On October 3, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) for the treatment of unresectable, recurrent/metastatic human papilloma virus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC) (Press release, PDS Biotechnology, OCT 3, 2022, View Source [SID1234621636]).

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"We are very pleased with the guidance received from FDA on key elements of the clinical program that will support the submission of a Biologics License Application (BLA) for our lead asset PDS0101," said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "The interim safety and efficacy data we presented to the FDA has allowed us to move into a registrational trial ahead of our projected schedule. This, along with the recent capital raise, allows us to efficiently advance our clinical programs."

Earlier this year, the FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA (pembrolizumab) for the treatment of HPV16-positive HNSCC. The FDA’s Fast Track designation program is designed to aid in the development and to expedite the review of drug candidate applications that could potentially treat serious or life-threatening conditions. Treatments granted this designation are given the opportunity to have more frequent meetings and interactions with the FDA throughout the entire drug development and review process, with the goal of moving promising new drugs more rapidly through the process.

Dr. Frank Bedu-Addo further commented, "PDS0101 represents a potentially transformative treatment approach for HPV16-positive HNSCC patients. We are committed to providing physicians and patients a possibly more effective and safer treatment option to address this debilitating and deadly disease."

On October 3, 2022 Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, reported the appointment of Alex Martin as Chief Executive Officer (Press release, Abcuro, OCT 3, 2022, View Source [SID1234621635]). He brings to Abcuro more than 30 years of leadership experience in the biopharmaceutical industry.

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"We are excited to welcome Alex Martin as CEO of Abcuro, as he brings extensive experience in building and leading biopharmaceutical companies as well as a track record of delivering value for patients, the clinical community, and investors," said John Edwards, Executive Chair of Abcuro. "I look forward to working with Alex as we accelerate Abcuro’s growth and advance our clinical programs in the areas of autoimmune disease and cancer."

Mr. Martin brings over 30 years of experience building companies and closing transactions in the biopharmaceutical industry. He was most recently Chief Executive Officer of Palladio Biosciences, a clinical stage biopharmaceutical company which was acquired by Centessa Pharmaceuticals (CNTA), and previously served as Chief Executive Officer of Realm Therapeutics (RLM) which was acquired by ESSA Pharma (EPIX). Prior to this, he was the Chief Operating Officer of Intercept Pharmaceuticals (ICPT), and Chief Finance Officer of BioXell (BXLN) which was acquired by Cosmo Pharmaceuticals (COPN). Mr. Martin began his career at SmithKline Beecham Pharmaceuticals where he held roles of increasing responsibility in marketing and business development and later joined Novartis as Vice President, Global Business Development & Licensing. He holds a BA from Cornell University and an MBA from Harvard.

"It’s an honor to join the team at Abcuro, a company built on an unmatched ability to selectively target highly cytotoxic T cells in diseases and conditions with high unmet need, and a strong commitment to delivering novel, life-changing therapies for patients," said Mr. Martin. "I look forward to working with the highly talented team at Abcuro and building on the company’s momentum and promising clinical data from the lead program ABC008, to make a positive impact on the lives of patients."

About ABC008
ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory and central memory T cells. ABC008 has been designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and other mature T cell malignancies. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to ABC008 for the treatment of IBM.

On October 3, 2022 Celularity Inc. (Nasdaq: CELU) (Celularity), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, reported that Adrian Kilcoyne, M.D., M.P.H., M.B.A., has been appointed Executive Vice President, Chief Medical Officer (CMO) and Head of Global Medical Affairs, Patient Safety and Patient Affairs, effective today (Press release, Celularity, OCT 3, 2022, View Source;utm_medium=rss&utm_campaign=celularity-appoints-adrian-kilcoyne-m-d-m-p-h-m-b-a-as-chief-medical-officer [SID1234621634]). Dr. Kilcoyne brings over 15 years of clinical experience to Celularity, having previously served in R&D, medical affairs, and commercialization roles, primarily focused on oncology. He has a track record of advancing early-stage clinical programs through commercialization and will provide senior leadership to advance Celularity’s clinical pipeline toward U.S. Food and Drug Administration (FDA) approval.

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"It is with great pleasure that we welcome Dr. Kilcoyne to Celularity’s leadership team during this critical stage of our growth trajectory," said Robert Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. "Dr. Kilcoyne will play a fundamental role in advancing our clinical pipeline, including our three Phase 1 studies in acute myeloid leukemia, glioblastoma multiforme and gastric cancer, and one IND-pending program in B-cell malignancies, all of which utilize our next-generation placental-derived cellular therapeutic candidates. I am confident Dr. Kilcoyne’s expertise and deep industry knowledge will help to accelerate Celularity’s achievement of key clinical development milestones and to establish Celularity as a leader in cellular immunotherapies."

"I am excited to be joining such a talented and experienced group of professionals, and look forward to working as part of the leadership team to support and execute on Celularity’s vision," commented Dr. Kilcoyne. "Natural killer cells, especially those derived from placental cells, are scalable and have potential to confer greater safety and efficacy, the latter due to their inherent stemness. I am optimistic that by leveraging this unique class of cells, Celularity will be successful in advancing therapies for the unmet clinical need in cancer, infectious and degenerative diseases."

Most recently, Dr. Kilcoyne served as the Chief Medical Officer of Humanigen, where he was responsible for building its oncology and immunology portfolio focused on the cytokine pathway, CAR-T therapy related toxicity, and antibody drug conjugates (ADCs) in solid tumors. Before that, he served as an integral member of the executive team at AstraZeneca as the Vice President of Global Oncology Evidence Generation and External Alliances. During his time at AstraZeneca, he was responsible for the creation, development, and delivery of the fully integrated Global Evidence strategy. Dr. Kilcoyne holds an M.D. from Trinity College in Dublin, an M.P.H. from the University of London, and an M.B.A. from Warwick Business School. Along with multiple publications in peer review journals, he co-authored the Oxford Specialist Handbook of Pharmaceutical Medicine.

On October 3, 2022 ChromaDex Corp. (NASDAQ:CDXC) (the "Company"), a global bioscience company dedicated to healthy aging, reported that it has established a joint venture through its wholly owned subsidiary ChromaDex Asia Pacific Ventures Limited (the "JV" or "ChromaDex Asia") (Press release, ChromaDex, OCT 3, 2022, View Source [SID1234621633]). The JV collectively consists of the Company and Hong Kong Taikuk (China) Group Limited. The purpose of the JV will be to commercialize Tru Niagen and other products containing Niagen in China. ChromaDex Asia will enter into a new distribution agreement with Sinopharm Xingsha ("Sinopharm") upon successfully attaining health food registration for Tru Niagen with the People’s Republic of China and will assume the cross border distribution agreement noted in a previous press release with Sinopharm at that time. Both agreements relate to the commercialization of Tru Niagen in mainland China and its territories, excluding Hong Kong, Macau and Taiwan (the "Territory").

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The Company also announced that it entered into a securities purchase agreement for the sale of $3.1 million of its common stock in a private placement. The private placement was led by existing strategic investors, and included an investment by ChromaDex CEO, Rob Fried. The private placement is expected to close on or about October 7, 2022, subject to the satisfaction of customary closing conditions. In connection with the investment, the Company agreed to sell 2,480,000shares of its common stock at a per share price of $1.25, for gross proceeds of approximately $3.1 million.

The net proceeds are expected to be invested in international expansion, including securing health food registration for Tru Niagen in mainland China, and to support general corporate purposes.

"This joint venture will help ChromaDex manage the sales and regulatory approval efforts of Tru Niagen in China where consumers already have an excellent understanding of the benefits of NAD+ for healthy aging," said Rob Fried, CEO of ChromaDex. "The investment in ChromaDex by our trusted long-term shareholders will be used to help support this effort. With several strong partnerships now firmly established in Asia, we are well positioned to realize the Tru Niagen potential."

"We are very excited about this opportunity to partner with ChromaDex and bring Tru Niagen into the China market," said Tianyi Zheng, Chairman of Hong Kong Taikuk (China) Group Limited. "We truly believe in the science behind the product and look forward to having more customers in the country to benefit from Tru Niagen."

For detailed transaction terms, see our Current Report on Form 8-K filed on October 3, 2022 concurrently with this release.

The shares of common stock being sold in the private placement will not have been registered under the Securities Act of 1933, as amended (the "Act"). Accordingly, such shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements under the Act. In connection with the private placement, ChromaDex has entered into a registration rights agreement with the investors. This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

Important Note on Forward Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements with respect to the formation of the JV and the commercialization of Tru Niagen and other products containing Niagen in the Territory, health food (Blue Hat) registration, the entry into the agreements contemplated by the JV, including the distribution agreement and the cross-border agreement, and the closing of the financing transaction. These forward-looking statements are based upon the Company’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the satisfaction of customary closing conditions related to the agreements, obtaining the health food (Blue Hat) registration, completing the financing transaction and successfully commercializing Tru Niagen and other products containing Niagen in the Territory. Additional risks and uncertainties relating to the Company and its business can be found under the caption "Risk Factors" in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as filed with the Securities and Exchange Commission and other filings submitted by the Company. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events, or changes in its expectations after the date of this press release.

About Tru Niagen :

Tru Niagen is a branded dietary supplement brought to market by key nicotinamide riboside innovator and patent holder, ChromaDex. Niagen nicotinamide riboside (NR), also supplied by ChromaDex, is the sole active ingredient in Tru Niagen. Multiple clinical trials demonstrate Niagen is proven to boost NAD+ (nicotinamide adenine dinucleotide) levels, which decline with age. Only NIAGEN has twice been successfully reviewed under FDA’s new dietary ingredient ("NDI") notification program and has also been successfully notified to the FDA as generally recognized as safe ("GRAS").

On October 3, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported that interim Phase 2 data evaluating the safety and efficacy of suprachoroidal (SC) administration using its first VDC product candidate, belzupacap sarotalocan (AU-011), for the first-line treatment of patients with early-stage choroidal melanoma (indeterminate lesions and small choroidal melanoma (IL/CM)), were presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting held September 30-October 3, 2022, in Chicago, IL (Press release, Aura Biosciences, OCT 3, 2022, View Source [SID1234621632]).

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"The Phase 2 interim safety and efficacy data that was presented at AAO is very encouraging for patients with primary choroidal melanoma, as the majority of patients are diagnosed with early-stage disease and have no vision-preserving treatment options. Interim data showed a statistically significant reduction in tumor growth rate and a robust tumor control response with a high rate of visual acuity preservation at the therapeutic regimen," said Dr. Ivana Kim, Director of the Ocular Melanoma Center, Massachusetts Eye and Ear. "Belzupacap sarotalocan offers a favorable safety profile supporting the potential to become the first vision-preserving treatment for early-stage choroidal melanoma, where patients have had to rely on radiotherapy for the last few decades."

"Preliminary analysis of the data from the Phase 2 trial using suprachoroidal administration supports tolerability up to three cycles of therapy and shows a dose-dependent anti-tumor response. The results provide further clinical evidence to support the potential use of belzupacap sarotalocan as a novel targeted therapy in patients with early-stage disease with this targeted route using suprachoroidal administration," said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. "We believe that the data to date provides proof of concept for an additional intraocular route of administration and further supports belzupacap sarotalocan’s target product profile."

The presentation can be accessed on the Company’s website: link

Interim Safety and Efficacy Data from the Ongoing Phase 2 Trial with SC Administration

This Phase 2 trial (NCT04417530) is assessing the safety and preliminary efficacy of single- and multiple ascending-doses of belzupacap sarotalocan up to three cycles of treatment via SC administration for the first-line treatment of early-stage choroidal melanoma (IL/CM). A total of 20 adult patients have been enrolled in the trial including the single dose Cohorts 1-3 (n=6) and multiple dose escalation Cohorts 4-6 (n=14). Cohorts 5 and 6 received up to three cycles of therapy, which was considered the therapeutic regimen for evaluation. One patient in Cohort 5 (n=3) received two cycles of therapy and two patients in Cohort 5 received three cycles of therapy (40 µg/dose). All patients from Cohort 6 (n=8) received three cycles of therapy at the highest dose (80 µg/dose). One patient from Cohort 6, who discontinued after

one cycle due to unrelated serious adverse events (SAEs), is not included. All patients in Cohorts 5 and 6 had active growth at study entry, as an enrichment strategy to evaluate preliminary efficacy. This group of patients with active growth treated at the therapeutic regimen of three cycles was evaluated for tumor growth rate, tumor control, and visual acuity preservation as the defined clinical endpoints to evaluate preliminary efficacy. These endpoints have been discussed with the U.S. Food and Drug Administration and are planned to be used in the pivotal program. The results, with an average of six months follow up in patients that received three cycles of therapy in Cohorts 5 and 6, showed a statistically significant reduction in the tumor growth rate (-0.296 mm/yr, p = 0.0007) compared to each patient’s documented growth rate at study entry, and an 88.9% (8/9) tumor control rate. In addition, the visual acuity preservation rate was 88.9% (8/9) in these cohorts, with the majority of patients being at high-risk for vision loss with tumors close to fovea or optic disk. The overall safety profile of belzupacap sarotalocan was generally favorable, with no dose-limiting toxicities or treatment-related SAEs reported as of August 19, 2022. There was no posterior inflammation and only mild anterior inflammation (Grade 1) in 20% of the patients. Treatment-related AEs were predominantly mild and resolved without sequalae. We believe these interim results indicate that belzupacap sarotalocan may offer a targeted vision preserving therapy for the first-line treatment of primary CM, where 80% of patients are diagnosed early and have no approved therapies to date.

Details for the Virtual Investor Day:

The Company will host a virtual Investor Day today at 11:30 a.m. Eastern Time to discuss belzupacap sarotalocan, its first VDC product candidate, for the first-line treatment of patients with early-stage choroidal melanoma. The Company’s executive management team will be joined by three distinguished ocular oncology thought leaders:

Carol Shields, MD, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University (USA)

Ivana Kim, MD, MBA, Director of the Ocular Melanoma Center, Massachusetts Eye and Ear & Associate Professor of Ophthalmology, Harvard Medical School (USA)

Martine Jager, MD, PhD, Professor of Ophthalmology, Leiden University (Netherlands) & Past President of the International Society of Ocular Oncology and the Association for Research in Vision and Ophthalmology

To access the virtual Investor Day, please dial (888) 660-6585 (U.S. and Canada) or (929) 203-0858 (international) at least 10 minutes prior to the start time and refer to conference ID 9748492. A live video webcast will be available in the Investor section of the Company’s website at View Source A webcast replay will also be available on the corporate website at the conclusion of the call.