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Regeneron will secure global rights to Libtayo from Sanofi for $900 million upfront

SOTIO Biotech

12/8/2022 | 3 minuty čtení

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A Sino Biopharm subsidiary’s acquisition of F-star represents will add a pipeline of tetravalent bispecifics and a STING program.

ACQUISITIONS

Sino’s invoX Pharma to acquire bispecifics developer F-Star

 The $161 million cash takeout by invoX Pharma will end the 16-year history of F-star Therapeutics as an independent company. Sino Biopharmaceutical established invoX as a UK-based international subsidiary last year to expand its business outside of China. The deal gives invoX a pipeline that includes three antibodies from F-star’s tetravalent bispecifics platform. The company designs molecules with two natural binding sites and two additional antigen binding sites in the Fc region. The most advanced is FS118, which targets LAG3 and PD-L1, and is in a Phase II proof-of-concept study. Trailing it in Phase 1 are FS120, which binds to OX40 and CD137; and FS222, targeting CD137 and PD-L1. F-star is also advancing next-generation STING agonist SB 11285, which is in Phase I testing. The deal’s price of $7.12 per share represents a 79% premium over F-star’s closing price of $3.98.

PARTNERING

Regeneron will secure global rights to Libtayo from Sanofi

Regeneron will pay Sanofi $900 million up front for full ownership of Libtayo cemiplimab-rwlc. The partners shared the oncology drug’s rights under a 2015 deal; Regeneron markets it in the US, and Sanofi elsewhere, and the partners split global profits equally. Sanofi will now receive an 11% royalty on Libtayo’s sales. The pharma is eligible for a $100 million milestone upon US or EU approval of the candidate in combination with chemotherapy to treat non-small cell lung cancer. Libtayo’s PDUFA date in the indication is Sept. 19; EMA’s decision is likely next half. Sanofi would also be due sales milestones of $65 million and $35 million based on Libtayo’s achievement of $475 million in annual sales during 2022 and 2023, respectively. Although Libtayo is already a first-in-class therapy for two non-melanoma skin cancer indications and is approved as monotherapy for NSCLC in a first-line setting, Regeneron believes much more opportunity lies in combinations, with Libtayo as an immunotherapy backbone. A Libtayo combination with chemotherapy for first-line NSCLC is under FDA and EMA review. Approval would broaden the eligible population for the drug, giving oncologists more flexibility around prescribing the best therapy for each patient. Regeneron sees promise in a Libtayo combination with anti-LAG3 antibody fianlimab. Data presented at last year’s ASCO meeting showed that the combo led to an objective response rate of 67% among 33 patients with advanced melanoma.

Astellas and Sutro enter a strategic collaboration to develop immunostimulatory ADCs

Astellas and Sutro Biopharma announced a strategic partnership to develop immunostimulatory ADCs against three undisclosed targets. Sutro will engage in research and preclinical studies to identify iADCs that Astellas will then develop in the clinic. Sutro will receive $90 million up front and is eligible to receive up to $422.5 million in milestones for each product candidate, as well as tiered royalties ranging from low double-digit to mid-teens on worldwide sales. Sutro has an option to share in the costs and profits for developing and commercializing product candidates in the U.S. iADCs are designed to induce antitumor immunity in addition to having antitumor activity; the partners flagged their potential for “cold” tumors.

BMS and Immatics expanded their collaboration to develop gamma delta T cells

BMS expanded a 2019 autologous T cell therapy partnership with Immatics to include allogeneic ɣδ T cells, a modality that has shown impressive early clinical proof-of-concept data in the past year. The partners will develop two TCR- or CAR-engineered ɣδ T cell programs that will be owned by BMS, and both companies will have an option to develop up to four additional programs based on Immatics’ allogeneic ɣδ T cell platform and complementary technologies from BMS. Immatics will receive $60 million up front, up to $700 million in milestones for each BMS program, and tiered royalties. The new collaboration also adds another TCR target discovered by Immatics to the 2019 deal for an additional $20 million up front, plus milestones and royalties.

Overview of transactions in oncology (values in m$)

Source

Partner

Product

Stage

Rights

Value

UF

MS

Epizyme

Ipsen Group

Acquisition of company with selective inhibitor or EZH2 tazemetostat approved for sarcoma and follicular lymphoma

Market

NV

417

247

170

F-Star Therapeutics

invoX Pharma

Acquisition of company developing bispecific antibodies, with lead FS118 targeting LAG3 and PD-L1

Ph 2

NV

161

161

0

Frame Therapeutics

CureVac

Acquisition of company developing anti-cancer vaccine FRAME-001 based on frame-shift mutations

Ph 2

NV

34

17

17

Turning Point Therapeutics

BMS

Acquisition of company with lead compound repotrectinib, small molecule inhibitor of ALK & ROS1, against NSCLC

Ph 1/2

NV

4 100

4 100

0

Sanofi

Regeneron

Regeneron buys back full rights to anti-PD1 antibody Libtayo cemiplimab approved for multiple cancer indications

Market

Ex-US

1 100

900

200

Repare Therapeutics

Roche

License to small molecule ATR inhibitor camonsertib developed against ovarian cancer

Ph 1

WW

1 325

125

1 200

Immatics

BMS

License to 2 TCR- and CAR-engineered ɣδ T cell programs and option for up to four additional cancer programs

RES

WW

1 460

60

1 400

Sutro Biopharma

Astellas

License to immunostimulatory ADCs against three targets against cold tumors

Res

WW

1 358

90

1 268

GO Therapeutics

Xyphos Biosciences

License to two novel immune-oncology antibody-based cancer therapeutics that specifically target cancer cells

Res

WW

784

21

763

BioInvent International

Exelixis

Option to license up to three cancer programs based on n-CoDeR antibody library and F.I.R.S.T platform

Res

WW

NA

25

NA

NASDAQ Initial Public Offerings (IPOs) in oncology

None

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