On November 16, 2021 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, reported an update on ongoing OT-101/IL-2 combination trial (the "Trial"), which has now successfully completed the safety evaluation of its safety cohort, allowing for further expansion of its clinical program into phase 2 clinical trials and higher doses (Press release, Mateon Therapeutics, NOV 16, 2021, View Source [SID1234595679]).

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The Trial, Multi-center, Open label, Phase Ib clinical study to evaluate the safety, tolerance, and efficacy of TASO-001 ("OT-101"), a TGF-β targeting anti-sense oligonucleotide, in combination with recombinant interleukin-2 (Aldesleukin, "IL-2"), in patients with advanced or metastatic solid tumor cancer. ClinicalTrials.gov Identifier: NCT04862767.

OT-101 is a first-in-class anti-TGF-β ribonucleic acid ("RNA") therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials. OT-101 has also demonstrated activity against the SARS-CoV-2 virus, the virus that causes COVID-19, and is currently being evaluated in the Company’s C001 clinical trial against hospitalized severe COVID-19.

In the safety cohort treated during the Trial, the standard dosage of 140mg/m2 of OT-101was well tolerated in combination with IL-2, which has allowed for ongoing dose escalation to 190 mg/m2. The 140 mg/m2 dose was shown to be the optimal dose for OT-101 in the prior trial targeting pancreatic cancer, melanoma, and colorectal cancer ("P001"). In the P001 trial, the maximum tolerated dose was not reached even at 330 mg/m2. Therefore, the Company believes that increasing the dose above 140 mg/m2 should further enhance the clinical activity of OT-101.

"We are excited to see this clear demonstration of safety for the OT-101/IL-2 combination," noted Dr. Vuong Trieu, CEO of Oncotelic. "Unlike other common treatments, such as chemotherapy, IL-2 has the potential to bring about long-lasting responses and even cures in about one in 10 patients with metastatic kidney cancer and metastatic melanoma. Our analysis to date suggests that the OT-101/IL-2 combination could further improve the cure rate of these cancers. We look forward to updating shareholders as we gain further insights with additional data."

The Trial is being conducted by Autotelic BIO, a partner of Oncotelic on the OT-101/IL-2 combination, and Clinigen Group, a UK-based global pharmaceutical company.

About OT-101

OT-101 has demonstrated robust efficacy against pancreatic cancer, glioblastoma, and melanoma during phase 2 clinical trials. The demonstration that OT-101 will synergize with IL-2 could further demonstrate its utility as adjunct to other immunotherapies. IL-2, immunotherapy is cancer treatment that stimulates the body’s immune system to fight cancer, such as melanoma. OT-101 has also received orphan drug designation for glioblastoma, melanoma, and pancreatic cancers. Furthermore, the Food and Drug Administration recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is being evaluated for effectiveness against coronaviruses, including COVID-19, and has been deployed against the COVID-19 epidemic in the Company’s C001 trial.

OT-101 is an antisense against the host TGF-β protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including Kawasaki syndrome (Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3(1): 1-3) and acute respiratory distress syndrome (ARDS) (Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19. Clin. Invest. (Lond.) 2020; 10(2), 167-176. DOI: 10.4172/ Clinical-Investigation.1000166.).

On November 16, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will present at the Evercore ISI 4th Annual HealthCONx Conference 2021 on Wednesday, December 1, 2021 at 10:30 a.m. ET (Press release, PerkinElmer, NOV 16, 2021, https://ir.perkinelmer.com/news-releases/news-release-details/perkinelmer-present-evercore-isi-healthconx-conference-2021 [SID1234595678]).

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Prahlad Singh, president and chief executive officer of PerkinElmer, will provide an update on the Company and its strategic priorities. To register, click here.

A live audio webcast will be available on the Investors section of the Company’s website at www.perkinelmer.com. A replay of the presentation will be posted on the PerkinElmer website after the event and will be available for 90 days following.

On November 16, 2021 Hoffmann-La Roche reported to invite investors and analysts to participate in our virtual event on Wednesday, 15 December, 2021, highlighting Roche data presented at the virtual American Society of Hematology (ASH) (Free ASH Whitepaper) 63rd Annual Meeting, from 11-14th December (Press release, Hoffmann-La Roche, NOV 16, 2021, View Source [SID1234595673]).

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On November 16, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on November 15, 2021, for FoundationOne CDx Cancer Genomic Profile to be used to identify advanced/recurrent tumor mutation burden-high (TMB-High; ≥10 mutations/megabase (mut/Mb)) solid tumors (Press release, Chugai, NOV 16, 2021, View Source [SID1234595672]). An application for a humanized anti-human PD-1 monoclonal antibody, pembrolizumab (genetical recombination) [Product name: Keytruda] in TMB-High solid tumors that have progressed following prior chemotherapy was submitted by MSD K.K. on March 11, 2021 and is currently under review with the MHLW.

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"The approval may enable physicians to make treatment suggestions based on TMB measurement. TMB is the third tumor-agnostic biomarker following NTRK fusion and high microsatellite instability," said Dr. Osamu Okuda, Chugai’s President and CEO. "We will continue to encourage the proper use of this test to support treatment decision-making, and therefore enable better access to targeted therapies by evaluating many potential gene alterations at one time."

With this approval, FoundationOne CDx Cancer Genomic Profile will help identify patients with TMB-High advanced/recurrent solid tumors.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized oncology care, and contributing to patients and healthcare professionals through improving access to comprehensive genomic profiling of cancers.

Approval information (underlined indicates newly added)

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Microsatellite instability high nivolumab (genetical recombination)
Microsatellite instability high Solid tumors pembrolizumab (genetical recombination)
Tumor mutational burden-high pembrolizumab (genetical recombination)*
NTRK1/2/3 fusion gene entrectinib, larotrectinib sulfate
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
FGFR2 fusion genes Biliary tract cancer pemigatinib
* Application under review and not yet approved for the drug indication as of November, 2021

About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro companion diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The device is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About tumor mutational burden
Tumor mutational burden (TMB) is a measure of the number of somatic mutations per coding region within a tumor’s genome. Levels are measured by the number of non-inherited mutations occurring per megabase (1 million DNA base pairs) of the tumor genome, and with a status of 10 mutations per megabase or more defined as TMB-High by the FoundationOne CDx Cancer Genomic Profile. More neoantigen is induced in TMB-High tumors, and such tumors may respond better to immune-checkpoint inhibitors. TMB-High tumors are reported to be relatively common in malignant melanoma, non-small cell lung cancer, colorectal cancer, and endometrial cancer1).

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On November 16, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported its results for the third quarter of 2021 (Press release, BerGenBio, NOV 16, 2021, View Source [SID1234595671]).

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A presentation and live webcast by BerGenBio’s senior management will take place at 10am CET today, please see below for details.

Operational Highlights – third quarter of 2021 (including post-period end)

Martin Olin appointed Chief Executive Officer, bringing 20 years of executive experience in the pharmaceutical and biotechnology industry. Previous roles include CEO of Symphogen
Post-period end, NSCLC data presented at SITC (Free SITC Whitepaper), highlighting bemcentinib’s potential in NSCLC patients harbouring STK11 mutations
AML data presented at EHA (Free EHA Whitepaper) indicate bemcentinib/LDAC combination is efficacious and well tolerated in relapsed elderly AML patients unfit for intensive chemotherapy
COVID-19 data in a late-breaking abstract presentation at ECCMID demonstrate encouraging evidence for the effect of bemcentinib in hospitalised patients receiving steroids ± remdesivir
Financial Highlights – third quarter of 2021

Revenue amounted to NOK 0.0 million (Q3 2020: NOK 0.0 million)
Total operating expenses were NOK 71.4 million (Q3 2020: NOK 68.3 million)
Q3 operating loss of NOK 70.5 million, decreased compared to previous quarters, (Q3 2020: NOK 67.3 million)
A strong cash position of NOK 509.4 million at end of Q3 2021
Martin Olin, Chief Executive Officer of BerGenBio, commented: "It is my great pleasure to provide an update on BerGenBio’s progress over the last quarter, my first since joining the Company as CEO in September 2021. Having completed a strategic review of operations following my appointment, we have reiterated our focus on pursuing a rigorous data driven approach of connecting a consistent scientific rationale, pre-clinical and clinical data to high unmet medical needs will enable us to define the best possible path to registration as well as unlocking significant market potential.

"Our focus will be the clinical development of bemcentinib as a second line treatment in relapsed AML, building on the promising data accumulated so far with the planned initiation of a confirmatory randomized placebo-controlled trial in H2 2022. The clinical development of the NSCLC program continues, and a Phase 1b trial investigating bemcentinib in patients with STK11 mutations in 1L NSCLC is also scheduled to be initiated in H1 2022.

"We will also look to validate our COVID-19 clinical data through a confirmatory randomized placebo-controlled trial supported by a major, multinational collaboration that provides access to a large number of sites across Europe and established infrastructure at significantly reduced cost to BerGenBio. We anticipate this study to commence in H1 2022.

"The Company is well-funded with a strong team in place to continue the advancement of its pipeline and working towards delivering new treatment options for patients in need and value for shareholders. I look forward to providing further updates on our progress in due course."

Presentation and Webcast Details

An in-person briefing will take place at 10:00 am CET at: Carnegie AS, Fjordalleen 16, Aker Brygge, 5th Floor, Oslo where BerGenBio’s senior management team will provide an update on the Company followed by a Q&A session.

The presentation will also be webcast live, details below.

The Q3 2021 report and presentation are available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.