On August 6, 2021 Sareum Holdings plc (AIM: SAR), the specialist drug development company, reported that Sierra Oncology, the licence holder for SRA737 (a novel Chk1 inhibitor), held an investor call last night at 10pm BST to discuss its newly announced global in-licensing agreement with AstraZeneca for AZD5153, a novel BRD4 BET inhibitor, to expand its myelofibrosis pipeline (Press release, Sareum, AUG 6, 2021, View Source [SID1234586710]).

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SRA737 was discovered and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, and with funding from Sareum and Cancer Research UK. SRA737 was licensed to Sierra in September 2016.

In discussing the rationale for adding AZD5153 to its pipeline, Sierra referred to possible pipeline expansion opportunities in other haematologic or solid tumour indications, through potential combinations with SRA737, immune-oncology agents, PARP inhibitors and drugs with other mechanisms of action.

Sierra also noted that AZD5153 had shown preclinical efficacy in combination with a diverse range of agents, and that synergy between AZD5153 and a family of DNA damage response agents, known as ATR inhibitors, suggested potential utility in combination with SRA737.

In its 10-K filing, published yesterday, Sierra reiterated that it is focusing its resources on the development of momelotinib and exploring options to potentially support the continued development of SRA737.

Sareum’s CEO, Dr Tim Mitchell, commented:

"It is encouraging to note from Sierra’s investor call that, while it has made no commitment towards the further development of SRA737, it sees further potential opportunities for this novel agent following the addition of AZD5153 into its pipeline. We remain optimistic that Sierra will find a solution to advance development of the SRA737 programme in the future."

On August 6, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported it will participate in the BTIG Biotechnology Conference being held virtually August 9-10, 2021 (Press release, Shattuck Labs, AUG 6, 2021, View Source [SID1234591767]).

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Presentation Details
Conference: BTIG Biotechnology Conference
Format: Fireside Chat
Presenters: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer, Lini Pandite, MBChB, M.B.A, Shattuck’s Chief Medical Officer, and Andrew Neill, M.B.A, Shattuck’s Chief Financial Officer
Date: August 10, 2021
Time: 1:30 p.m. EST

The live webcast will be available on BTIG’s conference website at the time of the event, and a replay will be available through BTIG’s research access.

On August 6, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported that CFO William Duke will participate in a fireside chat at the Canaccord Genuity Growth Conference at 2:30PM ET on Thursday, August 12 (Press release, Kaleido Biosciences, AUG 6, 2021, View Source [SID1234586005]).

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The webcast of the presentation will be made available in the Investors & Media section of Kaleido’s website at View Source An archived replay will be available for 90 days following the event.

On August 6, 2021 Akeso, Inc. (9926.HK, the "Company" or "Akeso") reported that the anti PD-1 monoclonal antibody drug Penpulimab monoclonal antibody injection co-developed by the Company with Sino Biopharmaceutical Limited (stock code: 1177.HK), has obtained marketing approval by the National Medical Products Administration (the "NMPA") of China, for treatment of patients with relapsed or refractory ("r/r") classic Hodgkin’s lymphoma ("cHL") after at least second-line systemic chemotherapy treatment (Press release, Akeso Biopharma, AUG 6, 2021, View Source [SID1234586029]).

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This approval of Penpulimab by the NMPA is based on a multicenter, single-arm, open-label pivotal clinical trial. Patients enrolled were r/r cHL patients who had failed at least second- line systemic chemotherapy and were administered 200 mg Penpulimab monoclonal antibody by intravenous injection once every two weeks until progress is made or reached unacceptable toxicity. The key research endpoint was the objective response rate ("ORR") evaluated by the independent radiology review committee ("IRRC") with reference to the Lugano 2014 lymphoma efficacy rating criteria.

The research shows that:

The ORR assessed by IRRC was 89.4% (76/85) with 47.1% (40/85) patients achieved complete response (CR). The median follow-up time was 15.8 months. The 12-month duration of response ("DoR") was 74.9%. And 12-month progression-free survival ("PFS") was 72.1%.
In terms of safety profile, the median exposure to Penpulimab antibody was 14.8 months, and 76.6% of patients were treated with Penpulimab antibody for 12 months or longer. Serious adverse events ("SAEs") associated with Penpulimab antibody was 10.6%, with no more than one patient experiencing a drug-related SAE. 26.6% of Grade 3 or higher adverse reactions had occurred, with equal to or greater than 2% of rash, hyperlipidemia, and lung infection. 4.3% of Grade 3 immune-related adverse events ("irAEs") had occurred, with no Grade 3 or higher irAEs.
Penpulimab is currently the only new PD-1 monoclonal antibody that applies IgG1 subtype and is modified by Fc segment, which has a lower antigen binding dissociation rate and a unique binding epitope as demonstrated by analysis on crystal structure. These features allow Penpulimab to effectively and continuously block PD-1/PD-L1 binding, thus differentiates it from other PD-1 products on the market, and may allow Penpulimab to more effectively enhance immunotherapeutic efficacy and reduce immune-related adverse reactions, as demonstrated by improved safety profile in clinical data.

Penpulimab is Akeso’s first innovative antibody protein drug that has been granted marking approval with major research studies covering major oncology diseases such as liver cancer, gastric cancer, lung cancer, Hodgkin’s lymphoma and nasopharyngeal carcinoma. In addition to the said approval for the treatment of cHL, Penpulimab has submitted 2 NDAs in China and 1 biologics license application ("BLA") in the U.S.:

In August 2021, NDA of Penpulimab for third-line treatment of metastatic nasopharyngeal carcinoma was submitted and was accepted by the NMPA.

In July 2021, NDA of Penpulimab for combined chemotherapy for first-line treatment of locally advanced or metastatic squamous non-small-cell lung cancer was submitted and was accepted by the NMPA.

In May 2021, Penpulimab for third-line treatment of metastatic nasopharyngeal carcinoma has been submitted to the Food and Drug Administration of the United States (FDA) for a BLA through the Real-Time Oncology Review (RTOR) program.

On August 6, 2021 EQRx, Inc., a new type of pharmaceutical company committed to developing and delivering important new medicines to patients at radically lower prices, and CM Life Sciences III, Inc. (NASDAQ: CMLTU), a life science-focused special purpose acquisition company, or SPAC, sponsored by affiliates of Casdin Capital, LLC and Corvex Management LP, reported that they have entered into a definitive business combination agreement. The transaction is expected to provide up to $1.8 billion in cash proceeds to EQRx, expanding the cash on its balance sheet to approximately $2.0 billion at closing (Press release, EQRx, AUG 6, 2021, View Source [SID1234586045]).

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"EQRx is new pharma, leading the way in how we develop and price innovative medicines," said Alexis Borisy, chairman and chief executive officer of EQRx. "We are excited to partner with a world-class group of investors who recognize the opportunity for change in our industry."

Upon closing of the business combination, CM Life Sciences III will be renamed "EQRx, Inc." and its common stock and warrants are expected to remain listed on the Nasdaq Global Market under ticker symbols "EQRX" and "EQRXW," respectively.

"This transaction propels us into the next phase of growth, and I am excited to lead EQRx as we work to make sustainable and affordable drug pricing a reality for patients, payers and health systems," added Melanie Nallicheri, president and chief operating officer of EQRx. "We are moving rapidly toward the potential commercialization of our lead oncology programs while continuing to grow our pipeline to address the high-cost disease areas of today and in the future."

EQRx Overview

EQRx is purpose-built, at scale, to develop and deliver innovative medicines to patients at radically lower prices through a late-stage and growing product pipeline across high-cost therapeutic categories and emerging partnerships with leading payers and healthcare providers.

EQRx is building a pipeline of innovative new drug candidates to address diseases like cancer and inflammatory conditions that are the top categories of drug spend today and in the future. By leveraging proven druggable targets and a focus on efficiency, together with building deep strategic partnerships with health systems and payers, EQRx anticipates a higher probability of regulatory success, a lower risk-adjusted cost of drug development and a more streamlined access model.

"The life science industry is undergoing a remarkable technology-driven revolution that has transformed drug development from historically low-probability science experiments into efficient engineering programs," said Eli Casdin, founder and CIO of Casdin Capital and CEO of CM Life Sciences III. "EQRx is leveraging that innovation in a new and disruptive business model to change the delivery and pricing of therapies and we could not be more excited to partner with them."

EQRx’s growing pipeline of 10+ programs includes two pre-registrational oncology assets that have shown promising Phase 3 data (aumolertinib and sugemalimab), and multiple other clinical-stage programs. In addition, EQRx is further expanding its portfolio through drug engineering collaborations with leading drug discovery companies including Exscientia and AbCellera Biologics Inc.

"EQRx leaders have done an exceptional job of building the company to date," said Keith Meister, chairman of the board of CM Life Sciences III. "This significant infusion of capital is going to set EQRx on its path to become a highly profitable, purpose-built disruptor at scale."

Transaction Overview

On August 5, 2021, CM Life Sciences III entered into a definitive agreement to combine with EQRx. The transaction is expected to provide up to $1.8 billion in cash proceeds to EQRx (assuming no redemptions). Upon completion of the transaction, EQRx expects to have up to $2.0 billion in cash available from the transaction ($1.8 billion from the transaction, plus existing cash on its balance sheet anticipated at closing, assuming no redemptions) to fund operations and support business initiatives.

The financing includes approximately $552 million of cash held in CM Life Sciences III’s trust account (assuming no redemptions), and a fully committed private placement of common stock (PIPE) of $1.2 billion at $10.00 per share from top-tier healthcare investors, led by SB Northstar LP, a fund managed by SB Management Limited, a 100% subsidiary of SoftBank Group Corp. and including funds advised by Casdin Capital and Corvex Management. Participants in the PIPE include leading institutional life science, growth and strategic investors that include Fidelity Management & Research Company LLC, Franklin Templeton, Invus, Rock Springs Capital, Bain Capital Life Sciences, BVF Partners L.P., Boxer Capital, LLC, Avidity Partners, Andreessen Horowitz (a16z), Mubadala Investment Company and its asset management subsidiary, Mubadala Capital, Verily and strategic partners spanning the healthcare ecosystem of integrated delivery networks, health insurers, health systems and therapeutic developers.

As part of the transaction, EQRx stockholders will receive common stock of CM Life Sciences III in exchange for shares of EQRx.

The transaction values EQRx at a pre-transaction enterprise value of $3.65 billion with an additional $500 million potential performance based earnout. The business combination has been approved by each of CM Life Sciences III’s and EQRx’s board of directors and the number of EQRx’s largest stockholders necessary to approve the combination have agreed to vote in favor of the transaction. The transaction is subject to the approval of the CM Life Sciences III shareholders and the satisfaction of other customary conditions and is expected to close in the fourth quarter of 2021.

Additional information about the proposed transaction, including a copy of the Merger Agreement and an investor presentation, will be provided in a Current Report on Form 8-K to be filed today with the Securities and Exchange Commission ("SEC") and available at www.sec.gov.

Proceeds from the transaction will provide EQRx with significant additional capital to continue building a modern clinical development organization with a focus on efficiency and cost-effectiveness, accelerate the business toward commercialization of its late-stage drug candidates, and continue to amass a robust pipeline of innovative medicines to address areas of high-cost burden. In addition, EQRx will be focused on the pursuit of strategic partnerships within the healthcare ecosystem to deliver high-quality medicines to patients and health systems around the world.

EQRx Leadership and Governance

Melanie Nallicheri will assume the role of chief executive officer of EQRx and join EQRx’s board of directors, effective September 1, 2021. Alexis Borisy will become executive chairman of EQRx’s board of directors.

At closing of the transaction, the EQRx board of directors will include:

Amy Abernethy, M.D., Ph.D., president of clinical research platforms, Verily;
Alexis Borisy, current chairman and current chief executive officer, EQRx;
Paul Berns, managing director, ARCH Venture Partners;
Eli Casdin, chief investment officer and founder, Casdin Capital;
Jorge Conde, general partner, Andreessen Horowitz (a16z);
Sandra Horning, M.D., EQRx co-founder and former executive vice president, chief medical officer and global head of product development, Genentech Roche;
Clive Meanwell, M.D., Ph.D., executive chairman and founder, Population Health Partners;
Melanie Nallicheri, current president and chief operating officer, EQRx; and
Krishna Yeshwant, M.D., MBA, managing partner, GV.
EQRx also recently announced the formation of its mission advisory board, which includes world leaders in pharmaceutical R&D, scientific research, healthcare economics and patient advocacy.

Advisors

J.P. Morgan Securities, LLC is acting as the lead financial advisor, with Goldman Sachs & Co. LLC also acting as a financial advisor. PJT Partners LP is also acting as a financial advisor and Goodwin Procter LLP is serving as the legal advisor to EQRx.

Jefferies LLC and Cowen and Company, LLC are acting as joint capital markets advisors and White & Case LLP is serving as legal advisor to CM Life Sciences III. Jefferies LLC, Cowen and Company, LLC and J.P. Morgan Securities LLC are acting as joint placement agents.

Webcast Details

A webcast of the conference call and associated presentation materials is available on Deal Roadshow