On May 16, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that a wide selection of abstracts highlighting the Company’s diverse oncology portfolio across a broad range of cancers have been accepted for oral and poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 1-5 in Chicago (Press release, Astellas Pharma US, MAY 16, 2018, View Source [SID1234526696]). Highlights of the data and studies being presented include findings for: men with non-metastatic Castration-Resistant Prostate Cancer (CRPC) taking enzalutamide* and androgen deprivation therapy; patients with locally advanced or metastatic urothelial cancer taking enfortumab vedotin**, an investigational antibody-drug conjugate (ADC); and patients taking gilteritinib in Phase 3 trial in FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML).

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Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)

"The Astellas abstracts accepted for presentation at this year’s ASCO (Free ASCO Whitepaper) meeting demonstrate the depth and breadth of our growing leadership in oncology across a broad range of cancers," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "These data demonstrate the strength and progress of our oncology pipeline driven by investment in R&D and collaborative partnerships."

The following will be presented during an oral presentation:

Title: (Abstract 4504) Updated Results from the enfortumab vedotin Phase 1 (EV-101) Study in Patients with Metastatic Urothelial Cancer (mUC)

Presenter: Jonathan E. Rosenberg, MD

Session Date/Time: June 3, 9:12 AM – 9:24 AM CDT
Oral Abstract Session: Genitourinary (Nonprostate) Cancer
Location: Arie Crown Theater
Additionally, the following data will be shared during poster presentations:

Title: (Abstract TPS4590) EV-201 Study: A Single-Arm, Open-Label, Multicenter Study of enfortumab vedotin for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer who previously Received Immune Checkpoint Inhibitor Therapy

Presenter: Jonathan E. Rosenberg, MD

Session Date/Time: June 2, 8:00 AM – 11:30 AM CDT
Poster Session: Genitourinary (Nonprostate) Cancer
Location: Hall A
Title: (Abstract 5010) Health-Related Quality of Life (HRQoL) Deterioration and Pain Progression in Men with Non-Metastatic Castration-Resistant Prostate Cancer (M0-CRPC): Results from the PROSPER study

Presenter: Gerhardt Attard, MD, PhD

Session Date/Time: June 2, 1:15 PM – 4:45 PM CDT
Poster Session: Genitourinary (Prostate) Cancer
Location: Hall A
Poster Discussion Session on June 2, 2018, 4:45 PM – 6:00 PM CDT, at S406
Title: (Abstract 5043) Association Between Health-Related Quality of Life (HRQoL) and clinical outcomes in non-metastatic castration-resistant prostate cancer (M0 CRPC): Results from the PROSPER study

Presenter: Gerhardt Attard, MD, PhD

Session Date/Time: June 2,1:15 PM – 4:45 PM CDT
Poster Session: Genitourinary (Prostate) Cancer
Location: Hall A
Title: (Abstract TPS7075) A Phase 3, Trial of Gilteritinib, as Maintenance Therapy after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with FLT3-ITD + AML

Presenter: Mark J. Levis, MD, PhD

Session Date/Time: June 4, 8:00 AM – 11:30 AM CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Location: Hall A
*Enzalutamide is developed through a collaboration between Pfizer and Astellas and commercialized under the brand name XTANDI.
**Enfortumab vedotin is developed through a collaboration between Seattle Genetics and Astellas

On May 16, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that abstracts from two Phase 2 studies of indoximod, used in combination with other agents, are now available on the website of the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, NewLink Genetics, MAY 16, 2018, View Source [SID1234526712]). Presentation sessions and times are noted below. Additional data will be presented at ASCO (Free ASCO Whitepaper).

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Abstract 9512, Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma, presented by Yousef Zakharia, MD, University of Iowa Hospitals and Clinics, Holden Comprehensive Cancer Center

Poster Session "Melanoma/Skin Cancers" – Poster Board #339 – Mon, Jun 4, 1:15PM – 4:45PM, McCormick Place, Hall A

Poster Discussion Session – Mon, Jun 4, 4:45PM – 6:00PM, McCormick Place, Rm E451

Abstract 4015, Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer, presented by Nathan Bahary, MD, PhD, University of Pittsburgh Medical Center Cancer Center Pavilion

Poster Session "Gastrointestinal (Noncolorectal) Cancer" – Poster Board #204 – Sun, Jun 3, 8:00AM – 11:30AM, McCormick Place, Hall A

Poster Discussion Session – Sun, Jun 3, 4:45PM – 6:00PM, McCormick Place, Hall D2

About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.

On May 16, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer reported positive data from the FORWARD II trial evaluating mirvetuximab soravtansine in multiple combination cohorts in patients with folate receptor alpha (FRα)-positive ovarian cancer (Press release, ImmunoGen, MAY 16, 2018, View Source [SID1234526746]). Results from the cohort assessing mirvetuximab in combination with Avastin (bevacizumab) in patients with platinum-resistant disease will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 1-5 in Chicago, IL. In addition, ImmunoGen reported updated data from the dose-escalation cohort evaluating mirvetuximab in combination with carboplatin in patients with recurrent platinum-sensitive ovarian cancer.

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"Building upon the encouraging data generated with mirvetuximab monotherapy, we have looked to expand our addressable patient population through combination regimens with both currently approved and experimental agents in ovarian cancer. In dose escalation, we have demonstrated that full dose mirvetuximab can be combined safely with full doses of Avastin, carboplatin, or Keytruda, with encouraging preliminary clinical activity," said Anna Berkenblit, MD, Vice President and Chief Medical Officer of ImmunoGen. "The promising new data reported in the FORWARD II Avastin and carboplatin arms support the potential of mirvetuximab combinations in earlier lines of therapy. Together, these results have informed the triplet combination study with mirvetuximab plus carboplatin and Avastin, which we initiated last quarter."

Berkenblit continued, "In addition, we plan to present initial data from the Keytruda expansion cohort later this year, building upon the dose escalation data recently presented at SGO. The totality of these data from FORWARD II will guide the next stages of development of mirvetuximab and support a path to registration for combination regimens."

DATA FROM FORWARD II EXPANSION COHORT WITH AVASTIN

Mirvetuximab soravtansine in combination with Avastin in patients with platinum-resistant ovarian cancer has demonstrated anti-tumor activity with durable responses and a favorable tolerability profile, particularly among the subset of patients who have received up to three prior lines of therapy and have medium or high levels of FRα expression. This is the population being studied in the FORWARD I Phase 3 registration trial.

Key findings in 59 patients with platinum-resistant ovarian cancer include:

In the subset of 23 patients evaluable for response with medium or high FRα expression levels who have received up to three prior lines of therapy, the confirmed overall response rate (ORR) was 48 percent (95% CI 27,69), with a median progression-free survival (PFS) of 9.9 months (95% CI 4.6,14.5) and a median duration of response (DOR) of 10.6 months (95% CI 3.3,12.0).

For the 54 patients evaluable for response, the confirmed ORR was 43 percent (95% CI 29,57), with a median PFS of 7.8 months (95% CI 5.6,10.2); patients in this cohort had received a median of 3 prior lines of systemic therapy, with 58 percent of patients having received prior bevacizumab.

The combination continues to display a safety profile in-line with the known profiles of each agent, with no new safety signals identified.

"The mirvetuximab and Avastin combination has demonstrated very encouraging initial clinical activity in ovarian cancer patients and a consistently favorable safety profile," stated David O’Malley, M.D., Professor, Director of Gynecology Clinical Trial and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center, and FORWARD II Investigator. "There is a significant need for new therapeutic options to improve outcomes and tolerability for this difficult-to-treat patient population, and I believe these results support further clinical evaluation of this combination regimen."

ASCO PRESENTATION DETAILS

Title: Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients (pts) with platinum-resistant ovarian cancer: maturing safety and activity profile from the FORWARD II Phase 1b study

Presenter: David M. O’Malley, MD, The Ohio State University College of Medicine

Day/Time: Monday, June 4, 1:15-4:45 pm CDT

Location: Hall A

Abstract: 5549

Additional information, can be found at www.asco.org.

UPDATED DATA FROM FORWARD II DOSE-ESCALATION COHORT WITH CARBOPLATIN

Initial findings from a dose escalation cohort of mirvetuximab in combination with carboplatin were presented at ASCO (Free ASCO Whitepaper) 2017. The data have matured and updated findings in heavily pre-treated patients with platinum-sensitive ovarian cancer include:

In the subset of 10 patients with medium or high FRα expression levels, the confirmed ORR was 80 percent (95% CI 44,98), with a median PFS of 15 months (95% CI 9.9,-), and with median DOR not reached.

For all 17 evaluable patients, the confirmed ORR was 71 percent (95% CI 44,90), with a median PFS of 15 months (95% CI 9.9, -), and with median DOR not reached; 50 percent of patients in this cohort had received 3 or more prior lines of systemic therapy.

The combination continues to display a favorable safety profile in-line with the known profiles of each agent, with no new safety signals identified.

Based on the findings from the carboplatin and Avastin cohorts, ImmunoGen recently initiated an additional cohort assessing a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with recurrent platinum-sensitive ovarian cancer as part of the FORWARD II trial.

DATA FROM FORWARD II DOSE-ESCALATION COHORT WITH KEYTRUDA

Additionally, ImmunoGen recently announced encouraging activity and favorable tolerability data from the FORWARD II cohort assessing mirvetuximab in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with platinum-resistant ovarian cancer at the Society of Gynecologic Oncology Annual Meeting. Based on these data, ImmunoGen is completing enrollment in an expansion cohort that includes an additional 35 patients with medium or high FRα expression levels. ImmunoGen plans to report initial findings from this cohort in the second half of this year.

CONFERENCE CALL INFORMATION

ImmunoGen will host a conference call on Thursday, May 17 at 8:00am ET to discuss new data from the FORWARD II trial. To access the live call by phone, dial 323-794-2423; the conference ID is 5718620. The call may also be accessed through the "Investors" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through June 7, 2018.

ABOUT FORWARD II

FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On May 16, 2018 Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, reported that the independent data monitor committee (IDMC) completed a second, interim analysis of tolerability data from the first eleven treated patients and recommended expansion of the initial cohort to continue enrolment of an additional 20 patients to complete the trial (Press release, Tiziana Life Sciences, MAY 16, 2018, View Source;intolerable-Unresectable-or-Metastatic-Hepatocellular-Carcinoma-HCC-Patients [SID1234526674]).

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This phase 2a multi-centre and multi-country clinical trial (CDKO-125A-010) in sorafenib-refractory or -intolerable patients with unresectable or metastatic HCC is being conducted in Greece, Italy and Israel. Since, this was the first trial with milciclib in HCC patients, a second, interim analysis was scheduled following completion of treatment for the first 11 patients before initiating enrolment of the next 20 patients. Thus, demonstration of good tolerability with acceptable incidence of serious adverse events is an important milestone to initiate a phase 2b trial evaluating combination of milciclib with sorafenib (Nexavar; Bayer Germany (BAYN.GR)) in HCC patient.

Major findings were as follows:

Milciclib treatment was well-tolerated with manageable drug-related toxicities. The IDMC concluded that there were no major signals of tolerability concerns and therefore favours proceeding to expand enrolment.

Four patients have completed the study per protocol (6 cycles of treatment in 6 months). Two of these patients and their care provider opted to continue receiving milciclib at full dose as part of compassionate use. A third patient is awaiting ethical committee (EC) approval.

Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented: ”Establishment of tolerability of milciclib as a single agent in HCC patients is a key pre-requisite to initiate the phase 2b trial to evaluate dosing, tolerability and clinical activity of milciclib in combination with sorafenib (Nexavar; Bayer Germany) in HCC patients”.

Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences, commented: "We are pleased with the conclusion of IDMC that milciclib treatment showed no major signals of tolerability concerns in sorafenib-refractory or -intolerable HCC patients. These findings are consistent with the findings reported earlier on the long-term tolerability and clinical activity of milciclib in thymic carcinoma, thymoma1 and other solid cancers2. Results from these clinical studies strongly warrant further clinical development of milciclib for treatments of HCC and other cancers".

Cited References

1. Press Release on announcement of clinical data in thymoma and thymic carcinoma.
www.tizianalifesciences.com

2 . Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. (2017). Phase I dose-escalation study of Milciclib in combination with gemcitabine in patients with refractory solid tumors. Cancer Chemother Pharmacol. 79:1257-1265

About Hepatocellular Carcinoma

Hepatocellular cancer is the 5th most common cancer and the 3rd cause of cancer mortality worldwide. In 2007 the approval by the European Medical Agency (EMA) and Food and Drug Administration (FDA) of sorafenib in HCC represented the first systemic therapy for improving outcome in patients unsuitable for loco-regional and surgical therapies and created a new standard of treatment for the disease. However, although significant in respect to placebo, the benefits of sorafenib are modest; the response rate is less than 3%, the improvement in median survival is 2-3 months and the drug-related symptoms are not ordinary. Therefore, more effective systemic therapy is required for both naive patients presenting with unresectable, advanced stage and those who suffer recurrence after curative treatments (resection, ablation and transplantation).

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases (CDKs) such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in thymic carcinoma, pancreatic carcinoma and colon cancer.

About Sorafenib

Sorafenib (co-developed and co-marketed by Bayer and Onyx Pharmaceuticals as Nexavar) is a small molecular multi tyrosine kinase inhibitor drug approved for the treatment of primary kidney cancer (advanced renal cell carcinoma), advanced primary liver cancer (HCC), and radioactive iodine resistant advanced thyroid carcinoma. Treatment with sorafenib induces autophagy, which may suppress tumor growth. However, autophagy can also cause drug resistance.

On May 16, 2018 BerGenBio ASA (OSE: BGBIO) reported that the company and its collaborators will present new interim clinical and biomarker data from its extensive Phase II clinical development programme with bemcentinib, a selective, oral AXL inhibitor, at the 2018 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) at McCormick Place in Chicago, IL (1-5 June 2018) (Press release, BerGenBio, MAY 16, 2018, View Source [SID1234526697]). Abstracts are now available online at View Source and details of the presentations are below. The posters presented at ASCO (Free ASCO Whitepaper) will be made available on www.bergenbio.com in the Investors / Presentations section following the sessions.

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Presentations at ASCO (Free ASCO Whitepaper)
Monday 4 June, 8:00 AM – 11:30 AM Central Daylight Time (Hall A)

Phase II open-label, multi-centre study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC.
James Lorens, PhD et al
Session: Developmental Therapeutics – Immunotherapy
Poster Board: #292, Abstract 3078
Identification of predictive and pharmacodynamic biomarkers associated with the first-in-class selective AXL inhibitor bemcentinib across multiple Phase II clinical trials.

Robert J Holt, PhD et al
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Poster Board: #385, Abstract 2559
Analysis of anti-leukemic activity, predictive biomarker candidates, immune activation and pharmakodynamics in R/R AML and MDS in response to treatment with bemcentinib (BGB324), a first-in class selective AXL inhibitor, in a Phase II open-label, multi-centre study.

Bjørn T. Gjertsen, MD, PhD et al
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Poster Board: #80, Abstract 7020
To be discussed at the Poster Discussion Session on Monday 4 June, 11:30 AM – 12:45 PM, at E450
Monday 4 June, 1:15 PM – 4:45 PM CDT (Hall A)

A randomized Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma.
Oddbjørn Straume, MD, PhD et al
Session: Melanoma/Skin Cancers
Poster Board: #375, Abstract 9548
BerGenBio reception
Coinciding with ASCO (Free ASCO Whitepaper), BerGenBio will host a reception for collaborators, investors, analysts, media and other interested parties on 2 June at The School of the Art Institute Ballroom in Chicago. At this event, short presentations will be given by clinical investigators participating in the bemcentinib clinical trials and by KOL experts in AXL kinase function. For further details and to receive an invitation, please click here.

The presentations will be made available on BerGenBio’s website in the Investors / Presentations section following the event.