On September 7, 2023 Natera, Inc. (Nasdaq: NTRA), a global leader in cell-free DNA (cfDNA) testing, reported the pricing of its underwritten public offering of 4,550,000 shares of its common stock at a price to the public of $55.00 per share (Press release, Natera, SEP 7, 2023, View Source [SID1234635013]). Closing of the offering is expected to occur on September 11, 2023, subject to customary closing conditions. In addition, Natera has granted the underwriters a 30-day option to purchase up to an additional 682,500 shares of its common stock at the public offering price less the underwriting discounts and commissions.

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Morgan Stanley, Goldman Sachs & Co. LLC, TD Cowen and Piper Sandler are acting as joint book-running managers for the offering. Baird is acting as lead manager for the offering. Raymond James and Craig-Hallum are acting as co-managers for the offering.

The securities described above are being offered pursuant to an automatically effective shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on September 6, 2023, including a preliminary prospectus. Copies of the preliminary prospectus and, when available, final prospectus may be obtained by contacting Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Goldman Sachs & Co. LLC, 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526 or by emailing [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 333-6000, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 7, 2023 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), a global biotech company focusing on the discovery of novel antibody therapeutics, reported an antibody evaluation, option and license agreement with Myricx Bio (‘Myricx’), a UK biotech company focusing on the discovery and development of a completely novel class of selective cytotoxic payloads for antibody drug conjugates (ADCs) (Press release, Biocytogen, SEP 7, 2023, View Source [SID1234635012]).

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Under the terms of the agreement, Myricx will provide its proprietary linker and payload and Biocytogen will conjugate them with its RenMice-derived fully human antibodies to make ADCs. Biocytogen will carry out feasibility tests for these ADCs as CRO services, and upon option exercise, Myricx will be responsible for further development and commercialization. Biocytogen will receive an upfront payment and, subject to exercise Biocytogen will be eligible to receive ongoing development and commercialisation milestone payments, as well as single-digit royalties on net sales.

In this project, the antibodies developed by Biocytogen were not only screened by its high specificity, cross-species reactivity, high affinity and good developabilities, but also by its high internalization activity specifically for ADC uses.

NMT is an enzyme that adds a specific lipid modification to a number of protein targets key to cancer cell survival. Myricx is developing a pipeline of ADCs to address serious unmet needs in oncology based on its NMT inhibitor (NMTi) payload chemistry platform and has demonstrated excellent preclinical efficacy and safety across multiple solid tumour associated antigens and cancer cell types.

"Thanks to Myricx recognition of our antibody assets, preclinical discovery expertise and CMC capabilities," said by Dr. Yuelei Shen, President and CEO of Biocytogen. "Myricx is a leading expert in NMTi payloads and we believe that the combination of both companies’ strengths will result in ADC drugs with first-in-class and best-in-class potential."

Myricx CEO Dr Robin Carr said: "We are delighted to have reached this agreement with Biocytogen with ground-breaking technology to develop novel antibodies for use in drug development. We believe that the combination of its antibody with our novel NMTi-based selective cytotoxic payloads will enable us to develop best-in-class ADCs to meet significant clinical needs in oncology. NMT inhibitors represent a novel class of ADC payloads that can be exploited as targeted therapies in cancer. Based on our positive proof of concept data we believe that ADC-NMTi offers huge potential for selective cancer cell killing via its unique mechanism of action."

On September 7, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer, reported that Maria Zannes, President and CEO, will present a corporate update and hold meetings with institutional investors during the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023 (Press release, BioAffinity Technologies, SEP 7, 2023, View Source [SID1234635011]).

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Institutional investors interested in arranging a meeting with bioAffinity Technologies management can register to attend the conference virtually or in-person at the Lotte New York Palace Hotel or contact Tirth Patel at LHA at [email protected].

On September 7, 2023 AnHeart Therapeutics ("AnHeart"), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, reported the first patient has been dosed in a Phase 2 clinical trial, G203, evaluating safusidenib in patients with Grades 2 or 3 recurrent or progressive mutant isocitrate dehydrogenase 1 (mIDH1) glioma, one of the most common types of adult primary brain cancer (Press release, AnHeart Therapeutics, SEP 7, 2023, View Source [SID1234635010]).

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Oncogenic mutations in IDH1 are frequently found in gliomas and current treatment options, including chemotherapy and radiotherapy, can cause significant impact on neurocognition and quality of life. Safusidenib is a novel, selective, potent, oral mIDH1 inhibitor. Safusidenib has shown high blood-brain barrier penetration in both pre-clinical and clinical studies. Encouraging anti-tumor activity was observed in a Phase 1 clinical trial in patients with recurrent IDH1-mutant gliomas.

"IDH1 mutations are now known to be a key driver in the development of IDH-mutant gliomas and we are excited by the potential of IDH targeted therapy for our patients, who tend to be in the prime of their life at diagnosis," said Professor David Reardon, the leading Principal Investigator of the G203 clinical trial and Clinical Director at the Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston. "Early data suggest safusidenib may have a role in IDH1-mutant gliomas, notably in high-risk populations, and we look forward to further evaluating this investigational therapy in the G203 trial."

"This marks an important milestone for AnHeart, as we now have two investigational precision therapies in late-stage clinical trials," said Jerry Wang, PhD, Chief Executive Officer of AnHeart. "Our mission is to improve the lives of people with cancer. Our strategy is to target known genetic drivers of cancer with the goal of bringing next-generation medicines that raise the bar for what patients should expect from cancer treatment. We look forward to sharing additional updates as we continue to progress our clinical programs."

About the G203 Phase 2 Safusidenib Trial

G203 (NCT05303519) is a global Phase 2, multicenter, open-label, two-part clinical trial evaluating the efficacy and safety of safusidenib as a monotherapy in approximately 95 patients with recurrent or progressive WHO Grade 2 or Grade 3 IDH1-mutant glioma. The trial is divided into two parts. Part 1 is designed to confirm the optimal dose of safusidenib. Part 2 will evaluate the efficacy and safety of safusidenib in Grade 2 or Grade 3 glioma. Currently, patients are being enrolled in the United States, with expansion to other countries planned for Part 2 of the trial.

About Safusidenib

Safusidenib is a novel, selective, potent, oral mIDH1 inhibitor. Safusidenib has shown high blood-brain barrier penetration in both pre-clinical and clinical studies. Encouraging anti-tumor activity was observed in a Phase 1 clinical trial (NCT03030066) evaluating safusidenib in patients with recurrent or progressive WHO Grades 2 to 4 IDH1-mutant gliomas. In the trial, the objective response rate (ORR) was 33% (4/12) and 17% (6/35) in patients with contrast non-enhancing and enhancing tumors, respectively. Tumors that show enhancement on MRI scans tend to have more vascularization and disruption to the blood-brain barrier and are generally associated with a higher degree of malignancy compared with non-enhancing tumors.

Safusidenib demonstrated a tolerable safety profile. Most adverse events (AEs) were Grades 1 or 2. 43% of patients experienced at least one Grade 3 treatment emergent AE. No Grade 4 or 5 AEs or serious treatment-related AEs were reported.

AnHeart licensed safusidenib from Daiichi Sankyo in 2020 and owns global rights for safusidenib, excluding Japan where Daiichi Sankyo retains development and commercial rights.

About Glioma

Glioma is the most common type of adult brain cancer. Approximately 30,000 patients are diagnosed with IDH1-mutant gliomas in the United States, Europe, and China annually. Patients are typically diagnosed in the prime of their life in their mid-forties to early-fifties. IDH1 mutations are present in the majority of Grade 2 or 3 diffuse gliomas and IDH-mutant gliomas are recognized as distinct tumor subtypes by the World Health Organization (WHO).

There are no targeted treatments approved for IDH-mutant glioma. Current treatment options include surgery, radiation, and chemotherapy, which can cause significant impact on neurocognition and quality of life.

On September 7, 2023 Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, reported that Dr. Phil Campbell, Professor of Biomedical Engineering at CMU, presented his talk, "Rapid Functionalization of Treg Exosomes for Targeted Immunotherapy" at the 5th Exosome Based Therapeutic Development Summit in Boston, MA this morning (September 7, 2023) (Press release, Coya Therapeutics, SEP 7, 2023, View Source [SID1234635009]). The presentation can be accessed here.

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Coya and CMU entered into a Research Collaboration Agreement and Option Agreement in 2022 to develop a unique patented technology intended to advance the potential use of exosomes for the treatment of diseases of unmet need.

In this study, it was demonstrated that by using a proprietary cholesterol DNA tether technology, Treg exosome membranes could be engineered to controllably immobilize CTLA-4, a membrane surface active protein, onto the Treg exosome surface resulting in stable CTLA-4-Treg exosomes. It was also demonstrated that CTLA-4-Treg exosomes exhibited far better cell uptake then non-modified Treg EVs in representative immune cells, macrophages (J7774 murine cell line) and T-cells (human Jurket cell line).

Previously, using the same technology, CMU demonstrated applications in Oncology by engineering mesenchymal derived exosomes with an immunomodulatory apoptotic inducing protein, Fas Ligand (FAS-L). The results demonstrate that targeted delivery of FASL-exosomes substantially increases its therapeutic effect with enhanced apoptosis in tumor cells and suppression of alloreactive T cells in mice, while minimizing potential off target effects. This publication is available here.

Tregs are important immunomodulatory cells, with a key role controlling inflammation, enabling self-tolerance, and promoting regenerative processes. Treg-derived exosomes share many of the properties of the parent Treg cells making them able to modulate physiological and pathophysiological processes. The proprietary technology generates Exosome Polymer Hybrids (EPHs) which allow for efficient and versatile method of engineering and customizing cargos of Treg-derived exosomes using oligonucleotide tethers. Delivering EPHs to sites of inflammation or epitopes that drive specific diseases, while delivering customized loads, enables the next generation of selectively targeted and potent Treg-derived exosomes.

Engineered exosomes may have multiple advantages, including low immunogenicity, improved stability, increased plasma retention after systemic delivery and increased residence time following local delivery, enhanced biodistribution, improved cell binding and uptake, and enhanced targeted therapeutic response.

Dr. Fred Grossman, President and Chief Medical Officer of Coya stated, "This proprietary technology expands Coya’s pipeline to include autoimmune disorders and cancer. These engineered exosomes are a cell – free drug delivery system without genetic modification that can travel throughout the body unimpeded, including through the blood brain barrier, to provide specific targeted therapies."