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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.

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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]).

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

Pionyr and Abcam extend partnership to evaluate TREM2-expressing cells in cancer patients

On June 22, 2021 Pionyr Immunotherapeutics, Inc., a company developing first-in-class antibody therapeutics that increase the body’s anti-tumor immunity and Abcam (AIM: ABC) (NASDAQ: ABCM), a global innovator in life science reagents and tools, reported the extension of their collaboration with a new commercial licensing agreement to support the progression of PY314, the first to the clinic of Pionyr’s compounds (Press release, Pionyr Immunotherapeutics, JUN 22, 2021, View Source [SID1234584252]).

Currently in Phase 1 clinical study[1], PY314 is an anti-TREM2 (Triggering Receptor Expressed on Myeloid cells 2) monoclonal antibody for the treatment of advanced solid tumors. PY314 is designed to tune the tumor microenvironment by selectively depleting immune suppressive TREM2-expressing tumor-associated macrophages to promote anti-tumor immunity.

Pionyr’s Phase 1 clinical study will recruit patients with predefined tumor types where macrophages expressing TREM2 in the tumor microenvironment are most likely implicated as a driver of resistant metastatic disease. Under the terms of the agreement, Pionyr will evaluate Abcam’s anti-TREM2 antibody to detect the presence of TREM2-expressing macrophages in tumor biopsy samples from patients enrolled in the first-in-human study. Pionyr will explore the potential for developing a companion diagnostic test leveraging Abcam’s high quality reagents and end-to end-expertise to facilitate and de-risk the diagnostics development journey.

Kevin Baker, SVP and Chief Development Officer at Pionyr, said: "We are excited to collaborate with Abcam to support the clinical development of our PY314 program for the treatment of solid tumors. Abcam’s in-depth knowledge and track record of successfully supporting diagnostic assay development is invaluable to anticipate late-stage development requirements, and to facilitate access to the right expertise at the right time."

John Baker, SVP Business Development at Abcam, said: "Pionyr’s Phase 1 PY314 is a promising therapy that has the potential to unlock durable benefits for cancer patients. Precise monitoring of the presence of TREM2 in tumor biopsy samples throughout the clinical development process, enabled by Pionyr’s use of Abcam’s EPR20243 clone, will provide vital support to the success of the trial. We are thrilled to be working with Pionyr and supporting their efforts to enhance the immune system’s anti-tumor response."

[1] Study of PY314 in Subjects With Advanced Solid Tumors – NCT04691375

Sintilimab in Combination with Chemotherapy Meets Overall Survival Primary Endpoint in the Global Phase 3 ORIENT-15 Study for the First-Line Treatment of Esophageal Squamous Cell Carcinoma

On June 22, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the Phase 3 ORIENT-15 study met the predefined overall survival primary endpoint. ORIENT-15 is a global randomized, double-blind, multi-center clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, Innovent Biologics, JUN 22, 2021, View Source [SID1234584250]).

Based on an interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy regardless of PD-L1 expression status. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab, and no additional safety signals were identified. These results will be presented at an upcoming medical meeting.

The principal investigator of the ORIENT-15 study, Prof. Shen Lin from Peking University Cancer Hospital and Institute stated, "More than half of new and fatal cases of esophageal cancer in the world occur in China every year. In China, esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer, and squamous cell carcinoma (ESCC) is the predominant histologic type. Treatment options for people with ESCC are limited. Chemotherapy is currently the main treatment for ESCC and, in recent years, immunotherapy has brought new hope in the treatment of this type of cancer, with some PD-1 inhibitors receiving approval as a second-line treatment for patients with ESCC in China. We are encouraged by these interim results of the ORIENT-15 study which demonstrated that sintilimab in combination with chemotherapy prolonged overall survival in the first-line treatment of patients with ESCC, regardless of PD-L1 status."

Dr. Zhou Hui, Senior Vice President of Clinical Development of Innovent, stated: "The treatment options for locally advanced or metastatic ESCC are limited and represent a significant unmet clinical need. ORIENT-15 is the largest clinical study of sintilimab conducted by Innovent to date. Despite the COVID-19 pandemic, the joint effort of the study’s investigators and broader team have enabled us to reach this milestone. We would like to express our sincere gratitude to all the patients who participated in the ORIENT-15 study. We hope these results can help to provide a new treatment option for patients with ESCC."

About the ORIENT-15 Study

ORIENT-15 is a global randomized, double-blind, multi-center Phase 3 clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil [5-FU]), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ClinicalTrials.gov, NCT03748134). At the time of interim analysis, a total of 659 eligible patients were enrolled and randomly assigned into the experimental group or control group in a 1:1 ratio. Patients were enrolled regardless of PD-L1 status. The primary endpoints included overall survival in all randomized patients and overall survival in PD-L1 positive (defined as CPS ≥10) patients.

About Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer is one of the most common malignant tumors worldwide that begins in the inner layer (mucosa) of the esophagus, which connects the throat to the stomach. Based on GLOBOCAN 2020 estimates, approximately 600,000 new cases of esophageal cancer are diagnosed and approximately 540,000 deaths result from the disease globally. Esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. More than half of new and fatal cases of esophageal cancer in the world occur in China. In China, it is estimated there were approximately 320,000 new cases of esophageal cancer diagnosed and approximately 300,000 deaths resulting from the disease in 2020. Esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer in China, which has a five-year survival rate of only 30 percent.

The two main types of esophageal cancer are squamous cell carcinoma (SCC) and adenocarcinoma. In China, SCC is the predominant histologic type – accounting for more than 90 percent of all esophageal cancer. Currently, first-line standard systemic therapy in China is chemotherapy based on platinum drugs for unresectable, locally advanced recurrent or metastatic ESCC. There have been a few PD-1 inhibitors recently approved for the second-line treatment of patients with ESCC.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for three indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
Additionally, Innovent currently has regulatory submissions under review in China for sintilimab:

In combination with BYVASDA (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma
The second-line treatment of squamous non-small cell lung cancer
Innovent also has two clinical studies that have met primary endpoint for sintilimab:

in combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma
The second-line treatment for esophageal squamous cell carcinoma
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

TRexBio Closes the Final Tranche of $59 Million Series A Financing to Advance Innovation in Tissue Immunobiology for the treatment of Cancer and Inflammatory Diseases

On June 22, 2021 TRexBio, a discovery stage company decoding human tissue immune biology to create revolutionary therapeutics, reported the successful close of the final tranche of a $59 million Series A financing (Press release, TRexBio, JUN 22, 2021, View Source [SID1234584249]). Proceeds from the financing will be used to expand the company’s unique discovery platform that maps human tissue regulatory T cell (Treg) behavior to dysregulation in disease, and to advance its six preclinical therapeutic programs. Investors include Eli Lilly and Company (Lilly), SV Health, Johnson & Johnson Innovation, Pfizer Ventures, and Alexandria Venture Investments.

"The continued support from our investors further validates our approach to creating breakthrough therapeutics," said Carol Gallagher, Pharm.D., Executive Chair of TRexBio, and former President and CEO of Calistoga Pharmaceuticals. "We look forward to working with our investors and our academic and industry collaborators as we continue to create and advance a robust pipeline that addresses serious illnesses including cancer and auto-immune diseases."

TRexBio also announced the appointment of Johnston Erwin as Chief Executive Officer, and Ovid Trifan, M.D., Ph.D., as Chief Medical Officer, as part of the company’s plan to accelerate growth. Johnston, a seasoned industry veteran with experience in business development, venture investment, collaboration management, and clinical and regulatory development, joins TRexBio after a 36 year career with Lilly. He most recently served as VP of Corporate Business Development leading Lilly’s internal venture portfolio.

"TRex is at the forefront of one of the most exciting new areas in immunobiology and tissue homeostasis," said Johnston. "The company has a significant foundation in place, with a compelling vision, dedicated team and robust science. I am excited to lead the company into its next stage of development and ultimately transform the lives of patients by bringing a new generation of immune-based therapies to the world."

Dr. Trifan brings more than 20 years of medical research experience to TRexBio. Most recently he was the Chief Medical Officer and VP of Development at Apexigen, a clinical stage biotech company focused on immuno-oncology. Prior to Apexigen he held senior roles in clinical research at leading pharmaceutical companies including Bristol Myers Squibb and Johnson & Johnson, where he contributed to the development of multiple successful oncology drugs. Dr. Trifan will lead the advancement of TRexBio’s oncology programs into the clinic by the end of next year.

Mr. Erwin and Dr. Trifan are joined on the management team by Chief Scientific Officer Melanie Kleinschek, DVM, Ph.D., who has led the development of TRexBio’s unique ‘deep biology’ discovery platform. The platform uses high-resolution profiling of human tissue, modern computational biology tools, a proprietary system to generate tissue-like Tregs and disease-relevant phenotypic assays to generate novel insights into human tissue biology.

TRexBio’s accomplishments to date include:

Foundational collaborations with Lilly and the University of California San Francisco.
Advancement of six preclinical therapeutic programs across immuno-oncology and inflammation, two of which are on track to name development candidates in the next 12 months.
Identification of more than 20 novel tissue-focused targets from its proprietary ‘deep biology’ platform
The company works with an internationally recognized team of founding scientific advisors, including

Michael D. Rosenblum, M.D., Ph.D., Professor of Dermatology, Vice Chair of Research UCSF, and Co-Founder of Delinia Therapeutics;
Houman Ashrafian, BM Bch, DPhil, Managing Partner at SV Health Investors and former VP, Head of Clinical Science at UCB;
Adil Daud, M.D., Professor, Department of Medicine, Hematology/Oncology Director Melanoma Clinical Research, UCSF;
Diane Mathis, Ph.D., Professor in the Department of Immunology at Harvard Medical School, and holder of the Morton Grove-Rasmussen Chair in Immunohematology; and
Allison Simmons, M.D., Ph.D., Professor of Gastroenterology and Director of the MRC Human Immunology Unit at the University of Oxford.