On May 27, 2021 Leaps by Bayer, the impact investment arm of Bayer AG reported that it has led a USD 90 million Series B investment in Berlin-based digital health company Ada Health GmbH ("Ada") (Press release, Bayer, MAY 27, 2021, View Source [SID1234580707]). Additional investors joined the round, including Samsung Catalyst Fund, Vitruvian Partners, Inteligo Bank, F4 and Mutschler Ventures.

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The investment will help advance Ada’s popular health assessment technology, enabling the digital health pioneer to accelerate its path towards becoming the world’s leading personalized operating system for health, as well as to further grow the company’s leading position in the United States. In addition to today’s announcement, Bayer and Ada Health are in discussions about entering into a longer-term strategic partnership to support the company’s healthcare businesses.

Ada Health has developed a powerful AI-based health assessment and care navigation platform that helps users to understand their symptoms, to identify and differentiate conditions with a high degree of medical accuracy, and to navigate safely to the right care, at the right time. Ada’s consumer app has become the world’s most popular and highest-rated symptom assessment app, with over 23 million assessments completed since its global launch.

Ada’s core technology is also available in a suite of AI-driven enterprise solutions. The company is collaborating with a range of leading health systems, insurers, life sciences companies, and global non-profit organizations to integrate its symptom assessment and care navigation solutions into a range of digital care journeys to improve outcomes for patients, consumers and healthcare providers.

"Investing in breakthrough technologies that drive digital change in healthcare is one of the strategic imperatives for Leaps by Bayer and for the entire field of healthcare," said Dr. Jürgen Eckhardt, Head of Leaps by Bayer. "Ada’s truly transformative technology, combining powerful artificial intelligence with an emphasis on medical rigor and high levels of clinical accuracy will lead the way in helping more patients and consumers in achieving better health outcomes sooner by intervening earlier in their healthcare journey."

The timely detection of diseases is one of the biggest challenges in guiding consumers and patients to appropriate care, with under-diagnosis, misdiagnosis, and long patient journeys to diagnosis and care unfortunately being commonplace. In addition, global healthcare systems are overburdened, with organizations required to meet pressures such as growing and ageing populations, emerging comorbidity requiring treatment, and the ongoing pandemic. Ada can help shorten time to diagnosis by providing medical guidance that is relevant, actionable and effective, and will increasingly leverage personalized data insights to support the prediction and prevention of diseases.

"Today’s investment will help bring us closer to our goal of improving healthcare outcomes for more than 1 billion people around the world. We’re proud to have investors on board who truly believe in Ada’s technology and vision of transforming the way people access healthcare," Daniel Nathrath, CEO and co-founder of Ada Health comments on today’s announcement. "We are thrilled to have Leaps by Bayer as the lead investor particularly as our values are very much aligned with putting science and technology as well as a commitment to medical quality and user-centricity at the heart of everything we do."

On May 27, 2021 FibroGen, Inc. (NASDAQ: FGEN) reported that Enrique Conterno, Chief Executive Officer, will participate in fireside chats at the following virtual healthcare Conference (Press release, FibroGen, MAY 27, 2021, View Source [SID1234580706]):

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Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 10:30 AM Eastern Time
Goldman Sachs 42nd Annual Global Healthcare Conference on Thursday, June 10, 2021 at 3:00 PM Eastern Time
A live audio webcast will be available on the "Events & Presentations" section of the FibroGen Investor webpage at www.fibrogen.com. A replay will be available for approximately 30 days.

On May 27, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that members of the management team will present during a fireside chat at the 2021 Jefferies Virtual Healthcare Conference, being held June 1 – 4, 2021 (Press release, Altimmune, MAY 27, 2021, View Source [SID1234580705]).

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Details on the Jefferies fireside chat presentation are as follows:

Title : 2021 Jefferies Virtual Healthcare Conference

Presenters: Vipin Garg, Ph.D., Chief Executive Officer
Scot Roberts, Ph.D., Chief Scientific Officer
Scott Harris, M.D., Chief Medical Officer

Date/Time: Wednesday, June 2, 2021 at 11:30 am ET
A webcast link to the fireside chat presentation will be accessible on the Events section of the Altimmune website.

On May 27, 2021 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported its Chief Executive Officer, John Fowler, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 2:00 p.m. ET (Press release, Kezar Life Sciences, MAY 27, 2021, View Source [SID1234580704]).

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A live webcast of the fireside chat may be accessed at the "Events & Presentations" section of the Company’s website at View Source Kezar Life Sciences will maintain an archived replay of the webcast on its website for 90 days after the conference.

On May 27, 2021 BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, announce that their Investigational New Drug (IND) application for BT-001 has been granted by the U.S. Food and Drug Administration (FDA) (Press release, BioInvent, MAY 27, 2021, View Source [SID1234580703]). This IND will allow patients in the U.S. to be enrolled into the ongoing Phase 1/2a clinical trial of this novel oncolytic virus BT-001. BT-001 is armed with both a differentiated Treg-depleting human recombinant anti-CTLA4 antibody and GM-CSF.

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The ongoing Phase 1/2a (NCT04725331) study is a multicenter, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment). The Phase 1 part of the trial has already been initiated in Europe, where it is enrolling patients in several countries.

BT-001 is expected to elicit a strong and effective antitumoral response by selectively targeting and modulating the tumor microenvironment. In addition, delivering the anti-CTLA4 antibody directly to the tumor aims to induce local Treg depletion and strong therapeutic activity. As a consequence, the safety and tolerability profile of the anti-CTLA4 antibody is expected to be greatly improved due to reduced systemic exposure.

BT-001 is being codeveloped through a 50/50 collaboration between BioInvent and Transgene.

"We are pleased to receive IND approval for this Phase 1/2a clinical trial of BT-001, which is BioInvent’s fourth clinical program. This unique oncolytic virus has very exciting potential as it combines multiple mechanisms of action and anti-cancer properties, and we are looking forward to developing it further with our partners at Transgene," said Martin Welschof, CEO of BioInvent.

Hedi Ben Brahim, Chairman and CEO of Transgene, said: "We have designed BT-001 to significantly improve treatment for patients with solid tumors by restoring their immune response against cancer. Its capacity to induce long-lasting antitumor immune responses and abscopal effects has been demonstrated in several tumor models. Patient accrual in the ongoing Phase 1 clinical trial is in line with our plan and highlight clinicians’ interest in this novel and promising immunotherapy approach. We are pleased to prepare the next step in its clinical development with this IND clearance which will allow us to enroll U.S. patients in this exciting clinical trial."

The Phase 1 trial is divided into two parts. Part A will enroll up to 36 patients with metastatic/advanced solid tumors. Patients will receive single agent, intra-tumoral administrations of BT-001. Part B will explore the combination of intra-tumoral injections of BT-001 with the standard treatment regimen of pembrolizumab in 12 patients. The Phase 2a part of the trial will evaluate BT-001-based combination regimen in several patient cohorts with different tumor types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.

About BT-001

BT-001 is a novel oncolytic virus developed with Transgene’s Invir.IO platform. Invir.IO’s viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR-. This optimization enhances the safety profile of the virus.

BT-001 is engineered to encode both a highly differentiated Treg depleting anti-CTLA4 antibody and the human GM-CSF cytokine. The recombinant antibody recognizing human CTLA4 was generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms. The use of an oncolytic virus to deliver the anti-CTLA4 locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both transgenes eliciting a stronger and more effective antitumor response, by reducing systemic exposure to a very low level.

Preclinical data have shown that BT-001 has potential for broad single agent activity, and that selective tumor-localized delivery of anti-CTLA4 may allow for a better tolerated, sustained and more effective combination therapy with antibodies targeting the PD-1/PDL1 axis.

The scientific and clinical development of the oncolytic virus candidate BT-001 is a 50/50 collaboration between BioInvent and Transgene.