On March 31, 2021 Alloy Therapeutics, a biotechnology ecosystem company empowering the global scientific community to make better medicines together, reported the close of a $75 million Series C financing round (Press release, Alloy Therapeutics, MAR 31, 2021, View Source [SID1234583285]). The round was led by 8VC, Presight Capital, and Peter Thiel with participation from new investors including Mubadala Capital, the asset management arm of Mubadala Investment Company, an unnamed sovereign wealth fund, Founders Fund and Gaingels, as well as Alloy’s existing investors Luma Bio-IT, Alexandria Venture Investments, and Ulysses Diversified Holdings.

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"The path to translate an idea into lifesaving medicine is long, challenging, and uncertain. At Alloy we are building an ecosystem of collaboration across the biopharma community to reduce the barriers of translation and make better medicines together," said Errik Anderson, CEO and founder of Alloy Therapeutics. "Alloy is a forever company, allowing us to be generous when others are in need. In joining the Alloy network, those taking the hard path of drug discovery can know that they are not alone. We are in this together."

Through partnership, Alloy Therapeutics democratizes access to tools, technologies, services, and company creation capabilities that are foundational for discovering and developing therapeutic biologics. Since its formation in 2017, Alloy’s community has grown to include over 70 partners of the ATX-Gx platform for human antibody discovery, and the formation of multiple new biotechnology companies, including Broadwing Bio, an ophthalmology company led by Dr. Andrew Peterson and created in partnership with Maze Therapeutics. Proceeds from the Series C financing will extend Alloy’s platforms and services into adjacent biologic modalities and further expand access to Alloy’s capabilities to more partners and geographies around the world.

"Alloy is building a true platform layer in the drug discovery industry," said Alex Kolicich, founding partner of 8VC. "We have seen firsthand how democratizing the product development process has transformed the technology industry through accelerating network effects. We are proud to support Alloy as they apply these lessons to the biopharmaceutical market. Our portfolio companies have benefited greatly from the Alloy ecosystem, and we are impressed with the team’s vision, leadership, and execution."

As part of the Series C financing, Fabian Hansen, founder and Managing Director of US venture capital fund Presight Capital, will join as a member of Alloy Therapeutics’ board of directors. In addition, Alaa Halawa, co-head of Mubadala Capital’s US Ventures business, will join as a board observer.

"Mubadala Capital partners with visionary founders building enduring life science and healthcare companies, supporting them with the global scale and longevity of Mubadala’s permanent and diversified capital base," said Halawa of Mubadala Capital. "We have deep roots in company building, particularly in healthcare. Alloy’s ambitious long-term vision is a natural fit for our partnership. We are excited to work with the Alloy team to support them in advancing the healthcare ecosystem into the new global bioeconomy."

About ATX-Gx

The ATX-Gx platform is the fastest growing in vivo human antibody discovery platform, used by over 70 discovery teams ranging from top biopharma to academic research labs. ATX-Gx is a suite of highly immunocompetent transgenic mice strains that together offer (i) full human heavy chain repertoire, (ii) human kappa and human lambda chain repertoire, (iii) haplotype diversity, and (iv) limited immunodominance. ATX-Gx is available to scientists worldwide at groundbreaking business terms including royalty free access, a simple licensing process (ability to start working with ATX-Gx in as little as two weeks), permission to design KO and bespoke genetic modifications, and expanding access to new platform innovation.

On April 2, 2021 NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that it has changed its corporate name to NKGen Biotech, Inc., which the Company believes best reflects its mission and strategic focus (Press release, NKMax America, APR 2, 2021, View Source [SID1234577554]). The name change is effective immediately.

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"We believe the name NKGen Biotech more accurately represents the direction our company is headed and our commitment to developing the next generation of natural killer cell immunotherapies with the potential to restore immune function in patients with cancer worldwide," said Stephen Chen, NKGen Biotech Chief Operating Officer and Chief Technical Officer.

Mr. Chen further commented, "Our clinical programs remain on track and we plan to report full data from our Phase 1 monotherapy trial of SNK01 in refractory solid tumors in the second quarter of 2021, while advancing our partnered combination programs with Merck KGaA and Affimed throughout the year. We are excited to embark on the next steps in our journey to become the leading player in NK cell therapeutics."

The Company’s lead drug candidate, SNK01, is an investigational autologous NK cell-based therapy which is currently being studied alone and in combination with other approved drugs for the treatment of cancer. NKGen Biotech also plans to file an IND for its allogeneic NK cell platform in 2022.

On April 2, 2021 Geoff Meyerson co-founded Locust Walk, a Boston-based life sciences consulting firm, on Sept. 15, 2008, the same day that Lehman Brothers filed for bankruptcy and Merrill Lynch sold itself to Bank of America (Press release, Locust Walk Partners, APR 2, 2021, View Source [SID1234577553]). Meyerson said he "figured the world didn’t need another investment bank," so he and his team found other ways to support biotech firms: advising on strategy, providing analytics, helping raise capital and preparing them for IPOs.

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Late last year, when the popularity of special-purpose acquisition companies, or SPACs, was exploding, Locust Walk was ready to jump in on the action. The firm filed to raise $130 million for Locust Walk Acquisition Corp., its first SPAC, in the fall. By mid-January, Locust Walk had secured $175 million for the vehicle and gone public on the Nasdaq.

Now, Locust Walk is using the same expertise it has developed over the last 12 years as it seeks a target for the SPAC.

"We basically used our engine that we built at Locust Walk to screen for the right types of companies, identify them, do due diligence and secure a deal," Meyerson said. "We’re kind of eating our own cooking."

Locust Walk is part of a rapidly growing group of companies and investment firms looking to strike gold via SPACs. RA Capital, MPM Capital, General Catalyst, Bain Capital Life Sciences and Omega Funds all launched SPACs of their own within the last year.

Also called blank-check companies, SPACs are formed with the purpose of using the proceeds from their initial public offerings to acquire one or more unspecified businesses, referred to as targets. SPACs have found a sweet spot in the Covid-19 era, offering a seemingly easier route to becoming a public company than a traditional IPO.

‘Not going anywhere’
Meyerson noted that even large, well-funded biotech firms are eyeing SPACs as a means to go public.

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"I think the biggest surprise we’ve had is we thought (those interested in SPACs) might be second-tier companies. We didn’t think some of the biggest companies would want to do that," Meyerson said. "We found that not to be the case. There are a lot of top-tier companies with plenty of investors that are seriously considering SPACs or have already merged with SPACs."

Meyerson declined to share many details about the criteria Locust Walk has outlined for a target for its SPAC. He said his team is looking for a biotech company of some kind, predominantly focused in the U.S., with a "great management team" that has raised adequate funding to support Locust Walk Acquisition Corp.’s $175 million raise. It is that amount of capital, Meyerson thinks, that sets Locust Walk apart from other SPACs in this space. With the exception of General Catalyst and Arch Venture Partners’ recently filed $500 million SPAC, most local biotech-focused SPACs are priced at around $100 million.

Meyerson doesn’t think the SPAC era is likely to be long-lived, however. The market might see a SPAC slowdown soon, or traditional IPOs may make a comeback. "There’s no way this pace can be sustained," he said.

Whatever the case, Locust is "not going anywhere," he said.

"We’re continuing to build and grow the core business. This is just one tool we offer to companies, and now, we can become more full-service, helping companies navigate the SPAC landscape because we’ve been a buyer," Meyerson said. "If the SPAC business continues, we’d like to continue to be a part of it as a SPAC issuer, but fundamentally, our job is to help biotech grow."

On April 2, 2021 IN8bio reported that it has trod an unusual path to an IPO but now has revived its once-dropped attempt (Press release, In8bio, APR 2, 2021, View Source [SID1234577550]).

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The phase 1 New York biotech made its first attempt at an IPO last year for $75 million but dropped its plans in November. Now, five months down the line, it’s trying again for the slightly lower amount of $69 million.

It is hoping to funnel any raised cash into its pipeline of allogeneic gamma-delta T-cell therapies for cancers and its two lead candidates: INB-200, in an early test for newly diagnosed glioblastoma, and INB-100, also in phase 1, for leukemia patients undergoing hematopoietic stem cell transplantation. Top-line data for both are expected late this year and next, respectively.

The biotech’s immuno-oncology programs include activated and gene-modified adoptive cellular therapies that are designed to protect cells from chemotherapy and may also allow for new combinations of drugs to disrupt the tumor microenvironment and increase immunogenicity.

It aims to list on the Nasdaq under the ticker symbol "INAB" and comes after it changed its name last summer from Incysus Therapeutics to IN8bio.

On April 2, 2021 Taiho Oncology, Inc. reported that Phase 2 clinical data, along with preclinical and Phase 1 clinical data for futibatinib (TAS-120) will be presented during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 Week 1, taking place virtually from April 10-15, 2021 (Press release, Taiho, APR 2, 2021, View Source [SID1234577548]). Futibatinib is a covalently-binding FGFR inhibitor being investigated for the potential treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions. Key presentations include:

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Primary results of phase 2 FOENIX-CCA2: the irreversible FGFR1-4 inhibitor futibatinib in intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements: Lipika Goyal, MD, MPhil, Massachusetts General Hospital Cancer Center (Presentation Number CT010). Results will be shared online as an oral plenary presentation from 2:00 – 3:45 PM ET on April 11, 2021.
Acquired resistance to ATP-competitive and irreversible FGFR inhibitors (FGFRi’s): A library-based approach: Hiroshi Sootome, MS, Manager, Translational Research Planning & Management group, Taiho Pharmaceutical Co., Ltd. (1117). Results will be shared online as a poster presentation from 8:30 AM – 11:59 PM ET on April 10, 2021.
Effect of futibatinib on QT/QTc interval: a randomized, controlled, double-blind study: Ikuo Yamamiya, PhD, Associate Director, Bioanalytics & DMPK, Taiho Oncology, Inc. (CT128). Results will be shared online as a poster presentation from 8:30 AM – 11:59 PM ET on April 10, 2021.
Evaluation of potential drug-drug interactions (DDIs) between futibatinib and CYP3A inhibitors/inducers, CYP3A substrates, or proton pump inhibitors (PPIs): Ikuo Yamamiya, PhD, Associate Director, Bioanalytics & DMPK, Taiho Oncology, Inc. (CT125). Results will be shared online as a poster presentation from 8:30 AM – 11:59 PM ET on April 10, 2021.
Please visit Taiho Oncology’s virtual Medical Booth when the exhibit opens on April 10, 2021.

"We are pleased to present these clinical and pre-clinical data for futibatinib in patients with advanced intrahepatic cholangiocarcinoma (iCCA) who have failed at least one line of therapy, including primary results from the Phase 2 FOENIX-CCA2 trial," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "These data add to the body of evidence for futibatinib and support this investigational compound as a potential treatment option for patients with iCCA whose disease has progressed following previous therapies."

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for futibatinib for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions, in February 2021 based on efficacy and safety results from the FOENIX-CCA2 study. The FDA Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma in May 2018.

About Futibatinib (TAS-120)
Futibatinib (TAS-120) is an investigational, oral, potent, selective, and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies. Futibatinib selectively and irreversibly binds to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations.

About Cholangiocarcinoma
Cholangiocarcinoma (CCA), also known as bile duct cancer, is not common. About 8,000 people in the U.S. are diagnosed with CCA each year.1 This includes both intrahepatic (inside the liver) and extrahepatic (outside the liver) cancers. CCA can occur at younger ages, but it is seen mainly in older people. The average age of people in the U.S. diagnosed with cancer of the intrahepatic bile ducts is 70, and for cancer of the extrahepatic bile ducts it is 72.1 The five-year survival rates of intrahepatic CCA (all SEER stages combined) is 9%.2

The main treatment for CCA is surgery. Radiation therapy and chemotherapy may be used if the cancer cannot be entirely removed with surgery and in cases where the edges of the tissues removed at the operation show cancer cells (also called a positive margin). Both stage III and stage IV cancers cannot be completely removed surgically. Currently, standard treatment options are limited to radiation, palliative therapy, liver transplantation, surgery, chemotherapy and interventional radiology.3