On May 10, 2022 Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, reported that it has successfully produced all batches of personalized cancer immunotherapies for all patients enrolled in the Phase 1/2a clinical trial of EVX-02 in adjuvant melanoma (Press release, Evaxion Biotech, MAY 10, 2022, View Source [SID1234614175]).

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Birgitte Rønø, Chief Scientific Officer of Evaxion, said: "I am extremely proud that the team behind EVX-02 has shown that this complex production chain is feasible and that we can provide truly unique, personalized DNA vaccines within a critical time window. And we are delighted that we mastered all steps in the production process. Every cancer is unique, as is every immune system, and this is why we create cancer therapies that are one size fits one – and only one."

She continues: "With the release of the final batch, we confirmed our manufacturing process, which we believe will allow us to progress our DNA cancer immunotherapy programs into larger global trials to explore the clinical benefits of the compounds further. We have again demonstrated our capabilities to timely deliver personalized cancer treatment tailored to the unique cancer profile of every patient in a clinical trial."

The production process of the personalized drug product consists of multiple steps. The sequencing of the tumor DNA is followed by AI-powered identification of the most promising therapeutic targets developed by Evaxion’s proprietary PIONEERTM technology. This leads to designing the personalized multi-target vaccine drug product, which is then manufactured, released to the clinical sites, and administered to the patient.

This is the second time Evaxion has conducted a clinical trial with personalized cancer immunotherapy, having previously used a peptide-based treatment.

About EVX-02

Our EVX-02 program (NCT04455503) treats adjuvant melanoma patients with our patented DNA-based immunotherapy in combination with standard of care. The patients are fully resected before the trial, meaning that their tumors have been successfully removed (surgically). In the study, the focus of the therapy is to prevent disease relapse. The EVX-02 program is a multicenter study conducted in Australia. There are currently 16 patients enrolled in the trial.

On May 10, 2022 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported the initiation of a Phase 1 clinical trial with its T cell engaging receptor (TCER) IMA401 for patients with recurrent and/or refractory solid tumors (Press release, Immatics, MAY 10, 2022, View Source [SID1234614047]). IMA401 is the most advanced product candidate from Immatics’ TCR Bispecific pipeline targeting an HLA-A*02-presented peptide derived from both MAGEA4 and MAGEA8. TCER IMA401 will be developed in collaboration with Bristol Myers Squibb. Immatics is responsible for conducting the Phase 1 clinical trial.

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The primary objectives of the clinical trial (NCT#05359445) are to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for IMA401 in biomarker-positive (HLA-A*02:01 and MAGEA4/8) patients with recurrent and/or refractory solid tumors. Secondary objectives are to characterize safety and tolerability, evaluate initial anti-tumor activity and assess pharmacokinetics of IMA401. The Phase 1 trial consists of a dose-escalation (Phase 1a) portion that will be followed by a dose-expansion (Phase 1b) portion to treat patients at the recommended dose level. The trial is planned to be conducted at up to 15 centers in Germany, with the first site already being initiated. The Phase 1 trial is designed to enroll approximately 50 patients.

"IMA401 is the first TCER candidate from our TCR Bispecifics pipeline entering clinical development, and expands our clinical portfolio with an exciting new TCR-based immunotherapy approach that can be supplied off-the-shelf compared to autologous cell therapies," said Cedrik Britten, Chief Medical Officer at Immatics. "Our innovative TCER format leads to an extended-half-life and incorporates novel binding-moieties that are designed to maximize efficacy while minimizing toxicities in patients. Our TCER IMA401 could treat a range of solid tumors and therefore meet currently unmet needs of a broad patient population. This is best achieved with a strong pharma partner which we have found in Bristol Myers Squibb."

Immatics entered into a global exclusive license agreement with Bristol Myers Squibb in December 2021 for the IMA401 program under which both companies will collaborate to advance the program through clinical development.

Immatics’ TCR Bispecific pipeline includes a second TCER product candidate, IMA402, which targets PRAME. Manufacturing of the clinical IMA402 batch is planned for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023. Immatics’ TCER pipeline is further strengthened by additional innovative TCER program(s), IMA40X, in preclinical development.

About IMA401
IMA401 is Immatics’ most advanced TCER molecule that targets an HLA-A*02-presented (human leukocyte antigen) peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 ("MAGEA4/8"). The MAGEA4/8 peptide has been identified and validated by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT and is presented at a 5-fold higher copy number per tumor cell than a MAGEA4 peptide targeted in other clinical trials. Following preclinical proof-of-concept data, including complete remissions of transplanted human-derived tumors in xenograft mouse models, the Phase 1 trial investigates IMA401 in patients with tumors of high MAGEA4/8 prevalence, such as squamous non-small cell lung carcinoma (sqNSCLC), small cell lung cancer (SCLC), head and neck squamous cell carcinoma (HNSCC), bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types.

About TCER
Immatics’ half-life extended TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. Immatics proprietary biologics are engineered with two binding regions: a TCR domain and a T cell recruiter domain. The TCER format is designed to maximize efficacy while minimizing toxicities in patients. It contains a high-affinity TCR domain that is designed to bind specifically to the cancer target peptide on the cell surface presented by an HLA molecule. The antibody-derived, low-affinity T cell recruiter domain is directed against the TCR/CD3 complex and recruits a patient’s T cells to the tumor to attack the cancer cells. With a low-affinity recruiter aiming for optimized biodistribution and enrichment of the molecule at the tumor site instead of the periphery, TCER are engineered to reduce the occurrence of immune-related adverse events, such as cytokine release syndrome. In addition, the TCER format consists of an Fc-part conferring half-life extension, stability, and manufacturability. TCER are "off-the-shelf" biologics and thus immediately available for patient treatment. They can be distributed through standard pharmaceutical supply chains and provide the opportunity to reach a large patient population without the need of specialized medical centers.

On May 10, 2022 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, reported that the company is scheduled to present at the RBC Capital Markets Global Healthcare Conference on Tuesday, May 17, 2022, at 10:30 a.m. ET (Press release, Agios Pharmaceuticals, MAY 10, 2022, View Source [SID1234614095]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

On May 10, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Cellectar Biosciences, MAY 10, 2022, View Source [SID1234614111]).

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First Quarter and Recent Corporate Highlights

Announced that an independent data monitoring committee (DMC) has completed its planned futility/efficacy assessment of the company’s pivotal Phase 2b study of iopofosine in Waldenstrom’s macroglobulinemia (WM) and unanimously recommended continuation of the trial as planned. The DMC is an independent committee of clinical research experts charged with the review of data from the company’s ongoing pivotal trial. The DMC assessment was based on a pre-specified futility analysis within the first 10 patients as defined in the study protocol.

Announced the appointment of two key executives to its commercial team: Matthew Hagan as vice president marketing and strategic alliances and David Lasecki as executive director, strategic alliances.
"The unanimous agreement of the independent DMC that the pre-specified futility analysis for our pivotal Phase 2b trial of iopofosine I-131 in WM was achieved represents an important milestone," said James Caruso, president and CEO of Cellectar. "We look forward to continuing iopofosine’s clinical development and remain appreciative of the strong support by the patient advocacy groups, community clinicians and WM academic thought leadership as we collectively partner to treat this orphan designated cancer. In multiple myeloma, we continue to enrich our CLOVER-1 trial and are optimistic that iopofosine I-131 will help to address an unmet medical need in this indication."

First Quarter 2022 Financial Highlights

Cash and Cash Equivalents: As of March 31, 2022, the company had cash and cash equivalents of $30.6 million, compared to $35.7 million as of December 31, 2021. Net cash used in operating activities during the three months ended March 31, 2022 was approximately $5.0 million. The company believes its cash on hand is adequate to fund basic budgeted operations for at least 12 months from the filing of the first quarter 2022 financial statements.

Research and Development Expense: R&D expense for the three months ended March 31, 2022 was approximately $3.9 million, compared to approximately $4.6 million for the three months ended March 31, 2021. The overall decrease in R&D expense of approximately $746,000 was primarily the result of a reduction in clinical project costs of approximately $1.5 million, partially offset by an increase in manufacturing and related costs related to production sourcing, general research and development costs resulting from an increase in personnel, and pre-clinical project costs.

General and Administrative Expense: G&A expense for the three months ended March 31, 2022 was $2.3 million, compared to $1.7 million for the same period in 2021. The overall increase in G&A expense of $527,000 was primarily driven by an increase in professional fees and personnel costs, including stock-based compensation expense and a resumption of travel.

Net Loss: The net loss attributable to common stockholders for the quarter ended March 31, 2022 was ($6.1) million, or ($0.10) per share, compared to ($6.4) million, or ($0.13) per share, in the quarter ended March 31, 2021.

On May 10, 2022 AbCellera (Nasdaq: ABCL), a technology company with a centralized operating system for next-generation antibody discovery, reported financial results for the first quarter of 2022 (Press release, AbCellera, MAY 10, 2022, View Source [SID1234614127]). All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"We entered 2022 with strong momentum that we leveraged to start new drug discovery programs and demonstrate the power of our platform by discovering a panel of CD3 antibodies for use in precision cancer treatments," said Carl Hansen, Ph.D., CEO and President of AbCellera. "With our strong cash position and book of business, we also continued pursuing deal structures that allow us to capture more downstream value and expanded an existing partnership to include the option to co-develop therapeutic programs."

Q1 2022 Business Summary

Earned $317 million in total revenue.
Generated net earnings of $169 million, compared to $117 million in Q1 2021.
Added two programs under contract with an existing partner, resulting in a cumulative total of 158 programs under contract with 36 different partners.
Started discovery on six programs, bringing the cumulative number of program starts to 84.
Confirmed one new molecule advanced into the clinic, bringing the cumulative total to six.
Key Business Metrics

AbCellera added two discovery programs in Q1 to reach a cumulative total of 158 discovery programs as of March 31, 2022 (up from 119 on March 31, 2021), that are either completed, in progress, or under contract with 36 different partners (up from 29 on March 31, 2021). AbCellera started discovery on an additional six programs in Q1 to reach a cumulative total of 84 program starts (up from 54 on March 31, 2021). AbCellera’s partners advanced one additional molecule into the clinic in Q1 2022, bringing the cumulative total to six.

Discussion of Q1 2022 Financial Results

Revenue – Total revenue was $316.6 million, compared to $202.7 million in Q1 2021. Royalties associated with bamlanivimab and bebtelovimab were $307.0 million. The partnership business produced research fees of $9.3 million, compared to $4.0 million in Q1 2021. Licensing revenue was $0.2 million.
Research & Development (R&D) Expenses – R&D expenses were $26.4 million, compared to $12.4 million in Q1 2021, reflecting continuing investments in the capacity and capabilities of AbCellera’s discovery and development platform.
Sales & Marketing (S&M) Expenses – S&M expenses were $2.4 million, compared to $2.6 million in Q1 2021.
General & Administrative (G&A) Expenses – G&A expenses were $14.3 million, compared to $6.4 million in Q1 2021, with the increase driven by investments to support the growth of the company and non-cash stock-based compensation.
Net Earnings – Net earnings were $168.6 million, or $0.59 per share on a basic and $0.54 on a diluted basis compared to $117.2 million, or $0.43 per share on a basic and $0.37 on a diluted basis in Q1 2021.
Liquidity – $786.1 million of cash, cash equivalents, and marketable securities.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.