On March 27, 2023 Jounce Therapeutics, Inc. (NASDAQ: JNCE) ("Jounce" or the "Company"), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it has entered into a definitive merger agreement whereby Concentra Biosciences, LLC ("Concentra") will acquire Jounce for $1.85 in cash per share plus a non-tradeable contingent value right (the "CVR") (Press release, Jounce Therapeutics, MAR 27, 2023, View Source [SID1234629382]).

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The $1.85 per share upfront consideration represents a premium of approximately 75% to Jounce’s closing share price immediately prior to the March 14, 2023 public disclosure of Concentra’s acquisition proposal.

Following a thorough review process conducted with the assistance of its legal and financial advisors, Jounce’s Board of Directors has determined that the acquisition by Concentra – of which Tang Capital Partners, LP is the controlling shareholder – is in the best interests of all Jounce shareholders, and has unanimously approved the merger agreement.

Jounce’s Board of Directors is no longer recommending the proposed all-share merger transaction (the "Redx Business Combination") with Redx Pharma Plc (AIM:REDX) ("Redx"). The Jounce Board of Directors has notified Redx of the withdrawal of its recommendation in favor of the Redx Business Combination and termination of the co-operation agreement dated February 23, 2023 between Jounce and Redx.

In conjunction with the merger agreement, Jounce is implementing a workforce reduction of approximately 84% of its employees. This reduction is expected to be completed within the next month and Jounce will incur restructuring costs totaling approximately $6.5 million1. The remaining Jounce employees will work to complete the sale of the Company, conduct activities to maximize the value of the CVR, work to ensure that patients on the SELECT and INNATE trials have the opportunity to continue receiving therapy with vopratelimab, JTX-8064 and pimivalimab and to otherwise ensure a smooth transition to Concentra.

Pursuant and subject to the terms of the merger agreement, a subsidiary of Concentra will commence a tender offer by April 7, 2023 to acquire all outstanding shares of Jounce for $1.85 in cash per share at closing plus a non-tradeable CVR representing the right to receive 80% of the net proceeds payable for a period of ten years post-closing from any license or disposition of Jounce’s programs effected within two years of closing and 100% of the potential aggregate value of certain specified potential cost savings.

Closing of the tender offer is subject to certain conditions, including the tender of Jounce shares representing at least a majority of the total number of outstanding shares as of immediately following the consummation of the offer; the availability of at least $110 million of cash and cash equivalents, net of any tail and closing costs, at closing, and other customary conditions. The acquisition is expected to close in the second quarter of 2023.

On March 27, 2023 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported dosing of the first patient in the company’s randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM) (Press release, Imvax, MAR 27, 2023, View Source [SID1234629380]).

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"Progression into this Phase 2b clinical study is a significant milestone for both Imvax and the many patients and families facing a life-altering GBM diagnosis," said John P. Furey, Chief Executive Officer of Imvax. "For too long, there have been few advancements in the treatment of GBM; with the initiation of this trial, we take an important step towards our mission to deliver a personalized immunotherapy that provides meaningful clinical benefit to these patients in need."

The trial is a randomized, multicenter, double-blind, placebo-controlled Phase 2b study (NCT04485949) designed to assess the safety and efficacy of IGV-001, an autologous biologic-device combination product, in ndGBM patients. The trial is expected to enroll up to 93 participants in a 2:1 randomization across approximately 25 sites in the United States. After surgical resection, participants in the IGV-001 arm will be implanted with biodiffusion chambers containing a combination of personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001); in the placebo arm, the chambers will contain an inactive solution only. In both arms, the biodiffusion chambers will be explanted approximately 48 hours later, and after six weeks all patients will be treated with standard of care (adjuvant radiotherapy and temozolomide followed by maintenance temozolomide).

The primary endpoint of the trial is progression-free survival (PFS) and key secondary endpoints include overall survival (OS) and safety.

"The Imvax trial is a truly personalized immunotherapy approach to treating newly diagnosed GBM patients," said John A. Boockvar, M.D., Vice-Chair, Department of Neurosurgery, Lenox Hill Hospital, Professor of Neurosurgery and Otolaryngology, Zucker School of Medicine at Hofstra/Northwell and the lead investigator of the Phase 2b trial. "With this treatment, signals from the patient’s glioblastoma are released into the body as we seek to harness the patient’s own immune system to fight the brain tumor. It is an exciting and novel approach that is both scientifically sound and has encouraging Phase 1 safety data in 45 patients."

About IGV-001

IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b ndGBM study also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response, and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC.

On March 27, 2023 Immunoprecise Antibodies Ltd. (NASDAQ: IPA) ("Immunoprecise" or "IPA" or the "Company"), the parent company of BioKey and affiliate of BioStrand, reported that the EPO has issued a "Decision to Grant" for BioKey’s patent application covering the company’s HYFT Technology used to organize and analyze biological sequence information (Press release, ImmunoPrecise Antibodies, MAR 27, 2023, View Source [SID1234629379]). The HYFT Technology and methodology provide a novel way to efficiently tap into sequence information, allowing the extraction and use the relevant information therein to address the current problems in omics data integration and analysis. The HYFT Technology serves as the core of the BioStrand’s LENSai Integrated TechnologyTM platform which provides cutting-edge data solutions and antibody discovery.

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The patent will provide BioStrand’s LENSai Integrated Technology with broad protection, further strengthening the Company’s patent portfolio position and enabling exclusive access to the HYFT Technology. The Company anticipates favorable outcomes in other countries as well, as many patent offices worldwide consider the status of related European cases to be highly relevant to the decision to grant patents.

"This is a significant and exciting decision by the EPO, and we view this announcement as a recognition of BioStrand’s important contributions to the fields of omic data integration and analysis, fields paramount to the future of cancer research, precision medicine, biomarker identification, and novel drug discovery and development," stated Dr. Jennifer Bath, CEO of IPA. "This patent provides protection for BioKey’s HYFT Technology, which will give scientists the ability to advance the development of safer and more effective therapies for the toughest medical challenges we face today."

The HYFT Technology

HYFT Technology is a way of organizing information about the natural world by creating connections between patterns found in living things, called HYFTs. These patterns can link genetic sequences to their structures and functions, as well as to other information such as scientific papers and medical records. The output, the HYFT knowledge graph, contains over 660 million patterns and 25 billion connections, and is continuously updated with new information. This provides a powerful tool for exploring relationships in the natural world, which can be used for research and applications in medicine and other fields. The HYFT graph is unique in its explicit representation of information from the whole biosphere, and it provides a transparent intermediate layer between sequences and predictions that allows for new knowledge to be extracted without the limitations of a black box.

HYFT-based technologies have numerous applications in various fields beyond just data integration, organization, and analysis, such as drug immunogenicity testing, drug discovery, and natural language processing (NLP). These applications have the potential to accelerate the drug development process and improve patient outcomes.

In the field of immunogenicity, HYFTs can help predict parts of a molecule that may trigger an immune response. This information is crucial in therapeutic and vaccine development, as it helps identify potential safety concerns before they become problematic. Moreover, HYFTs can predict off-target effects, which occur when a drug or therapy affects unintended targets in the body. Early identification of potential off-target effects allows researchers to design safer and more effective treatments.

In drug discovery, HYFT-based technologies have multiple potential applications, including:

Toxicity Prediction: By linking genetic sequences to toxicological data, HYFTs can predict the toxicity of potential drug candidates, helping researchers identify compounds likely to cause adverse effects before entering clinical trials.

Drug Repurposing: HYFTs can identify existing drugs for repurposing by linking genetic sequences to known targets and functions, accelerating the drug discovery process by finding compounds already approved for other indications.

Clinical Trial Design: HYFTs can optimize clinical trial design by linking genetic sequences to patient data and clinical outcomes, identifying patient subgroups more likely to benefit from specific treatments, and enabling personalized and efficient clinical trials.

Biomarker Discovery: By linking genetic sequences to disease-specific phenotypes, HYFTs can identify biomarkers of disease, helping to identify at-risk patients and enable earlier diagnosis and treatment.

Another application of HYFT-based technologies is tied to NLP, which involves analyzing and extracting information from written or spoken language. HYFTs can link text-based information, such as scientific papers or medical records, to specific genetic sequences or structures, facilitating more efficient and accurate analysis. This is particularly valuable in genomics and personalized medicine, where vast amounts of textual data must be processed and analyzed to identify potential therapies or treatments.

The Company believes that the utilization of HYFT-based technologies in drug discovery and other fields shows great promise for expediting the drug development process and enhancing patient outcomes.

On March 27, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that it will report its fourth quarter and full year 2022 financial results on Thursday, March 30, 2023 (Press release, IGM Biosciences, MAR 27, 2023, View Source [SID1234629378]).

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In connection with the earnings release, IGM’s management team will host a live conference call and webcast at 4:30 p.m. ET on Thursday, March 30, 2023, to discuss the Company’s financial results and provide a corporate update. The webcast can be accessed by clicking the link: View Source and will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website.

On March 27, 2023 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immuno-oncology company developing novel T cell engagers, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update (Press release, Harpoon Therapeutics, MAR 27, 2023, View Source [SID1234629377]).

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"Harpoon is well positioned to reach 2023 key milestones on our HPN217 and HPN328 clinical studies with a solid balance sheet extending the cash runway into the second half of 2024," said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics. "Our leadership team remains focused on advancing our clinical pipeline and we anticipate sharing Phase 1 data from our two clinical programs in the second half of 2023."

Corporate Update / Recent and Upcoming Highlights

Tri-specific T cell Activating Construct (TriTAC) Platform

HPN217 (BCMA) Phase 1 trial for relapsed, refractory multiple myeloma

Interim results presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (cut-off of October 17, 2022), with additional observations post-ASH include the following:

Continued evidence of clinical activity with 77% (10/13) ORR observed in the two highest target dose levels (12 and 24 mg).

Early durable responses for responding patients with at least 9 months follow up, the median time on treatment is 12 months.

86% (18 of 21) responders remain on study treatment with sustained response, with many responses deepening over time.

Low incidence of cytokine release syndrome (CRS) across the patient population studied to date.

Transient CRS has occurred in 27% of patients across highest step-dose levels.

Following ASH (Free ASH Whitepaper) 2022, one patient experienced Grade 3 CRS and Grade 1 ICANS followed by a post-traumatic Grade 5 event (subdural hematoma).

Phase 1 dose exploration is expected to complete in the first half of 2023, with up to 94 patients and identification of a recommended Phase 2 dose(s) by the end of 2023.

Data presentation anticipated in the second half of 2023.

Orphan and Fast Track designation granted for the treatment of relapsed and refractory multiple myeloma.

HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC) and other neuroendocrine cancers

As of February 2023, observations in the monotherapy cohorts included:

Early signs of anti-tumor activity seen, with two confirmed partial responses per RECIST in patients with SCLC.

Priming dose lowered to 1mg and patients requiring oxygen prior to dosing excluded due to two events of Grade 3 CRS after the initial priming dose of 2 mg including one Grade 5 respiratory failure after higher priming dose.

Phase 1/2 dose and schedule optimization trial ongoing with monotherapy cohorts enrolling at the 12mg target dose.

Enrollment in combination therapy of HPN328 with atezolizumab (Tecentriq) in patients with SCLC, as part of the Phase 1/2 dose escalation trial, is anticipated to begin in the second half of 2023.

Phase 1 dose exploration is expected to complete in the second half of 2023, including the identifying of a recommended Phase 2 dose(s) in the monotherapy setting by the end of 2023.

Data presentation anticipated in the second half of 2023.

ProTriTAC

HPN601 (EpCAM)

HPN601 is our first conditionally active T cell engager based on the ProTriTAC platform. EpCAM is expressed in a broad range of solid tumors, potentially enabling HPN601 to address multiple indications with high unmet medical need.

IND filing timeline to enable a Phase 1 dose exploration study dependent on resource allocation.

Two new candidates for IND-enabling studies from the ProTriTAC platform have been identified against the targets trophoblast cell surface antigen 2,(TROP2) and Integrin-ß6 (ITGB6).

TriTAC-XR

The proprietary TriTAC-XR extended-release T cell engager platform is designed to minimize on-target CRS, a characteristic of many T cell engagers that can lead to dose limiting toxicities and reduce the efficacy of these potent anti-tumor drugs.

AACR 2023 – Five Preclinical Posters to be Presented:

HPN217: Preclinical abstract to be presented at AACR (Free AACR Whitepaper) on April 18, 2023:

"Anti-tumor activity of HPN217, a BCMA-targeting tri-specific T cell engager, is enhanced by y-secretase inhibitors in preclinical models"

HPN328: Two preclinical abstracts to be presented at AACR (Free AACR Whitepaper) on April 18, 2023:

"Long-term anti-tumor immunity induced by HPN328, a DLL3-targeting tri-specific, half-life extended T cell engager, in a preclinical immunocompetent mouse model"

"Anti-tumor activity of HPN328, a DLL3-targeting tri-specific, half-life extended T cell engager, is enhanced by combining with an anti-PD-L1 antibody in an immunocompetent mouse model"

ProTriTAC: Two preclinical abstracts to be presented at AACR (Free AACR Whitepaper) on April 17, 2023:

"TROP2 ProTriTAC, a protease-activated T cell engager prodrug targeting TROP2 for the treatment of solid tumors"

"ITGB6 ProTriTAC, a protease-activated T cell engager prodrug targeting Integrin-ß6 for the treatment of solid tumors"

Corporate Update

Preferred equity financing closed in March 2023, extending cash runway into the second half of 2024.

In November 2022, Harpoon announced a corporate restructuring designed to reduce discovery research and other operating expenses in 2023 and align its core activities with the organization’s clinical pipeline.

In October 2022, Harpoon appointed Luke Walker, M.D., as Chief Medical Officer. Dr. Walker leads the clinical development strategy and execution for Harpoon’s multiple clinical programs.

Fourth Quarter and Full Year 2022 Financial Results

Harpoon ended the fourth quarter of 2022 with $53.1 million in cash, cash equivalents and marketable securities, compared to $136.6 million as of December 31, 2021. Following the $25.0 million preferred equity financing and year to date ATM sales, cash and cash equivalents are expected to fund current operations into the second half of 2024.

Revenue for the quarter ended December 31, 2022 was $4.1 million, compared to $4.3 million for the quarter ended December 30, 2021. For the year ended December 31, 2022, revenue was $31.9 million, compared to $23.7 million for the year ended December 31, 2022. The increase for the year primarily arose from revenue recognized in 2022 for research and development services performed on the third and fourth targets under Harpoon’s Restated Collaboration Agreement with AbbVie, and an increase in revenue recognized related to Harpoon’s Development and Option Agreement with AbbVie for research and development services performed.

Research and development (R&D) expense for the quarter ended December 31, 2022 was $18.9 million, compared to $20.7 million for the quarter ended December 31, 2021. For the year ended December 31, 2022, R&D expense was $81.4 million, compared to $72.1 million for the year ended December 31, 2021. The decrease in the fourth quarter was primarily due to lower costs in research and lab supplies due to the corporate restructuring and lower costs in clinical and development costs due to wind down of the HPN424 and HPN536 programs. The increase for the year primarily arose from higher clinical and development costs and personnel-related expense, which included conducting preclinical studies and the continuation and preparation of the clinical trials for HPN217, HPN328 and HPN601.

General and administrative (G&A) expense for the quarter ended December 31, 2022 was $3.9 million, compared to $5.2 million for the quarter ended December 31, 2021. For the year ended December 31, 2022, G&A expense was $18.8 million, compared to $18.3 million for the year ended December 31, 2021. The decrease in the fourth quarter was primarily due to lower personnel-related expense. The increase for the year was primarily attributable to an increase in legal fees, consulting and other professional services to support Harpoon’s operations.

Net loss for the quarter ended December 31, 2022 was $18.4 million, compared to $21.6 million for the quarter ended December 31, 2021. The net loss for the year ended December 31, 2022 was $67.7 million compared to $116.7 million for the prior year.