On March 2, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LBT4) systems are implicated, reported the appointment of Rachelle Jacques as President and Chief Executive Officer of Akari Therapeutics (Press release, Akari Therapeutics, MAR 2, 2022, View Source [SID1234609415]). Ms. Jacques will also join the company’s Board of Directors. Her appointment begins at the end of March 2022.

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Outgoing Chief Executive Officer, Clive Richardson, will continue to serve the Company, supporting Rachelle to accelerate business development and ensuring a smooth transition.

"I am very pleased to be able to welcome Rachelle as CEO of Akari Therapeutics. She has considerable biotechnology experience including a proven track record of bringing advanced therapies for rare diseases to the market," said Ray Prudo, M.D., Akari Therapeutics’ founder and Chairman of the company’s Board of Directors. "With her combined experience in C5 inhibition, immunology and rare diseases, Rachelle has a deep understanding of the potential of Akari’s pipeline. This, together with her strategic experience, affords a springboard to advance our Phase 3 pipeline through potential regulatory approval and towards commercialization, as well as and bring forward our earlier stage pipeline. I very much look forward to working with Rachelle who will be based in the Boston area."

"It’s an exciting time at Akari and I look forward to building on the robust research and development work that has already been completed to advance nomacopan, a unique drug differentiated by its dual mode of action which has the potential to deliver benefits beyond standard complement inhibition," stated Ms. Jacques. "Our pipeline, including two late-stage pivotal programs, has tremendous potential for patients with significant unmet needs and we are working with urgency to realize that promise for them."

Before this appointment, Ms. Jacques served as Chief Executive Officer of Enzyvant Therapeutics Inc., a commercial-stage biotechnology company developing transformative regenerative therapies for rare diseases. Prior to Enzyvant, she served as the Senior Vice President and Global Complement Franchise Head at Alexion Pharmaceuticals, Inc., where she was responsible for global franchise strategy development and execution of the C5 complement inhibitors, eculizumab and ravulizumab, across the therapeutic areas of hematology, nephrology and neurology. She was Vice President of U.S. Hematology Marketing at Baxalta Inc. and then Shire plc, following Shire’s acquisition of Baxalta in 2016. At Baxalta, she served as Vice President of Business Operations after its spinoff from Baxter International Inc. Ms. Jacques held multiple leadership positions at Baxter, including Vice President of Finance, U.S. BioScience Business. Earlier in her career, Ms. Jacques served in various roles at Dow Corning Corporation, including operational management positions in the U.S., Europe, and China.

Ms. Jacques serves on the boards of directors of uniQure N.V. (Nasdaq: QURE) and Corbus Pharmaceuticals (Nasdaq: CRBP). She is co-chair of the Alliance for Regenerative Medicine (ARM) Tissue Engineering & Biomaterials Committee and is a founding member of the ARM Action for Equality Task Force. Ms. Jacques received her B.A. in business administration from Alma College.

On March 2, 2022 Rondo Therapeutics, a biopharmaceutical company advancing a next-generation immuno-oncology platform for treating solid tumors, reported the closing of an oversubscribed $67 million Series A financing (Press release, Rondo Therapeutics, MAR 2, 2022, View Source [SID1234609412]). Proceeds will support the continued development of Rondo’s preclinical pipeline as the company advances its lead bispecific antibody candidates toward initial Phase 1 clinical studies. The financing was co-led by Red Tree Venture Capital and Canaan Partners, and included significant investment from Johnson & Johnson Innovation – JJDC, Inc. Additional investors included Novo Holdings A/S and SV Health Investors.

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"We are thrilled with the strong investment syndicate we have brought together. Each investment partner brings a unique perspective along with deep experience in therapeutics and a true understanding of what it takes to develop first- and best-in-class drugs. As repeat entrepreneurs, we know the value of having highly engaged investors that share our vision for building Rondo," said Shelley Force Aldred, Ph.D., co-founder and chief executive officer of Rondo Therapeutics.

Rondo is focused on addressing the significant unmet need for novel immunotherapy approaches capable of treating solid tumors. While T-cell engagers and other bispecific antibodies have shown tremendous success in treating hematologic cancers by engaging a patient’s immune system to eliminate tumor cells, translating this success to solid tumors has proved challenging with current approaches and biologic targets. The company, whose founders have deep expertise in bispecific antibody discovery, is committed to leveraging its proprietary immuno-stimulatory platform, to develop first-in-class therapeutics for the treatment of solid tumors.

"T-cell engagers targeting CD3 have successfully exploited the first signal in T-cell receptor signaling to treat liquid tumors, significantly expanding the treatment options for these cancers. However, solid tumors represent a much greater unmet clinical need that has yet to benefit from advances in immune-engaging bispecific antibodies," said Nathan Trinklein, Ph.D., co-founder and chief scientific officer of Rondo Therapeutics. "At Rondo we are building an exceptional team supported by world-class investors to develop unique bispecific platforms that stimulate a variety of downstream immune pathways with the intent of treating solid tumors."

"Canaan’s bar for new investments in the oncology field is quite high, with a premium placed on the ability to unlock entirely new mechanisms and platforms. As we dug into Rondo alongside Red Tree, with whom we launched another cancer start-up last year, we saw something truly special in these proven entrepreneurs and their next-generation approach to attacking solid tumors," said Nina Kjellson, partner, Canaan Partners and member of the board of directors of Rondo Therapeutics. "As my colleague, Nils Lonberg, Ph.D., put it, ‘the mechanism behind these new drugs that Rondo is pursuing is a deep and unexplored sandbox that I know is full of riches. The value here is not just in the pipeline they are building but in the tools they are creating.’"

"I am thrilled to be working with Shelley and Nathan again to support their mission of taking bispecifics into solid tumors. It is rare to find repeat entrepreneurs that combine deep domain expertise and such thoughtful scientific planning, as evidenced by their ability to consistently position themselves where the field is going," said Jon Edwards, Ph.D., managing director, Red Tree Venture Capital and member of the board of directors of Rondo Therapeutics. "Rondo is working to create a wholly owned toolbox of molecules enabling immune cell activation in a comprehensive fashion. This has the potential to create differentiated molecules with single agent activity and best-in-class combination potential. We believe the company has all the right ingredients for success, including a strong scientific rationale, phenomenal founders, and an outstanding syndicate. It’s going to be a lot of fun building this company together."

On March 2, 2022 Akeso, Inc. (9926.HK) ("Akeso"), a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of innovative antibody drugs that are affordable to patients worldwide reported that it has entered into a collaboration agreement with Shenzhen Chipscreen Biosciences, Ltd. (SHA Code 688321) to conduct a Phase Ib/II clinical study of combination therapy of Cadonilimab (PD-1/CTLA-4 bispecific antibody, AK104) and Chiauranib (a highly selective Aurora B/VEGFR/PDGFR /c-Kit/CSF1R inhibitor) in patients with ES-SCLC which progressed on combination therapy of platinum-based chemotherapy and PD-(L)1 inhibitor as first-line treatment (Press release, Akeso Biopharma, MAR 2, 2022, View Source [SID1234609411]).

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The drug development strategy of Akeso is to use its bispecific antibody as backbone of next generation immunotherapy to combo with innovative drugs or drug candidates from leading partners in respective fields. Akeso believes such a strategy will differentiate its therapy from peers, and further enhance the value of products, which will benefit the company and its partners. This collaboration provides a solid proof for Akeso’s commitment to promote combination therapy strategy. Combining the superior advantage of Cadonilimab as a dual immuno-checkpoint inhibitor and Chiauranib as an active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases, Akeso is confident this combination therapy will bring exciting new therapeutic solution for the patients suffering from cancers including lung cancer.

About Cadonilimab (PD-1/CTLA-4 bispecific antibody, AK104)

Cadonilimab (AK104) is a novel first-in-class PD-1/CTLA-4 bi-specific immuno-oncology backbone drug independently developed by the Company, and its major indications include lung cancer, liver cancer, stomach cancer, cervical cancer, renal cancer, esophageal squamous cell cancer, nasopharyngeal carcinoma and other malignant tumors. The periodic research data show that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrates promising safety profile and efficacy. Based on the positive effects of Cadonilimab obtained in the clinical trial of recurrent/metastatic cervical cancer, CDE accepted the new drug application of Cadonilimab for the treatment of recurrent/metastatic cervical cancer in September 2021 and granted priority review designation. Cadonilimab is therefore expected to be the world’s first-in-class PD-1 based bi-specific antibody approved for market launch. In addition, a global phase III clinical trial of Cadonilimab plus platinum-based chemotherapy combined with/without bevacizumab in the first-line treatment of persistent, recurrent or metastatic cervical cancer was initiated in May 2021.

About Chiauranib

Chiauranib, a highly selective Aurora B/VEGFR/PDGFR /c-Kit/CSF1R inhibitor, was developed by Chipscreen Biosciences specifically to address drug resistance.Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis, prevents tumor cell mitosis, and modulates the tumor microenvironment. With a favorable safety profile, Chiauranib has outperformed drugs with a similar mechanism in its pharmacodynamic activity in animal studies.

On March 2, 2022 PTC (Nasdaq: PTC) reported that management will participate in the following virtual conferences (Press release, PTC Therapeutics, MAR 2, 2022, View Source [SID1234609410]).

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What:

KeyBanc Capital Markets’ Emerging Tech Summit

When:

Tuesday, March 8th, 2022 at 1:00pm PT

What:

J.P. Morgan 50th Annual Global Technology, Media and Communications Conference

When:

Monday, May 23rd, 2022

What:

Baird’s 2022 Global Consumer, Technology and Services Conference

When:

Monday, June 6th, 2022

What:

Stifel 2022 Cross Sector Insight Conference

When:

Wednesday, June 8th, 2022

What:

Nasdaq Investor Conference

When:

Tuesday, June 14th, 2022

To view the webcast and replay for conferences please use the link below.

Webcast:

View Source

Please note that statements made at each conference are as of the date of the respective conference and PTC does not assume any obligation to update any statements made live or the archived calls. Matters discussed may include forward-looking statements about PTC’s anticipated financial results and growth, as well as about the development of products and markets, which are based on current plans and assumptions. Actual results in future periods may differ materially from current expectations due to a number of risks and uncertainties, including those described from time to time in reports filed by PTC with the U.S. Securities and Exchange Commission, including PTC’s most recent reports on Form 10-K and 10-Q.

On March 2, 2022 Avenge Bio, Inc., ("Avenge" or the "Company") a biotechnology company developing the LOCOcyte immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported a publication in the peer-reviewed journal Science Advances describing the foundational, preclinical research establishing the LOCOcyte platform proof of concept in animal models (Press release, Avenge Bio, MAR 2, 2022, View Source [SID1234609409]). The manuscript, entitled "Clinically translatable cytokine delivery platform for eradication of intraperitoneal tumors," was published today and can be viewed on the Science Advances website.

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Ovarian cancer is one of the most difficult cancers to treat. It is typically not detected until later stages, and about 70 percent of patients will have recurrence after an initial treatment, which is often fatal. Furthermore, ovarian tumors produce fluid that makes it challenging to deliver drugs locally. To overcome this challenge, a research team at Rice University led by Omid Veiseh, Ph.D., has developed an innovative immunotherapy platform that enables engineered cells to produce immune-activating molecules, for a specified duration, within this fluid tumor microenvironment.

The Science Advances manuscript details the immunotherapy platform and its safety and efficacy in preclinical models. The human cells are engineered to produce murine immune cell signaling molecule interleukin-2 (IL2), a critical cytokine that initiates a robust localized immune response when administered into the intraperitoneal (IP) cavity of tumor-bearing mice that model advanced ovarian cancer. Notably, 100% of mice showed a significant tumor burden reduction after 30 days, compared to controls. The study also demonstrated that IL2 was localized to the IP cavity and that IL2 production was limited to a 30-day window, both of which suggest a minimal risk of systemic toxicities. Furthermore, the study features robust anti-tumor data in mice with colorectal cancer, demonstrating the broad potential of the immunotherapy platform. Studies in non-human primates demonstrated similar proof of concept of both efficacy and safety, setting the stage for clinical studies in humans.

"We are excited to share these data with the scientific community. Ovarian cancer remains a significant clinical challenge, which drove our team’s dedication to discover and develop an innovative treatment approach," said Dr. Veiseh, Assistant Professor of Bioengineering at Rice University and a Founder of Avenge Bio. "I am grateful to all of the researchers and collaborators involved with this project, including Amanda Nash who has worked on this project from inception. Amanda and I look forward to working with Avenge to bring this technology in the clinic to help patients in need."

Avenge Bio has an exclusive license from Rice University for this technology. Avenge has been engaged in discussions with the U.S. Food and Drug Administration (FDA) and expects to begin clinical studies in the second half of 2022.

"I would like to congratulate Omid and Amanda on this groundbreaking scientific work that resulted in this publication. These discoveries have the potential to dramatically change the treatment paradigm for certain solid tumors including metastatic peritoneal cancers." We have been working closely with Omid and his team to bring this technology into the clinic and look forward to its continued development," said Michael Heffernan, CEO of Avenge.