News
ObsEva Added to the NASDAQ Biotechnology Index
GENEVA, Switzerland – December 20, 2021 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective as of market open on Monday, December 20, 2021.
Antios Therapeutics and Arbutus Biopharma Announce First Patient Dosed in Phase 2a Combination Trial of ATI-2173, AB-729 and Tenofovir Disoproxil Fumarate in Patients with Chronic Hepatitis B Virus Infection
MENDHAM, NJ and WARMINSTER, PA – December 14, 2021 – Antios Therapeutics, Inc. (“Antios”) and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced that the first patient has been dosed in a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a SAVE-1 (Sustained Anti-Viral Efficacy) clinical trial will evaluate a triple combination of Antios’ proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, Arbutus’ proprietary GalNAc delivered RNAi therapeutic, AB-729, and tenofovir disoproxil fumarate (TDF), a nucleotide reverse transcriptase inhibitor.
The multi-center, double-blind, combination clinical trial plans to enroll 40 patients including a cohort of 10 patients with chronic HBV infection assigned 8:2 to active drugs (ATI-2173+AB-729) or matching placebos. The active drugs (ATI-2173+AB-729) or placebos will be administered in combination with 300 mg of tenofovir disoproxil fumarate. ATI-2173 and tenofovir disoproxil fumarate will be administered orally and by injections once daily for 90 days. AB-729 will be administered by subcutaneous injection at Day 28 and Day 90. Following this 90-day treatment period, patients will be followed-up for safety and sustained antiviral responses for six additional months.
Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolix
- FDA Accepts NDA for Linzagolix for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids
- Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange
GENEVA, Switzerland – November 22, 2021 – Obseva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health,today announced that the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted for review by the United States Food and Drug Administration (FDA). The submission is based on data from the two Phase 3 PRIMROSE trials. Linzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones.1,4 The FDA set a target action date of September 13, 2022 for this NDA under the Prescription Drug User Fee Act (PDUFA).
Antios Therapeutics Raises $75 Million in a Series B-1 Funding to Advance Clinical Programs for HBV
- Financing round was co-led by GordonMD Global Investment LP
- Funding will support the Phase 2b clinical program of ATI-2173 in HBV
MENDHAM, NJ – Nov. 3, 2021 – Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced the successful closing of a $75 million Series B-1 financing. The financing round was co-led by GordonMD Global Investments, a firm focused on investments in private and publicly traded global growth and innovative biopharma companies primarily located in the United States, Japan, and Europe.
The proceeds from this financing will be used to advance the clinical development of ATI-2173, Antios’ lead Phase 2b clinical candidate. ATI-2173 is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development and has the potential, if approved, to become the cornerstone of a curative, once-daily HBV therapy. Pre-clinical data to date for ATI-2173, alone or combined with tenofovir disoproxil fumarate (TDF), indicate the potential for sustained HBV DNA suppression off treatment, unique among approved nucleosides and investigational anti-HBV therapies.
Harmony Biosciences to be Added to the S&P SmallCap 600® Index
PLYMOUTH MEETING, PA – Oct. 21, 2021 – Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY)(“Harmony” or the “Company”), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will be added to the S&P SmallCap 600® Index, effective prior to the open of trading on Friday, October 22, 2021.
Poseida Therapeutics Announces Research Collaboration with Takeda for Novel Non-Viral In Vivo Gene Therapies
- Collaboration to leverage Poseida’s non-viral piggyBac® DNA Modification System, Cas-CLOVER™ Site-Specific Gene Editing System, biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms
- Collaboration to initially include up to six liver- and hematopoietic stem cell (HSC)- directed indications with an option to add two additional programs
- In addition to an upfront payment, Poseida is eligible to receive preclinical, development and commercial milestone payments plus tiered royalties into the double digits
SAN DIEGO, CA – Oct. 12, 2021 – Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that it has entered into a research collaboration and exclusive license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) to utilize Poseida’s piggyBac, Cas-CLOVER, biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of up to eight gene therapies. The collaboration will focus on developing non-viral in vivo gene therapy programs, including Poseida’s Hemophilia A program.
Syndax Pharmaceuticals and Incyte Announce Global Collaboration to Develop and Commercialize Axatilimab for Chronic Graft-Versus-Host Disease and Other Fibrotic Diseases
- Syndax to receive $ 152 million in cash ($117 million upfront plus a $35 million equity investment, with potential for $450 million in additional milestone payments; 50:50 profit share in the U.S. and double-digit royalties on ex-U.S. sales –
- The two companies expect to expand development of axatilimab in chronic graft-versus-host disease (cGVHD) with additional monotherapy and combination trials planned in 2022 –
- Syndax to commence Phase 2 proof of concept trial in idiopathic pulmonary fibrosis (IPF) in early 2022 –
- Incyte to lead U.S. and global commercial activities; Syndax retains option to co-promote in the U.S. –
- Syndax to host conference call today at 8:00 a.m. ET; Incyte to host conference call today at 10:00 a.m. ET –
WALTHAM, MA. and WILMINGTON, DE – Sept. 27, 2021 – Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) and Incyte (Nasdaq: INCY) announced today that they have entered into an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab, Syndax’s anti-CSF-1R monoclonal antibody.
“This partnership has the potential to significantly expand and maximize the axatilimab program across multiple lines of treatment in chronic graft-versus-host Disease (cGVHD), as well as additional indications in which the monocyte-macrophage lineage plays a vital role in the fibrotic disease process, such as idiopathic pulmonary fibrosis (IPF),” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “Incyte is a proven leader in the development and commercialization of many important innovative therapies, including a treatment for GVHD. We are thrilled to be working alongside this talented and determined team to combine our expertise as we strive to provide new treatment options for patients in desperate need of effective interventions.”
Garuda Therapeutics Launches with $72 Million Series A Financing
- First off-the-shelf, long-term durable blood stem cell platform has potential to cure more than 70 diseases, eliminate dependency on donor or patient cells
CAMBRIDGE, MA – September 23, 2021 – Garuda Therapeutics, a company creating off-the-shelf, durable blood stem cell therapies, launched today with an oversubscribed $72 million Series A financing led by Aisling Capital, Northpond Ventures and Orbimed, supported by Cormorant Asset Management, Ridgeback Capital Investments, Monashee Investment Management, Sectoral Asset Management, National Resilience, Inc. (Resilience), Mass General Brigham Ventures, among others. Garuda is developing the world’s first, off-the-shelf hematopoietic stem cell platform that will eliminate dependency on donor or patient cells.
Garuda’s platform for generating off-the-shelf, self-renewing blood stem cells is designed to provide patients with rapid and broad access to consistent, durable, HLA-matched transgene-free blood stem cell therapies. Currently, patients seeking a blood stem cell transplant, must find a suitable human donor as a source of blood stem cells. Unfortunately, racial minority and mixed race patients face greater barriers than white patients in finding suitable blood stem cell matches. Like bone marrow transplants, Garuda’s technology has the potential to address, and possibly cure, more than 70 diseases. It also overcomes many limitations of current practices and could potentially offer treatment options to patients irrespective of their racial background.
“Our technology has the potential to transform blood stem cell transplants, revolutionizing the landscape of medicine,” said Dhvanit Shah, Ph.D., Co-Founder, President and CEO of Garuda Therapeutics. “Eliminating the need for donor or patient cells while gaining the ability to exploit stem cell engineering would democratize blood stem cell transplants, ensuring this vital, and often curative, therapy can be made accessible to any bone marrow transplant eligible patient in need. Today, we are thrilled to launch Garuda with the support of our incredible investors and management team, comprised of industry experts in blood stem cell and bone marrow transplants.”
BridgeBio Announces Clinical Collaboration With Bristol Myers Squibb To Study BBP-398, A Potentially Best-In-Class SHP2 Inhibitor, In Combination With OPDIVO® (Nivolumab) In Advanced Solid Tumors With KRAS Mutations
- First clinical combination study set to evaluate safety and preliminary efficacy in non-small cell lung cancer with KRAS mutations
PALO ALTO, CA – July 27, 2021 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced a non-exclusive, co-funded clinical collaboration with Bristol Myers Squibb to evaluate the combination of BBP-398, a potentially best-in-class SHP2 inhibitor, with OPDIVO® (nivolumab) in patients with advanced solid tumors with KRAS mutations with the hope of providing an effective new treatment option for patients with difficult-to-treat cancers.
The collaboration will also include the initiation of a Phase 1/2 study to evaluate the safety and preliminary efficacy of BBP-398 in combination with both OPDIVO as doublet therapy, and OPDIVO plus a KRASG12C inhibitor as triplet therapy in non-small cell lung cancer (NSCLC) with KRAS mutations, as first- and second-line treatment options. Under the terms of the non-exclusive collaboration, BridgeBio will sponsor the study and Bristol Myers Squibb will provide nivolumab. Both BridgeBio and Bristol Myers Squibb will share the cost of clinical development activities for the combination trial.
Wugen Raises $172 Million to Advance Clinical Stage Memory NK Cell Platform, Progress Best-In-Class AML Program, and Initiate Multiple Solid Tumor Trials
- Proceeds to advance clinical development of WU-NK-101 for relapsed/refractory AML, and initiate studies in solid tumor indications.
- Oversubscribed Series B co-led by Abingworth and Tybourne Capital Management, and joined by Fidelity Management & Research Company and Intermediate Capital Group (ICG) as well as existing investors RiverVest Venture Partners, LYZZ Capital, and Lightchain Capital.
- Wugen technology licensed from Washington University in St. Louis.
ST. LOUIS, MO and SAN DIEGO, CA, July 15, 2021 – Wugen, Inc., a clinical stage biotechnology company developing a pipeline of off-the-shelf cell therapies, today announced the completion of an oversubscribed $172 million Series B financing led by Abingworth and Tybourne Capital Management, and joined by new investors Fidelity Management & Research Company, Intermediate Capital Group (ICG), Sands Capital, Aisling Capital Management, Alexandria Venture Investments, Velosity Capital and Falcon Edge Capital. Existing investors, including RiverVest Venture Partners, LYZZ Capital, and Lightchain Capital, also participated. In connection with the financing, Bali Muralidhar, M.D., Ph.D., Managing Partner at Abingworth, Bosun Hau, Managing Director at Tybourne Capital Management, and Peter Kiener, Ph.D., Venture Partner at ICG, will join Wugen’s Board of Directors. The proceeds of the financing will support further clinical development of Wugen’s best-in-class memory natural killer (NK) cell platform and advance ongoing trials for patients with severe acute myelogenous leukemia (AML) and other oncology indications, including solid tumors. Wugen also plans to apply these proceeds to advance its broader pipeline of next-generation products into the clinic, including its allogeneic CD7-targeted CAR-T cell therapy to treat T-cell leukemia and lymphoma.