On November 6, 2020 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the closing of its exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, following expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, as amended (Press release, Vaccibody, NOV 6, 2020, View Source [SID1234570159]).

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As announced on October 1, 2020, Vaccibody and Genentech have entered into an agreement for the development and commercialization of DNA-based individualized neoantigen vaccines. With the expiration of the HSR Act waiting period, the agreement is now effective and Vaccibody is entitled to receive USD 200 million in initial upfront and nearterm payments.

Under the terms of the agreement, in addition to the USD 200 million in initial upfront and near-term payments that Vaccibody is entitled to receive, Vaccibody will be eligible to receive up to a further USD 515 million in potential payments and milestones, plus low double-digit tiered royalties on sales of commercialized products arising from the partnership. Through this partnership, Genentech and Vaccibody will progress Vaccibody’s investigational product candidate, VB10.NEO, into clinical trials in the U.S. and in Europe. Following completion of a planned Phase 1b trial, Genentech will have responsibility and bear all costs for clinical, regulatory, manufacturing and commercialization activities.

On November 6, 2020 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Crinetics Pharmaceuticals, NOV 6, 2020, View Source [SID1234570158]).

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"Crinetics made significant progress in the third quarter, and we are excited by the recently reported positive topline ACROBAT Edge results showing that the study met its primary endpoint," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "With this data, we are well positioned for a productive end-of-Phase 2 meeting with regulatory authorities and we look forward to finalizing our Phase 3 program for paltusotine in the first half of next year. In addition, we are eager to initiate clinical studies for our ACTH antagonist and SST5 agonist programs in the coming months, as there is a high unmet need for the patients who can be served by these novel approaches. Like paltusotine, Phase 1 studies for these drug candidates are expected to produce key biomarker data that are intended to be predictive of efficacy and de-risk the clinical programs."

Third Quarter and Subsequent Highlights

Reported positive topline results for the ACROBAT Edge and Evolve Phase 2 trials of paltusotine in acromegaly patients. In October 2020, Crinetics reported topline results from its ACROBAT Edge and Evolve Phase 2 trial. The prespecified primary endpoint in Edge was achieved, showing that once-daily oral paltusotine maintained insulin-like growth factor-1 (IGF-1) levels at Week 13 in acromegaly patients who were switched from an injected somatostatin receptor ligand (SRL) depot of either octreotide or lanreotide monotherapy. This data showed that acromegaly patients switching to once-daily oral paltusotine from first-line injected depot monotherapies maintained IGF-1 levels previously achieved with octreotide or lanreotide.

Received Rare Pediatric Disease Designation for CRN04777 for the treatment of congenital hyperinsulinism. In September 2020, the U.S. Food and Drug Administration (FDA) granted CRN04777 Rare Pediatric Disease (RPD) Designation for the treatment of congenital hyperinsulinism. The FDA developed the Rare Pediatric Disease Priority Review Voucher (PRV) Program whereby companies are eligible to receive a priority review voucher following approval of a product with an RPD designation if the marketing application submitted for the product satisfies certain additional conditions. If issued, a sponsor may redeem a PRV for priority review of a subsequent marketing application for a different product candidate, or the PRV could be sold or transferred to another sponsor.
Third Quarter 2020 Financial Results

Research and development expenses were $13.7 million for the three months ended September 30, 2020, compared to $11.8 million for the same period in 2019. The increase was primarily attributable to higher personnel costs and clinical and nonclinical development and manufacturing activities for the company’s programs.
General and administrative expenses were $4.8 million for the three months ended September 30, 2020, compared to $3.9 million for the same period in 2019. The increase was primarily due to personnel costs to support the company’s growth.
Net loss for the three months ended September 30, 2020 was $18.3 million, compared to a net loss of $14.4 million for the three months ended September 30, 2019.

Cash, cash equivalents and investments totaled $186.8 million as of September 30, 2020, compared to $118.4 million as of December 31, 2019. The cash balance includes the $107.9 million of net proceeds from the public equity offering completed in April.
As of October 31, 2020, the company had 32,922,328 common shares outstanding.

On November 6, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the third quarter ended September 30, 2020 and provided a business update (Press release, INmune Bio, NOV 6, 2020, View Source [SID1234570157]).

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"Since our second quarter update, we have made progress with our neuroinflammation franchise. First, we reported positive Phase 1b data in July demonstrating that XPro1595 decreased neuroinflammation by more than 40% in the arcuate fasciculus, a white matter pathway important for learning and memory in Alzheimer’s patients. More recently, we announced receipt of an NIH Small Business Innovation Research Grant of up to $2.9 million to support a Phase 2 study of XPro1595 in treatment resistant depression patients, or TRD," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We believe that TRD represents an important expansion of our neuroinflammation program, and we are working hard to initiate Phase 2 trials in Alzheimer’s and TRD next year."

"In addition, we continue to advance our other programs across both our DN-TNF and INKmune platforms. In DN-TNF, we have opened a Phase II clinical trial using Quellor to treat patients hospitalized from complications of COVID-19. In 2021, assuming the clinical landscape has not changed, and the pandemic is controlled, we will initiate planning for the Phase II trials of LIVNate in NASH and INB03 in cancer. We are also poised to advance our INKmune programs in ovarian cancer and high-risk MDS as well. Overall, we are pleased with our progress in the third quarter and year-to-date," concluded Dr. Tesi.

Q3 2020 and Recent Corporate Highlights

DN-TNF Platform Highlights:

Announced interim Phase Ib data demonstrating that over a 12-week period, XPro1595 decreased neuroinflammation by 40.6% in the arcuate fasciculus, a white matter pathway important for learning and memory in patients with Alzheimer’s disease. The 13 July KOL webinar discussing the data can be found by clicking here.
Awarded a National Institutes of Health (NIH) Small Business Innovation Research Grant of up to $2.9 million to support a phase 2 study of XPro1595 in patients with treatment resistant depression (TRD). The study, entitled, "Effects of the Next Generation TNF Inhibitor (XPro1595) on Inflammation-related Deficits in Reward Circuitry and Motivation in Depression," will be conducted at two sites in the U.S. – Emory University School of Medicine in Atlanta and University of Alabama in Birmingham.
Hosted a Key Opinion Leader (KOL) webinar on the topic of treatment resistant depression. The webinar discussed the role of neuroinflammation in TRD and featured presentations by two highly-regarded thought leaders in the field: Charles Raison, M.D., professor in the department of psychiatry at the University of Wisconsin at Madison, and John E. Schneider, Ph.D., chief executive officer and principal of Avalon Health Economics. A replay of the webinar can be found by clicking here.
Announced FDA acceptance of an Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating Quellor, a selective soluble tumor necrosis factor (sTNF) inhibitor, for the treatment of immune mediated complications in COVID-19 patients.
Announced that the European Patent Office has granted a patent covering XPro1595 and its peripheral administration for treating Alzheimer’s disease and other diseases of the CNS. The patent expires in 2033.
NK Priming Platform Highlights:

Announced that the US Patent and Trademark Office has issued a patent covering a method for treating cancer using INKmune, the company’s natural killer (NK) cell priming technology. The patent expires in 2036.
Financial Highlights:

Closed a $25 million public offering of common stock, including full exercise of the underwriters’ over-allotment option, resulting in net proceeds of approximately $23.1 million.
Upcoming Milestones:

2020:

Enroll first patient in Phase II Quellor program, targeting COVID-19 patients with immune mediated complications from COVID-19.
2021:

Report additional data on Phase 1b XPro1595 in Alzheimer’s Disease in January 2021. The company will host a KOL call in tandem with the announcement.
XPro1595 Phase 2 program for treatment resistant depression.
XPro1595 Phase 2 program for Alzheimer’s disease in patients with neuro-inflammation.
The company plans additional clinical trials after the COVID-19 pandemic has been controlled. The exact timing of these trials cannot be predicted at this time:

INKmune Phase 1 program for ovarian cancer.
INKmune Phase 1 program for high-risk MDS.
LIVNate Phase 2 program for NASH.
INB03 Phase 2 program for MUC4 expressing cancer.
Financial Results for the Third Quarter Ended September 30, 2020:

Net loss attributable to common stockholders for the third quarter ended September 30, 2020 was approximately $4.7 million, compared to approximately $3.1 million for the quarter ended September 30, 2019.

Research and development expense totaled approximately $2.4 million for the third quarter ended September 30, 2020, compared to approximately $1.2 million during the third quarter ended September 30, 2019.

General and administrative expense was approximately $2.5 million for the quarter ended September 30, 2020, compared to approximately $1.9 million during the third quarter ended September 30, 2019.

As of September 30, 2020, the Company had cash and cash equivalents of approximately $24.3 million and no debt. September 30 cash and cash equivalents reflects a public offering of common stock which the company completed in July which raised net proceeds of approximately $23.1 million.

As of November 5, 2020, the Company had approximately 13.4 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through November 12 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 21970461.

About XPro1595

XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro1595 could have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

On November 6, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the third quarter ended September 30, 2020, and provided a corporate update (Press release, Jounce Therapeutics, NOV 6, 2020, View Source [SID1234570127]).

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"Jounce made continued progress this quarter and I am very proud of the work our team has done to initiate our next clinical study, SELECT, and move our lead macrophage program, JTX-8064, an inhibitor of the LILRB2 (or ILT4) receptor, towards the clinic. Notably, we also entered into a license agreement with Gilead for our anti-CCR8 program JTX-1811," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Our broad pipeline of clinical and preclinical programs targets both PD-1 naïve and experienced patient populations, allowing for the potential to extend clinical benefit to individuals who have not previously benefited from IO therapy. We look forward to leveraging our expertise and IO pipeline to further our goal of bringing the right immunotherapies to the right patients."

Pipeline Update:
Clinical Programs: Vopratelimab and JTX-4014

Initiated Phase 2 SELECT trial of vopratelimab: Jounce initiated the randomized Phase 2 SELECT trial to evaluate vopratelimab in combination with JTX-4014, a PD-1 inhibitor, versus JTX-4014 alone in immunotherapy naïve TISvopra biomarker-selected, second line NSCLC patients. Jounce expects to enroll approximately 75 patients outside the U.S. and expects to report clinical data in late 2021.

Reported interim analysis data from Phase 2 EMERGE trial and announced no expansion of enrollment: The interim analysis of the EMERGE Phase 2 clinical trial of the ipilimumab and vopratelimab combination did not meet its pre-specified criteria for expansion of the study. Overall survival and biomarkers will continue to be evaluated.
Preclinical Development Programs: JTX-8064 and JTX-1811

On track to initiate Phase 1 clinical trial of JTX-8064 by year-end 2020: Enrollment in the Phase 1 dose escalation trial of JTX-8064, a highly-selective, potential first in class antibody that targets the Leukocyte Immunoglobulin Like Receptor B2 (LILRB2 or ILT4) on macrophages, is expected to begin by year-end 2020.

New JTX-8064 preclinical data to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2020 Annual Meeting: On November 11, 2020 Jounce will present additional preclinical data for JTX-8064 at the SITC (Free SITC Whitepaper) Annual Meeting. The poster will include data informing the indication selection and biomarker strategies for JTX-8064 to maximize potential therapeutic benefit for patients with solid tumor malignancies.

Established exclusive license agreement with Gilead for the development and commercialization of JTX-1811: In September 2020, Jounce announced an exclusive license agreement providing Gilead with the worldwide rights to JTX-1811, Jounce’s highly selective, potential first-in-class antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory cells. The transaction closed in October 2020 and Jounce received $120 million in cash, including a $35 million equity investment. Under the terms of the agreement, Jounce continues to progress JTX-1811 to IND clearance and is on track for an IND filing in the first half 2021.
Third Quarter 2020 Financial Results:

Cash position: As of September 30, 2020, cash, cash equivalents and investments were $105.3 million, compared to $170.4 million as of December 31, 2019. The decrease in cash, cash equivalents and investments was primarily due to operating expenses incurred during the period. Not included in the September 30, 2020 cash balance is the $120.0 million we received upon the closing of the Gilead agreements in October 2020.

License and collaboration revenue: Jounce did not recognize any revenue in the third quarter of 2020. License and collaboration revenue recognized during the third quarter of 2019 was comprised of $50.0 million of cash revenue related to Jounce’s license agreement with Celgene and $69.4 million of non-cash revenue recognition related to Jounce’s first strategic collaboration with Celgene, which ended in July 2019.

Research and development expenses: Research and development expenses were $18.0 million for the third quarter of 2020, compared to $15.1 million for the same period in 2019. The increase in research and development expenses was primarily due to increased IND-enabling expenses for JTX-1811, external clinical and regulatory costs associated with the SELECT clinical trial and increased employee compensation costs.

General and administrative expenses: General and administrative expenses were $7.1 million for the third quarter of 2020, compared to $6.5 million for the same period in 2019. The increase in general and administrative expenses was primarily due to increased employee compensation costs.

Net (loss) income: Net loss was $24.9 million for the third quarter of 2020, resulting in basic and diluted net loss per share of $0.73. Net income was $98.9 million for the same period in 2019, resulting in a basic net income per share of $2.99 and diluted net income per share of $2.90. The increase in net loss was primarily attributable to no license and collaboration revenue in the third quarter of 2020 and an increase in operating expenses.
Financial Guidance:

Based on its current operating and development plans, Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2020 to be approximately $80.0 million to $95.0 million.

Jounce expects its existing cash, cash equivalents and investments as of September 30, combined with the proceeds from Gilead, to be sufficient to enable the funding of its operating expenses and capital expenditure requirements into 2023.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 8009939. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

On November 6, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Wednesday, November 11, 2020, at 5:00 pm ET to discuss a corporate update and financial results for the third quarter of 2020 (Press release, Oncolytics Biotech, NOV 6, 2020, https://ir.oncolyticsbiotech.com/news/detail/520/oncolytics-biotech-to-host-conference-call-to-discuss-third-quarter-financial-results-and-operational-highlights [SID1234570126]).

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Conference Call & Webcast

A live webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (855) 859-2056 (North America) or (416) 849-0833 (International) and using reference code: 678-8931.