On April 6, 2021 MitoImmune Therapeutics Inc. reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for MIT-001, an innovative new drug candidate for the treatment of oral mucositis (Press release, MitoImmune Therapeutics, APR 6, 2021, View Source [SID1234577648]).

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MitoImmune plans to initiate a randomized, double–blind, placebo–controlled, multi–center trial in the first half of this year to evaluate the safety and efficacy of three different doses of MIT-001 compared to the placebo in prevention of OM in 60 patients with head and neck squamous cell carcinoma (HNSCC) who are undergoing concurrent chemoradiotherapy (CCRT) in the US and South Korea.

CCRT as a standard therapy for the treatment of a number of cancers can cause various side effects during the patient’s treatment process. One of the most serious side effects, oral mucositis, accompanied by intensive inflammation and necrosis in the oral cavity, leads to large restrictions on the patient’s dietary intake, increases the risk of severe infection, and even acts as a serious obstacle to CCRT. The unmet medical needs in developed countries remain very high, but there is no effective medical treatment for oral mucositis.

"We are very pleased to be advancing our therapy of anti-inflammatory and anti-necrotic agent based on the novel action mechanism of mitochondria-targeted reactive oxygen species (ROS) scavenger into the clinical development in our quest to bring an innovative, better treatment to the patients who need them," said Soon-Ha Kim, Ph.D., chief executive officer of MitoImmune.

In addition to phase 2 clinical trial for the patients with HNSCC in the United States and Korea, Mitoimune has recently received the IND approval from the Ministry of Food and Drug Safety (MFDS) in Korea for a phase 2 clinical trial, to verify the safety and efficacy for OM in the lymphoma/ multiple myeloma patients with chemotherapy (CT) undergoing hematopoietic stem cell transplantation (HSCT). The first HSCT patient administration is planned for the 2nd quarter of this year.

MIT-001 is a novel class of anti-inflammatory and anti-necrotic agent, specifically scavenging ROS in the mitochondria. This action mechanism of MIT-001 is expected to effectively suppress massive inflammation like oral mucositis occurring in the necrotic ulcers of oral mucous via removing excessive mitochondrial ROS, a major contributing factor in the CCRT-induced inflammation and necrosis.

MitoImmune is a leading biotech company focusing on the development of mitochondrial therapeutics providing a breakthrough for life-threatening diseases based on its proprietary structural platform technology, which was scientifically verified through more than 40 published papers. MitoImmune is seeking to expand its R&D pipelines to chronic inflammatory disorders and neurodegenerative diseases.

On April 6, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Organon Finance 1 LLC plans to offer, subject to market conditions, euro-denominated senior secured notes due 2028, U.S. dollar-denominated senior secured notes due 2028 and U.S. dollar-denominated senior unsecured notes due 2031 (collectively, the "notes"), in connection with the previously announced spinoff of Organon & Co. ("Organon") from Merck (Press release, Merck & Co, APR 6, 2021, View Source [SID1234577617]). As part of the spinoff, the notes will be assumed by Organon and a Dutch private limited company and wholly owned subsidiary of Organon which will act as co-issuer of the notes.

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Organon intends to use the net proceeds from the notes offering, together with available cash on its balance sheet and borrowings under senior secured credit facilities which Organon anticipates entering into, to repay one or more intercompany loans or notes owed by Organon to a Merck affiliate and to pay fees and expenses related to the spinoff. The proceeds of the notes offering will be held in escrow until satisfaction of the conditions precedent to the spinoff and certain other escrow release conditions.

The notes have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), any state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration. Accordingly, the notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers in accordance with Rule 144A under the Securities Act and to non-U.S. persons outside the United States in reliance on Regulation S under the Securities Act.

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the "Prospectus Regulation") or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation").

In member states of the European Economic Area, this announcement is directed only at persons who are "qualified investors" within the meaning of the Prospectus Regulation. In the United Kingdom, this announcement is directed only at persons who are "qualified investors" within the meaning of the UK Prospectus Regulation.

Manufacturer target market (MiFID II product governance / UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). No PRIIPs key information document has been prepared as not available to retail in the EEA. No UK PRIIPs key information document has been prepared as not available to retail in the UK.

In the United Kingdom, this announcement is directed only at persons (i) that have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"); (ii) falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations etc.") of the Order; or (iii) at whom this announcement may otherwise be directed without contravention of Section 21 of the Financial Services and Markets Act 2000, as amended (all such persons together being referred to as "relevant persons"). This announcement must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On April 6, 2021 Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that it has entered into a global distribution agreement with ABCAM plc (AIM: ABC; NASDAQ: ABCM) to sell the Group’s recently developed SARS-CoV-2 research ELISA Affimer reagents (Press release, Avacta, APR 6, 2021, View Source [SID1234577632]).

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Avacta has developed Affimer reagents which can be used in a high performance ELISA laboratory test to detect the SARS-CoV-2 spike protein with high sensitivity and excellent specificity for the spike protein of the original strain of the virus and other dominant variants such as B117 ("Kent" strain) and D614G.

ABCAM is one of the world’s leading suppliers of high-quality biological reagents and kits which are used in a wide range of fields including drug discovery, diagnostics and basic research. Under the worldwide, non-exclusive distribution agreement, ABCAM will enable the global research community to access Avacta’s SARS-CoV-2 spike protein Affimer research reagents through its on-line catalogue. This will allow scientists around the world to perform the ELISA test in their own laboratories and support the global fight against the pandemic.

Dr Alastair Smith, Chief Executive of Avacta Group commented: "We are delighted that we have established a global route to market for the SARS-CoV-2 spike protein Affimer reagents through ABCAM’s dedicated global commercialisation infrastructure.

As far as we are aware, our spike protein ELISA test is the most sensitive test of its kind and, in ABCAM, we have a world-leading partner capable of maximising the commercial potential of the Affimer reagents by making them globally available to scientists who are researching into the SARS-CoV-2 coronavirus.

I look forward to further updating the market on progress across the Group in due course."

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

On April 6, 2021 Umoja Biopharma, a biotechnology company pioneering an integrated, in vivo immunotherapy platform, reported the appointment of Nushmia Khokhar, M.D., as Chief Medical Officer (Press release, Umoja Biopharma, APR 6, 2021, View Source [SID1234577649]).

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"We are excited to welcome Dr. Khokhar to the Umoja team. Nushmia is an accomplished oncologist who has spent a significant portion of her career overseeing the transition of novel cancer therapeutics from discovery to clinical development," said Andy Scharenberg, M.D., co-founder and CEO of Umoja. "Her expertise across early and late-stage clinical development will be invaluable to the company during a milestone year."

Prior to joining Umoja, Dr. Khokhar was the Senior Vice President, Head of Clinical Development at Autolus where she played a critical role in advancing the company’s autologous T-cell products and clinical programs. She also held numerous roles at Janssen Oncology, leading several successful clinical trials, directing the Phase 3 registration trial of Yondelis in soft tissue sarcomas, and serving as the Global Clinical Leader for the breakthrough therapy daratumumab (Darzalex) for hematologic cancers. Dr. Khokhar received her medical training from the Aga Khan University in Pakistan before completing a post-doctoral fellowship at Memorial Sloan-Kettering Cancer Center with a focus on pharmacology and molecular therapeutics. She completed a residency in internal medicine at Washington Hospital Center in Washington, D.C. prior to completing a Hematology/Oncology Fellowship at the Northwestern University Feinberg School of Medicine.

"Umoja’s innovative and integrated in vivo approach, along with its TumorTag technology platform has the potential to overcome serious barriers that have held back the CAR-T cell therapeutic space," said Dr. Khokhar, CMO of Umoja Biopharma. "Now is our time to make CAR-T cell treatments better, more efficient, and applicable for maximum patient impact, not only in heme malignancies but also in solid tumors. I’m looking forward to joining the Umoja team in the hopes of making this promise a reality."

On April 6, 2021 Volastra Therapeutics, a biotechnology company developing novel therapies for the prevention and treatment of metastatic cancer, reported the extension of its original $12 million seed round to a total of $44 million (Press release, Volastra Therapeutics, APR 6, 2021, View Source [SID1234577601]). New investors Vida Ventures and Catalio Capital Management joined a syndicate that includes Polaris Partners, Droia Ventures, ARCH Venture Partners and Quark Venture.

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The funding supports the further build-out of Volastra’s technology platform, which exploits unique insights into chromosomal instability (CIN) to rapidly identify and validate novel targets to block metastasis. In the U.S. alone, more than 350,000 people a year are diagnosed with metastatic cancer. Less than a third respond to targeted or immuno-therapies, making metastasis one of the most pressing unsolved challenges in cancer.

"The support of our new and existing investors reflects the increasing interest around CIN as a core driver in cancer biology," said Charles Hugh-Jones, M.D., Volastra’s Chief Executive Officer. "This latest financing places us in a position of strength to advance our bold vision to change the treatment paradigm for patients with metastatic cancers."

"Our initial investment in Volastra reflected our excitement about the potential of this novel approach to address an unmet need in oncology," said Amy Schulman, Volastra Director and Managing Partner, Polaris. "With this seed extension, we are delighted to expand our syndicate with Vida Ventures and Catalio Capital Management, who share our commitment to identifying and funding innovation that has the potential to have a meaningful impact for patients."

Volastra’s scientific founders were the first to identify CIN as a key driver of metastatic cancer. The company is developing proprietary computational and experimental approaches to understand CIN biology and drive drug discovery. Among Volastra’s tools is a proprietary technology suite to bulk-measure and exploit vulnerabilities in chromosomally unstable cancer cells.

"Volastra’s approach is focused on defining and treating the biology of metastasis," said Lewis Cantley, Ph.D., Professor of Cancer Biology in Medicine and Meyer Director of the Sandra and Edward Meyer Cancer Center, Weill Cornell Medical College. "In just over a year, the Volastra team has shepherded this science into the next stage of development, building technologies to identify CIN at scale and developing novel compounds to block metastasis. By leveraging these unique insights into CIN, we are one step closer to unlocking new therapeutic options for some of the toughest-to-treat solid tumors."

Volastra recently announced a partnership with Dewpoint Therapeutics to discover novel molecules capable of blocking immuno-suppressive signaling in CIN-high tumors. In addition, Volastra announced a collaboration with Microsoft to develop proprietary artificial intelligence algorithms to detect and predict metastatic potential in human tissue samples