On February 8, 2024 BioNTech SE (Nasdaq: BNTX, "BioNTech"), a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, and Autolus Therapeutics plc (Nasdaq: AUTL, "Autolus"), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported a strategic collaboration aimed at advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory authorizations (Press release, Autolus, FEB 8, 2024, View Source [SID1234639935]). In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

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!

"The collaboration with Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way. Autolus’ state-of-the-art manufacturing facilities’ set-up for clinical and commercial supply will enhance our own capacities in addition to our existing U.S. supply network and the ongoing expansion of our site in Gaithersburg, Maryland," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "Furthermore, this collaboration grants us access to Autolus’ precise cell targeting tools to further support BioNTech’s development of in vivo cell therapy and antibody-drug conjugate candidates."

"We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities beyond autologous cell therapies," said Dr. Christian Itin, Chief Executive Officer of Autolus. "We look forward to investing a portion of the capital raised on delivering on obe-cel’s path in adult acute lymphoblastic leukaemia, potentially offering another treatment option for patients where there is still an unmet medical need. This collaboration creates a path for accelerating our respective oncology pipeline programs and broadening the use of Autolus’ technology outside of autologous cell therapy applications."

BioNTech has agreed to purchase $200 million of Autolus’ American Depositary Shares in a private placement. BioNTech will have a right to appoint a director to the Board of Autolus.

Under the terms of the license and option agreement, BioNTech will make a cash payment of $50 million and is granted the following rights in exchange:

•
BioNTech is eligible to receive an up to mid-single digit royalty on obe-cel net sales. Autolus will retain full rights to and control of the development and commercialization of obe-cel.

•
BioNTech has the option to access Autolus’ commercial and clinical site network, manufacturing capacities in the United Kingdom and commercial supply infrastructure in a cost-efficient set-up in order to accelerate the development of BNT211 in additional CLDN6+ tumor types. BioNTech plans to have 10 or more ongoing potentially registrational clinical trials in the pipeline by the end of 2024, including its fully owned CLDN6 CAR-T program BNT211 in relapsed or refractory germ cell tumors.

•
Autolus will lead the development and commercialization for AUTO1/22 and AUTO6NG in any oncology indication with BioNTech having an option to support certain development activities and co-commercialize both candidates in certain territories. If BioNTech exercises an option, it will receive a profit share with respect to such exercised product candidate worldwide while Autolus will be eligible to receive an option exercise fee, milestone payments and co-funding of development expenses.

•
Autolus granted BioNTech an exclusive license to develop and commercialize therapeutics incorporating certain of Autolus’ proprietary binders along with options to license binders and cell programming technology for use in BioNTech’s in vivo cell therapy development programs and investigational antibody-drug conjugates. If BioNTech exercises an option, Autolus will be eligible to receive exercise fees and milestones payments, with low-single digit royalties on net sales of the licensed products.

Evercore, goetzpartners and Cooley LLP acted as advisors to Autolus.

On February 8, 2024 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma (Press release, Corvus Pharmaceuticals, FEB 8, 2024, View Source [SID1234639936]). Soquelitinib, the Company’s lead ITK inhibitor candidate, is expected to advance into a Phase 3 registrational clinical trial in patients with relapsed peripheral T cell lymphoma (PTCL) in the second quarter 2024.

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!

"Peripheral T cell lymphoma is an aggressive subset of non-Hodgkin’s lymphoma typically associated with a poor prognosis," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "For these patients, there is significant need for new therapies given that existing drugs provide limited efficacy and are associated with significant toxicity. There are no FDA approved agents for relapsed PTCL. The orphan drug designation is an important milestone in the development of soquelitinib that reinforces the unmet need for patients with T cell lymphoma."

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

On February 8, 2024 Swedish Orphan Biovitrum AB (publ) (Sobi) reported its report for the fourth quarter 2023 (Press release, Swedish Orphan Biovitrum, FEB 8, 2024, View Source [SID1234642334]).

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!

On February 8, 2024 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported its business update and financial results for the quarter ended December 31, 2023 (Press release, Curis, FEB 8, 2024, View Source [SID1234639937]).

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!

Operational Highlights

In December at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper), the Company presented data from both the TakeAim Lymphoma and TakeAim Leukemia studies. A summary of key findings of the data that were presented from the on-going studies are as follows:

TakeAim Lymphoma – data for patients with primary CNS lymphoma (PCNSL) who had failed prior BTKi therapy showed 3 of 5 evaluable patients achieved Complete Response (CR).
TakeAim Leukemia – data for patients with relapsed/refractory (R/R) AML with a FLT3 mutation who received < 3 prior lines of treatment showed 2 of 3 patients achieved CR and the 3rd patient achieved Morphological Leukemia Free State (MLFS).
In addition to the presentations at ASH (Free ASH Whitepaper), Curis announced in December that it had entered into an agreement for an Investigator-Initiated Trial to study the combination of emavusertib and pembrolizumab in patients with metastatic melanoma. In this study, Curis will be responsible for the supply of emavusertib and Merck will be responsible for the supply of pembrolizumab and clinical study costs.

"The R/R PCNSL data presented at ASH (Free ASH Whitepaper) highlight the potential of emavusertib in combination with ibrutinib to address a critical unmet need, for a patient population with no approved treatments, and achieve CR in patients who have failed prior BTKi therapy. The R/R AML FLT3 data highlight emavusertib’s potential to provide targeted anti-cancer activity as a monotherapy. We have also begun working with clinical investigators to initiate a Phase 1 clinical study of emavusertib as an add-on agent to the combination of azacitidine and venetoclax in the front-line setting. Finally, the study evaluating emavusertib and pembrolizumab in metastatic melanoma will explore the potential of emavusertib and IRAK4 inhibition in solid tumors," said James Dentzer, President and Chief Executive Officer of Curis. "We are encouraged by the reaction of the clinical community to the data released at ASH (Free ASH Whitepaper) and are working to open additional clinical sites in the US and Europe for both the TakeAim Leukemia and Lymphoma studies."

Upcoming Milestones

TakeAim Leukemia – updated clinical data from the on-going monotherapy study in the first half of 2024.
TakeAim Lymphoma – updated clinical data from the on-going combination study of emavusertib with ibrutinib in the second half of 2024.
Curis expects initial clinical data from the recently initiated triplet combination study of emavusertib with azacitidine and venetoclax to treat AML patients in the second half of 2024.
Fourth Quarter 2023 Financial Results

For the year ended December 31, 2023, Curis reported a net loss of $47.4 million, or $8.96 per share on both a basic and diluted basis, as compared to a net loss of $56.7 million, or $12.14 per share on both a basic and diluted basis in 2022. For the fourth quarter of 2023, Curis reported a net loss of $11.7 million or $2.03 per share on both a basic and diluted basis as compared to a net loss of $11.3 million or $2.35 per share on both a basic and diluted basis for the same period in 2022.

Revenues, net for the year ended December 31, 2023, were $10.0 million as compared to $10.2 million for the same period in 2022. Revenues for both periods comprise primarily royalty revenues related to Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2023 and 2022 were $2.7 million and $2.9 million, respectively.

Cost of royalties, which relate to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, for the year ended December 31, 2023, were $0.2 million compared to $0.3 million for the same period in 2022. Cost of royalties for the fourth quarters of 2023 and 2022 were $0.1 million for both periods.

Research and development expenses were $39.5 million for the year ended December 31, 2023, as compared to $43.3 million for the same period in 2022. The decrease was primarily attributable to lower employee-related costs due to reduced headcount. Research and development expenses were $10.0 million and $8.7 million for the fourth quarters of 2023 and 2022, respectively.

General and administrative expenses were $18.6 million for the year ended December 31, 2023, as compared to $19.6 million for the same period in 2022. The decrease was primarily attributable to lower employee-related costs due to reduced headcount. General and administrative expenses were $4.9 million and $4.3 million for the fourth quarters of 2023 and 2022, respectively.

Other income, net was $0.9 million for the year ended December 31, 2023, as compared to other expense, net of $3.7 million for the same period in 2022. The increase was attributable to an increase in interest income and a decrease in the non-cash expense related to the sale of future royalties. Other income, net was $0.5 million for the fourth quarter of 2023 as compared to other expense, net of $1.1 million for the same period in 2022.

As of December 31, 2023, Curis’s cash, cash equivalents and investments totaled $56.3 million, and the Company had approximately 5.9 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments should enable its planned operations into 2025.

Conference Call Information

Curis management will host a conference call today, February 8, 2024, at 8:30 a.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website in the Investors section.

On February 8, 2024 Foghorn Therapeutics presented its corporate presentation (Presentation, Foghorn Therapeutics, FEB 8, 2024, View Source [SID1234639938]).

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!