On November 3, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for KRAZATI (adagrasib) as a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRASG12C mutation and have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy (Press release, Mirati, NOV 3, 2023, View Source [SID1234636923]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"KRAZATI offers a compelling therapeutic option for patients with previously treated locally advanced NSCLC with a KRASG12C mutation. MHRA’s authorization is a significant step towards improving the options available for patients and clinicians in Great Britain," said Alan Sandler, M.D., chief medical officer, Mirati Therapeutics, Inc. "We are encouraged by the opportunity to bring KRAZATI, a potential best-in-class treatment to qualified patients."

"Fourteen percent of people living with NSCLC harbour the KRASG12C mutation yet there are limited targeted treatment options for patients with this devastating disease1,2," said Dr Shobhit Baijal (Consultant Medical Oncologist of The University Hospital Birmingham). "The expansion of treatment options for NSCLC benefits patients and clinicians alike. As someone intensively involved in the management of lung cancer patients, I look forward to KRAZATI being available for use in clinical practice."

For more information, visit KRAZATI.com.

About KRAZATI (adagrasib)

Mirati has risen to meet one of the most challenging mutations in cancer research by developing KRAZATI, a highly selective and potent oral small-molecule inhibitor of KRASG12C.

Intentionally designed to meet the challenge of KRASG12C, adagrasib is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24−48 hours.1 Adagrasib has shown clinically to be a CNS penetrant, which may be important given that CNS metastases frequently occur in NSCLC and lead to poor prognosis.2,3,4

KRAZATI (adagrasib) GB Indication

KRAZATI as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.

Important Safety Information

The full Summary of Product Characteristics (SPC/SmPC) for KRAZATI (adagrasib) will be available on the MHRA website at View Source

About the KRYSTAL-1 Study

KRYSTAL-1 is an open-label Phase 1/2 multiple-expansion cohort trial evaluating adagrasib as monotherapy and in combination with other anti-cancer therapies in patients with advanced solid tumors harboring the KRASG12C mutation.

About KRASG12C in NSCLC

Lung cancer is one of the most common cancers worldwide, accounting for 2.21 million new cases and 1.8 million deaths worldwide in 2020.5 Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases.6 KRASG12C is the most common KRAS mutation in NSCLC, present in approximately 14% of patients with lung adenocarcinoma, and is a biomarker mutation of poor prognosis.

On November 3, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for KRAZATI (adagrasib) as a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRASG12C mutation and have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy (Press release, Mirati, NOV 3, 2023, View Source [SID1234636923]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"KRAZATI offers a compelling therapeutic option for patients with previously treated locally advanced NSCLC with a KRASG12C mutation. MHRA’s authorization is a significant step towards improving the options available for patients and clinicians in Great Britain," said Alan Sandler, M.D., chief medical officer, Mirati Therapeutics, Inc. "We are encouraged by the opportunity to bring KRAZATI, a potential best-in-class treatment to qualified patients."

"Fourteen percent of people living with NSCLC harbour the KRASG12C mutation yet there are limited targeted treatment options for patients with this devastating disease1,2," said Dr Shobhit Baijal (Consultant Medical Oncologist of The University Hospital Birmingham). "The expansion of treatment options for NSCLC benefits patients and clinicians alike. As someone intensively involved in the management of lung cancer patients, I look forward to KRAZATI being available for use in clinical practice."

For more information, visit KRAZATI.com.

About KRAZATI (adagrasib)

Mirati has risen to meet one of the most challenging mutations in cancer research by developing KRAZATI, a highly selective and potent oral small-molecule inhibitor of KRASG12C.

Intentionally designed to meet the challenge of KRASG12C, adagrasib is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24−48 hours.1 Adagrasib has shown clinically to be a CNS penetrant, which may be important given that CNS metastases frequently occur in NSCLC and lead to poor prognosis.2,3,4

KRAZATI (adagrasib) GB Indication

KRAZATI as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.

Important Safety Information

The full Summary of Product Characteristics (SPC/SmPC) for KRAZATI (adagrasib) will be available on the MHRA website at View Source

About the KRYSTAL-1 Study

KRYSTAL-1 is an open-label Phase 1/2 multiple-expansion cohort trial evaluating adagrasib as monotherapy and in combination with other anti-cancer therapies in patients with advanced solid tumors harboring the KRASG12C mutation.

About KRASG12C in NSCLC

Lung cancer is one of the most common cancers worldwide, accounting for 2.21 million new cases and 1.8 million deaths worldwide in 2020.5 Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases.6 KRASG12C is the most common KRAS mutation in NSCLC, present in approximately 14% of patients with lung adenocarcinoma, and is a biomarker mutation of poor prognosis.

On November 3, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for KRAZATI (adagrasib) as a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRASG12C mutation and have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy (Press release, Mirati, NOV 3, 2023, View Source [SID1234636923]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"KRAZATI offers a compelling therapeutic option for patients with previously treated locally advanced NSCLC with a KRASG12C mutation. MHRA’s authorization is a significant step towards improving the options available for patients and clinicians in Great Britain," said Alan Sandler, M.D., chief medical officer, Mirati Therapeutics, Inc. "We are encouraged by the opportunity to bring KRAZATI, a potential best-in-class treatment to qualified patients."

"Fourteen percent of people living with NSCLC harbour the KRASG12C mutation yet there are limited targeted treatment options for patients with this devastating disease1,2," said Dr Shobhit Baijal (Consultant Medical Oncologist of The University Hospital Birmingham). "The expansion of treatment options for NSCLC benefits patients and clinicians alike. As someone intensively involved in the management of lung cancer patients, I look forward to KRAZATI being available for use in clinical practice."

For more information, visit KRAZATI.com.

About KRAZATI (adagrasib)

Mirati has risen to meet one of the most challenging mutations in cancer research by developing KRAZATI, a highly selective and potent oral small-molecule inhibitor of KRASG12C.

Intentionally designed to meet the challenge of KRASG12C, adagrasib is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24−48 hours.1 Adagrasib has shown clinically to be a CNS penetrant, which may be important given that CNS metastases frequently occur in NSCLC and lead to poor prognosis.2,3,4

KRAZATI (adagrasib) GB Indication

KRAZATI as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.

Important Safety Information

The full Summary of Product Characteristics (SPC/SmPC) for KRAZATI (adagrasib) will be available on the MHRA website at View Source

About the KRYSTAL-1 Study

KRYSTAL-1 is an open-label Phase 1/2 multiple-expansion cohort trial evaluating adagrasib as monotherapy and in combination with other anti-cancer therapies in patients with advanced solid tumors harboring the KRASG12C mutation.

About KRASG12C in NSCLC

Lung cancer is one of the most common cancers worldwide, accounting for 2.21 million new cases and 1.8 million deaths worldwide in 2020.5 Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases.6 KRASG12C is the most common KRAS mutation in NSCLC, present in approximately 14% of patients with lung adenocarcinoma, and is a biomarker mutation of poor prognosis.

On November 3, 2023 iOnctura, a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumor survival pathways, reported abstract data to be presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, San Diego, California, from 9-12 December 2023 (Press release, iOnctura, NOV 3, 2023, View Source [SID1234636922]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Catherine Pickering, Chief Executive Officer of iOnctura, said: "We are excited to present new research for roginolisib and IOA-359 at ASH (Free ASH Whitepaper). These data highlight the progress we are continuing to make in characterising and targeting resistance mechanisms across a variety of malignancies. Complementing our recently published evidence of the synergy between autotaxin and TGF-β inhibition in the treatment of pancreatic cancer; at ASH (Free ASH Whitepaper) we will present data on the role of TGF-b inhibition in myeloproliferative disorders. Building on our ongoing clinical investigation of roginolisib in patients with lymphoma, we will also present evidence of the synergy between Bcl-2 and PI3Kδ inhibition in Chronic Lymphocytic Leukemia (CLL)."

Details of the presentations are as follow:

Presentation Title: Novel PI3Kδ Inhibitor Roginolisib Synergizes with the Bcl-2 Inhibitor Venetoclax in Hematological Malignancies

Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster III
Session Date: Monday, December 11, 2023
Presentation Time: 6:00 PM – 8:00 PM

Presenter: Dr. Kandathilparambil Sasi
Location: San Diego Convention Center, Halls G-H

Presentation Title: Preclinical Activity of Novel TGF Beta Receptor I Kinase Inhibitors IOA-359 and IOA-360 for Treatment of Anemia in MDS/AML

Session Name: 636. Myelodysplastic Syndromes–Basic and Translational: Poster III

Session Date: Monday, December 11, 2023
Presentation Time: 6:00 PM – 8:00 PM

Presenter: Dr. Charan Vegivinti
Location: San Diego Convention Center, Halls G-H

Abstract Title: Roginolisib a Highly Selective Allosteric Modulator of the Phosphoinositide 3-Kinase Delta (PI3Kδ) in Patients with Refractory/Relapsed Follicular Lymphoma

Author: Dr. Carmelo Carlo-Stella

Publication: November supplemental issue of Blood and will become part of the permanent ASH (Free ASH Whitepaper) and Blood Abstracts Archive.

On November 3, 2023 Pierre Fabre Laboratories reported an expanded global partnership with Atara Biotherapeutics, a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform, for EBVALLO (tabelecleucel) a monotherapy already registered in the EU for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein–Barr virus positive post–transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy (Press release, Pierre Fabre, NOV 3, 2023, View Source [SID1234636921]). EBV+ PTLD is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression.

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This geographical expansion of the licensing rights encompasses the USA, Canada and all remaining territories. Pierre Fabre Laboratories already acquired the rights for Europe in October 2021 and EBVALLO was approved by EMA in December 2022. EBVALLO is, as of today, commercialized in Germany and Austria.

"Since EBVALLO’s marketing authorization in Europe less than a year ago, patients have already been treated in Germany, or have benefited from the treatment through the Early Access Program in place in other European countries" said Eric Ducournau, CEO of Pierre Fabre Laboratories. "We are now eager to progress on the upcoming FDA milestones in the next months and ensure American patients diagnosed with EBV+ PTLD can access this novel therapy".

"We are proud to expand our global EBVALLO partnership with Pierre Fabre Laboratories, who is committed to deliver this first-of-its kind treatment to patients in need across the globe" said Pascal Touchon, President and Chief Executive Officer of Atara.

According to the expanded Global EBVALLO Partnership between Pierre Fabre Laboratories and Atara Biotherapeutics:

Atara will receive up to $640M and significant double-digit tiered royalties on net sales from Pierre Fabre Laboratories. In addition, Pierre Fabre Laboratories has agreed to reimburse Atara for expected EBVALLO global development costs through transfer of the BLA (Biologics License Application) approval by the FDA in the US and purchase current and future EBVALLO inventory through the BLA transfer date.
Near-term payments to Atara include:
Approximately $30M in cash up front and initial inventory purchase at closing
Approximately $30M in cash up front and initial inventory purchase at closing
$100M in potential regulatory milestones through BLA approval
Substantially all EBVALLO manufacturing, clinical, and regulatory activities are planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA approval transfer

Atara expects to submit the EBVALLO PTLD BLA in Q2 2024
The closing of the transaction, subject to expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, is expected to occur in December 2023.

"Pierre Fabre Laboratories have made oncology their top priority in Medical Care. Since 2019, we have almost tripled our revenues in this therapeutic field, and we expect to pass the 500M€ bar this year. This expansion of our partnership with Atara will allow us to make a first step in the US, by far the largest oncology market in the world, and to reach even more patients in need for innovative treatments" added Eric Ducournau, CEO of Pierre Fabre Laboratories.

About EBVALLO and EBV+ PTLD
EBVALLO (tabelecleucel) is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner. EBV+ PTLD is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression. It can impact patients who have undergone solid organ transplant (SOT) or allogeneic HCT. Poor median survival of 0.7 months and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patients for whom standard of care failed, underscoring the significant need for new therapeutic options.

EBVALLO has orphan designation in Europe. Orphan designation is reserved for medicines treating life-threatening or chronically debilitating diseases that are rare (affecting not more than five in 10,000 people in the EU).