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Decibel Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Update

On March 14, 2023 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update (Press release, Decibel Therapeutics, MAR 14, 2023, View Source [SID1234628645]).

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"I am incredibly pleased with the progress Decibel made throughout 2022. We believe the clearance of our IND and CTA for DB-OTO supports our belief that AAV gene therapy is an ideal modality for the inner ear. We remain on track to initiate CHORD, the global Phase 1/2 clinical trial of DB-OTO in the first half of the year, evaluating DB-OTO in pediatric patients of diverse ages, including infants two years of age and younger. Beyond our clinical stage product candidates, we are making encouraging progress on our other programs and platform and were pleased to present data supporting the selection of a product candidate for our GJB2 program. GJB2-related hearing loss is the leading cause of autosomal recessive, non-syndromic, congenital hearing loss worldwide. We believe cell-selective expression of GJB2 will be critical for future success of any gene therapy targeting GJB2-related hearing loss, and the identification of gene regulatory elements to confer this precise expression showcases the strength of our platform," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "In June 2022, we reported positive data from an interim analysis of our Phase 1b clinical trial of DB-020, supporting both its potential benefit and the integrated capabilities Decibel has implemented to develop innovative therapeutics for conditions of the inner ear. As we look ahead, we remain deeply committed to our mission of restoring and improving hearing and balance for those in need."

Pipeline Highlights and Upcoming Milestones:

Gene Therapies for Congenital, Monogenic Hearing Loss

Received Investigational New Drug (IND) Application and Clinical Trial Application (CTA) Clearance and On Track for Phase 1/2 Trial Initiation:
DB-OTO is an AAV-based dual-vector gene therapy product candidate designed to be delivered one time to selectively express functional otoferlin (OTOF) in the inner hair cells of individuals with OTOF deficiency with the goal of enabling the ear to transmit sound to the brain and enable durable, physiological hearing. Decibel is developing DB-OTO in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to the product candidate.
In October 2022, Decibel received clearance from the FDA for its IND application to initiate CHORD, a Phase 1/2 clinical trial in pediatric patients of DB-OTO. Additionally, in January 2023, Decibel announced authorization of its CTA by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) for its CTA for the trial. Decibel plans to initiate the CHORD clinical trial of DB-OTO in pediatric patients in the first half of 2023.
Decibel expects that the first two patients in the U.S. will be as young as seven years of age and that participants in the U.K. will be infants two years of age and younger.
CTA Application Filed for DB-OTO in Spain: In November 2022, Decibel announced the submission of its CTA to the Spanish Agency of Medicines and Medical Devices (AEMPS) to open sites in Spain for CHORD.
Presented New Non-Clinical Data of DB-OTO at the 46th Annual Association for Research in Otolaryngology (ARO) MidWinter Meeting: In February 2023, Decibel presented new non-clinical data supporting the strong safety profile of DB-OTO, Decibel’s lead gene therapy product candidate. In Good Laboratory Practices ("GLP") studies, Decibel did not observe any adverse DB-OTO-related findings in otic or non-otic tissues across any evaluation of OTOF-deficient mice or non-human primates.
Identified Product Candidate for AAV.103 GJB2-Related Hearing Loss Program: In February 2023, Decibel presented preclinical data at ARO on its AAV.103 gene therapy program designed to restore hearing in individuals with mutations in the gap junction beta-2 (GJB2) gene, the leading cause of autosomal recessive, non-syndromic, congenital hearing loss worldwide. In the data presented, selective targeting of GJB2-expressing cells resulted in robust and durable hearing restoration in a mouse model of GJB2 deficiency. Decibel is developing the AAV.103 program in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to the program.
Otoprotection Therapeutic

Provided Interim Analysis Update on DB-020 Phase 1b Clinical Trial: In February 2023, Decibel presented additional data from the interim analysis of the Phase 1b clinical trial of DB-020 in patients receiving cisplatin chemotherapy. The Company continues to explore strategic opportunities to advance development of DB-020 and expects to consult with regulatory authorities in 2023 regarding its clinical development plan.
Corporate Update:

Board of Directors Update: In October 2022, Decibel announced the appointment of Kevin F. McLaughlin to its Board of Directors.
Fourth Quarter and Full Year 2022 Financial Results:

Cash Position: As of December 31, 2022, cash, cash equivalents and available-for-sale securities were $104.6 million, compared to $162.3 million as of December 31, 2021.
Research and Development Expenses: Research and development expenses were $11.6 million for the fourth quarter of 2022, compared to $8.0 million for the same period in 2021. Research and development expenses were $40.3 million for the full year 2022, compared to $29.8 million for the full year 2021. The increase in research and development expenses for the fourth quarter and full year 2022 were primarily due to additional costs to advance DB-OTO in support of the Company’s IND and CTA filings, higher clinical development costs to support its upcoming Phase 1/2 clinical trial of DB-OTO, higher research costs related to its other preclinical gene therapy programs and higher personnel-related costs due to increased headcount, wages and stock-based compensation.
General and Administrative Expenses: General and administrative expenses were $4.9 million for the fourth quarter of 2022, compared to $4.9 million for the same period in 2021. General and administrative expenses were $23.6 million for the full year 2022, compared to $20.4 million for the full year 2021. The increase in general and administrative expenses for the full year 2022 was primarily due to higher professional fees including external consulting, advisory, legal and audit services, as well as higher personnel-related costs due to increased headcount, wages and stock-based compensation.
Financial Guidance:

Based on its current operating and development plans, Decibel believes that its cash, cash equivalents and available-for-sale securities as of December 31, 2022 will fund its operating expenses into the first half of 2024.

Curium confirms no supply challenges in North America and Europe for its ECLIPSE Phase 3 clinical trial

On March 14, 2023 Curium, a world leader in nuclear medicine, reported that the company has no foreseeable supply challenges of 177Lu-PSMA-I&T for the company’s ECLIPSE Phase 3 clinical trial (NCT05204927) ongoing in the USA, France, Spain, and Italy (Press release, Curium, MAR 14, 2023, View Source [SID1234628644]). Since patient enrollment started in March 2022, the ECLIPSE Phase 3 trial has experienced reliable and uninterrupted supply of 177Lu-PSMA-I&T.

ECLIPSE is a Phase 3, multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA-I&T versus hormone therapy in patients with metastatic castration-resistant prostate cancer.

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented: "We continue to make strong progress in conducting our ECLIPSE Phase 3 clinical trial in North America and in Europe. Reliability of clinical trial supply is extremely important for our patients and investigators, and we are pleased to confirm that our clinical trial supply with 177Lu-PSMA-I&T remains uninterrupted. Curium is committed to the ECLIPSE clinical trial as well as our other ongoing clinical trials in oncology to further our mission of redefining the experience of cancer through our trusted legacy in nuclear medicine."

For more information about the ECLIPSE trial: www.eclipseclinicaltrial.org To locate a clinical trial site or contact Curium’s clinical trial: [email protected]

Corvus Pharmaceuticals to Present New CPI-818 Data Demonstrating the Potential of ITK Inhibition as a Treatment for Solid Tumors at the American Association for Cancer Research (AACR) Annual Meeting

On March 14, 2023 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that it will present new data for CPI-818, the Company’s ITK inhibitor, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is taking place April 14-19, 2023 in Orlando, FL (Press release, Corvus Pharmaceuticals, MAR 14, 2023, View Source [SID1234628643]).

The data demonstrates that in a murine syngeneic CT26 colon cancer model, single-agent CPI-818 showed anti-tumor activity, and when CPI-818 was combined with suboptimal doses of anti-PD1 and anti-CTLA4 therapy, 100% of treated animals achieved complete tumor elimination. In addition, this triplet combination achieved durable anti-tumor immune memory demonstrated by the introduction and complete elimination of new CT26 tumor cells in already treated animals. Corvus believes these findings provide the foundation for potential future human clinical trials of CPI-818 for the treatment of solid tumors.

"We have prioritized the development of CPI-818 given its broad potential across oncology and immune disease," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Our strategy is similar to the development of BTK inhibitors, starting in lymphoma, where we have established CPI-818’s safety and activity profile with plans to explore other oncology and immune disease indications. The new data that will be presented at AACR (Free AACR Whitepaper) we believe provides the foundation for CPI-818 to be studied as a treatment for solid tumors. It shows that selective ITK inhibition modulates the immune response to be more active against tumor cells, which may enable the next generation of tumor immunotherapy."

CPI-818 is currently being studied in a Phase 1/1b clinical trial as a single agent therapy in patients with relapsed T cell lymphoma (TCL). Data from this study has shown that CPI-818 induces Th1 skewing, which is the maturation of T cells into mature effector T cells that are capable of eliminating cancer cells and viral infected cells. The data to be presented at AACR (Free AACR Whitepaper) further explores the mechanisms behind these properties, demonstrating that anti-tumor activity required CD8+ T cells, and that treatment with CPI-818 increased CD8+ T effector cell tumor infiltration. In addition, levels of several exhaustion makers were down-regulated by treatment with CPI-818, suggesting that inhibition of ITK by CPI-818 produces favorable changes in the tumor microenvironment that could enhance anti-tumor immune system activity.

Details regarding the CPI-818 poster presentation at AACR (Free AACR Whitepaper), which will be available in the poster hall and the Corvus website, are as follows:

Date and Time: Monday, April 17, 2023, from 9:00 am – 12:30 PM ET

Title: Selective ITK blockade induces antitumor responses and enhances efficacy to immune checkpoint inhibitors in preclinical models

Abstract #: 1813

Presenter: Lih-Yun Hsu, Ph.D., Director of Immunology, Corvus Pharmaceuticals

Allogene Therapeutics Announces Oral Presentation of Phase 1 Data on ALLO-316 at the American Association of Cancer Research (AACR) Annual Meeting

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.

"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.

Agenus Reports Fourth Quarter and Full Year 2022 Financial Results and Outlines 2023 Objectives

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]).

"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