On June 24, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that Thierry Guillaudeux, Ph.D., SVP Immuno-oncology at Kineta, participated on multiple panel presentations during the virtual symposium "VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond," that took place on June 18, 2021 (Press release, Kineta, JUN 24, 2021, View Source;utm_medium=rss&utm_campaign=kinetas-thierry-guillaudeux-participated-on-multiple-panel-presentations-during-virtual-symposium-on-vista-a-new-immunotherapy-approach-to-treating-cancer [SID1234584382]).

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"It was a great pleasure to participate in this symposium focused on VISTA", said Thierry Guillaudeux of Kineta. "The scientific presentations and discussions from the different panelists clearly emphasized how VISTA is a promising new immuno-oncology target for treating patients with advanced tumors. Its unique mechanism of action involving both an innate and adaptive immune response illustrates that antibody therapy targeting VISTA could be an important new path in cancer treatments with this new generation of checkpoint inhibitors."

The scientific symposium focused on the emerging checkpoint inhibitor VISTA, its function, the role it plays in several oncology and current development programs. The event was hosted by Randolph Noelle, Ph.D., Professor of Microbiology and Immunology, Department of Microbiology and Immunology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth; and Padmanee Sharma, M.D., Ph.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center.

"Kineta has made tremendous progress developing KVA12.1, our novel anti-VISTA antibody currently in preclinical evaluation", said Thierry Guillaudeux of Kineta. "We nominated KVA12.1 as our lead clinical candidate earlier this year and have initiated IND enabling studies. We expect to initiate Phase 1 safety and tolerability studies in mid-2022".

On June 24, 2021 Takara Bio Inc. reported that it has entered into a License and Supply Agreement with BioNTech Cell & Gene Therapies GmbH ("BioNTech"), a BioNTech SE company (www.BioNTech.de), Germany, under which Takara Bio grants BioNTech a commercial license to use applicable patents relating to RetroNectin (Press release, Lifescience Newswire, JUN 24, 2021, View Source [SID1234584381]). Under this agreement, Takara Bio provides BioNTech with reliable supplies of RetroNectin.

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The patented technologies licensed to BioNTech are based on Takara Bio’s proprietary RetroNectin method, which includes a technology enabling highly efficient gene transduction to cells by retrovirus/lentivirus vector and expansion of T-cells with high efficiency. With such advantages, RetroNectin method is one of the mostly used standard protocols utilized for "Engineered T-cell Therapy", which includes promising TCR and CAR gene therapies recently raising higher expectations.

Under the agreement signed with Takara Bio, BioNTech is allowed to use RetroNectin for production of its cell & gene therapy products, therapies in which a patient’s T cells are genetically engineered to express a CAR for the treatment of multiple solid tumors.

Takara Bio is promoting supply of RetroNectin to clinical development of Engineered T-cell Therapy actively pursued worldwide in recent years, and expects higher sales growth in the future.

On June 24, 2021 Boston Scientific Corporation (NYSE: BSX) reported it exercised its option to acquire the remaining shares of Farapulse, Inc (Press release, Boston Scientific, JUN 24, 2021, View Source,-Inc [SID1234584380]). The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the FARAPULSE Pulsed Field Ablation (PFA) System – a non-thermal ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias .

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"The emerging field of PFA has the potential to alter the future of ablation therapy and has shown the promise of improvements in both safety of cardiac ablations for patients and efficiency and ease-of-use of these procedures for physicians," said Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific. "The FARAPULSE PFA System is intended to enable physicians to precisely ablate cardiac tissue while minimizing procedural complications, and real-world and clinical evidence from trials throughout Europe have demonstrated encouraging, positive results."

Boston Scientific has been an investor in Farapulse since 2014 and currently holds an equity stake of approximately 27 percent. As a result, the transaction consists of an upfront payment of approximately $295 million for the 73 percent stake not yet owned, up to $92 million upon achievement of certain clinical and regulatory milestones as well as additional revenue-based payments for the next three years.+

"The more than $6 billion electrophysiology market continues to expand, growing double digits year-over-year, and adding this technology to our existing portfolio enables Boston Scientific to be the only company to offer physicians comprehensive therapeutic options they can select based on clinical preference and individualized patient needs," said Scott Olson, senior vice president and president, Rhythm Management, Boston Scientific.

Farapulse became the first company to commercialize a cardiac PFA technology after receiving CE Mark for the FARAPULSE PFA System in Europe in the first quarter of 2021. The company also initiated its pivotal IDE trial in the U.S. – the ADVENT trial – in March 2021. All trial sites have been identified and more than 100 patients have been enrolled to date in the prospective, randomized trial. The study is comparing the FARAPULSE PFA System to standard-of-care ablation in patients with paroxysmal – or intermittent – AF with a primary endpoint of freedom from AF at 12 months after a single ablation procedure.

"We are encouraged by the positive reception to the commercial launch of the FARAPULSE PFA System in Europe, which we believe underscores the demand for a simpler way to treat AF," said Allan Zingeler, president and chief executive officer, Farapulse, Inc. "The strength and breadth of the Boston Scientific team will position this breakthrough technology for success and accelerate progress towards regulatory approval in the U.S."

On an adjusted basis, the transaction is expected to be slightly dilutive to adjusted earnings per share (EPS) in 2021 and 2022, which Boston Scientific expects to offset via internal cost efficiencies and trade-offs. On a GAAP basis, the transaction is expected to be more dilutive due to amortization expense and acquisition-related charges, except for a one-time gain to be recognized at closing associated with our previously held equity interest in Farapulse. The transaction is anticipated to close in the third quarter of 2021, subject to customary closing conditions.

*In the U.S., the Farapulse platform is an investigational device and not available for sale.

+Preceding consideration of current equity ownership, debt and other closing adjustments, the transaction price consists of $450 million up front, up to $125 million upon achievement of certain clinical and regulatory milestones as well as additional revenue-based payments through calendar year 2023.

On June 24, 2021 Monte Rosa Therapeutics reported that it is capping off a fundraising spree with a $222.3 million IPO to get two of its "molecular glue" treatments into the clinic and advance its other discovery-stage programs (Press release, Monte Rosa Therapeutics, JUN 24, 2021, View Source [SID1234584378]).

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The company raised $96 million in September 2020 to develop its drug discovery platform and expand its pipeline into diseases beyond cancer. It followed up with another $95 million six months later, ending the first quarter of 2021 with $168.4 million, according to a securities filing. Of course, drug development is an expensive business, and Monte Rosa filed in early June to raise up to $100 million in its IPO.

Despite being a preclinical biotech with much to prove, it bumped that IPO goal up to $213 million earlier this week, eventually collecting $222.3 million by offering 20% more shares than originally planned. But seeing a biotech go public without any human data isn’t unusual these days; even before the COVID-19 pandemic spurred interest and investment in the sector, companies had been hitting Wall Street at increasingly earlier stages of development.

RELATED: Monte Rosa snags $95M to speed lead ‘molecular glue’ treatment into the clinic

Molecular glues are small molecules designed to treat disease by commandeering the body’s own protein degrading process. As their name suggests, they work by sticking proteins to each other.

Monte Rosa earmarked about $47 million to $57 million for a cancer treatment that targets GSPT1, which plays a role in cancers driven by the Myc family of transcription factors. The cash should get it through a phase 1/2 study.

Beyond GSPT1, Monte Rosa will use between $120 million and $130 million to get a second program into phase 1, a third program to an IND filing and a fourth to IND-enabling studies, according to the filing. Another $65 million to $75 million will bankroll the development of its drug discovery platform.

"[Molecular glues] work by allosterically changing the receptor surface of E3 ligases to attract a protein target," said Monte Rosa CEO Markus Warmuth, M.D., referring to enzymes that tag proteins with ubiquitin for degradation by a protein complex called a proteasome, in a previous interview. "We have a singular focus on finding these molecules that reshape the surface of an E3 ligase and thereby attract otherwise undruggable targets."

RELATED: Sana snags $587.5M IPO to catapult cell therapies into the clinic

The best-known molecular glue medicines are thalidomide and its successor molecule lenalidomide—aka Bristol Myers Squibb’s blood cancer drug Revlimid—which both reshape an E3 ligase receptor called cereblon. However, this class of drugs hasn’t been hunted in a systematic way in the past, which is exactly what Monte Rosa’s technology allows it to do.

Monte Rosa isn’t alone in the protein degradation field, but it believes molecular glues can go where other approaches cannot. Other players are working on the hypothesis that eliminating disease driving proteins is a better approach than inhibiting them. They’re "redrugging the druggable," Warmuth said, developing degraders for targets that can be inhibited by traditional drugs.

Arvinas, for example, is developing drugs called proteolysis targeting chimeras, or PROTACs, to degrade the androgen and estrogen receptors, which are major drivers of prostate cancer and breast cancer, respectively. And Kymera Therapeutics is working on degraders of scaffolding kinase IRAK4 and transcription factor STAT3, both of which play a role in cancer.

Monte Rosa wants to go after targets like GSPT1 that haven’t been accessible because drug developers didn’t have the technology to handle them.

On June 24, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported that Daniel O’Connor has resigned and that Brian Leuthner, formerly Chief Operating Officer, has been appointed Interim Chief Executive Officer, effective June 25, 2021 (Press release, OncoSec Medical, JUN 24, 2021, View Source [SID1234584371]). Mr. O’ Connor is also stepping down from his seat on the Board of Directors.

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"Under Dan’s leadership over the past four years, OncoSec has transformed itself into the leading intra-tumoral cancer immunotherapy Company," said Margaret Dalesandro, Ph.D., Chair of the Board of Directors at OncoSec. "Dan operationally drove several value-creating clinical programs with the Company’s lead product candidate, TAVO, including the now fully enrolled pivotal study in anti-PD-1 checkpoint refractory metastatic melanoma patients, KEYNOTE-695, as well as a phase 2 program in metastatic triple negative breast cancer. Under his leadership, OncoSec is well-capitalized to meet important inflection points and has established a string of strategic partnerships with large pharma companies and top research institutions. On behalf of the Board, I want to thank Dan for his tireless work ethic and leadership in delivering to our shareholders a Company that is now extremely well-positioned for success."

Dr. Dalesandro continued, "Brian Leuthner, a former public company CEO with decades of experience, will now step into the CEO role bringing fresh energy and his own brand of leadership, which we are confident will enhance the Company’s upward trajectory and further exploit the potential of our platform for the benefit of both cancer patients and our shareholders. In parallel, I, along with the Board, will evaluate and potentially identify a new CEO candidate who will work to ensure that we reach the next evolution as the leading intra-tumoral cancer immunotherapy company."

Mr. Leuthner joined OncoSec in February 2021. Over the course of his 32-year career in biotech and pharmaceuticals, Mr. Leuthner has held several leadership positions, including several public and private CEO positions. For a decade, Mr. Leuthner was co-founder, President, and CEO of Edge Therapeutics, Inc., an orphan disease-focused company.

Mr. Leuthner added, "I came to OncoSec because I saw it as a well-established company with valuable technology that I believed I could further enhance. As OncoSec’s Interim Chief Executive Officer, I look forward to adding to the momentum Dan built as we strive to improve the long-term outcomes to patients living with cancer"

About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.