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RemeGen grabs one of the world’s largest ever biotech IPOs

On November 9, 2020 RemeGen reported that it has raised $515 million on the Hong Kong exchange in one of the largest biotech IPOs ever produced (Press release, RemeGen, NOV 9, 2020, View Source [SID1234570577]).

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The largest to date in 2020, and one of the biggest after Moderna’s $600 million-plus IPO a few years back, the Yantai-based biotech in China will use its major cash haul toward its healthy pipeline of mid- to late-stage efforts.

This includes telitacicept and disitamab vedotin, both slated for approval within the next three to eight months.

A company was facing major challenges in a global clinical trial program with 30 studies for an uncommon indication. Not only did they need to transition all ongoing clinical trials to the Bioclinica Clinical Adjudication platform for better analysis — but they also needed to do it within 60 days.
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The former therapy is aimed at B cell-mediated autoimmune diseases, with an initial focus on systemic lupus erythematosus, a condition that has seen its share of R&D setbacks, though a consistent series of research in recent years has buoyed hopes of a renaissance in the area.

Disitamab vedotin, meanwhile, works as an in-demand antibody-drug conjugate targeting HER2 cancers, with a focus on gastric, urothelial and HER2-low-expressing breast cancers.

Further back in the pipeline, it also has a series of early-stage drugs working on fusion protein VEGFR/FGF in eye conditions including wet age-related macular degeneration and diabetic macular edema.

Genexine and NeoImmuneTech Announce Data Release for their Phase 1b/2 Study of GX-I7/NT-I7 (efineptakin alfa) and KEYTRUDA® (pembrolizumab) in patients with Triple-negative Breast Cancer

On November 9, 2020 Genexine, Inc. and NeoImmuneTech, Inc. reported the release of data for the dose escalation (DE) phase (Ph1b) of their Ph1b/2 study of GX-I7/NT-I7 (efineptakin alfa), a novel T cell amplifier, in combination with KEYTRUDA (pembrolizumab), a leading checkpoint inhibitor (CPI), for the treatment of heavily pretreated patients with relapsed or refractory triple-negative breast cancer (TNBC) (Press release, Genexine, NOV 9, 2020, View Source [SID1234570550]). These data were shared in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference on November 9th, 2020.

The primary objectives of the DE phase of this study are to evaluate safety and tolerability of GX-I7/NT-I7 in combination with pembrolizumab and to determine the recommended phase 2 dose (RP2D). Two combination schedules of GX-I7/NT-I7 and pembrolizumab were evaluated: 1. Sequential administration of pembrolizumab + GX-I7/NT-I7, after cyclophosphamide (CPA) chemotherapy pre-treatment, and 2. Concurrent administration of pembrolizumab + GX-I7/NT-I7, without CPA chemotherapy pre-treatment.

As of September 30th, 2020, a total of 60 patients have been enrolled and treated in the DE phase of the study. Based on the encouraging efficacy and safety data, the standard dose of pembrolizumab plus 1,200 ug/kg GX-I7/NT-I7 concurrent administration without CPA chemotherapy pre-treatment has been selected as the RP2D. At this level, an objective response rate (ORR) of 28% has been observed.

Both combination schedules were well tolerated, and the most common treatment-related AEs were injection site reaction (n=44, 73.4%), rash (n=26, 43.4%), pyrexia (n=21, 35.0%), ALT/AST increase (n=19, 31.7%), GGT increase (n=12, 20.0%), myalgia (n=12, 20.0%) and nausea (n=11, 18.4%). GX-I7/NT-I7 was dosed up to 1,440ug/kg, however this level was not selected due to one dose-limiting toxicity observed with no additional clinical benefit noted.

"In addition to a well tolerated safety profile, we are pleased to see promising initial efficacy data at the RP2D in the dose escalation phase of this combination study," said Jung Won Woo, Ph.D., Executive Vice President and Head of Research Institute at Genexine. "We look forward to completing the phase 2 portion of the study (dose expansion phase) and confirming the promising efficacy in a large dataset."

NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech, added: "Metastatic triple-negative breast cancer is an area of significant unmet need, making up 15-20% of breast cancers, and yielding progressively lower response rates and shorter survival after each subsequent relapse. These early efficacy signals in the dose escalation phase of our trial are encouraging and suggest that we may be able to provide a much needed chemo-free treatment option for these patients in dire need."

Additional information on the trial can be found on www.clinicaltrials.gov using the identifier NCT03752723.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About GX-I7/NT-I7 (efineptakin alfa)
GX-I7 (Genexine Code Name) / NT-I7 (NIT Code Name) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). GX-I7/NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. GX-I7/NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

IMV to Participate in Two Upcoming Investor Conferences

On November 9, 2020 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported that IMV’s executive management team will participate at two upcoming virtual investor Conferences (Press release, IMV, NOV 9, 2020, View Source [SID1234570546]).

Stifel Virtual Healthcare Conference
Date: Monday, November 16, 2020
Presentation Time: 10:40 a.m. Eastern Time

Piper Sandler 32nd Annual Virtual Healthcare Conference

Date: December 1 to 3 (institutional meetings)

Presentation: A fireside discussion between IMV’s Senior Management and Mr. Edward Tenthoff, Managing Director and Senior Research Analyst at Piper Sandler will be available on IMV’s website Monday, November 23 at 10:00 a.m. Eastern Time

A webcast of these presentations will be available under "Events, Webcasts and Presentations" in the investors section of IMV’s website and a replay will be available approximately one hour after the presentation. Afterwards, the replay will be available for approximately 30 days.

Personalis, Inc. to Present New Data at the Society for Immunotherapy of Cancer (SITC) 35th Annual Meeting

On November 9, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported that the company reported that it will participate in the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting online, November 11-14, including poster presentations on November 11th – 13th (Press release, Personalis, NOV 9, 2020, View Source [SID1234570542]).

The company will showcase ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. ImmunoID NeXT can be used to investigate the key tumor and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

Following is a list of abstracts that will be presented at the meeting.

Scientific Poster Presentations

Poster Number & Category

Title & Presenter

Day & Time

Biomarkers, Immune Monitoring, and Novel Technologies

Profiling Tumor Circulating Cell-Free DNA with an Enhanced Whole-Exome to Enable Sensitive Assessment of Somatic Mutations

Presenter: Simo V. Zhang, PhD

NOV 11 | 5:15 – 5:45 PM EST
and

NOV 13 | 4:40 – 5:10 PM EST

Biomarkers, Immune Monitoring, and Novel Technologies

Precision neoantigen discovery using novel algorithms and expanded HLA-ligandome datasets

Presenter: Dattatreya Mellacheruvu, PhD

NOV 11 | 5:15 – 5:45 PM EST
and

NOV 13 | 4:40 – 5:10 PM EST

Biomarkers, Immune Monitoring, and Novel Technologies

B-cell receptor heavy chain repertoire profiling using an augmented transcriptome

Presenter: Eric Levy, Ph.D.

NOV 11 | 5:15 – 5:45 PM EST
and

NOV 13 | 4:40 – 5:10 PM EST

Biomarkers, Immune Monitoring, and Novel Technologies

Orthogonally and functionally validated algorithm for detecting HLA loss of heterozygosity

Presenter: Rachel M. Pyke, PhD

NOV 11 | 5:15 – 5:45 PM EST
and

NOV 13 | 4:40 – 5:10 PM EST

Following are details of an industry-sponsored symposium which will be presented at the meeting.

Industry Sponsor Symposium

Presentation Category

Title & Presenter

Day & Time

NanoString Technologies Releases Operating Results for Third Quarter of 2020

On November 9, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the third quarter of 2020 (Press release, NanoString Technologies, NOV 9, 2020, View Source [SID1234570540]).

Third Quarter Financial Highlights

Product and service revenue of $30.1 million, 14% year-over-year growth. On a pro forma basis, reflecting the impact of the Veracyte transaction on revenue recorded for Prosigna IVD kits, product and service revenue increased by 22%
Instrument revenue of $12.9 million, 60% year-over-year growth. Instrument revenue includes $7.5 million of GeoMx Digital Spatial Profiler (DSP) instrument revenue
Consumables revenue of $13.7 million, 11% year-over-year decline. On a pro forma basis, reflecting the impact of the Veracyte transaction, consumables revenue was flat year-over-year. Consumables revenue includes $1.4 million of GeoMx DSP consumables revenue
Service revenue of $3.6 million, 16% year-over-year growth
"We delivered over 20% pro forma revenue growth in Q3, and extended our spatial genomics leadership with the launch of NGS readout for GeoMx," said Brad Gray, President and CEO of NanoString. "With our recent successful financing, we have the strongest balance sheet in our company’s history, positioning us to fully support our market and technology development initiatives."

GeoMx DSP Platform

GeoMx Orders: Received orders for more than 25 GeoMx DSP instruments in the third quarter, bringing cumulative orders received to more than 150 instruments since launch
GeoMx Shipments and Installs: Shipped more than 30 and installed approximately 35 GeoMx DSP instruments in the third quarter, bringing cumulative shipments to more than 120 and cumulative installs to approximately 100 instruments since launch
Launch of Next Generation Sequencing (NGS) Readout and Cancer Transcriptome Atlas (CTA): Announced the launch of GeoMx DSP compatibility with Illumina’s next generation sequencers, as well as the commercial availability of the CTA, the first in a portfolio of GeoMx DSP products that will utilize NGS readout
GeoMx Protein Readout for NGS: Launched new NGS panels that include more than 50 proteins for immuno-oncology applications. These protein assays can be used in combination with the Cancer Transcriptome Atlas to enable multi-analyte spatial readout using NGS
Launch of Whole Transcriptome Atlas under GeoMx Technology Access Program (TAP): Announced the availability of the new GeoMx Whole Transcriptome Atlas through TAP for the GeoMx DSP, which provides expanded access to next generation sequencing readout on GeoMx DSP
Continued Expansion of GeoMx TAP: Generated more than 75 new TAP orders, of which more than 50% included NGS readout
Publications: Continued growth of peer-reviewed publications utilizing GeoMx DSP technology, with 6 new publications in the third quarter, bringing the cumulative total to 29 peer-reviewed publications
nCounter Platform

nCounter Installed Base: Grew installed base to approximately 915 nCounter Analysis Systems at September 30, 2020, as compared to approximately 820 systems at September 30, 2019
nCounter Publications: Surpassed 3,800 cumulative peer-reviewed publications utilizing nCounter technology
New Panel Launch: Launched new nCounter Host Response Panel that allows scientists to study the immune response to SARS CoV2, or any other pathogen. The Host Response Panel can be combined with the COVID-19 Panel Plus spike-in or custom content, enabling researchers to characterize the host and viral genes simultaneously
Financial

Balance Sheet: Completed an underwritten public offering of 5,750,000 shares of our common stock in October 2020, for net proceeds of $215.8 million. Concluded the quarter with $231.0 million in cash, cash equivalents and short-term investments. Following the equity offering completed in October 2020, our cash, cash equivalents and short-term investments balance is $446.8 million
Corporate

Investor Day: Announced a virtual Investor Day that will be held on Tuesday, December 1st focused on updates to our product roadmap, commercial initiatives and the development of the spatial biology market
Third Quarter Financial Results

We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include collaboration revenue, stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the notes and table at the end of this press release.Supplemental Information

As a supplement to the table above, we have posted to the investor relations section of our website, at www.nanostring.com, supplemental financial data that includes our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the third quarter of 2020 and for each quarter of and the full year of 2019.

Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Investors and other interested parties can register for the call in advance by visiting View Source After registering, an email confirmation will be sent, including dial-in details and unique conference call codes for entry. Registration is open throughout the call but to ensure connection for the full call, registration in advance is recommended. The link to the webcast and audio replay will be made available at the Investor Relations website: nanostring.com. A replay of the call will be available beginning November 9, 2020 at 7:30pm ET through midnight ET on November 16, 2020. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 5172128. The webcast will also be available on our website for one year following the completion of the call.

Non-GAAP, or Adjusted, Financial Information

We believe that the presentation of non-GAAP, or adjusted, financial information provides important supplemental information to management and investors regarding financial and business trends relating to our financial condition and results of operations. Reconciliation of adjusted financial measures to the most directly comparable financial result as determined in accordance with GAAP are included at the end of this press release following the accompanying financial data. A reconciliation of adjusted guidance measures to corresponding GAAP measures is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding certain expenses that may be incurred in the future. For further information regarding why we believe that these adjusted measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to "Notes Regarding Non-GAAP Financial Information" at the end of this press release.

Pro Forma Financial Information

As used in this press release, "pro forma" percentages are calculated by comparing the applicable period-over-period financial results to reflect the impact of the Veracyte transaction as if such transaction had occurred on January 1, 2019, the beginning of the earliest period presented. Further disclosure regarding the terms and pro forma impact of the Veracyte transaction can be obtained in our Current Report on Form 8-K filed with the Securities and Exchange Commission on December 4, 2019.