On May 11, 2021 Upsher-Smith Laboratories reported that (Press release, Upsher-Smith Laboratories, MAY 11, 2021, View Source [SID1234580140])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Overall Japan: In February 2020, Sawai Pharmaceutical assembled a Crisis Management team and implemented thorough measures to prevent infection.
US: In March 2020, USL assembled a cross-functional Crisis Response Team to gather and review information and to develop and implement applicable policies and processes. USL transitioned to a remote working model, with the exception of critical workers who needed to remain on-site, and also shifted to a digitally based sales and marketing. Japan: Under the state of emergency declared by the government, due to medical institutions restricting inperson visits by Medical Representatives, the provision of medical information has shifted to delivery by online meetings, etc.

Sales of respiratory organ agents and antibiotics declined due to the decrease in the number of visits patients made to medical institutions. US: Shifted to digitally based sales and marketing due to restriction of in-person physician sales activities. Restriction of sales activities adversely impacted sales, including Tosymra, which was acquired in 2019. Japan: No significant impact on development schedule.

US: Several R&D projects have seen delays due to the shutdowns in US and OUS. Supply Chain Maintained stable supply function by thoroughly implementing infection prevention and control in Japan and the U.S. There has been no disruption in the importation of raw materials or logistics.Sawai’s Response to the Serious GMP Violation in the Japanese Generics Industry

2 Sawai’s internal action related to this matter Sawai’s action toward quality
・Our Quality Assurance Dept. internally disseminates all the product recall information of other companies and also shares Sawai products’ relevant information on the products related to the recall. (As needed.)
・In addition to information sharing, reconfirmed at all the factories a supervision system of accepting, weighing and adding APIs; a training system for factory workers; and a prevention system of mix-ups of APIs. (Implemented in Dec. 2020.
・Provided briefings on these cases to employees at all the factories and instruct to engage in operations strictly following procedures. (Implemented in Jan. 2021.
） To minimize quality-related risks, the following measures are taken;
・Ensure the quality of APIs in compliance with Good Manufacturing Practices (GMP).
・Implement a quality control system through constant confirmation of GMP compliance at manufacturing facilities. ・Adopt manufacturing and quality control measures based on the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S-GMP). Slight increase in net sales and the same level as the previous year in core operating income, despite the severe business environment in both Japan and the US.
 Operating income decreased due to impairment loss on intangible assets in the US.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On May 11, 2021 Acepodia, a biotechnology company developing next generation solid tumor and hematologic cancer cell therapies, reported the appointments of Thorsten Graef, M.D., Ph.D., as chief medical officer and Michael Brock as chief strategy officer (Press release, Acepodia, MAY 11, 2021, View Source [SID1234579658]). These key executive hires add to Acepodia’s growing management team, which comprises a deep bench of leading industry experts. Both Dr. Graef and Mr. Brock will be based at the company’s headquarters in San Mateo, California.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These experienced and accomplished industry executives add to the strategic expansion of our world class leadership team and will play pivotal roles in the company’s development as we continue to pioneer next generation natural killer cell therapies," said Sonny Hsiao, Ph.D., co-founder and chief executive officer of Acepodia. "Dr. Graef’s strong expertise in clinical drug development and knowledge of global regulatory environments will be invaluable as we advance our pipeline of novel antibody cell conjugation investigational therapies, and Mr. Brock’s decades of experience guiding public and private biopharmaceutical companies, financially and operationally, will be an asset to the company as we develop, focus, and execute on overall strategy."

"As Acepodia progresses toward corporate and clinical development milestones this year, we are committed to building a strong infrastructure of top people and key capabilities on which we will continue to grow the business," said Patrick Yang, Ph.D., co-founder and executive chairman of Acepodia.

Thorsten Graef, Chief Medical Officer

Dr. Graef brings to Acepodia more than a decade of experience as a global drug development leader across top-tier public life sciences companies building and overseeing broad clinical development organizations, global multidisciplinary groups and cross-functional teams. Most recently, Dr. Graef served as vice president of Oncology Early Development at AbbVie, Inc., overseeing clinical activities, including the development and regulatory preparations of 20+ clinical assets. In addition, he held a series of senior leadership roles at Pharmacyclics LLC prior to AbbVie, Inc.’s acquisition of the company in May of 2015, and also served as medical director of Merck Research Lab, Oncology at Merck & Co., Inc. Prior to his time in the life sciences industry, Dr. Graef was an attending physician in the hematology, oncology and immunology department at the University Hospital of Düsseldorf in Germany. He received his M.D. in internal medicine and his Ph.D. in molecular medicines from Heinrich-Heine University Medical School in Düsseldorf and completed his postdoctoral research fellowship at the Stanford University School of Medicine. Dr. Graef has published more than 50 original peer-reviewed publications, including in top journals such as NEJM, Lancet, Blood, PNAS and Journal of Experimental Medicine.

Michael Brock, Chief Strategy Officer

Mr. Brock brings to Acepodia more than 20 years of strategic healthcare investment banking experience and leadership, including expertise in industry capital raising, M&A, business development, and strategic analysis. For the past decade, Mr. Brock was a managing director in Wells Fargo Securities’ Healthcare Investment Banking group, where he was responsible for the coverage of public and private biopharmaceutical companies. Prior to that, he was a director in Bank of America Merrill Lynch’s Healthcare Investment Banking group, and he held a series of roles of increasing responsibility and leadership within the department, which followed his time as an associate in Healthcare Investment Banking at SG Cowen Securities Corporation. Mr. Brock received his Bachelors of Science degree from Clemson University and his Masters of Business Administration degree from the Mason School of Business at the College of William & Mary.

Acepodia previously announced the appointment of Jimmy Lai as chief financial officer. Anita Kawatra recently joined the company as an advisor on corporate affairs.

These four individuals join the company’s strong and experienced management team, including Mark Gilbert, M.D., executive vice president of Research & Development, Joe McCracken, D.V.M., senior vice president of Business Development, Bill Mackin, Ph.D., vice president of Regulatory Affairs and Michael Kurman, M.D., vice president of Clinical Operations.

On May 11, 2021 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported an update on recent company developments and reported first quarter financial results for the period ended March 31, 2021 (Press release, Olema Oncology, MAY 11, 2021, View Source [SID1234579673]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The first quarter of 2021 was very productive for Olema as we continued to advance our wholly-owned lead candidate, OP-1250, a complete estrogen receptor (ER) antagonist (CERAN), through dose escalation in the ongoing Phase 1/2 clinical trial in ER+ / HER2- breast cancer, and made substantial progress in building our organization," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Looking ahead, we remain on track to share initial clinical data at a medical meeting later this year and advance OP-1250 into Phase 2 monotherapy expansion. We also plan to initiate a Phase 1b study to evaluate OP-1250 in combination with a CDK4/6 inhibitor in the second half of 2021. We are in a strong financial position to execute on our strategy and are committed to working toward advancing the standard of care for people living with breast cancer."

Recent Corporate Highlights

Presented nonclinical data on OP-1250 in a late-breaking poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held virtually from April 10-15, 2021. Data presented showed that 10 mg/kg OP-1250, a complete estrogen receptor (ER) antagonist (CERAN), was superior to tamoxifen, fulvestrant and ovariectomy in shrinking mutant ESR1-Y537S tumors in an intracranial model of ER+ breast cancer brain metastasis.
Appointed Yi Larson to Olema’s Board of Directors in April 2021. Ms. Larson currently serves as Chief Financial Officer at LianBio and brings significant biotech operational leadership and global healthcare banking expertise.
Strengthened Olema’s research and discovery capabilities with the opening of new laboratory facilities in San Francisco, CA.
Financial Highlights

Cash, cash equivalents and marketable securities as of March 31, 2021 were $327.0 million. Olema anticipates that this balance of cash will be sufficient to fund operations through the end of 2023.
Net loss for the quarter ended March 31, 2021 was $15.3 million, compared to $1.7 million for the same period of the prior year.
Research and development (R&D) expenses were $10.7 million for the quarter ended March 31, 2021, compared to $0.8 million for the same period of the prior year. The increase in R&D expenses was primarily related to the increase in nonclinical development activities, execution of the ongoing Phase 1/2 clinical trial of OP-1250 and higher non-cash stock-based compensation expenses.
General and administrative (G&A) expenses were $4.8 million for the quarter ended March 31, 2021, compared to $0.2 million for the same period of the prior year. The increase in G&A expenses was primarily related to an increase in personnel, public company-related expenses, other corporate costs and higher non-cash stock-based compensation expenses.

On May 11, 2021 Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the first quarter ended March 31, 2021 and provided an update on recent clinical and development pipeline progress (Press release, Prelude Therapeutics, MAY 11, 2021, View Source [SID1234579689]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With several novel, internally discovered therapeutics now advancing in clinical trials, our pipeline products are off to a strong start in 2021 and we expect this momentum to carry us through multiple key inflection points," said Kris Vaddi, PhD, Chief Executive Officer. "We initiated numerous expansion cohorts for PRT543, our novel PRMT5 inhibitor, in the ongoing Phase 1 trial in patients with advanced solid tumors and hematologic malignancies. We expect to present initial clinical data for both PRT543 and PRT811, our brain penetrant PRMT5 inhibitor, in the second half of the year."

Dr. Vaddi added, "We continue to enroll the dose escalation portion of our Phase 1 trial of oral PRT1419, our MCL1 inhibitor, and plan to initiate dose expansion and combination cohorts in the second half of the year. Beyond our clinical pipeline, we remain focused on the advancement of our preclinical programs, and expect to submit an IND application for PRT2527, our CDK9 inhibitor, by year end. We are steadfast in our mission to develop novel therapeutic options for several cancers with high unmet need, and we look forward to providing updates on our continued progress as these programs mature."

Recent Highlights and Upcoming Milestones

PRT543

Enrollment Ongoing in Phase 1 Dose Expansion Cohorts. Patient enrollment is underway in additional solid tumor and hematologic malignancy expansion cohorts of the Company’s Phase 1 trial of PRT543, which is designed to be a potent and selective inhibitor of PRMT5. As previously announced, preliminary data from the dose escalation portion of the trial demonstrated early signs of clinical activity and tolerability. The Company anticipates presenting initial clinical data from the Phase 1 trial at medical meetings in the second half of 2021.

Preclinical Data Featured at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. Three preclinical presentations on PRT543 were featured at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021. A copy of each poster is available in the Publications section of the Prelude Therapeutics website.
PRT811

Phase 1 Dose Expansion Cohorts Remain on Track to Begin in Mid-2021. The dose escalation portion of the Company’s Phase 1 trial of its second clinical product candidate, PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, remains ongoing in patients with advanced solid tumors, including gliomas. As previously reported, the trial has demonstrated early signs of clinical activity and tolerability. Prelude remains on track to establish a recommended expansion dose and commence the dose expansion portion of the trial in mid-2021 in patients with central nervous system cancers, including glioblastoma multiforme (GBM), with initial clinical data expected by the end of 2021.
PRT1419

Oral Formulation: Planned Dose Expansion and Combination Cohorts Expected to be Added to Ongoing Phase 1 Trial in the Second Half of 2021. The dose escalation portion of the Company’s first-in-human Phase 1 study of oral PRT1419 in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, is ongoing. PRT1419, which is the Company’s third clinical candidate, is designed to be an orally available, potent, and selective MCL1 inhibitor. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the second half of 2021.

IND Application Cleared. In March 2021, the Company announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for an intravenous (IV) formulation of PRT1419. A Phase 1 trial of the IV formulation, which leverages the optimized physicochemical properties of PRT1419, is expected to commence in the coming months in patients with solid tumors.

Data on Preclinical Characterization Featured at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. Data on the preclinical characterization of PRT1419 was featured at the AACR (Free AACR Whitepaper) Annual Meeting in April 2021. A copy of the poster is available in the Publications section of the Prelude Therapeutics website.
Discovery Programs

Advancement of Earlier-Stage Candidates Expected in 2021. The Company remains on track to submit an IND application in 2021 for PRT2527, which is designed to be a potent and selective CDK9 inhibitor. Prelude also continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, in 2021.

Preclinical Data on SMARCA2 Protein Degradation Featured at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. A poster presentation on the Company’s SMARCA2 protein degradation program was featured at the AACR (Free AACR Whitepaper) Annual Meeting in April 2021. A copy of the poster is available in the Publications section of the Prelude Therapeutics website.
First Quarter 2021 Financial Results

Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2021 were $363.0 million.

Research and Development (R&D) Expenses: For the first quarter of 2021, R&D expense increased by $7.9 million to $16.5 million. The increase was mainly due to increased clinical research costs for the PRT543 and PRT811 clinical trials and increased costs associated with the initiation of the clinical trial for oral PRT1419, as well as preparation for the anticipated initiation of the Phase 1 trial for IV PRT1419 in the first half of 2021. We also incurred an increase in chemistry, manufacturing, and other costs for those trials.

General and Administrative (G&A) Expenses: For the first quarter of 2021, G&A expense increased by $4.3 million to $5.5 million. The increase was primarily due to an increase in personnel related expense due to increases in employee headcount and an increase in the Company’s professional fees as it expanded operations to support R&D efforts and incurred additional costs to operate as a public company.

Net Loss: For the first quarter of 2021, net loss was $21.3 million, or $0.47 per share, compared with a net loss of $9.5 million, or $5.12 per share, for the same period in 2020.

Financial Guidance: The Company believes that its current cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into 2023.