ImmunoPrecise Announces At-The-Market Facility of up to US$50 Million

On October 13, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA), a leader in full-service therapeutic antibody discovery and development, reported that it has entered into an At-The-Market Distribution Agreement (the "ATM Agreement") with H.C. Wainwright & Co., LLC, as sole sales agent (the "Agent") (Press release, ImmunoPrecise Antibodies, OCT 13, 2021, View Source [SID1234591196]). Under the ATM Agreement, the Company will be entitled, at its discretion and from time-to-time during the term of the ATM Agreement, to sell, through the Agent common shares of the Company (the "Common Shares") having an aggregate gross sales price of up to US$50 million (the "Offering" or "ATM Facility"). Sales of the Common Shares will be made in transactions that are deemed to be "at-the-market offerings" as defined in Rule 415 of the United States Securities Act of 1933, as amended, and "at-the-market distributions" as defined in National Instrument 44-102 – Shelf Distributions, including, without limitation, sales made directly on the Nasdaq Global Market or any other existing trading market for the Common Shares in the United States. No offers or sales of Common Shares will be made in Canada on the TSX Venture Exchange (the "TSXV") or other trading markets in Canada.

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The Company will determine, at its sole discretion, the date, minimum price and maximum number of Common Shares to be sold under the ATM Facility. The Common Shares will be distributed from time to time in negotiated transactions, at market prices prevailing at the time of sale, at prices relating to such prevailing market prices, and/or in any other manner permitted by applicable law. As such, the prices may vary between purchasers over time. The Company is not required to sell any Common Shares at any time during the term of the ATM Facility.

The Company intends to use the net proceeds of the Offering, if any and at the discretion of the Company, to support the growth and development of the Company’s existing operations as well as working capital and general corporate purposes. The Company will pay the Agent a cash fee for Common Shares sold under the ATM Agreement and will reimburse certain expenses incurred by the Agent.

The TSXV has conditionally approved the listing of the Common Shares distributed in the Offering, and the Nasdaq Global Market has been notified of the Offering.

The Offering will be made by way of a prospectus supplement dated October 13, 2021 (the "Prospectus Supplement") to the Company’s existing Canadian short form base shelf prospectus dated December 11, 2020 (the "Base Shelf Prospectus") and U.S. registration statement on Form F-10, as amended (File No. 333-249957), dated January 5, 2021 (the "Registration Statement"). The Registration Statement was declared effective by the United States Securities and Exchange Commission (the "SEC") on January 11, 2021. The Prospectus Supplement has been filed with the British Columbia Securities Commission and the SEC. The ATM Agreement, the Prospectus Supplement and the related Base Shelf Prospectus are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Alternatively, the Agent will send the documents upon request by contacting the Agent: H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, telephone: (646) 975-6996, email: [email protected]. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Immune-Onc Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients With Advanced Solid Tumors

On October 13, 2021 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, reported that the first patient has been dosed in the Company’s first-in-human clinical trial of IO-108, a novel antagonist antibody targeting the myeloid checkpoint Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) for the treatment of solid tumors (Press release, Immune-Onc Therapeutics, OCT 13, 2021, View Source [SID1234591194]).

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"The first patient dosed in our Phase 1 clinical trial for IO-108 represents a critical milestone in advancing the development and understanding of Immune-Onc’s novel myeloid checkpoint inhibitors targeting the LILRB family of immune inhibitory receptors. We believe our scientific platform holds vast promise and today’s news reflects our commitment to rapidly advancing programs in our portfolio that have the potential to improve outcomes for cancer patients," said Paul Woodard, MD, chief medical officer of Immune-Onc. "With enrollment now underway, we look forward to reporting top line data next year."

The Phase 1, multicenter, dose-escalation study will consist of a monotherapy cohort and a combination therapy cohort to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-108 alone and in combination with pembrolizumab, an anti-PD-1 antibody. Biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals. After determination of the recommended Phase 2 dose, Immune-Onc plans to evaluate the efficacy, safety, and tolerability of IO-108 in combination with pembrolizumab and as monotherapy in indication-specific expansion cohorts.

IO-108 binds to LILRB2 with high affinity and specificity and blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A, and CD1d. In preclinical studies, treatment of various primary human immune cell systems containing myeloid cells with IO-108 results in enhanced pro-inflammatory responses to multiple stimuli that are relevant to anti-tumor immunity. As a single agent, IO-108 reverses the anti-inflammatory myeloid cell phenotype that results from "tumor conditioning" and promotes the differentiation of monocytes into pro-inflammatory dendritic cells. Moreover, IO-108 potentiates the effect of PD-1 blocking antibodies on CD4+ T cell activation in co-cultures with allogeneic macrophages. In mouse models IO-108 inhibits the growth of solid tumors, which is associated with enhanced T cell responses. Together these data demonstrate that IO-108 has the potential to provide additive or synergistic benefit in combination with standard-of-care immunotherapies and/or immunogenic therapies for solid tumors that are both resistant and sensitive to T-cell checkpoint inhibitors.

ABOUT LILRB2 (ILT4)

LILRB2, also known as ILT4, is expressed mostly on myeloid cells, including monocytes, dendritic cells, macrophages, and neutrophils. In solid tumors, interaction of LILRB2 with tumor microenvironment (TME) relevant ligands, including HLA-G, ANGPTLs, SEMA4A, and CD1d, makes myeloid cells pro-tumorigenic (tolerating or promoting tumor growth) and promotes tumor immune evasion.

Rhizen Pharmaceuticals AG Announces First Patient Dosing in a Phase II Study of Tenalisib (RP6530) in Locally Advanced or Metastatic Breast Cancer Patients

On October 13, 2021 Rhizen Pharmaceuticals AG (Rhizen), a Switzerland-based privately held, clinical-stage oncology & inflammation-focussed biopharmaceutical company reported that it has commenced dosing in a phase II trial to evaluate Tenalisib (RP6530; isoform selective dual PI3K δ/γ inhibitor with additional SIK3 activity) in patients with locally advanced or metastatic breast cancer (Press release, Rhizen Pharmaceuticals, OCT 13, 2021, View Source [SID1234591193]). This multi-center, randomized phase II study is being conducted in eastern Europe and is designed to assess Tenalisib’s anti-tumor activity and safety across two dose levels. The study also includes translational assessments intended to delineate the effect of Tenalisib’s multivalent mechanism on relevant cytokines/chemokine levels and gene expression changes within the tumor microenvironment.

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Rhizen indicated that Tenalisib, in addition to its selective dual PI3K δ/γ inhibitory activity, also has Salt-Inducible Kinase 3 (SIK3) activity via its principal metabolite, that could potentially contribute to its chemo-sensitization effect as observed in its preclinical studies, especially in breast cancer. Rhizen hopes to establish the single agent activity of Tenalisib in this current study after which it plans to expand the assessment across additional solid tumor indications and combinations both with chemotherapeutic agents and with immune-checkpoint inhibitors.

"PI3K inhibition continues to remain a relevant therapeutic intervention across tumor types given the importance of its signalling in tumor development. We have demonstrated our ability to develop safe and differentiated isoform selective PI3K inhibitors that can withstand the rigors of development and be integrated into clinical practice" said Swaroop Vakkalanka, Founder & CEO of Rhizen Pharma. Swaroop also added that "This is a sentinel study that we expect will pave the way for Tenalisib’s potential to be expanded beyond haematological cancers into solid tumors, given its stellar safety profile, multivalent activity and consequent combinability."

About Tenalisib (RP6530):

Tenalisib (RP6530) is a highly selective, next-generation, orally active, dual PI3K δ/γ inhibitor with additional SIK3 activity, that is currently in phase II clinical development for haematological malignancies & solid tumors. Tenalisib has been granted US FDA Fast Track & Orphan-Drug Designations for treatment of r/r PTCL and CTCL and had recently published data from its phase II study evaluating Tenalisib both as monotherapy and in combination with Romidepsin in r/r PTCL & CTCL which showed robust responses of ~75% ORR in r/r PTCL and ~54% in r/r CTCL. The combination was well tolerated with no additional toxicities noted over & above those of the individual agents, confirming Tenalisib’s superior safety profile in its class. Overall, Tenalisib has been studied in over 165 patients across studies till now and has shown potentially better safety outcomes vis-à-vis other agents in the PI3K class.

Tarveda Therapeutics to Present at Solebury Trout/BMO Private Company Showcase

On October 13, 2021 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, reported that Brian Roberts, President and Chief Executive Officer, will present virtually at the Solebury Trout/BMO Fall 2021 Private Company Showcase on Thursday, October 14 (Press release, Tarveda Therapeutics, OCT 13, 2021, View Source [SID1234591192]).

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The presentation details are as follows:

Solebury Trout/BMO Fall 2021 Private Company Showcase
Date: Thursday, October 14
Time: 9:40am Eastern Time
Location: Virtual – register to attend

Twist Bioscience and the Broad Institute Create Custom Whole Exome Target Enrichment Panel for Clinical Research

On October 13, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported an agreement with the Broad Institute for the distribution of a customized next-generation sequencing (NGS) target enrichment exome panel designed for the identification and research of a wide range of cancer, rare and inherited disease genes from patient samples (Press release, Twist Bioscience, OCT 13, 2021, View Source [SID1234591190]). Twist will market this expert-developed exome panel as the Twist Alliance Clinical Research Exome.

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The Twist Alliance Clinical Research Exome helps support the Broad Institute Genomics Platform and was designed using validated data from clinical patient samples. The panel leverages Twist’s flexible NGS platform to easily and quickly customize content, resulting in a comprehensive survey of the exome with supplemental enrichment of clinically relevant areas of the genome related to cancer as well as rare and inherited diseases. By leveraging the best-in-class uniformity of Twist NGS probes, the assay enables a per sample cost and throughput efficiency that Broad has already leveraged to process more than 250,000 samples to date, keeping it on the leading edge of exome sequencing.

"Exome sequencing has long been a key part of our sequencing efforts for large cancer and germline research studies. Our development with Twist has leveraged many of our learnings on the technical side and pulls in knowledge from collaborating investigators to provide an enhanced exome that will increasingly span both research and clinical applications in which results are returned to patients" said Stacey Gabriel, senior director of the Broad Institute Genomics Platform.

The Twist Alliance Clinical Research Exome will be available for customers in mid-October. The full design of this panel includes the Twist Core exome, the mitochondrial genome, and additional validated coding and non-exonic regions of interest such as the ACMG73 genes, supplemental coverage of regions from OMIM and COSMIC, and specific Broad-defined targets. To see Broad’s Director of Genomics Research and Development Brendan Blumenstiel presenting data on the panel, visit: View Source

"Typically, in cancer research studies, there is a great need to focus sequencing efforts on particular genes or mutations but often with a small number of samples available. Leveraging the Broad’s vast expertise, together we have developed a specialized custom panel that enables deeper sequencing, producing validated genetic variants that could be used for therapeutic intervention," said Emily M. Leproust, PhD, chief executive officer and co-founder of Twist Bioscience. "We are thrilled to bring this important tool to our customers to drive deep insights into research and potentially therapeutic development."

About Twist Alliance Panels

In partnership with leading research institutions from around the world, Twist has curated a collection of high-quality target enrichment panels for applications ranging from carrier screening to cancer diagnostics and whole exome sequencing. The Twist Alliance Panels combine the strengths of precise, highly uniform oligonucleotide synthesis with the specialty expertise of leading scientific research partners.

Well designed, custom target enrichment panels enable increased sequencing depth on target genes while reducing overall