Kelonia Therapeutics Launches with $50 Million Series A Financing to Pioneer Precision Targeted Genetic Medicines

On April 28, 2022 Kelonia Therapeutics, a biotech company revolutionizing in vivo gene delivery, launched with a $50 million Series A financing to usher in a new era of genetic medicines for a wide range of diseases (Press release, Kelonia Therapeutics, APR 28, 2022, Kelonia Therapeutics Launches with $50 Million Series A Financing to Pioneer Precision Targeted Genetic Medicines [SID1234640176]). Kelonia’s platform overcomes the central challenge that has prevented the full realization of gene therapy for patients. Despite life-changing responses, existing gene therapies are highly complex, costly, and limited by complicated treatment paradigms, tractable therapeutic applications, and dose-limiting toxicities. By enabling precisely targeted, highly efficient, manufacturable "off-the-shelf" in vivo gene delivery, Kelonia’s technology has the potential to dramatically expand the impact and reach of genetic medicines to every patient in need.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Kelonia is backed by a strong syndicate of investors with a track record of successfully launching and building disruptive biotech companies. Alta Partners, Horizons Ventures, Venrock and other investors participated in the Series A round. The company will use the funding to redefine what’s possible for genetic medicines starting with an "off-the-shelf" chimeric antigen receptor (CAR) to treat hematologic cancer that may enable the unrivalled clinical benefit of CAR T without the typical toxicities and with the ease of access of conventional medicines. Additionally, the company will advance other programs for oncology and non-oncology indications, and further expand its gene delivery platform and capabilities.

"The cell and gene therapy field has been searching for solutions to durable in vivo genetic modifications regardless of whether applying gene editing, RNA expression or viral-mediated gene integration," said Kevin Friedman, Ph.D., President and Chief Scientific Officer of Kelonia. "At Kelonia, we believe we have found an in vivo gene delivery solution that is safe, effective, and manufacturable for broad therapeutic application. With our Series A funding and key strategic collaborations, we will advance our lead product candidate toward clinical studies and further optimize our technology to explore treating diseases never thought possible with genetic medicines."

Based on discoveries made in the lab of Massachusetts Institute of Technology’s Michael Birnbaum, Ph.D., and leveraging pioneering research from leading scientists at the French National Centre for Scientific Research (CNRS), Kelonia’s in vivo gene delivery technology enables a few potent lentiviral vector-like particles armed with an adjustable targeting system to precisely, efficiently, and safely deliver payloads exactly where needed to treat a broad range of diseases. The company’s early applications combine oncology-targeted therapeutics, such as CAR and T cell receptor molecules, with Kelonia’s precision in vivo targeting technology. When used in concert, this combination enables potent and precise tumor targeting with limited "off-tumor" toxicity, which would otherwise be a concern. Administered directly in vivo as an "off-the-shelf" medicine, Kelonia’s transformational therapies in development for solid and hematologic tumors have the potential to democratize patient access to genetic medicines. Beyond oncology, the company will advance its technology to unlock delivery to previously hard-to-reach tissues, such as neurological, muscular or renal, to deliver different types of genetic cargo with the goal of radically transforming the treatment of diseases in these areas.

"It turns out, a relatively simple and elegant idea to de-target and redirect lentivirus-like particles based on recently published research from my lab can potentially provide a solution to in vivo gene delivery," said Dr. Birnbaum, Ph.D., Co-Founder of Kelonia. "I’m incredibly excited about the potential of Kelonia’s platform and team to vastly expand the utility of gene therapies to treat oncology, autoimmune disease, rare monogenic or other diseases currently intractable to gene therapies."

"Kelonia is combining the two crucial elements required to develop truly novel medicines: breakthrough biology and an exceptional team," said Bryan Roberts, Partner at Venrock. "Michael Birnbaum’s industrially robust platform affords a targeting specificity log orders better than anything else out there and the team has a stellar track record for translating groundbreaking scientific gene therapy discoveries into viable products that are transformative for patients."

Strategic Collaborations

In addition to the completion of its Series A, Kelonia has established strategic collaborations with Adimab and ElevateBio. With both collaborations already successfully underway, each of these outstanding partners brings differentiating capabilities that enable and accelerate the company’s vision to bring breakthrough genetic medicines to patients.

Adimab is the leading provider of therapeutic antibody discovery and engineering technologies. Kelonia will leverage Adimab’s expertise and proprietary technologies, across a range of applications, to access tissue-specific antibodies that enable unlocking precise in vivo gene delivery to different tissues as well as antibodies that can be leveraged within the therapeutic genetic cargo.

ElevateBio is a technology-driven company focused on powering transformative cell and gene therapies with multiple next-generation technology platforms and a fully integrated R&D and manufacturing facility. Through an expanding partnership, Kelonia will utilize ElevateBio’s lentiviral vector platform, process and analytical development expertise, and cGMP manufacturing capabilities to develop and advance novel manufacturing processes for Kelonia and manufacture of Kelonia’s products.

Aadi Bioscience to Announce First Quarter 2022 Financial Results on May 12, 2022

On April 28, 2022 Aadi Bioscience, Inc. (Nasdaq: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that it will report results for the first quarter 2022 before market open on Thursday, May 12, 2022 (Press release, Aadi Bioscience, APR 28, 2022, View Source [SID1234614203]). Aadi management will then host a conference call and webcast at 8:30 am EDT (5:30 am PDT) to discuss the results as well as provide a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Individuals may join the webcast online by clicking here or may participate in the live call via telephone by dialing (877) 407-9716 (domestic) or (201) 493-6779 (international) and using conference ID 13729259. A replay of the call will also be available through Aadi’s website within the "Investors & News/Event Calendar" section.

Updated ASCO Guidelines Strongly Recommend Use of the Oncotype DX Breast Recurrence Score® Test in Node-Negative and the Majority of Node-Positive Early-Stage Breast Cancer Patients

On April 28, 2022 Exact Sciences Corp. (NASDAQ: EXAS), a leader in advanced cancer diagnostics, reported that recommended use of its Oncotype DX Breast Recurrence Score test in early-stage breast cancer patients has been expanded by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in its 2022 Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer guideline update (Press release, Exact Sciences, APR 28, 2022, View Source [SID1234613589]).i

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The test is now recommended for use in postmenopausal patients with up to three positive axillary lymph nodes and is the only test recommended for use in premenopausal patients with node-negative disease. Importantly, the test is recommended irrespective of clinical risk, and Oncotype DX is the most strongly recommended with the highest evidence quality of all multigene tests included in the guidelines.

"We are pleased that the updated ASCO (Free ASCO Whitepaper) guidelines recognize the strength of the data supporting Oncotype DX and expand the recommended use of the test based on findings from the RxPONDER study," said Rick Baehner, M.D., chief medical officer of Precision Oncology at Exact Sciences. "The Oncotype DX test has been used to guide the treatment decisions for more than one million women around the world, and the updated guidelines provide even greater clarity and confidence to physicians in individualizing the discussion of the risks and benefits of chemotherapy with their patients."

The updated guidelines incorporate results from the RxPONDER trial published in The New England Journal of Medicine.ii The study demonstrated that the test identifies a majority of early-stage breast cancer patients with one to three positive nodes who may be spared chemotherapy. Postmenopausal women with Oncotype DX Breast Recurrence Score results of 0 to 25 did not show benefit from the addition of chemotherapy to hormone therapy. Premenopausal women with a Recurrence Score result of 0 to 25 received a 2.4% benefit from chemotherapy in terms of distant recurrence at five years.iii

Approximately one-third of patients diagnosed with hormone receptor (HR)-positive, HER2-negative early breast cancer have a tumor that has spread to their lymph nodes.iv The vast majority of these patients currently receive chemotherapy[v] even though approximately 85% of them have Recurrence Score results of 0 to 25.vi In addition, about two out of three early-stage breast cancer patients are postmenopausal.vii

About the Oncotype DX and Oncotype MAP Portfolio of Tests
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. For patients with advanced and metastatic cancer, the company offers the Oncotype MAP Pan-Cancer Tissue test, a rapid, comprehensive tumor profiling panel, which provides results in three to five business days[viii] and allows physicians to understand a patient’s tumor profile and recommend actionable targeted therapies or clinical trials. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX and Oncotype MAP tests, visit www.OncotypeIQ.com/

ERYTECH Announces Filing of 2021 Universal Registration Document and 2021 Annual Report on Form 20-F, as well as its 2022 financial calendar

On April 28, 2022 ERYTECH Pharma (Euronext Paris: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it had filed its 2021 Universal Registration Document for the year ended December 31, 2021, including the management report and the annual financial report with the "Autorité des Marchés Financiers" (AMF) and its Annual Report on Form 20-F for the year ended December 31, 2021 with the U.S. Securities and Exchange Commission (SEC), as well as its 2022 financial calendar (Press release, ERYtech Pharma, APR 28, 2022, View Source [SID1234613276]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

These documents can be accessed on the Investors section of the Company’s corporate website (www.erytech.com). In addition, the Universal Registration Document is available on the website of the AMF (www.amf-france.org) and the Annual Report on Form 20-F is also available on the website of the SEC (www.sec.gov). Printed copies of these documents are also available free of charge, by sending a postal request to the registered offices of ERYTECH Pharma, Bâtiment Bioserra, 60 Avenue Rockefeller, 69008 in Lyon (France).

Financial Calendar 2022*

▪Business Update and Financial Highlights for the First Quarter of 2022: May 12, 2022 (after U.S. market close), followed by a conference call & webcast on May 13, 2022 (2:30pm CET/8:30am ET)

▪Shareholders’ Meeting: June 24, 2022 at 9.00am CET – Paris

▪Business Update and Financial Highlights for the Second Quarter & First Half of 2022: September 12, 2022 (after U.S. market close), followed by a conference call & webcast on September 13, 2022 (2:30pm CET/8:30am ET)

▪Business Update and Financial Highlights for the Third Quarter of 2022: November 8, 2022 (after U.S. market close), followed by a conference call & webcast on November 9, 2022 (2:30pm CET/8:30am ET)

Adaptimmune to Report Q1 2022 Financial Results and Business Updates on Monday, May 9, 2022

On April 28, 2022 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that will report financial results and provide business updates for the first quarter ended March 31, 2022, before the US markets open on Monday, May 9, 2022 (Press release, Adaptimmune, APR 28, 2022, View Source [SID1234613237]). Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) that same day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. A live webcast of the conference call and replay can be accessed at https://bit.ly/3k8uZcI.

To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (6779362).