On May 19, 2022 Avenge Bio, Inc. ("Avenge" or the "Company"), a biotechnology company developing the LOCOcyte immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported that two abstracts were selected for presentation as posters at the 25th Annual American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Meeting on May 17 and 18, 2022 (Press release, Avenge Bio, MAY 19, 2022, View Source;cell-therapy-asgct-annual-meeting-301551364.html [SID1234614895]).

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!

"We are excited to present additional preclinical data that support our lead development program, AVB-001, as we advance towards filing an IND in Q2 2022 and a Phase 1 clinical trial in ovarian cancer in 2H 2022," said Douglas Carlson, Chief Operating and Financial Officer. "In addition, we continue to build a robust data set for AVB-001, a novel immunotherapy, in malignant pleural mesothelioma. All of our development programs leverage Avenge’s LOCOcyte platform to deliver proprietary encapsulated engineered human cells to the local tumor environment."

Details on Avenge’s presentations at ASGTC are as follows:

Poster Title: Tumor Adjacent IL-2 Cytokine Factories for Eradication of Various Solid Tumor in Mice Through Cytotoxic T-cell Activation with Safe and Predictable Dosing in Non-human Primates.
Abstract #: 657
Date and Time: May 17, 2022, 5:30pm-6:30pm ET

Poster Title: Evaluation of Implantable Cytokine Factories in Combination with Checkpoint Inhibitors for Eradication of Malignant Pleural Mesothelioma (MPM) Tumors in Mice.
Abstract #: 1097
Date and Time: May 18, 2022, 5:30pm-6:30pm ET

The posters will be available on the Presentations and Publications section of www.avengebio.com following the conference.

On May 19, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and an emerging pre-clinical pipeline, reported that it will be presenting details on the trial design for the INBRX-109 Phase 2 potentially registration-enabling trial in conventional chondrosarcoma at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting to be held June 3rd through June 7th, 2022 in Chicago, Illinois (Press release, Inhibrx, MAY 19, 2022, View Source [SID1234614894]).

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!

Details on the poster presentation are shared below:

Title: A randomized, placebo-controlled phase 2 trial of INBRX-109 in unresectable or metastatic conventional chondrosarcoma
Track/Session: Sarcoma
Poster number:486a
Presenter: Sant P. Chawla, MD
Date & Time: Sunday, June 5, 2022 from 9 a.m. to 11 a.m. CST
Location: Exhibit Hall A

The poster will be available on-demand on the ASCO (Free ASCO Whitepaper) website for attendees beginning at 9:00 AM CST on Friday, June 3, 2022. Upon release at ASCO (Free ASCO Whitepaper), the scientific poster will be accessible through Inhibrx’s website at View Source

About Chondrosarcoma

Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed annually in the United States and the European Union. There are currently no systemic therapies approved for the treatment of chondrosarcoma.

About INBRX-109

INBRX-109 is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 signaling.

In January 2021, the FDA granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. Further, in December 2021, FDA granted Orphan Drug Designation to INBRX-109 for this indication.

In November 2021, Inhibrx provided updated results from its ongoing Phase 1 clinical trial evaluating the efficacy and safety of INBRX-109 in patients with conventional chondrosarcoma. Preliminary disease control was observed in 16 of the 18 evaluable patients (89%) measured by RECISTv1.1, with two of the 18 achieving partial responses (11%). Based on preliminary results of the ongoing Phase 1 trial, the median progression-free survival (PFS) is 7.4 months, and the median overall survival has not been reached. Three patients have exceeded 61 weeks on treatment with INBRX-109, with 77 weeks being the longest duration of stable disease observed to date.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, potentially registration-enabling Phase 2 trial of INBRX-109 in conventional chondrosarcoma. The trial will be conducted at approximately 51 sites within eight countries, with 30 of those sites in the United States.

On Mirati 19, 2022 Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy (Press release, Mirati, MAY 19, 2022, View Source [SID1234614892]).

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 MAA is supported by data from the registration enabling cohort of the Phase 2 KRYSTAL-1 study evaluating adagrasib 600mg BID in patients with advanced NSCLC harboring the KRASG12C mutation following prior treatment with immunotherapy and chemotherapy, either together or sequentially. The Company reported positive topline data from this cohort in September 2021 and plans to present detailed results at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"The submission of our application to the EMA is a significant milestone for Mirati and brings us closer to expanding the potential availability of adagrasib to patients with KRASG12C-mutated lung cancer in the European Union, if approved," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "Therapeutic options for KRASG12C-mutated lung cancer are limited, and this submission is an important step forward in our goal to deliver innovative, differentiated therapies in areas of high unmet need. We look forward to working with the EMA to potentially bring this therapy to patients. We also thank the patients and investigators who make our work possible by participating in clinical trials."

The adagrasib New Drug Application (NDA) is currently being reviewed by the U.S. Food and Drug Administration (FDA) for Accelerated Approval (Subpart H) as a treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy. The application is being reviewed under the FDA Real Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Adagrasib has also achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy.

About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24–48 hours. Adagrasib is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

Mirati has an Expanded Access Program (EAP) for investigational adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.

On May 19, 2022 Dxcover Limited, a clinical stage diagnostics company developing its spectroscopic biopsy technology for early detection of multiple cancers, reported that it will be presenting new data at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 3-7 (Press release, Dxcover, MAY 19, 2022, View Source [SID1234614891]).

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!

Dxcover has pioneered the early detection and identification of cancer by employing infrared spectroscopy of circulating non-genetic biomarkers. The company has completed two groundbreaking studies on earlier diagnosis of brain cancer and is currently developing its platform for the detection of commonly occurring cancers.

"While we know that earlier detection of cancer, when the patient’s tumor is small, results in significantly higher survival rates compared to late-stage diagnosis, the liquid biopsy tests currently used have limited ability to detect and identify early cancers and there are no effective first-line screening options for the early detection of many solid tumors," said Dr. Matthew J. Baker, Chief Technology Officer and co-founder of Dxcover. "Dxcover was founded precisely to solve the problem of shortening the time to cancer diagnosis and enable people to live better, longer lives and we look forward to sharing the results of our multicancer early detection study at ASCO (Free ASCO Whitepaper)."

In addition, Dxcover will also be releasing data for publication only during ASCO (Free ASCO Whitepaper) from its proof-of-concept study which investigates the use of the Dxcover cancer liquid biopsy as a novel approach for pancreatic cancer and detection of multiple cancers.

Details of the sessions are as follows:

Title: Multicancer early detection with a spectroscopic liquid biopsy platform.
Session Title/Track: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Type: Poster Discussion Session

Title: Machine learning based detection of pancreatic tumors using the Dxcover cancer platform.
Session Title/Track: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Type: Publication Only

On May 19, 2022 Tallac Therapeutics, Inc., a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, reported the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) Application to study TAC-001 in a Phase 1/2 clinical trial for patients with advanced or metastatic solid tumors (Press release, Tallac Therapeutics, MAY 19, 2022, View Source [SID1234614890]). TAC-001 is the company’s lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform.

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!

"We are delighted that our IND for TAC-001 was cleared by FDA," said Dr. Hong I. Wan, president, CEO and co-founder of Tallac Therapeutics. "TAC-001 is a novel antibody-oligonucleotide conjugate designed to deliver systemic TLR9 agonism with targeted immune activation of B cells, which plays a key role in cancer immunity. In preclinical studies, systemically administered TAC-001 is active as a single agent across a number of syngeneic tumor models including ones with immune suppression and resistance, leading to complete tumor eradication and immune memory. We believe this is a major advancement over the clinically validated intratumorally administered TLR9 agonists and we look forward to advancing TAC-001 into clinical development for cancer patients."

Toll-like receptor 9 (TLR9) agonists are a class of immunotherapy that generate both innate and adaptive immune response which may produce more robust and durable anti-cancer immunity to help overcome resistance to standard-of-care oncology treatments. TLR9 agonists have demonstrated clinical activity in melanoma patients when administered intratumorally. B cells express TLR9 and play pivotal roles in the immune system, and represent a major component of the tumor microenvironment, where they are predominantly associated with tertiary lymphoid structure (TLS). The presence of B cells and TLS is a positive prognostic factor and predicts treatment response to checkpoint inhibitors in multiple solid tumor types.

Tallac Therapeutic’s TRAAC platform is designed to deliver a potent and differentiated TLR9 agonist (T-CpG) for targeted immune activation via systemic administration. TAC-001 is comprised of T-CpG conjugated to an antibody against CD22, a receptor restricted to B cells, including tumor-infiltrating B cells. Preclinical studies demonstrate that the innate and adaptive immune responses triggered by TAC-001 leads to robust, curative, and durable single agent anti-tumor activity in checkpoint inhibitor resistant and refractory tumor models. Increased B cell infiltration, T cell effector functions and modulation of suppressive myeloid cells within the tumor microenvironment was observed following systemic TAC-001 administration. These results support the development of TAC-001 for a broad range of solid tumor malignancies, particularly in the tumor types with B cell/TLS involvement.

About TAC-001

TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a potent Toll-like Receptor 9 agonist (T-CpG) conjugated to an antibody against CD22, a receptor restricted to B cells, including tumor-infiltrating B cells. TAC-001 is designed to systemically deliver T-CpG to B cells by binding to CD22, leading to internalization of TAC-001, TLR9 signaling, B cell activation and a cascade of immune reactions. Preclinical studies demonstrate that the innate and adaptive immune responses triggered by TAC-001 leads to potent anti-tumor activity. TAC-001 is being developed for the potential treatment of solid tumors.