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Agenus Corporate Update and Third Quarter 2021 Financial Report

On November 9, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today provided a corporate update and reported financial results for the third quarter of 2021 (Press release, Agenus, NOV 9, 2021, View Source [SID1234594867]).

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"With more than 100 patients treated with our Fc-enhanced CTLA-4 antibody, AGEN1181, we are very encouraged by the clinical responses achieved across tumor types. Of note, we are seeing responses in patients who have failed to respond to all other treatment, including PD-1 inhibitors," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "We will be presenting detailed trial results at the SITC (Free SITC Whitepaper) conference this week. We have also successfully completed an initial public offering for MiNK Therapeutics, and have launched our adjuvant business, SaponiQx."

AGEN1181 (Fc-enhanced CTLA-4), as a monotherapy and in combination with balstilimab (anti PD-1), shows clinical benefit in 9 cold and treatment-resistant tumor types; data to be presented at SITC (Free SITC Whitepaper)

First presentation of clinical data from 100+ patients who represent a heavily pre-treated population, and were administered AGEN1181 as a monotherapy or in combination with balstilimab
Evidence of AGEN1181 monotherapy activity with multiple confirmed responses: microsatellite stable (MSS) – endometrial cancer (CR), melanoma (PR), cervical cancer (PR), and pancreatic cancer (PR), with the former three responses occurring in tumors which failed to respond to anti-PD-1 therapy
Additional responses in patients treated with AGEN1181 in combination with balstilimab, including in cold, poorly immunogenic tumors. These include:
Microsatellite stable colorectal cancer (MSS-CRC): 2 confirmed PRs, 2 unconfirmed PRs, and 7 stable disease (SD) among 17 evaluable patients for a disease control rate of 65%
Gynecological malignancies: 2 PRs, 3 SDs among 6 evaluable ovarian cancer patients; 1 PR and 1 unconfirmed PR in MSS-endometrial cancer
Other tumors: 2 unconfirmed responses in visceral angiosarcoma, and one unconfirmed response in PD-1-relapsed/refractory NSCLC
Majority of responses are durable and ongoing, with additional data to be presented at SITC (Free SITC Whitepaper) on November 12th (Abstract # 479)
Both monotherapy and combination therapy were well tolerated, with no cases of hypophysitis or pneumonitis
Based on these data, Agenus will commence Phase 2/3 trials evaluating AGEN1181, as a monotherapy and in combination with balstilimab, in colorectal and gynecological cancers
MiNK Therapeutics launched an IPO; its stock is trading on NASDAQ

MiNK Therapeutics launched a successful IPO, raising >$40M to support the rapid clinical development of its allogeneic cell therapies
MiNK has three presentations planned at SITC (Free SITC Whitepaper), which will showcase data on clinical-stage, allogeneic, iNKT cell therapy (AgenT-797), including clinical persistence and activity, preclinical anti-tumor activity and tissue distribution, as well as the tumor killing potential of engineered iNKT cells generated by leveraging a proprietary CAR platform
SaponiQx launch to accelerate development of proven and novel adjuvants, as well as optimized antigen-adjuvant constructs

Will address global need for vaccines offering long-lasting efficacy with secure production, which has been amplified by the current pandemic
QS-21 Stimulon adjuvant is proven to drive durable immunity – SHINGRIX (GSK zoster vaccine, recombinant) offers protection of >9 years
Collaborating with Phyton Biotech and Ginkgo Bioworks to develop and optimize a plant cell culture method of manufacturing QS-21 and next-generation saponin- based adjuvants for a secure and sustainable adjuvant supply
First patients dosed in multiple collaborator programs

First patient dosed with AGEN1777, our Fc-enhanced TIGIT bispecific antibody licensed to BMS, triggering a $20 million milestone payment. BMS intends to advance AGEN1777 in high-priority indications, such as non-small cell lung cancer
First patient dosed in clinical collaboration with Nelum, evaluating our first-generation CTLA-4, zalifrelimab, in combination with Nelum’s hedgehog inhibitor and chemotherapy in first-line pancreatic cancer
Planning underway to launch expanded access programs for balstilimab

BLA for balstilimab in second-line cervical cancer was withdrawn after full approval of pembrolizumab, four months ahead of the FDA goal date, based on data for pembrolizumab plus chemotherapy in first-line setting
Agenus will discontinue the confirmatory trial, resulting in a >$100M expense reduction
As balstilimab met trial endpoints with ORR of 20% in PD-L1 positive tumors and 8% in PD-L1 negative tumors, Agenus plans to launch an expanded access program in several countries, including the US, pending regulatory processes
Combination of balstilimab and zalifrelimab resulted in a near doubling of responses (33% vs. what has been reported with pembrolizumab in PD-L1+ cervical cancer patients); data was presented at this year’s ESMO (Free ESMO Whitepaper) Conference
Third Quarter 2021 Financial Results

We ended the third quarter of 2021 with a cash and short-term investment balance of $262 million as compared to $100 million at December 31, 2020.

For the third quarter ended September 30, 2021, our cash provided by operations was $131 million and we reported a net income of $177 million or $0.76 per share basic and $0.72 per share diluted. This compares to cash used in operations for the same period in 2020 of $32 million and a net loss of $52 million or $0.28 per share basic and diluted.

Our cash provided by operations for the nine-months ended September 30, 2021 was $33 million with net income of $39 million or $0.19 per share basic and $0.18 per share diluted, compared to cash used in operations of $104 million and a net loss for the same period in 2020 of $145 million or $0.87 per share, basic and diluted. Non-cash operating expenses for the nine-months ended September 30, 2021 were $46 million compared to $35 million for the same period of 2020.

We recognized revenue of $275 million and $57 million for the nine-months ended September 30, 2021 and 2020, respectively, which includes revenue related to upfront license fees received and milestones earned, non-cash royalties, and revenue recognized under our collaboration agreements.

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

Tempest to Present at Two Upcoming Investor Conferences in November

On November 9, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported that management will present at the following investor conferences in November (Press release, Tempest Therapeutics, NOV 9, 2021, View Source [SID1234594866]):

Jefferies London Healthcare Conference – Company presentation available on-demand Thursday, November 18, 2021 at 8:00 a.m. GMT
Piper Sandler 33rd Annual Virtual Healthcare Conference – Fireside chat available on-demand Monday, November 22, 2021 at 10:00 a.m. ET
To access the live or archived recording of the company presentaions, please visit the investor section of the Tempest website at View Source

Oncorus Announces Details of Upcoming ONCR-177 Phase 1 Initial Clinical Data Presentation at the Society for Immunotherapy of Cancer’s (SITC) 2021 Annual Meeting

On November 9, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapy company focused on driving innovation to transform outcomes for cancer patients, reported details of its upcoming presentation of initial data from the ongoing Phase 1 dose escalation and expansion clinical trial of ONCR-177 at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place November 12–14, 2021 in Washington, D.C. and virtually (Press release, Oncorus, NOV 9, 2021, View Source [SID1234594865]). ONCR-177, Oncorus’ lead product candidate built on the company’s oncolytic Herpes Simplex Virus (HSV) platform, is an intratumorally administered viral immunotherapy being developed for the treatment of multiple solid tumor indications.

Poster Presentation Details:
Title: Initial results of a Phase 1 study of intratumoral ONCR-177, an oncolytic herpes-simplex virus-1 expressing five immunomodulatory transgenes, in subjects with advanced injectable tumors
Presenter: Jong Park, M.D., Instructor, Medicine, Harvard Medical School and Assistant, Medicine, Massachusetts General Hospital
Abstract #: 511
Location: Poster Hall at the Walter E. Washington Convention Center
Date and Time: November 12–14th from 7:00 a.m.– 8:30 p.m. ET

An e-version of the poster will be available on Oncorus’ website, in the Publications & Presentations section, as of 7:00 a.m. ET on Friday, November 12th.

The submitted abstract reflects a data cut-off date of June 28, 2021, whereas the poster presentation will reflect a data cut-off date of November 1, 2021. Additional data will be presented on several evaluable patients treated with ONCR-177 monotherapy at the recommended Phase 2 dose since the June cut-off date.

Conference Call and Webcast Information
Oncorus will host a conference call and live webcast with slides and Q&A on Friday, November 12th at 8:30 a.m. ET. Igor Puzanov, M.D., MSCI, FACP, who serves as Director of Center for Early Phase Clinical Trials, Senior Vice President of Clinical Investigations, and Chief of the Melanoma Section, at the Roswell Park Comprehensive Cancer Center in Buffalo, New York, will join Oncorus management for the call. Dr. Puzanov is also participating as an investigator in the ONCR-177 Phase 1 clinical trial.

To participate in the conference call, please dial (833) 614-1530 (domestic) or (520) 809-9930 (international) and refer to conference ID 8556488. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Oncorus’ website for 30 days following the call.

Jounce Therapeutics to Present at Upcoming Investor Conferences in November

On November 9, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that company management will participate at the following upcoming investor conferences in November (Press release, Jounce Therapeutics, NOV 9, 2021, View Source [SID1234594864]):

5th Annual Cowen IO Next Summit: Fireside chat on Monday, November 15, 2021 at 10:45 a.m. ET.
33rd Annual Piper Sandler Healthcare Conference: Fireside chat available for on-demand viewing starting Monday, November 22, 2021 at 10:00 a.m. ET.
Webcasts of each fireside chat will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcasts will be archived for 30 days following the presentation.

Immatics Reports Clinical Responses across Multiple Solid Tumor Types in Ongoing ACTengine® IMA203 Phase 1a Trial Targeting PRAME

On November 9, 2021 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported an interim clinical data update from its TCR-engineered cell therapy (TCR-T) approach ACTengine IMA203 targeting PRAME (Press release, Immatics, NOV 9, 2021, View Source [SID1234594863]). Data from patients treated at the first three of four dose levels of the ongoing IMA203 Phase 1a dose escalation study show a high preliminary objective response rate (partial responses according to RECIST 1.1) at doses below 1 billion total transduced cells. The data will be presented as a late-breaking oral presentation on Saturday, November 13 at 12:00-12:15 pm EST at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). In addition, Immatics will present preclinical proof-of-concept data for its next-generation IMA203CD8 candidate at the SITC (Free SITC Whitepaper) Annual Meeting on Friday, November 12 and will provide an overall update on all IMA200 programs including IMA201 (MAGEA4/A8) and IMA202 (MAGEA1) in a conference call on November 9, 2021 at 8:30 am EST.

Key clinical findings from IMA203 Phase 1a trial
In the ongoing ACTengine IMA203 trial, Immatics is treating advanced solid cancer patients utilizing TCR-T cells directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME). PRAME is homogenously expressed and highly prevalent across several solid cancer indications. The chosen PRAME target peptide has been identified by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT, demonstrating natural and specific occurrence of the target on tumors at high copy numbers.

Clinical and biological activity: IMA203 demonstrates objective responses (RECIST 1.1.) at low cellular doses across several solid cancer types

At data cut-off on October 5, 2021, 18 patients received ACTengine IMA203 T cells across dose level 1 (DL1) to dose level 4 (DL4).
All patients were heavily pretreated with a median of 4 lines of prior systemic treatment.
16 patients were evaluable for tumor response analysis according to RECIST 1.1 with at least one post-treatment tumor assessment at the time of data cut-off. All 16 patients received dose levels 1 to 3 – below 1 billion total transduced cells. For the remaining 2 patients, the first tumor response assessment is still pending.
15 out of 16 patients (94%) achieved disease control. Tumor shrinkage was observed in 14 patients (88%).
8 out of 16 patients (50%) showed objective responses; onset of responses in all cases was detected within 6 weeks following infusion of IMA203 T cells.
All responses occurred above DL1; 8 out of 13 patients (62%) treated at DL20F1 and DL3 receiving up to 0.59 billion total transduced cells had objective partial responses. Responses were observed in patients with synovial sarcoma, malignant melanoma, uveal melanoma, and head and neck cancer.
As of data cut-off, partial responses were confirmed in subsequent scans in two synovial sarcoma patients and one uveal melanoma patient.
Longer follow-up is required for patients infused at higher dose levels DL3 and DL4 are required to assess response durability and response rate at target dose.
IMA203 continues to show high levels of T cell engraftment, persistence, and tumor infiltration at first three dose levels. Clinical response was associated (p=0.016) with infiltration of IMA203 T cells into the tumor tissue and showed an emerging trend towards higher peak vector copies of IMA203 T cells in blood (p=0.065) – supporting the mechanism-of-action.
The ACTengine IMA203 trial is currently recruiting patients to the 4th and highest dose level (up to approximately 2.5 billion total transduced cells) of the Phase 1a dose escalation cohort.
Preliminary Objective Response Rates (ORR; RECIST 1.1, confirmed and unconfirmed)

Dose Level ORR
DL1 0/3 (0%)
DL21 6/10 (60%)
DL3 2/3 (67%)

All dose levels DL21 & DL3
All comers 8/16 (50%) 8/13 (62%)
Melanoma 3/3 (100%) 3/3 (100%)
Head & Neck Cancer 1/3 (33%) 1/1 (100%)
Synovial Sarcoma 3/5 (60%) 3/5 (60%)
Uveal Melanoma 1/2 (50%) 1/2 (50%)
Safety: IMA203 treatment was well tolerated with transient and manageable treatment-emergent adverse events (TEAEs)

At data cut-off on October 5, 2021, 19 patients were evaluable for safety analysis.
Most frequent TEAEs included expected transient cytopenia (Grade 1-4) associated with lymphodepletion and transient low to moderate (Grade 1-2) cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS).
No additional dose limiting toxicities (DLT) were observed since the previous data release on March 17, 2021.

"We observed multiple clinical responses early-on during dose escalation and saw anti-tumor activity at much lower doses than would have been expected in the field of TCR-T. IMA203 T cells will now be tested at the target dose level and have the potential to provide meaningful benefits to patients with advanced stages of cancer," commented Martin Wermke, MD, Coordinating Investigator of Immatics’ ACTengine trials in Germany and Head of the Early Clinical Trial Unit of the National Center for Tumor Diseases at the University Hospital Carl Gustav Carus in Dresden, Germany. "I am looking forward to presenting this exciting data set to the scientific and medical community at SITC (Free SITC Whitepaper) and to supporting the further development of IMA203."

Following the completion of the dose escalation portion of the study (Phase 1a) and the determination of the recommended Phase 2 dose (RP2D), Immatics plans to expand the IMA203 study to multiple Phase 1b (dose expansion) study cohorts:

IMA203 as a monotherapy
IMA203 in combination with an immune checkpoint inhibitor
IMA203CD8, next-generation TCR-T where IMA203 cells are co-transduced with a CD8 co-receptor

Cedrik Britten, M.D., Chief Medical Officer at Immatics, commented: "The unexpected high clinical response rate in PRAME-positive patients before reaching our target cell dose has shifted our expectations of what cell therapy could potentially achieve in solid cancers. This is a very promising first step, which encourages us to double down efforts for a focused development strategy of our programs targeting PRAME. Our immediate next steps aim to maximize the benefit for PRAME-positive patients through (1) ACTengine IMA203 monotherapy at target dose, (2) combination with checkpoint inhibitors, and (3) our efficacy-enhanced next-gen TCR-T approach ACTengine IMA203CD8. In addition, we are gearing up for clinical testing of our off-the-shelf Bispecifics program, TCER IMA402 targeting PRAME, which has the potential of delivering transformational benefits for patients, combined with the advantages of easy and fast supply at significantly reduced cost of goods."

Preclinical update on next-generation ACTengine IMA203CD8
IMA203CD8 consists of IMA203-engineered T cells targeting PRAME co-transduced with CD8αβ T cell co-receptor that plays an important role during T cell antigen recognition and T cell activation. The IMA203CD8 product candidate has the potential to harness the potency of CD4 T cells. Engagement of CD4 T cells, in addition to CD8 T cells, might further enhance depth and durability of anti-tumor response and clinical outcome of TCR-T in solid cancer patients.

Immatics has exclusively licensed the CD8αβ technology from Baylor College of Medicine in Houston, Texas.
IMA203CD8 product candidate demonstrates enhanced anti-tumor activity in preclinical proof-of-concept data, which will be presented on-site at the SITC (Free SITC Whitepaper) Annual Meeting on Friday, November 12, 2021 between 7 am – 8:30 pm EST as well as virtually throughout the duration of the conference. The poster will also be available on Immatics’ website following the poster presentation.
IND submission for IMA203CD8 cohort is expected in the first half of 2022.

Further updates on the ACTengine IMA200 Programs

IMA201 (MAGEA4/A8) and IMA202 (MAGEA1)

The dose escalation Phase 1a study with ACTengine IMA201 and IMA202 product candidates directed at MAGEA4/8 and MAGEA1 HLA-A*02 peptides respectively, continue to advance with IMA202 at dose level 3 and IMA201 at dose level 2.
At data cut-off on September 17, 2021, 12 heavily pretreated patients have been treated; 8 out of 12 patients showed disease control. Tumor shrinkage was observed in 6 patients.
All treatment-emergent adverse events (TEAEs) for both IMA201 and IMA202 continue to be transient and manageable. No dose limiting toxicities (DLT) or higher grade CRS/ICANS have been observed.
The next step in the IMA201 and IMA202 trials is to complete dose escalation including target dose (DL3).
IMA204 (COL6A3 exon 6)

ACTengine IMA204 is a potential first-in-class TCR-T directed against COL6A3 exon 6, a novel tumor stroma target highly expressed in several solid cancers. IMA204 utilizes a next-generation CD8-independent TCR with full functionality in both CD4 and CD8 T cells.
IND-enabling studies are close to completion. Submission of the IND application for IMA204 is now expected in 2022 to allow accelerated initiation of the multiple ACTengine IMA203 Ph1b cohorts.
1DL2 here includes patients dosed with DL2, EC1 and EC2 (EC1: Enrichment cohort with intermediate dose level between DL1 and DL2 , EC2: between DL2 and DL3)

Immatics conference call
Immatics will host a conference call on Tuesday, November 9, 2021 at 8:30 am EST / 2:30pm CET to discuss these clinical data and the company’s comprehensive strategy to target PRAME via different programs. The webcast and presentation can be accessed directly through this link. Participants may also access the slides and the webcast on the Immatics website in the Investors section under "Presentations" at www.investors.immatics.com/events-presentations. A replay of the webcast will be made available shortly after the conclusion of the call and archived on the Company’s website for at least 90 days.

About Immatics’ PRAME Programs
Immatics’ PRAME programs are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers – such as uterine carcinoma, synovial sarcoma, melanoma, ovarian carcinoma, uveal melanoma, squamous NSCLC, breast carcinoma and HNSCC – thereby supporting the programs’ potential to address a broad cancer patient population. Immatics’ PRAME peptide demonstrates a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT. Through its proprietary TCR discovery and engineering platform XCEPTOR, the Company has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine IMA203, and its TCR Bispecifics pipeline, TCER IMA402. Both therapeutic modalities have distinct attributes and mechanisms of actions suitable for cancer patients at different disease stages and tumor types.

ACTengine IMA203 is currently being evaluated in an ongoing Phase 1a dose escalation cohort utilizing a 3+3 design with four increasing IMA203 dose levels to determine the Recommended Phase 2 Dose (RP2D). Immatics plans to expand the IMA203 study to multiple Phase 1b study cohorts including (1) IMA203 as a monotherapy, (2) IMA203 in combination with an immune checkpoint inhibitor and (3) IMA203CD8, a next-generation cell therapy where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor.

TCER IMA402 is a PRAME-specific "off-the-shelf" biologic that leverages the body’s immune system by redirecting and activating T cells towards cancer cells. TCER IMA402 has previously demonstrated anti-tumor activity against PRAME-positive cancer cells in an in vivo mouse model leading to consistent tumor regression including complete responses.

About ACTengine programs
ACTengine is a personalized approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine programs IMA201 (NCT03247309), IMA202 (NCT03441100) and IMA203 (NCT03686124) are currently in clinical development in the US and in Germany. The objective of the three Phase 1 clinical trials is to evaluate safety, tolerability and initial signs of clinical and biological efficacy in target-positive solid cancer patients. IMA204 is currently in pre-clinical development. All ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine IMA200 Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).