On May 9, 2022 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical stage biotechnology company pioneering a new class of medicines that modulate gene expression through selectively targeting the chromatin regulatory system, reported a corporate update in conjunction with the Company’s 10-Q filing for the quarter ended March 31, 2022 (Press release, Foghorn Therapeutics, MAY 9, 2022, View Source [SID1234613942]). With an initial focus in oncology, Foghorn’s Gene Traffic Control Platform and resulting broad pipeline has the potential to transform the lives of people suffering from a wide spectrum of diseases.

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"With $424.7 million in cash on the balance sheet, Foghorn is well capitalized, to execute on its strategy of developing precision medicines targeting the chromatin regulatory system. This quarter, we continued to advance our robust pipeline that includes clinical and pre-clinical programs evaluating targeted protein degraders, enzymatic inhibitors and transcription factor disruptors for diverse cancers," said Foghorn CEO Adrian Gottschalk. "Specifically, we continue to enroll patients and dose escalate in our Phase 1 clinical studies of FHD-286 and FHD-609 and look forward to disclosing initial clinical data."

Key First Quarter 2022 Updates

FHD-286 Update. Foghorn expects to provide initial Phase 1 clinical data for FHD-286, an inhibitor of BRG1/BRM, in metastatic uveal melanoma (mUM), relapsed and/or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in the second half of 2022.

FHD-609 Update. Enrollment is continuing in the Phase 1 clinical study of FHD-609, a potent and selective heterobifunctional protein degrader of BRD9, initially being developed for the treatment of synovial sarcoma with initial data expected in 2023.

2022 AACR (Free AACR Whitepaper) Annual Meeting. Presented preclinical data supporting the clinical development and mechanistic understanding of FHD-286’s anti-tumor activity in AML demonstrated by tumor inhibition in different cancer cell types, synergistic activity with combination medicines, including chemotherapy and other targeted therapies, and mutation agnostic responses in AML patient derived bone marrow samples.

BRM-selective Progress. Foghorn is advancing its BRM-selective programs in collaboration with Loxo Oncology at Lilly, with the BRM-selective inhibitor program in lead optimization and the protein degrader program in hit-to-lead stage. Foghorn is leading discovery and early research activities, and Lilly is leading development and commercialization activities with participation from Foghorn. U.S. economics will be shared equally, and Foghorn is eligible to receive royalties on ex-U.S. sales in the low double-digit to twenties range based on revenue levels.
Pipeline Advancement. Foghorn continued to advance its broad therapeutic pipeline of which the majority are wholly owned including protein degraders, enzymatic inhibitors and transcription factor disruptors targeting cancers impacted by breakdowns in the chromatin regulatory system.

Strong Balance Sheet and Cash Runway. As of March 31, 2022, the Company had $424.7 million in cash, cash equivalents and marketable securities.
About FHD-286

FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM, two highly similar proteins that are the ATPases, or the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors. To learn more about these studies please visit ClinicalTrials.gov. (Link here for metastatic uveal melanoma and here for AML and MDS).

About AML

Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.

About Uveal Melanoma

Uveal (intraocular) melanoma (UM) is a rare eye cancer that forms from cells that make melanin in the iris, ciliary body, and choroid. It is the most common eye cancer in adults. It is diagnosed in about 2,000 adults every year in the United States and occurs most often in lightly pigmented individuals with a median age of 55 years. However, it can occur in all races and at any age. UM metastasizes in approximately 50% of cases, leading to very poor prognosis.

About FHD-609

FHD-609 is a potent, selective, intravenously administered protein degrader of BRD9, a component of the ncBAF complex. Preclinical studies have demonstrated tumor growth inhibition in synovial sarcoma, a cancer genetically dependent on BRD9. To learn more about the first-in-human clinical trial of FHD-609 in synovial sarcoma, please visit ClinicalTrials.gov.

About Synovial Sarcoma

Synovial sarcoma is a rare, often aggressive soft tissue sarcoma that originates from different types of soft tissue, including muscle or ligaments. Synovial sarcoma can occur at any age but is most common among adolescents and young adults. It represents around 5-10% of all soft tissue sarcomas, with ~800 new cases each year in the United States. Surgery remains the most effective treatment for synovial sarcoma, and there are limited therapeutic treatment options.

On May 9, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported it has entered into a research collaboration and exclusive option license agreement with Astellas Pharma Inc (Press release, Twist Bioscience, MAY 9, 2022, View Source [SID1234613958]). Under the terms of the agreement, the companies will jointly conduct research activities to identify and optimize proprietary Twist antagonist antibodies, targeting an undisclosed checkpoint inhibitor pathway in the tumor microenvironment (TME), as potential therapeutic development candidates. Ligands in this pathway are found in relatively high concentrations in the tumor microenvironment. Blocking the receptor’s activation has the potential to markedly enhance anti-tumor immunity with other Astellas therapies including chimeric antigen receptor-based (CAR) technologies combined with Universal Donor Cells. Astellas will have the exclusive option to license any development candidates generated as part of the collaboration.

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"Our robust antibody discovery and optimization capabilities uniquely position us to develop antibodies with high affinity and specificity for historically difficult targets, such as those mediating immune suppression in the TME," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "This out-licensing agreement validates the capabilities of Twist-generated antibodies to enable the discovery and advancement of next generation therapies. As the first out-licensing agreement for Twist Biopharma, this deal will serve as an initial base that we intend to build on as we pursue increasingly larger and later stage out-licensing opportunities with additional partners and targets."

Targeting this pathway with antibody therapeutics is a novel approach with no antibodies in clinical development. Developing next-generation checkpoint inhibitor immunotherapies using new modalities is promising as an innovative healthcare solution. Through this collaboration we expect to stimulate a highly specific and targeted attack on cancer cells by optimizing these development candidates, and leveraging Astellas’ flexible convertibleCAR cell therapy technology.

Under the terms of the agreement, Twist will receive an upfront payment from Astellas as well as an additional payment upon the exercise of the licensing option. Twist will receive payments connected to success-based clinical milestones as well as royalty payments on product sales for each licensed product. Astellas will be responsible for the development, manufacturing and commercialization of any licensed products.

On May 9, 2022 Enara Bio, a biotechnology company advancing novel T-cell receptor (TCR) directed immunotherapies against unconventional, shared, cancer-specific antigens, reported that three abstracts from the Company and its academic collaborators have been selected for presentation at the 12th International CD1-MR1 European Molecular Biology Organization (EMBO) Meeting, which will be held in Gothenberg, Sweden, 22-26 May 2022 (Press release, Enara Bio, MAY 9, 2022, View Source [SID1234613975]).

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The three abstracts cover pioneering research being conducted by Enara Bio in collaboration with leading immunology and MR1 research groups at Monash University and the University of Oxford towards the identification and validation of cancer-specific MR1 ligands and the development of MR1-targeted T-cell receptor cell therapies (TCR-T).

MR1 is an unconventional antigen-presenting molecule that presents metabolites to the immune system in the context of cancer and infection. The monomorphic nature of MR1 strongly suggests that therapies based on MR1-displayed antigens could be effective across the entire human population. These unique properties make MR1 a promising target for off-the-shelf, HLA-independent, TCR-based immunotherapies for solid tumors.

The first presentation, from Enara scientists, highlights the progress the Company is making with its lead autologous MR1-targeting TCR-T program. The two other presentations, led by scientists from Jamie Rossjohn’s and Tony Purcell’s groups at the Monash Biomedicine Discovery Institute (BDI), and Nicola Ternette’s group at the University of Oxford’s Nuffield Department of Medicine, describe novel immunopeptidomic and metabolomic methods to identify and characterize the cancer-specific MR1 ligandome.

Joe Dukes, Vice President, Head of Research at Enara Bio, commented: "We are very pleased to be presenting important abstracts at the upcoming CD1-MR1 EMBO meeting, which showcase the continued developments we are making in partnership with our world-class collaborators to advance the next generation of cancer immunotherapies designed to treat a broad patient population. We have made remarkable progress in our mission to characterize unconventional immunotherapy targets, such as ligands presented by MR1, which we hope will enable development of a pipeline of product candidates that can be advanced into clinical development."

Details of the poster presentations (which will be available on the Company website at the time of the meeting) are as follows:

Enara Bio

– Abstract Title: A novel TCR-T cell therapy targeting a cancer-specific antigen presented by monomorphic MR1 to overcome the challenge of HLA restricted TCR therapies.
– Presenter: Dr. Jonathan Silk

Monash University

– Abstract Title: Design and testing of cleavable constructs for identification and functional validation of MR1 ligands.
– Presenter: Dr. Patricia Illing

The University of Oxford

– Abstract Title: Development of a metabolomics-based MR1 ligand discovery platform using proteomics instrumentation
– Presenter: Dr. Thierry Schmidlin

On May 9, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that the San Francisco Business Times and the Silicon Valley Business Journal ranked Allogene as the highest rated biotechnology company – and 12th company overall – on the 2022 Best Places to Work in the Bay Area list in the large company category (200-499 employees) (Press release, Allogene, MAY 9, 2022, View Source [SID1234616276]).

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Winning organizations were selected from over 400 competing Bay Area companies that have created exceptional workplaces that their employees value highly. Results were based on a survey of employees measuring engagement and other workplace factors including: communication and resources, individual needs, manager effectiveness, personal engagement, team dynamics and trust in leadership.

"Our people are the heart and soul of Allogene, and this recognition is a testament to the One Allogene company culture we’ve worked so hard to build," said David Chang, M.D., Ph.D., President, CEO and Co-Founder of Allogene. "This award is especially meaningful because it stems from honest, voluntary employee feedback and truly illustrates our collective mission of developing life-saving products for patients with cancer."

On May 1, 2022, Allogene celebrated its four-year anniversary with its more than 300 employees who together continue to nurture its One Allogene culture. The Company, which is actively recruiting new employees, was also recently named a 2022 Best Place to Work by BioSpace. For more information, visit the Allogene Careers web site.

On May 9, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the first quarter of 2022 as well as upcoming anticipated corporate milestones.

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"The first quarter of 2022 marked the beginning of a data-rich year for Surface, starting with the presentation of preclinical and translational SRF388 data at AACR (Free AACR Whitepaper) in April," said Rob Ross, M.D., chief executive officer. "We are actively developing two novel antibodies in Phase 2 studies, SRF388 and SRF617, and our runway now provides us with 12 months of cash beyond data readouts for up to six different indications and combination studies across the programs. We look forward to presenting our next update on SRF388, the only antibody targeting IL-27 in the clinic, at ASCO (Free ASCO Whitepaper), and we remain on track to share new clinical data for SRF617 in the second half of this year."

First Quarter and Subsequent Corporate Highlights

During the first quarter, Surface raised net proceeds of approximately $21 million through the company’s existing At-the-Market (ATM) facility with participation based on unsolicited interest received from EcoR1 and Octagon Capital Advisors.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, Surface presented SRF388 preclinical and translational data supporting the recommended Phase 2 monotherapy dose selection of 10 mg/kg administered intravenously every four weeks. This dose is being studied in dedicated expansion cohorts of treatment-refractory clear cell renal cell carcinoma (ccRCC), non-small-cell lung cancer (NSCLC), and hepatocellular carcinoma (HCC).

In March, Surface announced that the first patient had been dosed by GlaxoSmithKline (GSK) in a Phase 1 study evaluating GSK4381562 in patients with solid tumors. GSK4381562 is a fully human IgG1 antibody targeting PVRIG, an inhibitory protein on the TIGIT/DNAM/TACTILE axis that is expressed on natural killer cells (NK cells) and T cells. As a result, Surface is entitled to a $30 million milestone payment and is eligible to receive an additional $700 million in potential future milestone payments, and tiered royalties on global net sales.

In March, the company announced the appointment of Theresa Boni, J.D., as general counsel and senior vice president, legal. Ms. Boni brings more than 20 years of legal experience spanning the biopharmaceutical and medical device industries.
SRF388 Clinical Trial Progress and Updates

In April 2022, Surface announced the initiation of two Phase 2 clinical studies evaluating SRF388, a potential first-in-class antibody against IL-27. The initiations include the first patient dosed in a Phase 2 monotherapy clinical study in treatment-refractory NSCLC patients and the first patient dosed in the lead-in to a randomized Phase 2 clinical study in combination with atezolizumab and bevacizumab in patients with HCC who have not received prior systemic treatment (first-line).

With respect to the design of the SRF388 randomized Phase 2 study in first-line HCC, the company will expand the open-label lead-in from six patients, as originally planned, to approximately 30 patients. Management believes this expanded lead-in will provide more robust safety and efficacy data to inform the start of the randomized stage and could elucidate important biomarkers to support enriched patient selection. Data from the lead-in are anticipated in the first half of 2023.

New clinical data on SRF388 will be presented in an oral session at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. The session, entitled "First-in-human study of SRF388, a first-in-class IL-27 targeting antibody, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors," will be held Saturday, June 4, 2022, from 1:15 pm – 4:15 pm CDT.
Selected Anticipated Near-term Corporate Milestones

The company remains on track to provide a clinical data update on SRF617, a fully human antibody designed to inhibit CD39, in the second half of 2022.

Surface anticipates filing an Investigational New Drug application for SRF114, a fully human IgG1 anti-CCR8 antibody, in the second half of 2022.
Financial Results
As of March 31, 2022, cash, cash equivalents and marketable securities were $150.4 million, compared to $154.1 million on December 31, 2021.

General and administrative (G&A) expenses were $6.5 million for the first quarter ended March 31, 2022, compared to $5.6 million for the same period in 2021. This increase was primarily due to increases in personnel and facility-related costs and increased insurance premiums. G&A expenses included $1.3 million in stock-based compensation expense for the first quarter ended March 31, 2022.

Research and development (R&D) expenses were $16.6 million for the first quarter ended March 31, 2022, compared to $10.5 million for the same period in 2021. This increase was primarily driven by progress on our SRF617 and SRF388 Phase 1 clinical trials and advancement into Phase 2 trials. R&D expenses included $0.6 million in stock-based compensation expense for the first quarter ended March 31, 2022.

For the first quarter ended March 31, 2022, net income was $6.2 million, or basic net income per share of $0.13 and diluted net income per share of $0.13. Net loss was $15.6 million for the same period in 2021, or basic and diluted net loss per share of $0.37.

Based upon the current operating plan, Surface projects its cash runway extending into 2024.