On November 12, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present at two upcoming virtual investor conferences in November (Press release, aTyr Pharma, NOV 12, 2021, View Source [SID1234595452]).

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!

Details of the events are as follows:

Conference: Stifel 2021 Virtual Healthcare Conference
Date: Wednesday, November 17, 2021
Time: Live Corporate Presentation at 4:40pm EST / 1:40pm PST

Conference: Piper Sandler 33rd Annual Virtual Healthcare Conference
Date: Monday, November 22, 2021
Time: Pre-recorded Fireside Chat available on demand starting at 10:00am EST / 7:00am PST

In addition to the presentations, company management will be available to participate in virtual one-on-one meetings with investors who are registered attendees of the conferences. Following the events, a replay of each presentation will be available on the Investor’s section of the company’s website at www.atyrpharma.com.

On November 12, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported the presentation of new data from multiple preclinical XmAb bispecific antibody programs and its preclinical IL-12-Fc cytokine program, XmAb662, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Xencor, NOV 12, 2021, View Source [SID1234595469]).

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!

"XmAb bispecific Fc domains enable the rapid design and simplified development of a wide range of multi-specific antibodies and other protein structures, such as engineered cytokines. At SITC (Free SITC Whitepaper), we are presenting new data from multiple preclinical programs, including our first presentation of XmAb NK cell engagers, an exciting modality that mechanistically synergizes with our investigational engineered cytokine candidates," said John Desjarlais, Ph.D., senior vice president and chief scientific officer at Xencor. "Our preclinical programs show the power of Xencor’s platform to create exciting XmAb drug candidates that access new biologies and continually supply our clinical pipeline with differentiated molecules."

The posters will be archived under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com.

Abstract 707, "IL12 Fc-fusions engineered for reduced potency and extended half-life exhibit strong anti-tumor activity and improved therapeutic index compared to wild-type IL12 agents"

IL-12 is a potent pro-inflammatory cytokine that promotes high levels of interferon gamma secretion from T-cells and NK cells, increasing their cytotoxicity and the immunogenicity of the tumor microenvironment by making tumor antigens more visible to the immune system. Prior clinical studies have demonstrated IL-12 has significant anti-tumor activity; however, its toxicity has limited its potential. Xencor’s IL-12 program follows the same potency reduction design strategy as the Company’s IL15-Fc fusions in oncology, where reduced potency led to improved pharmacokinetics, pharmacodynamics and safety in preclinical studies. In addition, preliminary clinical data from Xencor’s IL15-Fc program, XmAb306, showed generally good tolerability and robust and sustained immune cell expansion.

IL12-Fc fusions were engineered with reduced potency in order to improve potential tolerability, slow receptor-mediated clearance and prolong half-life in vivo, compared to native IL-12. These potency-reduced IL12-Fc fusions demonstrated significant anti-tumor activity in vivo, concurrent with activation and proliferation of CD8+ T cells and with interferon gamma production.

The addition of Xencor’s half-life extending Xtend Fc mutations further improved exposure of the molecules over time. In non-human primates, the engineered cytokines had an improved pharmacokinetic profile and therapeutic window compared to a native cytokine-Fc fusion, with superior exposure, a more gradual dose response and similar levels of cytokine production in serum.

XmAb662 was selected for further development and demonstrated significant anti-tumor activity in vivo, concurrent with increases in NK cells, T cells, serum IP10 and serum interferon gamma, which were further enhanced when combined with an anti-PD-1 antibody. The Company anticipates submitting an IND application for XmAb662 in 2022.

Abstract 698, "PDL1-targeted CD28 costimulatory bispecific antibodies enhance T cell activation in solid tumors"

T cells in the tumor microenvironment require both T cell receptor (TCR) and co-stimulatory receptor engagement to achieve full activation. CD28 is a key immune co-stimulatory receptor on T cells; however, the ligands that activate T cells through CD28 are usually not expressed on tumor cells. Targeted CD28 bispecific antibodies, a new class of T cell engager, may provide conditional co-stimulation of T cells, for example, to T cells recognizing neoantigens or in concert with CD3 T-cell engaging bispecific antibodies.

Xencor engineered PD-L1 x CD28 bispecific antibodies to provide conditional co-stimulation of T cells, activating them when bound to PD-L1+ cells. PD-L1, which is expressed on many types of tumors, suppresses anti-tumor responses by the immune system and can inhibit CD28 by engaging PD-1. A PD-L1 x CD28 bispecific antibody, therefore, may promote CD28 co-stimulation and simultaneously block CD28’s suppression by PD-1.

In vitro, the combination of the PD-L1 x CD28 and a CD3 T cell engager enhanced T cell activation and proliferation compared to the CD3 bispecific alone. PD-L1 x CD28 also enhanced the interaction between T cells and antigen presenting cells and exhibited strong CD28-dependent anti-tumor activity in mice. PD-L1 x CD28 was well tolerated in non-human primates and exhibited favorable pharmacokinetics. Modeling and preclinical data suggest a dosing schedule consistent with typical checkpoint inhibitor regimens.

Abstract 872, "PD1 x TGFβR2 and CD5 x TGFβR2 bispecifics selectively block TGFβR2 on target-positive T cells, promote T cell activation, and elicit an anti-tumor response in solid tumors"

TGFβ is an inhibitory cytokine, and its production in solid tumors is a significant mechanism used by tumors to avoid recognition by the immune system. While TGFβ inhibition is expected to promote an anti-tumor response, systemic blockade of TGFβ has also been associated with toxicity.

Xencor engineered two XmAb bispecific antibodies, PD-1 x TGFβR2 and CD5 x TGFβR2, to selectively block the suppressive activity of TGFβ on specific T-cell populations and to enhance their anti-tumor activity while avoiding the toxicity associated with systemic blockade. PD-1 and CD5 were selected to direct TGFβ blockade to activated or all T cells, respectively.

In vitro, both bispecific antibodies exhibited highly selective blocking of TGFβ activity in PD-1-high and CD5-positive T cell populations. PD-1 x TGFβR2 and CD5 x TGFβR2 were active in vivo and promoted T cell engraftment and anti-tumor response. Anti-tumor activity was significantly enhanced when combined with an anti-PD-1 antibody, compared to either anti-PD-1 or the bispecific antibody alone.

Abstract 787, "Natural killer cell engagers activate innate and adaptive immunity and show synergy with proinflammatory cytokines"

Xencor’s XmAb natural killer cell engagers (NKEs) are multifunctional antibodies that target multiple activating receptors on the surface of NK cells and bind to tumor associated antigens.

Xencor engineered a B7-H3 x NKG2D NKE bispecific antibody with a modified Fc domain to enhance FcγR binding. The molecule’s design is intended to engage NK cells through the simultaneous binding to B7-H3 on tumor cells and the activating receptors NKG2D and CD16. Additionally, NKEs may provide co-stimulation to T cells through NKG2D expressed on T cells.

In vitro, B7-H3 x NKG2D NKEs activated NK cells, enhanced NK cell mediated lysis of tumor cells and provided co-stimulation to T cells. Additionally, in vitro anti-tumor activity was enhanced when combined with proinflammatory cytokines: an analog of the IL15-Fc cytokine XmAb306 and the IL12-Fc cytokine XmAb662.

On November 12, 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 Walter V. Kemp, Founder, President, CEO and Chairman and Dr. John Paul Waymack, Senior Chief Medical Officer will participate in the Virtual Investor Roundtable Event on Thursday, November 18, 2021 at 11:00 AM ET (Press release, Moleculin, NOV 12, 2021, View Source [SID1234595485]).

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!

Joining the Company’s management team for the roundtable discussion will be Sant P. Chawla, MD, Director, Sarcoma Oncology Center, Director, Cancer Center of Southern California.

As part of the virtual event, the Company will provide a brief presentation, followed by a moderated Roundtable discussion and an interactive Q&A session. In addition to the moderated portion of the event, all investors and interested parties will have the opportunity to submit questions live during the event. Interested parties may also pre-submit questions in advance of the live event, which can be sent via the conference website at virtualinvestorco.com. The Company will answer as many questions as possible during the event.

A live video webcast of the Roundtable Event will be available on the Events page of the Investors section of the Company’s website (moleculin.com). A webcast replay will be available two hours following the live presentation and will be accessible for one year.

On November 12, 2021 PLx Pharma Inc. (NASDAQ: PLXP) ("PLx" or the "Company"), reported that it is a commercial-stage drug delivery platform technology company focused on its clinically-validated and patent-protected PLxGuard that has the potential to improve the absorption of many drugs currently on the market and to reduce the risk of stomach injury associated with certain drugs (Press release, Vincerx Pharma, NOV 12, 2021, View Source [SID1234595508]). The Company, with its lead products VAZALORE 325 mg and VAZALORE 81 mg liquid-filled aspirin capsules (referred to together as "VAZALORE"), announced today certain financial and operational results for the three and nine months ended September 30, 2021.

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!

Highlights of, and certain events during and subsequent to, the third quarter of 2021 include:

Extensive VAZALORE commercial launch activities under way:
Successfully supplied three stock keeping units ("SKUs") of VAZALORE into more than 30,000 retail drugstores, supermarkets, mass merchandisers and e-commerce sites nationwide;
Deployed a cardiovascular specialty field force to engage with healthcare professionals at leading heart/stroke hospitals and affiliated clinical practices;
Launched a national media television campaign to raise awareness among providers and consumers;
Implemented a nationwide pharmacist outreach campaign including email alerts and education kits with information and coupon incentives;
Continue to receive very positive feedback from consumers and healthcare providers about the benefits of VAZALORE;
Reported third quarter 2021 revenue of $6.6 million and a net loss of ($0.80) per basic and diluted share; adjusted non-GAAP net loss was ($0.37) per basic and diluted share;
Preliminary results of study titled, Pharmacokinetic and Pharmacodynamic Profile of PL-ASA, a Novel Phospholipid-Aspirin Complex Liquid Formulation, Compared to Enteric-coated Aspirin at an 81 mg Dose – Results from a Prospective, Randomized Crossover Study (F. Franchi et al.), were included in a virtual poster presentation during the Transcatheter Cardiovascular Therapeutics Meeting of the Cardiovascular Research Foundation (TCT 2021) in Orlando, FL.; and
Cardiovascular thought leaders held a virtual town hall meeting on October 29, 2021 titled "Should You Stop (or Start) Aspirin? Ask Your Doctor" as a public health service for patients to help clarify the continued critical role of aspirin in secondary prevention.
"We remain focused on executing our VAZALORE commercial strategy with retailers, professionals and consumers," said Natasha Giordano, Chief Executive Officer of PLx. "The overwhelmingly positive feedback we have received strengthens our confidence in the potential of this brand," stated Natasha Giordano, Chief Executive Officer of PLx.

"Key thought leaders in the field have been pro-actively engaged in clarifying the foundational role of aspirin in secondary prevention of cardiovascular disease. Also, the availability of new scientifc data on VAZALORE, which is consistent with previous studies that supported the approvals of VAZALORE 81 mg and 325 mg, continues to demonstrate that VAZALORE delivers fast, reliable absorption that patients depend on to help prevent another heart attack or clot-related stroke," concluded Giordano.

Third Quarter 2021 Financial Highlights

Total revenues for the third quarter of 2021 were $6.6 million, compared to no revenue in the third quarter of 2020 and reflected the launch of VAZALORE 81 mg and 325 mg dose strengths with initial distribution to US retail channels. Net sales were led by 81 mg dose strength (consisting of two SKUs), which represented approximately two-thirds of total revenues in the third quarter of 2021.

Gross margin of 41% reflects outsourced manufacturing and packaging costs, shipping and warehousing costs, expenses related to order processing, quality assurance and royalties.

Total operating expenses were $12.6 million during the third quarter of 2021, compared to operating expenses of $3.2 million for the prior period, reflected the promotional activities and associated expenses for the commercial launch of VAZALORE.

Research and development expenses were $1.6 million for the third quarter of 2021, compared to $1.2 million in the third quarter of 2020. The increase reflects the rise in pre-commercial manufacturing-related activities for VAZALORE. Both periods included spending for VAZALORE clinical trials (81mg dose in 2021 and 325 mg dose in 2020).

Selling, marketing and administrative expenses totaled $11.0 million in the third quarter of 2021 compared to $2.0 million in the prior period, primarily due to VAZALORE launch expenses and increased non-cash stock-based compensation. During the third quarter of 2021, the Company launched a cardiovascular specialty field force and a national media television campaign to raise awareness for VAZALORE among healthcare professionals and consumers.

Other income (expense), net totaled $11.8 million of other expense and $61,847 of other income during the third quarter of 2021 and 2020, respectively. The variance is largely attributable to the non-cash change in fair value of warrant liability primarily due to the fluctuation of the price of the Company’s common stock offset by lower net interest due to the payoff of the term loan.

Net loss attributable to common stockholders for the third quarter of 2021 was $21.6 million, or ($0.80) per basic and diluted share, compared to $3.6 million, or ($0.40) per basic and diluted share, for the third quarter of 2020.

Adjusted non-GAAP net loss per basic and diluted per share was ($0.37) in the third quarter of 2021 compared to ($0.36) in the third quarter of 2020. See table for reconciliation of GAAP to adjusted non-GAAP net loss per basic and diluted share.

Non-GAAP Measures

PLx Pharma’s management considers adjusted non-GAAP net loss and adjusted non-GAAP net loss per basic and diluted earnings per share to be important financial indicators of operating performance, providing investors and analysts with useful measures of operating results unaffected by the impact on the financial statements of the volatility of the change in the fair value of the warrant liability and non-cash and non-recurring dividends and beneficial conversion features on our preferred stock. Management uses adjusted non-GAAP net loss and adjusted non-GAAP net loss per share when analyzing performance. Adjusted non-GAAP net loss and adjusted non-GAAP net loss per share should be considered in addition to, but not in lieu of net loss or net loss per share reported under GAAP.

Liquidity

As of September 30, 2021, the Company had cash and cash equivalents of $82.6 million and $3.3 million in accounts receivable and zero debt on its balance sheet.

Conference Call

As previously announced, PLx management will host its third quarter 2021 conference call as follows

The archived webcast will be available for 30 days via the aforementioned URL.

About VAZALORE
VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule allows for targeted release of aspirin, limiting its direct contact with the stomach. VAZALORE delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin. To learn more about VAZALORE, please visit www.vazalore.com.

On November 12, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported the presentation of interim data further demonstrating the tolerability and antitumor activity potential of CUE-101 as a monotherapy as part of the Company’s ongoing clinical trial for the treatment of recurrent/metastatic HPV+ head and neck cancer in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC 2021) (Press release, Cue Biopharma, NOV 12, 2021, View Source [SID1234608267]). Early data from the CUE-101 combination study with pembrolizumab will also be discussed, supporting the potential for mechanistic activity in frontline HPV+ HNSCC patients. SITC (Free SITC Whitepaper) 2021 will be held in Washington, D.C. and virtually November 10-14.

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!

Additionally, the Company will present two posters highlighting the broad potential of the interleukin 2 (IL-2)-based CUE-100 series for treating multiple cancers. This includes representative preclinical data from CUE-102, Cue Biopharma’s next clinical candidate developed to selectively target Wilms’ Tumor 1 (WT1) cancers, and preclinical progress on the Company’s Neo-STAT and RDI-STAT (Re-Directed Immuno-STAT) platforms, which provide modularity, flexibility and scalability and address tumor heterogeneity and tumor resistance or escape mechanisms.

SITC 2021 Presentation Highlights:

Title: A phase 1 trial of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer
Poster #: 438
Presenter: Dr. Sara I. Pai, M.D., Ph.D., associate professor, Department of Surgery; Director, Translational Research in Head and Neck Cancer Massachusetts General Hospital, Harvard Medical School, Boston MA
Date: Saturday, November 13, 2021, Poster Hall (Hall E) 7 a.m.–8:30 p.m. EST

Data as of November 2, 2021, include:

A durable partial response (PR) with an ongoing duration of 30 weeks and five durable stable disease responses (SD), as determined by RECIST 1.1. criteria, out of the 13 evaluable patients dosed at the recommended Phase 2 dose of 4mg/kg as part of the monotherapy trial.
Pharmacodynamic (PD) signals of expansion of HPV16+ cytotoxic T cells were observed in the monotherapy trial, which confirm CUE-101 mechanism of action by activation of tumor-specific T cells.
Demonstrated favorable tolerability to date, with more than 190 cumulative doses administered. Reported mild adverse events resolved while patients continued therapy.
Early signs of clinical activity of CUE-101 in combination with pembrolizumab with 3 out of 3 patients from cohort 2 at 2mg/kg, demonstrating tumor reductions in target lesions on their first scan after having received two cycles of therapy. Cohort 3 is currently enrolling.
"I am encouraged by the preliminary anti-tumor activity of CUE-101 and the positive tolerability profile, which are necessary to improve the survival and quality of care for this relatively young patient population," said Sara Pai M.D., Ph.D., associate professor of surgery and director of Translational Research in Head and Neck Cancer at the Massachusetts General Hospital, and principal investigator of the CUE-101 Phase 1 clinical trial. "Until this trial we haven’t seen an ‘off-the-shelf‘ HPV-targeted biologic administered in an outpatient setting with such durable responses in the second- and third-line treatment for recurrent/metastatic HPV16+ head and neck cancer patients and it is a significant advancement, presenting a potential path forward for a new therapeutic standard."

Ken Pienta, acting chief medical officer of Cue Biopharma, added, "We are very pleased by the emerging clinical data and growing body of evidence demonstrating the clinical potential of CUE-101 as a monotherapy in a highly pretreated, refractory, metastatic HPV+ HNSCC setting. In addition, we are encouraged by the promising, albeit early, emerging data from our combination study with pembrolizumab demonstrating potential mechanistic activity with the prospects of expanding patient reach and enhancing therapeutic responses. It is also encouraging to observe histology data demonstrating enhanced penetration of cytotoxic CD8+ T cells or "killer" T cells within the tumor and anti-tumor activity in patients failing 2-3+ previous lines of treatment."

Title: CUE-102 selectively activates and expands WT1-specific T cells for the treatment of patients with WT1+ malignancies
Poster #: 720
Presenter: Dr. Christie Zhang, Ph.D., senior scientist, discovery and translational immunology, Cue Biopharma
Date: Friday, November 12, 2021, Poster Hall (Hall E) 7 a.m.–8:30 p.m. EST

Multiple in vitro assessments demonstrated that CUE-102 selectively activated and expanded WT1-specific CD8+ T cells from peripheral blood mononuclear cells (PBMC) of healthy donors.
These CUE-102-expanded CD8+ T cells exhibited polyfunctional and cytotoxic responses upon challenge with WT1-presenting target cells.
Data showed that the attenuation of the interleukin 2 (IL-2) domains of CUE-102 led to a reduction of indiscriminate IL-2 activity, similar to results obtained with CUE-101.
In vivo studies in human leukocyte antigen (HLA)-A2 transgenic mice confirmed that CUE-102 elicited and expanded WT1-specific CD8+ T cells from naïve mice without significantly altering the frequencies of other immune lineages.
The WT1-specific CD8+ T cells expanded in vivo exhibited polyfunctionality and selectively killed WT1-presenting target cells in vivo.
Title: Targeting engineered interleukin-2 (IL-2) to antigen specific T cells via novel biologic platforms
Poster #: 793
Presenter: Raymond J. Moniz, associate director, discovery and translational immunology, Cue Biopharma
Date: Friday, November 12, 2021, Poster Hall (Hall E) 7 a.m.– 8:30 p.m. EST

Data demonstrated that the Company’s Neo-STAT (NST) biologics can be engineered with a diversity of T cell epitopes by efficient conjugation into an empty HLA-binding pocket, and that these molecules activated and expanded antigen specific T cells in vitro.
Data additionally demonstrated that the Company’s RDI-STAT biologics, were able to expand anti-viral T cell repertoires and drive anti-viral T cell redirected killing of tumor-associated antigen (TAA)-expressing cells.
In contrast to pan anti-CD3 bispecific molecules, RDI-STATs demonstrated significantly lower induction of pro-inflammatory cytokines, thus avoiding systemic activation of all T cells and offering a superior safety profile.
Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, said, "The demonstration of CUE-102 to activate and expand WT1-specific cytotoxic CD8+ T cells in vivo further supports the modularity of our platform and enhances the potential of our CUE-100 series to address a diversity of cancers, supporting the advancement of CUE-102 into the clinic. An Investigational New Drug filing for CUE-102 is scheduled for the first quarter of 2022. In addition, the data presented on our Neo-STAT and RDI-STAT platforms continue to demonstrate the versatility and modularity of our biologics to potentially address multiple cancers with flexibility and scalability. We are highly encouraged as we continue to explore the breadth of opportunities with our Immuno-STAT, Neo-STAT and RDI-STAT biologics platforms, to develop novel therapies that address diverse patient populations, tumor heterogeneity and tumor escape mechanisms."

For more information on all three posters please visit: View Source

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-major histocompatibility complex (pMHC) molecules along with rationally engineered interleukin 2 (IL-2) molecules. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About the CUE-101 Clinical Trial
The trial (NCT03978689) is a multi-center, first-in-human, open-label Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect and immunogenicity of CUE-101 as a monotherapy in second-line patients with confirmed human papilloma virus positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HPV+ HNSCC) and HLA-A*02:01 serotype. Patients receive CUE-101 as a monotherapy ranging from 0.06 mg/kg to 8 mg/kg. The maximum tolerated dose (MTD) has not been identified and a Phase 2 4 mg/kg dose has been selected. The company has expanded the study to evaluate CUE-101 in combination with 200 mg of KEYTRUDA (pembrolizumab) as first-line treatment in patients with HPV16-driven recurrent/metastatic HNSCC. Enrollment continues in both monotherapy and combination cohorts.

About CUE-102
Leveraging the Immuno-STAT (Selective Targeting and Alteration of T cells) platform of targeted interleukin 2 (IL-2) therapies and the ongoing development of CUE-101, CUE-102 is being developed as a novel therapeutic fusion protein to selectively activate tumor antigen-specific T cells to treat Wilms’ Tumor 1 (WT1)-expressing cancers. CUE-102 consists of two human leukocyte antigen (HLA) molecules presenting a WT1 peptide, four affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc domain.

About the Neo-STAT and RDI-STAT (Re-Directed Immuno-STAT) Platforms
Immuno-STAT biologics are rationally engineered Fc fusion proteins comprised of bivalent tumor-peptide-human leukocyte antigen (pHLA) complexes and four affinity-attenuated interleukin 2 (IL-2) molecules to preferentially engage and activate tumor-specific T cells directly in the patient. Building on the CUE-100 series framework, our Neo-STAT (NST) platform contains HLA molecules manufactured with an "empty" peptide-binding pocket, into which diverse tumor-peptides can be chemically conjugated, hence addressing tumor heterogeneity in a cost- and time-efficient manner. Our RDI-STAT (Re-Directed Immuno-STAT) platform further expands on the Immuno-STAT biologics by redirecting the pre-existing protective viral-specific T cell repertoire to target tumor cells via scFv moieties. RDI-STATs are designed to circumvent potential tumor escape mechanisms linked to HLA loss or defects in antigen-presenting pathways.

About SITC (Free SITC Whitepaper)
The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy.

SITC is a 501(c)(3) not-for-profit medical professional society of influential research scientists, physician scientists, clinicians, patients, patient advocates, government representatives and industry leaders dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Through educational programs that foster scientific exchange and collaboration, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere.

Currently, SITC (Free SITC Whitepaper) has more than 4,650 members who represent over 35 medical specialties in 63 countries around the world.

Through emphasis on high-caliber scientific meetings; dedication to education and outreach activities; focus on initiatives of major importance in the field; and commitment to collaborations with like-minded domestic and international organizations, government and regulatory agencies, associations and patient advocacy groups, SITC (Free SITC Whitepaper) brings together all aspects of the cancer immunology and immunotherapy community.