On June 15, 2021 Caris Life Sciences, a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine, and Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported a strategic collaboration to jointly identify oncogenic fusions and mutations that are driver alterations (Press release, Elevation Oncology, JUN 15, 2021, https://elevationoncology.com/caris-life-sciences-and-elevation-oncology-announce-joint-discovery-and-development-collaboration-focused-on-oncogenic-fusions-and-driver-mutations/?utm_source=rss&utm_medium=rss&utm_campaign=caris-life-sciences-and-elevation-oncology-announce-joint-discovery-and-development-collaboration-focused-on-oncogenic-fusions-and-driver-mutations [SID1234584018]). Together, Caris and Elevation Oncology will discover and develop therapeutics targeting these newly identified alterations.

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!

Under the terms of the agreement, Caris and Elevation Oncology will jointly evaluate potential targets, some of which are not currently actionable by an existing therapeutic, identified on an ongoing basis by analyzing Caris’ Whole Transcriptome Sequencing (WTS) and Whole Exome Sequencing (WES) data. The companies can then elect to initiate a novel drug discovery program for those targets, or pursue licensing or product acquisitions, while retaining exclusive access to all targets selected by the parties.

"Caris is dedicated to advancing precision oncology for patients. We are thrilled to build upon our strategic relationship with Elevation Oncology and deepen the connection between molecular diagnostics and clinical development," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris Life Sciences. "By pairing our unique insight into potential genomic driver alterations gained through Caris’ market-leading molecular profiling capabilities with Elevation Oncology’s strength in executing innovative clinical oncology programs in genomically-defined populations, we aim to further close the gap between target identification and clinical investigation for potential new therapeutics."

"Through this collaboration between Elevation Oncology and Caris, we hope to demonstrate how biopharmaceutical and molecular medicine companies can work hand in hand to realize visions that are shared across the precision oncology community," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "At Elevation Oncology, we believe every cancer patient deserves the opportunity to be matched with an actionable, purposely selected therapeutic that is precisely targeted to their tumor’s unique genomic biomarkers. In Caris, we have found a collaborator who both shares this vision as a leader in genomic testing and who can provide real-world insights into emerging or underserved genomically-defined patient populations. Together, we believe we are pioneering a platform to accelerate the development of precision therapeutics and build toward a future where patients have the option of a matched therapy for every driver alteration – no matter how rare."

Caris Molecular Intelligence, the company’s proprietary, comprehensive tumor profiling approach assesses all 22,000 genes in both DNA and RNA, and proteins – unique to an individual’s cancer – to reveal a molecular blueprint in order to guide more precise and individualized treatment decisions. Caris’ CODEai is the most comprehensive data solution in the industry, with cancer treatment information and clinical outcomes data for over 244,000 patients covering over 1,000,000 data points per patient. The analysis of oncogenic fusions and mutations that are driver alterations for assessment under the collaboration will be conducted on both the historical dataset that has been compiled by Caris, and on an ongoing basis from the future tumor profiling data routinely generated from Caris’ platforms over the term of the agreement.

Therapeutics selected by the parties, and subsequent companion diagnostics, will be developed on a cost-sharing basis with revenue being shared on any approved therapeutics.

On June 15, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that Chief Executive Officer, Bill Newell, will participate in two virtual investor conferences in June (Press release, Sutro Biopharma, JUN 15, 2021, View Source [SID1234584017]).

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!

Presentation Details
JMP Securities Life Sciences Conference

Format: Fireside Chat

Date: Thursday, June 17, 2021

Time: 3:30 p.m. ET / 12:30 p.m. PT

Raymond James Human Health Innovations Conference

Format: Panel Session

Panel Title: Targeted Oncology 2: Antibody Drug Conjugates

Date: Wednesday, June 23, 2021

Time: 10:40 a.m. ET / 7:40 a.m. PT

Live webcasts of each presentation can be accessed through the Events and Presentations page of the Investor Relations section on the company’s website at www.sutrobio.com. Archived replays of the webcasts will be available on the company’s website for approximately 30 days following each live presentation.

On June 15, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported it has received FDA authorization to conduct a Phase 1b/2 open-label study to evaluate the safety and preliminary efficacy of its superagonist Anktiva (N-803, an IL-15 superagonist) and PD-L1 targeted high-affinity natural killer (t-haNK) cells in combination with standard chemo and Trodelvy (sacituzumab govitecan-hziy), in subjects with advanced triple-negative breast cancer (TNBC) (Press release, NantKwest, JUN 15, 2021, View Source [SID1234584016]). The study may provide data indicating whether this combination can increase the effectiveness of Trodelvy in patients who have failed to respond to other treatments.

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!

Triple-negative breast cancer is a serious, aggressive cancer with a high mortality rate. While Trodelvy displayed efficacy against TNBC in phase 3 testing, only a third of third-line patients respond to it, and less than 17% of them continue to respond after a year. ImmunityBio proposed this new study based on data from a Phase 1 trial (NCT03387085) with Anktiva and the company’s haNK cells that elicited a significant response rate in refractory TNBC. Anktiva and PD-L1 t-haNK when used in combination with Trodelvy may show additive or even synergistic effects, greatly increasing the response rate and, importantly, durability of responses.

"Antibody-drug conjugates like Trodelvy have made tremendous progress in giving patients with TNBC more and higher-quality time, but we believe Anktiva could potentially fill remaining treatment gaps and offer patients additional hope," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. "We’re conducting multiple studies with Anktiva across different tumor types, in some cases in combination with our NK cell line, that are designed to determine if they can enhance the activity of therapeutic monoclonal antibodies like Trodelvy—and, ultimately, provide patients with longer, progression-free survival."

The strategy behind this approach is to attack the tumor in two distinct, complementary ways—with Trodelvy delivering the initial blow by targeting the protein Trop-2 displayed by many TNBC cells and delivering a chemotherapy payload while Anktiva recruits key cells of the immune system, including NK and T cells, to continue fighting the tumor. To further unleash the power of the immune system, PD-L1 t-haNK will be introduced.

QUILT 3.058 Study Details

This phase 1b/2 open-label study will evaluate the safety and efficacy of sacituzumab govitecan-hziy in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in subjects with TNBC after at least two prior treatments for metastatic disease.

The study consists of two phases and the maximum total enrollment for this study is 79 subjects.

The phase 1b portion of the study will be conducted in 2 parts: part 1 will involve dose escalation using a 3 + 3 design, and part 2 will involve the expansion of the recommended phase 2 dose (RP2D) to further evaluate the safety and efficacy of sacituzumab govitecan-hziy plus chemoimmunotherapy. The phase 2 portion of the study will be based on Simon’s two-stage optimal design.
In phases 1b and 2, all subjects will receive sacituzumab govitecan-hziy plus chemo- and immuno-therapy: cyclophosphamide, N-803, and PD-L1 t-haNK on a 3-week schedule. . The dose of sacituzumab govitecan-hziy will be dependent on dose level cohort for phase 1b and will be set at the RP2D for phase 2. The doses of cyclophosphamide, N-803, and PD‑L1 t haNK will remain the same in all dose level cohorts and phases.
An estimated 2.3 million women globally were diagnosed with breast cancer last year and 685,000 died from it. Triple negative breast cancer is an especially aggressive form of the disease and accounts for 10% to 15% of breast cancers, according to the American Cancer Society. TNBC tests negative for estrogen receptors (ER), progesterone receptors (PR) and human epidermal growth factor receptor 2 (HER2) protein. Therefore, TNBC does not respond to hormonal therapy or medicines that target ER, PR, or HER2 and other treatment options are limited, particularly after initial lines of therapy have failed. Innovative treatment approaches, such as the combination of Trodelvy, Anktiva, and PD-L1 t-haNK with chemotherapy described here may offer new hope to these advanced TNBC patients.

On June 15, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that as part of the annual reconstitution of the Russell stock indexes, Moleculin has been selected to be added to the Russell 2000 Index effective after the close of the U.S. equity markets on June 25, 2021 (Press release, Moleculin, JUN 15, 2021, View Source [SID1234584015]).

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!

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"We are pleased to have been included in this year’s reconstitution of the Russell 2000 Index. Our team has worked tirelessly to advance the Company on multiple fronts and we believe this inclusion is further evidence of those efforts. We are grateful for the opportunity to access increased market exposure to help drive awareness of our development programs seeking to solve the toughest challenges in highly resistant cancers and viruses," commented Walter Klemp, Chairman and CEO of Moleculin.

The Russell 2000 Index measures the performance of the small-cap segment of the US equity market. The Russell 2000 Index is a subset of the Russell 3000 Index representing approximately 10% of the total market capitalization of that index. It includes approximately 2,000 of the smallest securities based on a combination of their market cap and current index membership.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell’s U.S. indexes which are part of FTSE Russell, a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide.

On June 15, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported the U.S. Food and Drug Administration’s (FDA) clearance of its Investigational New Drug (IND) application for JTX-1811, an anti-CCR8 antibody, for which Gilead Sciences, Inc. (Nasdaq: GILD) has exclusive rights to develop and commercialize (Press release, Jounce Therapeutics, JUN 15, 2021, View Source [SID1234584014]). The IND clearance triggers a $25.0 million milestone payment to Jounce.

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!

JTX-1811, which will be referred to as GS-1811 in Gilead’s pipeline, is a monoclonal antibody created by Jounce and designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells. The target of JTX-1811 is CCR8, a chemokine receptor enriched on TITR cells. When JTX-1811 binds to CCR8, it targets TITR cells for depletion by enhancing an antibody-dependent cellular cytotoxicity mechanism.

"The clearance of the JTX-1811 IND marks an important and validating milestone for Jounce in our approach to cancer immunotherapy treatment. We have now been able to bring multiple novel and diversified immunotherapy development candidates into clinical development, further enhancing our opportunity to bring benefit to cancer patients who have few options. Specifically, this is our fourth internally-developed antibody in five years and is testament to the power of our discovery to early development engine" said Richard Murray, PhD, Chief Executive Officer and President of Jounce Therapeutics. "We look forward to JTX-1811’s continued advancement as Gilead progresses this program into the clinic."

Under the terms of the September 2020 agreement, Gilead invested $35.0 million in Jounce’s common stock and made an $85.0 million upfront payment to Jounce. Jounce has led the development of JTX-1811 through IND clearance, after which Gilead now has the sole right to develop and commercialize the program. After receiving this $25.0 million milestone payment, Jounce may receive up to an additional $660.0 million in future clinical, regulatory and commercial milestone payments and will also be eligible to receive royalties ranging from high single digit to mid-teens based upon worldwide sales. Any milestone or royalty paid to Jounce is subject to certain reductions as described in the license agreement