cyclacel, MAY 14, 2018, View Source [SID1234526579]).

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The Company’s net loss applicable to common shareholders for the three months ended March 31, 2018 was $1.4 million. As of March 31, 2018, cash and cash equivalents totaled $21.7 million.

"Two presentations at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighted CYC065, our lead CDK inhibitor drug candidate, confirming a strong rationale for advancing its clinical development in certain liquid and solid cancers," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The oral presentation confirmed proof of mechanism in patients with advanced solid tumors. Durable suppression of Mcl-1 in 11 of 13 patients was demonstrated for the first time in the literature after a single dose at the recommended Phase 2 level. In addition, anticancer activity was observed in patients with MYC amplified tumors, confirming the promise of a CDK inhibition strategy against this very difficult to treat tumor type. The poster presentation demonstrated preclinical synergy of CYC065 with venetoclax, supporting the Company’s plans to pursue a venetoclax combination study in patients with relapsed/refractory chronic lymphocytic leukemia, or CLL. We have also achieved another important objective by submitting an IND for CYC140, an internally-discovered, novel inhibitor of Polo-like-kinase 1, or PLK1."

Key Highlights

CYC065, CDK2/9 inhibitor, Phase 1 data at oral presentation at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. In part 1 of this ongoing, first-in-human, single agent, dose escalation study, prolonged reduction of Mcl-1 expression was observed in 11 out of 13 patients treated at the recommended Phase 2 dose, or RP2D, following a single dose of CYC065, which was generally well tolerated. Preliminary anticancer activity was observed in 6 patients, of which 5 were treated at the RP2D; genetic data was available for 3 out of 6 patients and all 3 were reported by investigators to have molecular features of their cancers associated with CYC065’s mechanism of action, including amplification of Mcl-1, MYC or cyclin E.

Following completion of part 1, Cyclacel has initiated part 2 of the study evaluating CYC065 in a more frequent dosing schedule of 2 days per week for 2 weeks of a three-week cycle. Part 2 will enroll patients with advanced cancers and evaluate efficacy in Mcl-1, MYC or cyclin E amplified cancers. Several biomarkers relevant to CYC065’s mechanism of action will be assessed.

A poster was presented at the 2018 AACR (Free AACR Whitepaper) meeting titled "Strategic combination of the cyclin-dependent kinase inhibitor CYC065 with venetoclax to target anti-apoptotic proteins in chronic lymphocytic leukemia". The preclinical study led by William Plunkett, PhD, Professor and Deputy Chair, Department of Experimental Therapeutics, The University of Texas MD Anderson Cancer Center, highlighted data that showed the efficacy of CYC065 therapy in combination with the Bcl-2 inhibitor, venetoclax (AbbVie), in CLL samples, including those with 17p deletions. The CYC065-venetoclax combination was also active in two CLL samples which were resistant to either agent alone. These findings support the hypothesis that dual targeting of the Mcl-1- and Bcl-2-dependent mechanisms could induce synergistic cell death.

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The Company plans to initiate a clinical study in patients with relapsed/refractory CLL in combination with venetoclax, in whom durable suppression of Mcl-1 may be beneficial.

Part 3 of the Phase 1 combination study of sapacitabine and seliciclib (Cyclacel’s first generation CDK inhibitor) continues enrolment with the objective of testing a revised dosing schedule in patients with advanced cancer, including BRCA positive breast, ovarian and pancreatic cancer patients.

The Company has completed statistical and exploratory analyses of the SEAMLESS Phase 3 study results and is preparing briefing documents for submission to regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in AML. The Company believes that the subgroup results have defined a patient population for whom the sapacitabine regimen may represent an improvement over low intensity treatment by decitabine alone.

2018 Key Upcoming Business Objectives

Report updated CYC065 Phase 1 data in patients with advanced cancers;

Initiate CYC065 Phase 1b in relapsed/refractory CLL in combination with venetoclax;

Start enrollment in a Phase 1b/2 IST of CYC065 in pediatric patients with neuroblastoma;

Start enrollment in a Phase 1b/2 IST of a combination regimen of an approved PARP inhibitor and sapacitabine in patients with BRCA mutant breast cancer;

Conduct regulatory authority meetings regarding the SEAMLESS study of sapacitabine in AML;

Update mature data from the part 1 extension of the sapacitabine and seliciclib combination in BRCA positive advanced breast cancer patients and complete part 3 enrollment of the sapacitabine and seliciclib combination in BRCA positive, breast, ovarian and pancreatic cancer patients;

IND review for CYC140 PLK1 inhibitor.

Financial Highlights

As of March 31, 2018, cash and cash equivalents totaled $21.7 million, compared to $23.9 million as of December 31, 2017. The decrease of $2.2 million was primarily due to net cash used in operating activities.

Research and development expenses were $0.8 million for the three months ended March 31, 2018 as compared to $1.3 million for the same period in 2017. The decrease was primarily due to reduced study and related costs associated with completion of the SEAMLESS study.

General and administrative expenses were $1.4 million for each of the three months ended March 31, 2018 and 2017.

Other income, net for the three months ended March 31, 2018 was $0.6 million compared to $0.8 million for the same period of the previous year. The decrease is primarily related to income received under an Asset Purchase Agreement with ThermoFisher Scientific Company, or TSC, (formerly Invitrogen Corporation), in respect of certain assets and intellectual property related to chimeric antigen receptor-T cell (CAR-T) manufacturing technology sold by the Company to TSC in December 2005.

The United Kingdom research and tax credits were $0.2 million for the three months ended March 31, 2018 compared to $0.3 million for the same period in 2017.

Net loss for the three months ended March 31, 2018 was $1.3 million compared to $1.6 million for the same period in 2017.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 6069578

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On May 14, 2018 Precision BioSciences, the ARCUS genome editing company with novel product development programs in gene therapy, cancer immunotherapy and non-GMO food, reported that it will give three presentations at the upcoming ASGCT (Free ASGCT Whitepaper) 21st Annual Meeting held in Chicago, Illinois, May 16-19, 2018 (Press release, Precision Biosciences, MAY 14, 2018, View Source [SID1234526597]).

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Precision’s co-founder and CSO, Derek Jantz, will attend the conference along with a group of Precision scientists. He notes,

"The Precision team is looking forward to participating in the research dialogue at ASGCT (Free ASGCT Whitepaper) this year. We are particularly eager to share our experiences towards developing an in vivo gene editing solution, including results of extensive NHP testing. We will also present new data from our gene-edited allogeneic T cell platform, including manufacturing results for our lead CAR T program."

Precision BioSciences presentations at ASGCT (Free ASGCT Whitepaper) include:

1. Development and Optimization of a PCSK9-Specific Meganuclease That Mediates Long-Term LDL Reduction in Non-Human Primates (#658; follows content of #657).
Oral Session Title: Cardiovascular and Pulmonary Diseases
Date and Time: Friday, May 18, 2018, 4:00 p.m. – 5:45 p.m. CDT
Location: International Ballroom South

2. Development of a Clinical-Grade Meganuclease for Allogeneic CAR T Cell Production (#784).
Poster Session Title: Cell Therapies III
Session Date and Time: Friday, May 18, 2018, 5:45 p.m. – 7:45 p.m. CDT
Location: Stevens Salon C & D

3. A P23H RHO-Specific Meganuclease Rescues Photoreceptor Morphology and Function in Mouse Models of Retinitis Pigmentosa (#565).
Poster Session Title: Neurologic Diseases II
Session Date and Time: Thursday, May 17, 2018, 5:15 p.m. – 7:15 p.m. CDT
Location: Stevens Salon C & D

On May 14, 2018 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported that the U.S. Food and Drug Administration (FDA) has accepted and acknowledged for review the re-submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate (Press release, Coherus Biosciences, MAY 14, 2018, View Source;p=RssLanding&cat=news&id=2348926 [SID1234526578]). In the communication, FDA indicated that they consider the resubmission a complete response to their June 9, 2017 action letter. FDA provided a biosimilar user fee act (BSUFA) action date of November 3, 2018. The letter did not indicate the need to prepare for an advisory committee meeting.

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"We appreciate FDA’s prompt action on our file and look forward to working with them on the review," said Denny Lanfear, President and CEO of Coherus BioSciences. "We believe that CHS-1701 is well-positioned to deliver greater access to oncology patients and savings to the healthcare system. We are continuing to make good progress in building inventory of CHS-1701 and in preparing for commercial launch in the U.S."

On May 14, 2018 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the Company’s PHP Therapy was featured in a Video Learning Session presented at the Annual Meeting of the European Conference of Interventional Oncology (ECIO). Dr. M.C. Burgmans of Leiden University Medical Center (LUMC) in the Netherlands presented the training in the main auditorium session dedicated to advances in liver cancer therapies (Press release, Delcath Systems, MAY 14, 2018, View Source;p=RssLanding&cat=news&id=2348840 [SID1234526580]). Dr. Burgmans presented an overview of the Percutaneous Hepatic Perfusion (PHP) procedure, discussed the therapy’s developmental history, demonstrating how to perform the procedure, as well as outlining its potential in ocular melanoma liver metastases and intrahepatic cholangiocarcinoma, and highlighting ongoing clinical research.

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"In his presentation, Dr. Burgmans stated his belief that PHP Therapy should be considered as first line therapy in ocular melanoma liver metastases, an opinion informed by both our commercial experience in Europe and our prior research into this tumor type," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems. "LUMC is one of the our most experienced treatment centers, and with CHEMOSAT recently added to the Dutch National Treatment Guidelines for use in ocular melanoma, we believe Dr. Burgmans comments reflect growing confidence in this therapy’s role in treating this disease. We continue to work tirelessly to advance our current clinical trial in this disease in order to further validate this role for our therapy and to deliver on its full potential to patients in need."

The ECIO was held in Vienna, Austria, April 22-25, 2018.