News

Sep 27 2021

Syndax Pharmaceuticals and Incyte Announce Global Collaboration to Develop and Commercialize Axatilimab for Chronic Graft-Versus-Host Disease and Other Fibrotic Diseases

Sep 27 2021
  • 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.”

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Sep 23 2021

Garuda Therapeutics Launches with $72 Million Series A Financing

Sep 23 2021
  • 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.”

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Sep 23 2021

Garuda Therapeutics Launches with $72 Million Series A Financing

Sep 23 2021

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.

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Jul 27 2021

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

Jul 27 2021
  • 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.

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Jul 15 2021

Wugen Raises $172 Million to Advance Clinical Stage Memory NK Cell Platform, Progress Best-In-Class AML Program, and Initiate Multiple Solid Tumor Trials

Jul 15 2021
  • 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, 2021Wugen, 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.

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Jun 29 2021

Reneo Pharmaceuticals Added to the Russell 2000® and Russell 3000® Indices

Jun 29 2021

SAN DIEGO, CA – June 29, 2021 – Reneo Pharmaceuticals, Inc. (NASDAQ: RPHM), a clinical stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, joined the broad-market Russell 3000 Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the close of the markets on June 28, 2021.

Membership in the US all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes, which are part of FTSE Russell, a leading global index provider.

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Jun 24 2021

Elevation Oncology Announces Pricing of Initial Public Offering

Jun 24 2021

NEW YORK, NY – June 24, 2021 – Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced the pricing of its initial public offering of 6,250,000 shares of its common stock at a public offering price of $16.00 per share. All of the shares are being offered by Elevation Oncology. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Elevation Oncology, are expected to be $100 million. The shares are expected to begin trading on the Nasdaq Global Select Market on June 25, 2021 under the ticker symbol “ELEV.” The offering is expected to close on June 29, 2021, subject to the satisfaction of customary closing conditions. In addition, Elevation Oncology has granted the underwriters a 30-day option to purchase up to an additional 937,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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Jun 23 2021

Monte Rosa Therapeutics Announces Pricing of Initial Public Offering

Jun 23 2021

Boston, MA – June 23, 2021 – Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing a portfolio of novel small molecule precision medicines that employ the body’s natural mechanisms to selectively degrade therapeutically relevant proteins, today announced the pricing of its initial public offering of 11,700,000 shares of common stock at a public offering price of $19.00 per share. All of the shares are being offered by Monte Rosa. The shares are expected to begin trading on the Nasdaq Global Select Market on June 24, 2021 under the ticker symbol “GLUE.” The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Monte Rosa, are expected to be approximately $222.3 million. The offering is expected to close on June 28, 2021, subject to the satisfaction of customary closing conditions. In addition, Monte Rosa has granted the underwriters a 30-day option to purchase up to an additional 1,755,000 shares of common stock at the initial public offering price.

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Jun 10 2021

Verona Pharma and Nuance Pharma Announce $219 Million Strategic Collaboration to Develop and Commercialize Ensifentrine in Greater China

Jun 10 2021
  • $40 million upfront including $25 million cash and $15 million in equity in Nuance Biotech (parent company)
  • Up to $179 million in potential clinical, regulatory, and commercial milestone payments plus tiered double-digit royalties
  • Nuance Pharma is responsible for all costs related to development and commercialization of ensifentrine in China

LONDON and RALEIGH, N.C. and SHANGHAI, China – June 10, 2021 – Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”) and Nuance Pharma Limited (“Nuance Pharma”), today announce that the companies have entered into an agreement granting Nuance Pharma, a Shanghai-based specialty pharmaceutical company, the rights to develop and commercialize ensifentrine in Greater China (mainland China, Taiwan, Hong Kong and Macau). Ensifentrine is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound. Verona Pharma is currently conducting a global Phase 3 program evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”), with sites in the US, Europe and South Korea.

“We are extremely excited about the formation of this strategic partnership with Nuance Pharma to further the development and future commercialization of ensifentrine in Greater China,” said David Zaccardelli, Pharm. D., President and CEO of Verona Pharma. “Nuance Pharma’s highly talented leadership team has deep experience developing and commercializing respiratory products across China and we look forward to working with them to bring ensifentrine to this important market.”

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Jun 8 2021

Aclaris Therapeutics Announces Positive Preliminary Topline Data from Phase 2a Trial of ATI-1777 for Moderate to Severe Atopic Dermatitis

Jun 8 2021
  • TI-1777 Achieved Statistically Significant Result in the Primary Efficacy Endpoint at Week 4
  • Minimal Systemic Exposure Supports “Soft” Topical JAK Inhibitor Approach
  • ATI-1777 was Generally Well Tolerated
  • Data Support Progression to Phase 2b

WAYNE, PA –  June 08, 2021 – Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive preliminary topline results from its first in human Phase 2a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to evaluate the efficacy, safety, tolerability and pharmacokinetics of ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor, in 50 subjects with moderate to severe atopic dermatitis (AD) (ATI-1777-AD-201). ATI-1777 is the second compound generated from Aclaris’ proprietary KINect® drug discovery platform to demonstrate positive proof of concept in clinical trials.

“We are very pleased that we achieved positive results in this trial of ATI-1777 in subjects with moderate to severe AD with minimal systemic exposure to drug,” said Dr. David Gordon, Chief Medical Officer at Aclaris. “Our approach to treating patients with moderate to severe atopic dermatitis is particularly relevant in light of some of the potential safety concerns with oral therapies.   We look forward to advancing ATI-1777 into the next phase of clinical development.”

In the trial, which consisted of a 4-week treatment period and a 2-week follow-up period during which no treatment was given, 50 subjects with moderate to severe AD were randomized in a 1:1 ratio into one of two arms: ATI-1777 topical solution 2.0% w/w or vehicle applied twice daily. One of the key objectives of this first in human trial was to assess the “soft” aspect of this topical JAK inhibitor compound in subjects with moderate to severe atopic dermatitis. A preliminary analysis of pharmacokinetic plasma samples in the ATI-1777 arm showed greater than 86% of the plasma samples had concentrations below 1 ng/ml and mean drug levels in the ATI-1777 arm (as a group) were not greater than 5% of the IC50 of ATI-1777.

The primary efficacy endpoint of this trial was the percent change from baseline in the modified Eczema Area and Severity Index (mEASI) score at week 4. The mEASI is a modified measure of EASI which excludes evaluation of the body areas that were not treated in the trial (i.e., the head, palms of hands, soles of feet, groin, or genitalia). Only the primary efficacy endpoint was powered to detect a statistically significant outcome.

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