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Takeda to Acquire Maverick Therapeutics to Advance T-Cell Engager Therapies for Solid Tumors and Expand Novel Immuno-Oncology Portfolio

On March 9, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the exercise of its option to acquire Maverick Therapeutics, Inc. a private biopharmaceutical company pioneering conditionally active bispecific T-cell targeted immunotherapies (Press release, Takeda, MAR 9, 2021, View Source [SID1234576342]). Under the agreement, Takeda will obtain Maverick’s T-cell engager COBRA platform and a broad development portfolio, including Maverick’s lead development candidate TAK-186 (MVC-101) currently in a Phase 1/2 study for the treatment of EGFR-expressing solid tumors, and TAK-280 (MVC-280), which is anticipated to enter the clinic in the second half of Takeda’s fiscal year 2021 for the treatment of patients with B7H3-expressing solid tumors. After closing of the transaction, Maverick employees, including its team of talented scientists, will join Takeda’s Research & Development organization.

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"Collaboration is paramount to our R&D strategy and our pursuit of novel approaches to treat cancer," said Chris Arendt, Ph.D., head of the Oncology Therapeutic Area Unit of Takeda. "By supporting pioneers like Maverick working in emerging areas of science, we can share expertise, resources and risk to bring transformational new therapies to patients faster. Maverick’s cutting-edge COBRA platform is an exciting addition to our oncology portfolio that provides a novel conditional bioengineering approach to advance redirected immunotherapies against solid tumors."

Maverick’s COBRA platform is designed to safely target a broad range of solid tumors with highly specific and potent activity while limiting toxicities in normal tissues. Unlike standard T-cell engaging immunotherapies that are systemically active when administered, COBRA-engineered, protein-based therapies are engineered to exploit the tumor microenvironment, triggering T-cell-mediated killing only at the site of the tumor while sparing damage to patients’ healthy tissues. The COBRA platform complements Takeda’s approach to redirecting immune cells to target cancer with the potential to unlock efficacy in solid tumors.

The acquisition follows a multi-year collaboration between Takeda and Maverick signed in 2017 to develop conditionally active T-cell engager therapies, in which Takeda received an equity stake and an exclusive right to purchase Maverick after five years. Based on the success of the lead programs and the promise of the COBRA platform, Takeda exercised its option to acquire Maverick for a pre-negotiated upfront payment as well as potential development and regulatory milestones totaling up to $525 million, subject to certain adjustments, including for Takeda’s current equity stake and Maverick debt. The deal is expected to be finalized in Q1 of Takeda’s fiscal year 2021. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S.

"Takeda’s exercise of their purchase option is a tribute to the Maverick team’s singular focus on improving outcomes for patients with solid tumor cancers," said James Scibetta, CEO of Maverick Therapeutics. "Through the acquisition, patients will benefit from the expansion of resources and experience Takeda brings to accelerate development of our COBRA-derived therapies. Takeda has been an excellent partner since Maverick’s inception, venerating our independence through a period marked by rapid innovation, providing actionable consultation, and providing direct cell line development and manufacturing support through the COVID-19 pandemic to keep us on our aggressive schedule."

Takeda’s Commitment to Oncology

At Takeda Oncology, we aspire to cure cancer, with inspiration from patients and innovation from everywhere. We ensure a tight connection from research to development to commercialization to rapidly meet the needs of the cancer community, optimizing our ability to bring transformative medicines to patients. Our demonstrated leadership in the treatment of hematologic cancers and solid tumors combined with cutting-edge science through multiple platforms, partnerships and therapeutic approaches, enable us to bring novel medicines to patients worldwide. For more information, visit www.takedaoncology.com.

Neurocrine Biosciences to Present at the Oppenheimer 31st Annual Healthcare Conference

On March 9, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the Oppenheimer 31st Annual Healthcare Conference at 4:30 p.m. Eastern Time on Tuesday Mar. 16, 2021 (Press release, Neurocrine Biosciences, MAR 9, 2021, View Source [SID1234576340]). Matt Abernethy, Chief Financial Officer, will present at the conference.

The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

Bavarian Nordic Reports 2021 Financial Guidance

On March 9, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported 2021 financial guidance (Press release, Bavarian Nordic, MAR 9, 2021, View Source [SID1234576339]).

In 2021, Bavarian Nordic expects revenue between DKK 1,900 million and DKK 2,200 million and an EBITDA between DKK 100 million and DKK 250 million. Cash and cash equivalents at year-end are expected to be between DKK 300 million and DKK 500 million, excluding proceeds from offering.

Key assumptions

Revenue:

The low end of the revenue range reflects a scenario where a lockdown due to COVID-19 continues beyond Q1 in key markets like the US and Germany. The higher end of the revenue range reflects a scenario where a gradual reopening will happen in key markets during Q2 and where travel starts picking up again in Q3 and Q4 of 2021.
The smallpox and Ebola business are not expected to be impacted by COVID-19.
Research and development:

Research and development costs of approximately DKK 750 million are expected for 2021. The single largest project in 2021 is the RSV project for which manufacturing of phase 3 material as well as cost for the announced Human Challenge Trial is included. For the COVID-19 program up to approximately DKK 200 million are expected for a phase 2 trial and scale-up of manufacturing in preparation for a phase 3 trial. These costs are being capitalized and hence the research and development costs expensed through the P&L are expected to be approximately DKK 550 million.
Cash position:

Expected payment of approximately DKK 375 million milestones to GSK relating to the tech-transfer process for Rabipur/RabAvert and Encepur.
Working capital changes of approximately DKK 300 million, primarily driven by increased inventory levels of Encepur and Rabipur/RabAvert products.
Investments of approximately DKK 650 million with the vast majority of the investment linked directly to the acquired vaccines Rabipur/RabAvert and Encepur and relates to the upgrade of the bulk facility and capitalized tech-transfer costs.
Draw-down of existing EUR 30 million loan facility with the European Investment Bank.
Investment in COVID-19 program of up to approximately DKK 200 million (capitalized R&D costs)
Investments:

Approximately half of the total investments relates to the new facility. The design of the facility has been revised to achieve a higher degree of flexibility enabling parallel manufacturing of Bavarian Nordic developed products and allowing space for specific Encepur/Rabipur/RabAvert equipment. The re-design has increased the total expected investments related to the plant to approximately DKK 650 million from previously announced DKK 450 million and the re-build is expected to be finalized in 2022.
Capitalization of tech-transfer costs in 2021 is expected to reach approximately DKK 150-200 million.
Beyond 2022, and with current plans, annual investments are expected to decline to a level of DKK 50 – 100 million.
The outlook is based on the following currency exchange rate assumptions: DKK 6.10 per 1 USD and DKK 7.45 per 1 EUR.

Moleculin to Participate in Four Upcoming Healthcare Conferences

On March 9, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that members of management will be presenting at four upcoming healthcare conferences (Press release, Moleculin, MAR 9, 2021, View Source [SID1234576338]).

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

Event:

H.C. Wainwright Global Life Sciences Conference

Format:

Presentation & 1×1 Meetings

Presentation:

Presentation will be available on-demand beginning on Tuesday, March 9, 2021

Location:

Webcast Link

Event:

33rd Annual Virtual ROTH Conference

Format:

Panel, Presentation & 1×1 Meetings

Date:

March 15 – 17, 2021

Presentation:

Presentation will be available on-demand beginning on Monday, March 15, 2021 at 9:00am ET

Location:

Webcast Link

Panel Discussion:

Cancer – Heterogeneous Approaches to a Heterogeneous Etiology

Panel Date:

Monday, March 15, 2021

Panel Time:

10am – 11am ET

Panel Location:

Interested parties may register for the panel here

Event:

Oppenheimer 31st Annual Healthcare Conference

Format:

Presentation & 1×1 Meetings

Date:

Wednesday, March 17, 2021

Time:

8:00am – 8:30am ET

Location:

Webcast Link

Event:

Maxim 2021 Emerging Growth Virtual Conference

Format:

Presentation

Date:

Wednesday, March 17 – 18, 2021

Presentation:

Presentation will be available on-demand beginning on Wednesday, March 17, 2021 at 9:00am ET

Location:

Investors can register for the conference here

Audio webcasts of Moleculin’s presentations will be available on the investor relations section of Moleculin’s website at View Source Replays of the webcasts will be available for 90 days after the date of the presentation.

Allarity Therapeutics Announces Positive Data from Preclinical Study of Dovitinib in Osteosarcoma

On March 9, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported positive data from its preclinical assessment of dovitinib’s antitumor activity in osteosarcoma, the most common primary malignant bone tumor in children and young adults (Press release, Allarity Therapeutics, MAR 9, 2021, View Source,-Email%20Print%20Friendly&text=by%2050%20%25%20as%20compared%20to%20control%20animals. [SID1234576337]). The purpose of the study was to investigate the capacity of dovitinib alone, and in combination with a specific checkpoint inhibition strategy (anti-PD-1), for slowing the progression of experimental pulmonary metastases in animal models of osteosarcoma.

Two separate studies, performed contemporaneously in a syngeneic, mouse model of experimental pulmonary osteosarcoma metastases in mice using the K7M2 cell line, generated the following key results:

Treatment with dovitinib, compared to control treatment (sucrose solution lacking dovitinib), increased the median survival time by 50 %.
Antitumor growth activity was also observed for dovitinib as a single agent in this model.
In addition, it was found that no significant antitumor activity was observed in mice treated with single-agent anti-PD-1 antibody at the investigated dosage and dosing schedule. Furthermore, the combination of dovitinib and anti-PD-1 antibody did not generate additive or synergistic antitumor activities equal or greater than observed by dovitinib alone in the mouse osteosarcoma model.

Allarity is preparing for the submission of a new drug application (NDA) for marketing approval, by the U.S. FDA, for dovitinib as a treatment for renal cell carcinoma (RCC). In support of its NDA filing, and in accordance with FDA requirements, the company is also planning a clinical trial in pediatric patients with osteosarcoma, where the patients will be selected with the DRP companion diagnostic for Dovitinib. The FDA defines pediatric patients as persons aged 21 or younger.

Allarity Therapeutics has chosen osteosarcoma as the pediatric indication in which to evaluate the efficacy and safety of dovitinib on the basis of the reported preclinical study. A positive preclinical assessment, as announced today, is a part of the normal prerequisites for initiating a clinical trial in pediatric patients with osteosarcoma.

Allarity’s CEO, Steve Carchedi, noted "These data further demonstrates that dovitinib is a therapy that has a potential beyond RCC. We look forward to continuing our work towards regulatory approval of dovitinib, and ultimately realize its potential as a personalized cancer treatment by applying our unique DRP technology."

M.D., D.Sc., Marie Foegh, CMO of Allarity Therapeutics, further stated. "We are now ready to move forward towards initiating a pediatric clinical trial for dovitinib after receiving these excellent preclinical results. If we can show that dovitinib is also a potential treatment for patients with osteosarcoma, it will further strengthen the case for bringing this new therapy to the market."

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.