On September 15, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Elaine Sun, senior vice president and chief financial officer, will present at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 1:20 p.m. Eastern Time / 10:20 a.m. Pacific Time (Press release, Halozyme, SEP 15, 2021, View Source [SID1234587782]).

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!

An audio-only direct link of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 6 months following the event. To access the link, please visit Halozyme’s website approximately 10 minutes prior to the presentation to register and download any necessary audio software.

On September 15, 2021 Obsidian Therapeutics, a biotechnology company pioneering engineered cell and gene therapies, reported that the Company will present data highlighting its cytoTIL15 program at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which will be hosted virtually September 16-21, 2021 (Press release, Obsidian Therapeutics, SEP 15, 2021, View Source [SID1234587780]).

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 abstract for the poster describes how Obsidian’s cytoTIL15 product (TIL engineered with membrane-bound IL15, or mbIL15) demonstrates enhanced in vitro potency and phenotype and in vivo persistence in the absence of IL-2, paving the way for more durable efficacy and improved safety in patients with solid tumor malignancies. The abstract has been published in ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021 Abstract Book.

Details of the poster presentation:
Title: cytoTIL15: A novel TIL therapy for melanoma with superior potency and enhanced persistence without IL2 to improve safety & efficacy and expand patient eligibility
Abstract Number: 1008P
Session: Investigational Immunotherapy
Abstract Summary: Tumor-infiltrating lymphocytes (TILs) have generated promising data in clinical trials as therapy for heavily pretreated patients with solid tumor malignancies, such as metastatic melanoma. TIL therapy currently requires IL2 for in vivo maintenance of TILs, significantly limiting its application due to patient safety and eligibility hurdles. Obsidian’s cytoTIL product is comprised of TILs engineered with mbIL15 that is regulatable using a drug responsive domain (DRD) designed via our cytoDRiVE platform. Our cytoTIL15 product displays a favorable cytotoxic CD8+ T cell phenotype while maintaining TCR Vbeta repertoire diversity during manufacturing. cytoTIL15 exhibit superior in vitro anti-tumor cytotoxicity as well as polyfunctionality, compared to conventional TILs + IL2. In vivo, cytoTIL15 demonstrate greater antigen-independent expansion and persistence compared to conventional TILs treated with IL2.

Jan ter Meulen, M.D., Ph.D., Chief Scientific Officer of Obsidian, commented, "We are very excited about the superior persistence and cytotoxicity profile exhibited by cytoTIL15 in our preclinical models, and are eager to continue to advance our mission to translate these benefits to patients with metastatic melanoma and other solid tumor malignancies."

About cytoTIL15
cytoTIL15 is Obsidian’s lead cytoTIL program, currently in preclinical development for the treatment of patients with metastatic melanoma and other solid tumors. cytoTIL15 is a novel engineered tumor infiltrating lymphocyte therapy engineered with regulated membrane-bound IL15 that does not require patients to receive concomitant IL2 therapy, a toxic and costly requirement for conventional TILs. The Company expects to submit an IND for cytoTIL15 in mid-2022.

On September 15, 2021 Thermo Fisher Scientific reported that The U.S. Food and Drug Administration (FDA) has granted premarket approval to it’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC) who are candidates for EXKIVITY (mobocertinib), a targeted drug developed by Takeda Pharmaceutical Company Limited ("Takeda") (Press release, Thermo Fisher Scientific, SEP 15, 2021, View Source [SID1234587776]).

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!

EXKIVITY is a small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target EGFR Exon20 insertion mutations. It received approval by the FDA on September 15, 2021 for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR Exon20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under Accelerated Approval based on overall response rate and duration of response demonstrated in the platinum-pretreated population of the Phase 1/2 trial of EXKIVITY. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

"Without proper and timely diagnoses, patients with EGFR Exon20 insertion mutations don’t have access to therapies that can most effectively treat their disease," said Dion Warren, vice president, head of U.S. Oncology Business Unit at Takeda Oncology. "We’re pleased to partner with Thermo Fisher to identify and address the unmet needs of patients with this rare cancer."

Lung cancer is the leading cause of cancer death among both men and women in the United States, and non-small cell lung cancer accounts for about 80 to 85 percent of all lung cancer cases.[i] Additionally, EGFR-positive mutations are observed in up to 18 percent of lung cancer cases in the U.S., offering an opportunity to identify and group patients based on this biomarker.[ii] While EGFR mutations are an important therapeutic target, there is a gap in therapies available for EGFR Exon20 insertion mutations,[iii] which affects approximately 1-2 percent of patients with NSCLC.[iv]

Conventional PCR methods can miss 50 percent or more of EGFR Exon20 insertion mutations[v],[vi], thus prompting diagnostic molecular testing with next-generation sequencing (NGS) technology. Testing with NGS is important for early identification and appropriate characterization of tested patients.

"EXKIVITY offers new hope to previously treated patients with mNSCLC and EGFR Exon20 insertion mutations, who usually do not respond well to other available treatments," said Garret Hampton, president, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "FDA approval of the Oncomine Dx Target Test as a companion diagnostic for EXKIVITY will allow clinicians to identify key biomarkers in patients who could benefit from this targeted therapy. Working closely with Takeda to scale the clinical adoption of the test as a companion diagnostic for EXKIVITY is an important next step to enabling precision medicine and potentially improving outcomes of lung cancer patients."

Oncomine Dx Target Test simultaneously evaluates 23 genes associated with NSCLC. The FDA first approved the test as a CDx in 2017 and it is now approved for five targeted therapies for NSCLC and one targeted therapy for cholangiocarcinoma in the U.S. The test has also been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a CDx for five biomarkers – EGFR, ALK, ROS1, BRAF, and RET – associated with 10 targeted therapies for NSCLC. The test is currently approved and reimbursed by government and commercial insurers in more than 15 countries, including the U.S., multiple European nations, Japan, South Korea and the Middle East, and covering more than 550 million lives globally.

On September 15, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that the poster "A pilot study of Engineered Adenovirus ONCOS-102 in combination with pembrolizumab (pembro) in checkpoint inhibitor refractory advanced or unresectable melanoma" is now available at the ESMO (Free ESMO Whitepaper) congress website and on the Company’s website (Press release, Targovax, SEP 15, 2021, View Source [SID1234587773]). The poster will be presented as an e-poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress by Dr Alexander N. Shoushtari, Memorial Sloan Kettering Cancer Center.

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 poster presents the pilot study of ONCOS-102 in combination with pembrolizumab (pembro) in checkpoint inhibitor refractory advanced or unresectable melanoma. The poster concludes that co-administration of ONCOS-102 and pembrolizumab is safe and feasible for patients with melanomas progressing on PD-1 blockade. Rapid clinical objective responses were seen in patients treated both sequentially and in combination, and immune markers demonstrating induction of beneficial tumor microenvironment changes support the role of ONCOS-102 as a complementary treatment with aPD1 and other IO modalities.

E-poster title:

A pilot study of Engineered Adenovirus ONCOS-102 in combination with pembrolizumab (pembro) in checkpoint inhibitor refractory advanced or unresectable melanoma

E-poster number:

1083P

Presenter:

Dr Alexander N. Shoushtari, Memorial Sloan Kettering Cancer Center

Please see the poster here: Targovax ESMO (Free ESMO Whitepaper) 2021 poster.pdf

On September 15, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the presentation of updated positive data from the first-line cohort of the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, and chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Press release, Leap Therapeutics, SEP 15, 2021, View Source [SID1234587771]). The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.

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 Company announced positive initial data from the DisTinGuish study on Monday, September 13, 2021 based on 25 G/GEJ patients enrolled in the trial that showed DKN-01 in combination with tislelizumab and chemotherapy as first-line therapy was well tolerated with compelling activity. The results presented at the ESMO (Free ESMO Whitepaper) Congress today included additional patient data stratified by tumoral PD-L1 expression levels based on visually-estimated combined positive score (vCPS), showing that robust objective clinical responses can be achieved from this combination regimen independently of PD-L1 expression.

"Initial data from this trial have shown that patients with high levels of DKK1 expression, a group with a poor prognosis, had encouraging responses to treatment. The additional data presented today show evidence that not only is DKK1 a critical biomarker in predicting response to DKN-01 and tislelizumab therapy, but also that the combination can induce deep responses regardless of the patient’s PD-L1 status, including particularly poor prognosis patients with both low PD-L1 and high DKK1," said Samuel Klempner, MD, Member of the Faculty at Massachusetts General Hospital Cancer Center and Harvard Medical School. "Taken together, these are promising results for the combination therapy of DKN-01 with tislelizumab and chemotherapy in first line patients with gastric or gastroesophageal junction cancers."

About the DisTinGuish Study

The DisTinGuish study (NCT04363801) is a Phase 2a study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in two parts in the United States and the Republic of Korea. Enrollment of Part A has been completed with 25 first-line HER2- G/GEJ cancer patients whose tumors express either high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B of the study will enroll up to 48 patients with second-line, DKK1-high G/GEJ cancer. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

Key Findings

Among patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in DKK1-high patients and 56% in DKK1-low patients
Response was independent of PD-L1 expression, and particularly strong in the less favorable to checkpoint inhibitor therapy, PD-L1 low (vCPS < 5), population
Among those patients with PD-L1-low expression (vCPS < 5), the ORR was 79%, with 100% in DKK1-high patients and 57% in DKK1-low patients
Among those patients with PD-L1-high expression (vCPS ≥ 5), the ORR was 67%, with 75% ORR in DKK1-high patients and 50% in DKK1-low patients
DKK1 levels could not be determined in one patient who had PD-L1 expression data; however, the patient’s PD-L1 expression level was determined to be low (vCPS score 0) and the patient achieved a partial response
DKK1 expression and PD-L1 expression are not correlated
Median duration of response and progression-free survival data are not yet mature, and patient follow-up continues
Twenty-five first-line patients were enrolled, and as of the cut-off date of the presentation, 15 patients had experienced a partial response (PR), six patients had a best response of stable disease (SD), one patient was non-evaluable for response (NE), and three patients were unable to complete a full cycle of DKN-01 therapy (non-modified ITT (mITT)).

Among the 21 patients that had RNAscope DKK1 expression available, 12 were DKK1-high [9 PR, 1 NE, 2 non-mITT] and 9 were DKK1-low [5 PR, 4 SD].

Among the 20 patients that had PD-L1 expression available, 14 were PD-L1 low vCPS < 5 [11 PR, 3 SD] and 6 were PD-L1 high vCPS > 5 [4 PR, 1 SD, 1 NE].

A copy of the poster presentation is available on the Company’s website at View Source

Conference Call

Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the data. In addition to Leap’s executive management team, Dr. Jaffer Ajani of M.D. Anderson Cancer Center and Dr. Samuel Klempner of Massachusetts General Hospital will be on the call. The call can be accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The passcode for the conference call is 1729397. The presentation will be webcast live and may be accessed on the Investors page of the Company’s website at View Source, where a replay of the event will also be available for a limited time.