On July 20, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will host a conference call and live webcast on Tuesday, August 3, 2021 at 8:30 a.m. Eastern Time to report its second quarter 2021 financial results and recent corporate and portfolio activity (Press release, Kiniksa Pharmaceuticals, JUL 20, 2021, View Source [SID1234585021]).

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A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will be available on Kiniksa’s website for 14 days following the conference. The conference call can be accessed by dialing (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 1485623.

On July 19, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the first patient has been dosed in the cohort expansion arm of the Phase 1/2 study evaluating the triple combination of COM701, Compugen’s first-in-class anti-PVRIG antibody, with Opdivo (nivolumab) and Bristol Myers Squibb’s investigational anti-TIGIT antibody, BMS-986207 (Press release, Compugen, JUL 19, 2021, View Source [SID1234584955]).

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"We continue to push forward as leaders in the DNAM axis space and as the only company evaluating a potential synergistic triple blockade of PVRIG, TIGIT and PD-1 in the clinic," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe that the future of immuno-oncology will be driven by combination therapy and this study examining our three-pathway hypothesis is an important component of our overall strategy and a key differentiator for Compugen in the TIGIT space. The study is designed to evaluate simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1 and test the hypothesis that blockade of both PVRIG and TIGIT, parallel DNAM pathways, may be required in certain tumor types to generate or enhance an anti-tumor immune response. The initiation of the cohort expansion phase of the study, allowing us to focus with the selected dose for expansion on specific patient populations where we believe the DNAM axis is dominant, is an important step to examine the potential benefit of this unique immunotherapy combination in a broader range of patients. We are on track to report preliminary data from the triple combination dose escalation arm of the study in the fourth quarter of this year."

Dr. Cohen-Dayag added, "We are delighted to have Bristol Myers Squibb as our partner in this study and are pleased to have their continued support and commitment to the collaboration."

The open-label Phase 1/2 trial is designed to evaluate the safety, tolerability, and preliminary antitumor activity of COM701 in combination with Opdivo and BMS-986207. Additional information is available at www.clinicaltrials.gov (NCT04570839).

Opdivo is a trademark of Bristol-Myers Squibb Company.

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated in preclinical studies potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. Compugen has identified PVRIG and TIGIT as key parallel and complementary inhibitory pathways in the DNAM axis, which also intersect with the well-established PD-1 pathway. Research from Compugen suggests that these three pathways have different dominance in different tumor types and patients, implying that to induce effective antitumor responses, certain patient populations may require the blockade of different combinations of these three pathways. To test this hypothesis, Compugen has established a science-driven, biomarker informed clinical program, which evaluates different combinations of these axis members across tumor types. Compugen is the only company with clinical assets targeting both PVRIG and TIGIT in its portfolio allowing it to more fully exploit the potential of blocking these parallel and complementary members of the DNAM axis to drive robust immune responses.

On July 19, 2021 Frontier Medicines Corporation, a precision medicine company seeking to unlock the proteome to advance breakthroughs against otherwise undruggable disease-causing targets, reported the closing of an $88.5 million Series B financing round (Press release, Frontier Medicines, JUL 19, 2021, View Source [SID1234585006]). The financing was co-led by Woodline Partners LP and RA Capital Management, with equal participation by Deerfield Management Company. Additional new investors in the round included Deep Track Capital, ArrowMark Partners, Driehaus Capital Management, and Sphera Healthcare alongside existing investors DCVC, Droia Ventures, and MPM Capital.

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"We welcome the new group of investors who participated in this financing and appreciate the confidence they have shown in our highly differentiated scientific approach," said Chris Varma, Ph.D., chairman, CEO, and co-founder of Frontier Medicines. "Between the substantial protein degradation partnership with AbbVie announced at the end of last year and this financing round, we have significantly strengthened our resources to deliver on our vision of developing breakthrough medicines for patients."

The proceeds will be used to advance Frontier’s wholly-owned pipeline of precision medicines against the most important drivers of cancer. The company’s lead program is uniquely focused on the inhibition of both the activated and inactive forms of KRASG12C, which is implicated in a number of cancers such as non-small cell lung cancer, colorectal carcinoma, and pancreatic ductal adenocarcinoma.

"The ability to target both forms of KRASG12C, which includes the active and inactive states of the protein, with a small molecule therapy would be a long-awaited scientific breakthrough," said Frank McCormick, Ph.D., FRS, professor of the UCSF Helen Diller Family Comprehensive Cancer Center. "Importantly for patients, a drug with this dual inhibition may be more efficacious than a drug that targets just the inactive form of KRASG12C by addressing the large majority of patients who are non-responders to first generation single-form KRASG12C inhibitors, as well as those patients whose tumors become resistant to the first-generation molecules."

Derek DiRocco, partner at RA Capital Management and the newest member of the Frontier Board of Directors, added, "The foundational technologies that Frontier has built are impressive and are uniquely integrated to form a compelling discovery and development platform. In addition to the lead programs targeting notable cancer drivers, Frontier has identified over 150,000 hotspots on proteins of interest that can fuel further pipeline growth across therapeutic areas and protein degradation."

In addition, the company revealed its Scientific Advisory Board (SAB), composed of renowned thought leaders and industry veterans who are an integral part of Frontier’s team:

Joan S. Brugge, Ph.D. is the director of the Harvard Ludwig Cancer Center and also a Louise Foote Pfeiffer Professor of Cell Biology at Harvard Medical School. She founded and was previously the scientific director of ARIAD Pharmaceuticals. She received the NIH Merit Award, an American Cancer Society Research Professorship and the ASCB Senior Career Recognition Award. She is an elected member of the American Academy of Arts and Sciences, the National Academy of Sciences and the National Academy of Medicine.

Giulio Draetta, M.D., Ph.D. is the chief scientific officer at the University of Texas MD Anderson Cancer Center. He is responsible for overall coordination of research efforts at MD Anderson, from discovery science to drug discovery and clinical translation, with the aim of better integrating academic and industrial science in the quest for cancer cures.

Steven Gygi, Ph.D. is a professor of Cell Biology at Harvard Medical School. His laboratory’s research centers around developing and applying new technologies in the field of mass spectrometry-based proteomics.

William C. Hahn, M.D., Ph.D. is the William Rosenberg Professor of Medicine and chief operating officer of Dana-Farber Cancer Institute, and is also an institute member of the Broad Institute. His laboratory focuses on understanding the cooperative interactions that conspire to transform human cells.

Kevin Koch, Ph.D. is the former chief scientific officer of Array BioPharma and a venture partner with OrbiMed. His expertise includes drug discovery, medicinal chemistry, and pre-clinical development.

Frank McCormick, Ph.D., FRS is a professor at the UCSF Helen Diller Family Comprehensive Cancer Center and a world-renowned expert in KRAS biology. His cancer-related work with biotechnology firms includes serving as director of molecular biology and vice president of research at Chiron Corporation. He founded and served as chief scientific officer at Onyx Pharmaceuticals, a company dedicated to developing new cancer therapies.

Daniel K. Nomura, Ph.D. is professor of Chemistry and professor of Molecular and Cell Biology, and Nutritional Sciences and Toxicology at UC Berkeley. He is a co-founder of Frontier Medicines and leading expert in chemoproteomics.

Roberto Zoncu, Ph.D. is an associate professor of Biochemistry, Biophysics and Structural Biology at UC Berkeley. He is a co-founder of Frontier Medicines and an expert in cancer biology, small GTPase signaling, and autophagy.

To further support its growth objectives, the company also announced the addition of a state-of-the-art facility in Boston, Massachusetts, where the company plans to build its employee expertise across research and development, including discovery, pre-clinical development, translational medicine, and early clinical development. The site will be integrated with Frontier’s South San Francisco, California headquarters, with department and project teams working across the two sites, including diverse talent that spans bench scientists to senior management.

On July 19, 2021 CytoDyn Inc. (OTCQB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Christopher Recknor, M.D., Chief Operating Officer and Head of Clinical Development, will host an investment community webcast on Thursday, July 22, 2021 (Press release, CytoDyn, JUL 19, 2021, View Source [SID1234585148]).

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Management will provide a full discussion of the results from the recently reported data from the mTNBC trials, along with updates on cancer, COVID-19, and NASH trials, and the status of the resubmission of the BLA for HIV.

Management will provide approximately 60 minutes to address questions submitted online by analysts and investors.

Prior to the webcast, questions can be submitted online to [email protected].
During the webcast, questions can be submitted through the webcast link below.
This is a "listen only" webcast, which can be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Participants are encouraged to go to the website 15 minutes prior to the start of the webcast to register, download and install any necessary software. Please note the below website will not be operational until approximately 60 minutes prior to the start of the webcast, which can be accessed via the following link:

https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/46064/indexl.html

The replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until August 22, 2021.

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.