The Daily Biotech Pulse: Moderna Inks 2 R&D Deals, BioNTech To Buy Manufacturing Facility, Dyne Therapeutics IPO

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Sept. 16)

• Arena Pharmaceuticals, Inc. ARNA (the first subject has been dosed in a Phase 3 trial evaluating etrasimod for the potential treatment of moderately to severely active ulcerative colitis)
• Beigene Ltd BGNE
• BioLife Solutions Inc BLFS
• Checkpoint Therapeutics Inc CKPT
• Denali Therapeutics Inc DNLI
• Dr.Reddy's Laboratories Ltd RDY (announced a deal with Russia for 100 million doses of Sputnik-V vaccine against the coronavirus)
• Fortress Biotech FBIO
• Guardant Health Inc GH
• Immunovant Inc IMVT
• Insmed Incorporated INSM
• InVitae Corp NVTA
• Marinus Pharmaceuticals Inc MRNS
• Mersana Therapeutics Inc MRSN
• Mirati Therapeutics Inc MRTX
• Myokardia Inc MYOK
• Nevro Corp NVRO
• Novocure Ltd NVCR
• Pacific Biosciences of California Inc PACB
• Protagonist Therapeutics Inc PTGX
• RedHill Biopharma Ltd RDHL
• Revance Therapeutics Inc RVNC
• SI-Bone Inc SIBN
• Silk Road Medical Inc SILK
• Turning Point Therapeutics Inc TPTX

• Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 16)

• PainReform Ltd PRFX
• Pandion Therapeutics Inc PAND
• SILENCE THERAPE/S ADR SLN

Stocks In Focus

Moderna Announces 2 R&D Collaborations For Up To $880M

Moderna Inc MRNA and Vertex Pharmaceuticals Incorporated VRTX announced a three-year strategic research collaboration and licensing agreement aimed at the discovery and development of lipid nanoparticles and mRNAs for the delivery of gene-editing therapies for cystic fibrosis.

The collaboration will initially focus on the discovery and optimization of novel LNPs and mRNAs that can deliver gene-editing therapies to cells in the lungs, the companies said.

Under the agreement, Moderna will receive $75 million upfront and will be eligible to receive up to $380 million in development, regulatory and commercial milestones, plus tiered royalties on any products that result from the collaboration.

Separately, Moderna announced a collaboration with Chiesi Farmaceutici S.p.A. for developing mRNA therapeutics for the treatment of pulmonary arterial hypertension.

The agreement provides for Moderna receiving $25 million upfront and potentially more than $400 million in development, regulatory and commercial milestones, as well as tiered double-digit royalties on net sales.

Moderna is also holding its R&D day Thursday, where it's giving updates on its coronavirus and CMV vaccine programs and announced plans to enter the seasonal flu business.

In premarket trading Thursday, Moderna shares were adding 2.73% to $70.72.

Genetron Announces Partnership For Cancer R&D Service Offering

Chinese precision oncology company Genetron Holdings Ltd – ADR GTH signed a partnership agreement with dMed Biopharmaceutical, a CDMO, for a "one-stop" new drug R&D service offering and registration services in both China and the U.S. for biopharmaceutical companies.

Genetron shares were adding 4.17% to $12 in after-hours trading.

BioNTech To Buy Novartis' Swiss Manufacturing Facility To Expand COVID-19 Vaccine Production Capacity

BioNTech SE – ADR BNTX, which is developing a coronavirus vaccine with Pfizer Inc. PFE, said it has signed a share purchase agreement with Novartis AG NVS to acquire the latter's GMP certified manufacturing facility in Marburg, Germany.

The manufacturing site will expand BioNTech's COVID-19 vaccine production capacity by up to 750 million doses per year — or over 60 million doses per month — once fully operational. The transaction is expected to close in the fourth quarter of 2020.

BioNTech shares were gaining 1.82% to $67.24 premarket Thursday.

Lilly, Amgen Strike COVID-19 Antibody Treatment Manufacturing Deal

Eli Lilly And Co LLY and Amgen, Inc. AMGN announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly's potential COVID-19 therapies.

In premarket trading, Lilly shares were rising 0.36% to $151.50.

See also: The Week Ahead In Biotech: Decision Day For Bausch Health, IPO Flow Resumes, Oncology Conference

Tiziana To Begin Clinical Testing Of Nasally Administered COVID-19 Treatment

TIZIANA LF SCIE/S ADR TLSA said it has signed an agreement for a collaborative clinical study investigating nasally administered foralumab in COVID-19 patients in Brazil, either alone or in combination with orally administered dexamethasone.

The company said it expects the trial to start over the next few weeks, with data potentially available before the end of 2020.

In premarket trading Thursday, the stock was advancing 5.11% to $3.91. 

Bristol-Myers Squibb, Dr. Reddy's Settle Revlimid Patent Lawsuit

Bristol-Myers Squibb Co BMY and Dr. Reddy's announced a settlement agreement on the multiple myeloma drug Revlimid that allows the latter to sell volume-limited amounts of generic Revlimid in the U.S. beginning on a confidential date after the March 2022 date previously granted to Natco.

Dr. Reddy's can sell Revlimid without volume restrictions beginning on Jan. 31, 2026.

In premarket trading Bristol-Myers Squibb shares were slipping 0.76% to $59, while Dr. Reddy's shares were rising 2.75% to $64.35.

Offerings

NuCana PLC NCNA said it has commenced an underwritten public offering of its ADSs, with each representing one ordinary share of NuCana. All of the ADSs are being offered by NuCana.

The stock was sliding 13.88% to $4.90 in premarket trading Thursday.

Strongbridge Biopharma plc SBBP said that it intends to offer ordinary shares in an underwritten public offering.

In premarket trading Thursday, the stock was plunging 14.29% to $2.40.

On The Radar

Clinical Readouts

Kezar Life Sciences Inc KZR is due to present at the 22nd Pan-American Congress of Rheumatology 2020 with interim data in a scientific poster session from the Phase 1b portion of MISSION, a Phase 1b/2 clinical trial of KZR-616 for the treatment of lupus and lupus nephritis.

ESMO 2020 Conference Presentations

IMMUTEP LTD/S ADR IMMP: initial results from a Phase 2 study of eftilagimod alpha and Keytruda as a second-line treatment for PD-L1 unselected metastatic head and neck cancer patients and non-small cell lung cancer patients; and safety data from stratum D of the Phase 1 trial evaluating the feasibility of IMP321 combined with avelumab in advanced stage solid tumors. 

VBI Vaccines Inc VBIV: additional biomarker data from the ongoing Phase 1/2a study of VBI-1901, its cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma.

Clovis Oncology Inc CLVS: initial presentation of data from the Phase 1b part of the LIO-1 trial of lucitanib in combination with nivolumab in advanced metastatic solid tumors.

Mersana Therapeutics: updated interim data from the ovarian cancer cohort of the ongoing Phase 1 expansion study evaluating XMT-1536.

Cardiff Oncology Inc CRDF: preliminary clinical data from the Phase 1b/2 trial evaluating onvansertib in combination with FOLFIRI and bevacizumab for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer.

IPOs

Waltham, Massachusetts-based Dyne Therapeutics, Inc. priced its upsized initial public offering of 12.253 million shares at $19 versus the estimated price range of $16 and $18, to generate gross proceeds of $233 million.

The shares of the muscle disease company, which is focused on therapeutics for patients with genetically driven diseases, will trade on the Nasdaq under the ticker symbol "DYN."

Related Link: Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates