On March 29, 2021 Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, reported the closing of its underwritten public offering of 11,500,000 shares of its common stock by certain existing stockholders at a public offering price of $25.00 per share (Press release, Certara, MAR 29, 2021, View Source [SID1234577953]). The closing includes 1,500,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock. Neither Certara nor its management team sold any shares or received any proceeds from the sale of shares in the offering by the selling stockholders.

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The offering was made through an underwriting group led by Jefferies, Morgan Stanley and BofA Securities, who acted as lead joint book-running managers, and Credit Suisse and Barclays, who acted as joint book-running managers.

A registration statement on Form S-1, including a prospectus, relating to these securities was declared effective by the Securities and Exchange Commission. 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 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.

Copies of the prospectus may be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 547-6340 or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 or by email at [email protected]; or BofA Securities, Inc., NC1-004-03-43, Attention: Prospectus Department, 200 North College Street, 3rd Floor, Charlotte, NC 29255, by telephone at (800) 294-1322 or by email at [email protected].

On March 29, 2021 Fortis Therapeutics, Inc., an immuno-oncology biotech developing FOR46, a novel antibody drug conjugate (ADC) against CD46, reported the close of a $40 million Series A financing (Press release, Fortis Therapeutics, MAR 29, 2021, View Source [SID1234577777]). Participating in this financing are existing investors, Avalon Ventures, Bregua Corporation, Lilly Asia Ventures, Osage University Partners, and Vivo Capital, as well as new investors, the Myeloma Investment Fund, the venture philanthropy fund of the Multiple Myeloma Research Foundation (MMRF), and Fulcrum 2020, LLC, which shares a portion of its profits with the Prostate Cancer Foundation (PCF) to fund future research. The proceeds of the financing will be used to advance FOR46 in clinical trials for the treatment of relapsed or refractory multiple myeloma and metastatic castration-resistant prostate cancer (mCRPC).

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"Our existing investors and new investors, the Myeloma Investment Fund and Fulcrum 2020, see the promise of FOR46 ADC therapy that could help patients where other treatments have failed," said Jay Lichter, Ph.D., President and CEO of Fortis. "Our preliminary clinical data is very exciting, and we are actively advancing our clinical studies in prostate cancer and multiple myeloma and pursuing additional indications."

"PCF is pleased that the 2017 funding to UCSF for their research on CD46 has been leveraged by Fortis for a meaningful Series A financing," said Howard R. Soule, PhD, Executive Vice President and Chief Science officer of PCF. "We are hopeful that CD46 treatment strategies will become a therapeutic option for patients with advanced prostate cancer." In 2017, PCF funded translational research of CD46 that supported clinical advancement of FOR46 through a PCF Challenge Award, which provides $1 million for innovative research with the highest potential for accelerating new and improved treatments for advanced prostate cancer.

In addition, the MMRF supported early development of FOR46 through an immune translational research grant to Fortis Founder Bin Liu at UCSF. The results of that research, published in The Journal of Clinical Investigation in 2016, identified CD46 as a promising target for treatment of multiple myeloma.

For the clinical study in relapsed or refractory multiple myeloma, Fortis has completed single patient cohorts and dose finding and is now enrolling patients in an expansion cohort for treatment with 2.4 mg/kg or FOR46 (ClinicalTrials.gov Identifier: NCT03650491). For the clinical study in mCRPC, Fortis has completed patient enrollment in the dose escalation cohorts (up to 3.0 kg/mg) and is beginning enrollment in dose expansion cohorts in mCRPC and additional indications (ClinicalTrials.gov Identifier: NCT03575819).

About FOR46

FOR46 binds a specific conformational epitope of CD46, a novel immune modulatory receptor. CD46 is highly expressed in multiple tumor types, is part of the tumor’s immune defense shield, and appears to be specific to tumor cells. FOR46 was identified through an antibody selection process that uses living tumor cells residing in their tissue microenvironment, thereby preserving the natural range of surface antigens present on the cells. To create FOR46, the fully human antibody was conjugated to a potent payload using a proven chemistry platform with well-characterized in vivo properties. Early in vitro studies of FOR46 demonstrated its potential to kill tumor cells with no effect on normal cells. Fortis Therapeutics exclusively licensed rights to the antibody in 2016 and maintains a strong intellectual property position.

On March 29, 2021 Herantis Pharma Plc ("Herantis or the Company"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative therapies, reported that the Board of Directors has decided to focus all company resources on Herantis’ CDNF and xCDNF assets and to commence seeking out-licensing partners for the Lymfactin program in the treatment of Breast Cancer Related Lymphedema (BCRL) (Press release, Herantis Pharma, MAR 29, 2021, View Source,c3316583 [SID1234577488]).

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As previously announced in a press release on March 2, 2021 that while a favourable safety profile for Lymfactin has been established, and important observations on the potential activity of Lymfactin were made, the efficacy data from the Phase II Lymfactin program was inconclusive.

This prompted a full evaluation of the overall program and the company resources required to move the program forward. The review focused on learnings from this pioneering study and how best to address them to accurately capture treatment effect, implications for the overall program, resourcing requirements for the Lymfactin program moving forward, and strategic considerations together with Herantis’ central nervous system (CNS) assets. As a result of this comprehensive evaluation, Herantis’ Board of Directors have concluded that the best course of action for the Company is firstly to focus all activities, strategy and resources solely on the exciting CNS portfolio, and secondly to seek a suitable partner to take over further development of the innovative Lymfactin program.

Craig Cook CEO commented "We are at an inflection point and this is an important strategic decision. It is the right time to separate the Company assets and move forward as a pure play Neuroscience company focusing on our CDNF and xCDNF portfolios. We are very grateful to the patients, investigators and medical professionals involved in the Lymfactin program, without their contributions, we would not have been able to advance this ground-breaking research into the treatment of BCRL with Lymfactin."

In-line with this decision, Herantis will structure all its research and operations on neurodegenerative diseases, accelerating its programs in Parkinson’s Disease and other neurodegenerative diseases.

Herantis will host a live session 30th March at 10am CET/11am EET with Craig Cook, CEO and Antti Vuolanto, COO, to further discuss the company’s new strategic focus.

About Cerebral Dopamine Neurotrophic Factor – CNDF and xCDNF

Herantis focuses on disease modifying therapies for debilitating neurodegenerative diseases by restoring the neuronal protective mechanism of proteostasis, a key system in neurodegenerative disease. Proteostasis regulates proteins within the body and influences the fate of every protein from synthesis to degradation. Its failure results in a vicious cycle of pathological accumulation of protein aggregates, neuroinflammation and various forms of cellular stress that is widely implicated with the development of many neurodegenerative diseases including Parkinsons Disease, Alzheimers and other diseases. CDNF is a natural protein that occurs naturally in the body whose natural role is to protect neurons by balancing and supporting proteostasis, thereby preventing and counteracting disease generating mechanisms. Herantis is taking this natural ability and harnessing it as a treatment for neurodegenerative disease. CDNF – a biological protein – is Herantis’ lead program and a clinical stage asset; and xCDNF – a synthetic peptide version of CDNF – is Herantis’ follow-on program. Both CDNF and xCDNF have, via their multimodal mechanism of action, the potential improves neuronal survival and to stop the progression of Parkinson’s and other neurodegenerative disease and have a significant therapeutic impact on the lives of patients.

About Lymfactin

Lymfactin is the world’s first and only clinical stage gene therapy that repairs damages of the lymphatic system. It expresses the human growth factor VEGF-C, which is naturally associated with the development of lymphatic vessels. Based on preclinical studies, Lymfactin triggers the growth of new functional lymphatic vasculature in the injured area and thus repairs the underlying cause of secondary lymphedema. The first target indication for Lymfactin is Breast Cancer Associated Lymphedema; Herantis believes that Lymfactin may also be suitable for the treatment of other forms of secondary lymphedema if its safety and efficacy are established in the first indication.

Lymfactin, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national center of excellence at the University of Helsinki.

On March 29, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAR 29, 2021, View Source [SID1234577319]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 3 February 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.0 billion in the period from 3 February 2021 to 3 May 2021.

Since the announcement as of 22 March 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 43,154,586 B shares of DKK 0.20 as treasury shares, corresponding to 1.8% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 3 February 2021. As of 26 March 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 4,251,974 B shares at an average share price of DKK 444.02 per B share equal to a transaction value of DKK 1,887,954,182.

On March 29, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported a business update on its ongoing programs (Press release, Sonnet BioTherapeutics, MAR 29, 2021, View Source [SID1234577318]).

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"Last year we continued execution across our pipeline, and I am excited to share an update on our ongoing activities," commented Pankaj Mohan, Ph.D., Founder and CEO. "This year we expect to be in the clinic with multiple programs, which we believe is an important milestone for patients."

SON-1010 (FHAB-IL12): Sonnet has completed nonhuman primate (NHP) GLP toxicity studies with SON-1010 and is awaiting data to prepare an IND submission, while working in parallel to initiate clinical trials during the second half of this year. Prior to IND submission, the Company will initiate pre-IND interactions with FDA, which are expected during the second quarter, and will work to finalize the first-in-human protocol, along with selecting a CRO to perform the studies. CMC activities are on schedule to deliver GMP material prior to the IND filing.

SON-080 (Fully Human IL-6) – Chemotherapy Induced Peripheral Neuropath (CIPN): With successful GLP toxicity studies completed, the CMC manufacturing is well underway, and product is expected to be available for a clinical trial commencing during the second half of this year. Plans have been initiated to complete the study design protocol for a Phase 1b/2a study, as well as the completion of diligence and selection of a CRO.

SON-081 (Fully Human IL-6) – Diabetic Peripheral Neuropathy (DPN): Sonnet anticipates completing the partnership deal in South East Asia during April 2021 that Sonnet expects will position New Life Therapeutics (NLT) to fund and progress the asset forward into a Phase 1b/2a clinical trial. NLT has elected to focus on the acceleration of the development of low dose IL-6 for DPN at this time, and to hold an option to the CIPN indication for several months following the execution of a definitive agreement. Sonnet anticipates that clinical trial initiation will occur during the second half of this year. Sonnet has recently obtained positive initial comparability data from the new batch being manufactured using an updated process and awaits final study completion and reports of product comparability, prior to IND filing.

SON-1210 (IL12-FHAB-IL15): Sonnet’s first bispecific candidate is undergoing cell line and process development. Sonnet has engaged a novel intensified perfusion manufacturing process to generate clinical grade material and expects completion of NHP studies in the second half of this year with an IND submission during the first half of 2022.

SON-2014 (GMcSF-FHAB-IL18): In addition to GMcSF-FHAB-IL18, Sonnet has manufactured bi-specific preclinical constructs of IL18-FHAB-IL12 and IL12-FHAB-GMcSF that are being evaluated for in vivo efficacy, biomarker profiles and fluorescence-activated cell sorting (FACS) assessment in single dose and multi-dose preclinical studies.

Upon completion of the preclinical efficacy evaluation in the second quarter of this year, Sonnet intends to initiate commercial cell line development necessary for future clinical trials. An IND submission for SON-2014 is currently targeted for the second half of 2022.

SON-3015 (Anti-IL6-FHAB-Anti-TGFβ): Sonnet is in the discovery phase of SON-3015 development and is currently panning the candidate for binding and stability, after which the preclinical bispecific product will be evaluated in a mice model, expected during the second half of 2021. Sonnet is planning to initiate commercial cell line development in the first quarter of 2022.

INTELLECTUAL PROPERTY: Sonnet has received Notice of Allowance from the USPTO for its first issued patent on the FHAB delivery technology. Formal issuance is expected during the balance of 1H21.