On October 15, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Carmustine for Injection, USP, a therapeutic equivalent generic version of BiCNU (carmustine for injection) approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, OCT 15, 2021, View Source [SID1234591297]).

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The BiCNU brand and generic market had U.S. sales of approximately $19.4 million MAT for the most recent twelve months ending in August 2021 according to IQVIA Health*.

Dr. Reddy’s Carmustine for Injection, USP is a lyophilized powder available as a package which includes a single-dose vial containing 100 mg Carmustine USP and a vial containing 3 mL sterile diluent.

Please click here for full prescribing information including boxed warning: View Source

WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY

Myelosuppression

Carmustine causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [see Warnings and Precautions (5.1) and Adverse Reactions (6)]. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [see Dosage and Administration (2.1)].

Do not administer a repeat course of Carmustine until blood counts recover.

Pulmonary Toxicity

Carmustine causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg/m2 cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions (6) and Use in Specific Populations (8.4)].

iCNU is a trademark owned or licensed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

*IQVIA Retail and Non-Retail MAT June 2021

RDY-0821-368

On October 15, 2021 Philogen, a clinical-stage biotechnology company focused on antibody and small molecule-based targeted therapeutics, reported that Philochem’s European Patent 3083957 relating to important features of proprietary DNA-encoded chemical libraries ("ESAC 2+1" technology) was upheld after Oral Proceedings in front of the Opposition Division at the European Patent Office (Press release, Philogen, OCT 15, 2021, View Source [SID1234591400]).

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The patent entitled "Production of Encoded Chemical Libraries", granted on May 23rd 2018, claims inventions that are instrumental for the isolation and discovery of novel ligands for biologically relevant targets.

The European Patent Office decision came in response to a notice of opposition filed by NuEvolution A/S, now part of Amgen, on February 23rd2019. The decision rejected all opposition grounds filed by NuEvolution and all claims were maintained.

"We are pleased that the European Patent Office has upheld the validity of this important patent" said Prof. Dario Neri, CEO of Philogen, "The confirmation of these inventions strengthens our patent portfolio and emphasizes the international value and appeal of our IP. We encourage companies focused on the discovery of important ligands from Encoded Chemical Libraries to join forces and discuss licensing agreements with us as we have the ability and the track-record to show that we can provide innovative solutions in finding ligands against difficult or undruggable targets""

On October 15, 2021 Abbisko, a Shanghai biopharma, reported that it completed a $226 million IPO in Hong Kong to support its small molecule therapies for cancer (Press release, Abbisko Therapeutics, OCT 15, 2021, View Source [SID1234591278]). At the IPO price, Abbisko has a $1.1 billion market capitalization. Formed in 2016, Abbisko has developed a portfolio of 14 drug candidates, five of them at clinical stage. Its lead program, a pan-FGFR inhibitor aimed at urothelial carcinoma, is partnered with AstraZeneca. The company plans to start Phase Ib/II China trials for the candidate soon.

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On October 15, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), ("Isofol" or the "Company"), reported that the Company intends to list its shares on Nasdaq Stockholm. Isofol’s shares are currently traded on Nasdaq First North Premier Growth Market under the ticker ISOFOL (Press release, Isofol Medical, OCT 15, 2021, View Source [SID1234591301]).

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Nasdaq Stockholm’s listing committee has made the assessment that Isofol fulfills the applicable listing requirements and will approve an application for admission to trading of the Company’s shares on Nasdaq Stockholm, provided that certain customary conditions are fulfilled, including approval and registration of a prospectus by the Swedish Financial Supervisory Authority (Finansinspektionen).

The first day of trading on Nasdaq Stockholm’s Main Market is planned to take place on Thursday, October 21, 2021 and the final day of trading on Nasdaq First North Premier Growth Market is expected to be Wednesday, October 20, 2021.

The Company’s shares will be traded with unchanged ticker ISOFOL and ISIN-code (SE0009581051). No new shares will be issued in connection with the shares being admitted to trading on Nasdaq Stockholm and the Company’s shareholders do not need to take any actions in connection with the uplisting.

"Being listed on Nasdaq Stockholm Main Market is an important milestone in the Company’s development and growth. The listing will raise awareness among investors about Isofol’s drug development within oncology" says Ulf Jungnelius, CEO of Isofol.

Prospectus

Isofol has prepared a prospectus in connection with the admission to trading of the Company’s shares on Nasdaq Stockholm. The prospectus is expected to be approved and registered by the Swedish Financial Supervisory Authority and made public on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website www.fi.se, on or around Monday October 18, 2021.

Advisors

Isofol has engaged Advokatfirman Vinge KB as legal advisor and Carnegie Investment Bank AB (publ) as financial advisor in connection with the listing on Nasdaq Stockholm.

For more information please contact

The information was submitted for publication, through the agency of the contact person set out above, at 15:30 CEST on October 15, 2021.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On October 15, 2021 Stilla Technologies, the multiplex digital PCR company, reported that researchers from SAGA Diagnostics in presenting a 24-plex digital PCR assay generated on Stilla’s six-color naica system (Press release, Stilla Technologies, OCT 15, 2021, View Source [SID1234591401]). To mark the platform’s global commercial launch at the American Society of Human Genetics (ASHG) 2021 Virtual Meeting, Stilla’s Cofounder and Chief Technology Officer Rémi Dangla, PhD, and researchers from SAGA Diagnostics, Fred Hutchinson Cancer Research Center, and University of Athens highlighted the new data during a discussion on how highly sensitive, multiplex digital PCR technology is transforming complex genomic data into actionable insights across a breadth of research and clinical applications.

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The six-color naica system is the industry’s first digital PCR system featuring six fluorescent channels, providing biomedical researchers and clinicians the highest multiplexing and detection capacity available on the market. Scientists are already using Stilla’s technology to advance their research and discovery across wide applications including cell and gene therapies, cancer and liquid biopsy studies, infectious disease detection including SARS-CoV-2 variant detection in wastewater, and food and environmental testing. Additional information on six-color digital PCR can be found here: www.stillatechnologies.com/6-color-dpcr.

"Modern genetics increasingly relies on more complex signatures from scarce samples to inform on a variety of biological events such as early and residual disease detection, drug mechanism of action and efficiency in patients or full characterization of products for use in gene and cell therapy. Building upon the well-established three-color naica system’s ease-of use and transparency of data delivered, our six-color naica system is democratizing digital PCR and enabling the world’s most powerful platform of its kind," said Dr. Dangla. "From quantifying circulating tumor cells (CTCs) and cell-free DNA (cfDNA) in liquid biopsies for oncology, to detecting low-level genetic variants in infectious diseases, multiplex digital PCR is allowing researchers to parse complex genomics data to gain real-world, clinical insights at both the patient and the population level."

Registered ASH (Free ASH Whitepaper)G 2021 attendees are encouraged to tune in here to join Dr. Dangla and other scientists from Stilla Technologies at the following upcoming sessions:

Presenter: Rémi Dangla, PhD, Cofounder and Chief Technology Officer
Topic: Democratizing digital PCR to bridge the gap between genomics data and genetics insights
Time: October 20, 2021, at 9 AM EDT

Presenter: Kimberley Gutierrez, PhD, Field Applications and Scientific Support Manager
Topic: User-friendly high-plex digital PCR for absolute quantitation of genetic targets
Time: October 21, 2021, at noon EDT