Grant of Restricted Stock Units and Warrants to Employees in Genmab

On June 22, 2021 Genmab A/S (Nasdaq: GMAB) reported that at a board meeting the board decided to grant 15,241 restricted stock units and 16,335 warrants to employees of the company and three of the company’s subsidiaries (Press release, Genmab, JUN 22, 2021, View Source [SID1234584260]).

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!

Each restricted stock unit is awarded cost-free and provides the owner with a right to receive one share in Genmab A/S of nominally DKK 1. The fair value of each restricted stock unit is equal to the closing market price on the date of grant of one Genmab A/S share, DKK 2,698.

The restricted stock units will vest on the first banking day of the month following a period of three years from the date of grant. Furthermore, the restricted stock units are subject to vesting conditions set out in the restricted stock unit program adopted by the board of directors in accordance with the Remuneration Policy adopted by the shareholders at the annual general meeting. Information concerning Genmab’s restricted stock unit program can be found on www.genmab.com under Investors > Governance > Compensation > Restricted stock units.

The exercise price for each warrant is DKK 2,698. Each warrant is awarded cost-free and entitles the owner to subscribe one share of nominally DKK 1 subject to payment of the exercise price. By application of the Black-Scholes formula, the fair value of each warrant can be calculated as DKK 839.14.

The warrants vest three years after the grant date, and all warrants expire at the seventh anniversary of the grant date. The new warrants have been granted on the terms and conditions set out in the warrant program adopted by the board of directors on February 23, 2021. Information concerning Genmab’s warrant schemes can be found on www.genmab.com under Investors > Governance > Compensation > Warrants.

Photocure: Asieris Announces First Patient Administration in Europe within the Phase III Clinical Trial for APL-1702 (Cevira)

On June 22, 2021 Photocure ASA (OSE:PHO) reported that its partner Asieris Pharmaceuticals (Asieris) has administered the first European patient in its phase III clinical trial for APL-1702 (Cevira) (Press release, PhotoCure, JUN 22, 2021, View Source [SID1234584253]).

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!

Asieris announced dosing of the first patient in Europe in its multinational, multicenter, Phase III clinical trial called APRICITY that started last November. The photodynamic drug-device combination product APL-1702, Cevira, licensed to Asieris by Photocure, is being developed for a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL).

"The multinational phase III clinical trial for Cevira is an important milestone towards a non-surgical treatment of high-grade cervical dysplasia. This step shows once more that our partner Asieris is making great progress and is on track with their clinical program and development of this innovative photodynamic drug-device combination," says Daniel Schneider, Chief Executive Officer of Photocure.

In China, the clinical trial application for APL-1702, Cevira multinational Phase III trial was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2020. Photocure reported Asieris’ dosing of the first patient in China on November 11, 2020 (View Source).

HSIL is a pre-cancerous condition caused by a persistent HPV infection. Each year there are approximately 10 million cases of high-grade disease and over 500,000 new cases of cervical cancer worldwide. In China, approximately 2% of women develop HSIL each year.

PerkinElmer Agrees to Acquire Viral Vector Gene Delivery Leader SIRION Biotech

On June 22, 2021 PerkinElmer, Inc. (NYSE: PKI) ("PerkinElmer") reported it has entered into an agreement to acquire SIRION Biotech GmbH, a leading, global provider of viral vector-based technologies that drive improved delivery performance for cell and gene therapies (Press release, PerkinElmer, JUN 22, 2021, View Source [SID1234584258]). The acquisition is expected to close during the third quarter of 2021.

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!

Headquartered in Munich, Germany, privately held SIRION has approximately 50 employees based in Germany, the U.S. and France. The company has established a strong licensing portfolio leveraged by over a dozen major pharmaceutical and biotech players researching more than twenty five diseases and conditions.

The addition of SIRION’s offerings will complement PerkinElmer’s Horizon Discovery portfolio which includes gene editing and modulation tools for CRISPR, CRISPRi and RNAi, custom cell lines for bio production and base editing technologies. Moreover, the acquisition will further broaden PerkinElmer’s existing cell and gene research solutions featuring industry-leading high content, in vivo, and cell painting screening technologies; innovative immunoassays; cell plate readers; and advanced automation, microfluidics and informatics and analytical platforms.

Commenting on the agreement to acquire the company, Prahlad Singh, president and chief executive officer of PerkinElmer, said, "Seventy percent of gene therapy trials today leverage viral vector approaches and we expect this to remain strong going forward given the demand for targeted, high-payload delivery in treating diseases like cancer. By combining SIRION’s innovative "payload" transport technology with our existing Horizon genetic material editing tools and phenotypic research solutions, we will be able to support organizations’ cell and gene therapy workflows as they look to streamline and accelerate their efforts."

Dr. Christian Thirion, CEO of SIRION, added, "Our team is excited to work with PerkinElmer to continue to grow our leading position in viral vector technologies for cell and gene therapy. We will benefit greatly from becoming part of the PerkinElmer portfolio, with increased access to genomics analysis, gene editing and base editing technologies, as well as a strong global infrastructure and reach."

To learn more about PerkinElmer’s full range of life sciences solutions, Informatics and OneSource services please visit: View Source

SAB Biotherapeutics to List on Nasdaq through Merger with Big Cypress Acquisition Corp., Advancing Unique Human Antibody Platform with Demonstrated Utility in Immunotherapy and Rapid Response to Emerging Diseases

On June 22, 2021 SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces targeted, high potency, fully-human polyclonal antibodies at scale, and Big Cypress Acquisition Corp. (NASDAQ: BCYP), a blank check company focused on innovative biopharmaceutical firms, reported that they have entered into a definitive business combination agreement (Press release, SAB Biotherapeutics, JUN 22, 2021, View Source [SID1234584257]). Upon closing of the proposed transaction, the combined company will operate as SAB Biotherapeutics and will continue to operate under the SAB management team, with Big Cypress Acquisition Corp.’s Samuel J. Reich and Jeffrey G. Spragens joining the SAB Board of Directors. SAB co-founder and current executive chairman, Dr. Edward Hamilton, plans to transition to a board observer role while remaining active in the company. Mr. Reich is expected to assume the role of executive chairman.

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!

SAB plans to be listed on NASDAQ following the closing of the transaction. The proposed transaction implies an enterprise value for SAB, on a post-merger basis, of approximately $325 million (assuming a share price of $10.10 per share) and is expected to provide the combined company with approximately $118 million of pro forma cash (assuming no redemptions from Big Cypress’ trust account), to fuel development and commercialization of SAB’s unique DiversitAb platform that leverages its proprietary transchromosomic (Tc) bovine herds to produce highly-potent targeted fully-human polyclonal antibody therapeutics for a wide range of immune system disorders, cancer and infectious diseases without the need for human donors.

Proceeds from the business combination are expected to support advancement of SAB’s robust pipeline and platform through multiple catalysts across several programs. These potentially include multiple clinical data read-outs, which represent potential value inflection events.

"The execution of this merger agreement caps 18 months of tremendous progress at SAB," said Eddie Sullivan, PhD, co-founder and chief executive officer of SAB Biotherapeutics. "Years of innovation and investment in our unique human polyclonal antibody platform have enabled us to rapidly respond to the COVID-19 pandemic, moving a therapeutic candidate from concept to the clinic in less than five months. The awarded funding and our collaboration with the federal government, as part of COVID-19 Response (formerly Operation Warp Speed), has enabled us to test, refine and advance our novel therapeutic development and internal production and regulatory processes, as well as provide a model for future rapid response. This period of intense activity leaves us well-positioned to advance our portfolio of novel therapies for immune system disorders, cancer and other infectious diseases. The unique attributes of our DiversitAb platform power our diversified strategy that includes rapid response, development of our own novel therapeutics, and a variety of pharma collaborations. We are excited at the expanded opportunities afforded by the merger to put our platform to work generating important new therapies for unmet medical needs."

"At Big Cypress we screened more than 60 biotech companies in our search for the perfect merger partner," noted Sam Reich, chief executive officer of Big Cypress Acquisition Corp. "We were thrilled when we found SAB Biotherapeutics, a distinctive and exciting approach to marrying the power of nature with advanced genomic technology. SAB met or exceeded our criteria, demonstrating de-risked early development processes, clinical proof-of-concept, therapeutic targets with large unmet needs and what we expect to be manageable Phase 3 trials, high-value indications, and the ability to efficiently put additional capital to work advancing a high potential pipeline. We like that SAB’s innovative technology and management team are unconventional by biotech standards, with their novel DiversitAb platform leveraging Tc bovine herds that rapidly produce fully-human polyclonal antibodies with almost unlimited therapeutic potential, as well as their location in our nation’s heartland. We look forward to working with the exceptional SAB team to advance this important technology."

SAB Biotherapeutics Overview

SAB Biotherapeutics is a clinical-stage biopharmaceutical company advancing a new class of immunotherapies based on its human polyclonal antibodies. Applying advanced genetic engineering and antibody science, SAB develops fully-human antibodies produced from transchromosomic (Tc) bovine herds targeted at addressing specific diseases, including infectious diseases such as COVID-19 and influenza, immune system disorders including type 1 diabetes and organ transplantation, and cancer. SAB’s versatile and scalable DiversitAb platform is applicable to a wide range of serious human diseases. It rapidly produces natural, specifically targeted, high-potency, human polyclonal immunotherapies at commercial scale. The platform has been developed and validated through funding awarded from US government emerging disease and rapid response programs. SAB is currently advancing multiple clinical programs in a number of indications, in addition to its collaborations with global pharmaceutical and other partners.

Summary of the Transaction

Upon the closing of the business combination, and assuming a share price of $10.10 per share and no redemptions of shares of Big Cypress by its public stockholders, SAB would be expected to have an enterprise value of approximately $325 million and cash resources of approximately $118 million, including the contribution of up to $116 million from cash held in Big Cypress’ trust account (less any redemptions). Pro forma for the business combination, legacy shareholders of SAB will own approximately 68% of the post-merger public company, excluding any contingent consideration and before giving effect to any potential exercise of Big Cypress’ common stock purchase warrants into shares of common stock following the closing. There is no minimum cash closing condition for the transaction.

The transaction has been unanimously approved by both Big Cypress’ and SAB’s respective Boards of Directors. The proposed transaction is subject to the approval of Big Cypress and SAB stockholders and the satisfaction or waiver of other customary conditions, including a registration statement being declared effective by the U.S. Securities and Exchange Commission (the "SEC"), and is expected to close in the fourth quarter of 2021.

Additional information about the proposed transaction, including a copy of the merger agreement and an investor presentation, will be provided in a Current Report on Form 8-K to be filed by Big Cypress with the SEC, which will be available at www.sec.gov.

Advisors

Lazard is serving as exclusive financial advisor to SAB and Stradling Yocca Carlson & Rauth is serving as legal counsel. Chardan is serving as exclusive M&A advisor and financial advisor to Big Cypress and Dentons US LLP is serving as legal counsel. Ladenburg Thalmann & Co. Inc. acted as sole book-running manager and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-manager of Big Cypress $115 million IPO in January 2021 and Ladenburg Thalmann & Co. Inc. is acting as a capital markets advisor to Big Cypress.

Conference Call and Webcast Details

SAB and Big Cypress Acquisition Corp. will host a conference call and live audio webcast to discuss the proposed transaction today at 8:00 a.m. ET. To access the live conference call, please dial (833) 882-5274 (domestic) or (409) 937-8892 (international) at least five minutes prior to the start time and refer to conference ID 1865196.

A live audio webcast of the call can be accessed here and an archive will be available approximately two hours after the event.

Nordic Nanovector Announces Initial Results from LYMRIT 37-05 Phase 1 Trial of Betalutin® in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

On June 22, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that encouraging initial results from the LYMRIT 37-05 Phase 1 trial investigating Betalutin (177Lu lilotomab satetraxetan) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) not eligible for stem cell transplantation (Press release, Nordic Nanovector, JUN 22, 2021, View Source [SID1234584254]).

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 initial results from the completed Phase I study (n=16 treated with Betalutin) show that Betalutin was well tolerated, with a good safety profile consistent with all previous studies with Betalutin. As reported previously, a single, reversible dose-limiting toxicity (DLT) was seen in the last cohort investigating the highest dosing regimen (20 MBq/kg Betalutin and 100 mg/m2 lilotomab), which on review by the Independent Review Committee (IRC) resulted in three additional patients being enrolled. No further DLTs were seen. Clinical activity of Betalutin was seen in 6 evaluable patients receiving the highest dosing regimen including one complete response and one partial response.The IRC commented that the safety and anti-tumour activity of the highest dosing regimen could be considered for investigation in combination with other therapies used in R/R DLBCL which the Company is now evaluating, with an emphasis on combination partners that would not compromise the current safety profile of Betalutin.

Peter Braun, Nordic Nanovector CEO, commented: "We continue to be very encouraged by the overall safety profile that Betalutin exhibits in even the most fragile and highly pre-treated NHL patients. We have also seen clinical activity in DLBCL patients from a single administration of Betalutin and we will now consider the next steps for its development in this large patient population potentially in combination with other therapies, as part of our overall strategy to develop Betalutin for difficult to treat haematological tumours. Our near-term focus remains very much on completing PARADIGME in 3rd-line follicular lymphoma and delivering top line 3-month data by the end of 2021."

About LYMRIT 37-05

The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study designed to assess the safety and preliminary anti-tumour activity of a single administration of Betalutin. Patients were enrolled at clinical trial sites in the US and Europe. More information on this study can be found at www.clinicaltrials.gov (NCT02658968).

The starting doses of Betalutin and lilotomab were 10MBq/kg and 60mg (Cohort 1, n=3), respectively, and then Betalutin 10MBq/kg and lilotomab 100mg (Cohort 2, n=3 treated with Betalutin). Cohort 3 received 15MBq/kg and lilotomab 100mg (n=3) and Cohort 4 received 20MBq/kg and lilotomab 100mg (n=7 treated, 6 evaluable).

About DLBCL

DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for up to 43% of all NHL cases, making it the most common form of the disease. Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by Stem Cell Transplantation (ref. 1). There are currently very few therapeutic options for patients not eligible for SCT, which makes relapsed DLBCL a serious unmet medical need. The number of diagnosed incident cases of DLBCL in the 7 major markets (U.S., and key 5 European markets and Japan) was 64,172 in 2018 and is expected to be 74,927 in 2028 (ref. 2). The value of the 3L DLBCL market segment in the key 7 pharma markets is expected to increase from USD 0.6B in 2019 to USD 1.3B in 2028, the value of the 2L DLBCL market segment is expected to increase from USD 0.4B in 2019 to USD 2.0B in 2028. (ref. 2).

1. L.S. Raut and P. P. Chakrabarti: Management of relapsed-refractory diffuse large B cell lymphoma (2014) South Asian J. Cancer 3(1): 66–70

2. NHL and CLL Report, CRG, 2000, Disease Landscape and Forecast