On May 6, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that that it plans to host a conference call on Thursday, May 13, 2021, at 8:30 a.m. ET to discuss its financial results for the quarter ended March 31, 2021 and provide a business update (Press release, Selecta Biosciences, MAY 6, 2021, https://selectabio.gcs-web.com/news-releases/news-release-details/selecta-biosciences-host-conference-call-and-webcast-discuss-4 [SID1234579385]).

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Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10147801. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

On May 6, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported financial results for the first quarter ended March 31, 2021 and provided business updates (Press release, ADC Therapeutics, MAY 6, 2021, View Source [SID1234579403]).

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"We are off to an exciting start to the year with the recent accelerated FDA approval of ZYNLONTA, bringing a new and differentiated treatment option to patients with relapsed or refractory diffuse large B-cell lymphoma," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "ZYNLONTA is approved for a broad population of r/r DLBCL patients, including DLBCL NOS, DLBCL arising from low grade lymphoma and also high-grade B-cell lymphoma. This reflects the real world population of patients enrolled in our LOTIS-2 pivotal trial including transplant eligible and ineligible patients, heavily pre-treated patients and patients with difficult-to-treat disease. In addition, we continue to advance our pipeline of next-generation ADCs for patients with difficult-to-treat hematologic and solid tumor cancers."

"On the occasion of the commercial launch of ZYNLONTA, it has been impressive to see the high quality of talented and experienced commercial and medical affairs professionals at ADC Therapeutics fully prepared for an early FDA approval," said Ron Squarer, Chairman of the Board and an advisor to the Company. "This team is executing on its launch plan and is well equipped to support the treating community in adopting an important new option with a broad label which included tough to treat patients in third-line plus DLBCL."

Recent Highlights

ZYNLONTA (loncastuximab tesirine-lpyl)

FDA accelerated approval and launch: ZYNLONTA was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on April 23, 2021, as a single-agent for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma, a key point of differentiation on the label. ZYNLONTA became commercially available last week and the commercial launch is fully underway.
Added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: As of May 5, 2021, ZYNLONTA was added to the NCCN guidelines with a category 2A recommendation for third-line plus DLBCL, including DLBCL arising from low-grade lymphoma such as follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Ongoing trials progressing:
The Phase 3 LOTIS-5 clinical trial is evaluating ZYNLONTA in combination with rituximab in second-line patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant. This trial will fulfill the post-marketing approval requirement with the FDA for a confirmatory study.
The pivotal Phase 2 LOTIS-3 clinical trial of ZYNLONTA in combination with ibrutinib for relapsed or refractory DLBCL patients is intended to support the submission of a supplemental Biologics License Application (BLA) for ZYNLONTA in combination with ibrutinib.
Additional planned trials in 2021 to potentially expand the ZYNLONTA opportunity:
Pivotal Phase 2 clinical trial in follicular lymphoma (FL).
Clinical trial to evaluate ZYNLONTA in combination with multiple other drugs in B-cell non-Hodgkin lymphoma (NHL).
Dose-finding study of ZYNLONTA in combination with R-CHOP in frontline DLBCL.
Camidanlumab Tesirine (Cami)

Ongoing trials progressing:
The pivotal Phase 2 clinical trial evaluating the efficacy and safety of Cami in patients with relapsed or refractory Hodgkin lymphoma (HL) has completed enrollment and is continuing to follow patients. The Company will present data from this study at an upcoming congress.
The Phase 1b clinical trial of Cami in combination with pembrolizumab in selected advanced solid tumors is an open-label, dose-escalation and dose-expansion trial evaluating the safety, tolerability, pharmacokinetics and antitumor activity of Cami in combination with pembrolizumab, a checkpoint inhibitor.
2021 Expected Milestones

ZYNLONTA

Initiate a pivotal Phase 2 clinical trial of ZYNLONTA in FL in the second quarter of 2021.
Report updated data from the Phase 1 clinical trial of ZYNLONTA in combination with ibrutinib in relapsed or refractory DLBCL in the second quarter of 2021.
Initiate the dose-finding study of ZYNLONTA in first-line DLBCL with R-CHOP in the second half of 2021.
Initiate the clinical trial to evaluate ZYNLONTA in multiple combinations in B-cell non-Hodgkin lymphoma in the second half of 2021.
Complete enrollment in the pivotal Phase 2 trial of ZYNLONTA in combination with ibrutinib in the second half of 2021.
Complete safety lead-in of the Phase 3 LOTIS-5 confirmatory study of ZYNLONTA in combination with rituximab in the second half of 2021.
Cami

Report interim results from the pivotal Phase 2 clinical trial of Cami in HL in the second quarter of 2021.
Earlier-Stage Pipeline

File Investigational New Drug (IND) application for ADCT-901, targeting KAAG1 in the second quarter of 2021.
Initiate a Phase 1b combination study of ADCT-601, targeting AXL, in multiple solid tumors in the first half of 2022.
First Quarter 2021 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $383.1 million as of March 31, 2021, compared to $439.2 million as of December 31, 2020. In the coming days, the Company will be drawing down $50 million associated with its Convertible Credit Facility with Deerfield, which was contingent upon ZYNLONTA approval.

Research and Development (R&D) Expenses

R&D expenses were $39.2 million for the quarter ended March 31, 2021, compared to $35.4 million for the same quarter in 2020. R&D expenses increased due to investments to explore the potential of ZYNLONTA in earlier lines of treatment and histologies and advance the portfolio. As a result of these initiatives, employee headcount and share-based compensation expense increased.

Selling and Marketing (S&M) Expenses

During the first quarter of 2021, S&M expenses were $13.9 million as compared to $2.6 million for the same quarter in 2020. The increase in S&M expenses related to the build-out of the Company’s commercial organization and preparation activities for the anticipated launch of ZYNLONTA in 2021. Prior to December 31, 2020, S&M expenses were reported within General and Administrative ("G&A") expenses within the condensed consolidated interim statement of operations. The period ended March 31, 2020 has been recast to conform to the current year presentation.

G&A Expenses

G&A expenses were $17.6 million for the quarter ended March 31, 2021, compared to $5.9 million for the same quarter in 2020. G&A expenses increased due to higher headcount to support the commercial launch, increased share‐based compensation expense and higher costs of being a public company.

Net Loss and Adjusted Net Loss

Net loss was $51.5 million, or a net loss of $0.67 per basic and diluted share, for the quarter ended March 31, 2021, compared to $43.5 million, or a net loss of $0.85 per basic and diluted share, for the same quarter in 2020. The net loss for the quarter ended March 31, 2021 includes a $21.2 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield. The decrease in fair value was driven by the decrease in the Company’s share price from December 31, 2020. In addition, net loss included share-based compensation expense of $14.0 million for the quarter ended March 31, 2021, compared to $3.8 million for the same quarter in 2020.

Adjusted net loss was $56.8 million, or an adjusted net loss of $0.74 per basic and diluted share, for the quarter ended March 31, 2021, compared to $39.7 million, or an adjusted net loss of $0.78 per basic and diluted share, for the same quarter in 2020. The increase in adjusted net loss was primarily driven by the expansion of the organization, investment in the expanding clinical portfolio and the preparation for the anticipated launch of ZYNLONTA.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2021 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the live call, please dial 888-771-4371 (domestic) or +1 847-585-4405 (international) and provide confirmation number 50158735. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

On May 6, 2021 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported its primary recruitment objective with the recruitment of 440 patients in the global phase III AGENT study (Press release, Isofol Medical, MAY 6, 2021, View Source [SID1234579419]). Today the company announces that it has completed the recruitment of Japanese patients in accordance with the regulatory requirements by the PMDA (the Japanese Medicines Agency) to reach market approval in Japan. As previously communicated, Isofol expects the top line results for the AGENT study to be available during H1 2022.

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Following today’s announcement of the completion of recruitment of Japanese patients, the full patient population, including the entire Japanese cohort, will be included in PMDA’s assessment for a potential market approval in Japan. For a market approval in Japan, the PMDA set a specific requirement for the number of participating Japanese patients of a total of 56 Japanese patients (of which 14 Japanese patients were already included in the primary recruitment of 440 patients) in the AGENT study. The rationale for the specific requirement from PMDA is e.g. that the metabolism of Japanese patients tends to differ from patients in other countries, which is why the effect and potential side effects must be investigated separately.

For the rest of the world, the original 440 patients will be analyzed for efficacy, but the full patient population will be analyzed for safety purposes.

"I am satisfied that we now have completed the recruitment of the Japanese patients, an important step on the way to receive market approval in Japan, the second largest oncology market worldwide. We are now looking forward to continue working with Solasia on the development and registration of arfolitixorin to bring a new treatment option to patients living with mCRC in Japan", said Ulf Jungnelius, M.D, CEO of Isofol.

Solasia Pharma ("Solasia") will fund and supervise clinical development activities in Japan and will be responsible for registrational filing, and following potential regulatory approvals, Solasia will, as the Market Authorization holder, be responsible for the commercialization of arfolitixorin in Japan. Isofol remain the global sponsor of the AGENT study.

"We are very pleased to have completed the recruitment of the target number of patients in Japan in the AGENT study and contributed to the global development of arfolitixorin. I would like to thank all the patients and investigators participating in the study, the CRO in charge of conducting the study, and Isofol, our partner and the sponsor of the AGENT study, for supporting us achieve this important goal. Patient recruitment was completed earlier than expected, and Solasia, together with Isofol, will further proceed development of arfolitixorin for market approval in Japan with the aim of becoming a new treatment option for mCRC patients", said Yoshihiro Arai, President & CEO of Solasia.

Arfolitixorin is evaluated in the AGENT study for the treatment of patients with first-line metastatic colorectal cancer (mCRC). The study is currently being conducted in the U.S., Canada, Europe, Australia and Japan in more than 90 clinics.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on May 6, 2021.

About the AGENT study

The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5- FU, oxaliplatin, and bevacizumab, in first-line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin. The study is ongoing at approximately 90 sites in the U.S., Canada, Europe, Australia and Japan. In December 2020, the last of the AGENT study’s 440 patients was recruited, which is the basis in the statistical analysis plan. Recruitment has since continued in Japan to reach 56 Japanese patients. Isofol is now focusing on completing the ongoing AGENT study where the patients receive first-line standard treatment for metastatic colorectal cancer (mCRC). The company expects that the results of the AGENT study will be available during H1 2022.Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id: NCT03750786.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

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])

On May 6, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended March 31, 2021 (Press release, Bio-Techne, MAY 6, 2021, View Source [SID1234579265]). The quarterly dividend will be payable May 28, 2021 to all common shareholders of record on May 17, 2021. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

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