On July 1, 2020 Bolt Biotherapeutics, Inc., a clinical-stage biotechnology company developing its Immune-Stimulating Antibody Conjugate (ISAC) platform technology to harness the power of the innate immune system to treat cancer, reported the closing of an oversubscribed $93.5 million Series C financing (Press release, Bolt Biotherapeutics, JUL 1, 2020, View Source [SID1234561613]). Led by Sofinnova Investments, the Series C financing included participation from new investors RA Capital Management, Surveyor Capital (a Citadel Company), Rock Springs Capital, Samsara BioCapital and Pfizer Ventures as well as existing investors Novo Holdings, Vivo Capital, Pivotal bioVenture Partners and others.

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Bolt is pioneering a new category of immunotherapies that combine the precision of antibody targeting with the power of the innate immune system via activating myeloid cells and reprogramming the tumor microenvironment. Bolt has raised more than $170 million since its founding in 2015, and this new round of funding will support the continued clinical development of its lead ISAC, BDC-1001, which is delivered systemically as monotherapy for HER2-expressing cancers. The financing will also support the expansion of the company’s pipeline of Boltbody therapeutics. Bolt’s expertise in myeloid biology lays the foundation for its innovative work developing proprietary innate immune stimulants for use in ISACs.

"The support from this marquee group of biotech investors is a testament to what we have recently accomplished, in particular the start of our first clinical trial for BDC-1001," said Randall Schatzman, Ph.D., the company’s chief executive officer. "We have built a strong team with expertise in key drug development areas, and this financing round will enable us to drive our ongoing clinical study and pipeline development work forward expeditiously. The Bolt technology has potential to significantly improve how we treat certain cancers and promises durable responses for patients. In addition to BDC1001, we are currently on track to nominate our next clinical candidates later this year."

In conjunction with the financing, Jason Pitts Ph.D., principal at Sofinnova Investments, will join the company’s board of directors. He states, "We believe Bolt is well-positioned to execute on its vision of developing immuno-oncology therapies with the potential to generate systemic immunological memory and provide durable clinical benefit. I look forward to helping the company realize their goal of developing the ISAC platform across a range of solid tumor targets."

Bolt is developing BDC-1001 as a monotherapy for patients with HER2-expressing solid tumors. The drug candidate is an ISAC comprised of trastuzumab conjugated to a Bolt proprietary TLR7/8 agonist payload. In preclinical models, systemic administration of HER2-ISACs demonstrate localized immune activation that results in robust single agent activity, generation of host immunological memory against cancer and epitope spreading. Preclinical data, which were presented at SITC (Free SITC Whitepaper) 2019, demonstrated complete, durable regression of established tumors resistant to trastuzumab and immunological memory providing protection against tumor cells that no longer express the HER2 antigen in syngeneic mouse cancer models. This offers the potential for durable and meaningful responses for HER2-expressing cancers.

On July 1, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pralsetinib for the treatment of patients with advanced or metastatic RET mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers (Press release, Blueprint Medicines, JUL 1, 2020, View Source [SID1234561612]). Pralsetinib is an investigational, once-daily precision therapy designed to potently and selectively inhibit RET fusions and mutations, including predicted resistance mutations.

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Blueprint Medicines submitted the NDA under the Real-Time Oncology Review pilot program (RTOR program), an initiative of the FDA’s Oncology Center of Excellence. The RTOR program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality by the FDA.

"Pralsetinib has broad potential to address the medical needs of patients with RET-altered cancers, who have not traditionally benefited from targeted therapy even though their tumors have a known disease driver," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "There are now pending marketing applications for pralsetinib in RET-altered non-small cell lung cancer and thyroid cancers, supporting our goal to advance treatment standards for these patients. We are working closely with the FDA and aim to bring this promising treatment to patients as expeditiously as possible."

In May 2020, Blueprint Medicines announced that the U.S. and EU marketing applications for pralsetinib for the treatment of locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC) were accepted by the FDA and validated by the European Medicines Agency, respectively.

About RET-Altered Solid Tumors

RET activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and MTC. RET fusions are implicated in approximately 1 to 2 percent of patients with NSCLC and approximately 10 to 20 percent of patients with papillary thyroid cancer, while RET mutations are implicated in approximately 90 percent of patients with advanced MTC. In addition, oncogenic RET alterations are observed at low frequencies in colorectal, breast, pancreatic and other cancers, and RET fusions have been observed in patients with treatment-resistant EGFR-mutant NSCLC.

About Pralsetinib

Pralsetinib is an investigational, once-daily oral precision therapy specifically designed for highly potent and selective targeting of oncogenic RET alterations. Blueprint Medicines is developing pralsetinib for the treatment of patients with RET-altered NSCLC, thyroid cancer and other solid tumors. The FDA has granted Breakthrough Therapy Designation to pralsetinib for the treatment of RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.

Pralsetinib was designed by Blueprint Medicines’ research team, leveraging the company’s proprietary compound library. In preclinical studies, pralsetinib consistently demonstrated sub-nanomolar potency against the most common RET fusions, activating mutations and predicted resistance mutations. In addition, pralsetinib demonstrated markedly improved selectivity for RET compared to pharmacologically relevant kinases, including approximately 80-fold improved potency for RET versus VEGFR2. By suppressing primary and secondary mutants, pralsetinib has the potential to overcome and prevent the emergence of clinical resistance. Blueprint Medicines believes this approach will enable durable clinical responses across a diverse range of RET alterations, with a favorable safety profile.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of pralsetinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for pralsetinib in the rest of the world.

On July 1, 2020 Akari Therapeutics, Plc ("Akari" or the "Company") (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement and or leukotriene systems are implicated, reported that it has entered into a Securities Purchase Agreement (the "Agreement") of up to $30 million with Aspire Capital Fund, LLC ("Aspire Capital") (Press release, Akari Therapeutics, JUL 1, 2020, View Source [SID1234561611]). Under the terms of the Agreement, Aspire Capital has committed to purchase up to $30 million of Akari’s American Depositary Shares ("ADSs") at Akari’s request from time to time during a period beginning on the effective date of a registration statement related to the transaction, and at prices based on the market price at the time of each sale. There are no warrants, derivatives, or other share classes associated with the Agreement. Akari will control the timing and amount of all sales of its ADSs to Aspire Capital.

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"Akari is very pleased to announce a second transaction with Aspire Capital, a long-term and supportive shareholder. During the second quarter 2020, Akari raised an additional $9.3 million from Aspire thereby completing our initial $20 million agreement. This new capital of $9.3m plus opportunistic access to an additional $30 million under our new agreement leaves Akari in a strong and flexible financial position to execute on its further development of nomacopan in critical areas of unmet need including Bullous Pemphigoid, Thrombotic Micro-angiopathy, Atopic Keratoconjunctivitis and COVID-19. This is an important partnership ahead of what we hope will be a transformative year for Akari as we seek to transition nomacopan into pivotal, phase III trials," said Clive Richardson, CEO of Akari Therapeutics.

"We’re delighted to extend this additional commitment to Akari during such an important and exciting transition period for the company. Given the strong safety and efficacy we have observed thus far across a broad range of inflammatory diseases, we firmly believe nomacopan is uniquely positioned amongst the field of complement inhibitors and other novel anti-inflammatory agents. Not only has nomacopan demonstrated deep and consistent suppression of aberrant complement activity in patients but its proven inhibition of leukotriene – LTB4 provides exciting differentiation and expands its potential application in disease settings where granulocyte infiltration is also driving pathology," said William Blank, Principal, Life Sciences at Aspire Capital.

Proceeds are intended to be used by Akari for general corporate purposes, including research and development, clinical trial activity and working capital. There are no restrictions on future financings and there are no financial covenants, participation rights, rights of first refusal, or penalties in the Agreement. Akari has the right to terminate the Agreement at any time, at its discretion, without any additional cost or penalty.

As consideration for Aspire Capital’s obligation under the Agreement, Akari will issue 40,760,900 ordinary shares at approximately $0.02 per ordinary share (equivalent to 407,609 ADSs at approximately $2.21 per ADS) to Aspire Capital as a commitment fee. Akari also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the Agreement. Additional detail regarding the Agreement and the related Registration Rights Agreement is set forth in Akari’s Current Report on Form 6-K filed today with the SEC.

On July 1, 2020 Sprint Bioscience AB (publ) reported that Petra Pharma, in accordance with the opportunities provided by the parties’ licensing agreements, has transferred the licensing agreement and the resulting collaboration project PIP4K2 to the newly formed company Ravenna Pharmaceuticals, Inc (Press release, Sprint Bioscience, JUL 1, 2020, View Source [SID1234561609]). Ravenna Pharmaceuticals thus assumes responsibility for the continued development and financial commitments to Sprint Bioscience. The project aims to develop a new type of drug for leukemia.

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Sprint Bioscience is eligible for up to $ 240 million in interim payments plus royalties on the sale of potential drugs generated within the scope of the project. To date, USD 5 million has been received. A drug candidate has been nominated and the next interim payment occurs when the first patient is dosed in a clinical trial.

"The transfer of the PIP4K2 project to Ravenna Pharmaceuticals does not affect Sprint Bioscience’s rights to future interim and royalty payments, and the newly started company has the same obligations as Petra Pharma to drive the project forward. We look forward to following the continued development of this urgent project, which is based on a whole new approach to the treatment of leukemia, "says Sprint Bioscience CEO Jessica Martinsson.

Ravenna Pharmaceuticals was founded by the same ownership group that was involved in Petra Pharma, including global pharmaceutical companies such as Eli Lilly, AbbVie, Johnson & Johnson and Pfizer.

On July 1, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its second-quarter 2020 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Friday, July 31 (Press release, Merck & Co, JUL 1, 2020, View Source [SID1234561608]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (833) 353-0277 or toll free (469) 886-1947 and using ID code number 2753878. Members of the media are invited to monitor the call by dialing (833) 353-0277 or toll free (469) 886-1947 and using ID code number 2753878. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.