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Adaptimmune Announces Initiation of Study to Evaluate SPEAR T-Cell Therapy Targeting NY-ESO in Combination with KEYTRUDA® (pembrolizumab) in Multiple Myeloma

On May 25, 2017 (GLOBE NEWSWIRE) — Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it has initiated its study of NY-ESO SPEAR T‑cells targeting NY-ESO in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 inhibitor marketed by Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), in patients with multiple myeloma (Press release, Adaptimmune, MAY 25, 2017, View Source [SID1234519288]). This study is now open for enrollment.

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This is Adaptimmune’s third clinical trial to initiate within the past month. The Company recently announced the initiation of clinical studies with its wholly-owned SPEAR T-cells targeting AFP in hepatocellular carcinoma, as well as its wholly-owned SPEAR T-cells targeting MAGE-A4 in seven malignant solid tumors.

"We are excited to initiate this study as we have already seen encouraging data in a previous single‑agent study of NY‑ESO SPEAR T-cells in patients with advanced myeloma in the context of stem cell transplantation," said Rafael Amado, Adaptimmune’s Chief Medical Officer. "KEYTRUDA has also shown preliminary evidence of activity in multiple myeloma in combination, and there is preclinical evidence to support the view that the combination of NY-ESO SPEAR T-cells and anti-PD-1 therapy may lead to meaningful antitumor activity."

This is an open-label, randomized pilot study designed to evaluate the safety and anti-tumor activity of Adaptimmune’s NY-ESO therapeutic candidate alone or in combination with KEYTRUDA in patients who are HLA-A*02 positive and have relapsed and refractory multiple myeloma expressing NY-ESO-1 and/or LAGE‑1a. The study will enroll up to 20 patients. The primary objective of the study is to evaluate the safety and tolerability of NY-ESO SPEAR T-cell therapy alone or in combination with KEYTRUDA. Additional objectives include anti‑tumor activity, persistence of genetically modified cells in the body, and evaluation of the phenotype and functionality of genetically modified cells isolated from peripheral blood or tumor post infusion.

Adaptimmune is developing the NY-ESO SPEAR T-cell program under a strategic collaboration agreement with GSK.

Clinical Trial Collaboration Agreement for use of KEYTRUDA

Adaptimmune has a clinical trial collaboration agreement with Merck & Co., Inc., Kenilworth, NJ, USA for the use of KEYTRUDA in this study. The agreement is between Adaptimmune and Merck & Co., Inc., Kenilworth, NJ, USA, through a subsidiary. Under the agreement, the trial will be sponsored by Adaptimmune. The agreement also includes provision for potential expansion to include Phase III registration studies in the same indication. Additional details were not disclosed.

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

TRACON Doses First Patient in Phase 1/2 Study of TRC253 in Patients with Prostate Cancer

On May 24, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration (AMD) and fibrotic diseases, reported that the first patient has been dosed in a Phase 1/2 clinical trial of TRC253 in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Tracon Pharmaceuticals, MAY 24, 2017, View Source [SID1234519286]).

"I am proud of the efforts of the TRACON team who made it possible for us to quickly file the IND, open multiple sites, and dose TRC253 in a Phase 1/2 trial following the establishment of our strategic licensing collaboration with Janssen," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We think TRC253 has the potential to be a best-in-class androgen receptor antagonist, and address an unmet medical need in the treatment of men with metastatic castration-resistant prostate cancer who develop resistance to androgen receptor inhibitors."

About the Phase 1/2 TRC253 Clinical Trial in mCRPC

The Phase 1/2 clinical trial is a multicenter, first-in-human, open-label, dose-escalation study in patients with mCRPC. The primary objectives of the Phase 1/2 study are to assess the safety of TRC253, determine its recommended Phase 2 dose and assess response by prostate-specific antigen (PSA) levels. In the Phase 2 portion of the trial, the Company plans to incorporate circulating tumor DNA testing in order to allow for biomarker-directed therapy of patients who have progressed following treatment with an androgen receptor (AR) inhibitor.

Further details of the study are available on www.clinicaltrials.gov under NCT02987829.

About TRC253

TRC253 is a novel, orally bioavailable small molecule, discovered by Janssen Research & Development, LLC and licensed to TRACON in September 2016, that is a potent, high affinity competitive inhibitor of the AR and AR mutations, including the F876L (also known as F877L) mutation. The AR F876L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer.

Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with mCRPC. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR.

MabVax Therapeutics Reports First Quarter 2017 Operational and Financial Results

On May 24, 2017 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical stage immuno-oncology company focused on the development of antibody based therapeutic and diagnostic products for cancer, reported its first quarter financial results and provided a corporate update (Press release, MabVax, MAY 24, 2017, View Source [SID1234519285]).

"We are very pleased with the progress we’ve made in the first quarter. The outcome of our recent financing provides valuable operational runway, enabling us to execute on our plans as well as continue our efforts in finalizing partnering collaborations, all of which we believe has the potential to drive significant value in MabVax," stated President and CEO, David Hansen.

First Quarter 2017 Corporate Highlights

Closed on a total of $5 million in new financing with proceeds intended to fund the early MVT-1075 radioimmunotherapy trial anticipated to enroll the first patient before mid-year;
Presented non-clinical IND enabling data for MVT-1075 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 in April. These data showed that in xenograft and orthotopic models of human pancreatic cancer tumor growth suppression and regression were achieved after a single dose of MVT-1075;
Presented the chemistry, manufacturing, and controls (CMC) IND enabling investigations for MVT-1075 at the AACR (Free AACR Whitepaper) Annual Meeting. These data demonstrated that MVT-1075 can be reproducibly manufactured as a high-quality product and support the manufacture and clinical use of MVT-1075 drug product; and
Provided a progress update for HuMab-5B1 MVT-5873 therapeutic and MVT-2163 imaging clinical programs at the PEGS Protein Engineering Summit. The interim data included safety, changes in circulating biomarker and time on treatment, as well as PET images of patients with cancer that demonstrate antibody targeting specificity and accumulation on tumor.
Mr. Hansen added, "We have made noteworthy clinical progress in the last six months, and have announced encouraging interim clinical study results for both our MVT-5873 therapeutic antibody product, as well as our MVT-2163 immunoPET imaging agent. We expect to continue our clinical progress with the commencement of patient enrollment in our MVT-1075 novel radioimmunotherapy in the Phase 1 trial for the treatment of difficult solid tumor cancers by mid-year. We remain focused on advancing our clinical programs, participating in key scientific meetings and building shareholder value in both the near and long-term."

Expected Near-Term Milestones

Poster presentation of the clinical safety profile, maximum tolerated dose, serum CA19-9 levels, and pharmacokinetics of the single agent MVT-5873 therapeutic antibody targeting pancreatic and other CA19-9 expressing cancers at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3rd;
Poster presentation at Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting on June 11, describing the biodistribution and radiation dose estimates for the Company’s PET imaging product MVT-2163 (89Zr-DFO-HuMab-5B1) in patients with CA19-9 positive pancreatic cancer;
Podium presentation at SNMMI on June 13, discussing the Company’s immunoPET imaging agent First-in-Human (Phase 1) study of MVT-2163 (89Zr-DFO-HuMab-5B1) in patients with pancreatic cancer and other CA19-9 positive malignancies;
Commencement of first-in-human (Phase 1) clinical study of MVT-1075 (177Lu- CHX-A˝-DTPA-HuMab-5B1) in patients with pancreatic cancer or other CA19-9 positive malignancies in June of 2017;
Poster presentation at Mucins in Health and Disease on July 24 – 28, discussing the development of translational approaches to understand the distribution of the sLea in patient samples;
Present additional data from the MVT-5873 Phase 1 program including interim results from the administration of MVT-5873 in combination with gemcitabine and Abraxane in first line therapy in the second half of 2017;
Present the preclinical data from our HuMab-GD2 immunoPET imaging agent in a human tumor xenograft model in the second half of 2017; and
Present the initial data from the Company’s HuMab-Tn preclinical program summarizing the selection of lead candidate next generation fully human antibodies, in the second half of 2017. This program is a novel fully human antibody and a follow-on development product.
Summary of Financial Results for First Quarter 2017

Cash and cash equivalents totaled approximately $600,000 as of March 31, 2017, compared with $4.0 million as of December 31, 2016. Cash and cash equivalents at March 31, 2017 does not include the approximate $5.0 million in capital raised by the Company in May 2017. Management expects that current cash and cash equivalents, together with the closing of the $4.1 million public offering and completion of the $850,000 private placement in May 2017, and without assuming additional near term funds from potential licensing agreements, will be sufficient to fund current operations into August 2017.
Research and development expenses for the first quarter of 2017 were $2.8 million, compared to $1.7 million for the first quarter of 2016.
General and administrative expenses for the first quarter of 2017 were $2.3 million, compared to $2.7 million for the first quarter of 2016.
Net loss for the first quarter of 2017 was $5.4 million, or $0.85 per share, compared to a net loss of $4.4 million, or $1.12 per share, for the first quarter of 2016.

Debiopharm International SA Enters the Field of Antibody-Drug Conjugates Through Acquisition of Phase II Asset from ImmunoGen

On May 24, 2017 Debiopharm International SA (Debiopharm – www.debiopharm.com), part of Debiopharm Group, a Switzerland-based biopharmaceutical company, and ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Debiopharm has acquired ImmunoGen’s IMGN529/Debio 1562, a clinical-stage anti-CD37 ADC for the treatment of patients with B-cell malignancies, such as non-Hodgkin lymphomas (NHL) (Press release, Debiopharm, MAY 24, 2017, View Source [SID1234519283]).

Under the terms of the agreement, ImmunoGen received a $25 million upfront payment for IMGN529/Debio 1562 and is entitled to a $5 million milestone payment to be paid after completion of the transfer of ImmunoGen technologies related to the asset, which the parties expect to achieve by the end of 2017. In addition, ImmunoGen is eligible for a second success-based milestone payment of $25 million upon IMGN529/Debio 1562 entering a Phase 3 clinical trial.

"The purchase of IMGN529/Debio 1562 from a pioneer in the field of ADCs represents a strategic investment leveraging our expertise and track record in Oncology and supports our strong commitment to deliver targeted therapies and precision medicines to help patients suffering from severe diseases" stated Bertrand Ducrey, CEO of Debiopharm.

"IMGN529/Debio 1562 has already generated compelling clinical data and we look forward to further exploring it in combination with Rituxan, which could provide an attractive alternative to conventional chemotherapies for patients with NHL such as diffuse large-cell B-cell lymphoma (DLBCL)," said Chris Freitag, Vice President of Clinical Research & Development of Debiopharm.

IMGN529/Debio 1562 demonstrated evidence of anticancer activity in NHL in a Phase 1 monotherapy trial and successfully completed a safety run-in study in combination with Rituxan. The product is now ready to move forward into a Phase 2 trial in NHL, and particularly in DLBCL for which it has Orphan Drug status.

"With a strong history of developing and bringing oncology drugs to market, Debiopharm offers the right mix of resources and capabilities to advance IMGN529/Debio 1562 through its next phase of development," stated Mark Enyedy, President and Chief Executive Officer of ImmunoGen. "Consistent with the strategic review of our portfolio undertaken last fall, this transaction further enables us to prioritize our development efforts on mirvetuximab soravtansine and our IGN programs, while generating near-term value from IMGN529/Debio 1562."

Sierra Oncology to Present Innovative Clinical Trial Enhancements Leveraging Chk1 Synthetic Lethality in Two Posters at ASCO Annual Meeting

On May 24, 2017 Sierra Oncology, Inc. (NASDAQ: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported that it will be presenting two Trials in Progress posters describing the innovative Phase 1 clinical designs for its Chk1 inhibitor, SRA737, at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago on June 5th (Press release, Sierra Oncology, MAY 24, 2017, View Source [SID1234519282]). These ongoing trials were recently amended to include cohort expansions of prospectively selected patients with tumors identified to have genetic aberrations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality.

The company also announced that Dr. Nick Glover, President and Chief Executive Officer of Sierra Oncology, will present an overview of the company entitled "Beyond PARP – Next Generation DDR Therapeutics" at the Jefferies Healthcare Conference in New York. The presentation is scheduled for 2:00pm ET on June 8th. A live audio webcast and archive of the presentation will be accessible through www.sierraoncology.com.

ASCO 2017 Poster Presentations
Title: A phase I study of SRA737 (formerly known as CCT245737) administered orally in patients with advanced cancer.
Trials in Progress Abstract: #TPS2607
Poster: #93b
Poster Session: Developmental Therapeutics — Clinical Pharmacology and Experimental Therapeutics
Date and Time: Monday, June 5, 2017, 8:00 – 11:30am CT
Location: McCormick Place, Event room: Hall A, 2301 S King Dr., Chicago, Illinois

Title: A phase I study of oral SRA737 (formerly CCT245737) given in combination with gemcitabine plus cisplatin or gemcitabine alone in patients with advanced cancer.
Trials in Progress Abstract: #TPS2613
Poster: #96b
Poster Session: Developmental Therapeutics — Clinical Pharmacology and Experimental Therapeutics
Date and Time: Monday, June 5, 2017, 8:00 – 11:30am CT
Location: McCormick Place, Event room: Hall A, 2301 S King Dr., Chicago, Illinois

The posters will be available on June 5, 2017 on the company’s website at www.sierraoncology.com
Jefferies Healthcare Conference
Title: Beyond PARP – Next Generation DDR Therapeutics
Date and Time: June 8, 2017, 2:00 pm ET

Live audio webcast and archive of the presentation will be accessible through www.sierraoncology.com.