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.

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.

On July 19, 2021 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) reported that it has entered into an exclusive, worldwide licensing agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to in-license the late stage monoclonal antibody candidate, suvratoxumab (Press release, Aridis Pharmaceuticals, JUL 19, 2021, View Source [SID1234584941]).

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The highlights of the agreement are:

Phase 3-ready candidate. Suvratoxumab monoclonal antibody (mAb) for prevention of pneumonia has been licensed from AstraZeneca. Suvratoxumab extends Aridis’ pneumonia franchise by complementing the existing AR-301 Phase 3 pneumonia treatment program.
Lancet ID publication. Phase 2 data involving n=196 patients recently published in The Lancet Infectious Diseases journal showed safety and a statistically significant (47%) relative reduction of pneumonia in S. aureus colonized, mechanically ventilated patients less than 65 years old, with corresponding reduction in the number of days needed in the ICU and hospital.i
Up to €25 million Euros funding (approximately $30 million). EU Commission’s Innovative Medicines Initiatives (IMI) funding for suvratoxumab Phase 3 clinical trial
AstraZeneca’s equity stake in Aridis. AstraZeneca becomes a shareholder of Aridis through the issuance of common stock and has right of first negotiation for future licensing of suvratoxumab.
Monoclonal
Antibody

Targeting

Disease

Development
Status

Next
Milestone

suvratoxumab or
‘AR-320’

Staphylococcus
aureus alpha
toxin

S. aureus colonized
patients at high risk
of developing
pneumonia

Phase 2
completed

Phase 3
launch

4Q-2021

Deal Highlights

Aridis acquires global exclusive rights for development and commercialization of
suvratoxumab for all indications
AstraZeneca retains rights of first negotiation for future licensing
Aridis will make an upfront payment to AstraZeneca of $11m in cash and Aridis common
stock. AstraZeneca will also receive up to a further $115m on achievement of certain
development and sales-related milestones, in addition to tiered royalties on net sales
Up to €25 million Euros (approximately $30m) from EU Commission’s Innovative Medicines
Initiative (IMI) COMBACTE clinical trial consortium for the Phase 3 trial for suvratoxumab
Development Overview: Suvratoxumab Phase 3 Clinical Study
Suvratoxumab and AR-301 are complementary products. Suvratoxumab’s focus on preventive treatment of S. aureus pneumonia complements Aridis’ AR-301 Phase 3 mAb program which is being developed as a therapeutic treatment of S. aureus pneumonia.

A multinational, randomized, double blinded, placebo controlled Phase 2 study (n=196 patients) showed that mechanically ventilated ICU patients colonized with S. aureus who are treated with suvratoxumab saw a relative risk reduction of pneumonia by 32% in the overall intend to treat (ITT) study population, and by 47% in the under 65 year old population, which is the target population in the planned Phase 3 study. The relative risk reduction in the target population reached statistical significance, and was also associated with a substantial reduction in the duration of care needed in the ICU and hospital.i [see https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30995-6/fulltext]

Aridis believes that suvratoxumab (product code name ‘AR-320’) will be first-line treatment, first to market, first-in-class pre-emptive treatment of S. aureus colonized patients. The same first-line, first to market and first-in-class strategy applies to the acute treatment with the monoclonal antibody AR-301 which the Company believes makes Aridis a globally dominant leader in this space.

Aridis comments
"We are pleased to have been selected as AstraZeneca’s licensee. The strong data from the Phase 2 trial gives us an advantage to define the patient population, primary endpoint, and the Phase 3 clinical study design to support a clear path to the Phase 3 confirmatory trial," said Vu Truong, Ph.D., Aridis’ Chief Executive Officer.

"We intend to efficiently leverage our collaboration with the globally renowned HAP/VAP experts in the EU Commission’s Innovative Medicines Initiative (IMI) COMBACTE consortium and our global network of existing clinical sites to launch the Phase 3 study for AR-320 in the 4th quarter this year," said Hasan Jafri, M.D., Aridis’ Chief Medical Officer. "We are delighted that this Phase 3-ready candidate is supported by IMI through the COMBACTE consortium and are excited to demonstrate the potential for suvratoxumab to fulfill an unmet medical need in a highly vulnerable and high-risk population, while also offering substantial pharmacoeconomic benefits," said Dr. Jafri.

AstraZeneca comments
Mark Esser, Vice President, Microbial Sciences, BioPharmaceuticals R&D, AstraZeneca said: "Suvratoxumab has the potential to transform pulmonary infection management in ventilated patients. We are pleased to complete this licensing deal with Aridis who we believe are well placed to take suvratoxumab forward."

IMI’s COMBACTE consortium comments
"On behalf of IMI’s COMBACTE consortium, I would like to express our continued support and strong enthusiasm for suvratoxumab," said Dr. Marc JM Bonten, MD/PhD, Managing Entity and Scientific and Academic coordinator of COMBACTE (University Medical Center, Utrecht). "We plan to leverage the consortium’s vast network of clinical sites and principal investigators across Europe to facilitate the execution of this important Phase 3 study to its timely completion," said Dr. Bonten.

Dr. Bruno Francois, a world renowned VAP expert and the Academic COMBACTE Lead for the Phase 3 study (University Hospital of Limoges) further added, "After the very promising SAATELLITE phase 2 trial, starting this phase 3 is very exciting as it could bring a new class of molecules to treat severe bacterial infections, to patients. The COVID pandemic has highlighted the importance of having therapeutic options to address emerging infectious threats and antimicrobial resistance (AMR) remains a serious threat. In this context, the AR-320 study is very timely. Lastly, the public-private partnership approach which made the phase 2 study successful, will undoubtedly be one of the major strengths of the coming phase 3 study."

About suvratoxumab (‘AR-320’)
Suvratoxumab (also referred to as MEDI4893) is a fully human, half-life extended IgG1 monoclonal antibody targeting S. aureus alpha toxin. Alpha-toxin is a key virulence factor that is secreted by both methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA). It is believed that AR-320 protects against alpha-toxin mediated destruction of host cells, preserving the human immune cells. AR-320’s mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA and MSSA.

About IMI’s COMBACTE Consortium
The European Commission’s Innovative Medicines Initiative (IMI) is the world’s biggest public-private partnership in the life sciences, whose goal is to develop next generation vaccines, medicines and treatments, such as new antibiotics [see View Source The IMI-funded COMBACTE project aims to give antibiotic drug development a much-needed boost by pioneering new ways of designing and implementing efficient clinical trials for novel antibiotics. COMBACTE forms part of the New Drugs for Bad Bugs (ND4BB) initiative, IMI’s wider program to tackle AMR. The COMBACTE consortium comprises a large network of over 1,000 hospitals in Europe that are potential clinical sites for clinical trial conduction [see View Source