On September 23, 2019 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported presentations highlighting AVID200’s immuno-oncology mode of action at the Fifth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (CICON) in Paris (Sep. 25 – 28) and European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress in Barcelona (Sep. 27 – Oct. 1) (Press release, Forbius, SEP 23, 2019, View Source [SID1234539690]).

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The presentations describe the selective targeting of TGF-beta by AVID200 to increase T-cell-mediated cytotoxicity and immune cell infiltration, resulting in enhanced efficacy of immune checkpoint inhibitors when combined with AVID200 in syngeneic mouse tumor models.

Details of the Presentations Are as Follows:

CICON

Date: Friday, Sep. 27, 2019

Time: 1:00 – 3:00 PM and 6:30 – 8:00 PM CEST (Poster Session B)

Abstract #B041

The full abstract will be available online on Sep. 25

ESMO

Date: Saturday, Sep. 28, 2019

Time: 12:00 – 1:00 PM CEST

Location: Hall 4

Abstract #3582, Presentation Number 504P

Link to online Program here (search for AVID200 to see full abstract)

About Forbius: Targeting TGF-beta and EGFR Pathways in Fibrosis and Cancer

Forbius is a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer. We are focused on the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Forbius’ team of TGF-beta biology experts have designed a proprietary platform of TGF-beta inhibitors with best-in-class potency and selectivity against the principal disease-driving isoforms 1 & 3. This novel class of TGF-beta inhibitors has proven highly active in preclinical models of fibrosis and cancer and was well-tolerated in long-term toxicology studies. Forbius’ lead TGF-beta 1 & 3 inhibitor, AVID200, is undergoing Phase 1 clinical trials in two fibrotic indications as well as in solid tumors.

Forbius’ lead program targeting EGFR is AVID100. AVID100 is an anti-EGFR antibody-drug conjugate (ADC) with a novel tumor-selective mode of action. This program is undergoing Phase 2a clinical trials in EGFR-overexpressing solid tumors.

About TGF-beta 1 & 3

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to anti-PD-(L)1 therapies such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

On September 23, 2019 Oncology Venture A/S (Nasdaq First North Growth Market Stockholm: OV.ST) reported that data on the ability of DRP to predict response to 5-FU anti-cancer treatment in late-stage colorectal cancer will be presented at the annual congress of European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in Barcelona (Press release, Oncology Venture, SEP 23, 2019, View Source [SID1234539706]).

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Fluorouracil (5-FU) is a central component of the standard of care in colorectal cancer treatment. Unfortunately, not all patients benefit from 5-FU, and individual risk assessment is needed to optimize the therapy for individual patients.

Oncology Venture is developing its first-in-class Drug Response Prediction (DRP) technology by utilizing Artificial Intelligence (AI) proprietary algorithms. It has previously been demonstrated that DRP can predict which patients will benefit from 5-FU when administered after surgery in the adjuvant setting. A new study now shows that the use of DRP can be successfully expanded to patients with late-stage, metastasized colorectal cancer. This by using the biopsy material obtained when the patient was initially diagnosed.

This data is presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual cancer congress in Barcelona September on 27 September – 1 October, 2019 as an abstract with the title "Independent clinical validation of a gene expression profile to predict benefit of 5-FU in metastatic colorectal cancer, and as a poster (please see below).

View Source

Poster Display session 2 (ID 211)
Date: 29.09.2019
Time: 12:00 – 13:00
Location: Poster Area (Hall 4)

For further information, please contact:
For investor inquiries
Ulla Hald Buhl, IR & Communication
E-mail: [email protected]
Telephone +45 21 70 10 49

For media inquiries
Thomas Pedersen, Carrotize PR & Communications
E-mail: [email protected]
Telephone +45 60 62 93 90

On September 23, 2019 Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, reported clearance from the Food and Drug Administration (FDA) for PhoenixMD’s Investigational New Drug (IND) application for its proprietary PMD-026 (Press release, PhoenixMD, SEP 23, 2019, View Source [SID1234539723]. That clearance permits PhoenixMD to begin patient enrollment into its Phase 1/1b clinical trial, which is expected to start in the United States during the fourth quarter of 2019.

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"Our IND clearance marks an important developmental milestone for PhoenixMD," said Sandra Dunn, Ph.D., chief executive officer of PhoenixMD. "To our knowledge, PMD-026 is the only purpose-built agent designed specifically to treat triple-negative breast cancer (TNBC). Additionally, we will be assessing the potential of PMD-026 to extend beyond TNBC and into other forms of advanced breast cancer."

PMD-026 is a proprietary first-in-class orally-available RSK (kinase) inhibitor being developed to treat certain forms of breast cancer. The Phase 1/1b clinical trial will evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with advanced disease and a sub-group of women with TNBC. Importantly, this trial will include a CAP/CLIA certified companion diagnostic designed to detect RSK2 activation in breast tumors and to then correlate it with response to PMD-026. This is a new approach for the treatment of cancer that hinges on precision medicine and functional kinomics.

"TNBC patients with metastatic disease have limited treatment options and new drugs have not generally been specifically developed based on the biology of this type of tumor," said Gerrit Los, Ph.D., chief scientific officer of PhoenixMD. "We have had substantial interest from some of the top clinical oncology centers eager to participate in our upcoming trial, underscoring the need for treatment options for women with advanced disease."

About PMD-026
PhoenixMD’s lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase, out of 519 kinases, that drives the growth of this breast cancer subtype. Preclinical data shows the potential for PMD-026 to be effective alone or in combination with conventional chemotherapies. It has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future.

On September 23, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will participate in the 2019 Cantor Global Healthcare Conference in New York, NY. Dr. Helen Torley, president and chief executive officer, will represent the company in a question and answer session on Thursday, October 3 at 3:35 p.m. ET / 12:35 p.m. PT (Press release, Halozyme, SEP 23, 2019, View Source [SID1234539691]).

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A live webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

On September 23, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that two posters on clinical studies combining domatinostat and anti-PD-(L)1 checkpoint inhibitor will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress being held on 27 September to 1 October 2019 in Barcelona, Spain (Press release, 4SC, SEP 23, 2019, View Source [SID1234539707]). The posters will be available on 4SC’s website after the presentation.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Poster presentations at the ESMO (Free ESMO Whitepaper) Congress 2019

Poster EMERGE: Epigenetic Modulation of the Immune Response in Gastrointestinal cancers (Trial in progress)
Session Poster Display session 2 (ID 211)
Time Sunday, 29 September 2019, 12:00 – 13:00 CEST
Location Poster Area (Hall 4)
Poster Phase Ib/II Study (SENSITIZE) assessing safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical outcome of domatinostat in combination with pembrolizumab in patients with advanced melanoma refractory/non-responding to prior checkpoint inhibitor therapy
Session Poster Display session 3 (ID 212)
Time Monday, 30 September 2019, 12:00 – 13:00 CEST
Location Poster Area (Hall 4)
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11 July 2019, 4SC AG: Positive safety review of Phase Ib/II SENSITIZE study of domatinostat + pembrolizumab in melanoma

8 April 2019, 4SC AG: Domatinostat’s mode of action in Merkel cell carcinoma

6 February 2019, First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer