On April 6, 2021 MyBiotics Pharma Ltd., a microbiome therapeutics company, and Hadasit Medical Research Services and Development Ltd., the technology transfer office of Hadassah Medical Center, reported that they have entered into a research collaboration and licensing agreement for the identification of microbiome-based therapeutics that will enhance the response to and reduce adverse effects of anti-PD-1 and anti-PD-L1 in melanoma patients (Press release, MyBiotics, APR 6, 2021, View Source [SID1234577652]).

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The collaboration will combine Hadassah’s knowhow and expertise in immunotherapy treatment of melanoma patients with MyBiotics’ proprietary microbiome technologies enabling development of novel therapeutics. The two-year joint research project will be conducted by researchers from MyBiotics together with a team of researchers at Hadassah Cancer Research Institute headed by Prof. Michal Lotem, MD., Head of the Center for Melanoma and Cancer Immunotherapy, Department of Oncology at Hadassah Medical Center. It will be funded by MyBiotics, which has an exclusive license for all data and inventions stemming from the collaboration.

The research is aimed at assessing the composition of the gut microbiome and secondary metabolites (organic compounds produced by the gut bacteria) in up to 100 melanoma patients treated with PD-1/PD-L1 checkpoint inhibitors, some of which already exhibited long-term response to the treatment. Stool and blood samples will be collected at various time points along the treatment, for the purpose of identifying microbiome components that promote treatment success.

"Recent research supports the important role played by the microbiome in promoting the success of cancer immunotherapies, and points to the possibility of influencing the composition of the microbiome as an adjunct treatment," stated David Daboush, CEO of MyBiotics Pharma. "In this collaboration with Hadassah we will leverage Mybiotics’ SuperDonor whole microbiome recovery technology in combination with the MyLiveIn computational and predictive tools to advance research in order to unravel new layers of understanding and findings that will enable the design of effective microbiome-based therapeutics."

"We look forward to the joint research with the team at Hadassah Cancer Research Institute, who bring excellent clinical capabilities combined with innovative thinking and expect this will be a significant partnership that will lead to better treatment options for oncology patients within the next few years," Daboush added.

"For years I have strived to study what was driving long-term survival of melanoma patients who did well beyond expectations," stated Prof Michal Lotem, and added, "This collaboration gives us advanced molecular and genomic tools to analyze treatment success. After years of studying how cancer deceives us, I cannot wait to translate lessons of the past to therapies of the future."

"This collaboration is an excellent example of the kind of partnerships we strive to create between medical companies and hospital-based research centers. I trust that the unique combination of scientific excellence and clinical expertise will work for the benefit of patients in Israel and worldwide", stated Dr. Tamar Raz, the CEO of Hadasit.

MyBiotics has developed breakthrough and robust culturing, fermentation and delivery technologies for generating a highly stable and diverse bacterial community that can be efficiently delivered to the gut and can reliably restore microbiome equilibrium. These technologies are effective for single microbes, complex microbial consortia and whole microbiome products, and are integrated with a computational AI platform which enables the design of unique microbial consortia and whole microbiome profiles. The technologies are highly potent and suitable for patients with microbiome-related medical conditions or for those who use antibiotics. Preclinical studies have shown that MyBiotics’ products deliver enhanced durability in various gastrointestinal and manufacturing conditions, enable targeted release in different gastrointestinal locations and exhibit robust colonization in the gut.

About the Microbiome and Cancer Immunotherapy

In the last 5 years, studies elucidating the possible contribution of the microbiome to cancer development and response to treatments has been at the forefront of scientific research. Findings have shown, for example, that broad-spectrum antibiotics can reduce the efficiency of checkpoint inhibitors. In addition, studies have pointed to differences between microbiomes of patients responding to immunotherapy and those who do not respond to treatment. In animal models, tweaking the microbiome or adding secondary metabolites thereof, influenced the efficiency of cancer immunotherapy. These findings and others support the potential of changing the microbiome composition as a tool for improving the efficacy and reducing the toxicity of checkpoint inhibitor immunotherapy in cancer patients.

On April 6, 2021 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) reported that it intends to offer, subject to market conditions and other factors, $500.0 million aggregate principal amount of Convertible Senior Notes due 2026 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Ionis Pharmaceuticals, APR 6, 2021, View Source [SID1234577950]). Ionis also intends to grant the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the first date on which the notes are issued, up to an additional $75.0 million principal amount of notes.

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The notes will be general unsecured obligations of Ionis and will accrue interest payable semiannually in arrears. Upon conversion, Ionis will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of pricing of the offering.

Ionis expects to use a portion of the net proceeds from the offering to repurchase for cash certain of its 1% Convertible Senior Notes due 2021 (the "2021 notes") in privately negotiated transactions. In addition, Ionis expects to use a portion of the net proceeds from the offering to pay the cost of the convertible note hedge transactions described below (after such cost is partially offset by the proceeds to Ionis from the sale of the warrant transactions described below). Ionis expects to use the remaining net proceeds from the offering for general corporate purposes, including expansion of manufacturing, research and development, and commercial infrastructure to support its wholly owned pipeline.

In connection with the pricing of the notes, Ionis expects to enter into convertible note hedge transactions with one or more of the initial purchasers or their affiliates and/or other financial institutions (the "Option Counterparties"). The convertible note hedge transactions are generally expected to reduce potential dilution to Ionis common stock upon any conversion of notes and/or offset any cash payments Ionis is required to make in excess of the principal amount of converted notes, as the case may be. Ionis also expects to enter into privately negotiated warrant transactions with the Option Counterparties. The warrant transactions would separately have a dilutive effect to the extent that the market price per share of Ionis common stock exceeds the strike price of the warrants. If the initial purchasers exercise their option to purchase additional notes, Ionis expects to enter into additional convertible note hedge and additional warrant transactions relating to the additional notes with the Option Counterparties.

In connection with establishing their initial hedges of the convertible note hedge and warrant transactions, Ionis expects that the Option Counterparties or their respective affiliates will purchase shares of Ionis common stock and/or enter into various derivative transactions with respect to Ionis’ common stock concurrently with or shortly after the pricing of the notes. This

activity could increase (or reduce the size of any decrease in) the market price of Ionis common stock or the notes at that time.

In addition, the Option Counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Ionis common stock and/or by purchasing or selling Ionis’ common stock or other securities of Ionis in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during any observation period related to a conversion of notes or in connection with any repurchase of notes by Ionis on any fundamental change repurchase date or otherwise). This activity could also cause or avoid an increase or a decrease in the market price of Ionis’ common stock or the notes, which could affect the ability of noteholders to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that noteholders will receive upon conversion of such notes.

Further, in connection with any repurchases of the 2021 notes, Ionis expects that holders of the 2021 notes who agree to have their 2021 notes repurchased and who have hedged their equity price risk with respect to such notes (the "hedged holders") will unwind all or part of their hedge positions by buying Ionis’ common stock and/or entering into or unwinding various derivative transactions with respect to Ionis’ common stock. The amount of Ionis’ common stock to be purchased by the hedged holders may be substantial in relation to the historic average daily trading volume of Ionis’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of Ionis’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price of the notes. Ionis cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes offered hereby or Ionis’ common stock.

The notes, the warrants and any shares of common stock issuable upon conversion of the notes or exercise of the warrants have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

On April 6, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that it will present at the European Biotech Investor Days 2021, a US based online event taking place April 7-8, 2021 and hosted by Goodwin, Solebury Trout, Deutsche Bank and Nasdaq (Press release, PCI Biotech, APR 6, 2021, View Source [SID1234585154]).

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On Thursday, April 8, 2021 at 15:00 (CEST), Dr. Per Walday, CEO, will present an overview of PCI Biotech’s proprietary platform technology via a general company presentation.

The presentation can be accessed live through this link View Source

The presentation slides will be made available on PCI Biotech’s website (www.pcibiotech.com) under "Other presentations" after the event.

On April 6, 2021 ORPHELIA Pharma and Biocodex reported the execution of an exclusive distribution and marketing agreement for Kigabeq (vigabatrin) for most of the European Union territory, including France (Press release, ORPHELIA Pharma, APR 6, 2021, View Source [SID1234577603]).

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Kigabeq, the first pediatric form of vigabatrin developed by ORPHELIA Pharma, is notably indicated in the treatment of infantile spasms (West syndrome). Kigabeq is approved in Europe, where this medicine, intended exclusively for children, benefits from a centralized marketing authorization (Pediatric Use Marketing authorization, PUMA).

"We are very pleased to release this collaboration agreement with Biocodex", says Hugues BIENAYME, Founder and CEO of ORPHELIA Pharma, "With their long-standing experience in the field of pediatric epilepsy, Biocodex is certainly the best partner for Kigabeq distribution in Europe".

"With Kigabeq, the only pediatric presentation of vigabatrin, Biocodex is expanding its portfolio of drugs intended for rare and serious pathologies in children" adds Nicolas Coudurier, CEO of Biocodex, " Kigabeq and Diacomit (stiripentol, developed and marketed by Biocodex) are two drugs which address unmet medical needs for young patients affected by severe and resistant to treatment epilepsies".

"Our objective is to make Kigabeq available to all European clinicians, so that children affected by West syndrome can benefit." concludes Gilles ALBERICI, President of ORPHELIA Pharma, "Thanks to this agreement with Biocodex, Kigabeq will soon be prescribed in most of the European territory."

About Kigabeq

Kigabeq is the first pediatric formulation of vigabatrin, an essential anti-epileptic drug. Presented as soluble and scored tablets of 100 mg and 500 mg for oral or nasogastric administration, Kigabeq is notably indicated for the treatment of infantile spasms (West syndrome), an extremely serious epileptic encephalopathy of the infant. Kigabeq was developed exclusively for children and has been granted European Pediatric Marketing Authorization (PUMA).

About infantile spasms

West syndrome, or infantile spasms, is an extremely serious epileptic encephalopathy in infants that combines epileptic spasms, psychomotor deterioration and a hypsarrhythmic type electroencephalogram. It is a rare disease, with an estimated incidence of 5 per 10,000 births. It can occur in an infant with previously normal development or with a pre-existing delay; in all cases, infantile spasms severely hamper the psychomotor development. Pharmacological treatment should be started quickly to allow the spasms to stop and to improve the prognosis.

On April 6, 2021 Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals and ADC Therapeutics SA (NYSE: ADCT), reported the appointment of Eric Koo, BSc, MBA, as Chief Executive Officer (Press release, ADC Therapeutics, APR 6, 2021, View Source [SID1234577619]). Mr. Koo brings more than 25 years of pharmaceutical industry and business management experience to Overland ADCT BioPharma with a proven track record of executing successful drug approvals and launches across Asia.

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"Overland ADCT BioPharma has a tremendous opportunity to bridge the clinical gap between the U.S., Europe and Asia through the expanded reach of innovative cancer medicines like antibody drug conjugates," said Eric Koo, BSc, MBA. "It is an honor to assume the role of Chief Executive Officer and I look forward to working closely with both teams at Overland Pharmaceuticals and ADC Therapeutics to develop and commercialize the pipeline in greater China and Singapore."

Mr. Koo most recently served as Vice President, Head of Oncology Business Unit at Takeda China focusing on multiple myeloma and lymphoma. Prior to Takeda China, Mr. Koo served as Director, Oncology Business Unit and Director, Market Access, External Affairs & Key Account Management at Merck, Sharp and Dome (MSD) Taiwan. Prior to MSD, he served as Regional Marketing Director for APAC & Specialty Care BU Head, Malaysia/Singapore at Bayer APAC. Mr. Koo started his pharmaceutical career at Pfizer, spending 16 years in various sales, product management and marketing positions at both Pfizer Taiwan and Pfizer Emerging Market Asia & China, including six years as the China/APAC Regional Marketing Director for Oncology.

Mr. Koo earned his BSc in Pharmacy from Taipei Medical University and his MBA from the University of North Carolina at Charlotte, Belk College of Business.

"Eric joins Overland ADCT BioPharma at an important time in the joint venture’s evolution as the U.S. PDUFA date for Lonca quickly approaches this May," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "We are thrilled to welcome a highly qualified, respected and visionary leader like Eric to lead Overland ADCT BioPharma in its quest to develop and commercialize Lonca and other ADCs for difficult-to-treat hematologic and solid tumor indications in greater China and Singapore."

"Eric’s deep expertise and history of expanding access to life-changing cancer therapies in greater China and beyond gives me great confidence in Overland ADCT Biopharma’s ability to fulfill its mission of bringing innovative ADC medicines to patients in Asia and around the world," said Ed Zhang, MBA, Co-founder of Overland Pharmaceuticals. "Since its launch in December 2020, Overland

ADCT BioPharma has submitted two clinical trial applications to evaluate Lonca, underscoring the differentiated scale, speed and execution of this strategic business model. We look forward to supporting the advancement of Overland ADCT BioPharma’s pipeline under Eric’s leadership."

The lead program in the Overland ADCT BioPharma pipeline is Lonca, an ADC composed of a humanized monoclonal antibody directed against human CD19 and conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Lonca has been evaluated by ADC Therapeutics in a pivotal Phase 2 clinical trial in patients with relapsed or refractory DLBCL and is in two ongoing trials – a Phase 1/2 trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma and a Phase 3 confirmatory trial in combination with rituximab in patients with relapsed or refractory DLBCL. The Overland ADCT BioPharma portfolio also includes the clinical-stage candidates ADCT-602 targeting CD22, which is currently in a Phase 1/2 clinical trial in patients with relapsed or refractory acute lymphoblastic leukemia, and ADCT-601 targeting AXL, which is currently in a Phase 1 clinical trial in patients with selected advanced solid tumors. ADCT-901 targeting KAAG1 is in preclinical development for the treatment of advanced solid tumors with high unmet medical needs.