On January 4, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it has expanded its oncology research and development pipeline to include small cell lung cancer (SCLC) as an additional disease indication for its lead drug candidate, REQORSA Immunogene Therapy (Press release, Genprex, JAN 4, 2022, View Source [SID1234598073]). SCLC represents approximately 10-15 percent of the lung cancer market, while REQORSA’s initial target indication of non-small cell lung cancer (NSCLC) represents approximately 84 percent of the lung cancer market.

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!

"Data from human studies indicate that REQORSA could be beneficial in targeting small cell lung cancer," said Mark S. Berger, MD, Chief Medical Officer at Genprex. "Like non-small cell lung cancer, small cell lung cancer consistently has low TUSC2 protein levels and is documented to often have deletion of one TUSC2 gene allele. Extensive stage small cell lung cancer has a very poor prognosis, with a median progression free survival of 5.2 months. Expanding the therapeutic indications targeted by REQORSA to include small cell lung cancer may provide us with another important clinical opportunity to combine REQORSA with small cell lung cancer therapies, including checkpoint inhibitors."

REQORSA consists of a TUSC2 gene expressing plasmid encapsulated in non-viral lipid nanoparticles. Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. The ONCOPREX Nanoparticle Delivery System could allow for the delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies to potentially address unmet medical need in cancer, thereby potentially improving patient outcomes through the advancement of multiple therapeutic approaches for large patient populations.

"REQORSA may have the potential to treat small cell lung cancer, in addition to non-small cell lung cancer, thus making REQORSA a possible drug candidate for the entire lung cancer market," said Rodney Varner, Genprex’s Chief Executive Officer. "Lung cancer continues to be the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver or stomach cancers. We hope that one day REQORSA will provide improved outcomes for virtually all lung cancer patients."

On January 4, 2022 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported that it has entered into an R&D collaboration and option agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to explore the immunogenicity of neoantigens and the role and impact of Inhibigens in the context of vaccine therapies for cancer (Press release, Genocea Biosciences, JAN 4, 2022, View Source [SID1234598071]). The agreement was facilitated by Johnson & Johnson Innovation.

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 collaboration, Genocea will use its clinically validated ATLAS platform to characterize Janssen-identified antigens as well as assess approaches that could mitigate the impact of Inhibigens. Genocea will receive a technology access fee and full R&D funding for its work under the collaboration. The agreement includes an option for Janssen to negotiate a future strategic partnership to develop non-personalized vaccine products using Genocea’s ATLAS platform and expertise on Inhibigens.

"ATLAS is the only technology that can identify Inhibigens, pro-tumor antigens that can undermine otherwise effective immunotherapies," said Chip Clark, Genocea’s President and Chief Executive Officer. "We are delighted to work with Janssen on this novel biology that has important implications for cancer treatment."

GEN-011 TiTAN trial update
Genocea reported significant progress in the Phase 1/2a TiTAN clinical trial for its lead program GEN-011, a neoantigen-targeted peripheral T cell (NPT) therapy candidate. GEN-011 is comprised only of CD8+ and CD4+ T cells, extracted from the patient’s peripheral blood, specific for ATLAS-prioritized neoantigens. GEN-011 has the potential to be differentiated from other cell therapies because of the breadth of surface-presented neoantigens it targets and the ease of manufacturing tumor-relevant T cells extracted from readily accessible peripheral blood. Patients receive either GEN-011 in multiple fractional doses without lymphodepletion and with intermediate doses of IL-2, or as a single dose after lymphodepletion and with intermediate or high doses of IL-2.

ATLAS performance
The GEN-011 NPTs are specific for neoantigens prioritized using ATLAS, Genocea’s proprietary neoantigen discovery platform. To date, Genocea has completed screening 19 patient samples with ATLAS in the TiTAN trial. On average in these samples, ATLAS has prioritized 12 neoantigens (range 0-43) and identified 14 Inhibigens (range 1-55) per patient. T cells specific for only the prioritized neoantigens (and therefore not the Inhibigens) are expanded in the PLANET process.

PLANET performance
These T cells are grown in PLANET, Genocea’s robust and rapidly scalable cell expansion process. Of the 16 patient samples entering the PLANET manufacturing process, 100% have either successfully yielded a released drug product (10) or are in process (6).

TiTAN update
Of the 10 manufactured GEN-011 drug products, five have been administered to patients across both the multidose and single dose cohorts, with the remaining five available for dosing upon patient need. Genocea expects to have initial data from the first five patients later this quarter or early Q2 2022. With eight sites currently accruing patients, Genocea expects to continuously enroll and dose patients throughout the year.

"We are proud of the tremendous GEN-011 progress," said Chip Clark, Genocea President and CEO. "Identifying the right tumor targets and robust and reliable T cell expansion remain vexing problems with adoptive T cell therapies, so we are particularly proud of the early successes our team has delivered with ATLAS and PLANET. We look forward to sharing our GEN-011 clinical results in the near future."

About GEN-011
GEN-011 is an investigational next-generation solid tumor cell therapy candidate comprised of CD4+ and CD8+ NPTs which are specific for up to 30 antigens, designed to limit tumor escape. NPTs have minimal bystander, non-tumor-specific cells, and are designed to be devoid of Inhibigen-specific cells which may be detrimental to clinical response.

About the GEN-011 TiTAN clinical trial
TiTAN is an open-label, multi-center Phase 1/2a trial evaluating the safety, tolerability, T cell persistence and proliferation and clinical efficacy of GEN-011. The TiTAN clinical trial is testing two dosing regimens, a regimen of GEN-011 in multiple fractional doses and without lymphodepletion, and a single administration of GEN-011 after lymphodepletion. Both groups will receive interleukin-2 after GEN-011 dosing to maximize the tumor-killing potential of the infused cells. Initial data from the TiTAN trial is expected late Q1 or early Q2 2022.

On January 4, 2022 Genmab A/S (Nasdaq: GMAB) and Synaffix B.V., reported that Genmab and Synaffix have signed a license agreement providing Genmab broad access to Synaffix’s ADC technologies (Press release, Genmab, JAN 4, 2022, View Source [SID1234598070]). Genmab is granted exclusive research rights to utilize Synaffix ADC technologies for one drug target with the option for the worldwide development and commercialization of the resulting ADCs. Genmab has the option to exercise exclusive research and commercial licenses for additional targets.

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!

For each specific target nominated under the license agreement, Genmab gains exclusive access to Synaffix’s clinical-stage GlycoConnect antibody conjugation technology, HydraSpace polar spacer technology, as well as select toxSYN linker-payloads, each designed to enable ADCs with best-in-class efficacy and tolerability for the development of multiple potential therapies.

Genmab will be responsible for the research, development, manufacturing and commercialization of any resulting ADC therapies. At the same time, Synaffix will support Genmab’s research activities, including manufacturing of components that are specifically related to its proprietary ADC technologies.

"At Genmab, we are committed to bringing differentiated medicines to patients, and we believe collaborations are foundational to accelerate innovation," said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. "We look forward to working with Synaffix toward our shared goal of developing best-in-class or first-in-class antibody therapies and make an impact on the lives of patients."

"In what represents our fifth out-licensing deal in the last six months, we are thrilled to partner with Genmab, an international biotechnology company," said Peter van de Sande, Chief Executive Officer of Synaffix. "In deploying our cutting-edge ADC technology platform together with Genmab’s robust antibody development capabilities, Synaffix is privileged to once more play an essential role in strengthening a partner’s pipeline with our innovative ADC technologies thereby aiding the transformation of cancer treatment."

Financial Terms
Under the terms of the agreement, Synaffix will receive an upfront payment of USD $4.5 million and, on a target-by-target basis, is eligible to receive option-exercise, development-, regulatory- and commercial milestone payments. The total potential deal value is USD $415 million plus tiered, mid-single digit royalties on commercial sales.

On January 4, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will participate in two upcoming virtual investor conferences in January (Press release, G1 Therapeutics, JAN 4, 2022, View Source [SID1234598069]).

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!

G1’s Chief Executive Officer Jack Bailey and Chief Medical Officer Raj Malik, M.D. will participate in a fireside chat during the H.C. Wainwright BioConnect 2022 conference. The webcast of the fireside chat will become available at 7:00 AM EST on January 10, 2022.
On January 12, 2022, at 1:30 PM EST, Mr. Bailey will provide a corporate presentation during the 40th Annual J.P. Morgan Healthcare Conference.
The webcast of both events will be accessible on the Events & Presentations page of View Source

On January 4, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported that Enrique Conterno, Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright Bioconnect Virtual Conference taking place January 10-13 (Press release, FibroGen, JAN 4, 2022, View Source [SID1234598068]). The on-demand webcast of the session will be available on January 10 at 7:00am EST.

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 audio webcast of the event will be available on the "Events & Presentations" section of the FibroGen Investor webpage at www.fibrogen.com. A replay will be available for approximately 30 days.