On May 3, 2021 CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, reported that it is preparing a request for a pre-Breakthrough Therapy designation (BTD) meeting ahead of preparing a Phase 3 clinical trial protocol for 22 solid tumor cancer indications (Press release, CytoDyn, MAY 3, 2021, View Source [SID1234578995]). The Company is extremely encouraged about the prospects of a Phase 3 trial and BTD based on preliminary indications of patients in the Company’s current Phase 2 basket trial, compassionate use study and a patient treated under an eIND, which may support a smaller trial.

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Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, stated, "We are very encouraged by leronlimab’s potential to control metastasis by blocking CCR5 overexpression in cells that undergo malignant transformation. We also believe in the potential of leronlimab in the tumor microenvironment, including decreased angiogenesis, macrophage polarization, and blocking T regulatory cells that turn off the immune system’s ability to fight cancer."

Dr. Kelly recently presented "The Role of Leronlimab to Treat TNBC" at the Triple Negative Breast Cancer Drug Development Digital Summit 2021 and added, "We appreciate the warm reception of our oncology colleagues at the TNBC digital summit, and the recognition of the potential of leronlimab’s role in the future of immunotherapy."

Nader Pourhassan, Ph.D., President and Chief Executive Officer, commented, "Our multi-pathway approach to exploring all potential indications for leronlimab is proving to be very encouraging. We look forward to accelerating our efforts in the oncology field with leronlimab. We are equally excited to update our stockholders on Wednesday, especially concerning the potential use of leronlimab in treating COVID-19 in severe, critical, and long-hauler populations."

About Leronlimab (PRO 140)
Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

Leronlimab is a viral-entry inhibitor in HIV/AIDS. It masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Nine clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies.

CytoDyn has successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been working diligently to resubmit its Biologics License Application ("BLA") for this HIV combination therapy since receiving a Refusal to File letter in July 2020 and subsequently meeting with the FDA telephonically to address their written guidance concerning the submission. CytoDyn expects to resubmit its BLA via a rolling submission starting in the third quarter of calendar 2021.

On May 3, 2021 XBiotech (NASDAQ: XBIT) reported that it had reached an agreement to supply its new cancer drug XB20-01 to INSERM, and its Federation of Digestive Oncology group, a French organization which supports world-leading innovation for treating colorectal cancer (Press release, XBiotech, MAY 3, 2021, View Source [SID1234579013]).

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Colorectal is one of the most common forms of cancer in Europe and the United States, with nearly 150,000 new cases and 53,000 deaths expected in the US alone in 2021. The current chemotherapy regimen uses a Trifluridine/Tipiracil combination, drugs that interfere with the genetic material of cells in an effort to kill tumors. However, inflammation and toxicity from the chemotherapy is offset only by modest response rates and less than ideal outcomes. Thus, there is significant unmet medical need for this group of colorectal cancer patients. XBiotech’s new drug candidate XB20-01 targets an inflammatory process potentially involved in the growth and spread of colorectal cancer; and the new drug may also block inflammation caused by chemotherapy, potentially reducing side effects and improving the treatment effect of chemotherapy.

The chair and lead investigator of the multicenter clinical study is Dr. François Ghiringhelli M.D. Ph.D, Director of INSERM, and Professor of Oncology at the University of Burgundy, Genetic and Immunotherapy Medical Institute. Dr. Ghiringhelli, a world-leading researcher in colorectal cancer, designed the study which features an innovative interim analysis to assess improvement in overall survival. If patients receiving XB20-01 have a predetermined improvement in survival compared to the placebo treated group, the randomized study will be expanded to enroll a phase III portion with overall survival as the primary outcome.

Professor Ghiringhelli, also a Director at the prestigious INSERM center and Head of a Division specializing in "Cancer and adaptive immune response", commented, "This is a very exiting clinical trial, granted by the French Cancer Institute, for a very frequent and devastating disease. Currently very few drugs give promising results for these patients. In case of success, this trial could be practice changing."

John Simard CEO XBiotech stated, "We are honored to be able to provide our new candidate drug to INSERM, an institution that is setting a global standard for public involvement in the promotion of innovation in medicine. François has developed a brilliant study design that we are very excited to support."

Cytotoxic chemotherapy agents result in systemic toxicity—considered to be a trade-off for potential anti-tumor activity. Toxicity is of acute importance clinically, but consequences of inflammatory responses induced by cytotoxic agents may also have a more profound impact, promoting tumor growth, and compromising the efficacy and durability of the therapy itself. Cytotoxic agents upregulate inflammatory pathways, including activation of leukocytes, vascular endothelium, and stromal cells of the tumor microenvironment. IL-1a is believed to play a key role in pro-tumor and treatment related inflammatory pathways.

XBiotech’s new drug XB20-01 is a naturally occurring antibody that potently neutralizes IL-1a and is thus a safe and promising approach to block inflammation that occurs with advanced malignancies and chemotherapy. Unchecked, IL-1a can stimulate angiogenesis, enhancing blood and nutrient supply to the tumor; IL-1a may also act to recruit unwanted leukocytes (such as myeloid suppressor cells) into the tumor, that can suppress the ability of the body’s immune system to fight off the tumor; and systemically, IL-1a can mediate metabolic dysfunction, and cause fatigue, anorexia, and anxiety in cancer patients. IL-1a is thus a unique target for addressing paraneoplastic inflammation—with XBiotech’s new drug therapy holding promise for treating a wide array of cancers.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

On May 3, 2021 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTC: BVAXF) ("BioVaxys" or "Company") reported that it has signed the definitive exclusive bioproduction agreement ("Agreement") with BioElpida S.A.S. ("BioElpida") of Lyon, France, to begin the clinical-grade bioproduction and aseptic packaging for BXV-0918A, BioVaxys’ vaccine candidate for Stage III/Stage IV ovarian cancer (Press release, BioVaxys Technology, MAY 3, 2021, View Source [SID1234579031]). BioVaxys and BioElpida executed a Term Sheet in February outlining the commercial relationship, with todays definitive Agreement focusing on the GMP facility build-out in Lyon, and technical aspects of the bioproduction protocol such as process design and validation, quality control and quality assurance steps, batch test runs, stability testing, and aseptic fill. BioVaxys expects to be able to prepare its regulatory submission for a EU Phase I study of BVX-0918A in Stage III/Stage IV ovarian cancer near the end of this year, with vaccine supply for the planned clinical study available early May 2022.

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BioElpida is a biotechnology contract development and manufacturing company ("CDMO") which applies single-use bioprocessing for development and manufacturing of biological and cell-based products. BioElpida’s expertise extends from R&D to pharmaceutical manufacturing and release of clinical batches, and intermediate steps such as process development, feasibility studies, analytical method validation, as well as aseptic fill & finish and other bioproduction services. BioElpida’s facility is certified for clinical bioproduction by France’s National Security Agency of Medicines and Health Products (ANSM).

"Early on we made the decision to seek a bioproduction partner with the ability to quickly move from smaller-yield GMP-grade clinical study supplies to large-scale manufacturing if our clinical trials prove successful and EU regulatory approval is granted," said Kenneth Kovan, Co-Founder, President and Chief Operating Officer of BioVaxys. "BioElpida’s technical experience and previous work on early generations of our cancer vaccine platform will be a significant advantage in our efforts to provide hope to those suffering from advanced ovarian cancer."

BioVaxys is collaborating on the ovarian cancer vaccine clinical program with Spanish biopharma company ProCare Health Iberia S.A.S., which plans to submit a Clinical Trial Application ("CTA") for BVX-0918A to the European Medicines Agency ("EMEA") later this year for a compassionate use approval in Stage III & Stage IV ovarian cancer. ProCare Health will have marketing rights to BVX-0918A in the EU and UK, whereas BioVaxys will market its ovarian cancer vaccine in North America and Rest of World.

Globally, there remain significant unmet therapeutic needs for ovarian cancer treatment. Worldwide, over 300,000 women are diagnosed with ovarian cancer each year (World Cancer Research Fund, 2020), with ovarian cancer the leading cause of death from gynecologic malignancy in the United States (American Cancer Society Facts & Figures 2020). An estimated 21,750 new cases of ovarian cancer were expected in the US in 2020 with 13,940 deaths (National Cancer Institute, Surveillance and Epidemiology Program, 2020). The majority of women with Stage III or Stage IV cancer will ultimately have recurrent disease resistant to chemotherapy. Patients who have relapsed after platinum-based chemotherapy have limited life expectancy even with multiple salvage regimens. This large group of non-responders to first line therapy, or those who relapse after first line therapy, are the initial target market for BioVaxys.

The global ovarian cancer drugs market was valued US$1.2B in 2017 and is expected to reach US$4.6B by 2026, at a CAGR of 18.29 % (www.medgadget.com/2020/11/ovarian-cancer-drugs-2020-global-market-to-reach-us-4-6-bn-and-growing-at-cagr-of-18-29-by-2026.html).

On May 3, 2021 Roivant Sciences, a biopharmaceutical and healthcare technology company, and Montes Archimedes Acquisition Corp. (Nasdaq: MAAC), a special purpose acquisition company sponsored by Patient Square Capital, reported that they have entered into a definitive business combination agreement (Press release, Roivant Sciences, MAY 3, 2021, View Source [SID1234578996]). Upon closing of the transaction, outstanding shares and warrants of MAAC will be exchanged for newly issued shares and warrants of Roivant Sciences, which is expected to be listed on Nasdaq under the new ticker symbol "ROIV."

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The transaction is expected to deliver up to $611 million of gross proceeds to fund discovery and development programs. This includes up to $411 million currently held in MAAC’s trust account, as well as a concurrent $200 million common stock private investment in public equity ("PIPE") priced at $10.00 per share. New institutional and strategic investors and existing Roivant shareholders have committed to participate in the PIPE, including Fidelity Management & Research Company LLC, Eventide Asset Management, Suvretta Capital, Palantir Technologies, RTW Investments, LP, Viking Global Investors, Sumitomo Dainippon Pharma, and SB Management, a subsidiary of SoftBank Group Corp. Proceeds are expected to extend the company’s operating runway through mid-2024.

Patient Square Capital and key Roivant equity holders and management have agreed to long-term lockups, with at least 50% of their holdings locked up for three years. In addition, Patient Square Capital has agreed to convert an additional 30% of its shares of MAAC to earn-out shares subject to performance vesting thresholds: 20% of its shares will vest at $15.00 per share and 10% will vest at $20.00 per share for 20 of 30 trading days within five years of closing.

Jim Momtazee, Managing Partner of Patient Square Capital, will join Roivant’s board of directors. Prior to founding Patient Square Capital, Mr. Momtazee was a 21-year veteran of KKR where he helped form its health care investment team 20 years ago and ran that team for over a decade.

"Roivant is at the cutting edge of using technology to discover and develop transformative medicines for a wide range of serious diseases, and in a very short time they have established a remarkable track record of building subsidiaries that have run successful registrational clinical trials for approved medicines," said Mr. Momtazee. "I first met the company in 2015 and have watched its growth over the last 6 years with admiration. Based on our extensive due diligence spanning the last 5 months, I look forward to a long-lasting partnership with one of the most exciting and innovative companies in the life sciences industry."

Roivant will continue to operate under its current management team led by Chief Executive Officer Matthew Gline. Roivant founder Vivek Ramaswamy will continue to serve as Executive Chairman.

"I look forward to the next chapter of Roivant’s growth by beginning our life as a public company with an exceptionally strong and diverse base of long-term investors," said Mr. Gline. "We look forward to continuing to deliver important medicines to patients through our development engine and our rapidly growing drug discovery capabilities spanning multiple therapeutic areas and modalities."

The boards of directors of both Roivant and MAAC have unanimously approved the proposed transaction. Completion of the transaction, which is expected in the third quarter of 2021, is subject to approval of MAAC shareholders and the satisfaction or waiver of certain other customary closing conditions. A link to investor presentation materials is included below.

Roivant Sciences Overview
Since its founding in 2014, Roivant has put over 40 medicines into development across a wide range of disease areas. Companies built by Roivant have conducted eight consecutive positive Phase 3 studies with two FDA approvals to date. Roivant is also a leader in computational drug discovery through its combination of computational physics and machine learning-based platforms for the in silico design of small molecules. Roivant has over 800 employees across its family of companies today.

Transaction Overview
In this all-primary transaction, current holders of Roivant shares and equity awards will maintain their existing equity interests in Roivant. Current shareholders and warrant holders of MAAC will convert their shares and warrants of MAAC into common shares and warrants of Roivant on a one-for-one basis. Assuming a share price of $10.00 per share and no redemptions of MAAC shares, Roivant is expected to have an initial market capitalization of $7.3 billion inclusive of its pro forma net cash balance of approximately $2.3 billion.

Assuming no redemptions of MAAC shares, current shareholders of Roivant will own approximately 92% of Roivant immediately post-closing (including shares issued in connection with Roivant’s recent acquisition of Silicon Therapeutics and existing Roivant shareholder participation in the PIPE).

The closing of this transaction is expected in the third quarter of 2021 and is subject to the approval of MAAC’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

Additional information about the proposed transaction, including a copy of the Business Combination Agreement and an investor presentation, will be provided in a Current Report on Form 8-K to be filed today by MAAC with the Securities and Exchange Commission ("SEC") and available at www.sec.gov.

Advisors
J.P. Morgan Securities LLC is serving as a financial advisor and capital markets advisor to Roivant and as a lead placement agent for the PIPE. SVB Leerink LLC is serving as a capital markets advisor to Roivant and as a lead placement agent for the PIPE. Goldman Sachs & Co. LLC is serving as a financial advisor to Roivant. Cowen and Company, LLC is serving as a financial advisor and capital markets advisor to Roivant. Citigroup Global Markets Inc. is serving as a placement agent for the PIPE. Truist Securities, Inc. is serving as a capital markets advisor to Roivant and as a placement agent for the PIPE. Davis Polk & Wardwell LLP is acting as legal counsel to Roivant. Kirkland & Ellis LLP is acting as legal counsel to MAAC.

On May 3, 2021 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, reported that management will present and hold 1×1 meetings at the following investor conferences (Press release, Reata Pharmaceuticals, MAY 3, 2021, View Source [SID1234579014]):

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Bank of America Merrill Lynch Global Healthcare Conference on May 12, 2021.
Jefferies Virtual Healthcare Conference on June 2, 2021.