On October 10, 2018 Incyte (Nasdaq: INCY) has reported that the Phase 2 intermediate data of its selective inhibitor of FGFR1 / 2/3 in the clinical research phase, pemigatinib (INCB54828), will be will present at the next European Congress of Oncology (ESMO) (Free ESMO Whitepaper) 2018 that will take place in Munich, Germany, from October 19 to 23, 2018 (Press release, Incyte, OCT 10, 2018, View Source [SID1234529846]).

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The information that will be announced in ESMO (Free ESMO Whitepaper) 2018 includes poster presentations on the FIGHT-202 study of pemigatinib in patients with advanced cholangiocarcinoma (cancer of the bile duct) and previously treated / metastatic or surgically unresectable with a genetic alteration of the factor of fibroblastic growth (FGF) / FGFR, as well as the FIGHT-201 study of pemigatinib in patients with metastatic or surgically unresectable urothelial carcinoma (cancer of the bladder) carrying an alteration of the FGF / FGFR gene.

"We are pleased that pemigatinib data – part of our portfolio of targeted treatments – have been selected for presentation at this year’s ESMO (Free ESMO Whitepaper) conference," said Steven Stein, MD, medical director, Incyte. "We are keen to share the latest intermediate data from the ongoing FIGHT-202 trial for pemigatinib in patients with cholangiocarcinoma, who continue to support our project to submit the new drug registration request in 2019 for this indication, as well as updated data from the FIGHT-201 study of pemigatinib in patients with urothelial carcinoma, which supports the recruitment for the continuous administration cohort of this trial ».

The summaries were made public today on the ESMO (Free ESMO Whitepaper) congress website, at View Source .

Poster details:

Intermediate results of FIGHT-202, an open and multicenter Phase 2 study of INCB054828 in patients (pts) with advanced and previously treated / metastatic or surgically unresectable cholangiocarcinoma (CCA) with / without alterations of the fibroblast growth factor (FGF) gene / FGF receptor (FGFR) (summary No. 756P, poster presentation session)

Sunday, October 21, 2018 from 12:45 pm Spanish Peninsular Time until 1:45 pm Spanish Peninsular Time (6:45 am East Coast Time at 7:45 am Eastern Time) in the Pavilion A3 – Poster Area Networking Hub
Intermediate results of FIGHT-202, an open-label multicentre study in Phase 2 of INCB054828 in patients (pts) with metastatic or surgically unresectable urothelial carcinoma (UC) carrying the genetic alterations (GA) of fibroblast growth factor (FGF) / FGF receptor (FGFR) (summary No. 900P, poster presentation session)

Monday, October 22, 2018 from 12:45 pm Spanish Peninsular Time at 1:45 pm Spanish Peninsular Time (6:45 am East Coast Time at 7:45 am Eastern Time) in Hall A3 – Poster Area Networking Hub
The details of the full session and the data submission lists for ESMO (Free ESMO Whitepaper) 2018 can be found at:

View Source .

About the FGFR and Pemigatinib (INCB54828)

Fibroblast growth factor receptors (FGFR) play an important role in the proliferation of tumor cells and in survival, migration and angiogenesis (formation of new blood vessels). The mutations, translocations and activating gene amplifications of the FGFRs are closely correlated with the development of various types of cancer.

Pemigatinib is a potent selective inhibitor of isoforms 1, 2 and 3 of FGFR that, in preclinical studies, has shown a selective pharmacological activity against cancer cells with alterations in FGFR. Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy for various neoplasms due to FGFR are underway. The FIGHT clinical trial program (FIbroblast Growth factor receptor in oncology and Hematology Trials) currently comprises the FIGHT-201 study in patients with metastatic or surgically unresectable bladder cancer, including activating alterations of FGFR3; the FIGHT-202 study in patients with metastatic or surgically unresectable cholangiocarcinoma who did not respond to previous treatment, including activating translocations of FGFR2; and the FIGHT-203 study in patients with myeloproliferative neoplasms with activating translocations of FGFR1.

On October 10, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its acquisition of Vernalis plc has successfully closed and Vernalis will now operate as a subsidiary of Ligand (Press release, Ligand, OCT 10, 2018, View Source [SID1234529847]). Vernalis is a structure-based drug discovery biotechnology company with a broad pipeline of partnered programs and ongoing collaborations. In conjunction with this event, Ligand announced that its portfolio now contains more than 178 shots on goal.

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"We welcome the Vernalis team into the Ligand family and are pleased to add its expertise in structure-based drug discovery to our discovery technology platforms that we offer partners. The Vernalis team has proven its ability to generate novel drug candidates for its partners, including the leading partnerships with Verona and Corvus for COPD and oncology," said John Higgins, Chief Executive Officer of Ligand. "As we advance the Ligand business model, we will continue to evaluate a variety of business, royalty and technology acquisitions, all with the objective of adding shots on goal to our portfolio and creating potential for long-term, diversified and sustainable cash flows for our investors."

Under the terms of the acquisition, Ligand paid Vernalis shareholders approximately $42.3 million, offset by approximately $32 million of net cash on hand at Vernalis, after deal costs.

As previously announced, the acquisition of Vernalis provides Ligand with the following:

A portfolio of more than 8 fully-funded partnered programs, or shots on goal, including:
RPL554, a Phase 2, novel treatment for COPD, which is partnered with Verona Pharma;
CPI-444, a Phase 1, adenosine A2A receptor antagonist for treatment of solid tumors, which is partnered with Corvus Pharmaceuticals.
A 70-person R&D team based in Cambridge, England focused on fragment- and structure-based drug discovery and partnering, with an active portfolio of collaboration agreements generating over $8 million per year of service revenue matched by a comparable level of costs, and partnerships that have the potential to generate additional near-term shots on goal. Ongoing collaboration partners include Servier, Daiichi Sankyo, Asahi Kasei and others.
An established compound library and additional early-stage, unpartnered programs in oncology, CNS and other areas that will provide business development out-licensing and corporate formation opportunities.
England-based operations that provide a platform to more efficiently pursue investment and acquisition opportunities in Europe and the United Kingdom.
Ligand 2018 Financial Outlook

As previously announced, revenue and operating expense impact from Vernalis in 2018 is currently expected to be small and mostly offset each other. Beyond 2018, research business revenue is expected to approximate expenses with longer-term milestones and royalties being accretive to future Ligand earnings.

Advisors

MTS Securities, LLC and finnCap Ltd. served as financial advisors and Latham Watkins LLP served as legal advisor to Ligand in this transaction.

On October 9, 2018 Oblique Therapeutics, a biotech focused on new medicines for severe diseases with large unmet medical needs, reported that it will present new promising preclinical data for the drug candidate OT-1096 in triple-negative breast cancer (TNBC) at the largest oncology congress in Europe, the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), held 19-23 October in Munich, Germany (Press release, Oblique Therapeutics, OCT 9, 2018, View Source [SID1234529831]).

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The new data of the first-in-class anti-cancer agent OT-1096 shows promising preliminary results with improved tumor growth inhibition compared to pembrolizumab, one of the blockbuster drugs within immunooncology. The humanized TNBC PDX mouse-model, used in this study, allows for the growth of a breast cancer derived from a patient, in the presence of a human immune system. The results suggest that OT-1096 reduces tumor growth by two associated mechanisms; direct cancer cell killing activity by redox system modulation that, in turn, results in a beneficial immunomodulatory action through lowering of regulatory T-cells within the TIL* population as compared to controls. The results warrant further investigations of OT-1096 in TNBC and other aggressive cancers. Treatment with OT-1096 shows no safety or tolerability concerns.

"First of all, it is an honor to be recognized by ESMO (Free ESMO Whitepaper), and we are thrilled to exhibit our promising results for OT-1096 for the first time. Even more so, being part of changing the treatment landscape for cancer at this time is exciting for us: the 2018 Nobel Prize in Medicine was awarded for pioneering work in immunooncology and we see more and more traction and exciting results from novel immunomodulatory small molecules, such as ours, with the capacity to favorably change the immune system inside tumors ," said Prof. Owe Orwar, CEO at Oblique Therapeutics.

TNBC is an aggressive subtype of breast cancer associated with poor prognosis and limited treatment options, and new effective medicines are needed. Globally, two million people are diagnosed with breast cancer every year; of which 10-13 percent has TNBC.

Prof. Owe Orwar, CEO at Oblique Therapeutics, will present a poster (441P) with the title: "OT-1096, a first-in-class immunoactivating small molecule that targets the thioredoxin reductase/thioredoxin axis causes strong tumor growth inhibition by downregulating intratumoral Tregs in a humanized TNBC-PDX model" on Monday 22 October 2018 at 12:45-13:45. The abstract is available through esmo.org: View Source (search: 441P)

For more information, please contact:

Prof. Owe Orwar
CEO
Email: [email protected]

About OT-1096

OT-1096 is a next-generation first-in-class small molecule immunomodulator with anti-cancer activity. The initial clinical focus is on targeting advanced triple-negative breast cancer (TNBC) but the program will be extended to include other forms of metastatic and advanced cancer that fits to the mechanism of action of OT-1096.

On October 9, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported that it will present 54 abstracts, including eight oral presentations and three late breakers, to the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (ESMO 2018) Congress in Munich, Germany, 19-23 October (Press release, AstraZeneca, OCT 9, 2018, View Source [SID1234529815]).

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Data span several tumour types and include full results from the Phase III SOLO-1 ovarian cancer trial to be presented in the Presidential Symposium, along with new research on resistance mechanisms in metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). In addition, MedImmune Senior Vice President, Head of Oncology Innovative Medicines and Professor of Medicine and Medical Oncology at South-Paris University, Jean-Charles Soria, will be recognised for his outstanding contribution to medical oncology by receiving the 2018 ESMO (Free ESMO Whitepaper) Award.

Dave Fredrickson, Executive Vice President, Head of Oncology Business Unit, said: "Our diversified Oncology portfolio prioritises medicines with the potential to redefine the clinical practice of cancer treatment. We are working to deliver potentially curative approaches earlier in the treatment paradigm across a range of cancers. We are also exploring how to stay a step ahead of disease progression by understanding how tumours become resistant to treatment over time."

Detailed Lynparza data from the Phase III SOLO-1 trial in women with newly-diagnosed, advanced BRCA-mutated ovarian cancer

SOLO-1 is the only trial of a poly (ADP-ribose) polymerase (PARP) inhibitor, Lynparza, to demonstrate a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for women with newly-diagnosed, advanced BRCA-mutated ovarian cancer. Data from the trial by AstraZeneca and MSD, known as Merck in the US and Canada, will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium (Presentation #LBA7_PRAbstract). In the 1st-line setting, only 20 percent of women have prolonged, relapse-free periods and are considered cured following surgery and chemotherapy, and 70 percent relapse within three years. These data will provide detailed PFS results for Lynparza, supporting the treatment goal of long-term remission in women with newly-diagnosed disease, where currently-available treatment options aimed at extending time to progression only offer modest improvements.

New understanding of acquired resistance mechanisms in lung cancer from the Phase III FLAURA trial

Preliminary data on acquired resistance mechanisms seen with 1st-line Tagrisso (osimertinib) use in the Phase III FLAURA trial (Presentation Number #LBA_5005) will be presented as a late-breaker, providing new insights into potential treatment strategies for patients with metastatic EGFR-mutated NSCLC.

Lung cancer Immuno-Oncology (IO): New insights from the Phase III PACIFIC trial

An oral presentation of subgroup analyses will explore the efficacy and safety of the PACIFIC regimen in unresectable, Stage III NSCLC evaluating differences in treatment and timing for chemoradiation therapy before Imfinzi (Abstract #1363O).

Early pipeline explores combinations in difficult-to-treat tumour types

Key presentations from AstraZeneca’s early stage pipeline include insight into novel DNA Damage Response (DDR)-IO combinations. A Phase I clinical and translational evaluation of the ATR inhibitor, AZD6738, in combination with Imfinzi in patients with lung or head and neck cancer will be featured as a poster discussion (Abstract #413PD).

Data from the early-stage IO pipeline, including updated results from the Phase Ib/II multi-indication SCORES trial of Imfinzi plus danvatirsen (AZD9150, STAT3) or AZD5069 (CXCR2), demonstrating the impact of targeting novel pathways, will also be presented (Abstract #1044O).

Additionally, new approaches to patient selection using different methods of detection of homologous recombination repair gene mutations will be highlighted in a Phase II trial of Lynparza plus abiraterone (Study 08) in metastatic castration-resistant prostate cancer (Abstract #97P).

Key AstraZeneca/MedImmune presentations at ESMO (Free ESMO Whitepaper) 2018:

Lead author

Abstract title

Presentation details

Ovarian cancer

Moore, K

Phase III SOLO1 trial: Maintenance olaparib following platinum-based chemotherapy in newly diagnosed patients (pts) with advanced stage ovarian cancer (OC) and a BRCA1/2 mutation (BRCAm)

Oral Presentation

Presidential Symposium 2

Sunday 21st October, 16:30-18:10

Presentation Time: 17:45-18:00

Location: Hall A2, Room 18

Abstract #LBA7_PR

Penson, RT

MEDIOLA: A Phase I/II trial of olaparib (PARP inhibitor) in combination with durvalumab (anti-PD-L1 antibody) in patients with advanced solid tumors – new ovarian cancer cohorts

Poster

Gynaecological cancers

Monday 22nd October, 12:45-13:45

Location: Hall A3

Abstract #448TiP

Colombo, N

BAROCCO: A randomized phase II study of weekly paclitaxel vs. cediranib-olaparib with continuous schedule vs. cediranib-olaparib with intermittent schedule in advanced platinum-resistant ovarian cancer

Poster

Gynaecological cancers

Saturday 20th October, 12:30-13:30

Location: Hall A3

Abstract #1002TiP

Lung Cancer

Ramalingam, S

Mechanisms of acquired resistance to first-line osimertinib: preliminary data from the phase III FLAURA study

Oral Presentation

NSCLC, metastatic

Friday 19th October, 16:00-17:30

Presentation Time: 16:00-16:12

Location: Hall A2, Room 18

Abstract #LBA50

Faivre-Finn, C

Efficacy and safety evaluation based on time from completion of radiotherapy to randomization with durvalumab or placebo in pts from PACIFIC

Oral Presentation​

Non-Metastatic NSCLC and Other Thoracic Malignancies

Sunday 21st October, 09:15-10:45

Presentation Time: 10:15-10:30

Location: Hall A1, Room 17
Abstract #1363O

Kowalski, D

ARCTIC: durvalumab + tremelimumab and durvalumab monotherapy vs SoC in ≥3L advanced NSCLC treatment

Oral Presentation ​

NSCLC, metastatic

Monday 22nd October, 09:15-11:00​

Presentation Time: 10:15-10:30

Location: Hall A1, Room 17​

Abstract #1378O

Bondarenko, I

Preliminary efficacy of durvalumab plus tremelimumab in platinum-refractory/resistant ED-SCLC from Arm A of the Phase II BALTIC study

Poster Discussion

Lung early

Sunday 21st October, 14:45-16:00

Discussion Time: 15:25-15:35

Location: ICM, Room 1

Abstract #1665PD

Early pipeline

Cohen, EW

Phase 1b/2 Study (SCORES) of Durvalumab (D) Plus AZD9150 or AZD5069 in Advanced Solid Malignancies and Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M-SCCHN): Updated Results

Oral Presentation

Head & Neck cancer
Monday 22nd October, 14:45-16:15

Presentation Time: 14:45-15:00

Location: ICM, Room 14b
Abstract #1044O

Krebs, MG

Phase I clinical and translational evaluation of AZD6738 in combination with durvalumab in patients (pts) with lung or head and neck carcinoma

Poster Discussion

Developmental therapeutics

Saturday 20th October, 15:00-16:15

Discussion Time: 15:00-15:20

Location: Hall B3, Room 22

Abstract #413PD

Carr, Thomas H

Multimodal detection of homologous recombination repair gene mutations (HRRm) in a Phase II trial of olaparib plus abiraterone in metastatic castrate resistant prostate cancer (mCRPC)

Poster

Biomarkers

Saturday 20th October, 12:30-13:30

Location: Hall A3

Abstract #97P

On October 9, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported the closing of the first $8 million tranche of its $15 million investment from Alpha Holdings, Inc. (KOSDAQ: 117670) (Press release, OncoSec Medical, OCT 9, 2018, View Source [SID1234529816]). This value-focused, fundamental strategic investment is centered on the clinical development of OncoSec’s lead immunotherapy product candidate, TAVO (tavokinogene telseplasmid). TAVO enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with powerful immune-stimulating functions.

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Alpha Holdings is a leading Korean technology company engaged in the design, development, service and manufacture of system semiconductors, as well as the development of biotechnologies and thermal compound materials. Since 2002, Alpha Holdings has successfully carried out many projects as a major partner of Samsung Advanced Foundry Eco-system (SAFE) of Samsung Electronics. Alpha Holdings, a listed company in the KOSDAQ Market, was founded in 2002 and is headquartered in Seongnam, South Korea.

Under the terms of the agreement, Alpha Holdings has committed to purchase a total of $15 million worth of shares of common stock from OncoSec in two tranches at $1.50 per share. The two tranches are each subject to a six-month holding requirement from date of funding. As stated above, Alpha has funded the first tranche of $8 million. The closing of the second tranche is subject to the satisfaction of certain closing conditions. Further details of the transaction can be found in the Form 8-K filed by the Company describing the agreement.