On January 20, 2023 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as "Dr. Reddy’s"), a global pharmaceutical company, reported it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions (Press release, Dr Reddy’s, JAN 20, 2023, View Source [SID1234626416]).

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DRL_RI is being developed as a biosimilar of rituximab, a cluster of differentiation 20 (CD20) directed cytolytic antibody for approval in the United States, European Union and other regions for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets. The company undertook further clinical development to meet regulatory requirements of highly regulated markets. With the successful completion of these clinical studies, Dr. Reddy’s is now preparing to file Biologics License Application (BLA) / Marketing Authorisation Application (MAA) dossiers with various regulatory authorities globally.

Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said: "This is a very important milestone in our biosimilars journey. The successful completion and positive outcome of these clinical studies highlights our capability for global clinical development of biosimilar products for highly regulated and global markets. These results underscore our commitment to developing high quality biosimilars and reinforce the potential of DRL_RI as a safe and effective treatment option to patients across the globe."

Dr. Reddy’s is currently collaborating with its partner Fresenius Kabi to commercialise its proposed biosimilar of rituximab in the United States. The company intends to commercialise the product in Europe and other geographies directly.

About Dr. Reddy’s clinical studies for its proposed biosimilar of rituximab, DRL_RI:

1. RI-01-003: This study demonstrated pharmacokinetic equivalence and similarity in pharmacodynamics, safety and immunogenicity between DRL_RI and EU reference medicinal product* and U.S. reference product**.
2. RI-01-006 (FLINTER): This study demonstrated efficacy equivalence and similarity in safety and immunogenicity between DRL_RI and EU reference medicinal product* in patients with Low Tumour Burden Follicular Lymphoma
3. RI-01-007: This study demonstrated similar safety and immunogenicity profile between the DRL_RI, EU reference medicinal product* and U.S. reference product** groups upon single transition from either of them, in subjects with active rheumatoid arthritis.

*EU reference medicinal product is MabThera

**U.S. reference product is Rituxan

MabThera and Rituxan are registered trademarks of Roche.

About Dr. Reddy’s biosimilars programme:

Dr. Reddy’s biosimilars business is part of our key strategic initiatives expected to drive both near-term and future growth. Over the last 20 years, our Biologics team has developed into a fully integrated organisation with robust capabilities in the development, manufacture and commercialisation of a range of biosimilar products in oncology and immunology. We have a current portfolio of six commercial products marketed in India and over 25 Emerging Markets. In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across regulated as well as emerging markets. We recently announced the successful completion of Phase I study and initiation of Phase III study of DRL_TC, our proposed biosimilar of tocilizumab, for global markets. We are also ramping up manufacturing capacity to support our global expansion plans.

On January 20, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that it has amended certain financial terms of the $20 million convertible note issued by its partner, Cytovia Therapeutics, LLC ("Cytovia") in payment of the upfront collaboration consideration provided for pursuant to the research collaboration and non-exclusive license agreement between Cellectis and Cytovia (Press release, Cellectis, JAN 20, 2023, View Source [SID1234626415]).

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The amended and restated note provides for automatic conversion into common stock of Cytovia in the case of certain fundamental transactions pursuant to which Cytovia becomes a public reporting company and for conversion at Cellectis’ option in connection with certain financing transactions, upon a company sale and at final maturity. In each case such conversion is subject to a 9.9% ownership cap, with the balance issuable in the form of pre-funded warrants. Among other changes, the amended and restated note increased the applicable interest rate of the note to 10% per annum, subject to a 10% step up upon the occurrence and continuation of an event of default, provided for the repayment of 50% of the outstanding amount on April 30, 2023 and extended the final maturity date for the repayment of the remaining outstanding amount to June 30, 2023.

On January 202, 2023 : Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to reported further details of its HER-Vaxx and CF33 technologies being featured at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium currently being held in San Francisco (Press release, Imugene, JAN 20, 2023, View Source [SID1234626398]).

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The presentation and posters being presented at the event can be downloaded and viewed in full on the Imugene website at View Source

Imugene and its technologies featured in the following sessions:

Oral Abstract Session

HERIZON: A phase 2 study of HER-Vaxx (IMU-131), a HER2-targeting peptide vaccine, plus standard of care chemotherapy in patients with HER2-overexpressing metastatic or advanced gastric/GEJ adenocarcinoma— Overall survival analysis.

In presenting the session Dr Tanuj Chawla outlined the following conclusions:
• HER-Vaxx (IMU-131) + chemotherapy showed a statistically significant 45% overall survival benefit compared to chemotherapy alone (14.0 vs 8.3 months)
• Duration of response was longer in HER-Vaxx + chemotherapy arm over chemotherapy alone arm (30 vs 19 weeks)
• Vaccination with HER-Vaxx induced persistent HER-2 specific antibodies which correlated with clinical response as proof of concept for a first-in-class B Cell Immunotherapy based on HER-2 peptides
• No additive toxicity was seen when HER-Vaxx was administered in combination with chemotherapy
• Exploring alternative HER-Vaxx doses in single arm phase 2 extension study
• The nextHERIZON study (NCT05311176) is currently enrolling (TIP #16 @ASCO GI): HER-Vaxx plus ramucirumab /paclitaxel OR pembrolizumab following progression with trastuzumab treatment in GC

Trials in Progress Poster Session nextHERIZON:

A phase 2 study of HER-Vaxx, a HER2-targeting peptide vaccine, in combination with chemotherapy or pembrolizumab in patients with HER2 metastatic or advanced gastric/gastroesophageal adenocarcinoma that progressed on or after trastuzumab treatment.

Imugene’s CMO Dr Giovanni Selvaggi presented this poster as part of a Trials in Progress Poster Session, outlining an introduction to HER-Vaxx and its clinical programme, the study design, objectives and key eligibility criteria.

Poster Sessions

Development of a novel chimeric oncolytic viral platform, CF33 and its derivatives, for peritoneal-directed CF33-OV treatment of gastric cancer peritoneal carcinomatosis.

Dr Annie Yang from City of Hope presented the following results in this poster session:
•CF33-OVs infects and replicates in a dose dependent manner in both diffuse and intestine subtypes of human GC cell lines without attenuation caused by insertion of human transgenes
•Immunofluorescence imaging showed virus-encoded hNISand anti-PD-L1 antibody expression in CF33-OV-infected GC cells
•CF33-OVs killed a range of GC cell lines in a dose dependent manner
•Flow cytometry confirmed GC cell surface PD-L1 blockade by virus-encoded anti-PD-L1
•In the xenograft model, CF33-hNIS-antiPDL1 (IP; 3x105pfu x 3 doses) significantly reduced peritoneal tumors (p<0.0001), decreased amount of ascites (62.5% PBS vs. 25% CF33-hNIS-antiPDL1) and prolonged animal survival (p<0.01). At day 91, 6/8 mice were alive in the virus-treated group vs.1/8 in the control group.

The poster concluded that CF33-OVs demonstrates robust infection, replication, functional protein delivery and killing of GC in vitro. IP CF33-hNIS-antiPDL1 treatment improves survival of GCPM xenograft mouse models when compared to PBS controls.

Ex vivo oncolytic and immune activity of CF33-hNIS-antiPDL1 against fresh peritoneal cells from patients with gastric cancer with and without peritoneal metastases.

Dr Yanghee Woo from City of Hope presented the following key takeaways from this poster session:
• Oncolytic CF33-hNIS-antiPDL1 virus is effective in infecting and killing fresh human peritoneal cancer cells of GCPM with expression of functional anti-PD-L1 scFv.
•Phase I trial investigating the safety and biologic activity of intraperitoneal CF33-hNIS-antiPDL1 for the treatment of GC patients with peritoneal metastases is planned.The 20th iteration of the annual ASCO (Free ASCO Whitepaper) GI event highlights the latest developments and breakthroughs in the field of gastrointestinal oncology, attended by more than 4,000 scientific figures, clinical researchers, academics, oncologists and medical practitioners from around the world.

On January 19, 2023 BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI) (the "Company" or "Bioasis"), a multi-asset rare and orphan disease biopharmaceutical company developing clinical stage programs based on epidermal growth factor and a differentiated, proprietary xB3 platform for delivering therapeutics across the blood-brain barrier ("BBB") and the treatment of central nervous system ("CNS") disorders in areas of high unmet medical need, reported that it has filed its unaudited quarterly financial statements and management’s discussion and analysis for the period ended November 30, 2022 (Press release, Bioasis Technologies, JAN 19, 2023, View Source [SID1234626414]). All are available under the Company’s profile on SEDAR and on the Company’s website at www.bioasis.us/investors/.

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On January 19, 2023 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported a global collaboration with Boehringer Ingelheim to develop the company’s tissue-based comprehensive genomic profiling test, FoundationOneCDx, as a companion diagnostic for Boehringer Ingelheim’s investigational MDM2-p53 antagonist, BI 907828, in the United States, Japan and European Union (Press release, Foundation Medicine, JAN 19, 2023, View Source [SID1234626412]).

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BI 907828 is an investigational, oral, small molecule MDM2-p53 antagonist. It is currently being evaluated as monotherapy in Brightline-2 (NCT05512377), an ongoing Phase IIa/IIb, open-label, single-arm, multi-center trial for the treatment of patients with locally advanced or metastatic, MDM2 amplified, TP53 wild-type biliary tract cancer in patients who have progressed on standard of care therapy.

"Biliary tract cancers are rare and aggressive cancers and those impacted have limited treatment options along with poor prognosis," said Francesco di Marco, Senior Vice President, Head of Therapeutic Area Oncology, Boehringer Ingelheim. "At Boehringer Ingelheim, we take a diligent and broad approach in some of the most difficult, but potentially most impactful, areas of cancer. Foundation Medicine’s deep understanding of cancer biology and regulatory process makes them an ideal partner for us as we further investigate the role of the MDM2-p53 pathway in cancer development. Our hope is that through this collaboration, we will be able to address the challenges these patients continue to face."

Comprehensive genomic profiling is emerging as an important tool in the treatment of biliary tract cancer given the rapidly evolving therapeutic landscape in this disease area.1 Foundation Medicine has the only FDA-approved portfolio of comprehensive genomic profiling tests, offering physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions.

"High quality, well-validated genomic testing is critical to identify biliary tract cancer patients with complex alterations like MDM2 amplifications," said Sanket Agrawal, Chief Biopharma Business Officer, Foundation Medicine. "We’re proud to partner with Boehringer Ingelheim as they advance this investigational therapy and if approved, create access to it through companion diagnostic development."