On May 7, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that its PARP inhibitor pamiparib has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy (Press release, BeiGene, MAY 7, 2021, View Source [SID1234579433]). The new drug application was previously granted priority review by the Center for Drug Evaluation (CDE) in July 2020. BeiGene is preparing to launch pamiparib this month.

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"Today’s NMPA approval makes pamiparib the third BeiGene internally discovered and developed medicine to receive marketing authorization, an incredible company milestone validating our scientific innovations," commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene. "With a broad commercial portfolio of seven medicines covering 15 indications across hematological malignancies and solid tumors in China, our science-based commercial team is well-positioned to serve patients in need. BeiGene will continue working to advance our broad, diverse pipeline and executing on our mission of expanding access to and improving affordability of impactful treatments for patients worldwide."

"We are thrilled that pamiparib is the first PARP inhibitor approved in China for patients with both platinum-sensitive and platinum-resistant relapsed ovarian cancer. Pamiparib was uniquely designed to reduce drug resistance and sustain anti-tumor response, and as reported at last year’s ESMO (Free ESMO Whitepaper), this selective PARP inhibitor demonstrated high response rates and was generally well tolerated among patients," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "We appreciate the patients and investigators who participated in this trial, and hope that pamiparib will become an important treatment option for patients in China with recurrent ovarian cancer. In addition, we are evaluating pamiparib in several other trials and indications, including as a maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer in an ongoing Phase 3 trial."

"Disease recurrence is common among patients with advanced ovarian cancer and, due to the limited efficacy and unacceptable toxicity of chemotherapy, PARP inhibitors have become established treatment options in later lines of therapy. The encouraging pivotal Phase 2 data demonstrated that pamiparib can provide clinically meaningful and durable responses for patients who are sensitive or resistant to platinum-based chemotherapy. We believe that the approval of pamiparib will bring a new hope for these patients and their loved ones," commented Xiaohua Wu, M.D., Ph.D., Professor and Chair of Gynecologic Oncology Department at Fudan University Shanghai Cancer Center and lead investigator for the trial.

The NMPA conditional approval of pamiparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer is based on clinical results from a pivotal Phase 2 portion of the Phase 1/2 trial (NCT03333915). A total of 113 patients in China with high-grade, non-mucinous, epithelial ovarian cancer (including fallopian or primary peritoneal cancer), harboring gBRCA mutations, following at least two prior lines of standard chemotherapy, were enrolled in the pivotal Phase 2 portion of the trial, including 90 patients with advanced platinum-sensitive ovarian cancer (PSOC), and 23 patients with advanced platinum-resistant ovarian cancer (PROC).

Clinical efficacy data in the pamiparib label in China, as assessed by independent review committee (IRC) per RECIST v1.1, were based on 101 patients evaluable for efficacy analysis, including 82 patients with PSOC and 19 patients with PROC. For patients with PSOC, with a median follow-up time of 17.0 months, the objective response rate (ORR) was 68.3% (95% CI: 57.1, 78.1) and the median duration of response (DoR) was 13.8 months (95% CI: 10.97, 20.73); for patients with PROC, the median follow-up time was 11.6 months, the ORR was 31.6% (95% CI: 12.6, 56.6) and the median DoR was 11.1 months (95% CI: 4.21, 16.59).

The safety profile of pamiparib in the label in China was based on 317 patients who received pamiparib as a monotherapy in three clinical trials. The most common adverse reactions (≥10%) were anemia, nausea, leukopenia, neutropenia, vomiting, fatigue, thrombocytopenia, decreased appetite, diarrhea, abdominal pain, aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, blood bilirubin increased, and lymphopenia. Grade ≥3 adverse reactions occurred in 55.8% of patients, with the most common (≥1%) being anemia, neutropenia, leukopenia, thrombocytopenia, lymphopenia, vomiting, fatigue, diarrhea, nausea, and AST increased. Serious adverse reactions occurred in 21.5% of patients, with the most common (≥1%) being anemia and leukopenia.

The most common adverse reactions reported from the pivotal Phase 2 trial in the label in China (≥10%) were anemia, leukopenia, nausea, neutropenia, vomiting, thrombocytopenia, decreased appetite, fatigue, abdominal pain, ALT increased, diarrhea, AST increased, lymphopenia, gamma-glutamyltransferase increased, upper respiratory tract infection, blood bilirubin increased, malaise, weight decreased, and dizziness. Grade ≥3 adverse reactions occurred in 71.7% of patients, with the most common (≥1%) being anemia, neutropenia, leukopenia, thrombocytopenia, lymphopenia, vomiting, diarrhea, gamma-glutamyltransferase increased, hypokalemia, abdominal pain, fatigue, upper respiratory tract infection, pancytopenia, and hypertension.

The recommended dose of pamiparib is 60 mg twice daily (BID) taken orally.

About Ovarian Cancer

Ovarian cancer is the seventh most common cancer among women, accounting for 295,525 cases in 2018.i More than 60 percent of patients are diagnosed with advanced disease and approximately 70 percent will develop recurrent disease due to chemotherapy resistance, resulting in a high mortality rate.ii,iii In China, ovarian cancer is the deadliest gynecologic cancer, responsible for approximately 22,500 deaths every year, and the five-year survival rate among Chinese patients is about 40%.iv,v

About Pamiparib

Pamiparib is an inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib is currently in global clinical development as a monotherapy or in combination with other agents for a variety of solid tumor malignancies. To date, more than 1,200 patients have been enrolled in clinical trials of pamiparib.

In China, pamiparib received conditional approval for treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy in May 2021. Full approval for this indication is contingent upon results from ongoing corroborative trials confirming the clinical benefit of pamiparib in this population.

About the Pamiparib Clinical Program

Clinical trials of pamiparib include:

Phase 3 trial in China of pamiparib as maintenance versus placebo in patients with platinum-sensitive recurrent ovarian cancer (NCT03519230);
Phase 2 trial of pamiparib in patients with metastatic castration-resistant prostate cancer with homologous recombination deficiency (NCT03712930);
Phase 2 trial in China of pamiparib in patients with metastatic HER2-negative breast cancer with BRCA mutation (NCT03575065);
Phase 2 trial of pamiparib in patients with advanced or inoperable gastric cancer (NCT03427814);
Phase 1/2 trial in China of pamiparib in patients with advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer (NCT03333915);
Phase 1b/2 trial of pamiparib in combination with radiation therapy and/or temozolomide in patients with first-line or recurrent/refractory glioblastoma (NCT03150862);
Phase 1b trial of pamiparib in combination with temozolomide in patients with locally advanced or metastatic solid tumors (NCT03150810); and
Phase 1b trial of pamiparib in combination with tislelizumab for a variety of solid tumor malignancies (NCT02660034).
BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines to patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 80 clinical trials involving more than 13,000 patients. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. The Company currently markets two medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets, and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, SeaGen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis Pharma AG granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

On May 7, 2021 AstraZeneca reported that POSEIDON was a Phase III trial of its Imfinzi (durvalumab) plus platinum-based chemotherapy or Imfinzi, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC) (Press release, AstraZeneca, MAY 7, 2021, View Source [SID1234579432]).

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Positive high-level results from the final analysis of POSEIDON showed the combination of Imfinzi, tremelimumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone. This immunotherapy combination also demonstrated a statistically significant improvement in progression-free survival (PFS) versus chemotherapy alone, as previously reported in October 2019. Patients in this arm were treated with a short course of tremelimumab, an anti-CTLA4 antibody, over a 16-week period in addition to Imfinzi and standard chemotherapy.

The Imfinzi plus chemotherapy arm demonstrated a statistically significant improvement in PFS versus chemotherapy in the previous analysis, but the OS trend observed in this analysis did not achieve statistical significance. Patients in the control arm were treated with up to six cycles of chemotherapy, while those in the experimental arms were treated with up to four cycles.

Each combination demonstrated an acceptable safety profile, and no new safety signals were identified. The combination with tremelimumab delivered a broadly similar safety profile to the Imfinzi and chemotherapy combination and did not lead to an increased discontinuation of treatment.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "We are pleased to see the POSEIDON Phase III trial demonstrate, for the first time, a significant and clinically meaningful overall survival benefit for Imfinzi plus tremelimumab with chemotherapy in metastatic non-small cell lung cancer. We were particularly pleased by the safety profile. We’ve seen encouraging uptake of novel combinations in this setting and believe this new approach will add a further option for patients with high unmet medical need. We look forward to discussing next steps with regulatory authorities."

The data will be presented at a forthcoming medical meeting.

Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy and is the global standard of care based on the PACIFIC Phase III trial. Imfinzi is also approved in the US, the EU, Japan and many countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial.

Imfinzi is being further assessed across all stages of lung cancer as part of an extensive Immuno-Oncology programme across NSCLC and SCLC, as well as in other tumour types.

The combination of Imfinzi and tremelimumab is being tested in lung cancer, bladder cancer and liver cancer settings.

Stage IV NSCLC
Lung cancer is the leading cause of cancer death accounting for about one-fifth of all cancer deaths.1 Patients are commonly diagnosed at Stage IV, when the tumour has spread outside of the lung.2

Lung cancer is broadly split into NSCLC and SCLC, with 80-85% classified as NSCLC.2,3 Within NSCLC, patients are classified as squamous, representing 25-30% of patients, or non-squamous, the most common type representing approximately 70-75% of NSCLC patients.2 Stage IV is the most advanced form of lung cancer and is often referred to as metastatic disease.4

POSEIDON
The POSEIDON trial was a randomised, open-label, multi-centre, global, Phase III trial of Imfinzi plus platinum-based chemotherapy or Imfinzi, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of 1,013 patients with metastatic NSCLC. The trial population included patients with either non-squamous or squamous disease and the full range of PD-L1 expression levels. POSEIDON excluded patients with certain epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions.

In the experimental arms, patients were treated with a flat dose of 1,500mg of Imfinzi with up to four cycles of chemotherapy once every three weeks or Imfinzi and 75mg of tremelimumab with chemotherapy, followed by maintenance treatment with Imfinzi, or Imfinzi and one dose of tremelimumab on a once-every-four-weeks dosing schedule. In comparison, the control arm allowed up to six cycles of chemotherapy. Pemetrexed maintenance treatment was allowed in all arms in patients with non-squamous disease if given during the induction phase.

Primary endpoints included PFS and OS for the Imfinzi plus chemotherapy arm. Key secondary endpoints included PFS and OS in the Imfinzi plus tremelimumab and chemotherapy arm. As both PFS endpoints were met for Imfinzi plus chemotherapy and Imfinzi, tremelimumab and chemotherapy, the prespecified statistical analysis plan allowed for independent OS testing for the Imfinzi plus tremelimumab and chemotherapy arm. The trial was conducted in more than 150 centres across 18 countries, including the US, Europe, South America, Asia and South Africa.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to approvals in the curative-intent setting of unresectable, Stage III NSCLC and ES-SCLC, Imfinzi is approved for previously treated patients with advanced bladder cancer in several countries.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer medicines for patients with NSCLC, SCLC, bladder cancer, hepatocellular carcinoma, biliary tract cancer (a form of liver cancer), oesophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer and other solid tumours.

Tremelimumab
Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, SCLC, bladder cancer and liver cancer.

AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines such as the EGFR-TKIs Tagrisso (osimertinib) and Iressa (gefitinib), and the PD-L1 inhibitor Imfinzi (durvalumab); alongside the CTLA-4 inhibitor tremelimumab and the next wave of innovations, including the HER2-directed antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) and the TROP2-directed ADC datopotamab deruxtecan; and a pipeline of new molecules and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer including and beyond treatment.

AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s IO portfolio is anchored in immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a single treatment and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small, targeted molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On May 7, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, reported that its President and Chief Executive Officer, Christopher U. Missling, PhD, will give a presentation titled, "Clinical Trials for Rare Diseases: Challenges and Opportunities", at the Precision in Clinical Trials Virtual Summit (East Coast) on Monday, May 10that 9:35 a.m. EDT (Press release, Anavex Life Sciences, MAY 7, 2021, View Source [SID1234579429]). The Precision in Clinical Trials Virtual Summit (East Coast) takes place May 10th – 11th 2021.

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On May 7, 2021 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the first quarter of 2021 and provided a corporate update (Press release, Aclaris Therapeutics, MAY 7, 2021, View Source [SID1234579427]).

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"We’re very pleased with the progress of our novel immuno-inflammatory drug development pipeline and look forward to reporting data from our Phase 2a trial of ATI-1777 in the second quarter of 2021," said Dr. Neal Walker, President & CEO of Aclaris. "ATI-1777 is our second development program generated by KINect, our proprietary drug discovery platform. After generating proof of mechanism in inhibiting TNFα, IL1β and IL6 in our Phase 2a trial of ATI-450 in moderate to severe rheumatoid arthritis, we are planning to move ATI-450 forward with a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021 and planning to initiate two additional trials of ATI-450 in hidradenitis suppurativa and psoriatic arthritis."

Research and Development Highlights:

The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

ATI-450, an investigational oral small molecule MK2 inhibitor compound:
ATI-450-RA-201: A Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in 19 subjects with moderate to severe rheumatoid arthritis. The trial consisted of a 12-week treatment period and a 4-week follow-up period. Two subjects withdrew from the trial during the treatment period, one in the treatment arm and one in the placebo arm.
Final per-protocol analysis, which consisted of 17 subjects who completed the treatment period (15 in the treatment arm and two in the placebo arm), confirmed that ATI-450 demonstrated durable clinical activity, as defined by a marked and sustained reduction in DAS28-CRP and improvement of ACR20/50/70 responses over 12 weeks.
Overall, ATI-450 was generally well tolerated. There were no treatment-related serious adverse events and all adverse events were mild to moderate. There was one non-treatment-related serious adverse event (COVID-19) reported in the 4-week follow-up period of the trial in a subject who was no longer receiving treatment. The subject withdrew during the 4-week follow-up period of the trial.
Aclaris intends to progress ATI-450 into a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021.
As part of its planned expansion of its Phase 2 immuno-inflammatory clinical development programs, Aclaris also plans to progress ATI-450 into Phase 2 trials in hidradenitis suppurativa and psoriatic arthritis.
ATI-1777, an investigational topical "soft" Janus Kinase (JAK) 1/3 inhibitor compound:
ATI-1777-AD-201: An ongoing Phase 2a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to investigate the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in 50 subjects with moderate to severe atopic dermatitis. The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4.
Enrollment in this trial was completed in March 2021.
Data from this trial are now expected in the second quarter of 2021.
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
Currently being developed as a potential treatment for T-cell mediated diseases such as psoriasis and/or inflammatory bowel disease.
Submission of Investigational New Drug Application is expected in the second half of 2021.
Aclaris is also expanding its Scientific Advisory Board with the addition of Dr. Philip Mease. Dr. Mease, a rheumatologist, currently serves as a Director of the Division of Rheumatology Clinical Research at the Swedish Medical Center/Providence St. Joseph Health and is a Clinical Professor at the University of Washington in Seattle. His major clinical and research focus is psoriatic arthritis and axial spondyloarthritis.

Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2021, Aclaris had aggregate cash, cash equivalents and marketable securities of $142.7 million compared to $54.1 million as of December 31, 2020. The primary factors for the change in cash, cash equivalents and marketable securities during the three months ended March 31, 2021 included:

Net proceeds of $103.3 million from a public offering in January 2021 in which Aclaris sold 6.3 million shares of common stock.

Net cash used in operating activities of $12.2 million resulting from net loss of $28.8 million and changes in operating assets and liabilities of $2.9 million, partially offset by non-cash adjustments of $19.4 million which was primarily related to a $16.4 million charge for the revaluation of contingent consideration.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2021 will be sufficient to fund its operations through the end of 2023, including estimated costs for the Phase 2b trial of ATI-450 for moderate to severe rheumatoid arthritis and the planned expansion of its Phase 2 immuno-inflammatory clinical development programs for hidradenitis suppurativa and psoriatic arthritis, without giving effect to any potential business development transactions or financing activities.

Financial Results

First Quarter 2021

Net loss was $28.8 million for the first quarter of 2021 compared to $15.6 million for the first quarter of 2020.

Total revenue was $1.8 million for the first quarter of 2021 compared to $1.4 million for the first quarter of 2020.

Research and development (R&D) expenses were $7.8 million for the quarter ended March 31, 2021 compared to $7.7 million for the prior year period.
The quarter-over-quarter increase of $0.1 million was primarily the result of continued investment in the further development of Aclaris’ immuno-inflammatory drug development pipeline, including ATI-450, ATI-1777 and ATI-2138, partially offset by a reduction in spend for legacy dermatology assets and personnel costs.
General and administrative (G&A) expenses were $4.8 million for the quarter ended March 31, 2021 compared to $6.2 million for the prior year period.
The quarter-over-quarter decrease of $1.4 million was primarily the result of lower personnel and non-cash stock-based compensation expenses.
Revaluation of contingent consideration charges related to the Confluence acquisition was $16.4 million for the quarter ended March 31, 2021 compared to $1.8 million for the prior year period.
The quarter-over-quarter increase in contingent consideration of $14.7 million primarily resulted from updates to probability of success and estimated future sales level assumptions following the completion of a Phase 2a clinical trial of ATI-450 in subjects with moderate to severe rheumatoid arthritis.

On May 6, 2021 Sporos Bioventures, LLC (the "Company" or "Sporos") reported the company officially launched with the close of a $38.1 million Series A financing. The Company, founded by a group of biotech executives, entrepreneurs, academic scholars, and investors, was formed to catalyze the rapid and accurate development of breakthrough therapies that target novel disease mechanisms in cancer and immune diseases. Harnessing its vast network of industry leaders, strategic resources, and operational expertise, Sporos aims to bring new hope to patients in a more efficient and impactful manner. In parallel to the Series A, Michael Wyzga, M.B.A., former chief financial officer of Genzyme, joins the team as Founding CFO.

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"Sporos was founded to accelerate the development of new medicines by addressing inefficiencies and risk in the establishment of new biotech companies," said Peter Feinberg, Sporos co-founder and member of the board of directors. "By leveraging our extensive network, including the Texas Medical Center, which is the world’s largest research and medical ecosystem, we first identify transformative scientific opportunities and then deploy our top-tier talent, funding and operational support to drive these insights into a growing pipeline of first-in-class treatment options."

Sporos launches with four entities, each founded on the basis of truly novel mechanisms governing cancer and immune disease. The Company plans to use the Series A proceeds to support the development of lead assets across its portfolio and build out the Sporos team.

Sporos’ most advanced company, Tvardi, is developing small molecule inhibitors to STAT3, a key regulatory protein integral to the survival and immune evasion of cancer cells as well as to the pathogenesis of many inflammatory and fibrotic diseases. Early clinical studies have shown that Tvardi’s lead asset in cancer, TTI-101, is well tolerated and has clinical activity across a broad range of tumors including multiple durable responses.

"By strategically deploying valuable resources to young companies that would not typically be supported by top-tier seasoned talent and infrastructure, we believe that we can efficiently bring a diverse set of therapies through clinical development," said Mr. Wyzga. "I am thrilled to join a team with decades of scientific and operational expertise and look forward to guiding our strategic and financial growth."

Sporos’ founding team includes industry veterans with a mix of impressive scientific expertise and operational understanding of the biotech industry, as well as deep roots in Boston, New York and the burgeoning Houston biotech ecosystem. Notable founders include: Sporos’ Chair of the Strategic Advisory Council, a group of medical and scientific advisors, Ronald DePinho, M.D., Ph.D. (hon), professor of Cancer Biology and past president of MD Anderson; Sporos Director Peter Feinberg, co-founder of BridgeBio Pharma, founding partner at Boxcar Partners and advisor and board member of Immuneering Corporation; Chief Scientific Officer Jeno Gyuris, Ph.D., an experienced biotech executive in oncology drug discovery and development; and Sporos Director Alex Cranberg, an entrepreneur and business leader with strong ties to the Texas and Houston biotech ecosystem through his time on the University of Texas Board of Regents.

(Press release, Sporos BioDiscovery, MAY 6, 2021, View Source [SID1234662125])