On May 25, 2017 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported the presentation of a poster describing the Phase 1 trial of CA-170, an oral small molecule dual inhibitor of immune checkpoints PD-1 and VISTA, in the treatment of patients with advanced solid tumors or lymphomas at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Curis, MAY 25, 2017, View Source [SID1234519291]). The meeting will take place from June 2-6 in Chicago.

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In addition, researchers from the Dana-Farber Cancer Institute and Boston Children’s Hospital will be presenting information on an investigator-initiated Phase 1 multicenter trial using CUDC-907, Curis’ proprietary drug candidate, to treat children and young adults with relapsed or refractory solid tumors, CNS tumors and lymphoma.

Additional information on the presentations can be found below and can be accessed at www.am.asco.org.

CA-170 Poster Presentation:

Date/Time: Monday, June 5, 8 AM — 11:30 AM CDT
Abstract Number: TPS3099
Presentation Title: Phase 1 trial of CA-170, a novel oral small molecule dual inhibitor of immune checkpoints PD-1 and VISTA, in patients (pts) with advanced solid tumor or lymphomas

CUDC-907 Poster Presentation:

Date/Time: Sunday, June 4, 8 AM — 11:30 AM CDT
Abstract Number: TPS10576
Presentation Title: Phase 1 multicenter trial of CUDC-907 in children and young adults with relapsed or refractory solid tumors, CNS tumors, and lymphoma

On May 25, 2017 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported its financial results for the first quarter ended March 31, 2017 (Press release, BioLineRx, MAY 25, 2017, View Source [SID1234519290]).

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Highlights and achievements during the first quarter 2017 and to date:

Continued advancing the Company’s lead project, BL-8040, in an extensive clinical development program:

Announced plans to initiate Phase 3 pivotal study with BL-8040 as novel stem cell mobilization treatment for autologous bone-marrow transplantation in H2 2017, following successful meeting with the FDA.
Initiated Phase 2b immuno-oncology collaboration with MD Anderson Cancer Center for additional BL-8040 and KEYTRUDA combination study in pancreatic cancer, as part of strategic cancer immunotherapy collaboration between MSD and MD Anderson Cancer Center.
Reported partial results on Phase 2 open label study for BL-8040 as novel stem cell mobilization treatment for allogeneic bone-marrow transplantation. Interim results support BL-8040 as a one-day dosing regimen for rapid mobilization of substantial amounts of stem cells, a significant improvement over the current standard-of-care which requires four-to-six daily injections of G-CSF; and
Reported filing of regulatory submissions to commence a Phase 1b trial for BL-8040 in combination with Genentech’s atezolizumab in acute myeloid leukemia (AML), which will be led by BioLineRx. This study is expected to commence in H2 2017.
In parallel, the Company made significant progress in expanding and accelerating its growth potential:

Acquired Agalimmune Ltd., a UK-based biopharmaceutical company developing cancer immunotherapy treatments, thereby broadening and bolstering BioLineRx’s position in immuno-oncology with a second novel lead compound, AGI-134;
Completed underwritten public offering of American Depository Shares for net proceeds of $26.2 million, which will be used to fund a number of clinical trials, including a Phase 3 pivotal study for BL-8040 in autologous stem-cell mobilization, as well as the aggressive clinical development of both BL-8040 and AGI-134 in the immuno-oncology space.
Expected significant upcoming milestones for 2017 and 2018:

Partial results from immuno-oncology Phase 2a study for pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA expected in H2 2017; top line results expected in H2 2018;
Initiation of Phase 3 pivotal study for BL-8040 in stem-cell mobilization for autologous transplantation in H2 2017;
Initiation of Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech’s atezolizumab in pancreatic, gastric, and non-small cell lung cancer, as well as AML, expected in H2 2017; partial results expected in H2 2018;
Completion of Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation, top line results expected by year end 2017; and
Initiation of Phase 1 immuno-oncology study for AGI-134 in several solid tumor indications expected in H1 2018.
Philip A. Serlin, Chief Executive Officer of BioLineRx, remarked, "Our 2017 activities have fueled significant excitement at BioLineRx, as we reinforced our position in the high value field of immuno-oncology following our acquisition of a second novel drug compound, AGI-134, and strengthened our balance sheet to fund our main development objectives with support from key fundamental investors. We ended the first quarter with pro forma cash of $57 million, including net proceeds of $26 million from our recent public offering, sufficient to fund – and accelerate – our clinical programs, including both BL-8040 and AGI-134, through late 2019."

"With important catalysts in the next 12-18 months, our team is driven and focused on advancing our asset pipeline. We look forward to providing updates as we execute on our plans," Mr. Serlin concluded.

Financial Results for the First Quarter Ended March 31, 2017

Research and development expenses for the three months ended March 31, 2017 were $3.6 million, an increase of $1.1 million, or 41%, compared to $2.5 million for the three months ended March 31, 2016. The increase resulted primarily from an increase in spending on BL-8040 and an increase in spending on new projects.

Sales and marketing expenses for the three months ended March 31, 2017 were $0.7 million, an increase of $0.4 million, or 175%, compared to $0.3 million for the three months ended March 31, 2016. The increase resulted primarily from market research activities and one-time professional fees related to business development activities.

General and administrative expenses for the three months ended March 31, 2017 were $1.0 million, similar to the comparable period in 2016.

The company’s operating loss for the three months ended March 31, 2017 amounted to $5.3 million, compared with an operating loss of $3.8 million for the corresponding 2016 period.

Non-operating income (expenses) for the three months ended March 31, 2017 and 2016 were not material, and primarily related to fair-value adjustments of warrant liabilities.

Net financial income amounted to $0.5 million for the three months ended March 31, 2017, compared to net financial income of $0.1 million for the corresponding 2016 period. The increase in net financial income related primarily to gains recorded on foreign currency hedging transactions.

The Company’s net loss for the three months ended March 31, 2017 amounted to $4.9 million, compared with a net loss of $3.5 million for the corresponding 2016 period.

The Company held $30.4 million in cash, cash equivalents and short-term bank deposits as of March 31, 2017. In April 2017, the Company completed an underwritten public offering of its American Depositary Shares for net proceeds of $26.2 million.

Net cash used in operating activities for the three months ended March 31, 2017 was $3.8 million, compared with net cash used in operating activities of $4.2 million for the three months ended March 31, 2016. The $0.4 million decrease in net cash used in operating activities was primarily the result of an increase in trade payables and accruals.

Net cash provided by investing activities for the three months ended March 31, 2017 was $1.4 million, compared to net cash provided by investing activities of $1.7 million for the three months ended March 31, 2016. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits, as well as the investment in Agalimmune.

Net cash provided by financing activities for the three months ended March 31, 2017 was $2.1 million, compared to net cash provided by financing activities of $1.6 million for the three months ended March 31, 2016. The increase in cash flows from financing activities primarily reflects funding under the share purchase agreement with LPC.

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.

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]).

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"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.

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]).

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"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.