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.

On March 2, 2022 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company"), reported the closing of its previously announced registered direct offering with certain institutional investors of 11,000 shares of Series O redeemable convertible preferred stock and 11,000 shares of Series P redeemable convertible preferred stock (Press release, AIkido Pharma, MAR 2, 2022, View Source [SID1234609408]). Each share of Series O and Series P preferred stock has a purchase price of $952.38, representing an original issue discount of 5% of the $1,000 stated value of each share. Each share of Series O and Series P preferred stock is convertible into shares of AIkido’s common stock at an initial conversion price of $1.00 per share. Shares of the Series O and Series P preferred stock are convertible at the option of the holder at any time following the Company’s receipt of stockholder approval for a reverse stock split of the Company’s common stock. AIkido will be permitted to compel conversion of the Series O and Series P preferred stock after the fulfillment of certain conditions and subject to certain limitations. Total net proceeds from the offerings, before deducting the placement agent’s fees and other offering expenses, is approximately $20.9 million. To the extent Series O or P preferred stock is converted or otherwise not redeemed after 120 days from closing, the Company will use the net proceeds from this offering for working capital and general corporate purposes.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The Series O and Series P preferred stock permit the holders thereof to vote together with the holders of the Company’s common stock and other voting preferred stock of the Company on a proposal to effectuate a reverse stock split of the Company’s common stock at an annual or special meeting of Company stockholders. The Series O preferred stock permits the holder to cast votes on such proposal on an as-converted to common stock basis. The Series P preferred stock permits the holder to cast votes equal to 30,000 votes per share of Series P preferred stock on such proposal. The Series O and Series P preferred stock will not be permitted to vote on any other matter. The holders of the Series O and P preferred stock agreed not to transfer their shares of preferred stock until after the meeting of Company stockholders. The holders of the Series P preferred stock have the right to vote their shares on such proposal in the same proportions as the shares of common stock, Series O preferred stock and other voting preferred stock of the Company are voted on that proposal. The holders of the Series O and Series P preferred stock have the right to require the Company to redeem their shares of preferred stock for cash at 105% of the stated value of such shares commencing after the earlier of the Company’s stockholders’ approval of the reverse stock split and 90 days after the closing and until 120 days after the closing.

Additional information regarding the securities described above and the terms of the offering are included in a Current Report on Form 8-K filed with the United States Securities and Exchange Commission ("SEC").

The Series O and Series P preferred stock and shares of common stock into which such preferred stock are convertible were offered pursuant to a registration statement on Form S-3 (333-238172), which was declared effective by the Securities and Exchange Commission on June 18, 2020. The offerings were made only by means of prospectus supplements and a prospectus that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of preferred stock and underlying shares of common stock offered has been filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

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

On March 2, 2022 Kashiv Biosciences, LLC ("Kashiv") reported the U.S. Food and Drug Administration (FDA) approval of its Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen (Press release, Kashiv BioSciences, MAR 2, 2022, View Source [SID1234609407]). The product will be marketed under the proprietary name RELEUKOTM.

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RELEUKOTM was developed in collaboration with Amneal Pharmaceuticals, Inc. and is expected to launch in the third quarter of 2022. It is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy. Kashiv is planning for a pegfilgrastim biosimilar referencing Neulasta to also be approved in 2022.

"It is a proud moment for the Kashiv team and our partners at Amneal to have our first biosimilar, RELEUKO, approved by the U.S. FDA. Kashiv is one of a few domestic companies to manufacture and launch a biosimilar in the United States. Kashiv aims to continue bringing high quality biosimilars to the global markets over the coming years. I would like to extend a humble ‘thank you’ to our highly talented team, without whom this would not have been possible," said Dr. Chandramauli Rawal, Chief Operating Officer for Kashiv.

"The U.S. approval of our first biosimilar is a very significant milestone for Amneal. Biosimilars represent the next wave of providing access to affordable medicines in the U.S. Amneal is building a global biosimilars business by leveraging partner assets to start and then leveraging our own key capabilities over time. Our goal is to become a meaningful long-term player in biosimilars," said Chirag and Chintu Patel, Co-Chief Executive Officers for Amneal.

According to IQVIA, U.S. annual sales for filgrastim for the 12 months ended December 2021 were $407 million, of which $275 million represents biosimilar sales.

RELEUKOTM in the U.S. is indicated:

To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever.
To reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
To reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
To reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
RELEUKOTM IMPORTANT SAFETY INFORMATION

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

Before you take RELEUKOTM, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

WARNINGS AND PRECAUTIONS

Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue RELEUKOTMin patients with ARDS.
Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving RELEUKOTM. Discontinue RELEUKOTMif sickle cell crisis occurs.
Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKOTM in patients with serious allergic reactions.
Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on RELEUKOTM. Consider dose-reduction or interruption of RELEUKOTMin patients with kidney injury.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using RELEUKOTMin conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.
ADVERSE REACTIONS

Most common adverse reactions in patients:

With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
With AML are pain, epistaxis and rash.
With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by Bone Marrow Transplant is rash.
With severe chronic neutropenia are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia