On June 29, 2022 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, reported the initiation of patient dosing in its Phase 1 clinical trial of exoASO-STAT6, an engineered exosome precision medicine candidate designed to selectively deliver antisense oligonucleotides to disrupt STAT6 signaling in tumor associated macrophages (TAMs) and induce an anti-tumor immune response (Press release, Codiak Biosciences, JUN 29, 2022, View Source [SID1234616363]). exoASO-STAT6 is Codiak’s third clinical program and the first to evaluate a systemically administered exosome-based drug candidate .

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"Targeting macrophages is the next great frontier in cancer immunotherapy and we are encouraged by the monotherapy anti-tumor activity exhibited by exoASO-STAT6 in preclinical models, which has not been observed among other approaches to date. We believe this may indicate the potential to bring transformative treatments to patients facing intractable forms of cancer," said Douglas E. Williams, Ph.D., CEO, Codiak. "The initiation of this trial is also a significant milestone for our company, as the advancement of exoASO-STAT6 into the clinic highlights the versatility of our engineering platform. This candidate is the first of our programs to target macrophages, the first to carry a nucleic acid and the first to be administered intravenously."

The Phase 1 clinical trial will evaluate the safety, tolerability, biomarkers and preliminary anti-tumor activity of exoASO-STAT6 in patients with advanced hepatocellular carcinoma (HCC), patients with liver metastases from primary gastric cancer and colorectal cancer (CRC). The study is anticipated to enroll patients across four cohorts at sequentially escalating dose levels, with subjects in the initial cohorts receiving biweekly exoASO-STAT6 administered intravenously over the course of 28 days. Ultimately the trial may enroll up to 30 patients. Initial Phase 1 data are expected in the first half of 2023.

TAMs promote tumor growth by exhibiting an immune suppressive M2 phenotype. Reprogramming TAMs toward a pro-inflammatory M1 phenotype may be a compelling approach to induce anti-tumor immunity. The M2 phenotype is controlled by key transcription factors such as STAT6, which have proven difficult to drug selectively in TAMs using prior approaches. Codiak plans to initially develop exoASO-STAT6 for primary cancers of the liver, where STAT6 expression has been correlated with poor survival.

In multiple in vivo preclinical studies, exoASO-STAT6 demonstrated potent single agent activity, including >90% tumor growth inhibition and 50-80% complete responses. In HCC models, exoASO-STAT6 induced significant knockdown of STAT6 mRNA, attenuated tumor growth and induced complete remission of tumor lesions in 50% of mice. This anti-tumor activity was enhanced (75% complete remissions) when exoASO-STAT6 was administered with anti-PD1 antibodies. The monotherapy activity was accompanied by remodeling of the tumor microenvironment including significant expansion of M1-like macrophages and induction of an adaptive anti-tumor immune response, enabling tumor elimination.

About the engEx Platform

Codiak’s proprietary engEx Platform is designed to enable the development of engineered exosome therapeutics for a wide spectrum of diseases and to manufacture them reproducibly and at scale to pharmaceutical standards. By leveraging the inherent biology, function and tolerability profile of exosomes, Codiak is developing engEx exosomes designed to carry and protect potent drug molecules, provide selective delivery and elicit the desired pharmacology at the desired tissue and cellular sites. Through its engEx Platform, Codiak seeks to direct tropism and distribution by engineering exosomes to carry on their surface specific targeting drug moieties, such as proteins, antibodies/fragments, and peptides, individually or in combination. Codiak scientists have identified two exosomal proteins that serve as surface and luminal scaffolds. By engineering the exosome surface or lumen and optimizing the route of administration, Codiak aims to deliver engEx exosomes to the desired cell and tissue to more selectively engage the drug target, potentially enhancing the therapeutic index by improving potency and reducing toxicity.

On June 29, 2022 Fuzionaire Diagnostics, Inc. ("Fuzionaire Dx") reported a collaborative research agreement with McMaster University ("McMaster") under which theranostic radiopharmaceuticals developed with Fuzionaire Dx’s HetSiFA platform will be evaluated at McMaster’s comprehensive preclinical nuclear medicine facilities (Press release, Fuzionaire Diagnostics, JUN 29, 2022, View Source [SID1234616380]).

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The collaboration expands Fuzionaire Dx’s capabilities to evaluate oncologic theranostics made from its HetSiFA platform. The collaboration will begin with the biological and preclinical evaluation of multiple theranostic candidates targeting an undisclosed type of cancer and selection of promising candidates for further development.

Fuzionaire Dx creates theranostic candidates by combining its HetSiFAs, or heteroaromatic silicon-fluoride acceptors, with cancer-targeting peptides and other ligands. With the HetSiFA library, new theranostic candidates are created within weeks. The HetSiFA platform is compatible with fluorine-18, the leading radionuclide used in positron-emission-tomography (PET) imaging, and leading alpha- and beta-emitting radionuclides used for therapy, providing unique flexibility in creating new candidates.

Theranostics is a term that describes a "see it, treat it" approach to cancer that uses one radioactive drug to reveal tumor locations and a second radioactive drug to deliver therapy that kills cancer cells.

Primary leadership for the scientific collaboration includes Christopher Waldmann, PhD, Chief Scientific Officer of Fuzionaire Dx, and Saman Sadeghi, PhD, Associate Professor, Chemistry & Chemical Biology, and Principal Investigator, Radiochemistry & Radiopharmaceuticals, at McMaster University.

On June 29, 2022, Seres Therapeutics, Inc. (the "Company") reported that entered into a Securities Purchase Agreement with certain institutional accredited investors (the "IAIs") named therein (the "Non-Affiliate Purchase Agreement") and a Securities Purchase Agreement with certain directors and officers of the Company (the "Affiliates", and collectively with the IAIs, the "Purchasers") named therein (the "Affiliate Purchase Agreement" and, together with the Non-Affiliate Purchase Agreement, the "Purchase Agreements") (Filing, 8-K, Seres Therapeutics, JUN 29, 2022, View Source [SID1234616399]). Pursuant to the Purchase Agreements, the Company agreed to issue and sell in a registered direct offering (the "Offering") (i) an aggregate of 31,238,094 shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at a purchase price of $3.15 per share (the "Purchase Price") to the IAIs, for aggregate gross proceeds to the Company of $98.4 million, and (ii) an aggregate of 507,936 shares of Common Stock at the Purchase Price to the Affiliates, for aggregate gross proceeds to the Company of $1.6 million, in each case pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-244401) and a related prospectus supplement filed with the Securities and Exchange Commission. The closing of the Offering is expected to occur on or about July 5, 2022, subject to the satisfaction of customary closing conditions.

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The Company expects to receive net proceeds from the Offering of approximately $96.8 million, after deducting the placement agent’s fees and estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for commercial readiness and manufacture of SER-109 for the U.S. market, including expanding longer-term commercial manufacturing capacity, advancing the clinical development of SER-109 for the EU market, and other general corporate and working capital purposes. The Company believes that its existing cash, cash equivalents and investments, together with the net proceeds from the Offering, will fund its operations for at least 12 months from the date of the prospectus related to the Offering filed with the Securities and Exchange Commission (the "SEC") on June 30, 2022. This evaluation does not take into consideration contingent payments associated with SER-109 FDA approval, which the Company anticipates in the first half of 2023, as these are uncertain and there is no assurance the Company will receive them. These contingent payments include the potential to receive a $125 million milestone payment pursuant to the Company’s collaboration and license agreement with NHSc Pharma Partners upon SER-109 FDA approval and a $25 million tranche under its existing term loan with Hercules Capital, Inc., which becomes available upon the satisfaction of certain conditions, including FDA approval of SER-109.

The Purchase Agreements contain customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Purchasers, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions.

The foregoing description of the Purchase Agreements is not complete and is qualified in its entirety by reference to the full text of the Non-Affiliate Purchase Agreement and Affiliate Purchase Agreement, forms of which are filed as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.

On June 29, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported that it has initiated ROSELLA, a pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, JUN 29, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-initiates-rosella-pivotal-phase-3-trial [SID1234616364]).

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"We are excited that our ROSELLA study is now open," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "The 20,000 women in the United States and an equal number in Europe with platinum-resistant ovarian cancer have few good treatment options. Our Phase 2 study demonstrated improvements in progression free survival, duration of response and overall survival without increased side effect burden. Our goal in Phase 3 is to replicate these positive results, which would be of unprecedented benefit to women with platinum-resistant ovarian cancer, for whom relacorilant plus nab-paclitaxel has the potential to become a new standard of care."

ROSELLA has a planned enrollment of 360 women with recurrent, platinum-resistant ovarian cancer, randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy. The primary endpoint will be progression-free survival, with overall survival as a key secondary endpoint. The ROSELLA trial design closely tracks the design of Corcept’s successful Phase 2 study. Additional information about ROSELLA and Corcept’s Phase 2 trial results can be found at the publications and press releases tabs of www.corcept.com.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women.1 Patients whose disease returns less than six months after receiving platinum-containing therapy are described as having "platinum-resistant" disease. In the United States, approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year.2 There are few treatment options and median overall survival following recurrence of disease is 12 months or less with single-agent chemotherapy.3 No approved therapy has been shown to significantly extend overall survival in patients with recurrent, platinum-resistant ovarian cancer compared to standard chemotherapy.4

About Corcept’s Oncology Programs

There is substantial evidence that cortisol activity at the glucocorticoid receptor ("GR") reduces the efficacy of certain anti-cancer therapies and that modulating cortisol’s activity may help anti-cancer treatments achieve their intended effect.

Many types of solid tumors express the GR and are potential targets for cortisol modulation therapy. In some cancers, cortisol inhibits cellular apoptosis – the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response; activating – not suppressing – the immune system is beneficial in fighting certain cancers.

Corcept is conducting clinical trials of its proprietary selective cortisol modulators in combination with three different anti-cancer treatments in patients with ovarian, adrenal and prostate cancers. Corcept’s first controlled study in oncology – relacorilant plus nab-paclitaxel for the treatment of patients with ovarian cancer – has demonstrated statistically significant and clinically meaningful results.

About Relacorilant

Relacorilant is a non-steroidal, selective glucocorticoid receptor modulator that does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian and adrenal cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents, as well as orphan drug designation in the United States for the treatment of pancreatic cancer and both the United States and the European Union for the treatment of Cushing’s syndrome.

On June 29, 2022 Bayer AG reported the opening of its new Research and Innovation Center at Kendall Square in Boston-Cambridge, Massachusetts (U.S.A.), expanding the company’s footprint into one of the world’s most innovative pharmaceutical research and development locations (Press release, Bayer, JUN 29, 2022, View Source [SID1234616381]). Representing a total $140M USD investment into the area, Bayer’s 62,100-square-foot facility houses a new center of precision molecular oncology research equipped with state-of-the-art laboratories and offices for the development of novel targeted cancer therapies for patients. In addition, the center comprises a newly established research team focused on leveraging chemical biology techniques to further propel the company’s oncology drug development process.

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"Our new Bayer research and innovation center at Kendall Square is part of our strategy to be at the forefront of scientific discovery and breakthrough innovation for better patient healthcare," said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division. "Being part of this unique innovation ecosystem will support our teams in creating breakthrough innovations for patients together with the experts here."

"Bayer is undergoing significant growth in the United States in both research and development and our commercial operations," said Sebastian Guth, Ph.D., President of Bayer Pharmaceuticals, Americas Region. "The opening of our new precision molecular oncology research center in Kendall Square reflects the deep commitment Bayer is making to scale our oncology presence in the United States. It also builds on collaborations already in place in Boston in cardiovascular, another key area of focus for Bayer, with our with joint laboratories in precision cardiology with the Broad Institute of MIT and Harvard."

Spanning across two floors, the new center currently provides space for 100 employees, while the company is prepared to fill an additional 50 roles in the coming months. It is designed to enhance the collaboration between Bayer research and development, its internal partners such as BlueRock Therapeutics, Asklepios BioPharmaceutical (AskBio) and Vividion Therapeutics, as well as external partners to accelerate the development of transformative treatments for patients. In addition to the new center at Kendall Square in Cambridge, Bayer has also established strategic research collaborations with top scientific partners in Boston, including joint laboratories in the areas of lung disease with Brigham and Women’s Hospital and Massachusetts General Hospital and precision cardiology with the Broad Institute of MIT and Harvard.

The Research and Innovation Center also marks a strategic investment into Bayer’s oncology innovation to transform healthcare for people living with cancer worldwide, and at the same time to, ensure sustainable long-term growth for the company. Striving to become a top 10 oncology company by 2030, Bayer is investing a significant portion of its global R&D budget toward oncology. The new precision molecular oncology research center will drive the development of targeted next-generation cancer therapies, including efforts to help people living with cancer benefit from molecular tests and targeted treatments through biomarker testing.

Bayer has a 160-year track record of delivering scientific innovation for patients in areas of high medical need and has long embraced external innovation and partnering. Since 2020, Bayer has secured more than 40 transactions in business development and licensing and has invested $1.2B USD in innovative healthcare companies through Leaps by Bayer. The new center is expected to play a role for future partnering investments and collaborations.

With this new center, Bayer is expanding its operations in the leading life sciences cluster worldwide. Boston-Cambridge is home to approximately 1,000 biotechnology companies, with Kendall Square being the center of pharmaceutical innovation on the East Coast of the USA. The company is now present in four of the largest biotechnology hubs in the United States – Boston, San Francisco, San Diego and Research Triangle Park, NC.