On April 17, 2023 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported the April 13th publication of preclinical data in Cell Press’s Med supporting DF6002 as a promising treatment option for cancer patients (Press release, Dragonfly Therapeutics, APR 17, 2023, View Source [SID1234630208]). DF6002 is Dragonfly’s novel half-life extended interleukin-12 (IL-12) cytokine immunotherapy, currently in Phase 1 clinical development with dose escalation progressing successfully in patients as a monotherapy and in combination with nivolumab, in the U.S. and in Europe.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Systemic IL-12 cytokine therapy was historically associated with severe toxicities due to its narrow therapeutic index. Dragonfly’s preclinical data demonstrates that DF6002 is well tolerated when administered systemically and results in potent anti-tumor responses in multiple preclinical models as monotherapy and in combination with checkpoint inhibitors. Dragonfly’s novel DF6002 IL-12 is designed for half-life extension which alters IL-12’s pharmacodynamic response profile and expands its therapeutic index. "We are excited about these findings, which provide compelling evidence supporting our ongoing Phase I clinical trial, which is evaluating the safety and tolerability of DF6002 in patients with advanced solid tumors," said Joseph Eid, MD, Dragonfly’s President of Research and Development. "Given the encouraging profile we have seen both in preclinical models and in the clinic to date, we are accelerating DF6002’s development across a range of indications and combinations."

About DF6002
DF6002, Dragonfly’s extended half-life IL-12 cytokine, is an investigational immunotherapy being evaluated alone and in combination with nivolumab in participants with locally advanced or metastatic solid tumors (NCT04423029). DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002 is the most advanced in a pipeline of cytokines that Dragonfly is developing to address the high unmet need in patients with advanced cancer.

On April 17, 2023 WuXi Biologics ("WuXi Bio") (2269. HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) and its subsidiary WuXi XDC congratulate their partner DualityBio, a clinical-stage biotech company focusing on the discovery and development of next generation ADC therapeutics for patients with cancer and autoimmune diseases, on entering into exclusive license and collaboration agreements with German based BioNTech, a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, for two investigative antibody-drug conjugates ("ADC") therapeutics (Press release, WuXi Biologics, APR 17, 2023, View Source [SID1234630207]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

WuXi Bio provided technical services, based on the companies’ versatile integrated service platforms, to support various manufacturing and process development activities of these ADC product candidates.

"We congratulate DualityBio for the license agreements for two of their ADC candidates and are pleased to have been able to support DualityBio with our diverse services and expertise in the field of ADC products," commented Dr. Chris Chen, CEO of WuXi Biologics, "Over the last couple of years, our advanced technology platforms and high-quality services have supported our clients to win the trust of their partners, which facilitates multiple global collaborations between biotech and multinational pharmaceutical companies."

"Congratulations to DualityBio on reaching the license agreements with BioNTech. We are honored to support innovative partners such as DualityBio in advancing ADCs with our premier quality systems and extensive expertise," commented Dr. Jimmy Li, CEO of WuXi XDC, "Innovative and differentiated ADCs are emerging driven by unmet medical needs. As a global CRDMO dedicated to bioconjugates, we’ll continue to accelerate and transform the discovery, development and manufacturing of bioconjugates, supporting our global partners for the benefit of patients globally."

On April 17, 2023 Medivir AB (NASDAQ Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that a poster entitled ‘A triple combination of fostrox (MIV-818) with immune checkpoint and kinase inhibition shows increased anti-tumor efficacy in vivo,’ will be presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting by Fredrik Öberg, CSO at Medivir (Press release, Medivir, APR 17, 2023, View Source [SID1234630206]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Fostroxacitabine bralpamide (fostrox) is an orally administered liver-targeted prodrug currently undergoing a phase 1/2a clinical study in advanced hepatocellular carcinoma (HCC), in combination with Keytruda (anti-PD1) or Lenvima (kinase inhibitor) (NCT0341818). In previous studies, Fostrox has shown significantly increased anti-tumor effect in combination with both anti-PD1 and kinase inhibitors in non-clinical tumor models, which opens the door for a potentially further enhanced tumor effect with a triple combination.

The poster supports this potential as it exhibits that fostrox combined with both anti-PD1 and Lenvima shows a synergistic anti-tumor effect in a non-clinical tumor model characterized by the same low, underlying DNA damage seen in patients with HCC. The poster also shows that fostrox induces increased tumor infiltration of CD8+ T cells as well as increased expression of PD-L1 and LAG-3, indicating increased immune-mediated antitumor activity. The results indicate a potential for triple combination of anti-PD1 and Lenvima with fostrox in the treatment of HCC.

"Although existing combination treatments for HCC can prolong patients’ lives, far from all patients respond to the treatment. In order for more patients to obtain a satisfactory effect on their treatment, new combination options with several different, additive mechanisms of action are needed. Fostrox, with its unique, liver-targeted activity, opens up for new combinations with three different approaches to effectively treat HCC," says Pia Baumann, CMO at Medivir.

The poster will be available on Medivir’s website after the presentation.

For additional information, please contact
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: [email protected]

About fostrox
Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is
11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On April 17, 2023 KaliVir Immunotherapeutics, Inc., a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, reported the presentation of new data on its lead pre-clinical candidate VET3-TGI presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Orlando, Florida (Press release, KaliVir Immunotherapeutics, APR 17, 2023, View Source [SID1234630205]). VET3-TGI is based on KaliVir’s unique Vaccinia Enhanced Template (VET) platform, capable of generating potent novel oncolytic vaccinia viruses with modifications to maximize viral replication and to enhance intravenous delivery and spread. VET3-TGI incorporates modifications granting the expression of CXCR3, IL-12 and a TGF-β inhibitor, allowing for efficient trafficking to the tumor, activation of anti-tumor immune responses and overcoming of local immunosuppressive activity.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The functionality and therapeutic activity of VET3-TGI were tested in multiple murine in vivo tumor models, and the mechanism of action and toxicity profile were assessed. VET3-TGI demonstrated potent therapeutic activity, even at doses several logs below equivalent clinical doses and in the presence of pre-existing anti-viral immunity. Mechanism of action studies confirmed enhanced IL-12 expression and reduced suppression of CD8 T cells mediated through blockade of TGF-β, and indicate that the therapeutic efficacy of VET3-TGI is associated with considerable modification of the tumor microenvironment. The data presented at AACR (Free AACR Whitepaper) also includes preliminary toxicity studies demonstrating the safety of VET3-TGI.

"This new in vivo data represents a significant validation of our lead pre-clinical candidate and builds upon the already robust in vitro data to further demonstrate the efficacy and safety of VET3-TGI in multiple tumor types," said Stephen Thorne, PhD, CSO and co-founder of KaliVir. "This is an exciting time for KaliVir as we expand our lead program into the next phase to develop a human version of the virus for efficacy and toxicology testing."

Presentation details

Date:

Wednesday, April 19th 9:00 AM – 12:30 PM ET

Title:

The oncolytic virus VET3-TGI both blocks TGF-beta signaling and activates type 2 IFN responses, resulting in potent therapeutic responses in multiple mouse models

Presented by:

Ravikumar Muthuswamy, Ph.D. Director of Immunology, KaliVir Immunotherapeutics

Poster number:

6789/5

Location:

Orange County Convention Center Level 2, West Hall B-E1, Section 44

On April 17, 2023 BridGene Biosciences, Inc., a biotechnology company using a proprietary chemoproteomics technology to discover and develop small molecules for high-value, traditionally undruggable targets, reported that it will present a poster, titled "Preclinical characterization of BGI-9004, a covalent TEAD inhibitor with exceptional anti-cancer activity and combination potential," at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 on April 18 in Orlando (Press release, Bridgene Biosciences, APR 17, 2023, View Source [SID1234630204]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Pharmacological inhibitors of TEAD transcription factors have emerged as a promising novel class of anti-cancer agents. TEAD inhibitors disrupt oncogenic YAP/TAZ signaling, resulting in cell cycle arrest and cell death in susceptible cancers.

"Using our IMTAC live-cell chemoproteomic platform to identify small molecules against challenging targets, we have successfully identified several potent and drug-like covalent ligands for TEAD. Based on this discovery, we rapidly developed the pre-clinical candidate BGI-9004," said Wolf Wiedemeyer, Ph.D., BridGene’s head of biology. "The covalent TEAD inhibitor BGI-9004 has demonstrated promising activity both as a single agent and in combination with other targeted agents, a favorable pharmacokinetic profile and high target selectivity in preclinical models, supporting its evaluation as a novel anti-cancer agent in clinical trials."

Details regarding the poster presentation are as follows:

Event:

AACR Annual Meeting 2023

Title:

Preclinical characterization of BGI-9004, a covalent TEAD inhibitor with exceptional anti-cancer activity and combination potential

Abstract Number:

4976

Date:

Tuesday, April 18, 2023

Time:

1:30-5 p.m. ET

Location:

Poster Section 16, Poster 22

Orange County Convention Center, Orlando, Fla.