On February 11, 2020, IntelGenx Technologies Corp. (the "Corporation") reported that it has entered into a warrant indenture (the "Warrant Indenture") with TSX Trust Company (the "Warrant Agent") (Filing, 8-K, IntelGenx, FEB 11, 2020, View Source [SID1234554196]). Pursuant to the Warrant Indenture, the Corporation issued an aggregate principal amount of CA$8,158,500 of units ("Units") at a price of CA$0.50 per Unit, each of which consists of one share of the Corporation’s common stock ("Common Stock") and one Common Stock purchase warrant ("Warrant"). Each Warrant is exercisable to purchase one share of the Corporation’s Common Stock ("Warrant Share") at an exercise price of CA$0.75 per Warrant Share, subject to adjustment. The Warrants are immediately exercisable and will expire at 5:00 p.m. (eastern time) on February 11, 2023.

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The Warrant Indenture contains customary terms and conditions for the issuance, transfer and exercise of the Warrants and the terms governing actions taken by the Warrant holders and the obligations of the Corporation and the Warrant Agent in relation to the Warrants. The Warrant Indenture provides that in the event there is a subdivision, redivision, reduction, combination, consolidation or other change of the shares of Common Stock into a greater or lesser number of shares of Common Stock or securities of the Corporation, the exercise price of the Warrants and the number of the Warrant Shares issuable upon conversion of the Warrants will be adjusted accordingly.

On February 11, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, and Personalis Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported a collaboration to leverage Personalis’ ImmunoID NeXT Platform in Advaxis’ ongoing Phase 1/2 ADXS-503 (HOT Lung) program evaluating ADXS-503 alone and in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC) (Press release, Advaxis, FEB 11, 2020, View Source [SID1234554169]). The ADXS-503 construct targets 11 public or shared, hotspot neoantigens in KRAS, EGFR and TP53 as well as 11 proprietary tumor-associated antigen targets. Under the terms of the expanded agreement, Personalis will conduct comprehensive tumor immunogenomic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance.

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Via the deep analysis of ~20,000 genes in both DNA and RNA, ImmunoID NeXT consolidates multiple biomarker assays into one; providing a multidimensional view of the tumor and the immune microenvironment from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery and CDx development.

"We are thrilled to expand our relationship with Personalis and believe the resulting analyses may lead to the establishment of predictive biomarkers and the characterization of immunological impact of treatment which will be relevant to the successful development of ADXS-503 and our other off-the-shelf neoantigen constructs," said Dr. Andres A. Gutierrez, Chief Medical Officer of Advaxis. "With the emerging clinical signals we are seeing in our ongoing ADXS-503 clinical study and the extensive capabilities of ImmunoID NeXT to interrogate a patient’s tumor and immune response at both the DNA- and RNA-level from a single FFPE tissue sample, the analysis will help guide our development plans in order to target the right patient population and to potentially increase the clinical benefit of our off-the-shelf, ADXS-HOT drug constructs."

This new agreement builds upon the prior two-year collaboration between Advaxis and Personalis for the genomic analysis of clinical tumor samples to manufacture the Company’s ADXS-NEO drug construct, its personalized, neoantigen-directed immunotherapy to treat a variety of late stage cancers. As previously published, the ADXS-NEO drug constructs were able to efficiently generate de novo CD8+ T cells versus KRAS and EGFR hotspot mutations in late stage-cancer patients, thus providing proof-of-mechanism for our ADXS-HOT program.

On February 11, 2020 Pinpoint Therapeutics, Inc. ("Pinpoint"), a privately held biopharmaceutical company focused on the development of novel autophagy inhibitors to treat cancer, reported that it has raised $1 million in debt financing led by Kairos Ventures of Beverly Hills, California (Press release, Pinpoint Therapeutics, FEB 11, 2020, View Source [SID1234554193]).

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Pinpoint was founded by researchers Ravi K. Amaravadi, M.D., and Jeffrey D. Winkler, Ph.D., from the University of Pennsylvania’s Abramson Cancer Center and the Department of Chemistry, to develop new autophagy inhibitors for cancer treatments. Autophagy is a well-established mechanism of cancer cell survival and drug resistance. Pinpoint’s novel compounds target a recently discovered enzyme in the autophagy pathway called PPT1, which is highly expressed across most cancers. These inhibitors could be applied to a broad range of cancers alone or in combination with other treatments to overcome therapy resistance. Pinpoint will develop first-in-class autophagy inhibitors into clinical drugs for testing in a range of treatment-refractory cancers.

"This initial round of financing will allow us to develop a new approach to drugging autophagy, which until now seemed difficult to target in cancer. The activity of PPT1 inhibitors in cancer models has not been seen before in the autophagy space," said Christian Peters, M.D., Ph.D., Chief Executive Officer of Pinpoint.

"Pinpoint has developed best-in-class compounds with unprecedented therapeutic potential and we are thrilled to support their efforts as they develop these novel drug-candidates for treatment of colon cancer, pancreatic cancer, melanoma, and other major unmet needs in oncology," said Jim Demetriades, founder and Managing Partner of Kairos Ventures.

On February 11, 2020 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its results for the fourth quarter and full year 2019 (Press release, BerGenBio, FEB 11, 2020, View Source [SID1234554192]).

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A presentation and live webcast by the Company’s management will take place today at 10.00 am CET in Oslo, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "I am pleased to report on another eventful quarter for BerGenBio. During the period bemcentinib was approved for Fast Track Designation by the USA FDA for AML, and we continued to see encouraging data emerge from our ongoing phase II clinical trials with bemcentinib. The primary endpoint was met in our lung cancer trail in combination with Merck’s checkpoint inhibitor Keytruda. We were particularly pleased to see responses among patients for whom checkpoint inhibitors would not usually be expected to be effective. In January we reported achieving a similar endpoint in NSCLC patients who had previously relapsed on checkpoint inhibitors. Looking forward, we anticipate reporting clinical and translational data updates at medical conferences, later in the year. In January we closed a PIPE funding providing an additional NOK 220m, subject to EGM approval, such that the Company is well-financed well beyond current milestones."

Operational Highlights – fourth quarter and full year 2019

Bemcentinib met primary endpoint in first cohort of Phase II NSCLC study in combination with KEYTRUDA
Primary endpoint, Overall Response Rate, was been met in predominantly PD-L1 negative/low patients
Secondary endpoint, median Progression Free Survival, exceeds expectations in AXL positive patients
Data was presented at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting on 8 November 2019
Preliminary clinical data from Phase II combination trial of bemcentinib and LDAC in elderly AML patients at ASH (Free ASH Whitepaper) 2019
Phase II trial data showed bemcentinib in combination with low-dose cytarabine (LDAC) in elderly AML patients unfit for intensive therapy is well tolerated and shows promising efficacy
Long duration of response (>9.9 mo., still maturing) with 50% complete response (CR/Cri) in 6 evaluable newly diagnosed patients receiving the bemcentinib-LDAC combination
Clinical benefit demonstrated in >2L relapsed and refractory AML patients with 1 CR/CRi and 3 SD out of 6 evaluable patients
Data presented in a poster presentation at the 61st Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting, on 7-10 December in Orlando, Florida.
U.S. Food and Drug Administration (FDA) approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed.
With this Fast Track designation, BGB is eligible for:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
Eligibility for Accelerated Approval and Priority Review
Clinical trial updates were presented at several major cancer scientific congresses and consistently confirm that NSCLC and AML are the optimal target indications
Phase II development programme read-outs according to plan
AML bemcentinib + LDAC: readouts at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Haematology Association (EHA) (Free EHA Whitepaper)
NSCLC bemcentinib + KEYTRUDA: readouts at ASCO (Free ASCO Whitepaper), World Conference on Lung Cancer (WCLC), European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Proprietary composite AXL tumour-immune (cAXL) score developed to identify & diagnose patients that show durable benefit
Completed Phase Ia trial with tilvestamab (BGB149) in healthy volunteers
Continued to build out the organisation with strategic medical, clinical, operational and regulatory hires
Private placement completed in June, raising NOK 74.2 million
Q4 2019 / FY 2019 Financial Highlights

(Figures in brackets = same period 2018 unless otherwise stated)

Revenue amounted to NOK 0.2 million (NOK 2.3 million) for the fourth quarter and NOK 8.9 million (NOK 2.3 million) for the full year 2019
Total operating expenses for the fourth quarter were NOK 59.3 million (NOK 53.2 million) and total operating expenses for the full year 2019 amounted to 213.3 million (NOK 196.9 million)
Research and development expenses accounted for 77% (74%) of total operating expenses in the full year 2019
The operating loss for the quarter came to NOK 59.1 million (NOK 50.9 million) and NOK 204.4 million (NOK 194.5 million) for the full year 2019, reflecting the level of activity related to the clinical trials BerGenBio is conducting
Cash and cash equivalents amounted to NOK 253.6 million at the end of December 2019 (NOK 360.4 million)
Post-period events

Private placement of NOK 219.9 million successful placed through new share allocation

Net proceeds to be used to advance bemcentinib trial programs in AML and NSCLC, manufacturing scale-up of bemcentinib, biomarker and companion diagnostic development, and phase 1b development of tilvestamab.
Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place today at 10:00 am CEST at:

Hotel Continental
Stortingsgata 24/26, Oslo

The presentation will be webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

On February 11, 2020 Medivir AB (Nasdaq Stockholm: MVIR) reported investors, analysts and the media to an R&D Day in Stockholm, Monday March 2, 2020, at 14:00 to 16:30 CET (Press release, Medivir, FEB 11, 2020, View Source [SID1234554191]).

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The presentations will, among other things, address new clinical results from the phase Ia study with MIV-818 in liver cancer patients. Members of Medivir’s management team and Professor Jeff Evans, Director of the Institute of Cancer Sciences at the University of Glasgow, will give presentations.

The meeting will be held at Helio GT30, Grev Turegatan 30 in Stockholm, on March 2 at 14:00 to 16:30 CET.

To register now, send an e-mail to: [email protected]

A formal invitation with a full program will be sent out and be available on www.medivir.se.

Warm welcome!

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer.