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8-K – Current report

On March 27, 2023 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the fourth quarter and year ended December 31, 2022 (Press release, LianBio, MAR 27, 2023, View Source [SID1234629383]).

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"2022 marked a pivotal year for LianBio, with sustained progress across our pipeline and building of our commercial infrastructure in anticipation of registration of mavacamten in China," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "This year, we look forward to pivotal data in the EXPLORER-CN trial of mavacamten and the LIBRA trial of TP-03, and to filing the mavacamten NDA in China. With a cash runway through the end of 2024, we believe LianBio is well positioned to become a commercial-stage company. Looking ahead, we are excited to continue advancing our mission to bring innovative medicines to patients in Asia."

Recent Business Highlights and Clinical Development Updates

Mavacamten late-stage clinical development and launch readiness activities on track in China; New Drug Applications now on file in Singapore, Hong Kong and Macau

•In March 2023, patient visits in the double-blinded placebo-controlled treatment period were completed in the Phase 3 EXPLORER-CN study of mavacamten in Chinese symptomatic oHCM patients.
•In February 2023, LianBio submitted an NDA for mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (oHCM) in the Macau Special Administrative Region. The submission was based on the U.S. Food and Drug Administration (FDA) approval of mavacamten. LianBio has now filed New Drug Applications to support approval of mavacamten in Hong Kong, Singapore and Macau.
•In January 2023, mavacamten was added to The Joint Committee of Cardiomyopathy Specialty Alliance, National Center for Cardiovascular Diseases/Cardiovascular Precision Medicine Branch of China International Exchange and Promotive Association for Medical and Health Care’s 2023 Guidelines for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy.

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•LianBio continues to hire key leadership roles to support the expected mavacamten commercial launch in China, including sales and marketing, market access, distribution, and medical affairs personnel.
•LianBio continues to work with the physician community and academic societies in China to drive disease awareness and improve the standardization of diagnosis and treatment of HCM.

Registrational Phase 3 LIBRA clinical trial of TP-03 for the treatment of Demodex blepharitis initiated in China

•In November 2022, LianBio announced the initiation of the Phase 3 LIBRA clinical trial of TP-03 in Demodex blepharitis. LianBio expects the LIBRA trial to support TP-03 registration in China.

Phase 1 clinical trial of BBP-398 SHP2 inhibitor initiated in China

•In November 2022, LianBio announced the initiation of a Phase 1 monotherapy dose escalation trial of BBP-398 in Chinese patients with advanced solid tumors.

Entered into commercial agreement with Pfizer for the development and commercialization of sisunatovir

•In December 2022, LianBio entered into a commercial agreement with Pfizer and ReViral Ltd., now a wholly owned subsidiary of Pfizer, with respect to sisunatovir as the first opted-in product under LianBio’s existing strategic collaboration with Pfizer. Pursuant to the commercial agreement, LianBio assigned and transferred development and commercialization rights to sisunatovir in Mainland China, Hong Kong, Macau and Singapore to Pfizer. LianBio received a $20.0 million upfront payment, which was released as part of previously restricted cash paid to LianBio by Pfizer in 2020 pursuant to the Pfizer strategic collaboration agreement. LianBio is eligible to receive up to $135.0 million in potential development and sales milestones. LianBio is further entitled to receive tiered payments in the low single digits on a percentage of net sales of sisunatovir in the territory. Pfizer will assume all development and commercial activities and costs in the region and will release LianBio from its royalty and milestone obligations for sisunatovir.

Business is well-positioned to achieve anticipated milestones

•Current cash runway is projected to extend through the end of 2024.

Key Milestones Anticipated in 2023

Mavacamten

•LianBio expects to report topline data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic oHCM in mid-2023.
•LianBio expects to file a New Drug Application (NDA) in 2023 to support regulatory approval of mavacamten in China.

TP-03

•LianBio expects to report topline data from the Phase 3 LIBRA trial of TP-03 in Chinese patients with Demodex blepharitis in the fourth quarter of 2023.

Infigratinib

•LianBio expects to report topline data from the ongoing Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR genomic alterations in the second half of 2023.
•LianBio expects to initiate a pivotal Phase 2 trial of infigratinib in locally advanced or metastatic gastric cancer patients with FGFR2 gene amplification in the first half of 2024 to support regulatory approval in China.

BBP-398

•LianBio expects to initiate a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer in the second half of 2023.

Fourth Quarter and Full-Year 2022 Financial Results:
Research & Development Expenses

Research and development expenses were $10.6 million for the fourth quarter of 2022 compared to $7.7 million for the fourth quarter of 2021, and $59.8 million for the year ended December 31, 2022 compared to $158.7 million for the year ended December 31, 2021. The decrease was primarily attributable to decreased milestone and upfront licensing payments. These decreases were partially offset by increases in development activities to support clinical trials and personnel-related expenses (including share-based compensation expense) as a result of increased employee headcount, development activities to support our clinical trials and professional fees.

General & Administrative Expenses

General and administrative expenses were $18.7 million for the fourth quarter of 2022 compared to $14.4 million for the fourth quarter of 2021, and $65.6 million for the year ended December 31, 2022 compared to $36.9 million for the year ended December 31, 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and increases in legal service costs, consulting costs and accounting services.

Net Loss
Net loss was $18.3 million for the fourth quarter of 2022 compared to net loss of $21.2 million for the fourth quarter of 2021, and $110.3 million for the year ended December 31, 2022 compared to $196.3 million for the year ended December 31, 2021.

Cash Balance

Cash, cash equivalents and marketable securities at December 31, 2022 totaled $302.4 million, reflecting a net decrease of $100.8 million from December 31, 2021. LianBio projects its cash position is sufficient to fund current operations through the end of 2024.

Jounce Therapeutics Enters Into Agreement to Be Acquired by Concentra Biosciences for $1.85 in Cash per Share Plus Contingent Value Rights

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]).

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.

Imvax Announces First Patient Dosed in Phase 2b Trial of IGV-001 for Glioblastoma

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]).

"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.

European Patent Office to Grant BioKey’s Patent Application for Foundational HYFT® Technology

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.

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.

IGM Biosciences to Announce Fourth Quarter and Full Year 2022 Financial Results and Host Conference Call and Webcast on March 30, 2023

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]).

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.