News

LONDON and RALEIGH, N.C., Aug. 09, 2022 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), today announces its top-line Phase 3 ENHANCE-2 (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) trial results evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). The ENHANCE-2 trial has successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function, and significantly reduced the rate and risk of COPD exacerbations.

Ensifentrine is a first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”) combining bronchodilator and anti-inflammatory activities in one compound.

Highlights

• Study population (n=789):
  • Subject demographics and disease characteristics were well balanced between treatment groups.
  • Approximately 52% of subjects received background COPD therapy, either a long-acting muscarinic antagonist (“LAMA”) or a long-acting beta-agonist (“LABA”). Additionally, approximately 15% of all subjects received inhaled corticosteroids (“ICS”) with concomitant LAMA or LABA.
• Primary endpoint met (FEV₁^* AUC 0-12 hr):
  • Placebo corrected, change from baseline in average FEV₁ area under the curve 0-12 hours post dose at week 12 was 94 mL (p<0.0001) for ensifentrine.
  • Statistically significant and clinically meaningful improvements with ensifentrine demonstrated across all subgroups including gender, age, smoking status, COPD severity, background medication, ICS use, chronic bronchitis, FEV₁ reversibility, and geographic region.
• Secondary endpoints of lung function met:
  • Placebo corrected, increase in peak FEV₁ of 146 mL (p<0.0001) 0-4 hours post dose at week 12.
  • Placebo corrected, increase in morning trough FEV₁ of 49 mL (p=0.0017) at week 12, confirming twice daily dosing regimen.
• Exacerbation rate reduced:
  • Subjects receiving ensifentrine demonstrated a 42% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks compared to those receiving placebo (p=0.0109).
  • Treatment with ensifentrine significantly decreased the risk of a moderate/severe exacerbation as measured by time to first exacerbation when compared with placebo by 42% (p=0.0088).
• COPD symptoms and Quality of Life (“QOL”):
  • Daily symptoms and QOL as measured by E-RS** Total Score and SGRQ** Total Score in the ensifentrine group improved from baseline to greater than the minimal clinically important difference (“MCID”) of -2 units and -4 units, respectively, at week 24. Improvements in these measures were seen as early as 6 weeks and showed continued improvement at 12 and 24 weeks, numerically exceeding placebo at each measurement. Statistical significance was not achieved due to improvements observed in the placebo group over time.
• Favorable safety profile:
  • Ensifentrine was well tolerated with safety results similar to placebo, including occurrence of pneumonia, gastrointestinal and cardiovascular adverse events.

• Leveraging Poseida's novel approach to cell therapy and Roche's expertise in developing and commercializing therapies to transform cancer care, the collaboration is focused on advancing multiple existing and additional next generation allogeneic CAR-T programs directed to hematologic malignancies
• Poseida will receive $110 million upfront, could receive up to $110 million in near-term milestones and other payments, and is eligible for future development and commercial milestones and tiered royalty payments
• Poseida to host a brief conference call today at 8:30 a.m. ET

SAN DIEGO, CA -- August. 3, 2022 -- 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 it has entered into a broad strategic collaboration and license agreement with Roche, focused on developing allogeneic CAR-T therapies directed to hematologic malignancies. The global collaboration covers the research and development of multiple existing and novel "off-the-shelf" cell therapies against targets in multiple myeloma, B-cell lymphomas and other hematologic indications. Under the agreement, Roche will receive from Poseida either exclusive rights or options to develop and commercialize a number of allogeneic CAR-T programs in Poseida's portfolio that are directed to hematologic malignancies, including P-BCMA-ALLO1, an allogeneic CAR-T for the treatment of multiple myeloma and for which a Phase 1 study is underway, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T for the treatment of B-cell malignancies with an IND expected in 2023. Building on complementary expertise and capabilities, the parties will also collaborate in a research program to create and develop next-generation features and improvements for allogeneic CAR-T therapies, from which they would jointly develop additional allogeneic CAR-T product candidates directed to existing and new hematologic targets. For a subset of both the Poseida portfolio programs licensed or optioned to Roche and the parties' future collaboration programs, Poseida will conduct the Phase 1 studies and manufacture clinical materials before transitioning the programs to Roche for further development and commercialization. Roche will be solely responsible for the late-stage clinical development and global commercialization of all products that are subject to the collaboration. Under the agreement, Poseida will receive $110 million upfront and could receive up to $110 million in near-term milestones and other payments in the next several years. In addition, Poseida is eligible to receive research, development, launch, and net sales milestones and other payments potentially up to $6 billion in aggregate value, as well as tiered net sales royalties into the low double digits, across multiple programs.

• Obtains exclusive worldwide rights (outside Greater China) to develop and commercialize EO-3021 (SYSA1801)
• Expands pipeline to now include two clinical stage precision oncology candidates for patients with genomically defined solid tumors, including those with Claudin18.2 overexpression
• Company expects to initiate a Phase 1 clinical trial in the U.S. evaluating EO-3021 (SYSA1801) in 2023
• Management to host an investor conference call and webcast today at 5:00 p.m. ET

NEW YORK, NY -- July 28, 2022 -- Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision oncology products for patients with genomically defined cancers, today announced that it has entered into an exclusive license agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093) to develop and commercialize EO-3021 (SYSA1801), a differentiated, clinical stage antibody drug conjugate (ADC) targeting Claudin18.2, in all global territories outside Greater China (mainland China, Hong Kong, Macau and Taiwan). SYSA1801 is currently being evaluated by CSPC in a Phase 1, dose-escalation clinical trial in China. Elevation Oncology expects to initiate a Phase 1 clinical trial evaluating EO-3021 in the U.S. in 2023. "This licensing transaction represents successful, continued execution of our business development strategy and expands our clinical-stage pipeline," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "We look forward to unlocking the potential of EO-3021 alongside our partner CSPC as we continue to build an industry-leading precision oncology company. EO-3021 is an exciting, differentiated ADC that has significant potential for the treatment of patients with solid tumors that express Claudin18.2, including those with genomically defined cancers. This transaction is a significant milestone for Elevation Oncology which further diversifies our company, expands our commercial potential and allows us to leverage our existing expertise in genomically defined cancers."

• Submitted NDA for rezafungin for candidemia and invasive candidiasis to the U.S. FDA on July 22, 2022, with an anticipated PDUFA target action date in the first quarter of 2023, if accepted for review following application validation
• Melinta acquires exclusive rights to commercialize rezafungin in the U.S.
• Cidara to receive up to $460 million, with an upfront cash payment of $30 million, $60 million in regulatory milestones, and up to $370 million in commercial milestones, plus tiered low double digits to mid-teens royalties on net sales
• Cidara to focus on advancing Cloudbreak DFC platform in oncology and viral infections

SAN DIEGO, CA -- July 27, 2022 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for rezafungin for the treatment of candidemia and invasive candidiasis. The company also announced that it has entered into a license agreement with Melinta Therapeutics under which Cidara has granted Melinta an exclusive license to commercialize rezafungin in the U.S. Rezafungin is a novel, once-weekly echinocandin antifungal being developed for the treatment of candidemia and invasive candidiasis, as well as for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation. Cidara submitted the NDA for rezafungin for candidemia and invasive candidiasis, for which no new therapies have been approved in over a decade, to the FDA on July 22, 2022. The FDA has previously granted Qualified Infectious Disease Product (QIDP) designation to rezafungin for injection which confers priority review of the NDA. Additionally, the treatment indication has orphan designation. Cidara expects to be assigned a Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of 2023, if the NDA is accepted for review following application validation. The NDA submission for rezafungin was based on positive results from Cidara’s global ReSTORE Phase 3 and STRIVE Phase 2 trials. ReSTORE met the primary endpoints for both the FDA and the European Medicines Agency (EMA). Rezafungin dosed once-weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once-daily. Under the terms of the agreement with Melinta, in exchange for granting Melinta exclusive commercialization rights to rezafungin in the U.S., Cidara will receive a $30 million upfront payment, and is eligible to receive $60 million in regulatory milestone payments and up to $370 million in commercial milestone payments, representing a total potential transaction value of $460 million, plus royalties on tiers of annual net sales of rezafungin in the U.S., subject to offset for certain expenses incurred by Melinta. Cidara will be responsible for completing the ongoing global Phase 3 ReSPECT prophylaxis study, CMC and other activities required by the FDA to obtain NDA approval of rezafungin in the treatment and prophylaxis indications in the U.S. Cidara retains the rights to rezafungin in Japan, while Mundipharma retains the commercial rights to rezafungin outside the U.S. and Japan.

- Momentum continues to build for Dren Bio after successfully forming highly experienced senior leadership team and earlier this year announcing research collaboration and license deal with Pfizer  – The financing round was co-led by Aisling Capital and HBM Healthcare Investments with participation from new investors Pfizer, ArrowMark Partners and Revelation Partners, along with all current insiders FOSTER CITY, CA – June 14, 2022 – Dren Bio, Inc. (“Dren Bio” or the “Company”) today announced the completion of their $65 million Series B financing, pushing the Company’s total capital received to date over $156 million. Following the financing, Dren Bio is well-capitalized to reach multiple key inflection points across both its drug discovery programs over the coming years. “We are truly grateful for all the support we continue to receive from such an outstanding syndicate of investors,” said Nenad Tomasevic, Ph.D., Chief Executive Officer of Dren Bio. “This financing comes at the perfect time as we prepare to initiate the first clinical trial evaluating DR-01, our lead asset, in patients with Large Granular Lymphocytic leukemia or cytotoxic lymphomas in mid-2022. In addition to advancing DR-01, the proceeds from this latest round will also enable us to further expand the development of our internal pipeline using our proprietary Targeted Myeloid Engager and Phagocytosis Platform.” The Series B financing was co-led by Aisling Capital and HBM Healthcare Investments, with participation by new marquee investors Pfizer, ArrowMark Partners and Revelation Partners. There was also significant participation in the round by Dren Bio’s existing insiders SR One, 8VC, Taiho Ventures, BVF PartneOKrs, Mission BioCapital and Alexandria Venture Investments, amongst others. In connection with the closing of the financing, the Company announced that Andrew Schiff, M.D., of Aisling Capital, and Chandra P. Leo, M.D., of HBM Partners, will join its Board of Directors. “We were thoroughly impressed by Dren Bio’s diversified R&D portfolio that encompasses two distinct therapeutic antibody programs including their attractive proprietary platform,” said Dr. Schiff, Managing Partner at Aisling Capital. “We are excited by the opportunity to support Dren Bio in progressing on their mission to deliver revolutionary therapies to patients with severe unmet needs, starting with difficult-to-treat cancers.”

-Treatment with encaleret resulted in rapid and sustained restoration of normal mineral homeostasis, with mean values of blood calcium, urinary calcium, and blood PTH within the normal range by day 5 of therapy and sustained at 24 weeks, and was well-tolerated without any reported serious adverse events – At week 24 of encaleret treatment, 92% (12/13) of participants had achieved normal trough blood calcium levels in the absence of extra-dietary calcium supplements and active vitamin D, and 77% (10/13) of participants had normal urinary calcium excretion – The Company completed its end of Phase 2 interaction with the US FDA; the Phase 3 pivotal study is anticipated to begin in 2022 and will evaluate a primary composite endpoint of blood and urinary calcium within target ranges in participants treated with encaleret compared to standard of care – Phase 2b data are featured in an oral presentation at the Endocrine Society (ENDO) 2022 Annual Conference – BridgeBio will host an investor call on June 13, 2022, at 4:30 pm ET to discuss the Phase 2b study results and the planned pivotal Phase 3 study design PALO ALTO, CA – June 13, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced positive Phase 2b data of encaleret in patients with autosomal dominant hypocalcemia type 1 (ADH1). The results are featured in an oral presentation at the Endocrine Society (ENDO) 2022 Annual Conference in Atlanta, GA. BridgeBio will also host an investor call on June 13, 2022, at 4:30 pm ET to discuss the results from the Phase 2b study. “ADH1 is a rare genetic form of hypoparathyroidism associated with lifelong abnormally high urine calcium and low blood calcium levels, sometimes leading to severe consequences such as seizures, heart rhythm abnormalities, muscle cramping, and breathing difficulties,” said Rachel Gafni, M.D., senior research physician and head of the Mineral Homeostasis Studies Group of the National Institute of Dental and Craniofacial Research of the National Institutes of Health (NIH). “Current management with calcium and vitamin D supplements is inadequate and may exacerbate high urine calcium levels, which can cause kidney complications. These 24-week outpatient data, evaluating an investigational calcilytic in a precision-medicine approach, demonstrate that encaleret has the potential to restore normal calcium and phosphate metabolism in individuals with ADH1.”

–Entered into a definitive agreement to sell the rare pediatric disease Priority Review Voucher (PRV) it obtained in February 2021 for $110 million –Secured a two-year extension of interest-only period on its existing senior secured credit facility PALO ALTO, CA – May 13, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that it has entered into a definitive agreement with an undisclosed purchaser to sell its PRV for $110 million. The Company received the voucher in February 2021 under a U.S. Food and Drug Administration (FDA) program intended to encourage the development of treatments for rare pediatric diseases. BridgeBio was awarded the voucher when its affiliate, Origin Biosciences Inc., received approval of NULIBRY™ (fosdenopterin) for injection as the first therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. The sale is subject to customary closing conditions and is expected to occur following the expiration of applicable U.S. antitrust clearance requirements. In connection with the PRV sale, BridgeBio has executed an amendment to its existing senior secured credit facility, extending the interest-only period by two years and principal repayment to November 17, 2026. The Company received consent for the PRV sale from its lenders with all proceeds retained by BridgeBio.  BridgeBio retains access to up to $100 million in delayed debt draws through year end 2022, subject to certain conditions.  The amendment was approved unanimously by existing lenders in the syndicate without adjusting pricing and without imposing financial covenants.

• Atreca Announces Licensing Agreement with Zymeworks
• Atreca Declares EphA2-Targeting ADC (ATRC-301) as Clinical Candidate

SAN CARLOS, CA -- April 05, 2022 -- Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced a licensing agreement with Zymeworks Inc. (Zymeworks) (NYSE: ZYME) to utilize their ZymeLink™ technology to develop novel antibody-drug conjugates (ADCs) and declared ATRC-301, an ADC targeting a novel epitope on EphA2, as the Company’s next clinical candidate. Atreca management will discuss the agreement, ATRC-301, and its earlier stage pipeline programs during today’s R&D Day beginning at 4:15pm EDT.

PALO ALTO, CA – April 3, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced updated data from its ongoing Phase 2 open-label extension (OLE) study of acoramidis (AG10) in patients with symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM). The results were featured in an oral presentation at the American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place in Washington, D.C. on April 2 – 4, 2022.

SAN DIEGO, CA - March 31, 2022 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, today announced that the first cohort of healthy volunteers has been dosed in its Phase 1 trial of CD388, a highly potent long-acting antiviral immunotherapy designed to deliver universal prevention of seasonal and pandemic influenza. The study is being conducted under an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize Cidara’s Cloudbreak drug-Fc conjugates (DFCs) for the prevention and treatment of seasonal and pandemic influenza.