On September 29, 2021 Flamingo Therapeutics., a biotechnology company pioneering RNA-targeting therapies in oncology, reported that Mike Garrett, Chief Executive Officer and Rob MacLeod, Chief Scientific Officer, will participate in a fireside chat at the Chardan Virtual 5th Annual Genetic Medicines Conference on Monday, October 4th, 2021 at 5:30 pm ET (Press release, Flamingo Therapeutics, SEP 29, 2021, View Source [SID1234590487]). The Flamingo management team will also participate in one-on-one meetings with investors during the conference.

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!

On September 29, 2021 GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, and Innovent Biologics (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the first patient with KRAS G12C mutation has been dosed in the first-in-human trial of GFH925 (ClinicalTrials.gov, NCT05005234) (Press release, GenFleet Therapeutics, SEP 29, 2021, View Source [SID1234590486]).

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!

Led by Professor Yilong Wu of Guangdong Provincial People’s Hospital, it is an open label, multicenter study treating advanced solid tumors patients with KRAS G12C mutation.

Designed to enroll over 100 patients with late stage NSCLC and gastrointestinal cancer, the study will evaluate the safety/tolerability/efficacy and characterize the pharmacokinetics profile of GFH925 administered orally to patients with KRAS G12C mutation. Moreover, this study will explore the potential mechanisms of primary and acquired resistance to KRAS inhibitors. Based on emerging data of GFH925 and other KRAS inhibitors including biomarkers, investigators will look to further optimize the precision treatment plans and the potential for combination therapies.

"KRAS mutation is widespread among patients of non-small cell lung cancer, pancreatic cancer, colorectal cancer, etc. Preclinical data has shown that GFH925 is differentiated from other KRAS G12C inhibiting products, and we look forward to positive results of GFH925’s safety/tolerability and efficacy to benefit patients with KRAS G12C gene mutation." said Professor Yilong Wu, Director of Guangdong Lung Cancer Institute.

"Current data demonstrates the higher response to selective KRAS G12C inhibitors in population of lung cancer patients with KRAS G12C mutation. The first patient with KRAS G12C mutation administrated after precision screening is a key milestone in the clinical development of GFH925. Thanks to our joint efforts with investigators from our sites, we have completed program initiation and began patient screening in a very short amount of time. We are also confident that our collaboration with Innovent, with its successful track records of developing and commercializing novel therapies, will speed up the study process in order to bring this life-saving treatment to patients across the globe." said Yu Wang, M.D./Ph.D., Chief Medical Officer of GenFleet Therapeutics.

"KRAS G12C is one of the most frequently mutated oncogenes in human cancer cells and RAS used to be an undruggable target over decades. So far there have been few treatments for patients with this mutation and we can see huge unmet medical needs. We are pleased to achieve the dosing of the first patient and it’s an important milestone in the development ofIBI351 (GenFleet R&D code: GFH925). Based on preclinical data, we believe that the clinical research of IBI351 in China will benefit more patients with KRAS G12C mutant lung cancer and other solid tumors and deliver more effective therapies for doctors in the world." said Hui Zhou, Senior Vice President of Clinical Development of Innovent.

About GFH925

Being developed by GenFleet Therapeutics, GFH925 is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest.

GenFleet Therapeutics and Innovent Biologics entered into an exclusive license agreement in early September for the development and commercialization of GenFleet’s lead KRAS G12C candidate, GFH925 in China, including the Chinese mainland, Hong Kong, Macau and Taiwan with additional option-in rights for global development and commercialization.

On September 29, 2021 Immunis.AI, Inc., an immunogenomics platform company developing noninvasive blood-based tests to optimize patient care, reported the close of additional financing that brings its total raised to $40 million to date for the ongoing development of its proprietary Intelligentia immunogenomic platform (Press release, ImmunisAI, SEP 29, 2021, View Source [SID1234590483]). The additional funding comes on the heels of successful completion of key development milestones, including three pivotal studies of the Intelligentia platform. Funding will support further validation and commercialization of the company’s first molecular test in prostate cancer and will also be used to expand development of new tests in breast, colon, lung cancer and other cancers.

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 Intelligentia liquid biopsy platform enables a highly sensitive method for the detection and grading of early-stage cancer and other diseases using a single blood sample. The platform is used to identify and interrogate novel disease-specific biomarkers as well as biomarkers indicative of the immune response to the disease.

"Immunis has developed a platform that harnesses the power of the immune system, achieving potent signal enrichment using proprietary methods and advanced machine learning," said Harry Stylli, Ph.D., Executive Chairperson of the Board at Immunis.AI. "With the recently achieved major milestones, the company is poised to deliver on its core mission to improve early detection and patient outcomes."

"We are grateful for the continuing support of our investors, who share our excitement about the potential of our proprietary immunogenomic platform to transform patient care paradigms," said Christopher Thibodeau, President & CEO of Immunis.AI. "We look forward to reporting results from our pivotal studies in prostate cancer and to delivering tests to better aid in the diagnosis and treatment of patients early, when there is the greatest opportunity for cure."

The successful completion of milestones triggered the final tranche of new capital received over the last several months and positions the company to capitalize on the strong performance of the Intelligentia platform, to develop new pan cancer and disease surveillance tests, and to further advance commercial readiness of its lead test for the active surveillance of prostate cancer. The financing was led by Savitr Capital, LLC with participation from existing investors and management.

On September 29, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that the first patient has been dosed in the dose confirmation study of SY-2101, a novel oral form of arsenic trioxide (ATO) (Press release, Syros Pharmaceuticals, SEP 29, 2021, View Source [SID1234590480]). The trial will evaluate the pharmacokinetics (PK), safety, and tolerability of SY-2101 to confirm the optimal dose to advance into a planned Phase 3 clinical trial in newly diagnosed acute promyelocytic leukemia (APL) patients.

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 current standard of care cures most patients but is tremendously burdensome, requiring regular and lengthy infusions of an IV formulation of ATO over nearly a yearlong course of treatment," said Farhad Ravandi, M.D., Professor of Medicine, Chief of Section of Acute Myeloid Leukemia, Department of Leukemia at The University of Texas – MD Anderson Cancer Center. "An oral form of ATO that offers similar efficacy while dramatically reducing the treatment burden would represent a major advance for APL patients. The preliminary Phase 1 data for SY-2101 are very promising, and I look forward to its continued advancement in the current and future studies."

APL is a well-defined subtype of acute myeloid leukemia (AML), which accounts for about 10% of AML cases, with approximately 2,000 APL patients diagnosed annually in the United States and Europe. An intravenously administered formulation of ATO is approved for use in combination with All-Trans-Retinoic-Acid (ATRA) in newly diagnosed APL and, while curative in more than 80% of patients, its administration requires up to 140 infusions over the typical 10-month course of induction and consolidation treatment. In an earlier Phase 1 clinical trial, SY-2101, which is dosed once daily, demonstrated oral bioavailability, PK exposures similar to IV ATO, and a generally well-tolerated safety profile.

"We are thrilled to now be dosing patients in our dose confirmation study of SY-2101," said David A. Roth, M.D., Chief Medical Officer at Syros. "This milestone represents an important step toward delivering a new option for people with APL and a meaningful advance in our efforts to build a leading portfolio of targeted hematology therapies. We believe SY-2101 could quickly become the new standard of care for APL by offering patients similar efficacy with a substantially more accessible and convenient therapy. We plan to move swiftly from our dose confirmation study into a Phase 3 trial next year, with the goal of filing a New Drug Application (NDA) in 2024."

The dose confirmation study is expected to enroll up to 24 patients with newly diagnosed APL and will evaluate safety, tolerability, and PK as well as the effect of food on the absorption of SY-2101. Patients will be enrolled during the consolidation phase of their APL treatment and will receive single doses of SY-2101 in a fasted state, SY-2101 in a fed state, and IV ATO. Patients will then have the option to roll over into a multiple-dose cohort to receive either SY-2101 or IV ATO, which will provide additional data on the steady state PK and safety of SY-2101 in comparison to IV ATO. Syros expects to report data from this study in the first half of 2022.

Based on the results of the dose confirmation study, Syros expects to initiate a Phase 3 clinical trial in newly diagnosed APL patients. Based on input from the FDA, Syros believes molecular complete response rate and event-free survival in comparison to historical control data with IV ATO may support accelerated and full approval, respectively.

On September 29, 2021 Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals and ADC Therapeutics SA (NYSE: ADCT), reported the first patient has been dosed with ZYNLONTA in a pivotal Phase 2 clinical trial in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in China (Press release, Overland ADCT BioPharma, SEP 29, 2021, View Source [SID1234590478]). In April 2021, ZYNLONTA was granted accelerated approval by the U.S. Food and Drug Administration (FDA) as the first and only CD19-targeted antibody drug conjugate (ADC) as a single-agent treatment for adult patients with r/r DLBCL after two or more lines of systemic therapy. This local pivotal study mirrors ADC Therapeutics’ ongoing global pivotal Phase 2 clinical trial of ZYNLONTA and its results are intended to support the potential registration of ZYNLONTA in China.

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!

"After receiving early FDA approval of ZYNLONTA in April, we are pleased that our colleagues at Overland ADCT BioPharma have rapidly initiated a pivotal study to potentially benefit patients in China," said Chris Martin, PhD, Chief Executive Officer of ADC Therapeutics. "We are eager for this bridging study to be completed, and we hope that ZYNLONTA will ultimately be available to all patients who can benefit from it globally."

"Dosing the first patient in this pivotal trial is a key milestone for Overland ADCT BioPharma as we collaborate to expand the clinical reach of ZYNLONTA in greater China and Singapore," said Eric Koo, Chief Executive Officer of Overland ADCT BioPharma. "With many patients in China affected by r/r DLBCL, we remain committed to addressing this unmet medical need and delivering promising antibody drug conjugates for underserved patients around the world. Together with ADC Therapeutics, we look forward to the continued development and commercialization of ZYNLONTA in Asia."

ZYNLONTA, Overland ADCT BioPharma’s lead product candidate, is an ADC composed of a humanized monoclonal antibody directed against human CD19 and conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. In clinical trials, ZYNLONTA has demonstrated significant single-agent clinical activity across a broad population of patients with r/r DLBCL, mantle cell, and follicular lymphomas.

The China Phase 2, multi-center, open-label, single-arm study will evaluate the efficacy and safety of ZYNLONTA used as monotherapy in patients with r/r DLBCL.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.