On November 12, 2021 Second Genome, a biotechnology company that leverages its proprietary platform sg-4sight to discover and develop precision therapies and biomarkers, reported that preclinical data demonstrating that the Company’s CXCR3-positive allosteric modulator, SG-3-00802, can reverse resistance to anti-programmed death protein-1 (PD-1) therapy, illustrating that the microbiome directly interacts with the human immune system to enhance immunity and impact antitumor activity (Press release, Second Genome, NOV 12, 2021, View Source [SID1234595493]). The data (E-Poster #569) were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, held virtually and in Washington, D.C. November 10-14.

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"We are encouraged by Second Genome’s growing body of preclinical data demonstrating that SG-3-00802’s differentiated mechanism of action has the potential to effectively target the tumor microenvironment and improve responses in combination with existing immunotherapies, such as checkpoint inhibitors and cytokines," said Karim Dabbagh, Ph.D., Chief Executive Officer at Second Genome. "At SITC (Free SITC Whitepaper), we presented new data showing SG-3-00802 potently enhances CXCR3 ligand-induced cell migration, a critical effector cell recruitment mechanism for anti-tumor immunity. We look forward to further advancing our program with an IND submission expected in 2022."

The poster presentation will be available for on-demand viewing on the SITC (Free SITC Whitepaper) website through January 9, 2022, and it will also be made available on the Company’s website at View Source

On November 12, 2021 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), an innovative biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported recent business highlights and financial results for its third quarter ended September 30, 2021 (Press release, HCW Biologics, NOV 12, 2021, View Source [SID1234595516]).

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"The third quarter of 2021 and recent weeks were an important period for HCW Biologics and our strategy to build a pipeline of first-in-class immunotherapeutic treatments for age-related diseases," stated Hing C. Wong, Ph.D., founder and CEO of HCW Biologics Inc. "The third quarter provided bookends to what has been a busy time for the Company. In July, we closed our initial public offering and subsequently listed our common stock on Nasdaq. The Company has never been on stronger financial footing, and we believe we now have capital resources sufficient to fund our operations into 2023. During the third quarter, we filed our first IND to evaluate our lead bifunctional molecule, HCW9218, in a pancreatic cancer trial. We completed the regulatory review shortly after the end of the third quarter, and we announced FDA clearance for the Phase 1b clinical trial on October 28, 2021."

Business Highlights:

On July 22, 2021, HCW Biologics closed on its IPO, raising $56 million in gross proceeds. The net proceeds of the offering and the Company’s existing cash and cash equivalents are sufficient to fund operating expenses and capital expenditure requirements into 2023.

HCW Biologics was added to S&P Total Market Index (TMI) on September 20, 2021.

The Company expanded its Board of Directors with the addition of two new independent directors in October 2021, Lisa M. Giles and Gary M. Winer. Ms. Giles has extensive experience in pharmaceutical, diagnostic, device, and other healthcare industries. She held senior leadership positions in strategic planning, operations, and commercial planning. In addition, she brings a wealth of corporate governance experience, having served as a board member for several public companies. Mr. Winer has led and built successful, multinational businesses in the biopharma and diagnostic healthcare sectors as a Chief Executive Officer or President, including senior leadership positions with AbbVie and Abbott. He brings valuable insights and experience for operations as well as support and advice for strategic transactions.

On October 28, 2021, HCW Biologics announced that it received clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for a Phase 1b first-in-human clinical trial to evaluate HCW9218 in patients with advanced pancreatic cancer. The Company is in discussions with several leading National Cancer Institute-designated cancer centers as potential clinical trial sites. Discussions are simultaneously underway with a research facility to sponsor an IND for a second, investigator-initiated trial to evaluate HCW9218 in patients with solid tumors (breast, ovarian, prostate, and colorectal cancers).

HCW Biologics continues IND-enabling studies involving HCW9302, its second lead investigational drug candidate. The Company expects to complete FDA-required preclinical studies in mice by the end of 2021 and non-clinical toxicology studies in non-human primates in the second half of 2022. HCW9302 is an IL-2-based immunotherapeutic designed to stimulate regulatory T (Treg) cells to suppress the activity of inflammasome-bearing cells and inflammatory factors. HCW Biologics intends to evaluate HCW9302 in autoimmune diseases.

The HCW Biologics’ founder and CEO, Dr. Hing C. Wong, has accepted invitations to present at two noted industry events. Dr. Wong will present at the BioFlorida Annual Conference taking place on December 8-10, 2021, in Orlando, Florida, where he will participate in the featured session, "New Strategies in the Fight Against Cancer." Dr. Wong will also lead a presentation during the Cambridge Healthtech Institute’s 24th Annual PepTalk taking place on January 17-19, 2022, in San Diego, California. His presentation, entitled "A Novel Platform to Create Multi-functional Immunotherapies for Cancer," will focus on the TOBI discovery platform and HCW9218.

The Company continues to expand its intellectual property portfolio through filing provisional U.S. applications based upon new research, filing non-U.S. national stage phase patent applications, and filing U.S. trademark applications. As of September 30, 2021, HCW Biologics is the owner of record of 60 pending patent applications worldwide, including 11 pending U.S. utility patent applications, two pending provisional U.S. patent applications, seven pending PCT applications, 36 pending non-U.S. national phase patent applications, and four pending Hong Kong patent applications. The Company also owns five U.S. trademark applications related to its corporate name and logo, and the TOBITM platform.
Third Quarter Financial Results:

Cash and cash equivalents: On September 30, 2021, the Company’s cash balance was $15.1 million, short-term investments were $25.0 million and long-term investments were $10.0 million. The net proceeds from the IPO were $49.0 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures into 2023. This estimated cash runway does not include potential sources of non-dilutive financing, which may be obtained from existing or new out-licensing agreements.

Research and development (R&D) expenses: R&D expenses were $2.7 million for the three-month period ended September 30, 2021, as compared to $2.1 million for the three-month period ended September 30, 2020. Higher costs in the third quarter of 2021 were primarily the result of higher manufacturing and IND-enabling activity costs. During the nine-month period ended September 30, 2021, R&D expenses were $6.7 million versus $5.8 million during the nine-month period ended September 30, 2020. The 14% increase in expense was driven primarily by an increase in IND-enabling and preclinical activities.

General and administrative expenses (G&A): G&A expenses were $1.4 million for the three-month period ended September 30, 2021, as compared to $0.6 million for the three-month period ended September 30, 2020. This reflects an increase in compensation expense including salaries, performance-based bonuses and board compensation, and an increase in certain operating expenses including higher insurance costs, professional fees, and legal services expenses. For the nine-month period ended September 30, 2021, G&A expenses were $3.6 million versus $2.0 million for the same period ended September 30, 2020. The 75% increase was primarily driven by an increase in expenses for salaries, performance-based bonuses, employee benefits, professional fees, and other expenses.

Net loss: Net loss was $4.1 million for the three-months ended September 30, 2021, compared to $2.7 million for the three-months ended September 30, 2020. For the nine-months ended September 30, 2021, net loss was $9.7 million, compared to $7.9 million for the same period in the prior year.
About the TOBI platform:
HCW Biologics has combined deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI discovery platform. The TOBI platform is a proprietary immunotherapeutic drug design and discovery platform. The Company has utilized this modular, tunable technology to generate a novel pipeline of immunotherapeutic candidates capable of activating and targeting desired immune responses while blocking unwanted immunosuppressive activities. The balancing of these two activities is believed to be the key to developing immunotherapeutic agents that will be safe, well tolerated and efficacious.

On November 12, 2021 Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the third quarter ended September 30, 2021 and provided an update on recent clinical and development pipeline progress (Press release, Prelude Therapeutics, NOV 12, 2021, View Source [SID1234595536]).

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"We continue to make significant progress advancing our novel pipeline of therapeutic candidates, most notably with the recent presentation of dose escalation data from the Phase 1 trials of our lead PRMT5 inhibitors, PRT543 and PRT811," said Kris Vaddi, PhD, Chief Executive Officer. "We were pleased by these initial data in unselected patients, which demonstrated key points of differentiation for our molecules, including good tolerability and potency, and a desirable therapeutic window. In addition, evidence of preliminary clinical activity was observed in multiple tumor types displaying preclinically validated genomic features. We look forward to leveraging learnings from these data as we execute on the dose escalation portion of the trials and evaluate PRT543 and PRT811 in biomarker-selected patient populations, with data readouts from these cohorts anticipated in 2022. Beyond our PRMT5 inhibitors, the balance of our pipeline continues to advance. During the quarter we received IND clearance from the FDA for PRT2527, our CDK9 inhibitor, positioning us to commence a Phase 1 study of this molecule before year-end."

Recent Highlights and Upcoming Milestones

PRT543

Phase 1 Dose Escalation Study Data Presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting; Data from Expansion Cohorts to be Presented in 2022: In October 2021, the Company presented data from the dose escalation portion of its Phase 1 trial of PRT543, which is designed to be a potent and selective inhibitor of PRMT5, in unselected patient populations. PRT543 demonstrated target engagement and inhibition of PRMT5 functional activity, as well as preliminary clinical activity. PRT543 was generally well tolerated. Patient enrollment is ongoing in specific biomarker-selected solid tumor and hematologic malignancy expansion cohorts. The Company expects to present data from the expansion cohorts in 2022.

Phase 1 Dose Escalation Data for PRT543 in Patients with Myeloid Malignancies to be Presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: Data from the dose escalation portion of the ongoing Phase 1 clinical trial of PRT543 in patients with myelodysplastic syndrome (MDS) and myelofibrosis (MF), including safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity, will be featured during a poster session at the 63rd ASH (Free ASH Whitepaper) Annual Meeting and Exposition being held December 11-14, 2021.

PRT811

Phase 1 Dose Escalation Study Data Presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting; Dose Expansion Portion of Phase 1 Trial to Commence 4Q21: In October 2021, the Company presented data from the dose escalation portion of its Phase 1 trial of PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, in patients with unselected advanced solid tumors. PRT811 demonstrated dose dependent inhibition of PRMT5 activity and demonstrated signs of preliminary clinical activity. PRT811 was generally well-tolerated. Prelude will shortly commence the dose expansion portion of the Phase 1 trial in selected patients with central nervous system cancers (CNS) and non-CNS cancers. The Company expects to present data from the expansion cohorts in 2022.

PRT1419

Phase 1 Dose Escalation Portion of Oral and Intravenous (IV) PRT1419 Trial Ongoing: The dose escalation portion of the Company’s first-in-human Phase 1 study investigating both an oral and IV formulation of MCL-1 inhibitor, PRT1419, the Company’s third clinical candidate, in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, and solid tumors, remains ongoing. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the first half of 2022.

PRT2527

Dose Escalation Phase 1 Trial of PRT2527 on Track to Begin by Year-End: During the third quarter the Company received clearance for an Investigational New Drug (IND) application for PRT2527, which is designed to be a potent and selective CDK9 inhibitor. The Company anticipates beginning a Phase 1 trial of PRT2527 by year-end evaluating IV infusion monotherapy in patients with selected solid tumors.

Preclinical Data Presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting: In October 2021, the Company presented new preclinical data demonstrating that intermittent intravenous administration of PRT2527 demonstrated strong efficacy in hematological malignancies and solid tumor models with MYC dysregulation.

Discovery Programs

The Company continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, by year-end. The Company also continues to make progress in the PRT-K4 discovery program and expects to initiate IND-enabling studies by year-end.

Corporate Update

On November 5, 2021, Brian Piper, our Chief Financial Officer, notified the Company that he will be resigning from the Company, effective November 19, 2021, to pursue other opportunities.

The Company reported the appointment of Laurent Chardonnet as its new Chief Financial Officer starting November 29, 2021. Mr. Chardonnet joins from Axcella Health where, since 2019, he served as Senior Vice President, CFO. Prior to Axcella, he spent 15 years at Incyte Corporation where he held roles of increasing responsibility including Vice President Finance, Treasurer and Principal Accounting Officer, Head of Finance and Administration for the company’s European division, and Vice President of Alliances and Global Strategy. Mr. Chardonnet received his Master of Business Administration from Vanderbilt University and his initial business degree from the Institut Supérieur de Gestion in Paris

The Company and Dr. David Mauro, the Company’s Chief Medical Officer, mutually agreed that Dr. Mauro would depart from the Company to pursue other opportunities. Dr. Mauro’s last day with the Company was on November 9, 2021. The Company has an ongoing search for a successor. Dr. Victor Sandor, former Chief Medical Officer of Array Biopharma and current board member and chair of the Science and Technology Committee, will provide strategic and operational oversight of clinical development during this time.

Third Quarter 2021 Financial Results

Cash, Cash Equivalents, and Marketable Securities: Cash, cash equivalents, and marketable securities as of September 30, 2021 were $320.9 million.

Research and Development (R&D) Expenses: For the third quarter of 2021, R&D expense increased by $7.4 million to $22.7 million for the three months ended September 30, 2021 from $15.3 million for the three months ended September 30, 2020. The increase was mainly due to increased clinical research costs to support the advancement of our clinical programs as well as an increase in discovery-stage program expenses. Our chemistry, manufacturing and other costs for the clinical trials also increased.

General and Administrative (G&A) Expenses: For the third quarter of 2021, G&A expense increased by $5.2 million to $8.1 million for the three months ended September 30, 2021 from $2.9 million for the three months ended September 30, 2020. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount and an increase in our professional fees as we expanded our operations to support our research and development efforts and incurred additional costs to operate as a public company.

Net Loss: For the third quarter of 2021, net loss was $30.7 million, or $0.66 per share, compared with a net loss of $16.8 million, or $5.25 per share, for the same period in 2020.

Financial Guidance: The Company believes that its current cash, cash equivalents and marketable securities will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2023.

On November 12, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that preclinical data from its AL009 immuno-oncology program in poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (Press release, Alector, NOV 12, 2021, View Source [SID1234595375]).

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AL009 is a first-in-class fusion protein engineered to block multiple Siglecs. Siglecs (sialic acid binding immunoglobulin-like lectins) are a family of receptors involved in immune regulation that bind to cell surface sialic acid glycans. Siglecs are predominantly expressed on myeloid cells and the overexpression of Siglecs has been linked to immune suppression and evasion by tumor cells, as well as modulating the differentiation of myeloid cells into tumor-promoting macrophages. AL009 acts as a checkpoint inhibitor, blocking the immunosuppressive effect of multiple Siglecs and thereby enhancing both the innate and adaptive immune system response to cancer. Alector is developing AL009 for the potential treatment of solid tumor cancers and plans to initiate a first-in-human clinical trial of AL009 in 2022.

"Siglecs play a critical role in regulating immune activity, and our research into the role of the Siglec family of inhibitory receptors in neurodegenerative disease led to the discovery and optimization of AL009 for immuno-oncology. AL009 is a fusion protein uniquely able to block multiple Siglec receptors and halt Siglec-sialic acid-mediated immune suppression, which may be beneficial in a number of disease states where evasion of the immune system allows disease to progress unchecked," said Daniel Maslyar, M.D., Alector’s Vice President Clinical Development. "As we compared AL009 with other immunotherapies in preclinical models, we observe higher potency in blocking immune cell suppression and promising anti-cancer activity alone and in combination with anti-PDL1 in multiple tumor types, including some that have been found resistant to other immunotherapies. We look forward to advancing AL009 into the clinic to characterize its potential to treat a variety of solid tumor types."

In a poster titled "AL009, a Fusion Protein and Multi-Siglec Inhibitor, Repolarizes Suppressive Myeloid Cells and Potentiates Anticancer Effects," Alector researchers highlighted:

AL009 led to dose-dependent increases in immune stimulatory molecules consistent with the repolarization of myeloid-derived suppressive cells to a proinflammatory state
In vitro, AL009 increased T cell function by approximately 10 to 100-fold compared to other cancer immunotherapies
In syngeneic tumor models in mice that were less responsive to anti-PD-L1, treatment with AL009 showed efficacy in reducing tumor growth both as a single agent and in combination with anti-PD-L1
In a murine model of lung metastasis, AL009 combined with anti-TRP1 therapy to reduce lung nodules
The poster is available on Alector website in the Investors section at www.alector.com. Alector management will also be conducting a call for analysts and investors to discussion data presented this week for four of the company’s pipeline programs, AL001, AL101 and AL003 being developed for the treatment of neurodegenerative diseases and AL009.

About AL009
AL009 is a first-in-class multi Siglec inhibitor that works to enhance both the innate and adaptive immune system response to tumors by blocking a critical glycan checkpoint pathway that drives immune inhibition. Alector is initially developing AL009 for the potential treatment of solid tumors, with plans to initiate first-in-human clinical studies in 2022.

On November 12, 2021 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported two ePoster presentations of preclinical data on its Amphiphile (AMP) platform in combination with TCR-T and CAR-T therapies, respectively, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting taking place in Washington D.C. and virtually November 10-14, 2021 (Press release, Elicio Therapeutics, NOV 12, 2021, https://elicio.com/2021/11/elicio-therapeutics-presents-preclinical-data-on-amp-tcr-t-and-car-t-combination-therapies-at-the-2021-society-for-immunotherapy-of-cancer-annual-meeting/ [SID1234595391]). The ePosters are available on the SITC (Free SITC Whitepaper) website starting November 12, 2021, at 7 a.m. ET., and accessible here.

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"These preclinical datasets demonstrate the broad potential of our AMP platform and build on previous data validating our AMP boosting approach to enhance already established TCR-T and CAR-T cell therapies. By successfully targeting the lymph nodes, AMP-boosting can enhance both adoptively transferred and endogenous T cell responses to activate potent, functional and durable immunity against tumors," said Peter DeMuth, Ph.D., Vice President of Research at Elicio Therapeutics. "We are excited to continue building on these data to enable clinical translation including through our collaboration with the Moffitt Cancer Center, where we are evaluating AMP-boosting of CD19 CAR-T therapies to promote durable CAR-T responses to tumors. With many patients failing to enter remission with CAR-T therapy alone or relapsing due to poor CAR-T persistence, this could be the boost that immunotherapy needs."

Data Presentation Details:

Title: Lymph Node Targeted Boosting with Cognate Amphiphile-Peptide Vaccines Enhances TCR-T Cell Therapy to Eradicate Solid Tumors

Abstract Number: 157

AMP boosting significantly enhanced TCR-T cell anti-tumor response and led to durable cures of solid tumors in an established, syngeneic tumor model.
AMP boosting delivers cognate peptides and adjuvant to lymph nodes, which induces dendritic cell (DC) activation and provides in vivo activation of tumor-specific TCR-T cells to amplify anti-tumor potency of adoptively transferred cells.
AMP-peptide pulsed autologous human DCs enhanced the function of clinically relevant human KRAS-specific TCR-T cells in vitro.
These studies provide direct rationale and evidence for the combination of AMP boosting with TCR-T cell therapies to augment clinical responses.
Title: Amphiphile-Peptide Boosting with FMC63-binding Surrogate Peptide Mimotopes Induces Activation and Potent Effector Function in CAR-T Cells Targeting CD19

Abstract Number: 552

The AMP platform can potentially be utilized as a mechanism to expand and functionally enhance CAR-T cells in vivo targeting blood and solid tumors.
AMP-peptides (AMPlifiers) effectively accumulate in lymph nodes and decorate lymph node resident antigen-presenting cells (APCs) as well as boost CAR-T activation and expansion in vivo.
Phage display screening enables AMPlifier discovery and validation for CAR scFv domains such as FMC63, the CD19 specific domain used in marketed CD19 CAR-T products.
In vitro, CD19 AMPlifiers induce phenotypic activation, cytotoxic and effector function in cognate CD19 CAR-T cells with 28z or BBz signaling domains.
About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform is thought to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.