On April 29, 2020 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported that it will report complete safety and biomarker data from its Phase 1 oncology trial with AVID200 in a virtual poster presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting 2020 (Virtual Format, May 29 – Jun. 2) (Press release, Forbius, APR 29, 2020, View Source [SID1234556757]).

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The Phase 1 clinical study (AVID200-03, NCT03834662) in patients with advanced solid tumor malignancies was designed to assess the safety, PK and pharmacodynamic response of escalating doses of AVID200 administered intravenously q3w as a monotherapy.

Doses of 5 – 30 mg/kg were well tolerated, led to peripheral target engagement, TGF-beta pathway biomarker modulation as well as immune activation.

The Phase 1 results serve as a proof-of-principle that AVID200-mediated selective inhibition of TGF-beta 1 & 3 is feasible in the clinic and support the company’s strategy to develop AVID200 across a broad range of immune-oncology and fibrosis indications.

Details of the Presentation:

Title: AVID200, First-in-Class TGF-beta 1 & 3 Selective and Potent Inhibitor: Safety and Biomarker Results of a Phase 1 Monotherapy Dose Escalation Study in Patients with Advanced Solid Tumors

Presenter: Dr. Timothy Yap, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center

Poster Viewing: Available on demand beginning May 29 at 8:00 AM ET

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).

About AVID200 and the AVID200-03 Trial (NCT03834662)
AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3 undergoing Phase 1 clinical testing in solid tumors and fibrotic diseases. TGF-beta 1 & 3 are the principal disease-driving isoforms, while TGF-beta 2 is responsible for normal cardiac function and hematopoiesis.

AVID200’s selectivity for TGF-beta 1 & 3 was designed to achieve optimal efficacy while circumventing cardiac and other safety issues that have limited the applicability of earlier-generation, non-selective TGF-beta inhibitors. Therefore, AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings, including in combination with anti-PD-(L)1 therapy.

AVID200-03 (NCT03834662) is an open label, multicenter, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor effects of AVID200 in patients with advanced or metastatic solid tumor malignancies.

On April 29, 2020 Stand Up To Cancer (SU2C) reported the recent Food and Drug Administration (FDA) approval this month of encorafenib in combination with cetuximab for patients with advanced BRAF-mutated colorectal cancer (Press release, SU2C, APR 29, 2020, View Source [SID1234556756]). Research by the SU2C-Dutch Cancer Society (KWF) Translational Research Team: Prospective Use of DNA-Guided Personalized Cancer Treatment contributed to the development of this treatment.

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"This is the seventh FDA approval for a new cancer therapy supported by SU2C research," said Nobel Laureate Phillip A. Sharp, PhD, chair of the SU2C Scientific Advisory Committee, and Institute professor, David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology. "The work of this team demonstrates how SU2C’s research accelerates development of new effective treatments showing promise in patients."

BRAF-mutant colorectal cancer is a hard to treat type of colorectal cancer that affects 10 to 15 percent of colorectal patients. Across the US and Canada, approximately, this new treatment could potentially help between 17,500-26,000 patients each year.

"Colorectal cancer is the second leading cause of cancer death in men and women combined," stated SU2C CEO Sung Poblete, PhD, RN. "Stand Up To Cancer is proud to have contributed to the development of this new targeted treatment option for people with the historically difficult to treat colorectal cancer whose cancer has progressed, despite receiving prior therapy."

The SU2C-KWF Research Team participated in a Phase 1b/ Phase 2 multi-institutional dose escalation clinical trial (NCT01719380) which studied the effects of encorafenib, alpelisib and cetuximab in BRAF-mutated colorectal cancers. The study compared a two-drug combination of encorafenib and cetuximab; and a triple-drug combination of encorafenib, alpelisib, and cetuximab. Both combinations showed promise for treating metastatic colorectal cancer characterized by BFAF mutations and were well tolerated by the patients. The team made an important observation that patients carrying key mutations in genes associated with the MAP kinase signaling pathway were more responsive to the combination.

Supported by the team’s findings, the FDA granted Breakthrough Therapy Designations for both the combination of encorafenib, binimetinib, and cetuximab and the combination of encorafenib and cetuximab for patients with BRAF V600E-mutant metastatic colorectal cancer, which sped regulatory review.

"We now have clinical proof that science can guide smart treatment combinations which will further stimulate intelligent use of combinations of targeted anti-cancer drugs," said Emile Voest, MD, PhD, professor of Medical Oncology, medical director of the Netherlands Cancer Institute, and leader of the SU2C-KWF Translational Research Team: Prospective Use of DNA-Guided Personalized Cancer Treatment.

"These results highlight how novel insights gained from basic research can lead to novel therapeutic options for cancer patients," said Rene Bernards, PhD, Netherlands Cancer Institute, and co-leader of the Research Team.

This Research Team engaged just over a dozen scientists from the Netherlands Cancer Institute, Erasmus Medical Center, University Medical Center Utrecht in the Netherlands, and University of California San Diego and UC San Francisco.

On April 29, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported the selection of seven presentations to be featured as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program taking place from May 29 – May 31, 2020 (Press release, CytomX Therapeutics, APR 29, 2020, View Source [SID1234556755]).

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The titles of the abstracts are currently available on ASCO (Free ASCO Whitepaper)’s 2020 Digital Scientific Program, with full abstracts, including the dates and times of presentations, scheduled for publication on May 13, 2020.

A list of accepted abstracts by CytomX and its partners is provided below.

ASCO 2020 Clinical Highlights From Across the CytomX Probody Portfolio

Preliminary Data from Phase 1/2 Trial of CX-2029, a CD71 Targeting Probody Drug Conjugate, Partnered with AbbVie
Preliminary Phase 1 Clinical Data Presented by Bristol Myers Squibb from the Ongoing First-in-Human Phase 1/2a trial of BMS-986249, a Probody Version of the anti-CTLA-4 Antibody ipilimumab
Updated Data from the Phase 1/2 Trial of CX-2009, an Anti-CD166 Probody Drug Conjugate
Updated Clinical Data from the Phase 1/2 Trial of CX-072, an Anti-PD-L1 Probody Therapeutic, as Monotherapy, in Selected Tumor Types and in Combination with ipilimumab
"Our presence at ASCO (Free ASCO Whitepaper) this year highlights the strong clinical progress made by CytomX and our partners in exploring the broad potential of the novel Probody technology platform," said Amy Peterson, M.D., chief development officer of CytomX Therapeutics. "We look forward to updating the oncology community on this progress and on next steps towards our vision of transforming the lives of patients with cancer."

CX-2029, An Anti-CD71 Probody Drug Conjugate

Presentation Title: CX-2029, a PROBODY Drug Conjugate Targeting CD71 (Transferrin Receptor): Results from a First-in-Human Study (PROCLAIM-CX-2029) in Patients (Pts) With Advanced Cancer
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 3502
Session Type: Oral Presentation

CX-072, An Anti-PD-L1 Probody Therapeutic

Presentation Title: PROCLAIM-CX-072: Analysis of Patients With Advanced Solid Tumors Receiving Long-Term Treatment With CX-072, a PD-L1 PROBODY Therapeutic, as a Single Agent or in Combination With Ipilimumab.
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 2005
Session Type: Oral Presentation

Presentation Title: Evidence of Intratumoral Localization, Activation, and Immunomodulatory Effect of CX-072, a PROBODY Therapeutic Targeting PD-L1, in a Phase 1/2 Trial
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 3108
Session Type: Poster Presentation (Poster #172)

Presentation Title: Preliminary Population Pharmacokinetics Supports Phase 2 Dose Selection for Masked Anti–PD-L1 Antibody CX-072
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 3602
Session Type: Poster Presentation (Poster #332)

CX-2009, An Anti-CD166 Probody Drug Conjugate

Presentation Title: CX-2009, A CD166-Directed PROBODY Drug Conjugate (PDC): Results From the First-in-Human Study in Patients With Advanced Cancer Including Breast Cancer
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 526
Session Type: Poster Presentation (Poster #18)

Presentation Title: Preliminary Clinical Pharmacokinetics and Dose-Response to Support a Phase 2 Dose Selection for CX-2009: A Masked PROBODY Drug Conjugate to CD166
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 3599
Session Type: Poster Presentation (Poster #329)

BMS-986249, An Anti-CTLA-4 Probody Therapeutic

Presentation Title: Anti–CTLA-4 probody BMS-986249 Alone or in Combination with Nivolumab in Patients with Advanced Cancers: Initial Phase 1 Results
Session Title: Developmental Therapeutics—Immunotherapy
Abstract: 3058
Session Type: Poster Presentation (Poster #122)

On April 29, 2020 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that its President and Chief Executive Officer, Patrick J. Mahaffy, will present at the Bank of America Health Care Conference 2020 on Tuesday, May 12, 2020 at 10:20 a.m. Eastern time (Press release, Clovis Oncology, APR 29, 2020, View Source [SID1234556754]).

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This conference is virtual and a live webcast of the presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

On April 29, 2020 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that it will report the first quarter 2020 on Wednesday, May 6, 2020, after the close of the US market (Press release, Cellectis, APR 29, 2020, View Source [SID1234556753]). The announcement will be followed by a conference call at 7:30 AM EDT / 1:30 PM CET on Thursday, May 7, 2020, prior to the open of the US market.

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The live dial-in information for the conference call is:

US & Canada only: +1 877-407-3104

International: +1 201-493-6792

In addition, a replay of the call will be available until May 20, 2020 by calling +1 877-660-6853 (Toll Free US & Canada); +1 201-612-7415 (Toll Free International)

Conference ID: 13688263