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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

29

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

57

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

67

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

73

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

Sponsored Symposia

Maximizing immunotherapy biomarker discovery with a multidimensional tumor immunogenomics platform

Presenter: Erin N. Newburn, PhD

NOV 12 | 12:30 – 12:50 PM EST

Personalis will also be exhibiting during the online conference. Representatives will be available to answer questions about the company’s cancer immunogenomics services.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On November 9, 2020 Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company focused on developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, reported interim Phase 1 results evaluating BDB001, its Toll-like receptor 7/8 (TLR7/8) agonist (NCT03486301), at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting to be held virtually November 9 – 14, 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The responses seen with BDB001 in anti-PD-(L)1 refractory tumors are notable and will guide our development program in these difficult to treat tumors"

The interim Phase 1 results show that intravenous administration of BDB001 as monotherapy is well-tolerated and induces robust immune activation resulting in clinical responses in solid tumors, including deep responses in anti-PD-(L)1 refractory tumors. BDB001 is an immune modulator capable of activating dendritic cells to initiate both innate and adaptive immunity against cancer. BDB001 is a first-in-class TLR7/8 agonist delivered intravenously, allowing for broader treatment of solid tumors compared to intratumoral TLR agonists in development.

"These initial data showing that BDB001 can be safely delivered intravenously and produce clinical responses in heavily pre-treated tumors are encouraging," said Dr. Manish R. Patel, presenter of the BDB001 Phase I clinical trial abstract, and a study investigator.

"The responses seen with BDB001 in anti-PD-(L)1 refractory tumors are notable and will guide our development program in these difficult to treat tumors," said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma. "The potential for BDB001, as an immuno-oncology backbone, in combination with anti-PD-(L)1 therapies is currently being evaluated in several clinical trials, and early findings are promising."

"We are very excited about the clinical BDB001 monotherapy data as we advance our robust immuno-oncology pipeline in treatments beyond anti-PD-(L)1, including preclinical platform programs in TLR Ligand Antibody Conjugation," said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma. "Our assets will help us expand our programs globally."

Presentation Details:

Title: BDB001, a Toll-Like Receptor 7 and 8 (TLR 7/8) agonist, can be safely administered intravenously ​and shows clinical responses in advanced solid tumors​
Abstract Authors: Manish R. Patel, Drew Rasco, Melissa Johnson, Anthony Tolcher, Lixin Li, Adam Zong, Alexander Chung, Robert H.I. Andtbacka
Abstract #: 324
Presenter: Manish R. Patel
Presentation times: November 9 – 14, 8:00 a.m. – 5:00 p.m. EST
Location: Virtual Poster Hall

The poster presentation will be available for virtual viewing at the SITC (Free SITC Whitepaper) meeting website until December 31, 2020 and will also be made available on the Company’s website at www.7and8biopharma.com.

Full abstract:

Background: TLR agonists mediate antitumor activity through dendritic cell (DC) activation. Most TLR agonists in development are administered intratumorally allowing for less than 30% of advanced solid tumor to be treated. BDB001 is an intravenously administered novel TLR7/8 agonist that activates plasmacytoid and myeloid DCs and has shown to have activity in preclinical studies. Here we report on BDB001 administration in patients with advanced solid tumors.

Methods: BDB001-101 is a Phase 1, open label, dose escalation/expansion trial of BDB001 administered intravenously weekly in patients with advanced solid tumors. The primary endpoint was safety and tolerability. Secondary endpoints included efficacy, pharmacokinetics and pharmacodynamic profiling of immune activation.

Results: Thirty-six subjects with 16 different tumor types were enrolled across 5 dose levels. Sixty seven percent were female, median age was 66 years (range, 38-88), median number of prior therapies was 4 (range, 0-12), and 61% of tumors had progressed on prior anti-PD-(L)1 therapy. BDB001 was well tolerated and a maximum tolerated dose was not reached. Eleven (30.5%) subjects had no treatment related adverse events (AEs) and the majority of AEs were Grade 1 or 2. Three (8.3%) subjects had Grade 3 AEs, including 2 with a cytokine release syndrome, both of whom were clinically stable and had symptoms fully resolved within 2 to 5 days. There were no Grade 4 or 5 AEs. The most common AEs included chills/rigor (19.4%), fever (19.4%), fatigue (11.1%), nausea (11.1%) and pruritus (11.1%). Of 32 subjects evaluable for efficacy, best overall response rate was: 6% durable partial response, 56% stable disease, 38% progressive disease, for a disease control rate of 62%. Durable responses were seen in renal cell carcinoma and non-small cell lung cancer. Interestingly, clinical activity favored subjects with tumors that had progressed on prior anti-PD-(L)1 therapy, compared to prior DNA-damaging chemotherapy, within 6 months of BDB001 initiation. Median time on treatment was 12.1 weeks (range, 3.1 – 68.0). Transcriptional profiling showed up-regulation of interferon inducible genes, activation of dendritic cells and macrophages. BDB001 also significantly increased serum levels of interferon gamma and interferon inducible protein-10 (IP-10).

Conclusions: Intravenously administered BDB001 monotherapy was well tolerated. Clinical responses were achieved, supported by BDB001-induced immune activation. Preliminary findings suggest that BDB001 is a promising therapeutic option for patients with tumors that progress on anti-PD-(L)1 therapy. BDB001 is also being evaluated in combination with pembrolizumab (anti-PD-1, NCT03486301) and with atezolizumab (anti-PD-L1, NCT04196530).