On March 14, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will present interim data from its Phase 1 TRAVERSE trial of ALLO-316, the Company’s first AlloCAR T candidate for solid tumors, in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in April in Orlando, Florida (Press release, Allogene, MAR 14, 2023, View Source [SID1234628642]). The AACR (Free AACR Whitepaper) conference presentation follows the release of preliminary ALLO-316 data reported at the Company’s R&D Showcase event in November 2022.

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"We are excited to present ALLO-316 data for the first time at a medical conference," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development. "There is an urgent need for innovation for patients with renal cell carcinoma who have failed immune checkpoint inhibitors and targeted therapy. Initial data from this trial shared at our R&D Showcase in November 2022 demonstrated the potential of ALLO-316 in patients with CD70 expressing advanced or metastatic RCC, and we look forward to further exploring the potential of this AlloCAR T product candidate in RCC and potentially other CD70-expressing tumors."

Dagger technology is a proprietary platform designed to control rejection of AlloCAR T cells by the host immune cells and is an intrinsic property of ALLO-316. The results from this trial indicate that ALLO-316 possesses antitumor activity as well as the anti-rejection effect.

"The Dagger technology has been shown preclinically to counter premature rejection of AlloCAR T cells via the elimination of CD70 positive, alloreactive host T cells," said Barbra Sasu, Ph.D., Chief Scientific Officer of Allogene. "The demonstration of this novel mechanism of action in the clinic opens the possibility of combining the CD70 Dagger receptor with other anti-tumor CARs to create dual-targeting, rejection-resistant next generation products that may be less dependent on lymphodepletion."

Allogene presentation at the 2023 AACR (Free AACR Whitepaper) Annual Meeting:

A phase 1 multicenter study (TRAVERSE) evaluating the safety and efficacy of ALLO-316 following conditioning regimen in pts with advanced or metastatic clear cell renal cell carcinoma (ccRCC)

Presenter: Dr. Samer Srour, MB ChB, MS, Assistant Professor, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Session Title: Promising Novel Antitumor Strategies in Early Phase Clinical Trials
Abstract #: CT011
Session Date and Time: Monday April 17, 2023 10:15 AM – 12:15 PM ET

Clear cell renal cell carcinoma is the most common type of RCC in adults, making up about 80% of all cases in the U.S., according to the National Cancer Institute (NCI). The five-year survival rate for patients with metastatic kidney cancer is less than 15%.1

The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. The Company is testing the need to prospectively assess CD70 expression levels in tumors to enhance patient selection using a new investigational in vitro companion diagnostic (IVD) assay. TRAVERSE will continue to explore varying cell dose and lymphodepletion regimens.

ALLO-316 for the treatment of advanced or metastatic RCC was granted Fast Track Designation (FTD) by the U.S. FDA in March 2022.

On March 14, 2023 Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with a pipeline of immunological agents targeting cancer and infectious disease, reported a corporate update and reported financial results for the fourth quarter and full year 2022 (Press release, Agenus, MAR 14, 2023, View Source [SID1234628641]).

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"Agenus has entered 2023 with strong momentum across our extensive and diverse clinical pipeline of immuno-oncology programs. Our anchor programs, botensilimab (Fc-enhanced, multi-functional anti-CTLA-4) and balstilimab (anti-PD-1), show exciting potential in combination to treat a broad spectrum of treatment-resistant cancers," said Garo Armen, PhD, Chairman, and Chief Executive Officer of Agenus. "With the growing body of data demonstrating robust, consistent, and durable efficacy signals from a trial of over 300 patients across nine metastatic, late-line cancers, we are expediting the expansion of our botensilimab/balstilimab development program in MSS CRC and other priority indications."

"The number of patients with solid tumors resistant to a variety of therapies, including current immunotherapies, is substantial. Existing treatment options for these patients after failure of initial standard treatments are limited and largely ineffective, resulting in a short overall survival rate," said Dr. Steven O’Day, Chief Medical Officer of Agenus. "Botensilimab’s clinical activity in advanced and refractory cancers has generated considerable interest from experts worldwide."

2022 Highlights

Botensilimab: Wholly Owned Lead Clinical Asset

Botensilimab’s clinical results have been presented at a late-breaking oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO GI) in 2023, and in plenary sessions at the European Society for Medical Oncology (ESMO-GI), Connective Tissue Oncology Society (CTOS), the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 annual meetings, as well as at a company-hosted R&D Event (‘The Road Taken’). The latest clinical study results, including those of the botensilimab and botensilimab/balstilimab combination, demonstrate durable responses and significant benefits compared to that reported for standard of care and other investigational therapies in patients with treatment-resistant tumors.

MSS CRC: most recent data update presented at ASCO (Free ASCO Whitepaper) GI

Out of 70 evaluable patients:

Survival:
12-month overall survival rate of 63%, including 81% for patients with no active liver metastases, and 40% for patients with active liver metastases, indicating clinical benefit across all patient populations.
Standard of care reported a 12-month overall survival rate of approximately 25%, inclusive of patients with and without active liver metastases.1,2
Median overall survival has not been reached.

Objective responses:
Overall response rate of 23%.
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations have reported response rates of 1-5%.3,4
69% of objective responses were ongoing at the data cut-off.
Disease control rate was 76% (complete response + partial response + stable disease).

Ovarian: most recent data update presented at SITC (Free SITC Whitepaper)

Out of 19 evaluable patients:

Objective responses:
Overall response rate was 26%.
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations reported response rates of 3-10%.5,6
Median duration of response has not been reached.
Disease control rate was 63%.

Sarcoma: most recent data update presented at CTOS

Out of 13 evaluable patients:

Survival:
12-month overall survival rate of 77%.
Median overall survival has not been reached.

Objective responses:
Overall response rate of 46%.
Other PD-(L)1 + CTLA-4 combination regimens in a comparable patient population reported response rates of 12-16%.7,8
67% of objective responses were ongoing at the data cut-off.
Disease control rate was 69%.

Anti-PD-(L)1 Relapsed/Refractory NSCLC: most recent data update presented at SITC (Free SITC Whitepaper)

Out of 8 evaluable patients:
Objective responses:
Overall response rate of 50%.
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations reported response rates of 6-13%.9,10
Median duration of response has not been reached.
Disease control rate was 75%.
Since SITC (Free SITC Whitepaper), a total of 4 out of 8 evaluable NSCLC patients have showed objective responses, consistent with the 50% overall response rate reported at SITC (Free SITC Whitepaper) 2022.

Botensilimab: Key Catalysts for 2023

Complete enrollment of the randomized Phase 2 ACTIVATE study in MSS CRC of botensilimab and the botensilimab/balstilimab combination compared to standard of care
Complete enrollment of Phase 2 ACTIVATE studies of botensilimab in melanoma and pancreatic cancer
Expect to launch a Phase 3 confirmatory study of botensilimab/balstilimab in MSS CRC
Continue enrollment of PD-(L)1 relapse/refractory NSCLC patients in the ongoing Phase 1b study; design randomized phase 3 study with potential launch in 2023 if response rates persist in expanded Phase 1b.
Present additional data from the botensilimab/balstilimab Phase I/II cohorts at upcoming medical conferences, including an oral plenary session at the Society of Gynecologic Oncology 2023 Annual Meeting in March with updated data from the ovarian cohort.
Clinical Pipeline of Majority-Owned Assets and Strategic Partnerships

Majority-Owned Assets:

AGEN2373 (CD137 agonist): Currently enrolling a Phase 1b combination study with botensilimab in PD-1 relapsed/refractory melanoma. We expect to complete dosing of this study in the first half of 2023. The onset of this trial triggered a milestone payment from partner Gilead, who has an exclusive option to license AGEN2373.
AGEN1571 (ILT2 antagonist): The first patient was dosed in a Phase 1 dose-escalating and expansion study in patients with advanced solid tumors. The study will evaluate safety and tolerability as a single agent and in combination with botensilimab and balstilimab.
Strategic Partnerships:

MK-4830 (ILT4 antagonist discovered by Agenus): Merck has initiated a randomized Phase II study evaluating MK-4830 in combination with pembrolizumab and chemotherapy in ovarian cancer, and two Phase I/II studies, evaluating MK-4830 in combination with pembrolizumab and chemotherapy or lenvatinib in advanced esophageal cancer. Additional Phase II studies are ongoing in advanced NSCLC, extensive stage small cell lung cancer, stage IV MSI-H colorectal cancer, second line plus renal cell carcinoma, and stage III melanoma.
INCAGN2385 (LAG-3 antagonist discovered by Agenus) and INCAGN2390 (TIM-3 antagonist discovered by Agenus): Incyte launched Phase II studies evaluating INCAGN2385 and INCAGN2390 in combination with retifanlimab in melanoma, squamous cell carcinoma of the head and neck, and endometrial cancer.
INCAGN1876 (GITR agonist discovered by Agenus): Incyte launched a Phase II study evaluating INCAGN1876 in combination with retifanlimab in squamous cell carcinoma of the head and neck.
BMS-986442 (AGEN1777; TIGIT bispecific discovered by Agenus): BMS launched a Phase I/II study evaluating BMS-986442 in combination with nivolumab +/- chemotherapy in patients with advanced solid tumors and non-small cell lung cancer.
UGN-301 (zalifrelimab intravesical solution; anti-CTLA-4): UroGen launched a Phase I study evaluating UGN-301 as monotherapy and in combination with other agents, including UGN-201, in patients with non-muscle invasive bladder cancer.
Additional 2023 Catalysts and Operational Objectives:

Complete enrollment of the Phase 1b study of AGEN2373 (anti-CD137) and botensilimab in melanoma.
Initiate combination cohorts of AGEN1571 (anti-ILT2) with botensilimab and balstilimab.
Potential income from existing and future collaborators.
Advance 7 existing clinical collaborations evaluating combinations of external agents with our PD-1 and CTLA-4 antibodies sponsored and executed by partners.
Fourth Quarter and Full Year 2022 Financial Results:

As of December 31, 2022, we had a cash, cash equivalent and short-term investment balance of $193 million, compared to $218 million and $307 million on September 30, 2022, and December 31, 2021, respectively. For the fourth quarter ended December 31, 2022, we recognized revenue of $28 million and incurred a net loss of $74 million (including non-cash expenses of $33 million) or $0.24 per share. For the year ended December 31, 2022, we recognized revenue of $98 million and incurred a net loss of $231 million (including non-cash expense of $96 million), or $0.78 per share. Revenue includes revenue under our collaboration agreements, revenue related to non-cash royalties earned, milestones received, and revenue from Agenus owned CROs.

Financial Highlights
(in thousands, except per share data)
(unaudited)

December 31,
2022 2021

Cash, cash equivalents and short-term investments $ 193,358 $ 306,923


Three months ended December 31, Year ended December 31,
2022 2021 2022 2021

Revenues, research and development $ 3,755 $ 2,157 $ 16,975 $ 244,422
Revenues, non-cash royalty 18,284 15,452 45,285 44,355
Revenues, royalty sales milestone - - 25,250 -
Revenues, other 6,347 2,652 10,514 6,888

Total Revenue 28,386 20,261 98,024 295,665


Research and development expenses 53,279 53,486 186,691 178,608
General and administrative expenses 25,036 21,971 81,007 76,359
Cost of service revenue 7,693 881 10,568 3,470
Other income (3,918 ) (2,744 ) (10,944 ) (3,951 )
Non-cash interest expense 18,326 16,324 62,955 64,619
(Gain) loss related to debt 1,937 - (782 ) (6,197 )
Non-cash contingent consideration fair value adjustment 135 (2,050 ) (815 ) 11,481
Net loss $ (74,102 ) $ (67,607 ) $ (230,656 ) $ (28,724 )

Net loss per share attributable to Agenus Inc. common stockholders $ (0.24 ) $ (0.26 ) $ (0.78 ) $ (0.11 )

Cash provided by (used in) operations $ (47,338 ) $ (22,927 ) $ (175,373 ) $ 10,145
Non-cash operating expenses $ 32,777 $ 17,743 $ 95,591 $ 99,164

Conference Call

Date: March 14, 2023, 8:30am ET
Dial-in numbers: 646-307-1963 (US-NY) & 800-715-9871 (Ex-US)
Event ID: 2699739

Webcast

A 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

References
1 Mayer et al. NEJM 2015
2 Grothey et al. Lancet 2013
3 Chen et al. JAMA Oncol. 2020
4 Overman et al. ASCO (Free ASCO Whitepaper) 2016
5 View Source
6 Hinchcliff et al. Gynecologic Oncology 2021
7 D’Angelo et al. Lancet Oncology 2018
8 Somaiah et al. Lancet Oncology 2022
9 View Source
10 Fisher et al. ASCO (Free ASCO Whitepaper) 2019

On March 14, 2023 Targovax ASA (OSE: TRVX), reported that the first patient has been dosed with cancer vaccine TG01 in the combination study with PD-1 checkpoint inhibitor (CPI) balstilimab in mutant RAS pancreatic cancer in the USA (Press release, Targovax, MAR 14, 2023, View Source [SID1234628636]). The study is led by gastrointestinal cancer expert Dr. Anup Kasi in a three-way clinical collaboration between Kansas University Cancer Center (KUCC), Agenus and Targovax, and represents the first time a patient is given the enhanced TG01 vaccine with immune-stimulatory adjuvant QS-21 STIMULON from Agenus.

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Pancreatic cancer is the third leading cause of cancer-related deaths with less than 10% 5-year survival from diagnosis, and chemotherapy remains the standard-of-care therapy for the vast majority of patients. Oncogenic RAS mutations are present in more than 90% of cases, but there are no approved therapies available against this important genetic driver. As such, there is a major unmet medical need for novel, effective agents to improve outcomes for pancreatic cancer patients.

In this study, 24 pancreatic cancer patients who have detectable tumor DNA in the blood following surgery and follow-up treatment will be randomly allocated to either TG/QS-21 vaccination alone or vaccination combined with PD-1 CPI balstilimab. The aim is to evaluate whether mutant RAS T-cell responses generated by TG01, and further boosted by QS-21 STIMULON and balstilimab, may have the potential to eliminate remaining cancer cells to prolong time to relapse and extend patient survival.

Dr Anup Kasi, Associate Professor at The University of Kansas Cancer Center, said: "I am very pleased to have dosed the first patient with the enhanced TG01 vaccine at our center. The aim of the study is to assess whether the expected synergy between TG01 and balstilimab can prolong time to relapse in a therapeutic window where we have nothing available today. To assess the clinical benefit, we are using cutting-edge ctDNA technology as a blood-based biomarker to track efficacy in real-time. If this concept works as anticipated, it has the potential to provide a novel targeted treatment alternative to a patient group with high unmet medical need."

Dr Lone Ottesen, Chief Medical Officer of Targovax ASA, added: "Having the first patient dosed in the Kansas study represents a major milestone for our mutant RAS program. It is the first time we test the TG01 cancer vaccine with adjuvant QS-21 STIMULON, the first time we combine TG01 with a PD-1 checkpoint inhibitor, and the first time TG01 enters the clinic in the USA. The scientific rationale behind the study is solid, and we believe minimal residual disease after surgery in pancreatic cancer is the ideal setting to test it. If successful, this can provide the first RAS-targeted therapy in pancreatic cancer."

About TG01 mutant RAS vaccine
Mutations in the RAS genes are found in over 90% of pancreatic cancers, but there are no RAS-targeted therapies available for this patient group. TG01 is a mutant RAS therapeutic cancer vaccine adjuvanted by QS-21 STIMULON, which targets the seven most commonly found RAS mutations in pancreatic cancer. TG01 has previously demonstrated robust immune responses and survival benefit in resected pancreatic cancer combined with standard of care chemotherapy.

About Agenus, QS-21 STIMULON and balstilimab
Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer and infections. In March 2022, Targovax announced a collaboration with Agenus to utilize the proprietary adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 STIMULON has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and as a component of the commercial Shingrix* and Mosquirix* vaccines. QS-21 STIMULON is expected to further potentiate the TG vaccines by driving stronger anti-RAS T-cell responses. In this KU Cancer Center trial, the collaboration has been broadened to also include supply of Agenus´ PD-1 CPI balstilimab for combination with TG01. Balstilimab is designed to block the protein PD-1 and mobilize a patient’s T cells to attack the tumor. Balstilimab has been evaluated in over 750 patients to date and demonstrated strong clinical activity and excellent tolerability in multiple tumor types.

*Trademarks owned by GSK.

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: [email protected]

Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: [email protected]

Media enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47 9300 1773
Email: [email protected]

On March 14, 2023 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported a business update and reported financial results for the fourth quarter and full year of 2022 (Press release, Cogent Biosciences, MAR 14, 2023, View Source [SID1234628634]).

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"2022 was a pivotal year for Cogent marked by our promising clinical data with bezuclastinib in systemic mastocytosis, the initiation of our Phase 3 PEAK trial in GIST, and the build-out of the Cogent Research Team," said Andrew Robbins, the company’s President and Chief Executive Officer. "We have laid the foundation for multiple catalysts in 2023 across all our programs. Based on the clinical performance of bezuclastinib, we believe it has the potential to be a best-in-class therapy for patients living with systemic mastocytosis and GIST. We continue to advance therapies that improve the lives of patients with genetically defined rare diseases while positioning ourselves as an industry leader in precision medicine."

Recent Highlights

•
In March 2023, Cogent received approvals from European regulatory authorities to initiate the Phase 2 SUMMIT trial in patients with nonadvanced systemic mastocytosis (NonAdvSM). Beginning in April 2023, the company expects to start activating clinical trial sites across major countries in the European Union.
•
In December 2022, Cogent reported positive updated clinical data from the ongoing Phase 2 APEX trial evaluating bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
o
As of the cutoff date, October 26, 2022, 11 patients were evaluable for response per the modified IWG-MRT-ECNM criteria. 89% ORR (including centrally adjudicated confirmed and unconfirmed responses) was seen in TKI therapy naïve patients, including 67% of patients achieving CR, CRh or PR, and 22% of patients achieving CR or CRh. Additionally, bezuclastinib demonstrated rapid reductions in serum tryptase, with an 85% mean reduction

in serum tryptase, 14/16 patients achieving ≥ 50% reduction in serum tryptase levels, and eight of these patients achieving serum tryptase of <20ng/mL. Bezuclastinib was generally well-tolerated at all doses. There were no related cases of cognitive impairment and no reported bleeding events, which have been associated with other KIT inhibitors.
•
In November 2022, Cogent reported positive clinical lead-in data from the ongoing Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST) at the Connective Tissue Oncology Society (CTOS) annual meeting.
o
As of the cutoff date, September 26, 2022, 17 of 19 patients remained on study. Early data suggested an encouraging safety and tolerability profile consistent with the previous Phase 1/2 study and the known safety profile for sunitinib monotherapy.
•
In October 2022, Cogent reported preclinical data at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) annual meeting on a next-generation fibroblast growth factor receptor 2 (FGFR2) program, which retains potency across all primary, gatekeeper and molecular brake resistance mutations, including N549K and V564I, while sparing FGFR1 inhibition. Also, Cogent presented preclinical data at ENA on a novel ErbB2 mutant selective program which demonstrates robust cellular inhibition of all key resistance and primary driver mutations, including L755S, V842I and S310F/Y, while sparing wild type EGFR target engagement.
•
Appointed Rachael Easton, MD, Ph.D., Vice President, Head of Clinical Development. Prior to joining Cogent, Dr. Easton was Group Senior Medical Director, Oncology Clinical Development at GSK​. Prior to GSK, she held clinical development roles of increasing responsibility at Immunocore and Sanofi. Before transitioning into the biotechnology industry, Dr. Easton was an instructor at the University of Pennsylvania School of Medicine where she conducted research in growth and metabolism and provided outpatient care for patients with endocrine disorders.
•
Appointed Sylvia Adams, MD to Cogent’s Scientific Advisory Board. Dr. Adams is a Professor of Medicine at the NYU Grossman School of Medicine and Director of the Breast Cancer Center at the Laura and Isaac Perlmutter Cancer Center. As an internationally recognized expert in breast cancer immunotherapy, she has led groundbreaking research and clinical studies leading to the first chemo-immunotherapy approval for breast cancer. She is a member of the ECOG-ACRIN Breast Cancer Committee and at present, co-chairs the NCI Breast Cancer Immuno-Oncology Task Force

Upcoming Milestones

•
Present updated clinical data from refractory GIST patients in the lead-in cohort of the Phase 3 PEAK trial of bezuclastinib plus sunitinib during the first half of 2023.
•
Provide a mid-year update on the planned initiation of APEX Part 2 based on clinical data from approximately 25-30 patients in APEX Part 1.
•
Present initial clinical data from SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with NonAdvSM in the second half of 2023. Clinical data is expected to include safety/tolerability, pharmacokinetics and measures of clinical activity.
•
Present updated preclinical data from Cogent’s selective FGFR2 and ErbB2 research programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting taking place April 14-19, 2023 in Orlando, Florida.
Fourth Quarter and Full Year 2022 Financial Results

Cash and Cash Equivalents: As of December 31, 2022, Cogent had cash, cash equivalents and marketable securities of $259.3 million. The company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into 2025. Cogent holds a de minimis amount of cash related balances at Silicon Valley Bank.

R&D Expenses: Research and development expenses were $36.7 million for the fourth quarter of 2022 and $121.6 million for the year ended December 31, 2022, as compared to $20.5 million for the fourth quarter of 2021 and $55.9 million for the year ended December 31, 2021. The increase is primarily a result of bezuclastinib clinical trial activities. R&D expenses include non-cash stock compensation expense of $2.4 million for the fourth quarter of 2022 and $8.5 million for the year ended December 31, 2022, as compared to $1.7 million for the fourth quarter of 2021 and $4.4 million for the year ended December 31, 2021.

G&A Expenses: General and administrative expenses were $7.0 million for the fourth quarter of 2022 and $26.2 million for the year ended December 31, 2022, as compared to $5.1 million for the fourth quarter of 2021 and $19.6 million for the year ended December 31, 2021. G&A expenses include non-cash stock compensation expense of $2.6 million for the fourth quarter of 2022 and $9.9 million for the year ended December 31, 2022, as compared to $2.1 million for the fourth quarter of 2021 and $7.3 million for the year ended December 31, 2021

Net Loss: Net loss was $39.6 million for the fourth quarter of 2022 and $140.2 million for the year ended December 31, 2022, as compared to a net loss of $24.9 million for the fourth quarter of 2021 and $72.3 million for the year ended December 31, 2021.

On March 14, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it hosted a Key Opinion Leader (KOL) Interview on the interim efficacy results from the OPTIMIZE-1 Phase 2 trial of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer, which will be available to view online from Tuesday 14 March, 2023 via this link (Press release, Alligator Bioscience, MAR 14, 2023, View Source [SID1234628633]).

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The discussion features Professor Jean-Luc Van Laethem, Head of the Digestive Oncology Clinic in the Gastroenterology Department of Erasmus Hospital (ULB) Brussels, an internationally-recognized specialist in the field of digestive cancers and the Principal Investigator of the OPTIMIZE-1 trial, and Dr. Sumeet Ambarkhane, Chief Medical Officer of Alligator Bioscience. They discuss perspectives on the current standard of care for patients with metastatic pancreatic cancer, what outcomes are associated with those therapies and the unmet medical needs. The function of mitazalimab and the OPTIMIZE-1 study design are elucidated, and the latest interim efficacy and safety data are presented and explained. Mitazalimab’s therapeutic potential, and other potential combinations with the drug candidate, are discussed as well.

OPTIMIZE-1 is an open-label, multi-center study assessing the safety and efficacy of mitazalimab (CD40 mAb) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. In January 2023, Alligator announced strong interim results from OPTIMIZE-1, in which mitazalimab combined with mFOLFIRINOX demonstrated an objective response rate (ORR) of 52% in 23 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Primary endpoint readout is expected in Q1 2024.

"The potential of mitazalimab as a combination therapy for pancreatic cancer can be seen by comparing these interim results to data from a similar patient population treated only with FOLFIRINIOX, which demonstrated an ORR of around 32 percent," said Dr. Sumeet Ambarkhane, CMO of Alligator Bioscience. "Pancreatic cancer is considered an immunologically cold tumor, meaning there is little influx of T cells which renders therapeutic approaches such as chemotherapy alone less effective. Mitazalimab has an important role to play here because it can activate better infiltration of T cells converting the tumor microenvironment from immune suppressive to immune active, to support the killing of tumor cells."