On January 10, 2021 Cerus Corporation (Nasdaq: CERS) reported preliminary product revenue for the fourth quarter and full-year 2021, provided product revenue guidance for 2022 and provided an update on its INTERCEPT Blood System for Cryoprecipitation offering, which is used to produce INTERCEPT Fibrinogen Complex (Press release, Cerus, JAN 10, 2022, View Source [SID1234598469]).

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Cerus’ unaudited preliminary product revenue for the fourth quarter of 2021 totaled $39.9 million, representing an increase of 41% over the $28.2 million recognized during the fourth quarter of 2020. The Company expects its unaudited preliminary full-year 2021 product revenue to be $130.9 million, exceeding the Company’s most recent 2021 product revenue guidance range of $127-$129 million. The preliminary product revenue results have not been audited and are subject to change.

"Cerus’ commercial momentum during the first three quarters of 2021 carried on during the fourth quarter, continuing the Company’s growth trajectory. Strong uptake of INTERCEPT platelets in the fourth quarter of 2021 was again led by U.S. blood center adoption and growing hospital demand. I am pleased to report yet another record quarter and the corresponding positive impact on patient access to INTERCEPT-treated blood components," stated William "Obi" Greenman, Cerus’ president and chief executive officer. "With the INTERCEPT Blood System for platelets being adopted so rapidly in the U.S. market, I am proud to say that on a run-rate basis, more than half of platelets in the U.S. are now treated with our technology, helping us realize our mission of making pathogen inactivation the standard of care globally. In this age of pandemic preparedness and awareness, we believe 2022 will see a continuation of our positive trajectory and result in another record year for product revenues for the Company."

The Company expects full-year 2022 product revenue will be in the range of $157-$164 million, representing strong growth of approximately 20%-25% compared to preliminary unaudited 2021 full-year product revenue of $130.9 million.

"In addition to the commercial momentum that we expect will continue in 2022, we have several exciting initiatives on tap that we believe will extend our leadership position in transfusion medicine globally," continued Greenman. "We remain committed to balancing these investments in these initiatives in the future with the financial discipline necessary to potentially achieve cash flow breakeven."

Finally, Cerus is beginning the nationwide launch early for INTERCEPT Fibrinogen Complex after one of the Company’s blood center production partners, Gulf Coast Regional Blood Center, received its Biological License Application (BLA) approval from U.S. Food and Drug Administration (FDA).

"As the launch of INTERCEPT Fibrinogen Complex continues in 2022, I am pleased to announce that we have made strides to expand access to this new product across the U.S.," added Greenman. "The receipt of the first BLA approval was sooner than we expected and we are excited about IFC’s potential to drive growth for us over the next several years."

Cerus will provide complete fourth quarter and full-year 2021 financial results and host a call to discuss both 2021 results and 2022 expectations in late February.

On January 10, 2022 Clovis Oncology, Inc. (NASDAQ:CLVS) reported its preliminary, unaudited global product revenues for the fourth quarter and full year ended December 31, 2021 (Press release, Clovis Oncology, JAN 10, 2022, View Source [SID1234598468]). The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures.

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Unaudited preliminary results include:

$35.5M – $36.1M in estimated Rubraca global product revenues for the fourth quarter of 2021 compared to $37.9M for Q3 2021 and $43.3M for Q4 2020
US and Europe product revenues approximately $27.5M – $27.9M and $8.0M – $8.2M
$148.3M – $148.9M in estimated Rubraca product revenues for FY 2021 compared to $164.5M for FY 2020
Approximately $143.4M in cash and cash equivalents and $27.8M in available funding under the ATHENA financing at December 31, 2021
Net cash used in operating activities for the fourth quarter of 2021 approximately $41.1M to $41.7M, down approximately 10 to 11 percent from the prior quarter
Cash used in operating activities does not reflect approximately $9.7M provided to the Company under the ATHENA financing
Clovis plans to discuss these results with investors this week at the 40th Annual J.P. Morgan Healthcare Conference which is being held virtually January 9-13, 2022.

"The ongoing COVID-19 pandemic and the consequent reduction in ovarian cancer diagnoses and treatments continue to impact Rubraca sales in both the US and Europe. Despite these continuing commercial headwinds, we anticipate 2022 will be the most significant year of clinical data readouts in the Company’s history," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "For Rubraca, we anticipate three Phase 3 readouts during the year: ATHENA-MONO as monotherapy in the first-line ovarian cancer maintenance treatment setting during Q1, TRITON3 in the second-line prostate cancer treatment setting for selected patients during Q2, and ATHENA-COMBO in combination with Opdivo in the first-line ovarian cancer maintenance treatment setting in the second half of 2022. In addition, for FAP-2286, we are actively enrolling the Phase 1 portion of LuMIERE and anticipate data presentations at nuclear medicine meetings during 2022. We and our investigators are extremely enthusiastic about this program and look forward to initiating the Phase 2 portion of the LuMIERE study later this year."

Clovis Oncology to Present at 40th Annual J.P. Morgan Healthcare Conference on January 12

Clovis’ President and CEO, Patrick J. Mahaffy, will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12 at 9:45 a.m. ET. A live audio webcast of the presentation/Q&A session, as well as the accompanying slide presentation, can be accessed through the investor relations section of the Company’s website at clovisoncology.com. Approximately 24 hours following the live presentation, a replay of the webcast will be available on the Company’s website for up to 30 days.

Fourth Quarter and Full Year 2021 Financial Results Release Planned for February 23

The Company plans to report financial results for the fourth quarter and full year ended December 31, 2021 on Wednesday, February 23, 2022, before the open of the US financial markets. Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the Company’s results in greater detail.

Additionally, the Company filed today with the Securities and Exchange Commission a Current Report on Form 8-K that provides additional information about the Company’s financial performance, status of clinical trials, liquidity position and impact of COVID-19.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the US for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the US and Europe.

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, and squamous head and neck cancers. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Targeted Radionuclide Therapy

Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.

About the LuMIERE Clinical Study

LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a peptide-targeted radionuclide therapy (PTRT) targeting fibroblast activation protein, or FAP, in patients with advanced solid tumors. The Phase 1 portion of the LuMIERE study -is evaluating the safety of the investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.

On January 10, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported that the Company will today provide an update on its Vision 3×3 and planned 2022 key milestones at the 40th Annual J.P. Morgan Healthcare Conference. Details of the update are outlined below, and CEO Jan Mikkelsen will give a virtual presentation to attendees from 3:00-3:40 p.m. Eastern Time (Press release, Ascendis Pharma, JAN 10, 2022, View Source;3-strategic-roadmap [SID1234598467]).

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"We took major steps in 2021 to becoming a viable, sustainable, and profitable biopharmaceutical company," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "A strong flow of clinical results and our first commercial TransCon product showcased how we are leveraging our technology platform to build a leading global biopharmaceutical company able to successfully meet the needs of patients with differentiated product candidates."

"This year, I am happy to report that our U.S. launch of SKYTROFA (lonapegsomatropin-tcgd), the first U.S. FDA-approved once-weekly treatment for pediatric growth hormone deficiency is off to a strong start," continued Mr. Mikkelsen. "In only two short months since launch, we have already seen 10% of our target prescribers’ writing prescriptions for SKYTROFA instead of daily growth hormone."

"During 2022, we look forward to sharing multiple clinical data readouts across our high-value endocrinology rare disease and oncology portfolios," continued Mr. Mikkelsen. "We believe the clinical readouts will demonstrate our ability to deliver therapies that make a meaningful impact on patients’ lives. In addition, we look forward to announcing a third independent therapeutic area with its own diversified pipeline in the fourth quarter of 2022."

Pipeline Updates

TransCon hGH: TransCon hGH is an investigational once-weekly prodrug designed to deliver somatropin over a one-week period. TransCon hGH is approved by the FDA in the U.S. under the brand name SKYTROFA (lonapegsomatropin-tcgd) for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone.

In mid-October, the Company commercially launched in the U.S. TransCon hGH under the brand name SKYTROFA. Since launch, physician enthusiasm for SKYTROFA is reflected by an increase in prescriptions, submission of formulary exceptions, and repeat prescribers. During the fourth quarter, 369 SKYTROFA prescriptions were written by 139 targeted prescribers, which includes 42% repeat prescribers.1
In November 2021, the Company received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for TransCon hGH for patients with pediatric growth hormone deficiency. The European Commission’s approval of the Marketing Authorisation Application (MAA) is expected by the end of January 2022.
During the second quarter of 2022, the Company plans to submit a protocol to the FDA for TransCon hGH in Turner Syndrome subjects.
Ascendis is targeting completion of enrollment in foresiGHt, a global Phase 3 trial evaluating the safety and efficacy of TransCon hGH in adult patients with growth hormone deficiency during the second quarter of 2022.

TransCon PTH: TransCon PTH is an investigational long-acting prodrug of parathyroid hormone (PTH) in development as a potential once-daily replacement therapy for adult hypoparathyroidism (HP):

During the first quarter of 2022, top-line results are expected from PaTHway, a Phase 3 randomized, double-blind, placebo-controlled clinical trial in North America and Europe, investigating the safety, tolerability, and efficacy of TransCon PTH in adults with HP.
If the Phase 3 PaTHway Trial results are positive, Ascendis plans to submit a New Drug Application (NDA) to the FDA in the third quarter of 2022 followed by a MAA submission to the EMA in the fourth quarter of 2022.
Top-line results from PaTHway Japan, a single-arm Phase 3 trial of TransCon PTH in a minimum of 12-Japanese subjects with HP are expected in the third quarter of 2022.
Initiation of a pediatric HP program is planned for the fourth quarter of 2022.

TransCon CNP: TransCon CNP, an investigational long-acting prodrug of C-type natriuretic peptide (CNP), as a potential therapeutic option for patients with achondroplasia (ACH):

Top-line data from the ACcomplisH Trial, a Phase 2 randomized, double-blind, placebo-controlled clinical trial in North America, Europe, and Oceania in subjects with achondroplasia (age 2–10) are expected in the fourth quarter of 2022.
During the second quarter of 2022, the Company plans to file an Investigational New Drug (IND) application or similar for the ACcomplisH Infants Trial in subjects with achondroplasia (age 0–2).

TransCon TLR7/8 Agonist: TransCon TLR7/8 Agonist is an investigational long-acting prodrug of resiquimod, a small molecule agonist of Toll-like receptors (TLR) 7 and 8 designed to provide sustained activation of intratumoral antigen-presenting cells driving tumor antigen presentation and induction of immune stimulatory cytokines for weeks or months with a single intratumoral injection:

Enrollment continues in transcendIT-101. Top-line data from monotherapy and combo-therapy dose escalation expected in the third quarter of 2022.
TransCon IL-2 β/γ: TransCon IL-2 β/γ is an investigational long-acting prodrug designed to improve cancer immunotherapy by sustained exposure to an IL-2 variant that selectively activates the IL-2Rβ/γ, with minimal binding to IL-2Rα:

Top-line monotherapy data from the IL-βelieγe Trial are expected in the fourth quarter of 2022.
The Company expects to dose the first patient in the combo-therapy and dose escalation arm of the IL-βelieγe Trial in the first quarter of 2022.
TransCon TLR7/8 Agonist and TransCon IL-2 β/γ Combinations:

During the fourth quarter of 2022, the Company plans to submit an IND or similar for Phase 2 cohort expansion for TransCon TLR7/8 Agonist and TransCon IL-2 β/γ.
Presentation at J.P. Morgan Healthcare Conference on Monday, January 10th
The live webcast of the J.P. Morgan presentation will be available on the Investors & News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days. The Company’s slides from the J.P. Morgan presentation also will also be available on the Investor Relations website.

On January 10, 2022 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is biologically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported that provided an overview of the Company’s achievements in 2021 and outlined its objectives for 2022 (Press release, Rubius Therapeutics, JAN 10, 2022, View Source [SID1234598466]). Pablo J. Cagnoni, M.D., president and chief executive officer, will present these updates on Wednesday, January 12, 2022, at 8:15 a.m. EST at the virtual 40th Annual J.P. Morgan Healthcare Conference.

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"In 2021, Rubius Therapeutics demonstrated strong execution in advancing our clinical oncology pipeline and showing preclinical proof of concept of our tolerance induction approach in autoimmunity that could extend well beyond type 1 diabetes to other T cell-mediated diseases," said Pablo J. Cagnoni, M.D., president and chief executive officer, of Rubius Therapeutics. "With the initial clinical results from the Phase 1 clinical trial of RTX-240 in patients with advanced solid tumors reported in March 2021, we provided clinical validation of the RED PLATFORM and increased our likelihood of success across our entire oncology pipeline of Red Cell Therapeutics. With multiple data milestones on the horizon in 2022, we are on the cusp of potentially further validating the RED PLATFORM and benefiting an even greater number of patients."

Anticipated 2022 Catalysts and Operational Objectives

Present additional clinical results from the Phase 1 arm of the RTX-240 Phase 1/2 clinical trial in advanced solid tumors and the Phase 1 arm in relapsed/refractory acute myeloid leukemia (AML) during the first quarter of 2022
Initiate RTX-240 Phase 2 expansion cohorts in select solid tumor types during the first quarter of 2022
Report initial clinical results from the Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers during the second half of 2022
Present initial clinical data from the Phase 1 arm of the RTX-240 clinical trial in combination with pembrolizumab in patients with advanced solid tumors during the second half of 2022
Scale to 200L bioreactors by mid-2022 to support potential pivotal trial and eventual commercialization
2021 Achievements and Operational Updates

RED PLATFORM

Enabling rapid and repeatable parallel generation of therapeutic candidates with the programmable RED PLATFORM
1,000 different therapeutic proteins biologically engineered since platform inception, underscoring the highly versatile and programmable nature of the platform
The platform creates multiple modalities for the treatment of cancer and autoimmune disease and the ability to express hundreds of thousands of copies of therapeutic proteins on or within the cell to access numerous immune pathways
Achieved clinical validation of the RED PLATFORM with initial clinical results from the single-agent RTX-240 Phase 1 clinical trial in advanced solid tumors, reported in March 2021
RCTs are well tolerated, induce the desired biological effect and generate clinical benefit in certain patients with advanced solid tumors
Advancing next generation artificial antigen-presenting cells (aAPCs) with loadable MHC Class I, enabling the presentation of multiple antigens on a single RCT and broadening the potential patient population with a library of HLA types
Oncology

Broad Immune Stimulation

RTX-240

RTX-240 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BB ligand (4-1BBL) and IL-15TP (trans-presentation of IL-15 on IL-15Rα) in their native forms. RTX-240 is designed to broadly stimulate the immune system by activating and expanding both NK and CD8+ memory T cells to generate a potent anti-tumor response.

Established clinical proof of concept of RTX-240 in advanced solid tumors, based on initial results reported in March 2021, potentially increasing the likelihood of clinical success across the oncology pipeline
Escalated the dose of single-agent RTX-240 in the Phase 1 solid tumor clinical trial to three doses of 5e10 cells followed by 1e10 cells until disease progression or unacceptable toxicity, based on no dose-limiting toxicities observed to date, a clear dose response in the increase of NK cells and other pharmacodynamic effects
Additional clinical results are expected from this trial and the Phase 1 arm in relapsed/refractory AML during the first quarter of 2022
The Company plans to initiate RTX-240 Phase 2 expansion cohorts in select solid tumor types during the first quarter of 2022
Continuing dose escalation in the RTX-240 Phase 1 combination study with pembrolizumab in patients with advanced solid tumors with initial clinical data expected during the second half of 2022
RTX-224

RTX-224 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to express hundreds of thousands of copies of 4-1BBL and interleukin-12 (IL-12) on the cell surface. While the lead oncology product candidate, RTX-240, is designed to broadly stimulate the immune system by activating and expanding NK and CD8+ memory T cells, RTX-224 is expected to produce a broad and potent anti-tumor T cell response, an innate immune response and have anti-tumor activity in those tumor types with known sensitivity to T cell killing, including tumor types with high mutational burden, PD-L1 expression and known responsiveness to checkpoint inhibitors.

Expect to begin dosing patients in the Phase 1/2 clinical trial of RTX-224 in selected relapsed/refractory or locally advanced solid tumors during the first quarter of 2022
Select cancers include non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma, urothelial (bladder) carcinoma and triple-negative breast cancer
Presented preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting in November 2021, demonstrating that the mouse surrogate of RTX-224, mRBC-224, generated potent anti-tumor activity in B16F10 melanoma models, intravenously and subcutaneously, that was associated with pharmacodynamic changes in the tumors, including activated CD8 + T cells, NK cells and macrophages
Antigen-Specific Immune Stimulation

RTX-321 Artificial Antigen-Presenting Cell (aAPC) Development Program for Human Papillomavirus (HPV) 16-Positive Cancers

RTX-321 is an allogeneic, off-the-shelf artificial aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex class I proteins, the costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions.

Continuing enrollment in the Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers
Based on no dose limiting toxicities to date, the Company plans to dose escalate beyond the current cohort of 1e10 cells
Plan to report initial clinical results during the second half of 2022
Autoimmune Diseases and Type 1 Diabetes

Red Cell Therapeutics for the treatment of autoimmune disease are biologically engineered to express proteins and peptides inside the cell and are designed to be phagocytized, or ingested, by dendritic cells or macrophages to induce tolerance, retraining the immune system to no longer recognize these self-antigens as foreign.

Demonstrated tolerance induction and bystander suppression in stringent type 1 diabetes preclinical models
Established efficacy in the BDC2.5 adoptive transfer model with data supporting that repeated dosing extended duration of disease protection, reversed established inflammation, which is important for the treatment of existing autoimmunity, and induced two types of regulatory T cells, resulting in protection against re-challenge
Showed efficacy in non-obese diabetes (NOD) preclinical model
Results at 25 weeks exhibit bystander suppression by delivering only two antigens, indicating the mouse surrogate of RTX-T1D prevented or delayed disease caused by many autoantigens
These findings are potentially translatable beyond type 1 diabetes to multiple autoimmune diseases, including other Rubius’ high priority target indications, including multiple sclerosis and celiac disease.
Fully Owned Manufacturing

Increased cells produced per batch by four times in 50L bioreactors from 2020 to 2021, enabling uninterrupted clinical supply for three Phase 1 arms of the RTX-240 clinical trial and Phase 1 RTX-321 trial
Additional accomplishments include:
High success rate: greater than 90% lot success rate for RTX-240 and RTX-321 clinical supply in 2021
Hundreds of doses administered across three arms of RTX-240 Phase 1 and RTX-321 Phase 1 trials
High transduction efficiency: greater than 90% of cells are transduced with therapeutic proteins
Highly consistent protein expression (dual or triple)
Introduced frozen drug substance for RTX-321 and RTX-224, enabling inventory storage of greater than two years
Developing frozen drug product to further simplify supply chain with the goal of making our therapies available around the world
Bringing all product testing in-house to strengthen supply chain and reduce time-to-product release
Continuing to invest in the platform to improve productivity and efficiency
Scaling to 200L bioreactors by mid-2022 to support potential pivotal trial and eventual commercialization
Listen to the Webcast

A live audio webcast of Dr. Cagnoni’s presentation will be available on January 12, 2022, at 8:15 a.m. EST within the Investors & Media section of the Rubius Therapeutics website. An archived replay will be accessible for 30 days following the event.

On January 10, 2022 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported the appointment of Jathin Bandari, M.D., as Chief Medical Officer (Press release, Protara Therapeutics, JAN 10, 2022, View Source [SID1234598465]). Dr. Bandari is a practicing urologic oncologist, recently serving at the University of Rochester where he specialized in both minimally invasive urologic oncology and advanced open pelvic retroperitoneal cancer surgery, and where he maintains a faculty appointment. Dr. Bandari joined Protara in April 2020 as Vice President, Head of Clinical Development, and most recently was Interim Chief Medical Officer.

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"We are thrilled for Dr. Bandari to expand his role with Protara," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "His deep experience working with urologic cancer patients is invaluable as we continue to advance our lead product candidate, TARA-002, for the treatment of non-muscle invasive bladder cancer (NMIBC)."

"Since joining Protara in April 2020, I have been fortunate to work with a talented and innovative team, progressing TARA-002 as a potential therapy for NMIBC, lymphatic malformations, and possibly other cancers," said Dr. Bandari. "I am thrilled to join this exemplary team as Chief Medical Officer and work to advance transformative therapies for people with cancer and rare diseases."

Dr. Bandari received his M.D. from Johns Hopkins University and completed his urology residency at University of Pittsburgh Medical Center. Following residency, he completed a Society of Urologic Oncology fellowship at the University of Pittsburgh Medical Center. He is an active member of the American Urological Association, Society of Urologic Oncology, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and Southwest Oncology Group. He has over 50 publications, national speakerships, textbooks, and grants.