On December 20, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that the company will present at two upcoming scientific meetings, the AACR (Free AACR Whitepaper) Special Conference: Targeting RAS, being held January 7-10, 2022 in Lake Buena Vista, Florida and the ASCO (Free ASCO Whitepaper) GI Cancers Symposium, being held January 20-22 in San Francisco, California (Press release, Kinnate Biopharma, DEC 20, 2021, View Source [SID1234597455]).

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!

"Since our founding, Kinnate has been driven by our mission to expand the availability of targeted therapies to all patients who may benefit from them," said Richard Williams, MBBS, Ph.D., Chief Medical Officer at Kinnate. "We are very pleased with the continued progress of both our RAF and FGFR inhibitor programs and look forward to sharing these updates with the oncology community at these upcoming meetings."

Details of the upcoming AACR (Free AACR Whitepaper) Special Conference: Targeting RAS presentation, which will be delivered by Paul Severson, Ph.D., Kinnate’s Senior Director of Translational Medicine and Bioinformatics, are as follows:

Abstract title: Real-World Clinico-Genomic Analysis of Patients with BRAF Mutated Solid Tumors Identifies BRAF Class II and III as a Significant Population of Unmet Need
Session: Poster Session A
Session date and time: Saturday, January 8, 2022, from 4:45PM -7:00PM ET
Additional information on the AACR (Free AACR Whitepaper) Special Conference: Targeting RAS is available through the conference website at: View Source

Details of the upcoming ASCO (Free ASCO Whitepaper) GI Cancers Symposium presentation, which will be delivered by Aleksandra Franovic, Ph.D., Senior Director of Translational Medicine at Kinnate, are as follows:

Abstract title: Activity of KIN-3248, a next-generation pan-FGFR inhibitor, against acquired FGFR-gatekeeper and molecular-brake drug resistance mutations
Session: Poster Session B
Session date and time: Friday, January 21, 2022, from 3:05PM – 4:35PM ET
Additional information on the ASCO (Free ASCO Whitepaper) GI Cancers Symposium is available through the conference website at: View Source

On December 20, 2021 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-MUC1C-ALLO1, the Company’s allogeneic CAR-T product candidate targeting multiple solid tumor indications (Press release, Poseida Therapeutics, DEC 20, 2021, View Source [SID1234597484]).

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!

Poseida announces FDA clearance of IND for P-MUC1C-ALLO1, a fully #allogeneic CAR-T targeting multiple solid tumors.
"We are excited to begin the P-MUC1C-ALLO1 trial, an evaluation of a fully allogeneic CAR-T product candidate with the potential to treat a wide range of solid tumors, including breast, ovarian and other cancers," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida Therapeutics. "The genetic edits in P-MUC1C-ALLO1 have been shown to reduce or fully eliminate alloreactivity, and our proprietary manufacturing process, which includes our booster molecule, has the potential to treat many patients from a single manufacturing run. We look forward to beginning this trial and to presenting initial clinical data in 2022."

P-MUC1C-ALLO1 is the Company’s second fully allogeneic CAR-T product candidate to receive IND clearance in 2021 following P-BCMA-ALLO1 for the treatment of relapsed/refractory multiple myeloma. P-MUC1C-ALLO1 is the first product candidate to be produced out of the Company’s new GMP facility, an internal pilot manufacturing plant located at its San Diego headquarters.

P-MUC1C-ALLO1 will be evaluated in a Phase 1 multi-center, open-label, dose escalation study in adults with locally advanced or metastatic epithelial-derived solid tumors refractory to standard of care therapy, or those deemed ineligible or refused another existing treatment option. The study will evaluate the safety, tolerability, and preliminary efficacy of P-MUC1C-ALLO1 and will follow a 3+3 design of dose-escalating cohorts. After a subject enrolls, P-MUC1C-ALLO1 allogeneic CAR-T cells will be administered, following a standard chemotherapy-based conditioning regimen. The study protocol allows for exploration of additional dosing regimens, including re-dosing once initial safety has been established.

About P-MUC1C-ALLO1
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in preclinical development for multiple solid tumor indications. P-MUC1C-ALLO1 has the potential to treat a wide range of solid tumors derived from epithelial cells, such as breast, colorectal, lung, ovarian, pancreatic and renal cancers, as well as other cancers expressing a cancer-specific form of the Mucin 1 protein, or MUC1C. P-MUC1C-ALLO1 is designed to be fully allogeneic, with genetic edits to eliminate or reduce both host-vs-graft and graft-vs-host alloreactivity. Poseida has demonstrated the elimination of tumor cells to undetectable levels in preclinical models of both triple-negative breast and ovarian cancer.

On December 20, 2021 Sandoz, a global leader in generic and biosimilar medicines, reported the submission of its Biologics License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix, Inc. to the US Food and Drug Administration (FDA) (Press release, Sandoz, DEC 20, 2021, View Source [SID1234597539]).

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!

Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers1. Sandoz is seeking approval for the same indications as the reference medicine, based on a comprehensive package that includes analytical, preclinical and clinical data.

"Approximately 15-20% of all breast cancer patients have tumors that are HER2- positive2 and, as these tumors tend to grow more quickly than HER2-negative tumors,3 getting treated swiftly can be live-saving," said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. "Trastuzumab is standard of care so, if approved, we will introduce more competition aiming to broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines in the US."

Breast cancer is the most commonly diagnosed cancer among women in the US and associated death rates are the second highest of all cancers. It is estimated that about 30% of newly diagnosed cancers in women will be breast cancers in 20214.

As part of the license agreement signed in April 2019, EirGenix, Inc. is responsible for development and manufacturing and Sandoz will have the right to commercialize the medicine upon approval in all markets excluding China and Taiwan.

Sandoz has been developing and providing oncology medicines for over 30 years. Today, it has well over 50 such medicines, including chemotherapeutics, biologics, hormones and supportive care treatments, for the treatment of a wide range of cancers. The collaboration with EirGenix will enable Sandoz to build on its leading generic and biosimilar oncology portfolio to further expand patient access, while contributing to the sustainability of healthcare systems.

On December 19, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported dosing in Australia of the first subject in the Phase I PROBE Trial, a first-in-human study of ATG-101 in patients with metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL) (Press release, Antengene, DEC 19, 2021, View Source [SID1234597415]). The primary objective of the study is to evaluate the safety and tolerability of ATG-101 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ATG-101; the secondary objective is to evaluate preliminary anti-tumor activity of ATG-101.

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!

ATG-101 is a novel bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that progressed on anti-PD-1/L1 treatment. Furthermore, no liver toxicity was observed in GLP toxicology studies in cynomolgus monkeys with doses up to 100 mg/kg.

"ATG-101 has been specifically designed to combine the proven activity of PD-1 inhibition with the immune stimulating activity of 4-1BB. Our intent is to further enhance the role of immune-oncological drugs, by turning "cold" tumors "hot" and thereby improve outcomes for patients who do not respond to anti-PD-1/PD-L1 monotherapies, or regain control of disease that has become resistant or refractory to these drugs. This has become a growing and increasingly important medical need." said Dr. Kevin Lynch, Chief Medical Officer of Antengene. "PROBE is Antengene’s first global trial of an in-house developed, novel drug. The program is now enrolling patients in Australia, thereafter expanding to the U.S. where the IND has been cleared by the FDA. Dosing of the first subject is an important milestone, highlighting our cross-regional Discovery and Clinical execution capabilities. We are very grateful to the patients, investigators and study site staff for their dedication and support for this program and hope we will be able to make an important difference in cancer with ATG-101."

"As many patients with malignancies are resistant or refractory to current therapies, including chemotherapy, targeted therapy and monoclonal antibodies, there remains a need for novel treatments for this patient population," said Dr. Charlotte Lemech, Medical Director of Scientia Clinical Research in Sydney, Australia.

Dr. Lemech continued, "Accumulating evidence suggests that bispecific antibodies will fill an important role as one of these novel strategies. We are excited to be leading this clinical trial, the first to administer ATG-101 – a novel PD-L1/4-1BB bispecific antibody – bringing together a group of highly experienced Australian investigators to collaborate with Antengene. The design of ATG-101 incorporates a high affinity for PD-L1 and conditional activation of 4-1BB, which potentially reduces the risk of 4-1BB related liver toxicity. We are looking forward to assessing whether this bispecific antibody can provide enhanced efficacy with a better safety profile and a new option for these patients."

About the PROBE Trial
The PROBE trial is a first-in-human Phase I trial of ATG-101 in patients with metastatic/advanced solid tumors and mature B-cell non-Hodgkin lymphomas (B-NHL). The study will be conducted in the Dose Escalation Phase and Dose Expansion Phase, with the primary objective to evaluate the safety and tolerability of ATG-101 and to determine the MTD) and/or RP2D) of ATG-101, and the secondary objective to evaluate preliminary anti-tumor activity of ATG-101. The study will also evaluate a range of pharmacology, immunology and biomarker measurements.

About ATG-101
ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of multiple kinds of cancer. ATG-101 was designed to activate anti-tumor immune effectors, by forming a cell-antibody-cell trimer to simultaneously block the binding of PD-L1/PD-1 and induce 4-1BB stimulation, with limited hepatoxicity. ATG-101 activates exhausted cells in vitro, signaling a potential in reversing T-cell dysfunction and exhaustion (on PD-1 cross-linking). In PD-L1 over-expressing cancer cells, ATG-101 demonstrated significant anti-tumor activity in animal tumors that progressed on anti-PD-1/L1 treatment and a favorable safety profile in GLP toxicology studies. Data from these studies, as well as unique computational semi-mechanistic pharmacology modeling work, was recently presented at the Society of Immunology and Cancer (SITC 2021).

On December 17, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, reported that updates from an oral presentation delivered by Dr. Zachary Crees from the Washington University School of Medicine in St. Louis (WUSTL) at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which was held December 11-14, 2021, in Atlanta, GA, and virtually (Press release, BioLineRx, DEC 17, 2021, View Source [SID1234597360]).

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 oral presentation, entitled, "Motixafortide (BL-8040) and G-CSF Versus Placebo and G-CSF to Mobilize Hematopoietic Stem Cells for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma: The GENESIS Trial" elaborated on the successful results of the Company’s GENESIS Phase 3 pivotal trial which assessed Motixafortide plus G-CSF for the mobilization of stem cells in multiple myeloma patients. The study showed highly significant and clinically meaningful results supporting the use of Motixafortide on top of G-CSF for mobilization of stem cells for subsequent collection and transplantation in patients with multiple myeloma.

Recapping the efficacy data previously reported, Dr. Crees noted that 92.5% of patients in the Motixafortide+G-CSF arm achieved the primary endpoint (the mobilization of ≥6M CD34+ cells/kg in up to two apheresis sessions, p<0.0001), versus 26.2% for the placebo+G-CSF arm. Furthermore, 88.8% of patients in the Motixafortide+G-CSF arm achieved the secondary endpoint (the mobilization of ≥6M CD34+ cells/kg in one apheresis session, p<0.0001), versus 9.5% for the placebo+G-CSF arm.

Of note, Dr. Crees also indicated that 15–35% of patients still failed to yield optimal stem cell yields of ≥6M CD34+ cells/kg in two previously published plerixafor trials, even with up to four apheresis sessions. Additionally, Dr. Crees noted that advances in modern induction therapies for multiple myeloma patients have made the harvesting of a sufficient number of stem cells even more challenging, a trend that is expected to continue in the future, thus highlighting the need for new and improved mobilization therapies.

"We were very pleased that Dr. Crees had an opportunity to deliver an oral presentation at ASH (Free ASH Whitepaper), one of the most prestigious and well attended oncology gatherings of the year, to provide additional details on the outstanding results from our GENESIS Phase 3 trial," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Along with the outstanding efficacy data from the trial and the positive results from the pharmacoeconomic study that we reported on previously, trends in the treatment paradigm, whereby new induction therapies in patients make the mobilization of stem cells ever more challenging, give us great enthusiasm for this molecule and emphasize its place as part of the standard of care in autologous stem cell transplantation. We look forward to a pre-NDA meeting with FDA in the coming days."