On October 6, 2016 Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), reported it will present clinical data from its CRLX101 and CRLX301 programs at the 2016 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting being held in Copenhagen, Denmark on October 7-11 (Press release, Cerulean Pharma, OCT 6, 2016, View Source [SID:SID1234515635]). Details of the ESMO (Free ESMO Whitepaper) poster presentations are as follows:

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Title: A phase 1b/2 study of the nanoparticle-drug conjugate CRLX101 in combination with weekly paclitaxel in patients with platinum-resistant ovarian cancer
Date and time: Saturday, October 8 – 13:00 to 14:00 pm Central European Time
Abstract number: 1483
Location: Hall E
Poster board number: 864P
Summary: CRLX101 is an investigational NDC containing the payload camptothecin. This Phase 1b/2 trial evaluates the potential synergy of CRLX101, a topoisomerase 1 inhibitor, in combination with paclitaxel, a standard of care taxane, in patients with platinum-resistant ovarian cancer (PROC). In this trial, CRLX101 is dosed every other week at 12 or 15 mg/m2 in conjunction with weekly paclitaxel at 80 mg/m2. Data from the nine patients in the Phase 1b portion of the trial suggest CRLX101 administered every other week in combination with weekly paclitaxel demonstrate antitumor activity. Additionally, the combination has been generally well tolerated with no dose-limiting toxicities reported. Early data from the first nine patients in the Phase 2 portion of the trial also show activity and tolerability.

Title: Evaluation of weekly dosing of CRLX101 alone and in combination with bevacizumab in patients with advanced solid tumors
Date and time: Monday, October 10 – 13:00 to 14:00 pm Central European Time
Abstract number: 1781
Location: Hall E
Poster board number: 393P
Summary: CRLX101, an investigational NDC containing the payload camptothecin, has been shown to be active in different tumor types as a topoisomerase 1 inhibitor. This study evaluated the dosing and tolerability of a weekly dosing schedule of CRLX101 alone and in combination with bevacizumab. In arm 1, CRLX101 was administered intravenously as a monotherapy at 12 or 15 mg/m2 weekly; in arm 2, this same dosing regimen was administered in combination with every other week dosing of bevacizumab at 10 mg/kg. In arm 1, the maximum tolerated dose for CRLX101 weekly monotherapy is 15 mg/m2. In arm 2, the maximum tolerated dose for CRLX101 in combination with bevacizumab is either 12 mg/m2 weekly or 15 mg/m2 for 3 of 4 weeks. Partial responses were observed in three patients. There was increased cystitis, but no new safety concerns were observed.

Title: Pharmacokinetics of CRLX101 administered weekly in patients with advanced solid tumors
Date and time: Monday, October 10 – 13:00 to 14:00 pm Central European Time
Abstract number: 1767
Location: Hall E
Poster board number: 394P
Summary: CRLX101 is an investigational NDC containing the payload camptothecin. This study evaluated the pharmacokinetics of CRLX101 in patients with advanced solid tumors. CRLX101 was administered intravenously at 12 or 15 mg/m2 on a weekly dosing schedule. The data suggest CRLX101 exhibits high drug retention in the plasma, slow clearance and controlled slow release of camptothecin from the NDC without drug accumulation, supporting weekly dosing of CRLX101 at 15 mg/m2, which represents a 100% increase in dose intensity when compared to a dosing schedule of every other week.

Title: A dose-escalation study of weekly intravenous CRLX301 in patients with advanced solid tumor malignancies
Poster presentation: Monday, October 10 – 13:00 to 14:00 pm Central European Time
Abstract number: 1793
Location: Hall E
Poster board number: 413Tip
Summary: CRLX301 is an investigational NDC containing the payload docetaxel currently being investigated in a Phase 1/2a trial of patients with advanced solid tumors. The first portion of the trial determined the maximum tolerated dose for IV CRLX301 administered every three weeks to be 75 mg/m2. The second portion of the trial is evaluating the maximum tolerated dose for weekly administration of CRLX301. Based on data from the first portion of this trial, the weekly starting dose was 25 mg/m2. This dose escalating trial also evaluates safety, PK and antitumor activity.

Electronic copies of the posters will be available upon request following ESMO (Free ESMO Whitepaper) by emailing [email protected].

About CRLX101

CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication. CRLX101 has shown activity in multiple tumor types, both as monotherapy and in combination with other cancer treatments. CRLX101 is in Phase 2 clinical development and has been dosed in more than 400 patients. The U.S. FDA has granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer, Fast Track designation in combination with paclitaxel for platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer, and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.

About CRLX301

CRLX301 is a dynamically tumor-targeted NDC designed to concentrate in tumors and slowly release its anti-cancer payload, docetaxel, inside tumor cells. In preclinical studies, CRLX301 delivers up to 10 times more docetaxel into tumors, compared to an equivalent milligram dose of commercially available docetaxel and was similar to or better than docetaxel in seven of seven animal models, with a statistically significant survival benefit seen in five of those seven models. In addition, preclinical data show that CRLX301 had lower toxicity than has been reported with docetaxel in similar preclinical studies. CRLX301 is in Phase 1/2a clinical development.

On October 6, 2016 Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading pure-play, global biosimilar company with late-stage clinical products, reported that the U.S. FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate (Press release, Coherus Biosciences, OCT 6, 2016, View Source;p=irol-newsArticle&ID=2210016 [SID:SID1234515636]).

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The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta. The biosimilar user fee act (BSUFA) action date is June 9, 2017.

On October 6, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima", the "Company") reported that an abstract for each of its two clinical trials for IMP321 has been accepted for Poster presentation (display) during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Symposium on ‘Immuno-Oncology—Advances in cancer immunotherapy; From vaccines to antibodies and cell therapies’ from 4-6 November 2016 in Lausanne, Switzerland (Filing, 6-K, Prima Biomed, OCT 6, 2016, View Source [SID:SID1234515644]).
The abstract titles are:

• TACTI-mel (Two ACTive Immunotherapeutics in melanoma): A Phase 1 trial in patients with unresectable or metastatic melanoma receiving IMP321 (LAG-3Ig fusion protein) as an adjunctive therapy to anti-PD-1 therapy with pembrolizumab (Poster #155); and

• AIPAC (Active Immunotherapy PAClitaxel): A Phase IIb trial in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3Ig fusion protein) or placebo as adjunctive to a standard chemotherapy regimen of paclitaxel (Poster #145).

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Both posters will be on display for the duration of the Symposium. The Poster viewing session will take place over lunch from 13:00-14:15 on Saturday 5 November 2016. The abstracts will also be published in the ESMO (Free ESMO Whitepaper) Symposium on Immuno-Oncology 2016 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal "Annals of Oncology".
For more schedule information see View Source

On September 5, 2016 Innocrin Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing the oral, dual-mechanism, selective CYP17 lyase and androgen receptor (AR) inhibitor, seviteronel, for the treatment of breast and prostate cancers resistant to recently-approved hormonal therapies, reported the appointment of Edwina Baskin-Bey, MD as Chief Medical Officer, effective August 30, 2016 (Press release, Innocrin Pharmaceutical, OCT 5, 2016, View Source [SID:SID1234515611]).

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William Moore, PhD, Innocrin Chief Executive Officer stated, "I’m very pleased to welcome Edwina to the senior management team. Her strong development experience with AR pathway-targeted therapies such as abiraterone, enzalutamide, and apalutamide will serve Innocrin well as we move into later-stage Phase 2 breast and prostate cancer clinical studies."

Dr. Baskin-Bey has extensive oncology research and drug development experience. Immediately prior to joining Innocrin, she led several prostate cancer development programs at Janssen as Global Director of Oncology Development. Prior to Janssen, she was Global Director of Oncology Development at Astellas Pharma, with responsibility for the development of various (Phase 0-4) oncology products, including enzalutamide. Following receipt of a Doctorate in Medicine degree from Mount Sinai/NYU, Dr. Baskin–Bey trained as a general surgeon at the Mayo Clinic, performing basic scientific and clinical research through the National Institutes of Health.

Said Dr. Baskin-Bey, "I am excited to join Innocrin as the company expands its Phase 2 breast and castration-resistant prostate cancer development programs. Seviteronel holds great promise for late-stage breast and prostate cancer patients whose disease has progressed while on currently available therapies."

Innocrin also announced that once-daily oral seviteronel has advanced to Stage 2 in both the ER+ and AR+ triple-negative breast cancer (TNBC) groups in its ongoing open- label Phase 2 study (NCT02580448). Phase 2 oncology studies typically employ early ‘stopping rules’ that prevent large numbers of patients from being exposed to inactive drugs. Seviteronel has advanced to Stage 2 in both the ER+ and TNBC populations based upon early signs of significant therapeutic activity.

Dr. Baskin-Bey commented, "It is encouraging to see early signs of single-agent seviteronel clinical benefit in these two breast cancer patient populations which are in need of new treatment options. The combined inhibition of CYP17 lyase and the AR is a novel approach for the treatment of TNBC and ER+ disease. Seviteronel potentially addresses an unmet medical need for women whose breast cancer has progressed despite treatment with traditional ER-targeting agents or chemotherapy."

Innocrin will present updated Phase 2 clinical study results from 7:30-9:00 AM on December 8, 2016 at the San Antonio Breast Cancer Symposium (poster P2-08-04).

About Seviteronel (VT-464) Seviteronel is a once-daily oral therapeutic that can be given without prednisone. Seviteronel selectively inhibits CYP17 lyase, an enzyme needed for the synthesis of androgens and estrogens, and also directly blocks the AR.

It is thought that the AR may stimulate disease progression of breast cancer tumors that no longer are ER+ (e.g., are triple-negative) or are ER+ but have become resistant to ER-directed therapies such as aromatase inhibitors or tamoxifen. Preclinical study results, presented at the 2015 San Antonio Breast Cancer Symposium, confirmed that seviteronel blocks the growth of resistant ER+ and AR+ breast cancer cells more potently than enzalutamide.

A growing body of preclinical and clinical evidence shows that seviteronel blocks the growth of deadly, castration-resistant prostate cancer that is resistant to abiraterone (a CYP17 hydroxylase inhibitor) or enzalutamide (an AR antagonist). CRPC disease progression following treatment with abiraterone, enzalutamide or both represents a major unmet medical need due to the widespread and growing use of both agents, as well as the high cross-resistance between these agents (e.g., cancers that are resistant to abiraterone are typically resistant to enzalutamide and vice versa).

About Breast Cancer Each year over 230,000 women are diagnosed with breast cancer in the United States, with almost 40,000 deaths attributable to the disease. While estrogen deprivation is currently the standard of care for postmenopausal women with ER+ BCa, the majority of patients eventually develop resistance. ER+ patients comprise ~75% of all metastatic breast cancer cases, and TNBC accounts for ~15-20%. TNBC has a more aggressive course than ER+ BCa does but both have poor survival rates post-failure of endocrine and/or chemotherapy.

About Prostate Cancer Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in six will be diagnosed with prostate cancer in his lifetime. Prostate cancer afflicts nearly 240,000 men each year in the US and approximately 36,000 men die due to metastatic CRPC.

On October 5, 2016 SYNCONA LLP and CANCER RESEARCH TECHNOLOGY (CRT) reported the formation of Achilles Therapeutics Ltd today (Press release, Cancer Research Technology, MAY 5, 2016, View Source [SID1234523180]).

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The new private company will bring together world-class research from UCL (University College London) and the Francis Crick Institute, funded by Cancer Research UK and the National Institute for Health Research (NIHR).

Achilles Therapeutics will design therapies to target truncal tumour neo-antigens – unique flags to the immune system present on the surface of every cancer cell*, which were first discovered by Cancer Research UK and the NIHR University College London Hospitals (UCLH) Biomedical Research Centre (BRC) funded scientists at the Francis Crick Institute and UCL Cancer Institute.

Truncal tumour neo-antigens are present on all cancer cells in an individual patient’s tumour but not on healthy cells, so could allow scientists to target and destroy tumours without harming healthy tissues.

Syncona and CRT, with the support of UCL Business (UCLB) and the Crick, formed Achilles Therapeutics with a successful financing round of £13.2 million ($17.5 million) led by Syncona with the CRT Pioneer Fund and the UCL Technology Fund.

The company founders bring together world-class capability from three prestigious institutions. They are:

Professor Charles Swanton, Group Leader and Royal Society Napier Professor at the Francis Crick and UCL Cancer Institute working on cancer evolution and genome instability and a consultant at UCLH
Professor Karl Peggs, Group Leader of the Stem Cell Transplantation and Cellular Immunotherapy Group at UCL Cancer Institute and a consultant at UCLH
Dr Sergio Quezada, Group Leader of the Immune Regulation and Tumour Immunotherapy Group at UCL Cancer Institute
Professor Mark Lowdell, Director of the Centre for Cell, Gene & Tissue Therapeutics at the Royal Free Hospital.
CRT will receive equity milestones and royalties from products developed and commercialised by Achilles Therapeutics. Any such financial reward from the company will be shared with UCLB and the Crick.

The company has exclusive rights to develop and commercialise neo-antigen technologies arising from Cancer Research UK’s £14million TRACERx study**. This clinical study, involving 850 people with non-small cell lung cancer, tracks the evolution of patients’ cancers over time, in different parts of their tumours and in response to treatment. It receives infrastructure support from the NIHR University College London Hospitals BRC and is being carried out at the Clinical Research Facility at UCLH.

Professor Charles Swanton, scientific founder of Achilles Therapeutics and a Group Leader at the Francis Crick Institute, said: "Our research could provide a truly personalised approach to lung cancer therapy by targeting cell surface markers that are specific to each patient and present on all cancer cells rather than just a subset of cells. We’re delighted to be able to bring this exciting science closer to the clinic. We hope to create a new and kinder treatment for this hard-to-treat disease that results in around 36,000 patient deaths each year in the UK ***."

Iraj Ali, Partner with Syncona LLP and Director of Achilles Therapeutics, said: "In founding Achilles we believe we are working with the world leaders capable of exploiting the confluence of two of the most exciting and innovative fields in healthcare today: cancer bioinformatics and immuno-therapy. Our ambition is to build a company to deliver personalised therapies with transformative potential for cancer patients with the greatest need."

Chris Ashton, CEO of Achilles Therapeutics, said: "This company is underpinned by world-leading science, committed investors and leading health institutes. Bringing all of these major players together holds great promise for non-small cell lung cancer patients and I hope that working alongside one another we will see great successes in the future."