On July 20, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its second quarter 2021 financial results on Tuesday, August 3, 2021 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, JUL 20, 2021, View Source [SID1234584972]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

To access the conference call and webcast, please register at the link below:
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Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

The live webcast of the call and slide deck, may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to [email protected].

On July 20, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2021 second quarter financial results on Tuesday, August 3, 2021 after the close of the financial markets (Press release, Jazz Pharmaceuticals, JUL 20, 2021, View Source [SID1234584990]). Company management will host a live audio webcast at 4:30 p.m. ET/9:30 p.m. IST to discuss second quarter 2021 financial results and provide a business and financial update.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

On July 20, 2021 Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, reported that Honorable Mark Dybul, M.D. has been named as Chief Executive Officer (CEO) (Press release, Enochian BioSciences, JUL 20, 2021, View Source [SID1234585128]).

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Dr. Dybul, who has served as Executive Vice-Chair of the Board of Enochian BioSciences since January 2019, is a globally recognized leader in pandemics. He was a principal architect and ultimately the head of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the largest international health initiative in history dedicated to a single disease, that achieved historic prevention, care and treatment goals on time and on budget. During his tenure, the program grew from approximately $500 million to $6.5 billion annually. Dr. Dybul went on to transform the Global Fund to Fight AIDS, Tuberculosis and Malaria and, during Dr. Dybul’s four-year tenure, both President Barack Obama and Prime Minister Justin Trudeau hosted funding rounds that raised $25 billion for the Global Fund.

Dr. Dybul has been deeply involved in the fight against COVID-19. He was the only American appointed to the 15-member Independent Panel for Pandemic Preparedness and Response, mandated by the World Health Assembly and co-chaired by former Liberian President Ellen Johnson Sirleaf and former New Zealand Prime Minister Helen Clark. Dr. Dybul also was a member of the High Level Scientific Advisory Group for the G20’s Global Health Summit focused on COVID-19.

Under the mentorship of Dr. Anthony Fauci, Dr. Dybul began his career in public health as a researcher at the National Institute of Allergy and Infectious Diseases, ultimately leading a section of Dr. Fauci’s lab and serving as the Assistant Director for Medical Affairs.

"It is a great privilege to have one of the world’s preeminent public health experts assume the role of CEO of Enochian BioSciences," said Enochian BioSciences’ Chair of the Board René Sindlev. "Mark’s deep expertise in science, combined with his long experience managing research programs and advising on strategy, brings key and difficult-to-find competencies to Enochian BioSciences. Under Mark’s leadership, we are excited to see the organization rapidly advance toward its goal of developing cures for HBV, HIV and potentially, to address inhaled pan-coronavirus and pan-influenza treatment and prevention."

Gregg Alton, Enochian BioSciences’ Board Director, and former interim CEO and longtime General Counsel of Gilead Sciences, said, "I have known Mark since he worked closely with Tony Fauci. I watched him lead what was effectively a start-up in the U.S. Government, PEPFAR, and make it one of the most successful public health programs in history. Mark then went on to transform the Global Fund, a public-private partnership, introducing business models for purchasing, supply chain, and many others. He knows how to lead, develop strategy, maintain the teams’ focus and achieve success."

"As a long-time researcher, clinician, and leader of large global diseases programs, I am very honored to transition from my current role of Executive Vice-Chair to full-time CEO of Enochian BioSciences," said Dr. Dybul. "Based in elegantly brilliant science, we have made significant progress in the past 18 months building a deep and wide pipeline with platforms that address major killers including cancer and infectious diseases. The recent acceleration of potential cures for Hepatitis B, HIV and potential inhaled pan-coronavirus, including the cause of COVID-19, and pan-influenza treatment and prevention — makes it an extremely exciting time to become the CEO of Enochian BioSciences."

On July 19, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Kite, a Gilead Company (Nasdaq: GILD, "Kite") reported the two companies have entered into a purchase agreement for BioNTech to acquire Kite’s solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, MD (Press release, BioNTech, JUL 19, 2021, View Source [SID1234584940]). The acquired Gaithersburg facility will provide production capacity to support clinical trials in the United States and will complement BioNTech’s existing cell therapy manufacturing facility in Idar-Oberstein, Germany. The facility will support the development of BioNTech’s expanding pipeline of novel cell therapies, including cancer product candidates based on its CAR-T Cell amplifying mRNA vaccine (CARVac) and NEOSTIM platforms as well as the newly acquired individualized neoantigen TCR program.

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"The development of individualized cancer therapies is at the core of our work at BioNTech. The acquisition of the Kite facility and its individualized TCR platform allows us to accelerate the clinical development of our cell therapies in the U.S. and advance at the forefront of individualized cell therapies," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "It also strengthens our presence in the U.S., building on our successful integration of adoptive T-cell and neoantigen TCR therapies as part of our acquisition of Neon Therapeutics last year."

All Kite employees at the Gaithersburg facility will be offered employment with BioNTech prior to the date of closing. To support its growing cell therapy pipeline, BioNTech plans to further invest in the site including hiring additional personnel. Under the terms of the agreement, Kite will receive a one-time upfront payment from BioNTech to purchase Kite’s indiviualized solid tumor neoantigen TCR discovery platform as well as the Gaithersburg R&D and clinical manufacturing facility. Financial terms were not disclosed. Kite’s new manufacturing facility in Frederick, MD for commercial production of CAR T-cell therapy is not part of the purchase agreement.

"In order to serve more patients that need cell therapy today, Kite is rapidly growing both through global expansion and seeking new indications for our existing approved CAR T-cell therapies. This transaction will enable us to focus our energies and investment on accelerating the reach of our current CAR T-cell therapies and midterm pipeline," said Christi Shaw, Chief Executive Officer of Kite. "As a company solely focused on cell therapy for over a decade, our approach to solid tumors and allogeneic cell therapy will progress through a combination of both internal research and external partnerships as we are an excellent partner for likeminded companies that share our vision of the power of CAR T-cell therapy to create better outcomes for patients."

TCR therapy is a type of cellular immunotherapy designed to redirect the patient’s immune system in order to recognize and target tumors. In contrast to CARs that recognize antigens on the cell surface, TCR therapy involves engineering an individual’s T cells to express TCRs that can recognize peptide fragments from both intracellular and extracelluar antigens. As a result, complex TCR therapies may be more effective in the treatment of solid tumors. Neoantigens are immune targets derived from somatic mutations displayed by cancer cells offering the potential for more targeted anti-tumor activity. Kite’s neoantigen TCR platform enables the development of individualized TCR therapies that are custom designed to target individual neoantigens on a patient’s tumor. This program builds and further extends BioNTech’s leadership in individualized neoantigen targeting programs such as BNT122 (iNeST) and BNT221 (NEOSTIM).

Cowen & Company LLC acted as financial advisor to Kite for this transaction.

On July 19, 2021 PEP-Therapy, a biotechnology company developing cell penetrating peptides as targeted therapies for the treatment of cancers, reported that it raised an additional €2.6 million ($3 million) in an extension of its Series A financing round, bringing the total raised in this round to €5.4 million ($6.4 million) (Press release, PEP-Therapy, JUL 19, 2021, View Source;301335760.html [SID1234584956]). This new funding comprises €1.6 million in equity from Anaxago, i&i Prague and BADGE as well as a €1 million loan from Bpifrance. This increased financial support highlights the potential of PEP-010, as well as PEP-Therapy’s Cell Penetrating & Interfering Peptide (CP&IP) technology platform, which was first developed at Sorbonne University and Institut Curie.

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PEP-010 is the first of a new class of therapeutic peptides based on PEP-Therapy’s innovative Cell Penetrating & Interfering Peptide (CP&IP) technology. These innovative molecules penetrate cells and specifically block relevant intracellular protein-protein interactions, leading to the inhibition of key pathological mechanisms, without altering physiological mechanisms.

PEP-Therapy will use the funds to finance the Phase I a/b clinical trial of PEP-010, PEP-Therapy’s lead candidate, for the treatment of advanced solid tumors. The first part of the Series A, which closed in April 2021, will finance the Phase Ia dose escalation part of the study, with the additional funds being used for the development of PEP-010 until the end of the expansion cohorts, Phase Ib.

PEP-Therapy expects to generate promising clinical data from this study, particularly in two indications: metastatic triple negative breast cancer and platinum resistant ovarian cancer. Patients with these two types of solid tumors have a poor prognosis and limited therapeutic alternatives.

Antoine Prestat, CEO and co-founder of PEP-Therapy, said: "We are delighted to have completed this financing round via an attractive balance of dilutive and non-dilutive funds from new high quality and diversified investors who will bring expertise and new insights to support our development."

Jaromír Zahrádka, PhD, CEO of i&i, commented: "PEP-Therapy has developed an extensive knowledge of targeted peptides and the promising preclinical data the company has generated show great potential. We are looking forward to seeing the confirmation of the positive results seen in preclinical data in the upcoming Phase I study."

Gaston Vasseur, Investment Manager at Anaxago, added "This extended financing highlights PEP-Therapy’s capacity to attract highly specialized as well as diversified investors. The Company has managed to rapidly secure the funding for the Phase I trial with PEP-010, a very important milestone for the company. We are happy to contribute to this financing round in conjunction with a number of experienced life science investors."

In addition, PEP-Therapy and its clinical partners, Institut Curie and Gustave Roussy, previously received a €2.9 million grant from the French state innovation fund – Fonds Unique Interministériel (FUI) – to finance nonclinical and early clinical development of PEP-010.