On February 11, 2021 Notch Therapeutics, Inc., a biotechnology company developing renewable, induced pluripotent stem cell (iPSC)-derived cell therapies for cancer, reported the closing of an oversubscribed U.S. $85 million Series A financing (Press release, Notch Therapeutics, FEB 11, 2021, View Source [SID1234574943]). The financing was led by an exclusively healthcare-focused investment fund, with participation by existing investors Allogene Therapeutics, Inc. (NASDAQ: ALLO), Lumira Ventures, and CCRM Enterprises Holdings Ltd., an affiliate of Centre for Commercialization of Regenerative Medicine (CCRM); along with new investors EcoR1 Capital, a undisclosed leading global investment firm, Casdin Capital, Samsara BioCapital, and Amplitude Ventures. Proceeds from the financing will support the continuing development of Notch’s portfolio of iPSC-derived T cell therapeutic product candidates and clinical readiness of the company’s proprietary Engineered Thymic Niche (ETN) platform. The financing will also enable Notch to expand its team to support the company’s future growth, including establishing operations in Seattle, in addition to the company’s existing operations in Vancouver and Toronto.

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!

"We are gratified to have the confidence of this exceptional group of investors and have them share in our vision that our platform can be game-changing for cell therapies by easing cell manufacturing and broadening their clinical and commercial potential," said David Main, President and Chief Executive Officer of Notch. "The level of interest in this financing round enabled us to far exceed our original capital-raising goals. With this support, Notch is well positioned to support our partners and advance development of our initial cell therapy products for patients with cancer."

Notch is applying its scalable Engineered Thymic Niche (ETN) technology platform to develop homogeneous and universally compatible, stem cell-derived cell therapies. To date, Notch has assembled a world-class scientific team and built a fully integrated, tightly controlled platform for generating and editing immune cells from clonal stem cells to enable development of a broad range of T cell therapeutics. Notch has an existing partnership with Allogene Therapeutics to apply Notch’s proprietary ETN platform to develop CAR-targeted, iPSC-derived, off-the-shelf T cell or natural killer (NK) cell therapies for hematologic cancer indications.

"We have great confidence in Notch’s high-caliber management team and the rigorous science underlying its research programs," said David Chang, M.D., Ph.D., President, Chief Executive Officer, and Co-Founder of Allogene and a member of the Notch Board of Directors. "We are impressed by the company’s innovation and accomplishments and pleased to continue our support of Notch as the company advances the development of a new generation of cell therapies for cancer and other immune disorders."

On February 11, 2021 Molecular Templates, Inc. (Nasdaq: MTEM; "Molecular Templates" or "MTEM") reported that it has entered into a worldwide strategic research collaboration with Bristol Myers Squibb to discover and develop multiple novel therapies designed for specific oncology targets (Press release, Molecular Templates, FEB 11, 2021, https://www.mtem.com/investors/news-events/press-releases/detail/89/molecular-templates-establishes-multi-target-collaboration [SID1234574942]). The collaboration will seek to discover new molecules utilizing MTEM’s next generation engineered toxin body (ETB) platform. ETBs represent a new class of targeted therapeutics that act through differentiated mechanisms of actions including the ability to force receptor internalization, deliver therapeutic payloads, and directly kill targeted cells through the enzymatic inactivation of ribosomes.

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!

"Bristol Myers Squibb is a leading global pharmaceutical company with a strong oncology franchise and a history of innovation, making them an ideal partner for the discovery and development of novel ETBs for the treatment of cancer," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "MTEM is excited to be working with Bristol Myers Squibb to focus on discovering and developing new ETBs against promising oncology targets. This collaboration provides further validation of our ETB platform while we continue to advance our wholly-owned product pipeline to offer promising therapeutic options for patients."

Under the terms of the agreement, MTEM will conduct research activities for the discovery of next generation ETBs for multiple targets, of which the first target has been selected by Bristol Myers Squibb. Bristol Myers Squibb will have the option to obtain an exclusive worldwide license to develop and commercialize ETBs directed to each selected target. Following the exercise of the option, Bristol Myers Squibb would be solely responsible for developing and commercializing the licensed ETBs.

Bristol Myers Squibb will make an up-front payment of $70 million to MTEM. MTEM is also eligible to receive near-term and development, regulatory and sales milestone payments of up to approximately $1.3 billion as well as tiered royalty payments on future sales.

On February 11, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the publication of a peer-reviewed study in the European Journal of Cancer which shows the potential utility of MNPR-101 as a uPAR imaging agent to improve surgical outcomes in bladder cancer (Press release, Monopar Therapeutics, FEB 11, 2021, View Source [SID1234574941]).

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!

Using Monopar’s proprietary humanized uPAR antibody, MNPR-101, a multimodal imaging probe was developed and tested in vivo in human bladder cancer models. The publication reports that high expression of uPAR in bladder cancer is localized at the tumor periphery, suggesting that using a fluorescent-conjugated MNPR-101 probe might allow surgeons to better visualize the borders of the tumor, potentially resulting in more complete tumor resection and thereby minimizing relapse. Similar approaches have been utilized successfully in the resection of other tumor types, such as breast cancer.

Bladder cancer is often treated with transurethral resection to remove cancerous tissue; however, recurrence can occur in up to 78% of patients within 5 years. Up to 40% of recurrent cases develop muscle invasive disease, which has a poor prognosis and requires complete removal of the bladder. Many patients with muscle-invasive bladder cancer unfortunately go on to develop and succumb to metastatic disease.

"This novel MNPR-101 based imaging agent has promising utility in allowing surgeons to easily identify tumor margins during surgery," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar and a co-author of the publication. "Given the specificity of uPAR expression in bladder cancer versus normal bladder tissue, and its high expression at the border of the tumor, we believe imaging uPAR using MNPR-101 targeting could improve surgical outcomes and potentially reduce recurrence of the disease."

"If confirmed in a clinical setting, an imaging probe based on MNPR-101 could result in a paradigm shift, altering how urologists survey and treat bladder cancer," said Cornelis Sier, PhD, member of the Image-Guided Surgery group at Leiden University Medical Center (LUMC), and the principal investigator on the study.

On February 11, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, reported that Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, will participate in the BIO CEO & Investor Digital Conference being held February 16-18, 2021 (Press release, Cytori Therapeutics, FEB 11, 2021, View Source;Investor-Digital-Conference/default.aspx [SID1234574940]).

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 Company’s presentation will be made through the BIO CEO & Investor Digital Conference website and available on demand to registered participants during the conference at View Source Subsequent to the conference, the presentation will be made available under the ‘Events’ tab of the Investor Relations section of the Plus Therapeutics website at www.plustherapeutics.com.

In December, BIO and voter participants named Plus Therapeutics as this year’s Public Therapeutic Company "Buzz of BIO", recognizing the Company’s promising work developing novel therapies for rare and difficult to treat cancers, such as recurrent glioblastoma.

On February 11, 2021 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that a $10 million milestone has been achieved related to development progress of retifanlimab outside the U.S., under its exclusive global collaboration and license agreement with Incyte (Press release, MacroGenics, FEB 11, 2021, View Source [SID1234574939]). Retifanlimab is an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012).

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!

As previously announced in January 2021, the U.S. Food and Drug Administration (FDA) has accepted for Priority Review Incyte’s Biologics License Application (BLA) for retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The Prescription Drug User Fee Act (PDUFA) target action date for retifanlimab is July 25, 2021. In addition, Incyte has stated it is pursuing development of retifanlimab as monotherapy in potentially registration-enabling studies in patients with MSI-high endometrial cancer and Merkel cell carcinoma.

In 2020, Incyte initiated two Phase 3 studies of retifanlimab in combination with chemo-radiation or chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) and in patients with metastatic SCAC, known as POD1UM-304 and POD1UM-303, respectively. Incyte is also pursuing development of retifanlimab in combination with multiple product candidates from its pipeline.

MacroGenics is currently evaluating retifanlimab in combination with margetuximab, an investigational Fc-engineered, anti-HER2 monoclonal antibody (mAb), in a potentially registration-enabling study of patients with HER2-positive gastric cancer. The Company also plans to initiate a study of retifanlimab in combination with enoblituzumab, an investigational Fc-engineered, anti-B7-H3 mAb, in patients with squamous cell carcinoma of the head and neck (SCCHN).

Under the collaboration agreement with Incyte, MacroGenics has received $65 million in milestones to date and is eligible to receive up to a total of $355 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the molecule.