On April 10, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a late-stage targeted oncology company, reported initial preclinical results evaluating its investigational synthetic lethal PRMT5 inhibitor in methylthioadenosine phosphorylase (MTAP)-deleted cancer models (Press release, Mirati, APR 10, 2021, View Source [SID1234577848]). Mirati’s internally discovered PRMT5 compound is the first to specifically target the PRMT5/methylthioadenosine (MTA) complex. This approach is designed to leverage elevated levels of MTA in cancers exhibiting an MTAP deletion and to selectively kill cancer cells harboring this genetic alteration. The results were presented today during a late-breaking minisymposium at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting [Abstract # LB003].

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Preclinical results showed that the Mirati PRMT5 compound bound selectively to the PRMT5/MTA complex and demonstrated a greater than 100-fold selectivity for MTAP-deleted cells compared with cells that do not exhibit this genetic defect in both proliferation and mechanistic assays. This selectivity for the PRMT5/MTA complex and MTAP-deleted cancer cells allows for the selective targeting of cancer cells while sparing healthy cells, which are also dependent on PRMT5 for cell growth and survival. In addition, treatment of MTAP-deleted tumor xenograft-bearing mice with the Mirati PRMT5 compound resulted in halted tumor growth and near complete reduction of symmetric dimethylarginine (SDMA), a biomarker of PRMT5 activity, at well-tolerated dose levels.

"We are proud to have a potential first-in-class therapeutic agent to specifically target the PRMT5/MTA complex in MTAP-deleted cancer cells," said James Christensen, Ph.D., executive vice president and chief scientific officer, Mirati Therapeutics, Inc. "Based on discoveries made by Mirati scientists, we have designed a novel approach to specifically bind to and inhibit PRMT5 in complex with MTA. With this approach, we are able to target MTAP-deleted tumors, which should result in an improved therapeutic index relative to known PRMT5 and MAT2A inhibitors."

About PRMT5 Inhibition in MTAP-deleted Cancers

PRMT5 is an enzyme critical to the survival of both healthy and cancer cells and is partially inhibited by MTA, which accumulates in MTAP-deleted cancers. The MTAP deletion is present in approximately 10 percent of all cancers and is the most frequently observed gene deletion event (MTAP/CDKN2A) across several cancer types. Cancers with an MTAP deletion, such as pancreatic, lung, and bladder cancers, are associated with a poor prognosis, representing a significant unmet medical need.

Activated PRMT5 is crucial for the regulation of cellular processes essential for cell survival, including regulation of RNA splicing, gene expression and protein translation. In MTAP-deleted cancer cells, the inhibitory cofactor MTA accumulates and binds to PRMT5. Mirati’s PRMT5 compound selectively targets the PRMT5/MTA complex in MTAP-deleted cancer cells while sparing healthy cells. The Mirati PRMT5 compound is advancing toward an Investigational New Drug (IND) filing in the first half of 2022.

On April 10, 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 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held virtually April 10-15, 2021 (Press release, Xencor, APR 10, 2021, View Source [SID1234577864]).

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"Xencor’s XmAb bispecific Fc domains enable the rapid design and simplified development of Fc-containing protein structures and are being used to create new platforms, a wide range of multi-specific antibodies and engineered cytokines. At AACR (Free AACR Whitepaper), we are presenting emerging preclinical data from early-stage programs that highlight the potential of our CD28 platform and XmAb 2+1 bispecific antibody format, as well as our more advanced IL-12 cytokine, which builds off our prior work with IL-15 and IL-2," said John Desjarlais, Ph.D., senior vice president and chief scientific officer at Xencor. "In 2021, we anticipate submitting an IND for XmAb819, our lead XmAb 2+1 CD3 bispecific antibody targeting ENPP3, and initiating a Phase 1 study in early 2022. We are also advancing through preclinical development our wholly owned lead CD28 candidate, a B7-H3 x CD28 bispecific antibody designed to be evaluated for the treatment of patients with a range of solid tumors."

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

XmAb Engineered Cytokine Platform

Abstract 1743, "IL12 heterodimeric Fc-fusions engineered for reduced potency exhibit strong anti-tumor activity and improved therapeutic index compared to native IL12 agents"
IL-12 is a potent proinflammatory cytokine produced by activated antigen-presenting cells, and it leads to proliferation of T cells and NK cells and increased cytotoxicity through high levels of interferon gamma signaling. As a potent immune stimulating protein, IL-12 can have a significant effect on shrinking tumors; however, prior clinical studies have demonstrated it to have a narrow therapeutic window, limiting potential response rates.

Xencor’s IL-12-Fc cytokine program builds on the Company’s prior work with IL-15-Fc cytokines in oncology, where reduced potency led to improved pharmacokinetics, pharmacodynamics and tolerability in preclinical studies. IL-12-Fc fusions were engineered with reduced potency in order to improve potential tolerability, slow receptor-mediated clearance and prolong the molecules’ half-lives, compared to native IL-12. The potency-reduced IL-12-Fc fusions demonstrated significant anti-tumor activity in vivo concurrent with activation and proliferation of CD8+ T cells and increased levels of interferon gamma in serum. 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.

XmAb CD28 Bispecific Antibody Platform

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.

Abstract: 1880, "PDL1-targeted CD28 costimulatory bispecific antibodies enhance T cell activation in solid tumors"
Xencor engineered PD-L1 x CD28 bispecific antibodies to provide conditional co-stimulation of T cells, activating them when bound to tumor cells. PD-L1, which is expressed on many types of tumors, suppresses anti-tumor responses by the immune system and has been shown to directly inhibit CD28 co-stimulation. A PD-L1 x CD28 bispecific antibody, therefore, may promote CD28 co-stimulation and simultaneously block CD28’s suppression by PD-L1.

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, as designed. 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.

XmAb 2+1 Bispecific Antibody Format

Xencor’s XmAb 2+1 bispecific antibodies are a type of CD3 T cell engager, with two tumor binding domains and one CD3 binding domain. The affinities for tumor binding are tuned, allowing for selective killing of high antigen-expressing tumor cells, potentially sparing low antigen-expressing normal cells. The XmAb 2+1 format may be especially beneficial when developing bispecific antibodies that target solid tumors, where tumor-associated antigens are often expressed on a range of normal tissues, including critical organs.

Abstract: 1860, "Bispecific claudin-6 x CD3 antibodies in a 2+1 format demonstrate selectivity and activity on human ovarian cancer cells"
Claudin-6 (CLDN6) is a tumor-associated antigen overexpressed in ovarian cancer and other solid tumors, and its differential expression in cancerous tissue makes CLDN6 an intriguing target for CD3 bispecific antibodies. Many members of the claudin family, which are small transmembrane proteins, have high sequence identity, which complicates selectivity among claudins. CLDN6 x CD3 bispecific antibodies were engineered in the XmAb 2+1 format, and the tumor binding domain was further engineered for improved selectivity of CLDN6 over similar claudin family members, such as CLDN9. In preclinical models, CLDN6 x CD3 bound more preferentially to tumor cells compared to cell lines with normal tissue CLDN9 expression levels. Lead candidates demonstrated reversal of tumor growth in human-cell engrafted mouse models of ovarian cancer. Further data from non-human primate studies demonstrated the candidates were well-tolerated with favorable pharmacokinetic profiles.

Abstract: 1831, "Affinity tuned XmAb 2+1 GPC3 x CD3 bispecific antibodies demonstrate selective activity in liver cancer models"
GPC3 is an antigen associated with hepatocellular carcinoma, squamous cell carcinoma of the lung and other cancers. Under certain conditions, GPC3 can trigger Wnt signaling and promote tumor proliferation. Despite a favorable expression profile, unfavorable tolerability has been reported from multiple clinical studies evaluating CAR-T therapy and T cell engaging bispecific antibodies that target GPC3. GPC3 x CD3 bispecific antibodies in the XmAb 2+1 format selectively recruited T cells to kill high GPC3-expressing cancer cells and avoided cytotoxicity to a low GP3C-expressing cell line. A comparison of GPC3 x CD3 bispecific antibodies with the XmAb 2+1 format and first-generation T cell engagers demonstrated similar anti-tumor activity and immune cell proliferation in vitro.

On April 10, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported initial efficacy and safety data from the Phase 1 dose-escalation portion of its ongoing Phase 1/2 clinical trial of ZN-c3 in patients with advanced solid tumors who are refractory to or ineligible for standard therapy or for whom no standard therapy is available (Press release, Zentalis Pharmaceuticals, APR 10, 2021, View Source [SID1234577815]). Initial results showed that monotherapy ZN-c3 use resulted in Exceptional Responses in heavily pre-treated patients in a range of solid tumors, including Partial Responses (PRs) in ovarian cancer, colorectal cancer, non-small cell lung carcinoma and uterine serous carcinoma. Data were reviewed as a late-breaking abstract during the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held virtually April 10-15, 2021 and May 17-21, 2021.

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"The initial clinical data on our WEE1 inhibitor are extremely promising and showcase ZN-c3’s strong potential to improve outcomes in patients with advanced solid tumors who have exhausted available treatment options," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Our WEE1 candidate, which we believe is potentially a best-in-class small molecule, demonstrated favorable safety results with a wide therapeutic window, and resulted in Partial Responses in five patients with a range of cancers. Having identified a recommended dose for future studies, we look forward to advancing clinical trials in a larger number of patients, as well as novel biomarkers that may help select patients who are likely to respond to treatment with ZN-c3. We are looking to make Exceptional Responses commonplace."

Initial Efficacy and Safety Data

In the Phase 1 dose-escalation trial, ZN-c3 was dosed starting at 25 mg and going as high as 450 mg QD in patients with advanced or metastatic solid tumors. At the time of the data cutoff on February 12, 2021, 55 patients were evaluated for safety, the primary endpoint. The study remains ongoing and based on the data presented at AACR (Free AACR Whitepaper), ZN-c3 generated 5 Partial Responses.

Best Overall Responses:

Two confirmed PRs in ovarian cancer and colorectal cancer (CRC) patients

After receiving 18 prior lines of therapy, 11 prior lines in the advanced metastatic setting, a patient with Stage IV ovarian cancer had a RECIST-confirmed PR with a 56% reduction in overall target lesions. The patient also experienced a large rapid drop in CA-125 from 610 kU/L at baseline to 125 kU/L within 4 weeks on treatment, with her CA-125 level normalizing 3 weeks later. The patient was on study for 186 days and remains on study drug.

After receiving 5 prior lines of therapy in the advanced metastatic setting, a patient with Stage IV CRC had a RECIST-confirmed PR with a 42% reduction in overall target lesions, as well as a rapid decrease in CEA tumor marker from 327 ng/mL at baseline to <50 ng/mL after 3 weeks on treatment. The patient remained on study for 169 days until clinical disease progression.

In addition, three unconfirmed PRs—one in non-small cell lung carcinoma (NSCLC) and two in uterine serous carcinoma (USC) patients

After receiving 3 prior lines of therapy in the advanced metastatic setting, a patient with Stage IV NSCLC had an unconfirmed (per RECIST) PR with a 50% reduction in overall target lesions. The patient was on study for 145 days and remains on study drug.

ZN-c3 was generally well-tolerated as a single agent. As of the cutoff date, the most common treatment-related adverse events were mainly Grade 1/2, including nausea (49.0% of patients), diarrhea (32.7% of patients), fatigue (29.0% of patients) and vomiting (29.0% of patients) across all doses. Significant hematological adverse events were limited; treatment-related white blood cell count decrease / neutropenia (7.2% all Grades, 3.6% Grade ≥3), anemia (7.2% all Grades, 5.4% Grade ≥3) and thrombocytopenia (7.2% all Grades, 3.6% Grade ≥3).

Results from this study indicate that an oral dose of 300 mg QD with continuous dosing is the recommended Phase 2 dose of ZN-c3 when used as a monotherapy. The 300 mg QD dose demonstrated high plasma exposure levels, while minimizing adverse events. In addition, the pharmacodynamic marker of pCDK1 levels in skin punch biopsies showed active target engagement at relevant pharmacological doses. The Company initiated the Phase 1 expansion portion of the trial with the 300 mg QD dose earlier in 2021 and is exploring this candidate’s potential in combination trials including in ovarian cancer and osteosarcoma. Using this recommended dose, Zentalis will also coordinate with Zentera Therapeutics, Zentalis’ majority-owned joint venture, to initiate a Phase 1b trial investigating ZN-c3 as a single agent in China.

"WEE1 is a promising target for cancer therapy, and this dataset provides further validation on the importance of candidates like ZN-c3 that are designed to inhibit the DNA damage checkpoint, resulting in tumor cell death," said Dr. Anthony Tolcher, CEO, Founder and Director of Clinical Research at NEXT Oncology. "ZN-c3 was shown to be tolerable in this heavily pretreated patient population. Furthermore, this candidate’s early signals of anti-tumor activity are very exciting, and I am even more optimistic that WEE1 inhibition may become an important treatment approach for a wide range of cancers."

KOL Webcast Event:

Zentalis will host a webcast event with key opinion leaders Monday, April 12, 2021 at 4:00 p.m. EDT. To register and access the event, the webcast link is available on the Investors & Media section of the Zentalis website at www.zentalis.com.

About ZN-c3

ZN-c3 is an oral inhibitor of WEE1 in development for the treatment of advanced solid tumors. The inhibition of WEE1, a DNA damage response protein, aims to generate sufficient DNA damage in cancer cells, causing cell death, thereby preventing tumor growth and potentially causing tumor regression. Zentalis is currently conducting a Phase 1/2 clinical trial in patients with advanced solid tumors and reported initial data from the Phase 1 portion at the AACR (Free AACR Whitepaper) Annual Meeting 2021. In addition, the Company is also conducting a Phase 1b trial evaluating ZN-c3 in combination with chemotherapy in patients with advanced ovarian cancer, with plans to initiate a Phase 1/2 in combination with chemotherapy in osteosarcoma and a Phase 2 trial investigating ZN-c3 as a monotherapy in patients with uterine serous carcinoma in 2021.

On April 10, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that for the first time, preclinical work describing the discovery of BT7480, a novel Nectin-4/CD137 tumor-targeted immune cell agonist (TICATM), will be presented virtually in a "New Drugs on the Horizon" session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 10-15, 2021 (Press release, Bicycle Therapeutics, APR 10, 2021, View Source [SID1234577833]). Additional work covering TICAs and Bicycle Toxin Conjugates (BTCs), will also be covered in a late-breaking mini-symposium, as well as in five e-posters.

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"Our TICA platform has made significant progress, and we are thrilled to present information about the discovery of BT7480, as well as preclinical data across multiple programs in our immuno-oncology pipeline," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "These presentations highlight the potential utility of Bicycle-based therapeutic candidates for treating multiple tumor types via diverse mechanisms as we pursue our goal of improving the treatment paradigm for patients with cancer."

Bicycle TICAs are potent, fully synthetic compounds that represent an immuno-oncology approach engineered to overcome the limitations of other immunomodulatory mechanisms. Bicycles are small, structurally constrained peptides discovered via phage display and optimized using structure-driven design and medicinal chemistry approaches. Bicycle has applied this disruptive technology by identifying CD137 Bicycles and chemically linking these to tumor antigen binding Bicycles to generate multifunctional molecules that induce tumor antigen-dependent, tumor-localized agonism of CD137. Bicycle expects BT7480 to enter the clinic in the second half of 2021.

Details on Bicycle’s presentations and posters at AACR (Free AACR Whitepaper) are as follows:

Poster Title: Molecular-based enrichment strategy for Nectin-4 targeted Bicycle toxin conjugate BT8009
Abstract #: 391
Session, Date and Time: Biomarkers Predictive of Therapeutic Benefit, April 10, 8:30 AM

Poster Title: Nectin-4-dependent immune cell stimulation and anti-tumor efficacy by BT7480, a Nectin-4/CD137 Bicycle tumor-targeted immune cell agonist (TICA)
Poster #: 1728
Session, Date and Time: Immunomodulatory Agents and Interventions, April 10, 8:30 AM

Poster Title: Microinjection of Nectin-4/CD137 tumor-targeted immune cell agonist (TICA) activates the local tumor microenvironment
Poster #: 1724
Session, Date and Time: Immunomodulatory Agents and Interventions, April 10, 8:30 AM

Poster Title: A multi tumor survey of Nectin-4 expression to guide BT8009 indication selection
Poster #: 1197
Session, Date and Time: Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes, April 10, 8:30 AM

Poster Title: Rapid Accumulation of Cytotoxic Payload in Tumor Tissue Drives BT5528 Activity in Tumor Models
Poster #: 1319
Session, Date and Time: Novel Drug Delivery Systems, April 10, 8:30 AM

Presentation Title: BT7480, a novel Nectin-4 dependent agonist of the immune cell costimulatory receptor CD137
Session, Date and Time: New Drugs on the Horizon: Part 1, April 10, 1:30 – 3:15 OM, Channel 1

Presentation Title: Integrative surfaceome profiling identifies immunotherapeutic targets in osteosarcoma and preclinical testing of BT1769, an MT1-MMP-targeted Bicycle toxin conjugate, in osteosarcoma by the Pediatric Preclinical Testing Consortium (PPTC)
Session, Date and Time: Late-Breaking Mini-symposium 2, April 12, 1:35 – 1:45 OM, Channel 7

The posters will be available on the Publications section of bicycletherapeutics.com following each session.

On April 10, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported new clinical data on AGEN1181, its next-generation anti-CTLA-4 antibody, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 10 – 15, 2021 (Press release, Agenus, APR 10, 2021, View Source [SID1234577849]).

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"The preclinical and translational data in conjunction with our updated clinical data with AGEN1181 alone or in combination with our PD-1, balstilimab, continue to strongly support and differentiate our next-generation CTLA-4 antibody," said Steven O’Day, MD, Chief Medical Officer of Agenus. "AGEN1181 is showing activity in patients with tumors which typically do not respond to first-generation CTLA-4 and PD-1 antibodies. Equally important, the safety data continues to show no immune mediated hypophysitis, pneumonitis, or hepatitis to date. Given the efficacy and favorable safety profile, we have expanded AGEN1181 into Phase 2 in colorectal cancer patients as a first step in our efforts to expand to additional important cancer indications."

In two separate presentations at AACR (Free AACR Whitepaper), Agenus showcased the optimal performance of AGEN1181 in relevant models. In addition, as the clinical data matures, additional responses as well as a conversion from a partial response to a complete response, have been observed. The new data announced today include the following clinical responses:

New partial response in the first melanoma patient treated (monotherapy)

New conversion to complete response in ovarian cancer patient (AGEN1181 plus balstilimab)

Partial response in microsatellite stable (MSS) colorectal cancer patient (AGEN1181 plus balstilimab)

Partial response in PD-L1(-) ovarian cancer patient (AGEN1181 plus balstilimab)

Partial response in MSS colorectal cancer patient (AGEN1181 plus balstilimab)

Complete response in PD-L1(-) MSS endometrial cancer patient (monotherapy)

Complete response by PET in PD-L1(-) MSS endometrial cancer patient (AGEN1181 plus balstilimab)
Presentation Details:
E-poster presentations were made available on the conference platform on April 10 at 8:30am ET. Posters with accompanying audio will be available for viewing to meeting registrants until June 21.

Session: PO.IM02.10 – Therapeutic Antibodies, Including Engineered Antibodies
Poster title: Fc-enhanced anti-CTLA-4 antibody, AGEN1181: New mechanistic insights for potent antitumor immunity and combination potential in treatment-resistant solid tumors
Abstract number: 1878
Presenting author: Antoine Tanne, PhD

Session: PO.IM02.05 – Immune Monitoring / Clinical Correlates
Poster title: Characterization of the pharmacodynamic activity of AGEN1181, an Fc-enhanced CTLA-4 antibody, alone and in combination with the PD-1 antibody balstilimab
Abstract number: 1677
Presenting author: Irina Shapiro, PhD

In addition, Dr. Steven O’Day, Chief Medical Officer, Dr. Dhan Chand, Scientific Director, Head of Drug Discovery, and Dr. Jennifer Buell, President and COO, at Agenus, will participate in a webcast hosted by Dr. Matt Phipps of William Blair on Saturday, April 10, 2021 at 10:30 a.m. ET.

Registration for the webinar can be done in advance at View Source

A replay will be available after the call on the Events & Presentations page of the Agenus website at View Source