On August 24, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that it will host its fifth annual virtual R&D Day for analysts and investors at 8:00 a.m. ET on Thursday, September 9 (Press release, Moderna Therapeutics, AUG 24, 2021, View Source [SID1234586853]).

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Moderna’s R&D Day will include presentations from Stéphane Bancel, Chief Executive Officer, Paul Burton, M.D., Ph.D., Chief Medical Officer, Stephen Hoge, M.D., President, clinical team leaders and key opinion leaders with a focus on the Company’s clinical development pipeline.

Register for the virtual event here. The webcast will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for one year following the presentation.

On August 24, 2021 Novartis reported an update on the Phase III BELINDA study investigating Kymriah (tisagenlecleucel) in aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment (Press release, Novartis, AUG 24, 2021, View Source [SID1234586837]). The BELINDA study did not meet its primary endpoint of event-free survival compared to treatment with the standard-of-care (SOC). SOC was salvage chemotherapy followed in responding patients by high-dose chemotherapy and stem cell transplant. The safety profile was consistent with the established safety profile of Kymriah. Novartis will complete a full evaluation of the BELINDA data and work with investigators on the future presentation of the results.

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"Patients with aggressive B-cell non-Hodgkin lymphoma who are refractory to first-line treatment are vulnerable and we are disappointed that the BELINDA study did not meet its primary endpoint in this setting," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development. "Kymriah continues to demonstrate durable responses for patients with certain advanced blood cancers in the third-line setting. We remain committed to accelerating development of Kymriah and our next-generation CAR-Ts and anticipate sharing early clinical results for these therapies at an upcoming medical meeting."

"We were hopeful the BELINDA study would show that Kymriah could improve outcomes and the overall treatment experience for these patients in need. The study investigators will work together with Novartis in the coming weeks and months to understand the factors that contributed to this outcome," said Michael R. Bishop, MD, Professor of Medicine and Director of the Hematopoietic Stem Cell Transplantation Program, University of Chicago Medicine and BELINDA Steering Committee Chair.

Novartis is grateful to the patients, families and investigators who participated in this trial for their determination to contribute to advancing the treatment of this aggressive blood cancer.

About the BELINDA study
The BELINDA study is a pivotal Phase III, randomized, open label, multicenter trial comparing two treatment strategies and assessing the efficacy, safety, and tolerability of Kymriah (tisagenlecleucel) compared to standard-of-care (SOC). Patients in the trial had aggressive B-cell non-Hodgkin lymphoma with primary refractory disease, or which relapsed within 12 months of first-line treatment. SOC was salvage chemotherapy followed in responding patients by high-dose chemotherapy and hematopoietic stem cell transplant (HSCT).

This international trial enrolled patients from over 73 sites in 18 countries worldwide. The primary endpoint was event-free survival (EFS) defined as the time from the date of randomization to the date of the first documented disease progression or stable disease at or after the week 12 assessment, per blinded independent review committee (BIRC), or death at any time. Secondary endpoints include EFS as assessed by local investigator, overall survival, overall response rate, duration of response, time to response and safety. Patients in the control arm, receiving SOC, had the opportunity to cross over to receive Kymriah upon progression determined by BIRC.

About Novartis Commitment to Oncology Cell & Gene
Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of the Novartis commitment to CAR-T cell therapy.

Kymriah is currently approved for the treatment of relapsed or refractory (r/r) pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL). Kymriah is available in 30 countries and 330 certified treatment centers, with the ambition for further expansion.

The Novartis global CAR-T manufacturing footprint spans seven facilities, across four continents and includes both Novartis-owned and contract manufacturing sites. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain.

US FDA approved indication for Kymriah
Kymriah (tisagenlecleucel) is a CD19-directed genetically modified autologous T cell immunotherapy, which is indicated for:

The treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
The treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma (FL). Limitations of Use: Kymriah is not indicated for treatment of patients with primary central nervous system lymphoma.
Kymriah (tisagenlecleucel) US Important Safety information
Kymriah may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS may experience symptoms including difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, or dizziness/lightheadedness. Patients may be admitted to the hospital for CRS and treated with other medications.

Patients with neurological toxicities may experience symptoms such as altered or decreased consciousness, headaches, delirium, confusion, agitation, anxiety, seizures, difficulty speaking and understanding, or loss of balance. Patients should be advised to call their healthcare provider or get emergency help right away if they experience any of these signs and symptoms of CRS or neurological toxicities.

Because of the risk of CRS and neurological toxicities, Kymriah is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Kymriah REMS.

Serious allergic reactions, including anaphylaxis, may occur after Kymriah infusion. Kymriah can increase the risk of life-threatening infections that may lead to death. Patients should be advised to tell their healthcare provider right away if they develop fever, chills, or any signs or symptoms of an infection.

Patients may experience prolonged low blood cell counts (cytopenia), where one or more types of blood cells (red blood cells, white blood cells, or platelets) are decreased. The patient’s healthcare provider will do blood tests to check all of their blood cell counts after treatment with Kymriah. Patients should be advised to tell their healthcare provider right away if they get a fever, are feeling tired, or have bruising or bleeding.

Patients may experience hypogammaglobulinemia, a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is increased. It is expected that patients may develop hypogammaglobulinemia with Kymriah and may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with Kymriah. Patients should tell their healthcare provider about their treatment with Kymriah before receiving a live virus vaccine.

After treatment with Kymriah, patients will be monitored lifelong by their healthcare provider, as they may develop secondary cancers or recurrence of their cancer.

Patients should not drive, operate heavy machinery, or do other dangerous activities for eight weeks after receiving Kymriah because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.

Some of the most common side effects of Kymriah are difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, confusion, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, dizziness/lightheadedness, and headache. However, these are not all of the possible side effects of Kymriah. Patients should talk to their healthcare provider for medical advice about side effects.

Prior to a female patient starting treatment with Kymriah, their healthcare provider may do a pregnancy test. There is no information available for Kymriah use in pregnant or breast-feeding women. Therefore, Kymriah is not recommended for women who are pregnant or breast feeding. Patients should talk to their healthcare provider about birth control and pregnancy.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

After receiving Kymriah, patients should be advised that some commercial HIV tests may cause a false-positive test result. Patients should also be advised not to donate blood, organs, or tissues and cells for transplantation after receiving Kymriah.

On August 24, 2021 Atavistik Bio ("Atavistik", "Company"), a pre-clinical biotechnology company pioneering the identification of metabolite-protein interactions that have the potential to lead to the discovery and development of first-in-class drug candidates powered by distinct allosteric control mechanisms, reported that the Company had completed a $60 million Series A financing round (Press release, Atavistik Bio, AUG 24, 2021, View Source [SID1234586854]). The financing was led by The Column Group and joined by Lux Capital, and Nextech Invest, Ltd.

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The new financing will support development of Atavastik’s drug discovery platform, and future identification of select drug candidates based on deep knowledge of disease relevant pathways that have evolved over millions of years by nature to be allosterically regulated by metabolites.

The Company will be helmed by John A. Josey, PhD, Acting CEO of Atavistik Bio, who was formerly CEO at Peloton Therapeutics, which was acquired by Merck in 2019. Dr. Josey is an experienced CEO with a long track record of novel drug discovery. Marion Dorsch, PhD, has been appointed President and CSO. Dr. Dorsch is a highly accomplished scientist and senior executive with more than twenty years of biotech and pharma experience in oncology, inflammation and rare genetic diseases. She is known for her innovative drug discovery that has contributed to several accelerated drug approvals in oncology. Prior to this role, Dr. Dorsch was CSO at Blueprint Medicines.

"Our unique approach marries a validated platform with structure-aided drug design capabilities and cutting-edge insights into the regulation of metabolic systems, which will be applied to genetically validated targets in metabolic disease and cancer," said John A. Josey, PhD, CEO of Atavistik Bio and Venture Partner at The Column Group. "We are delighted to gain the support of such an esteemed collection of venture investors in our quest to find first-in-class drug compounds in metabolic diseases and cancer."

Atavistik was co-founded by prominent scientific investigators and members of the Howard Hughes Medical Institute. Atavistik’s platform is built on technology developed by co-founder Jared Rutter, PhD, Professor of Biochemistry at the University of Utah. Professor Rutter is well-known for his work regarding novel protein metabolite interactions that has resulted in identification of novel allosteric regulatory sites for proteins of interest in disease. Additionally, co-founder Dr. Ralph DeBerardinis, MD, PhD is a professor at the University of Texas Southwestern Medical Center. He is a leading medical geneticist with a deep understanding of human metabolism with a focus on pediatrics. Dr. DeBerardinis still attends to patients and has a unique understanding of the high unmet need in this critical area of human health. The co-founders will stay closely involved with the scientific direction at Atavistik as advisors.

"Atavistik has a differentiated platform that has tremendous potential to identify novel regulatory sites to tackle the underlying cause of many diseases," said Marion Dorsch, PhD, President and Chief Scientific Officer, Atavistik Bio. "Our technology was founded by a leading metabolism expert and validated by the discovery of numerous known and novel metabolite-protein interactions. We look forward to building on this technology and utilizing our drug discovery platform to identify first-in-class drug candidates."

"Atavistik has positioned itself at the forefront of allosteric regulated metabolic drug discovery, a novel and exciting new area of drug discovery and medicine, that has immense potential," said Tim Kutzkey, Managing Partner at The Column Group and Atavistik Bio board member. "The company is built around Marion’s drug-discovery expertise and successful track record of bringing experimental medicines to market quickly. She will be joined by a team of experts in metabolism and a robust investment syndicate that will support Atavistik’s scientific focus."

Atavistik has opened a new office in Cambridge at 38 Sidney St. To learn more, please visit AtavistikBio.com.

On August 23, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the closing of its previously announced registered direct offering priced at-the-marked under Nasdaq rules, of 14,000,000 shares of the Company’s common stock (or pre-funded warrants to purchase common stock in lieu of common stock) at an effective purchase price of $5.00 per share for gross proceeds of approximately $70 million, before deducting the placement agent’s fees and other offering expenses payable by the Company (Press release, PharmaCyte Biotech, AUG 23, 2021, View Source [SID1234586820]). In a concurrent private placement, PharmaCyte also issued to the investors in the offering unregistered warrants to purchase up to an aggregate 7,000,000 shares of common stock.

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Immediately following the closing of the registered direct offering and the concurrent private placement, the number of outstanding shares of common stock of the Company will be 18,979,465 and the Company will have approximately $90 million in cash in its bank account.

H.C. Wainwright acted as the exclusive placement agent for the offering.

The warrants have an exercise price equal to $5.00 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

The Company intends to use the net proceeds of this offering (i) to complete activities requested by the U.S. Food and Drug Administration (FDA) to address the FDA’s clinical hold on its Investigational New Drug application (IND) with respect to the Company’s planned Phase 2b clinical trial in locally advanced, inoperable, pancreatic cancer (LAPC), including conducting several additional preclinical studies and assays and providing the FDA with the additional information it requested, (ii) to fully fund and conduct the Phase 2b clinical trial in LAPC, if and when the clinical hold on the IND is lifted, (iii) to continue clinical development of the Company’s cancer program, (iv) to continue development of the Company’s diabetes program, (v) to continue development of the Company’s malignant ascites program and (iv) for general corporate purposes.

The shares of common stock (and common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the U.S. Securities and Exchange Commission (SEC) on April 14, 2021, and an additional registration statement on Form S-3 filed on August 19, 2021, pursuant to Rule 462(b), which became effective automatically upon filing. The offering of the shares of common stock (or common stock equivalents) was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The final prospectus supplement and the accompanying base prospectus relating to the shares of common stock (or common stock equivalents) being offered in the registered direct offering have been filed with the SEC and are available on the SEC’s website at View Source Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended ("Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On August 23, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported that it has reacquired the exclusive rights to develop and commercialize its all-oral combination product candidate in the People’s Republic of China previously licensed to Shenzhen Salubris Pharmaceuticals Co., Ltd. (Salubris) (Press release, Sunesis, AUG 23, 2021, View Source [SID1234586838]). Pursuant to the mutual termination agreement between Viracta and Salubris, all development and commercialization rights under the license have been returned to Viracta in exchange for a $4.0 million cash payment to Salubris.

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"We thank the Salubris team for their support of Viracta and their collaborative contributions. As Viracta’s strategic focus remains in precision oncology and Salubris focuses their development efforts on cardiovascular and related disease areas, we agreed the reversion of these rights to Viracta was in the best interest of patients," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "China represents an important geographical region for the treatment of patients with EBV-associated cancers. We believe regaining the development and commercial rights in China will enable Viracta to expand our global development strategy and has the potential to unlock significant, long-term and unencumbered value to our shareholders."

Viracta’s combination therapy of nanatinostat, its proprietary investigational drug, and valganciclovir is currently being evaluated in a global Phase 2 pivotal trial for the treatment of patients with Epstein-Barr virus-positive (EBV+) lymphoma. Viracta has also received United States Food and Drug Administration clearance of an Investigational New Drug application to proceed into a global Phase 1b/2 trial evaluating its combination therapy in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors. Initiation of this Phase 1b/2 trial is expected in the second half of 2021.

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in various subtypes of relapsed/refractory EBV+ lymphoma in multiple clinical trials, including a registration-enabling global, multicenter, open-label basket trial.